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SAFETY DATA SHEET Date of issue: xxx Disodium dihydrogenpyrophosphate Revision date: X Version: XX Page 1/77 NB. Please read the NOTICE on the front page. Table of Contents SECTION 1. Identification of the substance/mixture and of the company/undertaking .....2 SECTION 2. Hazards identification ..................................................................................2 SECTION 3. Composition / information on ingredients ....................................................3 SECTION 4. First aid measures.......................................................................................4 SECTION 5. Fire fighting measures .................................................................................4 SECTION 6. Accidental release measures ......................................................................5 SECTION 7. Handling and storage ..................................................................................5 SECTION 8. Exposure controls / personal protection ......................................................5 SECTION 9. Physical and chemical properties ................................................................8 SECTION 10. Stability and reactivity................................................................................9 SECTION 11. Toxicological information ...........................................................................9 SECTION 12. Ecological information .............................................................................10 SECTION 13. Disposal considerations ..........................................................................11 SECTION 14. Transport information ..............................................................................12 SECTION 15. Regulatory information ............................................................................12 SECTION 16. Other information ....................................................................................13 ES1: Manufacture and processing of SAPP ...................................................................14 ES2: Use as raw material and additive in manufacture of dyes and auxiliary chemicals and mixing into final products (including dentifrice, oral care products, water treatment chemicals and construction materials).....................19 ES3: Leather, textiles and paper manufacturing and treatment and use in dyes and auxiliary chemicals and construction chemicals ...............................................25 ES4: Use as neutralising agent in the process of manufacturing polymers ....................33 ES5: Use in peroxide stabilisation..................................................................................36 ES6: Use in oil well drilling fluid applications ..................................................................41 ES7: Industrial and professional end use in/for: metal and non-metal surface treatment, metal working fluids, lubricants, greases, heat transfer fluids and hydraulic fluids .................................................................................................47 ES8: Professional use of cleaning products containing SAPP in dairy cleaning applications ......................................................................................................67 ES9: Professional and consumer use of construction and D.I.Y products ......................71 ES10: Consumer use of toothpaste and other dental care products containing SAPP ...75 NOTICE : Important information Please note that this generic exposure scenario is by no means intended to be mandatory, prescriptive or exhaustive. The content of this document is intended for guidance only and whilst the information on uses covered is provided in utmost good faith and has been based on the best information currently available, is to be relied upon at the user’s own risk. Ultimately, it is for each company to assess the appropriateness and completeness of the information on a case-by case basis and decide what elements they wish to adopt or to add. In particular, the preparation and content of the e-SDS is the legal responsibility of each company for its own products placed on the market, and the user should verify, complete, correct or adapt this generic document appropriately. No representations or warranties are made with regards to its completeness or accuracy, in particular

Transcript of SAFETY DATA SHEET Date of issue: xxx Disodium ... Documents/P-I093/Other/P_I… · SAFETY DATA...

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Table of Contents

SECTION 1. Identification of the substance/mixture and of the company/undertaking .....2

SECTION 2. Hazards identification ..................................................................................2

SECTION 3. Composition / information on ingredients ....................................................3

SECTION 4. First aid measures .......................................................................................4

SECTION 5. Fire fighting measures .................................................................................4

SECTION 6. Accidental release measures ......................................................................5

SECTION 7. Handling and storage ..................................................................................5

SECTION 8. Exposure controls / personal protection ......................................................5

SECTION 9. Physical and chemical properties ................................................................8

SECTION 10. Stability and reactivity................................................................................9

SECTION 11. Toxicological information ...........................................................................9

SECTION 12. Ecological information ............................................................................. 10

SECTION 13. Disposal considerations .......................................................................... 11

SECTION 14. Transport information .............................................................................. 12

SECTION 15. Regulatory information ............................................................................ 12

SECTION 16. Other information .................................................................................... 13

ES1: Manufacture and processing of SAPP ................................................................... 14

ES2: Use as raw material and additive in manufacture of dyes and auxiliary chemicals and mixing into final products (including dentifrice, oral care products, water treatment chemicals and construction materials)..................... 19

ES3: Leather, textiles and paper manufacturing and treatment and use in dyes and auxiliary chemicals and construction chemicals ............................................... 25

ES4: Use as neutralising agent in the process of manufacturing polymers .................... 33

ES5: Use in peroxide stabilisation .................................................................................. 36

ES6: Use in oil well drilling fluid applications .................................................................. 41

ES7: Industrial and professional end use in/for: metal and non-metal surface treatment, metal working fluids, lubricants, greases, heat transfer fluids and hydraulic fluids ................................................................................................. 47

ES8: Professional use of cleaning products containing SAPP in dairy cleaning applications ...................................................................................................... 67

ES9: Professional and consumer use of construction and D.I.Y products ...................... 71

ES10: Consumer use of toothpaste and other dental care products containing SAPP ... 75

NOTICE : Important information

Please note that this generic exposure scenario is by no means intended to be mandatory, prescriptive or exhaustive. The content of this document is intended for guidance only and whilst the information on uses covered is provided in utmost good faith and has been based on the best information currently available, is to be relied upon at the user’s own risk. Ultimately, it is for each company to assess the appropriateness and completeness of the information on a case-by case basis and decide what elements they wish to adopt or to add. In particular, the preparation and content of the e-SDS is the legal responsibility of each company for its own products placed on the market, and the user should verify, complete, correct or adapt this generic document appropriately. No representations or warranties are made with regards to its completeness or accuracy, in particular

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regarding the list of uses that are covered, and no liability will be accepted by [the consortium members] for damages of any nature whatsoever resulting from the use of or reliance on the information. The consortium members acknowledge that any activities carried out under REACH have to be carried out in full compliance with EU competition law, in particular but not limited to Articles 101 and 102 of the Treaty on the Functioning of the European Union (TFEU) as well as any applicable national laws.

SECTION 1. Identification of the substance/mixture and of the company/undertaking

1.1 Product identifier:

Disodium dihydrogenpyrophosphate EINECS Number: 231-835-0 CAS Number: 7758-16-9 REACH Registration number: [to be filled in by company] Other identifiers: sodium acid pyrophosphate, SAPP

1.2 Relevant identified uses of the substance or mixture and uses advised against:

Industrial / professional uses:

- Manufacture and processing of SAPP (exposure scenario 1) - Using SAPP as raw material and additive in chemical synthesis and mixing SAPP into final products

(exposure scenario 2) - Leather, textiles and paper manufacturing and treatment with products containing SAPP (exposure

scenario 3) - Use as neutralising agent in manufacture of polymers (exposure scenario 4) - Use of SAPP in peroxide stabilisation (exposure scenario 5) - Use in drilling fluid applications (exposure scenario 6) - Industrial and professional end use in/for: metal and non-metal surface treatment, metal working

fluids, lubricants, greases, heat transfer fluids and hydraulic fluids (exposure scenario 7) - Professional use of cleaning products containing SAPP (exposure scenario 8) - Professional use of construction and D.I.Y products containing SAPP (exposure scenario 9)

Consumer uses:

- Consumer use of construction and D.I.Y products containing SAPP (exposure scenario 9) - Consumer use of toothpaste and dental care products containing SAPP (exposure scenario 10)

No known uses advised against.

1.3 Details of the supplier of the safety data sheet:

[Insert relevant details including contact name, address, phone number, email here]

1.4 Emergency telephone number:

[Insert suitable emergency number and hours of operation]

SECTION 2. Hazards identification

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2.1 Classification of the substance

2.1.1 According to Regulation (EC) No. 1272/2008 (EU CLP):

2.1.2 According to Directive 67/548/EC (DSD):

Eye Irritation 2. H319: Causes serious eye damage

Xi; R36 Irritant; Irritating to eyes

2.2 Label elements

2.2.1 According to Regulation (EC) No. 1272/2008 (EU CLP):

Name: disodium dihydrogenpyrophosphate Index Number: Not applicable CAS Number: 7758-16-9

Signal word: Warning Hazard Statements: H319: Causes serious eye irritation Precautionary Statements: Prevention: P264: Wash hands thoroughly after handling. P280: Wear protective gloves, eye protection and face protection. Response: P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337 + P313: If eye irritation persists: Get medical advice/attention. NOTE: Information in Section 2.2 MUST be consistent with the information provided on the supplier’s labels.

2.3 Other hazards

The material is not considered to be PBT or vPvB.

SECTION 3. Composition / information on ingredients

3.1 Substance:

Name EC Number CAS Number Typical Concentration

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concentration Range Disodium dihydrogenpyrophosphate

231-835-0 7758-16-9 >90% [Taken from SIP - specific company to update where necessary]

[to be provided by company]

Registration Number (if available): [specific to each registrant – insert number here] EC name: disodium dihydrogenpyrophosphate Identification of hazardous impurities (where applicable):

All impurities > 1% are other inorganic phosphates or other related inorganic substances, similar to the Registered substance, and which do not significantly affect its toxicological and ecotoxicological properties

All hazardous impurities are < 0.1% NOTE: The above information on impurities is company specific therefore suppliers to update where necessary and in line with the data that is provided in their joint registration dossier Section 1.2.

SECTION 4. First aid measures

4.1 Description of first aid measures

Inhalation In case of exposure by inhalation, provide fresh air, seek medical advice in case of symptoms. Ingestion Rinse out mouth and then drink plenty of water (approx. 500 ml). Skin Contact In case of contact with skin, rinse with plenty of soap and water. Eye Contact In case of contact with eyes, rinse immediately with plenty of water. Seek medical advice.

4.2 Most important symptoms and effects, both acute and delayed

Disodium dihydrogenpyrophosphate is irritating to the eyes. No delayed effects are noted.

4.3 Indication of any immediate medical attention and special treatment needed

No specific information available.

SECTION 5. Fire fighting measures

5.1 Extinguishing media

Suitable extinguishing media: Disodium dihydrogenpyrophosphate is not flammable. Use fire-fighting measures that suit the environment; CO2, extinguishing powder or water jet. Fight larger fires with foam. Inappropriate extinguishing media: Not applicable.

5.2 Special hazards arising from the substance or mixture

None identified.

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5.3 Advice for fire-fighters

In cases where dust particles of disodium dihydrogenpyrophosphate may be present respiratory ventilation is recommended. Wear appropriate eye protection. See Section 8.2.

SECTION 6. Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures

Avoid contact with eyes. Use personal protection equipment.

6.2 Environmental precautions

Do not allow concentrated solutions to enter drainage system, surface or ground water.

6.3 Methods and material for containment and cleaning up

Shovel up material and recycle if possible. Dispose of contaminated material according to the waste disposal recommendations.

6.4 Reference to other sections

Refer to Section 8 for suitable PPE. Refer to Section 13 for disposal considerations.

SECTION 7. Handling and storage

7.1 Precautions for safe handling

Technical measures: sufficient ventilation and local suction is required in accordance with the details in the annex to the SDS. Do not eat, smoke or drink.

7.2 Conditions for safe storage, including any incompatibilities

Disodium dihydrogenpyrophosphate is to be transported and stored in the original packaging in cool, dry conditions.

7.3 Specific end use(s)

See annex for details of end uses covered in the exposure scenarios and CSR. The exposure scenarios detailed in the annex represent a worst case for exposure to humans and the environment.

SECTION 8. Exposure controls / personal protection

8.1 Control parameters

Workplace exposure limits: Workplace exposure limits: General dust exposure limit: 10 mg/m3 (inhalable fraction), 3 mg/m3 (alveolic fraction). German TRGS 900 (2006). [please check occupational limits for the country you supply to and insert limit here if available] DNELS (worker):

Exposure route Exposure pattern DNEL (workers)

Inhalation Acute systemic effects As no acute toxicity hazard has identified, there is no requirement to derive acute DNELs. Therefore only long term DNELs have been derived.

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Long term systemic 44.08 mg/m³

Dermal Acute systemic effects As no acute toxicity hazard has identified, there is no requirement to derive acute DNELs. Therefore only long term DNELs have been derived.

Long term systemic As the substance to be registered is an inorganic solid, absorption through the skin is not an appropriate route of exposure. Dermal exposure will not result in systemic toxicity and therefore it is not considered to be appropriate to calculate a dermal DNEL.

No DNELs can be derived for local effects as no dose-response relationship can be identified in any of the studies available.

DNELs (general population):

Exposure route Exposure pattern DNEL (general population)

Inhalation Acute systemic effects As no acute toxicity hazard has identified, there is no requirement to derive acute DNELs. Therefore only long term DNELs have been derived.

Long term systemic 10.87 mg/m³

Oral Acute systemic effects As no acute toxicity hazard has identified, there is no requirement to derive acute DNELs. Therefore only long term DNELs have been derived.

Long term systemic Consumer uses of inorganic phosphates (with Na+, K+, Ca2+, Mg2+ and Al3+ cations), besides food and water, do not contribute noticeably to the oral intake of phosphates. Oral intake is predominately via food and water in the form of food additives or similar or from natural sources. It is therefore considered appropriate to use the Maximum tolerable daily intake (MTDI) value of 70 mg/kg bw /day of phosphorus as calculated by the Joint FAO/WHO Expert Committee on Food Additives (JEFCA) as any toxicity effects noted via the oral route are not attributable to the cation but are as a result of high doses of phosphates

Dermal Acute systemic effects As no acute toxicity hazard has identified, there is no requirement to derive acute DNELs. Therefore only long term DNELs have been derived.

Long term systemic As the substance to be registered is an inorganic solid, absorption through the skin is not an appropriate route of exposure. Dermal exposure will not result in systemic toxicity and therefore it is not considered to be appropriate to calculate a dermal DNEL.

No DNEL can be derived for local effects as no dose-response relationship can be identified in any of the studies available. PNECs:

Compartment PNEC Remarks

PNEC aqua (freshwater)

0.05 mg/L No long-term toxicity studies are available and therefore the PNEC is based on the lowest value from the short-term studies (100 mg/L), the assessment factor used takes the use

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of short-term data and read-across data into account. (AF = 2000)

PNEC aqua (marine water)

0.005 mg/L

No reliable studies are available on marine species. The PNEC is therefore based on the short-term studies conducted on freshwater species. The assessment factor used takes the use of short-term data in freshwater species and read-across data into account. (AF = 20000)

PNEC aqua (intermittent releases)

0.5 mg/L The PNEC is based on the lowest value from the short-term studies (100 mg/L), the assessment factor used takes the use of read-across data into account. (AF = 200)

PNEC STP 50 mg/L

The PNEC is based on the NOEC from the ASRI study. The assessment factor used takes the use of read-across data into account and uses the assessment factor appropriate for use of a NOEC value. (AF = 20)

PNEC sediment (freshwater)

No data is available for freshwater sediments. Na+, K+, Mg2+, Ca2+ and PO43- ions are ubiquitous in the environment and are found naturally in soil, water and sediment. All are assimilated by species residing in the sediment, water or soil and are essential for maintaining a good chemical balance. It is therefore unlikely that inorganic phosphates of this nature would be toxic to sediment organisms and hence toxicity studies are scientifically unjustified.

PNEC sediment (marine water)

No data is available for marine sediments. Na+, K+, Mg2+, Ca2+ and PO43- ions are ubiquitous in the environment and are found naturally in soil, water and sediment. All are assimilated by species residing in the sediment, water or soil and are essential for maintaining a good chemical balance. It is therefore unlikely that inorganic phosphates of this nature would be toxic to sediment organisms and hence toxicity studies are scientifically unjustified.

PNEC soil

No data is available for soil macroorganisms. Na+, K+, Mg2+, Ca2+ and PO43- ions are ubiquitous in the environment and are found naturally in soil, water and sediment. All are assimilated by species residing in the sediment, water or soil and are essential for maintaining a good chemical balance. Furthermore inorganic phosphate fertilizers (containing Na+, K+, Mg2+, Ca2+ and PO4- ions) are often added to soils to improve soil quality. Given the extensive use of inorganic phosphates as soil fertilizers and the natural occurrence of the ions in the environment it is unlikely that inorganic phosphates of this nature would have a detrimental effect on soil macroorganisms and plants and hence toxicity studies are scientifically unjustified.

PNEC oral

Inorganic phosphates are not considered to pose a risk of secondary poisoning as they are unlikely to bioaccumulate due to the fact that they are not lipophillic and will therefore not accumulate in fatty tissues. It not considered necessary to derive a PNEC to take into account the risk of secondary poisoning and no further testing is considered necessary.

8.2 Exposure controls

Appropriate engineering controls: Ensure work area is well ventilated or exhausted (where appropriate and in line with the exposure scenarios). Provide eye wash station. Respiratory protection: See annex for details of processes requiring respiratory protection. In case of insufficient ventilation, wear suitable respiratory device such as EN141 or EN405, Type A. Skin protection: Laboratory coat or overalls and plastic or rubber boots. Store protective clothing separately. Eye protection: Tightly sealed chemical safety goggles (compliant with EN 166:2001) Hand protection: Wear suitable gloves that are compliant with EN 374.

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Environmental controls: Refer to Sections 6, 7, 12 and 13 of the SDS.

SECTION 9. Physical and chemical properties

9.1 Information on basic physical and chemical properties

Property Value Method

Appearance; including colour and physical state

Solid, white granules

Observed

Odour Odourless Observed

Odour threshold Not available

pH pH 3.6 to pH 4.0 As measured in the water solubility study (EU Method A.6)

Melting point/freezing point >450°C EU Method A.1

Initial boiling point and boiling range Not determined According to Regulation No. 1907/2006, a study for boiling point is not required for solids which melt above 300°C

Flash point Not determined According to Regulation No. 1907/2006, the flash point does not need to be assessed for inorganic chemicals.

Evaporation rate Not available

Flammability (Solid, gas) Not flammable Based on prediction and use based observations

Upper/lower flammability or explosive limits

Not applicable

Vapour pressure Not determined According to Regulation No. 1907/2006, a study for the vapour pressure need not be conducted if the melting point is above 300°C.

Vapour density (Air = 1) Not applicable

Relative density 2.63 at 22.5°C EU Method A.3, Klimisch reliability 1.

Solubility(ies) Water: 170g/L at 20 ± 0.5°C

(very soluble)

EU Method A.6 A temperature range 10 to 30°C had no significant influence on the observed solubility of the test material.

Partition coefficient: N-octanol/water Not determined According to Regulation No. 1907/2006, the partition coefficient n-octanol/water does not need to be assessed for inorganic chemicals.

Auto-ignition temperature No auto-ignition anticipated

Based on prediction

Decomposition temperature Not applicable

Viscosity Not determined Testing not technically possible: According to the relevant OECD guideline (OECD 114) a study cannot be conducted on a substance that is a solid at room temperature.

Explosive properties Not considered to be explosive

Prediction – in accordance with EU Method A14

Oxidising properties No oxidising properties

Prediction – in accordance with EU Method A17

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9.2 Other information

Testing has been performed on disodium dihydrogenpyrophosphate, in accordance with Annex X of REACH.

SECTION 10. Stability and reactivity

10.1 Reactivity

Non-reactive under recommended storage and handling conditions.

10.2 Chemical stability

Stable under recommended storage and handling conditions.

10.3 Possibility of hazardous reactions

Hazardous reactions are considered unlikely.

10.4 Conditions to avoid

None identified.

10.5 Incompatible materials

None identified.

10.6 Hazardous decomposition products

None.

SECTION 11. Toxicological information

11.1 Information on toxicological effects

Toxicological endpoint Value (including relevance to CLP

criteria) Method

Acute toxicity

Oral

Oral; LD50(rat) = >2000 mg/kg bw/day. Not classified.

In accordance with Regulation (EC) No. 1907/2006 , Annex XI, Section 1.2. A weight of evidence approach indicates that disodium dihydrogenpyrophosphate should not be classified via the oral route and an LD50 of >2000 mg/kg bw is applicable. Based on data with varying Klimisch reliabilities.

Dermal LD50 = 2000 mg/kg bw/day Rat, OECD 402. Klimisch reliability 1.

Inhalation LC50 = > 0.58 mg/L Rat, EPA OPP 81-3, OECD 403, EU

Method B.2. Klimisch reliability 1

Skin corrosion/irritation Not irritating Rabbit, equivalent or similar to OECD Guideline 404 / equivalent or similar to EU Method B.4. Klimisch reliability 2

Serious eye/damage/irritation Irritating to eyes – category 2

Rabbit, OECD 405. Klimisch reliability 1. .

Respiratory or skin sensitisation Non - sensitiser Mouse, OECD 429, EU Method B.42.

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Klimisch reliability 1. No data to suggest substance is a respiratory sensitiser.

Germ cell mutagenicity Not considered to be mutagenic.

Disodium dihydrogenpyrophosphate is not expected to produce germ cell genotoxic damage.

Carcinogenicity Not considered to be a carcinogen.

Not required for REACH. No data to suggest likelihood of carcinogenicity.

Reproductive toxicity Not considered to be a reproductive toxicant

STOT-single exposure – all routes

No STOT SE observed via the oral, dermal or inhalation route.

Not applicable.

STOT-Repeated exposure - all routes

Not considered to induce specific organ toxicity after repeated exposure via oral route. NOAEL: 500 mg/kg bw/day

Rat, OECD 408 (90-day oral toxicity). Klimisch reliability 2 (Study performed on analogous substance; TSPP).

Aspiration hazard No aspiration hazard identified

Not applicable.

The substance has been assessed with regards to the data requirements of Annex X of REACH.

SECTION 12. Ecological information

12.1 Toxicity

Toxicological endpoint Value (including relevance to CLP

criteria) Species, Method

Acute fish toxicity

96 hr LC50 = > 100 mg/L 96 hr NOEC = 100 mg/L

Rainbow trout, OECD 203, EU Method C.1.

Conducted on analogous substance, reliability 2.

Acute Daphnia toxicity 48 hr EC50 = > 100 mg/L

48 hr NOEC = >100 mg/L

Daphnia magna, OECD 202, EU Method

C.2.

Conducted on analogous substance,

reliability 2.

Algal growth inhibition

72 hr EC50 = > 100 mg/L

72 hr NOEC = >100 mg/L

Basis for effect: growth rate

Desmodesmus subspicatus (algae), OECD

201, EU Method C.3.

Conducted on analogous substance,

reliability 2.

Activated Sludge Respiration 3 hr EC50 = > 1000 mg/L

3 hr NOEC = 1000 mg/L

Activated sludge of a predominantly

domestic sewage, OECD 209, EU Method

C.11, EPA OPPTS 850.6800.

Conducted on analogous substance,

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reliability 2.

The substance has been assessed with regards to the data requirements of Annex X of REACH

12.2 Persistence and degradability

Disodium dihydrogenpyrophosphate is an inorganic substance, biodegradation studies are not applicable. No further testing is deemed to be necessary.

12.3 Bioaccumulative potential

Disodium dihydrogenpyrophosphate is hydrolysed to orthophosphate and sodium ions in aqueous and biological systems. The degradation products of disodium dihydrogenpyrophosphate are essential nutrients (food elements) for plants, and stimulate the growth of water plants (macrophytes) and/or algae (phytoplankton) and are ubiquitous in the environment. The potential for bioaccumulation is therefore considered to be minimal.

12.4 Mobility in soil

No data available: A batch equilibrium study according to OECD Guideline 106 was deemed to be not applicable to disodium dihydrogenpyrophosphate for the following reasons: Firstly, analysis of the test material may not be possible due to interference from the soil extracts that may leach into the aqueous media during the test. This would prevent quantification of the test material. In addition, the mobility of the test item would be dependent on the anion exchange capacity of the soils as the main component of the test material is an anion. This absorption relationship would not be anticipated to correlate with the organic carbon content of the soils and is considered to be beyond the scope of the OECD 106 method.

12.5 Results of PBT and vPvB assessment

According to the Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.11: PBT Assessment, the PBT and vPvB criteria of Annex XIII to the regulation do not apply to inorganic substances. Therefore disodium dihydrogenpyrophosphate is not considered to require any further assessment of PBT properties.

12.6 Other adverse effects

No sediment or terrestrial toxicity data exists. Substance is not considered to be hazardous to sediment dwelling or terrestrial organisms. According to the criteria of the European classification and labelling system, the substance does not require classification as hazardous for the environment

SECTION 13. Disposal considerations

13.1 Waste treatment methods

Disposal recommendations are made based on the material as supplied. Disposal must be in accordance with current applicable laws and regulations. Disposal of substance: Dispose of in accordance with national and local regulations for special waste via an appropriately licensed waste contractor. Do not discharge to drains or STP. Disposal of packaging: Empty containers and clean out appropriately before reuse or disposal. Packaging may be recycled if thoroughly cleaned. Packaging that cannot be cleaned should be disposed of according to national and local regulations for special waste via an appropriately licensed waste contractor. Regulatory disposal information: European waste codes: Waste producers need to asses the process used when generating the waste and its contaminants in order to assign the most appropriate waste disposal code(s).

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Recommended code: European waste catalogue 16 03 03 inorganic wastes containing dangerous substances

SECTION 14. Transport information

Transport classifications (ADR/RID/IMDG/IATA) are not defined in the REACH Registration Dossier for the substance. The information provided here is therefore not derived from this Dossier and is based on other information available to the Consortium Members. The Transport classifications (ADR/RID/IMDG/IATA) provided here are indicative and based on the data in the REACH dossier for the pure substance only and may not be applicable for solutions or other preparations. Please seek advice from your Dangerous Good Safety Advisor.

According to information available: UN transport classification: Not Classified (for pure substance as solid and solution in water

14.1 UN number

LAND (ADR/RID) SEA (IMDG) AIR (IATA)

14.2 UN proper shipping name

14.3 Transport hazard class(es)

Labels

14.4 Packing group

14.5 Environmental hazards

14.6 Special precautions for user

14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC code

Other Information:

SECTION 15. Regulatory information

15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture.

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[COMPANY TO INCLUDE ANY INFORMATION RELEVANT TO THE COUNTRY OF PRODUCT AND/OR SUPPLY] This safety data sheet is compliant with Regulation (EC) No 1907/2006 (REACH) (including the amendment, Regulation (EU) No 453/2010 and Regulation (EC) No. 1272/2008 (EU CLP).

15.2 Chemical Safety Assessment.

A Chemical Safety Assessment is available for disodium dihydrogenpyrophosphate.

SECTION 16. Other information

This SDS supersedes the SDS dated [TO BE COMPLETED BY COMPANY SUPPLYING SDS] The following amendments have been made:

- SDS has been fully revised and re-written in accordance with Regulation (EU) No 453/2010 and Regulation (EC) No. 1272/2008 (EU CLP).

- Any further amendments to be detailed by supplier of SDS Sources of Key data used: - Registration dossier submitted to ECHA in accordance with Regulation (EC) No. 1907/2006 and therefore a full reference list can be found in the corresponding CSR.

Abbreviations and acronyms used: AF = Assessment factor DNEL = Derived no effect level EC50 = Median effect concentration LC50 = Median lethal concentration LD50 = Median lethal dose LEV = Local Exhaust Ventilation NOAEL = No observed adverse effect level NOEC = No observed effect concentration PBT Persistent bioaccumulative toxic PEC = Predicted effect level PNEC = Predicted no effect level PRE = Personal Respiratory Equipment OEL = Occupational Exposure Limit SDS = Safety data sheet STOT–SE = Specific target organ toxicity – single exposure STOT–RE = Specific target organ toxicity – repeated exposure STP = Sewage treatment plant vPvB = Very persistent very bioaccumulative

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Annex: summary of relevant exposure scenarios

SECTION 1. Identification of the substance/mixture and of the company/undertaking .....2

SECTION 2. Hazards identification ..................................................................................2

SECTION 3. Composition / information on ingredients ....................................................3

SECTION 4. First aid measures .......................................................................................4

SECTION 5. Fire fighting measures .................................................................................4

SECTION 6. Accidental release measures ......................................................................5

SECTION 7. Handling and storage ..................................................................................5

SECTION 8. Exposure controls / personal protection ......................................................5

SECTION 9. Physical and chemical properties ................................................................8

SECTION 10. Stability and reactivity................................................................................9

SECTION 11. Toxicological information ...........................................................................9

SECTION 12. Ecological information ............................................................................. 10

SECTION 13. Disposal considerations .......................................................................... 11

SECTION 14. Transport information .............................................................................. 12

SECTION 15. Regulatory information ............................................................................ 12

SECTION 16. Other information .................................................................................... 13

ES1: Manufacture and processing of SAPP ................................................................... 14

ES2: Using SAPP as a raw material and additive in chemical synthesis and mixing SAPP into final products .....................................Error! Bookmark not defined.

ES3: Leather, textiles and paper manufacturing and treatment with products containing SAPP .................................................Error! Bookmark not defined.

ES4: Use as neutralising agent in manufacture of polymersError! Bookmark not defined.

ES5: Use of SAPP in peroxide stabilisation ......................Error! Bookmark not defined.

ES6: Use in drilling fluid applications ................................Error! Bookmark not defined.

ES7: Professional use of cleaning products containing SAPPError! Bookmark not defined.

ES8: Consumer use of toothpaste and dental care products containing SAPPError! Bookmark not defined.

ES1: Manufacture and processing of SAPP

1. Short title of exposure scenario 1

Manufacture and processing of SAPP

2. Description of activities and processes covered in the exposure scenario

Sector of use (SU)

SU 3: Industrial uses: uses of substances as such or in preparations at industrial sites SU 8: Manufacture of bulk, large scale chemicals (including petroleum products). SU 9: Manufacture of fine chemicals. 20

Product category (PC)

Not applicable

Process category (PROC)

PROC 2: Use in closed, continuous process with occasional controlled exposure. 3 4

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PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities. PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing). 20 PROC 26: Handling of solid inorganic substances at ambient temperature.

Article category (AC)

Not applicable

Environmental release category (ERC)

ERC 1: Manufacture of substances

3. Operational conditions

3. 1 Operational conditions related with frequency and quantities of use

Duration of exposure at workplace:

24 hours/day (3 working shifts of 8 hours/shift)

Frequency of exposure at workplace:

365 days/year for each worker

Annual amount used per site:

The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure.

3.2 Operational conditions related with substance/ product

Physical state Solid / Liquid

Concentration of substance in mixture

A concentration of 100% w/w was used to assess exposure to the solid substance. The SAPP concentration in the aqueous mixtures was set to 5-25% w/w.

3.3 Other relevant operational conditions

The substance is manufactured on a large scale in closed, continuous processes by neutralisation of purified phosphoric acid with sodium hydroxide and sodium carbonate. The type of poylphosphate produced depends on the degree of neutralisation of the liquor and the temperature and residence time in the kiln. After subsequent drying and condensation of the obtained orthophosphate solution in a spray tower or rotary kiln SAPP is produced. After heating for a length of time (ageing step) the product is slowly cooled down. The cooled product may be hydrated and milled or screened to obtain various particle sizes. Depending on the setup of the SAPP plant, fine or coarse powders or granules are obtained. In addition, SAPP is also formulated into aqueous mixtures in maximum concentrations ranging from 5 - 25% w/w. Samples of the manufactured SAPP have to be taken regularly and are analysed for quality assurance in an on-site laboratory. Workers operate the processes by remote control and do regular inspection rounds at each shift. The manufactured substance is automatically transferred to storage tanks at dedicated facilities. Workers are loading transport containers or bags with solid product at dedicated facilities. In case of defects, such as leakage of pipes or gaskets, repair and maintenance work is done after the affected part of the system has been separated from the process, completely emptied and flushed with water where possible. Cleaning tasks such as wiping of floors or manufacturing and packaging equipment are performed regularly.

4. Risk Management Measures

4.1 RMMs related to workers

Organisational measures

The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions.

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Eye wash stations should be available in case of accidental contact.

Technical measures

Transport over pipes, technical barrel filling/emptying of barrel with automatic systems (suction pumps etc.) (Good practice)

Use of pliers, grip arms with long handles with manual use “to avoid direct contact and exposure by splashes (no working over one’s head)” (Good practice)

Store in cool, dry, clean, well ventilate areas. (Good practice).

Local exhaust / general ventilation should be present when solids are handled to reduce the likelihood of inhalation exposure to dusts.

Workers wear appropriate personal protective equipment, such as gloves, breathing masks and safety glasses when breaching the system or else being in contact with the undiluted substance.

Respiratory protection

Respiratory protection: Personal respiratory protection is not required but exposure to dusts from the handling of solid materials should be reduced by the use of local exhaust ventilation. If local exhaust ventilation is not present then it will be necessary to use personal respiratory protection that is compliant with EN 141 or EN 405.

Hand protection

Hand protection is recommended: impervious chemical resistant protective gloves. Material: chloroprene gloves or equivalent.

Eye protection The use of safety goggles when handling the undiluted substance is required due to the eye irritating properties of SAPP. Goggles or face protection shield should be consistent with EN 166 or equivalent.

Skin and body protection

Wearing of suitable protective clothing and rubber boots is recommended.

Hygiene measures

Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate.

4.2 RMMs related to the environment

Organisational measures

Emissions to the environment must meet the requirements of Council Directive 96/61/EC and National Regulations concerning phosphate in industrial wastewater.

Abatement measures related with wastewater

The efficiency of the process is maximised in such a way that minimal emission of phosphates into the wastewater will occur. In addition, phosphate can be precipitated from the wastewater by addition of metal ions.

Abatement measures waste air and solid waste

Emissions of particles into the air of workplaces or the atmosphere can be significantly reduced by the use of cyclones, gas scrubbers or bag filters. Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste.

4.3 Waste related measures

Type of waste Liquid waste, solid residues.

Disposal technique

The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information.

Fraction released to environment during waste treatment

Not determined.

5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation)

5.1. Human exposure

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Exposure estimation tool(s)

ECETOC TRA (2010), MEASE (ver 1.02.01, April 2010, EBRC) (used for inorganic liquids and PROC 26).

Workers (oral) The manufacture and processing of SAPP will not notably contribute to the oral intake of phosphates.

Workers (inhalation)

DNEL: Worker, long-term, systemic, inhalation: 2.79 mg/m

3

It is also considered that workplace exposure limits for dust are also applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany). This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety.

A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits.

A number of industrial activities associated with the manufacture and processing of SAPP may result in inhalation exposure of workers to the substance. The risk characterisation ratios for these activities are given in the table below. Workers handling the pure, solid substance are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the manufacture and processing of SAPP are adequately controlled.

Pro

ce

ss

Cate

go

ry

LE

V/ P

RE

Du

ratio

n

(ho

urs

)

We

igh

t

frac

tion

(%)

Airb

orn

e

SA

PP

co

nc

.

(mg

/m3

)

RC

R

(DN

EL

)

Co

nc

lus

ion

RC

R (O

EL

)

Co

nc

lus

ion

Activities performed with aqueous solutions (Calculated with MEASE)

2 No >4 5-25 0.001 2.2E-05 Risk controlled 1E-04

Risk controlled

3 No >4 5-25 0.006 1.36E-04 Risk controlled 6E-04

Risk controlled

4 No >4 5-25 0.03 6.8E-04 Risk controlled 3E-03

Risk controlled

8b No >4 5-25 0.006 1.36E-04 Risk controlled 6E-04

Risk controlled

9 No >4 5-25 0.006 1.36E-04 Risk controlled 6E-04

Risk controlled

Activities performed with solids of low dustiness

2 No >4 100 0.01 2.27E-04 Risk controlled 1E-03

Risk controlled

3 No >4 100 0.1 2.27E-03 Risk controlled 0.01

Risk controlled

4 No >4 100 0.5 0.01 Risk controlled 0.05

Risk controlled

8b No >4 100 0.1 2.27E-03 Risk controlled 0.01

Risk controlled

9 No >4 100 0.1 2.27E-03 Risk controlled 0.01

Risk controlled

26 No >4 100 1.5 0.03 Risk controlled 0.15

Risk controlled

Activities performed with solids of medium dustiness

2 No >4 100 0.5 0.01 Risk controlled 0.05

Risk controlled

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3 No >4 100 1 0.02 Risk controlled 0.1

Risk controlled

4 No >4 100 5 0.11 Risk controlled 0.5

Risk controlled

8b No >4 100 5 0.11 Risk controlled 0.5

Risk controlled

9 No >4 100 5 0.11 Risk controlled 0.5

Risk controlled

26 No >4 100 4 0.09 Risk controlled 0.4

Risk controlled

Activities performed with solids of high dustiness

2 No >4 100 1 0.02 Risk controlled 0.1

Risk controlled

3 No >4 100 1 0.02 Risk controlled 0.1

Risk controlled

4

No >4 100 25 0.57 Risk controlled 2.5

RMMs required

90% >4 100 2.5 0.06 Risk controlled 0.25

Risk controlled

8b

No >4 100 25 0.57 Risk controlled 2.5

RMMs required

90% >4 100 1.25 0.03 Risk controlled 0.125

Risk controlled

9

No >4 100 20 0.45 Risk controlled 2

RMMs required

90% >4 100 2 0.05 Risk controlled 0.2

Risk controlled

26

No >4 100 10 0.23 Risk controlled 1

RMMs required

82% >4 100 1.8 0.04 Risk controlled 0.18

Risk controlled

Workers (dermal)

No systemic toxicity effects are expected due to the inorganic nature of the substance however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application.

Indirect exposure via the environment

No indirect exposure of humans via the environment is expected for SAPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed.

Consumer exposure

No direct consumer exposure is anticipated with the manufacture and processing of SAPP. It is concluded that the manufacture and processing of SAPP is of no risk for the general public.

5.2. Environmental exposure (qualitative assessment)

Environmental release

The production of SAPP can potentially result in aquatic emissions and locally increase the phosphate (PO4

3-) concentration. Phosphates reaching surface water increase the

phosphorus content in the water body which may cause eutrophication and water quality deterioration.

Waste water treatment plants (WWTP)

Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases.

Aquatic pelagic compartment

No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment.

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Sediments No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment.

Soil and groundwater

No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment.

Atmospheric compartment

The manufacture and processing of SAPP is not considered to pose a risk to the atmospheric compartment.

Secondary poisoning

Bioaccumulation in organisms is not relevant for inorganic phosphates.

ES2: Use as raw material and additive in manufacture of dyes and auxiliary chemicals and mixing into final products (including dentifrice, oral care products, water treatment chemicals and construction materials)

1. Short title of exposure scenario 2

Use as raw material and additive in manufacture of chemicals and mixing into final products

2. Description of activities and processes covered in the exposure scenario

Sector of use (SU)

SU 3: Industrial uses. SU 9: Manufacture of fine chemicals SU 10: Formulation [mixing] of preparations and/or re-packaging (excluding alloys). SU 20: Health services.

Product category (PC)

PC 4: Anti-freeze and de-icing products.

PC 19: Intermediate

PC 20: Products such as pH-regulators, flocculants, precipitants, neutralisation agents. PC 23: Leather tanning, dye, finishing, impregnation and care products. PC 29: Pharmaceuticals. PC 35: Washing and cleaning products (including solvent based products). PC 36: Water softeners. PC 37: Water treatment chemicals. PC 39: Cosmetics, personal care products.

Process category (PROC)

PROC 1: Use in closed process, no likelihood of exposure. PROC 2: Use in closed, continuous process with occasional controlled exposure. PROC 3: Use in closed batch process (synthesis or formulation). PROC 4: Use in batch and other process (synthesis) where opportunity for exposure arises. PROC 5: Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact). PROC 6: Calendering operations. PROC 7: Industrial spraying. PROC 8a: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities. PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities. PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing). PROC 10: Roller application or brushing. PROC 13: Treatment of articles by dipping and pouring. PROC 14: Production of preparations or articles by tabletting, compression, extrusion, pelletisation. PROC 24: High (mechanical) energy work-up of substances bound in materials and/or articles.

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PROC 26: Handling of solid inorganic substances at ambient temperature.

Article category (AC)

Not applicable

Environmental release category (ERC)

ERC 1: Manufacture of substances. ERC 2: Formulation of preparations. ERC 3: Formulation in materials. ERC 4: Industrial use of processing aids in processes and products, not becoming part of articles. ERC 5: Industrial use resulting in inclusion into or onto a matrix. ERC 6a: Industrial use resulting in manufacture of another substance (use of intermediates). ERC 6b: Industrial use of reactive processing aids. ERC 6d: Industrial use of process regulators for polymerisation processes in production of resins, rubbers, polymers. SPERCS: EFCC 1, 2, 3

3. Operational conditions

3. 1 Operational conditions related with frequency and quantities of use

Duration of exposure at workplace:

8 hours/day

Frequency of exposure at workplace:

Frequency of task: once per day

Annual amount used per site:

The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure.

3.2 Operational conditions related with substance/ product

Physical state Solid / Liquid

Concentration of substance in mixture

A concentration of 100% w/w was used to assess exposure to the solid substance.

The SAPP concentration in the aqueous mixtures was set to 5–25% w/w.

3.3 Other relevant operational conditions

The fine chemicals industry uses SAPP in the manufacture of dyes and auxiliary chemicals for textiles, leather and paper and also ‘non-ink’ applications such as the manufacturing of printing plates, sleeves and in solvent mixtures. Formulators mix the substance into a variety of final products, such as toothpaste, oral care products, construction materials and cleaners. The substance as a solid product or in aqueous solution is delivered to chemical or formulation plants in appropriate containers and unloaded at dedicated facilities, stored at the chemical plants and formulation sites and on demand automatically transferred to the chemical synthesis or formulation process. Samples may be taken from the delivered material and analysed in on-site laboratories for quality assurance. The manufacture of chemicals and formulation of solid or liquid mixtures is performed in a wide variety of processes ranging from closed, continuous or batch processes to semi-closed or open batch processes. Chemical synthesis and formulation involves an extensive mixing or blending step that may run continuously during a working shift of 8 hours. Workers have to control the formulation process, do regular inspection rounds and perform cleaning, repair and maintenance tasks. The final mixtures may be transferred to storage tanks and subsequently weighed, filled into small containers, packaged and made ready for shipment at dedicated filling lines. Formulated preparations may be agglomerated to form tablets, e.g. of detergent and dishwashing powders.

4. Risk Management Measures

4.1 RMMs related to workers

Organisational measures

The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or

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handling the pure substance and concentrated solutions.

Eye wash stations should be available in case of accidental contact.

Technical measures

Transport over pipes, technical barrel filling/emptying of barrel with automatic systems (suction pumps etc.) (Good practice)

Use of pliers, grip arms with long handles with manual use “to avoid direct contact and exposure by splashes (no working over one’s head)” (Good practice)

Store in cool, dry, clean, well ventilate areas. (Good practice).

Local exhaust / general ventilation should be present when solids are handled to reduce the likelihood of inhalation exposure to dusts.

Workers wear appropriate personal protection equipment, such as gloves and safety glasses when handling the raw materials.

Respiratory protection

Respiratory protection: Personal respiratory protection is not required but exposure to dusts from the handling of solid materials should be reduced by the use of local exhaust ventilation. If local exhaust ventilation is not present then it will be necessary to use personal respiratory protection that is compliant with EN 141 or EN 405.

Hand protection

Hand protection is recommended: impervious chemical resistant protective gloves. Material: chloroprene gloves or equivalent.

Eye protection Workers handling concentrated SAPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Goggles or face protection shield should be consistent with EN 166 or equivalent.

Skin and body protection

Wearing of suitable protective clothing and rubber boots is recommended.

Hygiene measures

Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate.

4.2 RMMs related to the environment

Organisational measures

Emissions to the environment must meet the requirements of Council Directive 96/61/EC and National Regulations concerning phosphate in industrial wastewater.

Abatement measures related with wastewater

The efficiency of the process is maximised in such a way that minimal emission of phosphates into the wastewater will occur. In addition, phosphate can be precipitated from the wastewater by addition of metal ions.

Abatement measures waste air and solid waste

Emissions of particles into the air of workplaces or the atmosphere can be significantly reduced by the use of cyclones, gas scrubbers or bag filters. Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste.

4.3 Waste related measures

Type of waste Liquid waste, solid residues.

Disposal technique

The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information.

Fraction released to environment during waste treatment

Not determined.

5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation)

5.1. Human exposure

Exposure estimation

ECETOC TRA (2010)

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tool(s) MEASE (version 1.02.01, April 2010, EBRC)

Workers (oral) The use of SAPP as raw material and additive in manufacture of dyes and auxiliary chemicals and mixing into final products will not notably contribute to the oral intake of phosphates.

Workers (inhalation)

DNEL: Worker, long-term, systemic, inhalation: 44.08 mg/m

3

It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany). This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety. A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits. Various industrial activities associated with the mixing of SAPP into final products may result in inhalation exposure of workers to the substance. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated SAPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the mixing of SAPP into final products are adequately controlled.

Pro

cess

Cate

go

ry

LE

V/P

RE

*

Du

ratio

n

(ho

urs

)

Weig

ht

fractio

n (%

)

Airb

orn

e

SA

PP

co

nc

(mg

/m3)

RC

R

(DN

EL

)

Co

nc

lus

ion

RC

R (O

EL

)

Co

nc

lus

ion

Activities performed with aqueous solutions (calculated with MEASE)

1 No >4 5-25 0.001 2.2E-05 Risk controlled 1E-04

Risk controlled

2 No >4 5-25 0.001 2.2E-05 Risk controlled 1E-04

Risk controlled

3 No >4 5-25 0.006 1.36E-04 Risk controlled 6E-04

Risk controlled

4 No >4 5-25 0.03 6.8E-04 Risk controlled 3E-03

Risk controlled

5 No >4 5-25 0.03 6.8E-04 Risk controlled 3E-03

Risk controlled

7

No >4 5-25 12 0.27 Risk controlled 1.2

RMMs required

95% >4 5-25 0.6 0.01 Risk controlled 0.06

Risk controlled

8a No >4 5-25 0.06 1.36E-03 Risk controlled 6E-03

Risk controlled

8b No >4 5-25 0.006 1.36E-04 Risk controlled 6E-04

Risk controlled

9 No >4 5-25 0.006 1.36E-04 Risk controlled 6E-04

Risk controlled

10 No >4 5-25 0.03 6.8E-04 Risk controlled 3E-03

Risk controlled

13 No >4 5-25 0.006 1.36E-04 Risk controlled 6E-04

Risk controlled

14 No >4 5-25 0.006 1.36E-04 Risk controlled 6E-04

Risk controlled

Activities performed with solids of low dustiness

1 No >4 100 0.01 2.27E-04 Risk controlled 1E-03

Risk controlled

2 No >4 100 0.01 2.27E-04 Risk controlled 1E-03

Risk controlled

3 No >4 100 0.1 2.27E-03 Risk 0.01 Risk

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controlled controlled

4 No >4 100 0.5 0.01 Risk controlled 0.05

Risk controlled

5 No >4 100 0.5 0.01 Risk controlled 0.05

Risk controlled

6 No >4 100 0.1 2.27E-03

Risk controlled 0.01

Risk controlled

7 No >4 100 1 0.02 Risk controlled 0.1

Risk controlled

8a No >4 100 0.5 0.01 Risk controlled 0.05

Risk controlled

8b No >4 100 0.1 2.27E-03 Risk controlled 0.01

Risk controlled

9 No >4 100 0.1 2.27E-03 Risk controlled 0.01

Risk controlled

10 No >4 100 0.5 0.01 Risk controlled 0.05

Risk controlled

13 No >4 100 0.1 2.27E-03 Risk controlled 0.01

Risk controlled

14 No >4 100 0.1 2.27E-03 Risk controlled 0.01

Risk controlled

24 low fugacity No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

24 medium fugacity No >4 100 3 0.07

Risk controlled 0.3

Risk controlled

24 high fugacity

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 2 0.05 Risk controlled 0.2

Risk controlled

26 No >4 >25 1.5 0.03 Risk controlled 0.15

Risk controlled

Activities performed with solids of medium dustiness

1 No >4 100 0.01 2.2E-04 Risk controlled 1E-03

Risk controlled

2 No >4 100 0.5 0.01 Risk controlled 0.05

Risk controlled

3 No >4 100 1 0.02 Risk controlled 0.1

Risk controlled

4 No >4 100 5 0.11 Risk controlled 0.5

Risk controlled

5 No >4 100 5 0.11 Risk controlled 0.5

Risk controlled

6 No >4 100 5 0.11 Risk controlled 0.5

Risk controlled

7

No >4 100 20 0.45 Risk controlled 2

RMMs required

90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

8a No >4 100 5 0.11 Risk controlled 0.5

Risk controlled

8b No >4 100 5 0.11 Risk controlled 0.5

Risk controlled

9 No >4 100 5 0.11 Risk controlled 0.5

Risk controlled

10 No >4 100 5 0.11 Risk controlled 0.5

Risk controlled

13 No >4 100 1 0.02 Risk controlled 0.1

Risk controlled

14 No >4 100 1 0.02 Risk controlled 0.1

Risk controlled

24 low fugacity No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

24 medium fugacity No >4 100 3 0.07

Risk controlled 0.3

Risk controlled

24 high fugacity

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 2 0.05 Risk controlled 0.2

Risk controlled

26 No >4 >25 4 0.09

Risk controlled 0.4

Risk controlled

Activities performed with solids of high dustiness

1 No >4 100 0.01 2.27E-04 Risk controlled 1E-03

Risk controlled

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2 No >4 100 1 0.02 Risk controlled 0.1

Risk controlled

3 No >4 100 1 0.02 Risk controlled 0.1

Risk controlled

4

No >4 100 25 0.57 Risk controlled 2.5

RMMs required

90% >4 100 2.5 0.06 Risk controlled 0.25

Risk controlled

5

No >4 100 25 0.57 Risk controlled 2.5

RMMs required

90% >4 100 2.5 0.06 Risk controlled 0.25

Risk controlled

6 No >4 100 25 0.57

Risk controlled 2.5

RMMs required

90% >4 100 2.5 0.06 Risk controlled 0.25

Risk controlled

7

No >4 100 100 2.27 RMMs required

10 RMMs required

90% >4 100 5 0.11 Risk controlled

0.5 Risk controlled

8a

No >4 100 50 1.13 RMMs required

5 RMMs required

90% >4 100 5 0.11 Risk controlled 0.5

Risk controlled

8b

No >4 100 25 0.57 Risk controlled 2.5

RMMs required

90% >4 100 1.25 0.03 Risk controlled 0.125

Risk controlled

9

No >4 100 20 0.45 Risk controlled 2

RMMs required

90% >4 100 2 0.05 Risk controlled 0.2

Risk controlled

10

No >4 100 10 0.23 Risk controlled

1 RMMs required

90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

13 No >4 100 5 0.11 Risk controlled 0.5

Risk controlled

14

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

24 low fugacity No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

24 medium fugacity

No >4 100 3 0.07 Risk controlled 0.3

Risk controlled

90% >4 100 6 0.14 Risk controlled 0.6

Risk controlled

24 high fugacity

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 2 0.05 Risk controlled 0.2

Risk controlled

26 No >4 >25 10 0.23

Risk controlled 1

RMMs required

82% >4 >25 1.8 0.04 Risk controlled 0.18

Risk controlled

* % efficiency

Workers (dermal)

No systemic toxicity effects are expected due to the inorganic nature of the substance however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application.

Indirect exposure via the environment

No indirect exposure of humans via the environment is expected for SAPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed.

Consumer exposure

No direct consumer exposure is anticipated with the use of SAPP as a raw material and additive. It is concluded that the use of SAPP in manufacture of dyes and auxiliary chemicals and mixing into final products (including dentifrice, oral care products, water treatment chemicals and construction materials) is of no risk for the general public.

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5.2. Environmental exposure (qualitative assessment)

Environmental release

The use of SAPP can potentially result in aquatic emissions and locally increase the phosphate (PO4

3-) concentration. Phosphates reaching surface water increase the

phosphorus content in the water body which may cause eutrophication and water quality deterioration.

Waste water treatment plants (WWTP)

Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases.

Aquatic pelagic compartment

No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment.

Sediments No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment.

Soil and groundwater

No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment.

Atmospheric compartment

The use of SAPP as a raw material and additive is not considered to pose a risk to the atmospheric compartment.

Secondary poisoning

Bioaccumulation in organisms is not relevant for inorganic phosphates.

ES3: Leather, textiles and paper manufacturing and treatment and use in dyes and auxiliary chemicals and construction chemicals

1. Short title of exposure scenario 3

Leather, textiles and paper manufacturing and treatment and use in dyes and auxiliary chemicals and construction chemicals

2. Description of activities and processes covered in the exposure scenario

Sector of use (SU)

SU 3: Industrial uses. SU 5: Manufacture of textiles, leather, fur SU 6b:Manufacture of pulp, paper and paper products

Product category (PC)

PC 20: Products such as pH-regulators, flocculants, precipitants, neutralisation agents. PC 23: Leather tanning, dye, finishing, impregnation and care products.

Process category (PROC)

PROC 3: Use in closed batch process (synthesis or formulation). PROC 4: Use in batch and other process (synthesis) where opportunity for exposure arises. PROC 5: Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact). PROC 6: Calendering operations. PROC 7: Industrial spraying. PROC 8a: Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities. PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities. PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including

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weighing). PROC 10: Roller application or brushing. PROC 13: Treatment of articles by dipping and pouring. PROC 14: Production of preparations or articles by tabletting, compression, extrusion, pelletisation. PROC 26: Handling of solid inorganic substances at ambient temperature.

Article category (AC)

AC 5: Fabrics, textiles and apparel AC 6: Leather articles AC 8: Paper articles

Environmental release category (ERC)

ERC 2: Formulation of preparations. ERC 3: Formulation in materials. ERC 4: Industrial use of processing aids in processes and products, not becoming part of articles. ERC 5: Industrial use resulting in inclusion into or onto a matrix. ERC 6a: Industrial use resulting in manufacture of another substance (use of intermediates). ERC 10a: Wide dispersive outdoor use of long-life articles and materials with low release. ERC 11a: Wide dispersive indoor use of long-life articles and materials with low release.

3. Operational conditions

3. 1 Operational conditions related with frequency and quantities of use

Duration of exposure at workplace:

8 hours/day

Frequency of exposure at workplace:

Frequency of task: once per day

Annual amount used per site:

The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure.

3.2 Operational conditions related with substance/ product

Physical state

Solid / Liquid

Concentration of substance in mixture

A concentration of 100% w/w was used to assess exposure to the solid substance.

The SAPP concentration in the aqueous solutions delivered to downstream users was set to 5–25% w/w.

The concentration in the working solution was set to 1–5% w/w.

3.3 Other relevant operational conditions

The textile and leather industry uses SAPP and products containing the substance prior to or after tanning and as sequestering agent during dyeing. The pulp and paper industry uses SAPP as a bleaching agent for pulps. The solid substance or aqueous solutions containing SAPP are delivered to textile, leather and paper manufacturing and processing plants in appropriate containers and stored on-site until use. Diluted aqueous solutions are on demand prepared from the undiluted raw material products and transferred into the processes. Leather tanning, textile dyeing and pulp bleaching is performed in closed or open batch processes by dipping or pouring, which may be done either automatically or manually. Manual processes may involve the mixing of solutions by hand. Solutions of SAPP may also be used in industrial spray applications.

4. Risk Management Measures

4.1 RMMs related to workers

Organisational measures

The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions.

Eye wash stations should be available in case of accidental contact.

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Technical measures

Transport over pipes, technical barrel filling/emptying of barrel with automatic systems (suction pumps etc.) (Good practice)

Use of pliers, grip arms with long handles with manual use “to avoid direct contact and exposure by splashes (no working over one’s head)” (Good practice)

Store in cool, dry, clean, well ventilate areas. (Good practice).

Local exhaust / general ventilation should be present when solids are handled and should be working at 90% efficiency.

Workers wear appropriate personal protection equipment, such as gloves, working suits and safety glasses, when handling the SAPP in solid form or as solutions.

Respiratory protection

Respiratory protection: LEV and personal respiratory equipment with 90% efficiency will be required to lower the occupational exposure resulting from industrial spraying to acceptable levels. In addition, exposure to dusts from the handling of solid materials should be reduced by the use of local exhaust ventilation.

Hand protection

Hand protection is required when spraying: impervious chemical resistant protective gloves. Material: chloroprene gloves or equivalent.

Eye protection

Workers handling concentrated SAPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Goggles or face protection shield should be consistent with EN 166 or equivalent.

Skin and body protection

Wearing of suitable protective clothing and rubber boots is recommended. If spraying, skin protection is required.

Hygiene measures

Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate.

4.2 RMMs related to the environment

Organisational measures

Emissions to the environment must meet the requirements of Council Directive 96/61/EC and National Regulations concerning phosphate in industrial wastewater.

Abatement measures related with wastewater

The efficiency of the process is maximised in such a way that minimal emission of phosphates into the wastewater will occur. In addition, phosphate can be precipitated from the wastewater by addition of metal ions.

Abatement measures waste air and solid waste

Emissions of particles into the air of workplaces or the atmosphere can be significantly reduced by the use of cyclones, gas scrubbers or bag filters. Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste.

4.3 Waste related measures

Type of waste

Liquid waste, solid residues.

Disposal technique

The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information.

Fraction released to environment during waste treatment

Not determined.

5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation)

5.1. Human exposure

Exposure estimation tool(s)

ECETOC TRA (2010)

MEASE (version 1.02.01, April 2010, EBRC)

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Workers (oral)

The use of SAPP for leather, textiles and paper manufacturing and treatment and use in dyes and auxiliary chemicals and construction chemicals will not notably contribute to the oral intake of phosphates.

Workers (inhalation)

DNEL: Worker, long-term, systemic, inhalation: 44.08 mg/m

3

It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany). This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety.

A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits.Various industrial activities associated with leather, textiles and paper manufacturing and treatment may result in inhalation exposure of workers to SAPP. The risk characterisation ratios for these activities are given in the table below.

Workers handling concentrated SAPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the use of SAPP in leather, textiles and paper manufacturing and treatment are adequately controlled.

Process Category

LEV/PRE*

Duration (hours)

Weight fraction (%)

Airborne SAPP conc (mg/m3)

RCR (DNEL) Conclusion

RCR (OEL) Conclusion

Activities performed with 1-5% w/w SAPP solutions (calculated with MEASE)

3 – Use in closed batch process (synthesis or formulation) No >4 1-5 0.002 4.5E-05

Risk controlled 2E-04 Risk controlled

4 – Use in batch and other process (synthesis) where opportunity for exposure arises No >4 1-5 0.01 2.27E-04

Risk controlled 1E-03 Risk controlled

5 – Mixing or blending in batch processes (multistage and/or significant contact) No >4 1-5 0.01 2.27E-04

Risk controlled 1E-03 Risk controlled

7 – Industrial spraying No >4 1-5 4 0.09

Risk controlled 0.4 Risk controlled

8a – Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities No >4 1-5 0.01 2.27E-04

Risk controlled 1E-03 Risk controlled

8b – Transfer of chemicals from/to vessels/ large containers at dedicated facilities No >4 1-5 0.002 4.5E-05

Risk controlled 2E-04 Risk controlled

9 – Transfer of chemicals into small containers (dedicated filling line) No >4 1-5 0.002 4.5E-05

Risk controlled 2E-04 Risk controlled

10 – Roller application or brushing No >4 1-5 0.01 2.27E-04

Risk controlled 1E-03 Risk controlled

13 – Treatment of articles by dipping and pouring No >4 1-5 0.002 4.5E-05

Risk controlled 2E-04 Risk controlled

14 – Production No >4 1-5 0.002 4.5E-05 Risk 2E-04 Risk controlled

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of preparation or articles by tableting, compression, extrusion, pelletisation

controlled

Activities performed with 5 - 25% w/w SAPP solutions (calculated with MEASE)

3 – Use in closed batch process (synthesis or formulation) No >4 5-25 0.006 1.36E-04

Risk controlled 6E-04 Risk controlled

4 – Use in batch and other process (synthesis) where opportunity for exposure arises No >4 5-25 0.03 6.8E-04

Risk controlled 3E-03 Risk controlled

5 – Mixing or blending in batch processes (multistage and/or significant contact) No >4 5-25 0.03 6.8E-04

Risk controlled 3E-03 Risk controlled

7 – Industrial spraying

No >4 5-25 12 0.27 Risk controlled 1.2

RMMs required

95% >4 5-25 0.6 0.01 Risk controlled 0.06 Risk controlled

8a – Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities No >4 5-25 0.06 1.36E-03

Risk controlled 6E-03 Risk controlled

8b – Transfer of chemicals from/to vessels/ large containers at dedicated facilities No >4 5-25 0.006 1.36E-04

Risk controlled 6E-04 Risk controlled

9 – Transfer of chemicals into small containers (dedicated filling line) No >4 5-25 0.006 1.36E-04

Risk controlled 6E-04 Risk controlled

10 – Roller application or brushing No >4 5-25 0.03 6.8E-04

Risk controlled 3E-03 Risk controlled

13 – Treatment of articles by dipping and pouring No >4 5-25 0.006 1.36E-04

Risk controlled 6E-04 Risk controlled

14 – Production of preparation or articles by tableting, compression, extrusion, pelletisation No >4 5-25 0.006 1.36E-04

Risk controlled 6E-04 Risk controlled

Activities performed with solids of low dustiness

3 – Use in closed batch process (synthesis or formulation) No >4 100 0.1 2.27E-03

Risk controlled 0.01 Risk controlled

4 – Use in batch and other process (synthesis) where opportunity for exposure arises No >4 100 0.5 0.01

Risk controlled 0.05 Risk controlled

5 – Mixing or blending in batch processes No >4 100 0.5 0.01

Risk controlled 0.05 Risk controlled

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(multistage and/or significant contact)

6 – Calendering operations No >4 100 0.1 2.27E-03

Risk controlled 0.01 Risk controlled

7 – Industrial spraying No >4 100 1 0.02

Risk controlled 0.1 Risk controlled

8a – Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities No >4 100 0.5 0.01

Risk controlled 0.05 Risk controlled

8b – Transfer of chemicals from/to vessels/ large containers at dedicated facilities No >4 100 0.1 2.27E-03

Risk controlled 0.01 Risk controlled

9 – Transfer of chemicals into small containers (dedicated filling line) No >4 100 0.1 2.27E-03

Risk controlled 0.01 Risk controlled

10 – Roller application or brushing No >4 100 0.5 0.01

Risk controlled 0.05 Risk controlled

13 - Treatment of articles by dipping and pouring No >4 100 0.1 2.27E-03

Risk controlled 0.01 Risk controlled

14 – Production of preparation or articles by tableting, compression, extrusion, pelletisation No >4 100 0.1 2.27E-03

Risk controlled 0.01 Risk controlled

Activities performed with solids of medium dustiness

3 – Use in closed batch process (synthesis or formulation) No >4 100 1 0.02

Risk controlled 0.1 Risk controlled

4 – Use in batch and other process (synthesis) where opportunity for exposure arises No >4 100 5 0.11

Risk controlled 0.5 Risk controlled

5 – Mixing or blending in batch processes (multistage and/or significant contact) No >4 100 5 0.11

Risk controlled 0.5 Risk controlled

6 – Calendering operations No >4 100 5 0.11

Risk controlled 0.5 Risk controlled

7 – Industrial spraying

No >4 100 20 0.45 Risk controlled 2

RMMs required

90% >4 100 1 0.02 Risk controlled 0.1 Risk controlled

8a – Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities No >4 100 5 0.11

Risk controlled 0.5 Risk controlled

8b – Transfer of chemicals from/to vessels/ large containers at dedicated facilities No >4 100 5 0.11

Risk controlled 0.5 Risk controlled

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9 – Transfer of chemicals into small containers (dedicated filling line) No >4 100 5 0.11

Risk controlled 0.5 Risk controlled

10 – Roller application or brushing No >4 100 5 0.11

Risk controlled 0.5 Risk controlled

13 - Treatment of articles by dipping and pouring No >4 100 1 0.02

Risk controlled 0.1 Risk controlled

14 – Production of preparation or articles by tableting, compression, extrusion, pelletisation No >4 100 1 0.02

Risk controlled 0.1 Risk controlled

26 – Handling of solid inorganic substances at ambient temperatures (Calculated using MEASE) No >4 >25 4 0.09

Risk controlled 0.4 Risk controlled

Activities performed with solids of high dustiness

3 – Use in closed batch process (synthesis or formulation) No >4 100 1 0.02

Risk controlled 0.1 Risk controlled

4 – Use in batch and other process (synthesis) where opportunity for exposure arises

No >4 100 25 0.57 Risk controlled 2.5

RMMs required

90% >4 100 2.5 0.06 Risk controlled 0.25 Risk controlled

5 – Mixing or blending in batch processes (multistage and/or significant contact)

No >4 100 25 0.57 Risk controlled 2.5

RMMs required

90% >4 100 2.5 0.06 Risk controlled 0.25 Risk controlled

6 – Calendering operations

No >4 100 25 0.57 Risk controlled 2.5

RMMs required

90% >4 100 2.5 0.06 Risk controlled 0.25 Risk controlled

7 – Industrial spraying

No >4 100 100 2.27 RMMs required 10

RMMs required

90% >4 100 5 0.11 Risk controlled 0.5 Risk controlled

8a – Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities

No >4 100 50 1.13 RMMs required 5

RMMs required

90% >4 100 5 0.11 Risk controlled 0.5 Risk controlled

8b – Transfer of chemicals from/to vessels/ large containers at dedicated facilities

No >4 100 25 0.57 Risk controlled 2.5

RMMs required

90% >4 100 1.25 0.03 Risk controlled 0.125 Risk controlled

9 – Transfer of chemicals into small containers (dedicated filling line)

No >4 100 20 0.45 Risk controlled 2

RMMs required

90% >4 100 2 0.05 Risk controlled 0.2 Risk controlled

10 – Roller application or brushing

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 1 0.02 Risk controlled 0.1 Risk controlled

13 - Treatment No >4 100 5 0.11 Risk 0.5 Risk controlled

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of articles by dipping and pouring

controlled

14 – Production of preparation or articles by tableting, compression, extrusion, pelletisation

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 1 0.02 Risk controlled 0.1 Risk controlled

26 – Handling of solid inorganic substances at ambient temperatures (Calculated using MEASE)

No >4 >25 10 0.23 Risk controlled 1

RMMs required

82% >4 >25 1.8 0.04 Risk controlled 0.18 Risk controlled

* % efficiency

Workers (dermal)

No systemic toxicity effects are expected due to the inorganic nature of the substance however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application.

Indirect exposure via the environment

No indirect exposure of humans via the environment is expected for SAPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed.

Consumer exposure

No direct consumer exposure is anticipated with the use of SAPP for leather, textiles and paper manufacturing and treatment and use in dyes and auxiliary chemicals and construction chemicals. It is concluded that the use of SAPP for these purposes is of no risk for the general public.

5.2. Environmental exposure (qualitative assessment)

Environmental release

The use of SAPP for leather, textiles and paper manufacturing and treatment and use in dyes and auxiliary chemicals and construction chemicals can potentially result in aquatic emissions and locally increase the phosphate (PO4

3-) concentration. Phosphates reaching surface water increase the

phosphorus content in the water body which may cause eutrophication and water quality deterioration.

Waste water treatment plants (WWTP)

Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases.

Aquatic pelagic compartment

No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment.

Sediments No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment.

Soil and groundwater

No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment.

Atmospheric compartment

The use of SAPP for leather, textiles and paper manufacturing and treatment and use in dyes and auxiliary chemicals and construction chemicals is not considered to pose a risk to the atmospheric compartment.

Secondary poisoning

Bioaccumulation in organisms is not relevant for inorganic phosphates.

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ES4: Use as neutralising agent in the process of manufacturing polymers

1. Short title of exposure scenario 4

Use as neutralising agent in manufacture of polymers

2. Description of activities and processes covered in the exposure scenario

Sector of use (SU)

SU 3: Industrial uses.

Product category (PC)

Not applicable.

Process category (PROC)

PROC 4: Use in batch and other process (synthesis) where opportunity for exposure arises.

Article category (AC)

Not applicable

Environmental release category (ERC)

ERC 1: Manufacture of substances.

3. Operational conditions

3. 1 Operational conditions related with frequency and quantities of use

Duration of exposure at workplace:

8 hours/day

Frequency of exposure at workplace:

Frequency of task: once per day.

The open processes may run continuously during 24 hours a day.

Annual amount used per site:

The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure.

3.2 Operational conditions related with substance/ product

Physical state Solid / Liquid

Concentration of substance in mixture

A concentration of 100% w/w was used to assess exposure to the solid substance.

The concentration of SAPP in undiluted aqueous solutions was set to 5–25% w/w.

3.3 Other relevant operational conditions

SAPP is used as a neutralising agent in the manufacture of polymers. The solid substance or aqueous SAPP solutions are delivered to manufacturers of polymers by road trucks or train in appropriate containers. The substance is transferred to storage facilities at dedicated transfer facilities. The solid SAPP or its aqueous solutions are added as neutralising agent in open parts of the processes. The open processes may run continuously during 24 hours a day.

4. Risk Management Measures

4.1 RMMs related to workers

Organisational measures

The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions.

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Eye wash stations should be available in case of accidental contact.

Technical measures

Transport over pipes, technical barrel filling/emptying of barrel with automatic systems (suction pumps etc.) (Good practice)

Use of pliers, grip arms with long handles with manual use “to avoid direct contact and exposure by splashes (no working over one’s head)” (Good practice)

Store in cool, dry, clean, well ventilate areas. (Good practice).

Local exhaust / general ventilation should be present when solids are handled.

Workers wear appropriate personal protection equipment, such as gloves, working suits and safety glasses, when handling the SAPP in solid form or as solutions.

Respiratory protection

Personal respiratory protection is not required but exposure to dusts from the handling of solid materials should be reduced by the use of local exhaust ventilation.

Hand protection

Hand protection is recommended: impervious chemical resistant protective gloves. Material: chloroprene gloves or equivalent.

Eye protection Workers handling concentrated SAPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Goggles or face protection shield should be consistent with EN 166 or equivalent.

Skin and body protection

Wearing of suitable protective clothing and rubber boots is recommended.

Hygiene measures

Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate.

4.2 RMMs related to the environment

Organisational measures

Emissions to the environment must meet the requirements of Council Directive 96/61/EC and National Regulations concerning phosphate in industrial wastewater.

Abatement measures related with wastewater

The efficiency of the process is maximised in such a way that minimal emission of phosphates into the wastewater will occur. In addition, phosphate can be precipitated from the wastewater by addition of metal ions.

Abatement measures waste air and solid waste

Emissions of particles into the air of workplaces or the atmosphere can be significantly reduced by the use of cyclones, gas scrubbers or bag filters. Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste.

4.3 Waste related measures

Type of waste Liquid waste, solid residues.

Disposal technique

The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information.

Fraction released to environment during waste treatment

Not determined.

5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation)

5.1. Human exposure

Exposure estimation tool(s)

ECETOC TRA (2010) MEASE (version 1.02.01, April 2010, EBRC)

Workers (oral) The use of SAPP as a neutralising agent will not notably contribute to the oral intake of phosphates.

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Workers (inhalation)

DNEL: Worker, long-term, systemic, inhalation: 44.08 mg/m

3

It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany). This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety. A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits.

The use of solid SAPP or its aqueous solutions as neutralising agent in open processes of polymer manufacture may lead to inhalation exposure to the substance. The risk characterisation ratios for handling of SAPP in open processes are given in the table below.

Workers handling concentrated SAPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the use of SAPP as neutralising agent are adequately controlled.

Process Category LEV/PRE*

Duration (hours)

Weight fraction (%)

Airborne SAPP conc (mg/m3)

RCR (DNEL) Conclusion

RCR (OEL) Conclusion

Activities performed with 1-5% w/w SAPP solutions (calculated with MEASE)

4 – Use in batch and other process (synthesis) where opportunity for exposure arises No >4 1-5 0.01 2.27E-04

Risk controlled 1E-03

Risk controlled

Activities performed with 5-25% w/w SAPP solutions (calculated with MEASE)

4 – Use in batch and other process (synthesis) where opportunity for exposure arises No >4 5-25 0.03 6.8E-04 Risk controlled 3E-03

Risk controlled

Activities performed with solids of low dustiness

4 – Use in batch and other process (synthesis) where opportunity for exposure arises No >4 100 0.5 0.01 Risk controlled 0.05

Risk controlled

Activities performed with solids of medium dustiness

4 – Use in batch and other process (synthesis) where opportunity for exposure arises No >4 100 5 0.11 Risk controlled 0.5

Risk controlled

Activities performed with solids of high dustiness

4 – Use in batch and other process (synthesis) where opportunity for exposure arises

No >4 100 25 0.57 Risk controlled 2.5 RMMs required

90% >4 100 2.5 0.06 Risk controlled 0.25 Risk controlled

* % efficiency

Workers (dermal)

No systemic toxicity effects are expected due to the inorganic nature of the substance however local effects may occur but these effects will not be dose-dependent but will depend on the concentration

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of the substance present in the mixture/solution used in a specific application.

Indirect exposure via the environment

No indirect exposure of humans via the environment is expected for SAPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed.

Consumer exposure

No direct consumer exposure is anticipated with the use of SAPP as a neutralising agent in manufacture of polymers. It is concluded that the use of SAPP for this purpose is of no risk for the general public.

5.2. Environmental exposure (qualitative assessment)

Environmental release

The use of SAPP can potentially result in aquatic emissions and locally increase the phosphate (PO4

3-) concentration. Phosphates reaching surface water increase the phosphorus content in the

water body which may cause eutrophication and water quality deterioration.

Waste water treatment plants (WWTP)

Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases.

Aquatic pelagic compartment

No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment.

Sediments No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment.

Soil and groundwater

No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment.

Atmospheric compartment

The use of SAPP as a neutralising agent in manufacture of polymers is not considered to pose a risk to the atmospheric compartment.

Secondary poisoning

Bioaccumulation in organisms is not relevant for inorganic phosphates.

ES5: Use in peroxide stabilisation

1. Short title of exposure scenario 5

Use in peroxide stabilisation

2. Description of activities and processes covered in the exposure scenario

Sector of use (SU)

SU 3: Industrial uses. SU 8: Manufacture of bulk, large scale chemicals. SU 9: Manufacture of fine chemicals.

Product category (PC)

Not applicable.

Process category (PROC)

PROC 1: Used in closed process, no likelihood of exposure. PROC 2: Use in closed, continuous process with occasional controlled exposure. PROC 3: Use in closed batch process (synthesis or formulation). PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities. PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing).

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Article category (AC)

Not applicable

Environmental release category (ERC)

ERC 6a: Industrial use resulting in manufacture of another substance (use of intermediates) ERC 6b: Industrial use of reactive processing aids.

3. Operational conditions

3. 1 Operational conditions related with frequency and quantities of use

Duration of exposure at workplace:

8 hours/day

Frequency of exposure at workplace:

Frequency of task: once per day. The closed processes may run continuously during 24 hours a day.

Annual amount used per site:

The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure.

3.2 Operational conditions related with substance/ product

Physical state

Solid / Liquid

Concentration of substance in mixture

A concentration of 100% w/w was used to assess exposure to the solid substance.

The concentration of SAPP in undiluted aqueous solutions was set to 5–25% w/w. The concentration of stabiliser in the peroxide solution will be very low. In addition, worker will be sufficiently protected against direct contact with peroxide solutions.

3.3 Other relevant operational conditions

The substance is used for the stabilisation of peroxides as it helps to remove catalytic impurities by precipitation. The solid substance or aqueous SAPP solutions are delivered to peroxide manufacturers by road trucks or train in appropriate containers. It is transferred to storage facilities at dedicated transfer facilities. The solid SAPP or aqueous solutions of the substance on demand are added to aqueous peroxide solutions in closed processes that may run continuously during 24 hours a day. Workers have to control the transfer process, do regular inspection rounds and perform cleaning, repair and maintenance tasks.

4. Risk Management Measures

4.1 RMMs related to workers

Organisational measures

The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions.

Eye wash stations should be available in case of accidental contact.

Technical measures

Transport over pipes, technical barrel filling/emptying of barrel with automatic systems (suction pumps etc.) (Good practice)

Use of pliers, grip arms with long handles with manual use “to avoid direct contact and exposure by splashes (no working over one’s head)” (Good practice)

Store in cool, dry, clean, well ventilate areas. (Good practice).

Local exhaust / general ventilation should be present when solids are handled and should be working at 90% efficiency.

RMMs relevant for the handling of peroxide solutions must be employed.

Respiratory protection

Respiratory protection: Local exhaust ventilation with 90% efficiency is required to keep the airborne SAPP concentrations for transfer operations and in the case of dusty solids also for closed processes with occasional exposure at acceptable levels.

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Hand protection

Hand protection is recommended: impervious chemical resistant protective gloves.

Eye protection

Workers handling concentrated SAPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Chemical goggles or face protection shield should be consistent with EN 166 or equivalent.

Skin and body protection

Wearing of suitable acid resistant protective clothing and rubber boots is required.

Hygiene measures

Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate.

4.2 RMMs related to the environment

Organisational measures

Emissions to the environment must meet the requirements of Council Directive 96/61/EC and National Regulations concerning phosphate in industrial wastewater.

Abatement measures related with wastewater

The efficiency of the process is maximised in such a way that minimal emission of phosphates into the wastewater will occur. In addition, phosphate can be precipitated from the wastewater by addition of metal ions.

Abatement measures waste air and solid waste

Emissions of particles into the air of workplaces or the atmosphere can be significantly reduced by the use of cyclones, gas scrubbers or bag filters. Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste.

4.3 Waste related measures

Type of waste

Liquid waste. Packaging material containing solid waste.

Disposal technique

The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information.

Fraction released to environment during waste treatment

Not determined.

5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation)

5.1. Human exposure

Exposure estimation tool(s)

ECETOC TRA (2010) MEASE (version 1.02.01, April 2010, EBRC)

Workers (oral)

The use of SAPP in peroxide stabilisation will not notably contribute to the oral intake of phosphates.

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Workers (inhalation)

DNEL: Worker, long-term, systemic, inhalation: 44.08 mg/m

3

It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany). This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety.

A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits.

Various industrial activities associated with use of SAPP in peroxide stabilisation may result in inhalation exposure of workers to SAPP. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated SAPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the use of SAPP in peroxide stabilisation are adequately controlled.

Process Category

LEV/PRE*

Duration (hours)

Weight fraction (%)

Airborne SAPP conc (mg/m3)

RCR (DNEL) Conclusion

RCR (OEL) Conclusion

Activities performed with aqueous solutions containing 5-25% w/w SAPP (calculated with MEASE)

1 – Use in closed process, no likelihood of exposure No >4 5-25 0.001 2.27E-05

Risk controlled 1E-04 Risk controlled

2 – Use in closed, continuous process with occasional controlled exposure No >4 5-25 0.001 2.27E-05

Risk controlled 1E-04 Risk controlled

3 – Use in closed batch process (synthesis or formulation) No >4 5-25 0.006 1.36E-04

Risk controlled 6E-04 Risk controlled

8b – Transfer of chemicals from/to vessels/ large containers at dedicated facilities No >4 5-25 0.006 1.36E-04

Risk controlled 6E-04 Risk controlled

9 – Transfer of chemicals into small containers (dedicated filling line) No >4 5-25 0.006 1.36E-04

Risk controlled 6E-04 Risk controlled

Activities performed with solids of low dustiness

1 – Use in closed process, no likelihood of exposure No >4 100 0.01 2.27E-04

Risk controlled 1E-03 Risk controlled

2 – Use in closed, continuous process with occasional controlled exposure No >4 100 0.01 2.27E-04

Risk controlled 1E-03 Risk controlled

3 – Use in closed batch process (synthesis or formulation) No >4 100 0.1 2.27E-03

Risk controlled 0.01 Risk controlled

8b – Transfer of chemicals from/to vessels/ large containers No >4 100 0.1 2.27E-03

Risk controlled 0.01 Risk controlled

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at dedicated facilities

9 – Transfer of chemicals into small containers (dedicated filling line) No >4 100 0.1 2.27E-03

Risk controlled 0.01 Risk controlled

Activities performed with solids of medium dustiness

1 – Use in closed process, no likelihood of exposure No >4 100 0.01 2.27E-04

Risk controlled 1E-03 Risk controlled

2 – Use in closed, continuous process with occasional controlled exposure No >4 100 0.5 0.01

Risk controlled 0.05 Risk controlled

3 – Use in closed batch process (synthesis or formulation) No >4 100 1 0.02

Risk controlled 0.1 Risk controlled

8b – Transfer of chemicals from/to vessels/ large containers at dedicated facilities No >4 100 5 0.11

Risk controlled 0.5 Risk controlled

9 – Transfer of chemicals into small containers (dedicated filling line) >4 100 5 0.11

Risk controlled 0.5 Risk controlled

Activities performed with solids of high dustiness

1 – Use in closed process, no likelihood of exposure No 4 to 8 100 0.01 2.27E-04

Risk controlled 1E-03 Risk controlled

2 – Use in closed, continuous process with occasional controlled exposure No 4 to 8 100 1 0.02

Risk controlled 0.1 Risk controlled

3 – Use in closed batch process (synthesis or formulation) No 4 to 8 100 1 0.02

Risk controlled 0.1 Risk controlled

8b – Transfer of chemicals from/to vessels/ large containers at dedicated facilities

No 4 to 8 100 25 0.57 Risk controlled 2.5 RMMs required

90% 4 to 8 100 1.25 0.03 Risk controlled 0.125 Risk controlled

9 – Transfer of chemicals into small containers (dedicated filling line)

No 4 to 8 100 20 0.45 Risk controlled 2 RMMs required

90% 4 to 8 100 2 0.05 Risk controlled 0.2 Risk controlled

* % efficiency

Workers (dermal)

No systemic toxicity effects are expected due to the inorganic nature of the substance however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application.

Indirect exposure via the environment

No indirect exposure of humans via the environment is expected for SAPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed.

Consumer No direct consumer exposure is anticipated with the use of SAPP in peroxide stabilisation. It is

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exposure concluded that the use of SAPP for this purpose is of no risk for the general public.

5.2. Environmental exposure (qualitative assessment)

Environmental release

The use of SAPP can potentially result in aquatic emissions and locally increase the phosphate (PO4

3-) concentration. Phosphates reaching surface water increase the phosphorus content in the

water body which may cause eutrophication and water quality deterioration.

Waste water treatment plants (WWTP)

Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases.

Aquatic pelagic compartment

No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment.

Sediments No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment.

Soil and groundwater

No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment.

Atmospheric compartment

The use of SAPP in peroxide stabilisation is not considered to pose a risk to the atmospheric compartment.

Secondary poisoning

Bioaccumulation in organisms is not relevant for inorganic phosphates.

ES6: Use in oil well drilling fluid applications

1. Short title of exposure scenario 6

Use in oil well drilling fluid applications

2. Description of activities and processes covered in the exposure scenario

Sector of use (SU)

SU 2a: Mining (without offshore industries). SU 2b: Offshore industries. SU 3: Industrial uses.

Product category (PC)

PC 20: Products such as pH-regulators, flocculants, precipitants, neutralization agents.

Process category (PROC)

PROC 3: Use in closed batch process (synthesis or formulation). PROC 4: Use in batch and other process (synthesis) where opportunity for exposure arises. PROC 5: Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact). PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities. PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing). PROC 13: Treatment of articles by dipping and pouring. PROC 26: Handling of solid inorganic substances at ambient temperatures.

Article category (AC)

Not applicable

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Environmental release category (ERC)

ERC 2: Formulation of preparations ERC 4: Industrial use of processing aids in processes and products, not becoming part of articles ERC 6a: Industrial use resulting in manufacture of another substance (use of intermediates) ERC 6b: Industrial use of reactive processing aids ERC 9b: Wide dispersive outdoor use of substances in closed systems

3. Operational conditions

3. 1 Operational conditions related with frequency and quantities of use

Duration of exposure at workplace:

8 hours/day

Frequency of exposure at workplace:

Drilling may be operated for 365 days a year for 24 hours a day.

Annual amount used per site:

The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure.

3.2 Operational conditions related with substance/ product

Physical state

Solid / Liquid

Concentration of substance in mixture

A concentration of 100% w/w was used to assess exposure to the solid substance.

The SAPP concentration in the aqueous solutions delivered to downstream users was set to 5–25% w/w.

The concentration in the working solution was set to 1–5% w/w.The concentration of stabiliser in the peroxide solution will be very low. In addition, worker will be sufficiently protected against direct contact with peroxide solutions.

3.3 Other relevant operational conditions

SAPP is a component of drilling fluids used in mining and offshore drilling. The drilling process may be described as a closed or open batch processes that may results in intimate contact of workers with the drilling mud. SAPP is delivered to mining sites in appropriate containers, unloaded, transferred and stored on-site at dedicated facilities. The substance is transferred to mixing vessels and diluted in water to prepare solutions that are continuously added to the drilling fluid. The drilling may be operated by remote control and is running more or less automatically. Manual intervention may be necessary from time to time. Change, maintenance, repair and cleaning of drilling equipment is performed manually.

4. Risk Management Measures

4.1 RMMs related to workers

Organisational measures

The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions.

Eye wash stations should be available in case of accidental contact.

Technical measures

Store in cool, dry, clean, well ventilate areas. (Good practice).

Workers wear appropriate personal protection equipment, such as gloves, working suits and safety glasses, when handling the SAPP in solid form or as solutions.

Local exhaust ventilation may be present in some situations where solids are handled.

Respiratory protection

Respiratory protection: Personal respiratory protection is not required but exposure to dusts from the handling of solid materials should be reduced by the use of local exhaust ventilation. If local exhaust ventilation is not present then it will be necessary to use personal respiratory protection that is compliant with EN 141 or EN 405.

Hand Hand protection is recommended: impervious chemical resistant protective gloves. Material:

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protection chloroprene gloves or equivalent.

Eye protection

Workers handling concentrated SAPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Goggles or face protection shield should be consistent with EN 166 or equivalent.

Skin and body protection

Wearing of suitable protective clothing and rubber boots is recommended.

Hygiene measures

Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate.

4.2 RMMs related to the environment

Organisational measures

Pyrophosphates are listed in the OSPAR list of substances/preparations used and discharged offshore which are considered to pose little or no risk to the environment (PLONOR). Further, national regulations are available to regulate the waste management from offshore and mining industry.

Abatement measures related with wastewater

Abatement measures waste air and solid waste

Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste.

4.3 Waste related measures

Type of waste

Liquid waste. Packaging material containing solid waste.

Disposal technique

The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information.

Fraction released to environment during waste treatment

Not determined.

5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation)

5.1. Human exposure

Exposure estimation tool(s)

ECETOC TRA (2010) MEASE (version 1.02.01, April 2010, EBRC)

Workers (oral)

The use of SAPP in drilling fluid applications will not notably contribute to the oral intake of phosphates.

Workers (inhalation)

DNEL: Worker, long-term, systemic, inhalation: 44.08 mg/m

3

It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany). This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety.

A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits.

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Various industrial activities associated with the drilling fluid applications may result in inhalation exposure of workers to SAPP. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated SAPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the use of SAPP in drilling fluid applications are adequately controlled.

Process Category Setting

LEV/ PRE*

Duration (hours)

Weight fraction (%)

Airborne SAPP conc (mg/m3)

RCR (DNEL) Conclusion

RCR (OEL)

Conclusion

Activities performed with 1-5% w/w SAPP solutions (calculated with MEASE)

3 – Use in closed batch process (synthesis or formulation)

Indoors No >4 1-5 0.002 4.5E-05 Risk controlled

2E-04 Risk controlled

Outdoors No >4 1-5 0.002 4.5E-05 Risk controlled

2E-04 Risk controlled

4 – Use in batch and other process (synthesis) where opportunity for exposure arises

Indoors No >4 1-5 0.01 2.27E-04 Risk controlled

1E-03 Risk controlled

Outdoors No >4 1-5 0.008 1.8E-04 Risk controlled

8E-04 Risk controlled

5 – Mixing or blending in batch processes

Indoors No >4 1-5 0.01 2.27E-04 Risk controlled

1E-03 Risk controlled

Outdoors No >4 1-5 0.008 1.8E-04 Risk controlled

8E-04 Risk controlled

8b – Transfer of chemicals from/to vessels/ large containers at dedicated facilities

Indoors No >4 1-5 0.002 4.5E-05 Risk controlled

2E-04 Risk controlled

Outdoors No >4 1-5 0.002 4.5E-05 Risk controlled

2E-04 Risk controlled

9 – Transfer of chemicals into small containers (dedicated filling line)

Indoors No >4 1-5 0.002 4.5E-05 Risk controlled

2E-04 Risk controlled

Outdoors No >4 1-5 0.002 4.5E-05 Risk controlled

2E-04 Risk controlled

13 – Treatment of articles by dipping and pouring

Indoors No >4 1-5 0.002 4.5E-05 Risk controlled

2E-04 Risk controlled

Outdoors No >4 1-5 0.002 4.5E-05 Risk controlled

2E-04 Risk controlled

Activities performed with 5-25% w/w SAPP solutions (calculated with MEASE)

3 – Use in closed batch process (synthesis or formulation)

Indoors No >4 5-25 0.006 1.36E-04 Risk controlled

6E-04 Risk controlled

Outdoors No >4 5-25 0.005 1.13E-04 Risk controlled

5E-04 Risk controlled

4 – Use in batch and other process (synthesis) where opportunity for exposure arises

Indoors No >4 5-25 0.03 6.8E-04 Risk controlled

3E-03 Risk controlled

Outdoors No >4 5-25 0.025 5.67E-04 Risk controlled

2.5E-03

Risk controlled

5 – Mixing or blending in batch processes

Indoors No >4 5-25 0.03 6.8E-04 Risk controlled

3E-03 Risk controlled

Outdoors No >4 5-25 0.025 5.67E-04 Risk controlled

2.5E-03

Risk controlled

8b – Transfer of chemicals from/to vessels/ large containers at dedicated facilities

Indoors No >4 5-25 0.006 1.36E-04 Risk controlled

6E-04 Risk controlled

Outdoors No >4 5-25 0.005 1.13E-04 Risk controlled

5E-04 Risk controlled

9 – Transfer of chemicals into small containers (dedicated filling line)

Indoors No >4 5-25 0.006 1.36E-04 Risk controlled

6E-04 Risk controlled

Outdoors No >4 5-25 0.005 1.13E-04 Risk controlled

5E-04 Risk controlled

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13 – Treatment of articles by dipping and pouring

Indoors No >4 5-25 0.006 1.36E-04 Risk controlled

6E-04 Risk controlled

Outdoors No >4 5-25 0.005 1.13E-04 Risk controlled

5E-04 Risk controlled

Activities performed with solids of low dustiness

3 – Use in closed batch process (synthesis or formulation)

Indoors No >4 100 0.1 2.27E-03 Risk controlled

0.01 Risk controlled

Outdoors No >4 100 0.07 1.59E-03 Risk controlled

7E-03 Risk controlled

4 – Use in batch and other process (synthesis) where opportunity for exposure arises

Indoors No >4 100 0.5 0.01 Risk controlled

0.05 Risk controlled

Outdoors No >4 100 0.35 7.94E-03 Risk controlled

0.035 Risk controlled

5 – Mixing or blending in batch processes

Indoors No >4 100 0.5 0.01 Risk controlled

0.05 Risk controlled

Outdoors No >4 100 0.35 7.94E-03 Risk controlled

0.035 Risk controlled

8b – Transfer of chemicals from/to vessels/ large containers at dedicated facilities

Indoors No >4 100 0.1 2.27E-03 Risk controlled

0.01 Risk controlled

Outdoors No >4 100 0.07 1.59E-03 Risk controlled

7E-03 Risk controlled

9 – Transfer of chemicals into small containers (dedicated filling line)

Indoors No >4 100 0.1 2.27E-03 Risk controlled

0.01 Risk controlled

Outdoors No >4 100 0.07 1.59E-03 Risk controlled

7E-03 Risk controlled

Activities performed with solids of medium dustiness

3 – Use in closed batch process (synthesis or formulation)

Indoors No >4 100 1 0.02 Risk controlled

0.1 Risk controlled

Outdoors No >4 100 0.7 0.02 Risk controlled

0.07 Risk controlled

4 – Use in batch and other process (synthesis) where opportunity for exposure arises

Indoors No >4 100 5 0.11 Risk controlled

0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled

0.35 Risk controlled

5 – Mixing or blending in batch processes

Indoors No >4 100 5 0.11 Risk controlled

0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled

0.35 Risk controlled

8b – Transfer of chemicals from/to vessels/ large containers at dedicated facilities

Indoors No >4 100 5 0.11 Risk controlled

0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled

0.35 Risk controlled

9 – Transfer of chemicals into small containers (dedicated filling line)

Indoors No >4 100 5 0.11 Risk controlled

0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled

0.35 Risk controlled

Activities performed with solids of high dustiness

3 – Use in closed batch process (synthesis or formulation)

Indoors No >4 100 1 0.02 Risk controlled

0.1 Risk controlled

Outdoors No >4 100 0.7 0.02 Risk controlled

0.07 Risk controlled

4 – Use in batch and other process (synthesis) where opportunity for exposure

Indoors No >4 100 25 0.06 Risk controlled

2.5 RMMs required

Indoors 90% >4 100 2.5 0.57 Risk controlled

0.25 Risk controlled

Outdoors No >4 100 17.5 0.39 Risk controlled

1.75 RMMs required

Outdoors 90% >4 100 1.75 0.04 Risk controlled

0.175 Risk controlled

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arises

5 – Mixing or blending in batch processes

Indoors No >4 100 25 0.06 Risk controlled

2.5 RMMs required

Indoors 90% >4 100 2.5 0.57 Risk controlled

0.25 Risk controlled

Outdoors No >4 100 17.5 0.39 Risk controlled

1.75 RMMs required

Outdoors 90% >4 100 1.75 0.04 Risk controlled

0.175 Risk controlled

8b – Transfer of chemicals from/to vessels/ large containers at dedicated facilities

Indoors No >4 100 25 0.06 Risk controlled

2.5 RMMs required

Indoors 90% >4 100 1.25 0.03 Risk controlled

0.125 Risk controlled

Outdoors No >4 100 17.5 0.39 Risk controlled

1.75 RMMs required

Outdoors 90% >4 100 1.75 0.04 Risk controlled

0.175 Risk controlled

9 – Transfer of chemicals into small containers (dedicated filling line)

Indoors No >4 100 20 0.45 Risk controlled

2 RMMs required

Indoors 90% >4 100 2 0.05 Risk controlled

0.2 Risk controlled

Outdoors No >4 100 14 0.32 Risk controlled

1.4 RMMs required

Outdoors 90% >4 100 1.40 0.03 Risk controlled

0.14 Risk controlled

* % efficiency

Workers (dermal)

No systemic toxicity effects are expected due to the inorganic nature of the substance however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application.

Indirect exposure via the environment

No indirect exposure of humans via the environment is expected for SAPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed.

Consumer exposure

No direct consumer exposure is anticipated with the use of SAPP in drilling fluid applications. It is concluded that the use of SAPP in drilling fluid applications is of no risk for the general public.

5.2. Environmental exposure (qualitative assessment)

Environmental release

Pyrophosphates are listed in the OSPAR list of substances/preparations used and discharged offshore which are considered to pose little or no risk to the environment (PLONOR). Further, national regulations are available to regulate the waste management from offshore and mining industry.

Waste water treatment plants (WWTP)

Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases.

Aquatic pelagic compartment

No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment.

Sediments No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment.

Soil and groundwater

No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment.

Atmospheric compartment

The use of SAPP in drilling fluid applications is not considered to pose a risk to the atmospheric compartment.

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Secondary poisoning

Bioaccumulation in organisms is not relevant for inorganic phosphates.

ES7: Industrial and professional end use in/for: metal and non-metal surface treatment, metal working fluids, lubricants, greases, heat transfer fluids and hydraulic fluids

1. Short title of exposure scenario 6

Industrial and professional end use in/for metal and non-metal surface treatment, metal working fluids, lubricants, greases, heat transfer fluids and hydraulic fluids

2. Description of activities and processes covered in the exposure scenario

Sector of use (SU)

SU 2a: Mining (without offshore industries). SU 2b: Offshore industries. SU 3: Industrial uses. SU 10: Formulation [mixing] of preparations and/or re-packaging (excluding alloys). SU 14: Manufacture of basic metals, including alloys. SU 15: Manufacture of fabricated metal products, except machinery and equipment. SU 16: Manufacture of computer, electronic and optical products, electrical equipment. SU 17: General manufacturing, e.g. machinery, equipment, vehicles, other transport equipment. SU 22: Professional uses.

Product category (PC)

PC 7: Base metals and alloys. PC 14: Metal surface treatment products, including galvanic and electroplating products. PC 15: Non-metal-surface treatment products. PC 17: Hydraulic fluids. PC 20: Products such as pH-regulators, flocculants, precipitants, neutralization agents. PC 24: Lubricants, greases, release products. PC25: Metal working fluids.

Process category (PROC)

PROC 2: Use in closed, continuous process with occasional controlled exposure. PROC 5: Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact). PROC 7: Industrial spraying. PROC 8a: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities. PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities. PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing). PROC 10: Roller application or brushing. PROC 11: Non industrial spraying PROC 13: Treatment of articles by dipping and pouring. PROC 17: Lubrication at high energy conditions and in partly open process. PROC 18: Greasing at high energy conditions. PROC 19: Hand-mixing with intimate contact and only PPE available. PROC 20: Heat and pressure transfer fluids in dispersive, professional use but closed systems PROC 21: Low energy manipulation of substances bound in materials and/or articles. PROC 22: Potentially closed processing operations with minerals/metals at elevated temperature. PROC 23: Open processing and transfer operations with minerals/metals at elevated temperature. PROC 24: High (mechanical) energy work-up of substances bound in materials and/or articles. PROC 25: Other hot work operations with metals. PROC 26: Handling of solid inorganic substances at ambient temperatures.

Article category (AC)

AC 1: Vehicles. AC 2: Machinery, mechanical appliances, electrical/electronic articles.

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Environmental release category (ERC)

ERC 2: Formulation of preparations. ERC 3: Formulation in materials. ERC 4: Industrial use of processing aids in processes and products, not becoming part of articles. ERC 5: Industrial use resulting in inclusion into or onto a matrix. ERC 6a: Industrial use resulting in manufacture of another substance (use of intermediates) ERC 6b: Industrial use of reactive processing aids. ERC 7: Industrial use of substances in closed systems. ERC 8a: Wide dispersive indoor use of processing aids in open systems ERC 8b: Wide dispersive indoor use of reactive substances in open systems ERC 8c: Wide dispersive indoor use resulting in inclusion into or onto a matrix ERC 8d: Wide dispersive outdoor use of processing aids in open systems ERC 8e: Wide dispersive outdoor use of reactive substances in open systems ERC 8f: Wide dispersive outdoor use resulting in inclusion into or onto a matrix ERC 10a: Wide dispersive outdoor use of long-life articles and materials with low release. ERC 10b: Wide dispersive outdoor use of long-life articles and materials with high or intended release (including abrasive processing). ERC 11a: Wide dispersive indoor use of long-life articles and materials with low release. ERC 11b: Wide dispersive indoor use of long-life articles and materials with high or intended release (including abrasive processing).

3. Operational conditions

3. 1 Operational conditions related with frequency and quantities of use

Duration of exposure at workplace:

8 hours/day

Frequency of exposure at workplace:

Frequency of task: once per day

Annual amount used per site:

The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure.

3.2 Operational conditions related with substance/ product

Physical state

Solid / Liquid

Concentration of substance in mixture

A concentration of 100% w/w was used to assess exposure to the solid substance.

The concentration of SAPP in undiluted aqueous solutions was set to 5–25% w/w.

3.3 Other relevant operational conditions

No information about frequency and duration of the various tasks is available. In the first-tier assessment of exposure a frequency of once a day and an exposure duration of 8 hours was considered. Certain professional activities with solid SAPP (high dustiness) result in exposures greater than the DNEL (PROC 1, PROC 8a, PROC 19/PROC 5). These activities were subsequently modelled using the Advanced REACH Tool ver. 1.0 (ART Consortium 2010) in order to determine a more refined estimate of exposure concentrations. As the ART tool was not specifically developed for professional uses, attempts have been made to model the described processes in a manner that reflects a worst-case for the scenario (e.g. No secondary containment, minimal LEV, etc). Where the exposure estimates were found to be greater than the DNEL, minimal RMM’s were added, the results of the risk characterisation are presented in the table below. This tier 2 assessment indicated that all process were safe, with the exception of outdoor professional spray applications, for which personal respiratory equipment (PRE) with an efficiency of 75% is required to ensure an exposure level below the OEL of 10 mg/m

3.

4. Risk Management Measures

4.1 RMMs related to workers

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Organisational measures

The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions.

Eye wash stations should be available in case of accidental contact.

Technical measures

Store in cool, dry, clean, well ventilate areas. (Good practice).

Workers wear appropriate personal protection equipment, such as gloves, working suits and safety glasses, when handling the SAPP in solid form or as solutions.

Local exhaust ventilation may be present in some situations where solids are handled.

Respiratory protection

Respiratory protection: Personal respiratory protection is not required but exposure to dusts from the handling of solid materials should be reduced by the use of local exhaust ventilation. If local exhaust ventilation is not present then it will be necessary to use personal respiratory protection that is compliant with EN 141 or EN 405.

Hand protection

Hand protection is recommended: impervious chemical resistant protective gloves. Material: chloroprene gloves or equivalent.

Eye protection

Workers handling concentrated SAPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Goggles or face protection shield should be consistent with EN 166 or equivalent.

Skin and body protection

Wearing of suitable protective clothing and rubber boots is recommended.

Hygiene measures

Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate.

4.2 RMMs related to the environment

Organisational measures

Emissions to the environment must meet the requirements of Council Directive 96/61/EC and National Regulations concerning phosphate in industrial wastewater.

Abatement measures related with wastewater

The efficiency of the process is maximised in such a way that minimal emission of phosphates into the wastewater will occur. In addition, phosphate can be precipitated from the wastewater by addition of metal ions.

Abatement measures waste air and solid waste

Emissions of particles into the air of workplaces or the atmosphere can be significantly reduced by the use of cyclones, gas scrubbers or bag filters. Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste.

4.3 Waste related measures

Type of waste

Liquid waste. Packaging material containing solid waste.

Disposal technique

The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information.

Fraction released to environment during waste treatment

Not determined.

5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation)

5.1. Human exposure

Exposure estimation tool(s)

ECETOC TRA (2010) MEASE (version 1.02.01, April 2010, EBRC)

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Advanced REACH Tool ver. 1.0 (ART Consortium 2010)

Workers (oral)

The end use of SAPP in industrial and professional settings will not notably contribute to the oral intake of phosphates.

Workers (inhalation)

DNEL: Worker, long-term, systemic, inhalation: 44.08 mg/m

3

It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany). This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety. A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits. Various industrial activities associated with industrial and professional end use may result in inhalation exposure of workers to the substance. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated SAPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from industrial and professional use are adequately controlled.

Industrial uses

Process Category

LEV /PRE*

Duration (hours)

Weight fraction (%)

Airborne SAPP conc (mg/m3)

RCR (DNEL) Conclusion

RCR (OEL) Conclusion

Activities performed with aqueous solutions (5-25%) (calculated with MEASE)

2 - Use in closed, continuous process with occasional controlled exposure No >4 5-25 0.001 2.27E-05

Risk controlled 1E-04

Risk controlled

5 -Mixing or blending in batch processes (multistage and/or significant contact) No >4 5-25 0.03 6.8E-04

Risk controlled 3E-03

Risk controlled

7 – Industrial spraying

No >4 5-25 12 0.27 Risk controlled 1.2

RMMs required

95% >4 5-25 0.6 0.01 Risk controlled 0.06

Risk controlled

8a – Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities No >4 5-25 0.06 1.36E-03

Risk controlled 6E-03

Risk controlled

8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities No >4 5-25 0.006 1.36E-04

Risk controlled 6E-04

Risk controlled

9 -Transfer of chemicals into small containers (dedicated filling line) No >4 5-25 0.006 1.36E-04

Risk controlled 6E-04

Risk controlled

10 – Roller application or No >4 5-25 0.03 6.8E-04

Risk controlled 3E-03

Risk controlled

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brushing

13 – Treatment of articles by dipping and pouring No >4 5-25 0.006 1.36E-04

Risk controlled 6E-04

Risk controlled

17 – lubrication at high energy conditions and in partly open process No >4 5-25 0.06 1.36E-03

Risk controlled 6E-03

Risk controlled

18 – Greasing at high energy conditions No >4 5-25 0.06 1.36E-03

Risk controlled 6E-03

Risk controlled

20 – Heat and pressure transfer fluids in dispersive professional use but closed systems No >4 5-25 <0.001

<2.27E-05

Risk controlled <1E-04

Risk controlled

Activities performed with solids of low dustiness

2 - Use in closed, continuous process with occasional controlled exposure No >4 100 0.01 2.27E-04

Risk controlled 1E-03

Risk controlled

5 -Mixing or blending in batch processes (multistage and/or significant contact) No >4 100 0.5 0.01

Risk controlled 0.05

Risk controlled

7 – Industrial spraying No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

8a – Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities No >4 100 0.5 0.01

Risk controlled 0.05

Risk controlled

8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities No >4 100 0.1 2.27E-03

Risk controlled 0.01

Risk controlled

9 -Transfer of chemicals into small containers (dedicated filling line) No >4 100 0.1 2.27E-03

Risk controlled 0.01

Risk controlled

10 – Roller application or brushing No >4 100 0.5 0.01

Risk controlled 0.05

Risk controlled

13 - Treatment of articles by dipping and pouring No >4 100 0.1 2.27E-03

Risk controlled 0.01

Risk controlled

17 – lubrication at high energy conditions and in partly open process No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

18 – Greasing at high energy conditions No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

21 - Low energy manipulation of substances bound in materials and/or articles No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

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22 – Potentially closed processing operations with minerals/metals at elevated temperature. Industrial setting.(low fugacity) No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

22 – Potentially closed processing operations with minerals/metals at elevated temperature. Industrial setting.(medium fugacity) No >4 100 3 0.07

Risk controlled 0.3

Risk controlled

22 – Potentially closed processing operations with minerals/metals at elevated temperature. Industrial setting.(high fugacity)

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

23 – Open processing and transfer operations with minerals/metals at elevated temperature. (low fugacity) No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

23 – Open processing and transfer operations with minerals/metals at elevated temperature. (medium fugacity) No >4 100 3 0.07

Risk controlled 0.3

Risk controlled

23 – Open processing and transfer operations with minerals/metals at elevated temperature. (high fugacity)

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

24- High (mechanical) energy work-up of substances bound in materials and/or articles (low fugacity) No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

24- High (mechanical) energy work-up of substances bound in materials and/or articles (medium fugacity) No >4 100 3 0.07

Risk controlled 0.3

Risk controlled

24- High (mechanical) energy work-up of substances

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 2 0.05 Risk controlled 0.2

Risk controlled

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bound in materials and/or articles (high fugacity)

26 – Handling of solid inorganic substances at ambient temperatures (Calculated using MEASE) No >4 >25 1.5 0.03

Risk controlled 0.15

Risk controlled

Activities performed with solids of medium dustiness

2 - Use in closed, continuous process with occasional controlled exposure No >4 100 0.5 0.01

Risk controlled 0.05

Risk controlled

5 -Mixing or blending in batch processes (multistage and/or significant contact) No >4 100 5 0.11

Risk controlled 0.5

Risk controlled

7 – Industrial spraying

No >4 100 20 0.45 Risk controlled 2

RMMs required

90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

8a – Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities No >4 100 5 0.11

Risk controlled 0.5

Risk controlled

8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities No >4 100 5 0.11

Risk controlled 0.5

Risk controlled

9 -Transfer of chemicals into small containers (dedicated filling line) No >4 100 5 0.11

Risk controlled 0.5

Risk controlled

10 – Roller application or brushing No >4 100 5 0.11

Risk controlled 0.5

Risk controlled

13 - Treatment of articles by dipping and pouring No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

17 – lubrication at high energy conditions and in partly open process

No >4 100 20 0.45 Risk controlled 2

RMMs required

90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

18 – Greasing at high energy conditions

No >4 100 20 0.45 Risk controlled 2

RMMs required

90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

21 - Low energy manipulation of substances bound in materials and/or articles No >4 100 3 0.07

Risk controlled 0.3

Risk controlled

22 – Potentially closed processing operations with minerals/metals at elevated No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

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temperature. Industrial setting.(low fugacity)

22 – Potentially closed processing operations with minerals/metals at elevated temperature. Industrial setting.(medium fugacity) No >4 100 3 0.07

Risk controlled 0.3

Risk controlled

22 – Potentially closed processing operations with minerals/metals at elevated temperature. Industrial setting.(high fugacity)

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

23 – Open processing and transfer operations with minerals/metals at elevated temperature. (low fugacity) No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

23 – Open processing and transfer operations with minerals/metals at elevated temperature. (medium fugacity) No >4 100 3 0.07

Risk controlled 0.3

Risk controlled

23 – Open processing and transfer operations with minerals/metals at elevated temperature. (high fugacity)

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

24- High (mechanical) energy work-up of substances bound in materials and/or articles (low fugacity) No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

24- High (mechanical) energy work-up of substances bound in materials and/or articles (medium fugacity) No >4 100 3 0.07

Risk controlled 0.3

Risk controlled

24- High (mechanical) energy work-up of substances bound in materials and/or articles (high fugacity)

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 2 0.05 Risk controlled 0.2

Risk controlled

26 – Handling of solid inorganic No >4 >25 4 0.09

Risk controlled 0.4

Risk controlled

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Disodium dihydrogenpyrophosphate

Revision date: X Version: XX Page 55/77

NB. Please read the NOTICE on the front page.

substances at ambient temperatures (Calculated using MEASE)

Activities performed with solids of high dustiness

2 - Use in closed, continuous process with occasional controlled exposure No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

5 -Mixing or blending in batch processes (multistage and/or significant contact)

No >4 100 25 0.57 Risk controlled 2.5

RMMs required

90% >4 100 2.5 0.06 Risk controlled 0.25

Risk controlled

7 – Industrial spraying

No >4 100 100 2.27 RMMs required 10

RMMs required

90% >4 100 5 0.11 Risk controlled 0.5

Risk controlled

8a – Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities

No >4 100 50 1.13 RMMs required 5

RMMs required

90% >4 100 5 0.11 Risk controlled 0.5

Risk controlled

8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities

No >4 100 25 0.57 Risk controlled 2.5

RMMs required

90% >4 100 1.25 0.03 Risk controlled 0.125

Risk controlled

9 -Transfer of chemicals into small containers (dedicated filling line)

No >4 100 20 0.45 Risk controlled 2

RMMs required

90% >4 100 2 0.05 Risk controlled 0.2

Risk controlled

10 – Roller application or brushing

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

13 - Treatment of articles by dipping and pouring No >4 100 5 0.11

Risk controlled 0.5

Risk controlled

17 – lubrication at high energy conditions and in partly open process

No >4 100 50 1.13 RMMs required 5

RMMs required

90% >4 100 2.5 0.06 Risk controlled

0.25 Risk controlled

18 – Greasing at high energy conditions

No >4 100 50 1.13 RMMs required 5

RMMs required

90% >4 100 2.5 0.06 Risk controlled

0.25 Risk controlled

21 - Low energy manipulation of substances bound in materials and/or articles

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

22 – Potentially closed processing operations with minerals/metals at elevated temperature. Industrial setting.(low fugacity) No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

22 – Potentially No >4 100 3 0.07 Risk 0.3 Risk

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NB. Please read the NOTICE on the front page.

closed processing operations with minerals/metals at elevated temperature. Industrial setting.(medium fugacity)

controlled controlled

22 – Potentially closed processing operations with minerals/metals at elevated temperature. Industrial setting.(high fugacity)

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

23 – Open processing and transfer operations with minerals/metals at elevated temperature. (low fugacity) No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

23 – Open processing and transfer operations with minerals/metals at elevated temperature. (medium fugacity) No >4 100 3 0.07

Risk controlled 0.3

Risk controlled

23 – Open processing and transfer operations with minerals/metals at elevated temperature. (high fugacity)

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

24- High (mechanical) energy work-up of substances bound in materials and/or articles (low fugacity) No >4 100 1 0.02

Risk controlled 0.1

Risk controlled

24- High (mechanical) energy work-up of substances bound in materials and/or articles (medium fugacity)

No >4 100 3 0.07 Risk controlled 0.3

Risk controlled

90% >4 100 6 0.14 Risk controlled 0.6

Risk controlled

24- High (mechanical) energy work-up of substances bound in materials and/or articles (high fugacity)

No >4 100 10 0.23 Risk controlled 1

RMMs required

90% >4 100 2 0.05 Risk controlled 0.2

Risk controlled

26 – Handling of solid inorganic substances at ambient temperatures (Calculated using MEASE)

No >4 >25 10 0.23 Risk controlled 1

RMMs required

82% >4 >25 1.8 0.04 Risk controlled 0.18

Risk controlled

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Disodium dihydrogenpyrophosphate

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NB. Please read the NOTICE on the front page.

* % efficiency

Professional Uses

Process Category Setting

LEV /PRE*

Duration (hours)

Weight fraction (%)

Airborne SAPP conc (mg/m3)

RCR (DNEL) Conclusion

RCR (OEL) Conclusion

Activities performed with aqueous solutions (5-25%) (calculated with MEASE)

5 -Mixing or blending in batch processes (multistage and/or significant contact) Indoors No >4 5-25 0.06

1.36E-03 Risk controlled 6E-03

Risk controlled

8a – Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities

Indoors No >4 5-25 0.03 6.8E-04 Risk controlled 3E-03 Risk controlled

Outdoors No >4 5-25 0.021

4.37E-04 Risk controlled

2.1E-03

Risk controlled

8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities

Indoors No >4 5-25 0.03 6.8E-04 Risk controlled 3E-03 Risk controlled

Outdoors No >4 5-25 0.021

4.37E-04 Risk controlled

2.1E-03

Risk controlled

9 -Transfer of chemicals into small containers (dedicated filling line)

Indoors No >4 5-25 0.03 6.8E-04 Risk controlled 3E-03 Risk controlled

Outdoors No >4 5-25 0.021

4.37E-04 Risk controlled

2.1E-03

Risk controlled

10 – Roller application or brushing

Indoors No >4 5-25 0.03 6.8E-04 Risk controlled 3E-03 Risk controlled

Outdoors No >4 5-25 0.021

4.37E-04 Risk controlled

2.1E-03

Risk controlled

11- Non industrial spraying

Indoors No >4 5-25 12 0.27 Risk controlled 1.2 RMMs required

Indoors 77% >4 5-25 2.7 0.06 Risk controlled 0.27 Risk controlled

Indoors

PRE: 75% (APF = 4) >4 5-25 3 0.07 Risk controlled 0.3

Risk controlled

Outdoors No >4 5-25 8.55 0.19 Risk controlled 0.86

Risk controlled

Outdoors

PRE: 75% (APF = 4) >4 5-25 2.138 0.05 Risk controlled 0.21

Risk controlled

13 – Treatment of articles by dipping and pouring

Indoors No >4 5-25 0.03 6.8E-04 Risk controlled 3E-03 Risk controlled

Outdoors No >4 5-25 0.021

4.37E-04 Risk controlled

2.1E-03

Risk controlled

17 – lubrication at high energy conditions and in partly open

Indoors No >4 5-25 0.6 0.01 Risk controlled 0.06 Risk controlled

Outdoors No >4 5-25 0.428 9.7E-03 Risk controlled 0.043

Risk controlled

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NB. Please read the NOTICE on the front page.

process

18 – Greasing at high energy conditions

Indoors No >4 5-25 0.3 6.8E-03 Risk controlled 0.03 Risk controlled

Outdoors No >4 5-25 0.214

4.88E-03 Risk controlled 0.021

Risk controlled

20 – Heat and pressure transfer fluids in dispersive professional use but closed systems Indoors No >4 5-25 0.001

2.27E-05 Risk controlled 1E-04

Risk controlled

Activities performed with solids of low dustiness

5 -Mixing or blending in batch processes (multistage and/or significant contact) Indoors No >4 100 1

2.27E-03 Risk controlled 0.01

Risk controlled

8a – Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities

Indoors No >4 100 0.5 0.01 Risk controlled 0.05 Risk controlled

Outdoors No >4 100 0.35

7.94E-03 Risk controlled 0.035

Risk controlled

8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities

Indoors No >4 100 0.5 0.01 Risk controlled 0.05 Risk controlled

Outdoors No >4 100 0.35

7.94E-03 Risk controlled 0.035

Risk controlled

9 -Transfer of chemicals into small containers (dedicated filling line)

Indoors No >4 100 0.5 0.01 Risk controlled 0.05 Risk controlled

Outdoors No >4 100 0.35

7.94E-03 Risk controlled 0.035

Risk controlled

10 – Roller application or brushing

Indoors No >4 100 0.5 0.01 Risk controlled 0.05 Risk controlled

Outdoors No >4 100 0.35

7.94E-03 Risk controlled 0.035

Risk controlled

11 – Non-industrial spraying

Indoors No >4 100 1 0.02 Risk controlled 0.1 Risk controlled

Outdoors No >4 100 0.7 0.016 Risk controlled 0.07

Risk controlled

13 - Treatment of articles by dipping and pouring

Indoors No >4 100 0.5 0.01 Risk controlled 0.05 Risk controlled

Outdoors No >4 100 0.35

7.94E-03 Risk controlled 0.035

Risk controlled

17 – lubrication at high energy conditions and in partly open process

Indoors No >4 100 10 0.23 Risk controlled 1 RMMs required

Indoors 90% >4 100 1 0.02 Risk controlled 0.1 Risk controlled

Outdoors No >4 100 7 0.16 Risk controlled 0.7

Risk controlled

18 – Greasing at high energy

Indoors No >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoor No >4 100 3.5 0.08 Risk controlled 0.35 Risk

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NB. Please read the NOTICE on the front page.

conditions s controlled

19 – Hand-mixing with intimate contact and only PPE available

Indoors No >4 100 0.5 0.01 Risk controlled 0.05 Risk controlled

Outdoors No >4 100 0.35

7.94E-03 Risk controlled 0.035

Risk controlled

20 – Heat and pressure transfer fluids in dispersive, professional use but closed systems

Indoors No >4 100 0.01 2.45E-03 Risk controlled 1E-03

Risk controlled

Outdoors No >4 100 0.007

1.59E-04 Risk controlled 7E-04

Risk controlled

21 - Low energy manipulation of substances bound in materials and/or articles

Indoors No >4 100 3 0.07 Risk controlled 0.3 Risk controlled

Outdoors No >4 100 2.1 0.05 Risk controlled 0.21

Risk controlled

23 – Open processing and transfer operations with minerals/metals at elevated temperature. (low fugacity)

Indoors No >4 100 3 0.07 Risk controlled 0.3 Risk controlled

Outdoors No >4 100 2.1 0.05 Risk controlled 0.21

Risk controlled

23 – Open processing and transfer operations with minerals/metals at elevated temperature. (medium fugacity)

Indoors No >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

23 – Open processing and transfer operations with minerals/metals at elevated temperature. (high fugacity)

Indoors No >4 100 20 0.45 Risk controlled 2 RMMs required

Indoors 90% >4 100 4 0.09 Risk controlled 0.4 Risk controlled

Outdoors No >4 100 14 0.32 Risk controlled 1.4

RMMs required

Outdoors

PRE: 90% >4 100 1.4 0.03 Risk controlled 0.14

Risk controlled

24- High (mechanical) energy work-up of substances bound in materials and/or articles (low fugacity)

Indoors No >4 100 3 0.07 Risk controlled 0.3 Risk controlled

Outdoors No >4 100 2.1 0.05 Risk controlled 0.21

Risk controlled

24- High (mechanical) energy work-up of substances bound in

Indoors No >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

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Revision date: X Version: XX Page 60/77

NB. Please read the NOTICE on the front page.

materials and/or articles (medium fugacity)

24- High (mechanical) energy work-up of substances bound in materials and/or articles (high fugacity)

Indoors No >4 100 20 0.45 Risk controlled 2 RMMs required

Indoors 90% >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 14 0.32 Risk controlled 1.4

RMMs required

Outdoors

PRE: 90% >4 100 1.4 0.03 Risk controlled 0.14

Risk controlled

25 – other hot work operations with metals (low fugacity)

Indoors No >4 100 2 0.05 Risk controlled 0.2 Risk controlled

Outdoors No >4 100 7 0.16 Risk controlled 0.7

Risk controlled

25 – other hot work operations with metals (medium fugacity)

Indoors No >4 100 2 0.05 Risk controlled 0.2 Risk controlled

Outdoors No >4 100 7 0.16 Risk controlled 0.7

Risk controlled

25 – other hot work operations with metals (high fugacity)

Indoors No >4 100 10 0.23 Risk controlled 1 RMMs required

Indoors 90% >4 100 2 0.05 Risk controlled 0.2 Risk controlled

Outdoors No >4 100 7 0.16 Risk controlled 0.7

Risk controlled

26 – Handling of solid inorganic substances at ambient temperatures (Calculated using MEASE)

Indoors No >4 >25 3 0.07 Risk controlled 0.3 Risk controlled

Outdoors No >4 >25 2.14 0.05 Risk controlled 0.21

Risk controlled

Activities performed with solids of medium dustiness

5 -Mixing or blending in batch processes (multistage and/or significant contact) Indoors No >4 100 5 0.11 Risk controlled 0.5

Risk controlled

8a – Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities

Indoors No >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities

Indoors No >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

9 -Transfer of chemicals Indoors No >4 100 5 0.11 Risk controlled 0.5

Risk controlled

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Revision date: X Version: XX Page 61/77

NB. Please read the NOTICE on the front page.

into small containers (dedicated filling line)

Outdoors No >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

10 – Roller application or brushing

Indoors No >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

11 – Non-industrial spraying

Indoors No >4 100 20 0.45 Risk controlled 2 RMMs required

Outdoors No >4 100 14 0.32 Risk controlled 0.14

Risk controlled

13 - Treatment of articles by dipping and pouring

Indoors No >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

17 – lubrication at high energy conditions and in partly open process

Indoors No >4 100 50 1.13 RMMs required 5

RMMs required

Indoors 90% >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 35 0.79 Risk controlled 3.5

RMMs required

Outdoors

PRE: 90% >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

18 – Greasing at high energy conditions

Indoors No >4 100 50 1.13 RMMs required 5

RMMs required

Indoors 90% >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 35 0.79 Risk controlled 3.5

RMMs required

Outdoors

PRE: 90% >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

19 – Hand-mixing with intimate contact and only PPE available

Indoors No >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

20 – Heat and pressure transfer fluids in dispersive, professional use but closed systems

Indoors No >4 100 1 0.02 Risk controlled 0.1 Risk controlled

Outdoors No >4 100 0.7 0.015 Risk controlled 0.07

Risk controlled

21 - Low energy manipulation of substances bound in materials and/or articles

Indoors No >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

23 – Open processing and transfer operations with minerals/metals at elevated temperature. (low fugacity)

Indoors No >4 100 3 0.07 Risk controlled 0.3 Risk controlled

Outdoors No >4 100 2.1 0.05 Risk controlled 0.21

Risk controlled

23 – Open processing and transfer operations with

Indoors No >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

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Disodium dihydrogenpyrophosphate

Revision date: X Version: XX Page 62/77

NB. Please read the NOTICE on the front page.

minerals/metals at elevated temperature. (medium fugacity)

23 – Open processing and transfer operations with minerals/metals at elevated temperature. (high fugacity)

Indoors No >4 100 20 0.46 Risk controlled 2 RMMs required

Indoors 90% >4 100 4 0.09 Risk controlled 0.4 Risk controlled

Outdoors No >4 100 14 0.32 Risk controlled 1.4

RMMs required

Outdoors

PRE: 90% >4 100 1.4 0.03 Risk controlled 0.14

Risk controlled

24- High (mechanical) energy work-up of substances bound in materials and/or articles (low fugacity)

Indoors No >4 100 3 0.07 Risk controlled 0.3 Risk controlled

Outdoors No >4 100 2.1 0.05 Risk controlled 0.21

Risk controlled

24- High (mechanical) energy work-up of substances bound in materials and/or articles (medium fugacity)

Indoors No >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

24- High (mechanical) energy work-up of substances bound in materials and/or articles (high fugacity)

Indoors No >4 100 20 0.46 Risk controlled 2 RMMs required

Indoors 90% >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 14 0.32 Risk controlled 1.4

RMMs required

Outdoors

PRE: 90% >4 100 1.4 0.03 Risk controlled 0.14

Risk controlled

25 – other hot work operations with metals (low fugacity)

Indoors No >4 100 10 0.23 Risk controlled 1 RMMs required

Indoors 90% >4 100 2 0.05 Risk controlled 0.2 Risk controlled

Outdoors No >4 100 7 0.16 Risk controlled 0.7

Risk controlled

25 – other hot work operations with metals (medium fugacity)

Indoors No >4 100 10 0.23 Risk controlled 1 RMMs required

Outdoors No >4 100 7 0.16 Risk controlled 0.7

Risk controlled

25 – other hot work operations with metals (high fugacity)

Indoors No >4 100 10 0.23 Risk controlled 1 RMMs required

Indoors 90% >4 100 2 0.05 Risk controlled 0.2 Risk controlled

Outdoors No >4 100 7 0.16 Risk controlled 0.7

Risk controlled

26 – Handling of solid inorganic substances at ambient temperatures

Indoors No >4 >25 8 0.18 Risk controlled 0.8 Risk controlled

Outdoors No >4 >25 5.7 0.13 Risk controlled 0.57

Risk controlled

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Disodium dihydrogenpyrophosphate

Revision date: X Version: XX Page 63/77

NB. Please read the NOTICE on the front page.

(Calculated using MEASE)

Activities performed with solids of high dustiness

5 -Mixing or blending in batch processes (multistage and/or significant contact)

Indoors No >4 100 50 1.13 RMMs required 5

RMMs required

Indoors 90% >4 100 10 0.23 Risk controlled 1 RMMs required

Indoors

90% PRE: 90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

8a – Transfer of chemicals from/to vessels/ large containers at non-dedicated facilities See below for Tier 2 assessment

Indoors No >4 100 50 1.13 RMMs required 5

RMMs required

Indoors 90% >4 100 10 0.23 Risk controlled 1 RMMs required

Indoors

90% PRE: 90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

Outdoors No >4 100 35 0.79 Risk controlled 3.5

RMMs required

Outdoors

PRE: 90% >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities See below for Tier 2 assessment

Indoors No >4 100 50 1.13 RMMs required 5

RMMs required

Indoors 90% >4 100 10 0.23 Risk controlled 1 RMMs required

Indoors

90% PRE: 90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

Outdoors No >4 100 35 0.79 Risk controlled 3.5

RMMs required

Outdoors

PRE: 90% >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

9 -Transfer of chemicals into small containers (dedicated filling line)

Indoors No >4 100 20 0.46 Risk controlled 2 RMMs required

Indoors 90% >4 100 4 0.09 Risk controlled 0.4 Risk controlled

Outdoors No >4 100 14 0.32 Risk controlled 1.4

RMMs required

Outdoors

PRE: 90% >4 100 1.4 0.03 Risk controlled 0.14

Risk controlled

10 – Roller application or brushing

Indoors No >4 100 10 0.23 Risk controlled 1 RMMs required

Indoors 90% >4 100 2 0.05 Risk controlled 0.2 Risk controlled

Outdoors No >4 100 7 0.16 Risk controlled 0.7

Risk controlled

Outdoors

PRE: 90% >4 100 0.7 0.02 Risk controlled 0.07

Risk controlled

11 – Non-industrial spraying See below for Tier 2 assessment

Indoors No >4 100 200 4.54 RMMs required 20

RMMs required

Indoors 90% >4 100 40 0.91 Risk controlled 4 RMMs required

Indoors

90% PRE: 90% >4 100 40 0.91 Risk controlled 4

RMMs required

Outdoors No >4 100 140 3.18

RMMs required 14

RMMs required

Outdoors

PRE: 90% >4 100 14 0.32 Risk controlled 1.4

RMMs required

13 - Treatment of articles by dipping and pouring

Indoors No >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

17 – lubrication at high energy

Indoors No >4 100 200 4.54 RMMs required 20

RMMs required

Indoors 90% >4 100 20 0.45 Risk controlled 2 RMMs required

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Disodium dihydrogenpyrophosphate

Revision date: X Version: XX Page 64/77

NB. Please read the NOTICE on the front page.

conditions and in partly open process

Indoors

90% PRE: 90% >4 100 2 0.05 Risk controlled 0.2

Risk controlled

Outdoors No >4 100 140 3.18

RMMs required 14

RMMs required

Outdoors

PRE: 95% >4 100 7 0.16 Risk controlled 0.7

Risk controlled

18 – Greasing at high energy conditions

Indoors No >4 100 200 4.54 RMMs required 20

RMMs required

Indoors 90% >4 100 20 0.45 Risk controlled 2 RMMs required

Indoors

90% PRE: 90% >4 100 2 0.05 Risk controlled 0.2

Risk controlled

Outdoors No >4 100 140 3.18

RMMs required 14

RMMs required

Outdoors 95% >4 100 7 0.16 Risk controlled 0.7

Risk controlled

19 – Hand-mixing with intimate contact and only PPE available See below for Tier 2 assessment

Indoors No >4 100 50 1.13 RMMs required 5

RMMs required

Indoors 90% >4 100 10 0.23 Risk controlled 1 RMMs required

Indoors

90% PRE: 90% >4 100 1 0.02 Risk controlled 0.1

Risk controlled

Outdoors No >4 100 35 0.79 Risk controlled 3.5

RMMs required

Outdoors

PRE 95% >4 100 1.75 0.04 Risk controlled 0.175

Risk controlled

19 – Hand-mixing with intimate contact and only PPE available (reduced activity time)

Indoors No 1 - 4 100 30 0.68 Risk controlled 3 RMMs required

Indoors 90% 1 - 4 100 6 0.14 Risk controlled 0.6 Risk controlled

Outdoors No 1 - 4 100 21 0.48 Risk controlled 2.1

RMMs required

Outdoors

PRE 90% 1 - 4 100 2.1 0.05 Risk controlled 0.21

Risk controlled

20 – Heat and pressure transfer fluids in dispersive, professional use but closed systems

Indoors No >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

21 - Low energy manipulation of substances bound in materials and/or articles

Indoors No >4 100 20 0.45 Risk controlled 2 RMMs required

Indoors

90% PRE: 90% >4 100 4 0.09 Risk controlled 0.4

Risk controlled

Outdoors No >4 100 14 0.32 Risk controlled 1.4

RMMs required

Outdoors

PRE: 90% >4 100 1.4 0.03 Risk controlled 0.14

Risk controlled

23 – Open processing and transfer operations with minerals/metals at elevated temperature. (low fugacity)

Indoors No >4 100 3 0.07 Risk controlled 0.3 Risk controlled

Outdoors No >4 100 2.1 0.05 Risk controlled 0.21

Risk controlled

23 – Open processing and transfer operations with minerals/metals at

Indoors No >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

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Revision date: X Version: XX Page 65/77

NB. Please read the NOTICE on the front page.

elevated temperature. (medium fugacity)

23 – Open processing and transfer operations with minerals/metals at elevated temperature. (high fugacity)

Indoors No >4 100 20 0.45 Risk controlled 2 RMMs required

Indoors 90% >4 100 4 0.09 Risk controlled 0.4 Risk controlled

Outdoors No >4 100 14 0.32 Risk controlled 1.4

RMMs required

Outdoors

PRE: 90% >4 100 1.4 0.03 Risk controlled 0.14

Risk controlled

24- High (mechanical) energy work-up of substances bound in materials and/or articles (low fugacity)

Indoors No >4 100 3 0.07 Risk controlled 0.3 Risk controlled

Outdoors No >4 100 2.1 0.05 Risk controlled 0.21

Risk controlled

24- High (mechanical) energy work-up of substances bound in materials and/or articles (medium fugacity)

Indoors No >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 3.5 0.08 Risk controlled 0.35

Risk controlled

24- High (mechanical) energy work-up of substances bound in materials and/or articles (high fugacity)

Indoors No >4 100 20 0.45 Risk controlled 2 RMMs required

Indoors 90% >4 100 5 0.11 Risk controlled 0.5 Risk controlled

Outdoors No >4 100 14 0.32 Risk controlled 1.4

RMMs required

Outdoors

PRE: 90% >4 100 1.4 0.03 Risk controlled 0.14

Risk controlled

25 – other hot work operations with metals (low fugacity)

Indoors No >4 100 10 0.23 Risk controlled 1 RMMs required

Indoors 90% >4 100 2 0.05 Risk controlled 0.2 Risk controlled

Outdoors No >4 100 7 0.16 Risk controlled 0.7

Risk controlled

25 – other hot work operations with metals (medium fugacity)

Indoors No >4 100 10 0.23 Risk controlled 1 RMMs required

Indoors 90% >4 100 2 0.05 Risk controlled 0.2 Risk controlled

Outdoors No >4 100 7 0.16 Risk controlled 0.7

Risk controlled

25 – other hot work operations with metals (high fugacity)

Indoors No >4 100 10 0.23 Risk controlled 1 RMMs required

Indoors 90% >4 100 2 0.05 Risk controlled 0.2 Risk controlled

Outdoors No >4 100 7 0.16 Risk controlled 0.7

Risk controlled

26 – Handling of solid inorganic substances at ambient temperatures (Calculated

Indoors No >4 >25 20 0.45 Risk controlled 2 RMMs required

Indoors 80% >4 >25 4 0.09 Risk controlled 0.4 Risk controlled

Outdoors No >4 >25 14.24 0.32 Risk controlled 1.42

RMMs required

Outdoors

PRE: 75% (APF >4 >25 3.563 0.08 Risk controlled 0.36

Risk controlled

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using MEASE)

= 4)

* % efficiency

Tier 2 assessment; High exposure professional applications

PROC Concentration of SAPP in product

LEV Inhalation Exposure Estimate (mg/m3)

RCR (DNEL) Conclusion

RCR (OEL) Conclusion

PROC 11: Professional spraying (indoors)

50 – 90% Other LEV systems (50% reduction). No secondary containment No PRE.

3.4 0.07 Risk controlled

0.34 Risk controlled

PROC 11: Professional spraying (outdoors)

PROC 11: Professional spraying (outdoors)

50 – 90% Outdoors. No PRE

12 0.27 Risk controlled

1.2 RMMs required

50 – 90% Outdoors. PRE: Efficiency = 75% (APF=4)

3 0.07 Risk controlled

0.3 Risk controlled

PROC 8a: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities (Indoors).

Also considered to cover PROC 8b

50 – 90% Other LEV systems (50% reduction). No secondary containment No PRE.

1 0.02 Risk controlled

0.1 Risk controlled

PROC 8a: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities (outdoors).

Also considered to cover PROC 8b

50 – 90% Outdoors. No PRE.

3.5 0.08 Risk controlled

0.35 Risk controlled

PROC 19: Hand-mixing with intimate contact and only PPE available (indoors)

50 – 90% Other LEV systems (50% reduction). No secondary containment No PRE

0.34 7.7E-03 Risk controlled

0.034 Risk controlled

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PROC 19: Hand-mixing with intimate contact and only PPE available (outdoors)

50 – 90% Outdoors. No secondary containment No PRE

1.2 0.03 Risk controlled

0.12 Risk controlled

Workers (dermal)

No systemic toxicity effects are expected due to the inorganic nature of the substance however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application.

Indirect exposure via the environment

No indirect exposure of humans via the environment is expected for SAPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed.

Consumer exposure

No direct consumer exposure is anticipated with the use of SAPP for industrial and professional end use. It is concluded that the use of SAPP in metal and non-metal surface treatment, metal working fluids, lubricants, greases, heat transfer fluids and hydraulic fluids is of no risk for the general public.

5.2. Environmental exposure (qualitative assessment)

Environmental release

The use of SAPP can potentially result in aquatic emissions and locally increase the phosphate (PO4

3-) concentration. Phosphates reaching surface water increase the phosphorus content in the

water body which may cause eutrophication and water quality deterioration.

Waste water treatment plants (WWTP)

Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases.

Aquatic pelagic compartment

No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment.

Sediments No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment.

Soil and groundwater

No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment.

Atmospheric compartment

Industrial and professional end use of SAPP is not considered to pose a risk to the atmospheric compartment.

Secondary poisoning

Bioaccumulation in organisms is not relevant for inorganic phosphates. m

ES8: Professional use of cleaning products containing SAPP in dairy cleaning applications

1. Short title of exposure scenario 8

Professional use of cleaning products in dairy cleaning applications

2. Description of activities and processes covered in the exposure scenario

Sector of use (SU)

SU 10: Formulation [mixing] of preparations and/or re-packaging (excluding alloys) SU 22: Professional uses.

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Product category (PC)

PC 35: Washing and cleaning products (including solvent based products).

Process category (PROC)

PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities. PROC 19: Hand-mixing with intimate contact and only PPE available.

Article category (AC)

Not applicable

Environmental release category (ERC)

ERC 8b: wide dispersive indoor use of reactive substances in open systems. ERC 8e: wide dispersive outdoor use of reactive substances in open systems.

3. Operational conditions

3. 1 Operational conditions related with frequency and quantities of use

Duration of exposure at workplace:

The transfer of cleaners may occur once a day during a short period of time of approximately 15 minutes. This may be followed by a short mixing and blending process of 15 minutes duration. The cleaning process occurs inside the equipment so that there is very limited opportunity for exposure. At the end of the cleaning procedure the equipment will be emptied and flushed with water to remove residuals of cleaning solutions and impurities. The watering will considerably dilute any remaining SAPP in the milking equipment.

Frequency of exposure at workplace:

Annual amount used per site:

The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure.

3.2 Operational conditions related with substance/ product

Physical state

Solid / Liquid

Concentration of substance in mixture

No information about the concentration of the substance in cleaners or in dilute solutions is available. In the first-tier assessment of exposure the concentration of SAPP in liquid or solid cleaning products was set to 5–25% w/w.

3.3 Other relevant operational conditions

SAPP is used as cleaning agent in dairy applications, for example to remove soapstone. Appropriate liquid or powdery cleaning agents are available to professional users. The products are filled into the milking equipment at dedicated facilities. A short mixing and blending process with some opportunity for exposure may follow. The cleaning process occurs inside the equipment so that there is limited opportunity for exposure.

4. Risk Management Measures

4.1 RMMs related to workers

Organisational measures

The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions.

Eye wash stations should be available in case of accidental contact.

Technical measures

Store in cool, dry, clean, well ventilate areas. (Good practice).

Workers handling concentrated SAPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles.

Respiratory protection

Respiratory protection: Respiratory protection is not required but breathing masks may be used when solid cleaners are handled.

Hand Hand protection is recommended: impervious chemical resistant protective gloves. Material:

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protection chloroprene gloves or equivalent.

Eye protection

Workers handling concentrated SAPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Goggles or face protection shield should be consistent with EN 166 or equivalent.

Skin and body protection

Wearing of suitable protective clothing and rubber boots is recommended.

Hygiene measures

Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate.

4.2 RMMs related to the environment

Organisational measures

Emissions to the environment must meet the requirements of Council Directive 96/61/EC and National Regulations concerning phosphate in industrial wastewater.

Abatement measures related with wastewater

The efficiency of the process is maximised in such a way that minimal emission of phosphates into the wastewater will occur. In addition, phosphate can be precipitated from the wastewater by addition of metal ions.

Abatement measures waste air and solid waste

Emissions of particles into the air of workplaces or the atmosphere can be significantly reduced by the use of cyclones, gas scrubbers or bag filters. Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste.

4.3 Waste related measures

Type of waste

Liquid waste. Packaging material containing solid waste.

Disposal technique

The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information.

Fraction released to environment during waste treatment

Not determined.

5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation)

5.1. Human exposure

Exposure estimation tool(s)

ECETOC TRA (2010) MEASE (version 1.02.01, April 2010, EBRC)

Workers (oral)

The use of SAPP in dairy cleaning applications will not notably contribute to the oral intake of phosphates.

Workers (inhalation)

DNEL: Worker, long-term, systemic, inhalation: 44.08 mg/m

3

It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany). This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety.

A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits.

Various professional activities associated with this cleaning activity may result in inhalation exposure of workers to SAPP. The risk characterisation ratios for these activities are given in the table below.

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Workers handling concentrated SAPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the use of SAPP in dairy cleaning applications are adequately controlled.

Process Category

LEV/ PRE

Duration (hours)

Weight fraction (%)

Airborne SAPP conc (mg/m3)

RCR (DNEL)

Conclusion

RCR (OEL) Conclusion

Activities performed with undiluted cleaner containing 5-25% w/w SAPP (calculated with MEASE)

8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities No 0.25 5-25 0.03 6.81E-04

Risk controlled 3E-03

Risk controlled

19 – Hand-mixing with intimate contact and only PPE available No 0.25 5-25 0.03 6.81E-04

Risk controlled 3E-03

Risk controlled

Activities performed with solid cleaner of low dustiness containing SAPP

8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities No 0.25 100 0.1 2.27E-03

Risk controlled 0.01

Risk controlled

19 – Hand-mixing with intimate contact and only PPE available No 0.25 100 0.1 2.27E-03

Risk controlled 0.01

Risk controlled

Activities performed with solid cleaner of medium dustiness containing SAPP

8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities No 0.25 100 1 0.03

Risk controlled 0.1

Risk controlled

19 – Hand-mixing with intimate contact and only PPE available No 0.25 100 1 0.03

Risk controlled 0.1

Risk controlled

Workers (dermal)

No systemic toxicity effects are expected due to the inorganic nature of the substance however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application.

Indirect exposure via the environment

No indirect exposure of humans via the environment is expected for SAPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed.

Consumer exposure

No direct consumer exposure is anticipated with the industrial and professional use of washing and cleaning products. It is concluded that the use of SAPP in dairy cleaning applications is of no risk for the general public.

5.2. Environmental exposure (qualitative assessment)

Environmental release

The use of SAPP can potentially result in aquatic emissions and locally increase the phosphate (PO4

3-) concentration. Phosphates reaching surface water increase the phosphorus content in the

water body which may cause eutrophication and water quality deterioration.

Waste water treatment plants (WWTP)

Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases.

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Aquatic pelagic compartment

No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment.

Sediments No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment.

Soil and groundwater

No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment.

Atmospheric compartment

The use of SAPP in detergents and cleaning fluids is not considered to pose a risk to the atmospheric compartment.

Secondary poisoning

Bioaccumulation in organisms is not relevant for inorganic phosphates.

ES9: Professional and consumer use of construction and D.I.Y products

1. Short title of exposure scenario 9

Professional and consumer use of construction chemicals

2. Description of activities and processes covered in the exposure scenario

Sector of use (SU)

SU 19: Building and construction work SU 21: Consumer uses. SU 22: Professional uses.

Product category (PC)

PC 1: Adhesives, sealants PC 9a: Coatings and paints, thinners, paint removes PC 9b: Fillers, putties, plasters, modelling clay

Process category (PROC)

PROC 8a: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities. PROC 10: Roller application or brushing. PROC 11: Non industrial spraying. PROC 13: Treatment of articles by dipping and pouring.

Article category (AC)

AC 4: Stone, plaster, cement, glass and ceramic articles. AC 11: Wood articles. AC 13: Plastic articles.

Environmental release category (ERC)

ERC 8a: wide dispersive indoor use of processing aids in open systems. ERC 8c: Wide dispersive indoor use resulting in inclusion into or onto a matrix. ERC 8d: Wide dispersive outdoor use of processing aids in open systems. ERC 8f: Wide dispersive outdoor use resulting in inclusion into or onto a matrix.

3. Operational conditions

3. 1 Operational conditions related with frequency and quantities of use

Duration of exposure at workplace:

No measured workplace concentrations or personal exposure concentrations are available to describe the professional use of SAPP in construction materials. The CEPE has developed exposure scenarios for consumer use of coatings in the context of the REACH regulation (CEPE 2009). These scenarios indicate a maximum duration of use ranging from 4 to 8 hours. No use frequency is given in the CEPE scenarios. The frequency of paint use by consumers is between 1 to 3 times a year depending on the type of paint used; the amount of paint used per application ranges from approximately 1 to 1.3 kg (RIVM 2007a).

Frequency of exposure at workplace:

Annual amount used per site:

The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure.

3.2 Operational conditions related with substance/ product

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Physical state

Solid / Liquid

Concentration of substance in mixture

The concentration of SAPP in construction chemicals for professional use was set to 5–25% w/w. Consumer exposure to SAPP resulting from the brushing and rolling of paints containing up to 10% w/w of the substance was assessed.

3.3 Other relevant operational conditions

Professional exposure to SAPP was modelled with the Tier 1 exposure estimation tool MEASE (EBRC) due to the fact that the ECETOC TRA tool (ECETOC 2010) does not consider solid preparations. The ConsExpo tool (RIVM 2006) was used to assess the consumer exposure to SAPP resulting from the brushing and rolling of paints containing up to 10% w/w of the substance.

4. Risk Management Measures

4.1 RMMs related to workers and consumers

Organisational measures

No specific risk management measures may be expected.

Technical measures

No specific risk management measures may be expected.

Respiratory protection

Good general ventilation, e.g. by open doors and windows, should be established.

The use of half-face respiratory masks during spray painting is recommended to consumers.

Hand protection

Hand protection is recommended: impervious chemical resistant protective gloves. Material: chloroprene gloves or equivalent.

Eye protection

Workers handling concentrated SAPP solutions are obliged to wear chemical resistant safety goggles.

Skin and body protection

Use of appropriate gloves and working suits is recommended.

Hygiene measures

Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate.

4.2 RMMs related to the environment

Organisational measures

Not applicable

Abatement measures related with wastewater

Wastewater is treated via chemical/biological municipal wastewater treatment plants.

Abatement measures waste air and solid waste

Not applicable.

4.3 Waste related measures

Type of waste

Minor amounts of product may remain in the packages, which will be disposed of via waste and may be incinerated or deposited in landfills.

Disposal technique

Fraction released to

Not determined.

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environment during waste treatment

5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation)

5.1. Human exposure

Exposure estimation tool(s)

MEASE (version 1.02.01, April 2010, EBRC) ConsExpo (RIVM 2006)

Workers (oral)

The use of SAPP in construction materials will not notably contribute to the oral intake of phosphates.

Workers (inhalation)

DNEL: Worker, long-term, systemic, inhalation: 44.08 mg/m

3

It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany). This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety. A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits. Various industrial activities associated with industrial and professional end use may result in inhalation exposure of workers to the substance. The risk characterisation ratios for these activities are given in the table below. The use of safety goggles when handling the undiluted substance is required due to the eye irritating properties of SAPP. The MEASE tool predicts dermal doses of liquid and solid materials applied to the unprotected skin. A number of activities may lead to extensive skin contact with undiluted substance or concentrated solutions. The use of appropriate gloves and working suits when handling the undiluted substance is recommended.

Process Category LEV/PRE Duration (hours)

Weight fraction (%)

Airborne SAPP conc. (mg/m3)

Dermal dose substance (mg/kg/day)

Activities performed with aqueous solutions containing 5-25% w/w SAPP (calculated with MEASE)

8a - Transfer of substances or preparations from/to vessels/ large containers at non-dedicated facilities

No >4 5-25 0.03 2.06

Outdoors (ventilation) >4 5-25 0.021 2.06

10 – Roller application or brushing

No >4 5-25 0.03 2.06

Outdoors (ventilation) >4 5-25 0.021 2.06

11 – Non-industrial spraying

No >4 5-25 12 2.06

LEV 77% >4 5-25 2.7 2.06

Outdoors (ventilation) >4 5-25 8.55 2.06

13 – Treatment of articles by dipping and pouring

No >4 5-25 0.03 2.06

Outdoors (ventilation) >4 5-25 0.021 2.06

Activities performed with solid preparations of low dustiness containing SAPP (calculated with MEASE)

8a - Transfer of substances or preparations from/to vessels/ large containers at non-dedicated facilities

No >4 5-25 0.3 4.11

Outdoors (ventilation) >4 5-25 0.21 4.11

10 – Roller application or brushing

No >4 5-25 0.3 4.11

Outdoors (ventilation) >4 5-25 0.21 4.11

11 – Non-industrial spraying

No >4 5-25 0.6 6.43

Outdoors (ventilation) >4 5-25 0.43 6.43

13 – Treatment of articles by dipping and No >4 5-25 0.3 2.06

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pouring Outdoors (ventilation) >4 5-25 0.21 2.06

Activities performed with solid preparations of medium dustiness containing SAPP (calculated with MEASE)

8a - Transfer of substances or preparations from/to vessels/ large containers at non-dedicated facilities

No >4 5-25 3 4.11

Outdoors (ventilation) >4 5-25 2.1

10 – Roller application or brushing

No >4 5-25 3 4.11

Outdoors (ventilation) >4 5-25 2.1

11 – Non-industrial spraying

No >4 5-25 12 6.43

PRE: 75% (APF = 4) >4 5-25 3 6.43

Outdoors (ventilation) >4 5-25 8.55 6.43

Outdoors (ventilation) & PRE: 75% (APF=4) >4 5-25 2.1 6.43

13 – Treatment of articles by dipping and pouring

No >4 5-25 3 2.06

Outdoors (ventilation) & PRE: 75% (APF=4) >4 5-25 2.1 2.06

Workers (dermal)

No systemic toxicity effects are expected due to the inorganic nature of the substance. Local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application.

Indirect exposure via the environment

No indirect exposure of humans via the environment is expected for SAPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed.

Consumer exposure (inhalation)

DNEL: Consumer, long-term, systemic, inhalation: 10.87 mg/m

3

Consumer exposure from a range of construction and or do it yourself products is likely. The risk characterisation ratios for the main products are given in the table blow. Consumers handling D.I.Y products, paints and construction products are not expected to wear PRE or dermal protection, however absorption via the dermal route is not considered to be major route of exposure. Likewise, such products are not expected to contribute significantly to oral SAPP exposure and, as such, only the inhalation route is assessed. Filler and plaster products would not be expected to result in inhalation exposure (in accordance with ConsExpo).

Product type Exposure estimate (8hr TWA)

RCR (inhalation) Conclusion

High-solid paint 1.8E-06 1.66E-07 Risk controlled

Water-based point 1.84E-07 1.69E-08 Risk controlled

Solvent-based paints 1.09E-06 1.0E-07 Risk controlled

Wall-based paints 5.15E-06 4.74E-07 Risk controlled

Spray paint 1.97 0.18 Risk controlled

Pneumatic spraying 0.482 0.04 Risk controlled

Bottled glue – universal wood glue

9.01E-06 8.29E-07 Risk controlled

General coatings 2.27E-06 2.09E-07 Risk controlled

5.2. Environmental exposure (qualitative assessment)

Environmental release

The use of SAPP can potentially result in aquatic emissions and locally increase the phosphate (PO4

3-) concentration. Phosphates reaching surface water increase the phosphorus content in the

water body which may cause eutrophication and water quality deterioration.

Waste water treatment plants (WWTP)

Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC

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concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases.

Aquatic pelagic compartment

No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment.

Sediments No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment.

Soil and groundwater

No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment.

Atmospheric compartment

The use of SAPP in professional and consumer D.I.Y and construction products is not considered to pose a risk to the atmospheric compartment.

Secondary poisoning

Bioaccumulation in organisms is not relevant for inorganic phosphates.

ES10: Consumer use of toothpaste and other dental care products containing SAPP

1. Short title of exposure scenario 10

Consumer use of toothpaste and other products

2. Description of activities and processes covered in the exposure scenario

Sector of use (SU)

SU 21: Consumer uses: private households.

Product category (PC)

PC 39: Cosmetics, personal care products.

Process category (PROC)

Not applicable.

Article category (AC)

Not applicable

Environmental release category (ERC)

ERC 8a: wide dispersive indoor use of processing aids in open systems. ERC 8b: wide dispersive indoor use of reactive substances in open systems.

3. Operational conditions

Human exposure to SAPP from use of toothpaste and other dental care products is to be assessed under the EU Cosmetics Directive and is not investigated under the REACH regulation. Therefore, operational conditions are not relevant for this scenario.

4. Risk Management Measures

4.1 RMMs related to consumers

General advice

Consumer products should be intrinsically safe. The human exposure to SAPP from use of toothpaste and other dental care products is to be assessed under the EU Cosmetics Directive and is not investigated under the REACH regulation. Risk management measures relating to the use of SAPP in dental care products should be conveyed on the package and no further consideration is required.

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4.2 RMMs related to the environment

Organisational measures

Not applicable

Abatement measures related with wastewater

Wastewater is treated via chemical/biological municipal wastewater treatment plants.

Abatement measures waste air and solid waste

Not applicable.

4.3 Waste related measures

Type of waste

After brushing teeth the mouth is flushed with water and the greatest portion of the toothpaste is disposed of via the sewer system. Sewage will be treated in municipal wastewater treatment plants. Minor amounts of products remain in the packages and will be disposed of via the regular household waste. Household waste may be deposited in a landfill.

Disposal technique

Fraction released to environment during waste treatment

Not applicable.

5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation)

5.1. Human exposure

Exposure estimation tool(s)

Not applicable

Consumer exposure

Consumer exposure to SAPP from the use of toothpaste is not assessed under REACH. The potential risk for consumers from the use of cosmetics and personal care products falls under the EU Cosmetics Directive.

Worker exposure

No occupational exposure to SAPP is expected from the use of toothpaste.

Indirect exposure via the environment

No indirect exposure of humans via the environment is expected for SAPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed.

5.2. Environmental exposure (qualitative assessment)

The use of SAPP can potentially result in aquatic emissions and locally increase the phosphate (PO43-

) concentration. Phosphates reaching surface water increase the phosphorus content in the water body which may cause eutrophication and water quality deterioration. Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases. No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment. Bioaccumulation in organisms is not relevant for inorganic phosphates.

Page 77: SAFETY DATA SHEET Date of issue: xxx Disodium ... Documents/P-I093/Other/P_I… · SAFETY DATA SHEET Date of issue: xxx Disodium dihydrogenpyrophosphate Revision date: X Version:

SAFETY DATA SHEET Date of issue: xxx

Disodium dihydrogenpyrophosphate

Revision date: X Version: XX Page 77/77

NB. Please read the NOTICE on the front page.