01/04/2018 Kit Components Product code Description GSP Neonatal Total Galactose kit Components: ......

Kit Components01/04/2018

Product code Description

3309-001U GSP Neonatal Total Galactose kit

Components:

13807549-2 Neonatal Extraction Solution

13807625 Neonatal Total Galactose Assay Reagent 1

13807626 Neonatal Total Galactose Assay Reagent 2

13807624 Neonatal Total Galactose Assay Buffer

13807627 Neonatal Total Galactose Reconstitution Solution

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Safety Data Sheetacc. to OSHA HCS

Printing date 01/04/2018 Reviewed on 10/30/2017

46.0.2

* 1 Identification

· Product identifier

· Trade name: Neonatal Extraction Solution

· Article number: 13807549-2· Application of the substance / the mixture

Laboratory chemicalsIn vitro diagnostics

· Details of the supplier of the safety data sheet· Manufacturer/Supplier:

PerkinElmerWallac OyP.O. Box 10FI-20101 TurkuFinland

· Information department:Product safety [email protected]

· Emergency telephone number:CHEMTREC (within U.S.) 800 424-9300CHEMTREC (from outside U.S.) +1-703-572-3887

* 2 Hazard(s) identification

· Classification of the substance or mixture

GHS02 Flame

Flam. Liq. 2 H225 Highly flammable liquid and vapor.

GHS07

Eye Irrit. 2A H319 Causes serious eye irritation.

STOT SE 3 H336 May cause drowsiness or dizziness.

· Label elements· GHS label elements

The product is classified and labeled according to the Globally Harmonized System (GHS).· Hazard pictograms

GHS02 GHS07

· Signal word Danger

· Hazard-determining components of labeling:propan-2-ol

· Hazard statementsHighly flammable liquid and vapor.Causes serious eye irritation.May cause drowsiness or dizziness.

· Precautionary statementsKeep away from heat/sparks/open flames/hot surfaces. - No smoking.Ground/bond container and receiving equipment.Use explosion-proof electrical/ventilating/lighting/equipment.Use only non-sparking tools.

(Contd. on page 2) US

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Trade name: Neonatal Extraction Solution

(Contd. of page 1)

46.0.2

Take precautionary measures against static discharge.Avoid breathing dust/fume/gas/mist/vapors/sprayWash thoroughly after handling.Use only outdoors or in a well-ventilated area.Wear protective gloves/protective clothing/eye protection/face protection.If on skin (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower.IF INHALED: Remove person to fresh air and keep comfortable for breathing.If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do.Continue rinsing.Call a poison center/doctor if you feel unwell.If eye irritation persists: Get medical advice/attention.In case of fire: Use for extinction: CO2, powder or water spray.Store in a well-ventilated place. Keep container tightly closed.Store in a well-ventilated place. Keep cool.Store locked up.Dispose of contents/container in accordance with local/regional/national/international regulations.

· Classification system:· NFPA ratings (scale 0 - 4)

23

0

Health = 2Fire = 3Reactivity = 0

· HMIS-ratings (scale 0 - 4)

HEALTH

FIRE

REACTIVITY

*2

3

0

Health = *2Fire = 3Reactivity = 0

· Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.

* 3 Composition/information on ingredients

· Chemical characterization: Mixtures· Description: Mixture of the substances listed below with nonhazardous additions.

· Dangerous components:

67-63-0 propan-2-ol 25-50%

7733-02-0 zinc sulphate 1-2.5%

* 4 First-aid measures

· Description of first aid measures· After inhalation: Supply fresh air; consult doctor in case of complaints.· After skin contact: Generally the product does not irritate the skin.· After eye contact:

Rinse opened eye for several minutes under running water. If symptoms persist, consult a doctor.· After swallowing: If symptoms persist consult doctor.· Information for doctor:· Most important symptoms and effects, both acute and delayed No further relevant information available.· Indication of any immediate medical attention and special treatment needed

No further relevant information available. US

(Contd. on page 3)

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(Contd. of page 2)

46.0.2

5 Fire-fighting measures

· Extinguishing media· Suitable extinguishing agents:

CO2, extinguishing powder or water spray. Fight larger fires with water spray or alcohol resistant foam.· Special hazards arising from the substance or mixture No further relevant information available.· Advice for firefighters· Protective equipment: No special measures required.

* 6 Accidental release measures

· Personal precautions, protective equipment and emergency proceduresWear protective equipment. Keep unprotected persons away.

· Environmental precautions:Dilute with plenty of water.Do not allow to enter sewers/ surface or ground water.

· Methods and material for containment and cleaning up:Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).Ensure adequate ventilation.

· Reference to other sectionsSee Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.

· Protective Action Criteria for Chemicals

· PAC-1:

67-63-0 propan-2-ol 400 ppm

7733-02-0 zinc sulphate 15 mg/m³

· PAC-2:

67-63-0 propan-2-ol 2000* ppm


· PAC-3:

67-63-0 propan-2-ol 12000** ppm


7 Handling and storage

· Handling:· Precautions for safe handling No special precautions are necessary if used correctly.· Information about protection against explosions and fires:

Keep ignition sources away - Do not smoke.Protect against electrostatic charges.

· Conditions for safe storage, including any incompatibilities· Storage:· Requirements to be met by storerooms and receptacles: Store in a cool location.· Information about storage in one common storage facility: Not required.· Further information about storage conditions:

Keep receptacle tightly sealed.Store in cool, dry conditions in well sealed receptacles.

· Specific end use(s) No further relevant information available. US

(Contd. on page 4)

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(Contd. of page 3)

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* 8 Exposure controls/personal protection

· Additional information about design of technical systems: No further data; see item 7.

· Control parameters· Components with limit values that require monitoring at the workplace:

The following constituent is the only constituent of the product which has a PEL, TLV or other recommendedexposure limit.At this time, the remaining constituent has no known exposure limits.

67-63-0 propan-2-ol

PEL Long-term value: 980 mg/m³, 400 ppm

REL Short-term value: 1225 mg/m³, 500 ppmLong-term value: 980 mg/m³, 400 ppm

TLV Short-term value: 984 mg/m³, 400 ppmLong-term value: 492 mg/m³, 200 ppmBEI

· Ingredients with biological limit values:

67-63-0 propan-2-ol

BEI 40 mg/LMedium: urineTime: end of shift at end of workweekParameter: Acetone (background, nonspecific)

· Additional information: The lists that were valid during the creation were used as basis.

· Exposure controls· Personal protective equipment:· General protective and hygienic measures:

Keep away from foodstuffs, beverages and feed.Immediately remove all soiled and contaminated clothing.Wash hands before breaks and at the end of work.Avoid contact with the eyes.Avoid contact with the eyes and skin.

· Breathing equipment: Not required.· Protection of hands:

The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/the chemical mixture.Selection of the glove material on consideration of the penetration times, rates of diffusion and thedegradation

· Material of glovesThe selection of the suitable gloves does not only depend on the material, but also on further marks of qualityand varies from manufacturer to manufacturer. As the product is a preparation of several substances, theresistance of the glove material can not be calculated in advance and has therefore to be checked prior to theapplication.

· Penetration time of glove materialThe exact break through time has to be found out by the manufacturer of the protective gloves and has to beobserved.

· Eye protection:

Tightly sealed goggles

US

(Contd. on page 5)

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(Contd. of page 4)

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* 9 Physical and chemical properties

· Information on basic physical and chemical properties· General Information· Appearance:

Form: FluidColor: Colorless

· Odor: Like alcohol· Odor threshold: Not determined.

· pH-value: Not determined.

· Change in conditionMelting point/Melting range: Undetermined.Boiling point/Boiling range: 82 °C (179.6 °F)

· Flash point: 13 °C (55.4 °F)

· Flammability (solid, gaseous): Not applicable.

· Ignition temperature: 425 °C (797 °F)

· Decomposition temperature: Not determined.

· Auto igniting: Product is not selfigniting.

· Danger of explosion: Product is not explosive. However, formation of explosive air/vapormixtures are possible.

· Explosion limits:Lower: 2 Vol %Upper: 12 Vol %

· Vapor pressure at 20 °C (68 °F): 43 hPa (32.3 mm Hg)

· Density: Not determined.· Relative density Not determined.· Vapor density Not determined.· Evaporation rate Not determined.

· Solubility in / Miscibility withWater: Fully miscible.

· Partition coefficient (n-octanol/water): Not determined.

· Viscosity:Dynamic: Not determined.Kinematic: Not determined.

· Solvent content:Organic solvents: 40.0 %Water: 58.3 %VOC content: 40.00 %

Solids content: 2.0 %· Other information No further relevant information available.

* 10 Stability and reactivity

· Reactivity No further relevant information available.· Chemical stability· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.· Possibility of hazardous reactions No dangerous reactions known.· Conditions to avoid No further relevant information available.· Incompatible materials: No further relevant information available.


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(Contd. of page 5)

46.0.2

· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information

· Information on toxicological effects· Acute toxicity:· Primary irritant effect:· on the skin: No irritant effect.· on the eye: Irritating effect.· Sensitization: No sensitizing effects known.· Additional toxicological information:

The product shows the following dangers according to internally approved calculation methods forpreparations:Irritant

· Carcinogenic categories

· IARC (International Agency for Research on Cancer)

67-63-0 propan-2-ol 3

· NTP (National Toxicology Program)

None of the ingredients is listed.

· OSHA-Ca (Occupational Safety & Health Administration)


* 12 Ecological information

· Toxicity· Aquatic toxicity: No further relevant information available.· Persistence and degradability No further relevant information available.· Behavior in environmental systems:· Bioaccumulative potential No further relevant information available.· Mobility in soil No further relevant information available.· Additional ecological information:· General notes:

Water hazard class 2 (Self-assessment): hazardous for waterDo not allow product to reach ground water, water course or sewage system.Danger to drinking water if even small quantities leak into the ground.

· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.· Other adverse effects No further relevant information available.

13 Disposal considerations

· Waste treatment methods· Recommendation:

Must not be disposed of together with household garbage. Do not allow product to reach sewage system.

· Uncleaned packagings:· Recommendation: Disposal must be made according to official regulations.· Recommended cleansing agent: Water, if necessary with cleansing agents.

US

(Contd. on page 7)

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(Contd. of page 6)

46.0.2

* 14 Transport information

· UN-Number· DOT, ADR, IMDG, IATA UN1993

· UN proper shipping name· DOT Flammable liquids, n.o.s. (Isopropanol)· ADR 1993 Flammable liquids, n.o.s. (Isopropanol)· IMDG, IATA FLAMMABLE LIQUID, N.O.S. (ISOPROPANOL (ISOPROPYL

ALCOHOL))

· Transport hazard class(es)

· DOT

· Class 3 Flammable liquids· Label 3

· ADR, IMDG, IATA

· Class 3 Flammable liquids· Label 3

· Packing group· DOT, ADR, IMDG, IATA II

· Environmental hazards:· Marine pollutant: No

· Special precautions for user Warning: Flammable liquids· Danger code (Kemler): 33· EMS Number: F-E,S-E· Stowage Category B

· Transport in bulk according to Annex II ofMARPOL73/78 and the IBC Code Not applicable.

· Transport/Additional information:

· DOT· Quantity limitations On passenger aircraft/rail: 5 L

On cargo aircraft only: 60 L

· ADR· Excepted quantities (EQ) Code: E2

Maximum net quantity per inner packaging: 30 mlMaximum net quantity per outer packaging: 500 ml

· IMDG· Limited quantities (LQ) 1L· Excepted quantities (EQ) Code: E2

Maximum net quantity per inner packaging: 30 mlMaximum net quantity per outer packaging: 500 ml


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(Contd. of page 7)

46.0.2

· UN "Model Regulation": UN 1993 FLAMMABLE LIQUIDS, N.O.S. (ISOPROPANOL), 3,II

* 15 Regulatory information

· Safety, health and environmental regulations/legislation specific for the substance or mixture· Sara

· Section 355 (extremely hazardous substances):


· Section 313 (Specific toxic chemical listings):

67-63-0 propan-2-ol

7733-02-0 zinc sulphate

· TSCA (Toxic Substances Control Act):

All ingredients are listed.

· Proposition 65

· Chemicals known to cause cancer:


· Chemicals known to cause reproductive toxicity for females:


· Chemicals known to cause reproductive toxicity for males:


· Chemicals known to cause developmental toxicity:



· EPA (Environmental Protection Agency)

7733-02-0 zinc sulphate D, I, II

· TLV (Threshold Limit Value established by ACGIH)

67-63-0 propan-2-ol A4

· NIOSH-Ca (National Institute for Occupational Safety and Health)


· GHS label elementsThe product is classified and labeled according to the Globally Harmonized System (GHS).

· Hazard pictograms

GHS02 GHS07

· Signal word Danger

· Hazard-determining components of labeling:propan-2-ol

· Hazard statementsHighly flammable liquid and vapor.Causes serious eye irritation.May cause drowsiness or dizziness.

· Precautionary statementsKeep away from heat/sparks/open flames/hot surfaces. - No smoking.Ground/bond container and receiving equipment.


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(Contd. of page 8)

46.0.2

Use explosion-proof electrical/ventilating/lighting/equipment.Use only non-sparking tools.Take precautionary measures against static discharge.Avoid breathing dust/fume/gas/mist/vapors/sprayWash thoroughly after handling.Use only outdoors or in a well-ventilated area.Wear protective gloves/protective clothing/eye protection/face protection.If on skin (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower.IF INHALED: Remove person to fresh air and keep comfortable for breathing.If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do.Continue rinsing.Call a poison center/doctor if you feel unwell.If eye irritation persists: Get medical advice/attention.In case of fire: Use for extinction: CO2, powder or water spray.Store in a well-ventilated place. Keep container tightly closed.Store in a well-ventilated place. Keep cool.Store locked up.Dispose of contents/container in accordance with local/regional/national/international regulations.

· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other informationThis information is based on our present knowledge. However, this shall not constitute a guarantee for anyspecific product features and shall not establish a legally valid contractual relationship.

· Department issuing SDS: Product safety department.· Contact: [email protected]· Date of preparation / last revision 01/04/2018 / -· Abbreviations and acronyms:

RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning theInternational Transport of Dangerous Goods by Rail)ICAO: International Civil Aviation OrganisationADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsDOT: US Department of TransportationIATA: International Air Transport AssociationACGIH: American Conference of Governmental Industrial HygienistsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)NFPA: National Fire Protection Association (USA)HMIS: Hazardous Materials Identification System (USA)VOC: Volatile Organic Compounds (USA, EU)PBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very BioaccumulativeNIOSH: National Institute for Occupational SafetyOSHA: Occupational Safety & HealthTLV: Threshold Limit ValuePEL: Permissible Exposure LimitREL: Recommended Exposure LimitBEI: Biological Exposure LimitFlam. Liq. 2: Flammable liquids – Category 2Eye Irrit. 2A: Serious eye damage/eye irritation – Category 2ASTOT SE 3: Specific target organ toxicity (single exposure) – Category 3

· * Data compared to the previous version altered. US

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46.0.2

* 1 Identification


· Trade name: Neonatal Total Galactose Assay Reagent 1

· Article number: 13807625· Application of the substance / the mixture








GHS07

Skin Irrit. 2 H315 Causes skin irritation.


STOT SE 3 H335 May cause respiratory irritation.



GHS07

· Signal word Warning

· Hazard-determining components of labeling:p-hydroxyphenylacetic acid

· Hazard statementsCauses skin irritation.Causes serious eye irritation.May cause respiratory irritation.

· Precautionary statementsAvoid breathing dust/fume/gas/mist/vapors/sprayWash thoroughly after handling.Use only outdoors or in a well-ventilated area.Wear protective gloves / eye protection / face protection.If on skin: Wash with plenty of water.IF INHALED: Remove person to fresh air and keep comfortable for breathing.If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do.Continue rinsing.


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Trade name: Neonatal Total Galactose Assay Reagent 1

(Contd. of page 1)

46.0.2

Call a poison center/doctor if you feel unwell.Specific treatment (see on this label).If skin irritation occurs: Get medical advice/attention.If eye irritation persists: Get medical advice/attention.Take off contaminated clothing and wash it before reuse.Store in a well-ventilated place. Keep container tightly closed.Store locked up.Dispose of contents/container in accordance with local/regional/national/international regulations.


20

0



HEALTH

FIRE

REACTIVITY

2

0

0






156-38-7 p-hydroxyphenylacetic acid 25-50%


· Description of first aid measures· After inhalation: In case of unconsciousness place patient stably in side position for transportation.· After skin contact: Immediately wash with water and soap and rinse thoroughly.· After eye contact:


No further relevant information available.


· Extinguishing media· Suitable extinguishing agents: Use fire fighting measures that suit the environment.· Special hazards arising from the substance or mixture No further relevant information available.· Advice for firefighters· Protective equipment: No special measures required.

US

(Contd. on page 3)

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(Contd. of page 2)

46.0.2


· Personal precautions, protective equipment and emergency procedures Not required.· Environmental precautions: No special measures required.· Methods and material for containment and cleaning up: Ensure adequate ventilation.· Reference to other sections

See Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.


· PAC-1:


· PAC-2:


· PAC-3:


* 7 Handling and storage

· Handling:· Precautions for safe handling No special precautions are necessary if used correctly.· Information about protection against explosions and fires: No special measures required.

· Conditions for safe storage, including any incompatibilities· Storage:· Requirements to be met by storerooms and receptacles: No special requirements.· Information about storage in one common storage facility: Not required.· Further information about storage conditions: Keep receptacle tightly sealed.· Specific end use(s) No further relevant information available.




The product does not contain any relevant quantities of materials with critical values that have to bemonitored at the workplace.



Keep away from foodstuffs, beverages and feed.Immediately remove all soiled and contaminated clothing.Wash hands before breaks and at the end of work.Avoid contact with the eyes and skin.

· Breathing equipment:In case of brief exposure or low pollution use respiratory filter device. In case of intensive or longer exposureuse respiratory protective device that is independent of circulating air.

· Protection of hands:

Protective gloves


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(Contd. of page 3)

46.0.2




· Eye protection:




Form: Solid massColor: Whitish

· Odor: Characteristic· Odor threshold: Not determined.

· pH-value: Not applicable.

· Change in conditionMelting point/Melting range: Undetermined.Boiling point/Boiling range: Undetermined.

· Flash point: Not applicable.

· Flammability (solid, gaseous): Not determined.



· Danger of explosion: Product does not present an explosion hazard.

· Explosion limits:Lower: Not determined.Upper: Not determined.

· Vapor pressure: Not applicable.

· Density: Not determined.· Relative density Not determined.· Vapor density Not applicable.· Evaporation rate Not applicable.

· Solubility in / Miscibility withWater: Soluble.


· Viscosity:Dynamic: Not applicable.


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(Contd. of page 4)

46.0.2

Kinematic: Not applicable.

· Solvent content:VOC content: 0.00 %

Solids content: 100,0 %· Other information No further relevant information available.


· Reactivity No further relevant information available.· Chemical stability· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.· Possibility of hazardous reactions No dangerous reactions known.· Conditions to avoid No further relevant information available.· Incompatible materials: No further relevant information available.· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information

· Information on toxicological effects· Acute toxicity:· Primary irritant effect:· on the skin: Irritant to skin and mucous membranes.· on the eye: Irritating effect.· Sensitization: No sensitizing effects known.· Additional toxicological information:










· Toxicity· Aquatic toxicity: No further relevant information available.· Persistence and degradability No further relevant information available.· Behavior in environmental systems:· Bioaccumulative potential No further relevant information available.· Mobility in soil No further relevant information available.· Additional ecological information:· General notes: Not known to be hazardous to water.· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.


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(Contd. of page 5)

46.0.2

· Other adverse effects No further relevant information available.





14 Transport information

· UN-Number· DOT, ADR, ADN, IMDG, IATA Void

· UN proper shipping name· DOT, ADR, ADN, IMDG, IATA Void


· DOT, ADR, ADN, IMDG, IATA· Class Void

· Packing group· DOT, ADR, IMDG, IATA Void


· Special precautions for user Not applicable.


· UN "Model Regulation": Void








99-20-7 trehalose

156-38-7 p-hydroxyphenylacetic acid

7365-82-4 N-(carbamoylmethyl)taurine

9003-99-0 Peroxidase

· TSCA new (21st Century Act) (Substances not listed)

156-38-7 p-hydroxyphenylacetic acid(Contd. on page 7)

US

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(Contd. of page 6)

46.0.2

· Proposition 65


















GHS07


· Hazard-determining components of labeling:p-hydroxyphenylacetic acid

· Hazard statementsCauses skin irritation.Causes serious eye irritation.May cause respiratory irritation.

· Precautionary statementsAvoid breathing dust/fume/gas/mist/vapors/sprayWash thoroughly after handling.Use only outdoors or in a well-ventilated area.Wear protective gloves / eye protection / face protection.If on skin: Wash with plenty of water.IF INHALED: Remove person to fresh air and keep comfortable for breathing.If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do.Continue rinsing.Call a poison center/doctor if you feel unwell.Specific treatment (see on this label).If skin irritation occurs: Get medical advice/attention.If eye irritation persists: Get medical advice/attention.Take off contaminated clothing and wash it before reuse.Store in a well-ventilated place. Keep container tightly closed.Store locked up.Dispose of contents/container in accordance with local/regional/national/international regulations.

· Chemical safety assessment: A Chemical Safety Assessment has not been carried out. US

(Contd. on page 8)

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(Contd. of page 7)

46.0.2

* 16 Other informationThis information is based on our present knowledge. However, this shall not constitute a guarantee for anyspecific product features and shall not establish a legally valid contractual relationship.


RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning theInternational Transport of Dangerous Goods by Rail)ICAO: International Civil Aviation OrganisationADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsDOT: US Department of TransportationIATA: International Air Transport AssociationACGIH: American Conference of Governmental Industrial HygienistsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)NFPA: National Fire Protection Association (USA)HMIS: Hazardous Materials Identification System (USA)VOC: Volatile Organic Compounds (USA, EU)PBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very BioaccumulativeNIOSH: National Institute for Occupational SafetyOSHA: Occupational Safety & HealthTLV: Threshold Limit ValuePEL: Permissible Exposure LimitREL: Recommended Exposure LimitSkin Irrit. 2: Skin corrosion/irritation – Category 2Eye Irrit. 2A: Serious eye damage/eye irritation – Category 2ASTOT SE 3: Specific target organ toxicity (single exposure) – Category 3


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46.0.2

* 1 Identification


· Trade name: Neonatal Total Galactose Assay Reagent 2








· Classification of the substance or mixtureThe product is not classified according to the Globally Harmonized System (GHS).

· Label elements· GHS label elements· Hazard pictograms Void· Signal word Void· Hazard statements Void· Classification system:· NFPA ratings (scale 0 - 4)

00

0



HEALTH

FIRE

REACTIVITY

0

0

0





· Dangerous components: Void US

(Contd. on page 2)

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(Contd. of page 1)

46.0.2


· Description of first aid measures· General information: No special measures required.· After inhalation: Supply fresh air; consult doctor in case of complaints.· After skin contact: Generally the product does not irritate the skin.· After eye contact: Rinse opened eye for several minutes under running water.· After swallowing: If symptoms persist consult doctor.· Information for doctor:· Most important symptoms and effects, both acute and delayed No further relevant information available.· Indication of any immediate medical attention and special treatment needed




6 Accidental release measures

· Personal precautions, protective equipment and emergency procedures Not required.· Environmental precautions: Do not allow to enter sewers/ surface or ground water.· Methods and material for containment and cleaning up: Pick up mechanically.· Reference to other sections

No dangerous substances are released.See Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.


· PAC-1:

7758-98-7 copper sulphate 7.5 mg/m³

· PAC-2:

7758-98-7 copper sulphate 9.9 mg/m³

· PAC-3:

7758-98-7 copper sulphate 59 mg/m³


· Handling:· Precautions for safe handling No special measures required.· Information about protection against explosions and fires: No special measures required.

· Conditions for safe storage, including any incompatibilities· Storage:· Requirements to be met by storerooms and receptacles: No special requirements.· Information about storage in one common storage facility: Not required.· Further information about storage conditions: None.· Specific end use(s) No further relevant information available.

US

(Contd. on page 3)

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(Contd. of page 2)

46.0.2

8 Exposure controls/personal protection






The usual precautionary measures for handling chemicals should be followed.· Breathing equipment: Not required.· Protection of hands:




· Eye protection: Not required.

9 Physical and chemical properties


Form: Solid massColor: Whitish


· pH-value: Not applicable.

· Change in conditionMelting point/Melting range: Undetermined.Boiling point/Boiling range: Undetermined.


· Flammability (solid, gaseous): Not determined.






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(Contd. of page 3)

46.0.2

· Vapor pressure: Not applicable.

· Density: Not determined.· Relative density Not determined.· Vapor density Not applicable.· Evaporation rate Not applicable.

· Solubility in / Miscibility withWater: Soluble.


· Viscosity:Dynamic: Not applicable.Kinematic: Not applicable.

· Solvent content:VOC content: 0.00 %

Solids content: 100,0 %· Other information No further relevant information available.



11 Toxicological information

· Information on toxicological effects· Acute toxicity:

· LD/LC50 values that are relevant for classification:

7758-98-7 copper sulphate

Oral LD50 300 mg/kg (rat)

· Primary irritant effect:· on the skin: No irritant effect.· on the eye: No irritating effect.· Sensitization: No sensitizing effects known.· Additional toxicological information:

The product is not subject to classification according to internally approved calculation methods forpreparations:When used and handled according to specifications, the product does not have any harmful effects accordingto our experience and the information provided to us.





None of the ingredients is listed.(Contd. on page 5)

US

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(Contd. of page 4)

46.0.2





Water hazard class 1 (Self-assessment): slightly hazardous for waterDo not allow undiluted product or large quantities of it to reach ground water, water course or sewagesystem.



· Waste treatment methods· Recommendation: Smaller quantities can be disposed of with household waste.












US

(Contd. on page 6)

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(Contd. of page 5)

46.0.2






7758-98-7 copper sulphate



· TSCA new (21st Century Act) (Substances not listed)· Proposition 65
















· GHS label elements Void· Hazard pictograms Void· Signal word Void· Hazard statements Void· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other informationThis information is based on our present knowledge. However, this shall not constitute a guarantee for anyspecific product features and shall not establish a legally valid contractual relationship.


RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning theInternational Transport of Dangerous Goods by Rail)ICAO: International Civil Aviation OrganisationADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsDOT: US Department of TransportationIATA: International Air Transport AssociationACGIH: American Conference of Governmental Industrial HygienistsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)NFPA: National Fire Protection Association (USA)


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HMIS: Hazardous Materials Identification System (USA)VOC: Volatile Organic Compounds (USA, EU)LC50: Lethal concentration, 50 percentLD50: Lethal dose, 50 percentPBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very BioaccumulativeNIOSH: National Institute for Occupational SafetyOSHA: Occupational Safety & HealthTLV: Threshold Limit ValuePEL: Permissible Exposure LimitREL: Recommended Exposure Limit


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46.0.2

1 Identification


· Trade name: Neonatal Total Galactose Assay Buffer


In vitro diagnosticsLaboratory chemicals







GHS07

Skin Sens. 1 H317 May cause an allergic skin reaction.



GHS07


· Hazard-determining components of labeling:reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H-isothiazol-3-one [EC no. 220-239-6] (3:1)

· Hazard statementsMay cause an allergic skin reaction.

· Precautionary statementsAvoid breathing dust/fume/gas/mist/vapors/sprayContaminated work clothing must not be allowed out of the workplace.Wear protective gloves.If on skin: Wash with plenty of water.Specific treatment (see on this label).If skin irritation or rash occurs: Get medical advice/attention.Wash contaminated clothing before reuse.Dispose of contents/container in accordance with local/regional/national/international regulations.


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Trade name: Neonatal Total Galactose Assay Buffer

(Contd. of page 1)

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00

0



HEALTH

FIRE

REACTIVITY

0

0

0



3 Composition/information on ingredients



55965-84-9 reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H-isothiazol-3-one [EC no. 220-239-6] (3:1)

<0.01%

4 First-aid measures

· Description of first aid measures· After inhalation:

Supply fresh air and to be sure call for a doctor.In case of unconsciousness place patient stably in side position for transportation.

· After skin contact: Immediately wash with water and soap and rinse thoroughly.· After eye contact: Rinse opened eye for several minutes under running water.· After swallowing: If symptoms persist consult doctor.· Information for doctor:· Most important symptoms and effects, both acute and delayed No further relevant information available.· Indication of any immediate medical attention and special treatment needed





· Personal precautions, protective equipment and emergency procedures Not required.· Environmental precautions:

Dilute with plenty of water.Do not allow to enter sewers/ surface or ground water.


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(Contd. of page 2)

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· Methods and material for containment and cleaning up:Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).



· PAC-1:

57-55-6 Methyl glycol 30 mg/m³

· PAC-2:

57-55-6 Methyl glycol 1,300 mg/m³

· PAC-3:

57-55-6 Methyl glycol 7,900 mg/m³



· Conditions for safe storage, including any incompatibilities· Storage:· Requirements to be met by storerooms and receptacles: No special requirements.· Information about storage in one common storage facility: Not required.· Further information about storage conditions: None.· Specific end use(s) No further relevant information available.

8 Exposure controls/personal protection






Immediately remove all soiled and contaminated clothing.Wash hands before breaks and at the end of work.


Protective gloves


· Material of glovesThe selection of the suitable gloves does not only depend on the material, but also on further marks of qualityand varies from manufacturer to manufacturer. As the product is a preparation of several substances, theresistance of the glove material can not be calculated in advance and has therefore to be checked prior to the


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(Contd. of page 3)

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application.· Penetration time of glove material

The exact break through time has to be found out by the manufacturer of the protective gloves and has to beobserved.

· Eye protection: Goggles recommended during refilling.



Form: FluidColor: According to product specification



· Change in conditionMelting point/Melting range: Undetermined.Boiling point/Boiling range: 100 °C (212 °F)








· Density: Not determined.· Relative density Not determined.· Vapor density Not determined.· Evaporation rate Not determined.





· Other information No further relevant information available.

10 Stability and reactivity

· Reactivity No further relevant information available.· Chemical stability· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.


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· Possibility of hazardous reactions No dangerous reactions known.· Conditions to avoid No further relevant information available.· Incompatible materials: No further relevant information available.· Hazardous decomposition products: No dangerous decomposition products known.


· Information on toxicological effects· Acute toxicity:· Primary irritant effect:· on the skin: No irritant effect.· on the eye: No irritating effect.· Sensitization: Sensitization possible through skin contact.· Additional toxicological information:









12 Ecological information







· Uncleaned packagings:· Recommendation: Disposal must be made according to official regulations.


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· Recommended cleansing agent: Water, if necessary with cleansing agents.


















7365-82-4 N-(carbamoylmethyl)taurine

57-55-6 Methyl glycol

7732-18-5 water

· TSCA new (21st Century Act) (Substances not listed)

55965-84-9 reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H-isothiazol-3-one [EC no. 220-239-6] (3:1)

· Proposition 65









US

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(Contd. of page 6)

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GHS07


· Hazard-determining components of labeling:reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H-isothiazol-3-one [EC no. 220-239-6] (3:1)

· Hazard statementsMay cause an allergic skin reaction.

· Precautionary statementsAvoid breathing dust/fume/gas/mist/vapors/sprayContaminated work clothing must not be allowed out of the workplace.Wear protective gloves.If on skin: Wash with plenty of water.Specific treatment (see on this label).If skin irritation or rash occurs: Get medical advice/attention.Wash contaminated clothing before reuse.Dispose of contents/container in accordance with local/regional/national/international regulations.




ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsDOT: US Department of TransportationIATA: International Air Transport AssociationACGIH: American Conference of Governmental Industrial HygienistsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)NFPA: National Fire Protection Association (USA)HMIS: Hazardous Materials Identification System (USA)VOC: Volatile Organic Compounds (USA, EU)PBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very BioaccumulativeNIOSH: National Institute for Occupational SafetyOSHA: Occupational Safety & HealthTLV: Threshold Limit ValuePEL: Permissible Exposure Limit


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REL: Recommended Exposure LimitSkin Sens. 1: Skin sensitisation – Category 1


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1 Identification


· Trade name: Neonatal Total Galactose Reconstitution Solution


In vitro diagnosticsLaboratory chemicals







GHS07

Skin Irrit. 2 H315 Causes skin irritation.




GHS07

· Signal word Warning· Hazard statements

Causes skin irritation.Causes serious eye irritation.

· Precautionary statementsWash thoroughly after handling.Wear protective gloves / eye protection / face protection.If on skin: Wash with plenty of water.If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do.Continue rinsing.Specific treatment (see on this label).If skin irritation occurs: Get medical advice/attention.If eye irritation persists: Get medical advice/attention.Take off contaminated clothing and wash it before reuse.


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Trade name: Neonatal Total Galactose Reconstitution Solution

(Contd. of page 1)

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20

0



HEALTH

FIRE

REACTIVITY

2

0

0



3 Composition/information on ingredients



67-68-5 dimethyl sulfoxide 25-50%


· Description of first aid measures· After inhalation: In case of unconsciousness place patient stably in side position for transportation.· After skin contact: Immediately wash with water and soap and rinse thoroughly.· After eye contact:






· Personal precautions, protective equipment and emergency procedures Not required.· Environmental precautions:

Dilute with plenty of water.Do not allow to enter sewers/ surface or ground water.

· Methods and material for containment and cleaning up:Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).


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(Contd. of page 2)

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· PAC-1:

67-68-5 dimethyl sulfoxide 150 ppm

· PAC-2:

67-68-5 dimethyl sulfoxide 290 ppm

· PAC-3:

67-68-5 dimethyl sulfoxide 1,800 ppm

* 7 Handling and storage


· Conditions for safe storage, including any incompatibilities· Storage:· Requirements to be met by storerooms and receptacles: No special requirements.· Information about storage in one common storage facility: Not required.· Further information about storage conditions: Keep receptacle tightly sealed.· Specific end use(s) No further relevant information available.



· Control parameters

· Components with limit values that require monitoring at the workplace:

67-68-5 dimethyl sulfoxide

WEEL Long-term value: 250 ppm



Keep away from foodstuffs, beverages and feed.Immediately remove all soiled and contaminated clothing.Wash hands before breaks and at the end of work.Avoid contact with the eyes and skin.


Protective gloves


· Material of glovesThe selection of the suitable gloves does not only depend on the material, but also on further marks of qualityand varies from manufacturer to manufacturer. As the product is a preparation of several substances, the


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resistance of the glove material can not be calculated in advance and has therefore to be checked prior to theapplication.


· Eye protection:




Form: FluidColor: According to product specification



· Change in conditionMelting point/Melting range: Undetermined.Boiling point/Boiling range: 100 °C (212 °F)



· Ignition temperature: 270 °C (518 °F)




· Explosion limits:Lower: 1.8 Vol %Upper: 63 Vol %


· Density at 20 °C (68 °F): 1.03 g/cm³ (8.6 lbs/gal)· Relative density Not determined.· Vapor density Not determined.· Evaporation rate Not determined.






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· Other information No further relevant information available.

10 Stability and reactivity



· Information on toxicological effects· Acute toxicity:· Primary irritant effect:· on the skin: Irritant to skin and mucous membranes.· on the eye: Irritating effect.· Sensitization: No sensitizing effects known.· Additional toxicological information:









12 Ecological information




US

(Contd. on page 6)

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· Proposition 65









US

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GHS07

· Signal word Warning· Hazard statements

Causes skin irritation.Causes serious eye irritation.

· Precautionary statementsWash thoroughly after handling.Wear protective gloves / eye protection / face protection.If on skin: Wash with plenty of water.If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do.Continue rinsing.Specific treatment (see on this label).If skin irritation occurs: Get medical advice/attention.If eye irritation persists: Get medical advice/attention.Take off contaminated clothing and wash it before reuse.




ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsDOT: US Department of TransportationIATA: International Air Transport AssociationACGIH: American Conference of Governmental Industrial HygienistsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)NFPA: National Fire Protection Association (USA)HMIS: Hazardous Materials Identification System (USA)VOC: Volatile Organic Compounds (USA, EU)PBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very BioaccumulativeNIOSH: National Institute for Occupational SafetyOSHA: Occupational Safety & HealthTLV: Threshold Limit ValuePEL: Permissible Exposure LimitREL: Recommended Exposure LimitSkin Irrit. 2: Skin corrosion/irritation – Category 2


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Eye Irrit. 2A: Serious eye damage/eye irritation – Category 2A· * Data compared to the previous version altered.

US

01/04/2018 Kit Components Product code Description GSP Neonatal Total Galactose kit Components: ......

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