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Version 2 - benzene, ethenyl-, polymer with 1,3-butadiene, brominated, 06-07-2014

Submission of information on

TEMPLATE

for third party submission of information on alternatives for

Applications for Authorisation

HBCD use in EPS for Building Applications

NON-CONFIDENTIAL

CORRECTED VERSION 06-07-2014

Legal name of submitter(s): ICL-IP Europe BV

Fosfaatweg 48 1013 BM Amsterdam

SUBMISSION OF INFORMATION ON ALTERNATIVES (NON-CONFIDENTIAL)


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TABLE OF CONTENTS

1. ALTERNATIVE ID AND PROPERTIES ......................................................................... 2

2. TECHNICAL FEASIBILITY ........................................................................................ 3

3. ECONOMIC FEASIBILITY ......................................................................................... 4

4. HAZARDS AND RISKS OF THE ALTERNATIVE ............................................................. 5

5. AVAILABILITY ....................................................................................................... 6

6. CONCLUSION ON SUITABILITY AND AVAILABILITY OF THE ALTERNATIVE .................... 8

7. OTHER COMMENTS ................................................................................................ 9

REFERENCES ............................................................................................................ 9

APPENDIXES ............................................................................................................. 9

1. ALTERNATIVE ID AND PROPERTIES

ICL-IP alternative to Hexabromocyclododecane (HBCD Cas No. 3194-55-6) for use in EPS and XPS

insulation foams is FR-122P.

FR-122P chemical designation is benzene, ethenyl-, polymer with 1,3-butadiene, brominated (FR-

122P) (CAS # 1195978-93-8). The chemical structure is shown in figure 1 below.

Figure 1: Chemical Structure of FR-122P

The polymeric flame retardant (pFR) has been developed by Dow Chemicals Company as a

polymeric, high molecular weight flame retardant alternative to HBCD. Exclusive rights for the

production, sales and marketing of the pFR have been granted by Dow to three flame retardant

manufacturers worldwide: ICL-IP, Chemtura and Albemarle. The new product is marketed by ICL-

IP as FR-122P.


Version 2, benzene, ethenyl-, polymer with 1,3-butadiene, brominated , 06-07-2014 3

Figure 2 illustrates FR-122P properties.

Figure 2: Properties of FR-122P

Properties of FR-122P

Physical appearance white to off-white powder

white to off-white compacted

Bromine content, w % 65

Solubility (water), g/L Insoluble

Loss on drying, % 0.50 max

Molecular Weight, Daltons 100,000

Specific gravity, g/cm3 1.6

TGA, %weight loss@T0C 2%@243

5%@257

10%@264

FR-122P has been proven to be effective in EPS and XPS applications due to:

- Chemical compatibility with styrenic polymers, see chemical structure in figure 1.

- Flame retardancy efficiency, aliphatic Bromine being readily available at the adequate

burning temperature for styrenic polymers.

2. TECHNICAL FEASIBILITY

For many years, Hexabromocyclododecane (HBCD CAS No. 3194-55-6) was used as a flame

retardant in polystyrene foams, both in the expanded (EPS) and extruded version (XPS). Only very

small quantities of HBCD are needed to meet the flame retardancy standards. In EPS production,

HBCD is added to a 50/50 suspension of monomeric Styrene and water, together with other

additives (catalysts, nucleation agents, etc.), with a final concentration of 0.5%-1.0%.. HBCD

dissolves in the styrene which is polymerized into the small Polystyrene beads. During

polymerization a blowing agent is added. The beads are later foamed into blocks or shaped articles

by application of steam in an autoclave.

The XPS process makes use of a two-step extrusion process. It starts from polystyrene which is

blended with the flame retardant in a first step and the addition of a blowing agent in a second

step. Leaving the second extruder, the product expands into sheets which are cut in shape. In

view to the flame retardant, XPS requires slightly higher levels of addition, 1.5 -2.5%. Also, the

flame retardant is introduced into the polystyrene as masterbatch (a concentrate containing about

50 % of flame retardant). For XPS production, the flame retardant is mainly sold to producers of

masterbatches who have developed formulations based on their own know-how.



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In 2012 ICL-IP signed the license agreement with DOW Global Technologies Inc. on production and

marketing of a polymeric brominated flame retardant (pFR) for use in polystyrene foams, replacing

HBCD. The new product, CAS No 1195978-93-8, is marketed by ICL-IP as FR-122P and shown to

be effective in both EPS and XPS.

In December 2010, first samples of FR-122P from lab trial runs were sent to all ICL-IP customers.

The product was found to be suitable and effective. Although in some cases it was reported as a

drop-in solution to HBCD, in others, the level of addition and formulation had to be adapted.

Together with internal production and product development, the number and size of samples to

customers increased constantly. Pilot production trials were carried out after September 2011 and

a production line was adapted technically to the process. With further optimization of the process,

the quality of the FR-122P was also improved. By mid-2012, the production level reached 20

tons/month. In parallel, customers were able to adapt their processes to the new flame retardant

additive, namely FR properties and λ values were now found by customers to be in the desired

range. Large scale pilot samples were offered to all customers. All major producers of EPS received

FR-122P in 500 kg to 4 tons quantities, allowing them full scale production runs. The current

status as of June 2014 indicates that over 80% of ICL-IP customers have found FR-122P to be a

suitable alternative for their application, and the remaining 20% are in an advanced approval

process. The market share in volume of the customers who have approved FR-122P is more than

90% of the market in the EU and Japan.

In March 2013, the German EPS foam industry organisation IVH published results of a round robin

series of tests on various flame retarded EPS products (Südddeutsches Kunstoffzentrum (SKZ)

Würzburg, 13.Februar 2014Fachtagung „EPS Partikelschaum“ Ulrich Meier, IVH,

Heidelberg, „Erfahrungen mit der Umstellung auf ein neues Flammschutzmittel“).

Amongst others, HBCD and the new pFR containing materials were also tested in parallel. The FR

results were found to be identical within the statistical error margins. Although the physical and

mechanical properties were slightly below standards, it was confirmed that further optimization of

the production processes would result in properties equal to the standard materials.

Based on the positive feedback from the market, ICL-IP has decided to advance its plans to initiate

commercial production. In mid-2013, ICL-IP plant in the Netherlands, with a nameplate production

of over 2000 MT/A , went on-stream and is capable to supply the market with the current required

quantities. Customers, including HBCD authorization consortium members, have started to take

full commercial quantities. ICL-IP is now in the start-up process for its 10.000 MT/A in Israel which

will be fully operational in Q4 2014.

3. ECONOMIC FEASIBILITY

The polymeric flame retardant FR-122P (pFR) is an economy-wise feasible alternative to HBCD.

It has to be noted that ICL-IP does not have access to all economic criteria developed by HBCD

users. Therefore, the following is based on our best evaluation and knowledge of the current pFR

alternative status

- Research and development investments:

For the pFR: done and completed by Dow Chemicals Company as well as by the pFR

producers.

For EPS and XPS production and implementation: done and completed by the vast majority

of customers (see section 2 above).

- Investments:

For the pFR: done and completed by the pFR producers.


of ICL-IP customers (see section 2 above).

- Other costs of transfer to the alternative:



For pFR production: done and completed by the pFR producers.


of ICL-IP customers (see section 2).

- Costs and time spent by downstream users in re-specifying alternative products:

pFR based EPS and XPS final article foams exhibit the same properties as HBCD foams.

Therefore no costs are associated to HBCD substitution with the pFR.

- Potential market distortions:

The pFR will be supplied by all three producers, namely ICL-IP, Chemtura and Albemarle.

Additional information pertinent to the economic feasibility:

- pFR and EPS estimated cost: according to ICL-IP cost data, FR-122P is expected to be more

expensive compared to HBCD. This is due to higher costs of raw materials and production

process. However, the overall extra cost of the final EPS article is estimated to be higher by

2% to 3% compared to the present cost of HBCD based final EPS article. This calculation is

based on a 0.7% - 1% concentration of FR-122P in the EPS final article.

- As mentioned, investments related to R&D, production and supply of pFRhave already been

completed. Although costs associated with non-utilization of production and supply facilities

for this pFR are not fully estimated, ICL-IP estimation is that those are high.

- According to “Analysis of Alternatives” submitted by the EPS producers’ consortium: “It is

known that the pFR costs more than HBCD, but it is assumed that this will be economically

feasible……”(1).

4. HAZARDS AND RISKS OF THE ALTERNATIVE

The alternative chemical designation is: Benzene, ethenyl-, polymer with 1,3-butadiene,

brominated (FR-122P) (CAS # 1195978-93-8)

FR-122P is a high molecular weight Polymeric Flame Retardant additive (CAS # 1195978-93-8) for

use in Extruded Polystyrene Foam (XPS) and Expanded Polystyrene Foam (EPS) insulation

applications, as a replacement for FR-1206 Hexabromocyclododecane (HBCD).

Compared to HBCD, FR-122P exhibits a more sustainable health, safety and environmental profile.

High molecular weight polymeric additives by nature have inherently better environmental and

health risk profiles and often provide a more sustainable solution than smaller molecules.

Series of mammalian and environmental studies performed under internationally accepted

guidelines and principles of Good Laboratory Practice have been conducted on FR-122P.

The list of results is summarized below:

1. FR-122P has been shown to be non-toxic to test animals when administered orally. It was

found to be not irritant to skin and eyes and not a skin sensitizer.

2. FR-122P is not mutagenic by the Ames test and not clastogenic in the Chromosome

Aberration test.

3. FR-122P is persistent and not toxic to Daphnia.

4. FR-122P as a high molecular weight polymeric molecule is not expected to bioaccumulate.



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5. FR-122P is neither a PBT substance nor a CMR.

Further, Benzene, ethenyl-, polymer with 1,3-butadiene, brominated was scored “Low” in all

parameters tested except persistency in the EPA DfE assessment report “Flame Retardant

Alternatives For Hexabromocyclododecane” (appendix 1).

The above data, including details in appendix 2, clearly demonstrate that FR-122P is a suitable

alternative to HBCD in respect to its toxicological and environmental profile.

The full product profile of FR-122P can be found in appendix 2.

5. AVAILABILITY

Availability of the pFR alternative has to be assessed by combining expected global demand and

planned supply. Global demand over the years is based on the following, confirmed data for past

years and forecasted figures for the 2015-2019 coming years, according to conversion ratio of

HBCD to pFR and substitution of HBCD by pFR in all geographic relevant areas.

5.1 HBCD global demand in 2011 summed up to 31,000 MT/A, based on ICL-IP internal

marketing figures. By 2013, this demand decreased by 12% worldwide due to the economic

recession (at an average rate of 10% for 2012 and 10% for 2013) and was steady in 2014. In

2015, demand for HBCD will be influenced by the following:

- Full switch in the EU from HBCD to pFR, as per end of March 2015.

- Japan is to switch to FR-130, a non-polymeric HBCD substitute as well as to the pFR

alternative Switching from HBCD will be initiated in October 2014.

- In 2015, Korea will keep HBCD use at a 75% level compared to 2014.

- A forecasted 3% CAAGR in HBCD demand in 2015; no growth for non-EU countries.

Figure 3 illustrates these evolutions:

Figure 3: HBCD global demand (MT/A), 2011-2015

2011 2012 2013 2014 2015

HBCD demand EU 12,300 11,560 10,800 10,800 2,800

HBCD demand non EU 18,700 17,600 16,500 15,900 13,950

TOTAL 31,000 29,160 27,300 26,700 16,750

2011 2012 2013 2014 2015

HBCD demand America 2,500 2,350 2,200 2,200 2,200

HBCD demand CHINA 12,100 11,400 10,700 10,700 10,700

HBCD demand Japan 2,500 2,350 2,200 1,600 0

HBCD demand Korea 1,600 1,500 1,400 1,400 1,050

Total non EU 18,700 17,600 16,500 15,900 13,950

5.2 pFR global demand: According to market data gathered by ICL-IP and expected

implementation dates for the HBCD ban in the relevant countries, demand over the years 2015-

2019 is subject to the following assumptions:



- EU will fully switch from HBCD to pFR alternative by end of March 2015.. Although some

XPS producers might switch to non-pFR alternative, we assume in this analysis all HBCD

substitution is to come from the pFR.

- Substitution rate of HBCD by the pFR is 1:1.2 (based on confirmations from ICL-IP

customers which tested and approved the pFR alternative in both EPS and XPS

applications).

- In America, 50% of the HBCD will be gradually replaced by pFR from 2015 to 2018 and

fully replaced in 2019.

- Japan will fully switch from HBCD to FR-130, a non-pFR alternative, in October 2014 as well

as to the pFR alternative. In 2015, Japan is expected to have substituted 50% of the

non-pFR with the pFR

- It is assumed that Korea will switch to 25% pFR consumption in 2015 and to 50% from

2016 to 2019.

- EU demand for flame retardants for EPS and XPS is expected to grow as follows:

In 2015 by 3%; in 2016 by 5%; in 2017 by 6%; in 2018 and 2019, both years by 7%. - It is assumed China will replace HBCD in 2020 and start the transition by 2019.

Figure 4 reflects this forecast:

Figure 4: Global forecasted pFR demand (MT/A), 2015-2019

Global pFR demand 2015 2016 2017 2018 2019

PFR demand EU 10,000 14,020 14,860 15,900 17,010 PFR demand non EU 1,480 2,560 3,220 3,220 10,440

Total 11,480 16,580 18,080 19,120 27,450

Non EU PFR demand 2015 2016 2017 2018 2019

America 0 660 1,320 1,320 2,640

Japan 1,060 1,060 1,060 1,060 1,060

China 0 0 0 0 5,900

Korea 420 840 840 840 840

Total 1,480 2,560 3,220 3,220 10,440

5.3 Global supply of pFR:

ICL-IP Netherland plant is already producing in commercial quantities since Q4/2013 at a capacity

of over 2000mt/a. A scaling up of this plant is the additional 10,000 MT/A in Israel. This project is

finalizing construction and starting the commissioning stage. Initiation of production is expected by

30/9/2014.This schedule will be fully met thanks to ICL-IP’s technical capability to extent

production in Israel based on the acquired experience in the Netherlands (see appendix 3 for

further details). ICL-IP plans to bring production to a level of 20,000MT/A already in 2017, as

expansion in the NL site can be achieved according to current existing planning, permits and partly

existing equipment at a relatively short period of time. As per 2014, Chemtura production capacity

is already of 10,000MT/A.



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Figure 5 illustrates pFR global supply over the years 2015-2019. Global pFR supply for the years

2015-2019 is in accordance with the “Analysis of Alternatives- HBCDD use in EPS for building

applications”, submitted by the HBCD Authorization consortium.

Figure 5: Global forecasted pFR supply (MT/A), 2015-2019

PFR GLOBAL SUPPLY 2015 2016 2017 2018 2019

23,350 29,850 31,350 31,350 31,350

5.3 Global demand and supply: Figure 6 shows clearly that no shortage is expected in the years

2015-2019. The pFR commercial activity is expected to be initiated in March 2015, as a

preparation of the HBCD sunset date in Europe.

Figure 6: Global forecasted demand and supply (MT/A) for pFR, 2015-2019

PFR Supply versus Demand 2015 2016 2017 2018 2019

Total demand 11,480 16,580 18,080 19,120 27,450

Total Supply Availability 23,350 29,850 31,350 31,350 31350

Difference 11,870 13,270 13,270 12,230 3,900

It should be noted that ICL-IP is in advanced stages of supply agreements negotiations with

several EPS and XPS producers. Based on the FR-122P availability described above, ICL-IP is

willing to engage in similar discussions towards such agreements with additional EPS and XPS

producers.

6. Conclusion on suitability and availability of the Alternative

In accordance with all data presented above, it can be reasonably concluded that the pFR (ICL-

IP product code FR-122P) is a true and feasible alternative to HBCD in EPS and XPS

applications.

PFR technical substitution of HBCD has been already proven to be feasible by a vast majority

of EPS and XPS manufacturers.

Economic feasibility has been shown as a non-issue, since both pFR suppliers and users have

already made all necessary investments to ensure a smooth switch to the pFR alternative, in full

accordance with the HBCD banning timetable in the EU and in the others concerned regions of

the globe. These investments can definitely be regarded as “sunk costs”.

The hazards and risks analysis of the pFR alternative show a superior toxicological and

environmental profile compared to HBCD. In that respect, it should be mentioned that continued

use of HBCD in Europe beyond the year 2015 will have an additional drawback: due to HBCD

content, recycling of EPS and XPS will be delayed by four years. This will certainly contribute to

further environmental issues in the EU.

Availability of pFR as per the pertinent period of 2015 and on is well confirmed.

7. OTHER COMMENTS



REFERENCES

1. Analysis of Alternatives- HBCDD use in EPS for building applications, submitted by the EPS

producers consortium, p. 81, §4.4a.

2. Great Lakes Chemical Corporation. Ames/Salmonella plate assay report on bis(2,3-

dibromopropyl)ether of tetrabromobisphenol A with attachments. TSCA Section

8E, OTS0503680. U.S. EPA Doc. No. 8888200436.

3. Evaluation of the mutagenic activity of FR-720-purified in the salmonella

typhimurium reverse mutation assay and the escherichia coli reverse mutation

assay (with independent repeat), 2002, NOTOX B.V., Hambakenwetering 7 5231

DD’s-Hertogenbosch, The Netherlands.

4. http://ntp.niehs.nih.gov/?objectid=BD48F894-123F-7908-7B7E35D7CFAA5298

(NTP site)

5. In vitro sister chromatid exchange in chinese hamster ovary cells with GLCC #

785-104C, 1984, Hazelton Biotechnologies Corporation, 9200 Leesburg Turnpike,

Vienna, Virginia 22180 USA.

6. Evaluation of the mutagenic activity of FR-720 in an in vitro mammalian cell gene

mutation test with L5178Y mouse lymphoma cells, 2002, NOTOX B.V.,

Hambakenwetering 7 5231 DD’s-Hertogenbosch, The Netherlands.

APPENDIXES

Appendix 1: DfE report

http://www.epa.gov/dfe/pubs/projects/hbcd/hbcd-full-report-508.pdf

Appendix 2: FR-122P data sheet

FR-122 Fact Sheet_06-05-2013.pdf

Appendix 3: ICL-IP polymeric FR-122P capacity expansion, attached.

http://ntp.niehs.nih.gov/?objectid=BD48F894-123F-7908-7B7E35D7CFAA5298

Appendix 3- FR122P Capacity expansion

To the

TEMPLATE

for third party submission of information on alternatives for

Applications for Authorisation

HBCD use in EPS for Building Applications

NON-CONFIDENTIAL

Updated July 2014

Legal name of submitter(s): ICL-IP Europe BV

Fosfaatweg 48 1013 BM Amsterdam

1. FR-122P (ICL-IP polymeric Flame Retardant), Israeli plant status:

Stage Status

Design process completion 100%

Equipment procurement 100%

Production facilities construction and installation 100%

Ancillary equipment installation 100%

Raw materials testing, approval and supplied 100%

Production router and debottlenecking Initiated

Overall project status versus schedule On track

2. Illustrations:

Tel: +972-8-6297672 | Fax: +972-8-6297832 | [email protected]

1

May 2013

FR-122P is a new high molecular weight Polymeric Flame Retardant additive (CASRN 1195978-93-8)

for use in Extruded Polystyrene Foam (XPS) and Expanded Polystyrene Foam (EPS) insulation

applications, as a replacement for FR-1206 Hexabromocyclododecane (HBCD).

With a more sustainable health, safety and environmental profile, FR-122P is positioned to be the

‘next generation’ flame retardant. Polymeric additives by their very nature have inherently better

environmental and health risk profiles and often provide a more sustainable solution than smaller

molecules.

FR-122P is designed to enable producers to continue to meet stringent flammability and critical foam

performance criteria. It has typically 63-65% bromine and its thermogravimetric analysis indicates a

5% weight loss at minimum 250oC, while this value for HBCD stands at 247oC.

The polymer physical characteristics and chemical structure are presented in Table 1 and Figure 1.

Physical appearance white to off-white powder

Bromine content, w % 62.5 min.

Solubility (water), g/L Insoluble

Loss on drying % 0.50 max.

Brominated polybutadien block


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The regulatory status of FR-122 is shown in Table 2.

EH&S laboratory testing has demonstrated that FR-122 is an environmentally sustainable alternative to

HBCD. FR-122 has been tested in a series of mammalian and environmental studies conducted according

to internationally accepted guidelines and the principles of Good Laboratory Practice. EH&S testing reveals

the following:

Assessment Health and Environmental

The product has been shown to be non-toxic to test animals when administered orally. It was found to be

not irritant to skin and eyes and not a skin sensitizer. In a Combined repeated dose toxicity study (28-day)

with reproductive/developmental toxicity screening test FR-122 was found to be non-toxic (28-days oral

administration) with no effect on the animals, and the NOAEL was >1000 mg/kg/day. FR-122 was not

mutagenic by the Ames test and not clastogenic in the Chromosome Aberration test.

FR-122 was designed to be persistent. The product was found to be not readily biodegradable.

In an acute daphnia toxicity test (WAF*; EL50 > 1000 mg/L) FR-122 was found to be not toxic.

Additional Ecotox studies have not been conducted as they are not required for registration purposes

based on polymer exemption criteria.

Bioaccumulation study in the fish was not conducted as polymers are not expected to penetrate biological

cell membranes and thus, not expected to bioaccumulate. Furthermore, this study is not required for

registration purposes based on polymer exemption criteria.

PBT Assessment

Based on the above FR-122 is NOT considered PBT* as follows:

• Persistent (P): The product was designed to be persistent, which means that it is considered P.

• Bioaccumulative (B): The product is not bioaccumulative, meaning that it is considered NOT B.

• Toxic (T): The product is not toxic, meaning that it is NOT T.

*See Glossary for details


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Degradation Summary

FR-122 is thermally stable at typical XPS processing temperatures. XPS foam surface photo-degradation

results in non-PBT and non-CMR substances

ICL-IP is committed to sustaining economic growth without harming the planet or exhausting its resources,

while improving the quality of life for its current and future inhabitants. ICL-IP practices Sustainable

Development in the knowledge that it makes good business sense and will incorporate sustainability

considerations in all operations and business decisions in alignment with a commitment to the global

Sustainable Development effort.

As part of this commitment and to ensure customer satisfaction with its products, ICL-IP herewith states as

following:

Compliance with RoHS Directives –

EU Directive 2002/95/EC and its amendments (the Restriction on use of Hazardous Substances Directive;

RoHS 1) and the new version of RoHS Directive, EU Directive 2011/65/EC (RoHS 2) require that no

electrical equipment sold in Europe shall contain Polybrominated Biphenyls (PBBs), Polybrominated

Diphenyl Ethers (PBDE’s), or specified heavy metals (lead, mercury, cadmium, hexavalent chromium) at

specified levels.

Based on its raw materials and production process, FR-122 is in compliance with both directives.

SVHC List (Substances of Very High Concern under REACH) –

FR-122 is NOT included in the substances listed in the European Chemicals Agency (ECHA) Candidate List

of Substances of Very High Concern (SVHC) dated 19th December, 2012.

US Environmental Protection Agency (EPA) Design for Environment Program –

FR-122 is one of two identified solutions being assessed in the USA EPA Design for Environment (DfE)

HBCD Analysis of Alternatives program. The final report on alternatives in this program is expected to be

available by summer, 2013.


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More information on FR-122 is provided on the product Material Safety Data Sheet (MSDS) which can be

found on the ICL Industrial Products Website www.icl-industrial.com.

Europe Polymer exemption. Monomers are REACH* compliant

USA Listed in EPA TSCA* Inventory

Canada Listed in DSL*

Japan Meets inventory requirements of ENCS*

S. Korea Registration completed (KECI*)

Australia Not Listed in AICS*

Philippines Not Listed in PICCS*

China Registration Completed *

New Zealand Not Listed in NZIoC*

Taiwan Registration Completed


Physical and chemical properties

Water solubility

Not water soluble

(Physico-chemical properties)

Solution-Extraction behavior in water No detectable organic compounds released into

aqueous solution.

Environmental fate and pathways

Hydrolysis Not susceptible to hydrolysis

http://www.icl-ip.com/


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Anaerobic Biodegradation No biodegradation observed.

Ecotoxicological Information

Acute invertebrate toxicity (Daphnia) Not classified as toxic. EL50 > 1000 mg/L (the

limit loading rate tested). Study conducted using

the water accommodated fraction (WAF).

Acute vertebrate toxicity (fish);

Chronic daphnia;

Acute aquatic plant toxicity (algae);

Daphnia reproduction;

Fish early life stage test;

Sediment toxicity;

No toxicity classification based on Daphnia acute

toxicity study of FR-122 WAF . Testing is not

required for registration purposes based on

polymer exemption criteria.

Fish Bioconcentration (BCF) Testing not required based on Physico-chemical

properties and polymer exemption

Toxicological information

Acute Oral Toxicity LD50 > 5000 mg/kg bw

Irritation (Eye/Skin) Non-irritant

Sensitization Non-sensitizer (Buehler Method)

Combined repeated dose toxicity study

(28-day) with reproductive/developmental

toxicity screening test

No effect was observed NOAEL>1000 mg/kg/day

Ames test Not mutagenic

Chromosome Aberration test Not clastogenic


AICS The Australian Inventory of Chemical Substances is the legal device that

distinguishes new from existing chemicals. AICS has a public (non-confidential) section and confidential section. http://www.nicnas.gov.au

BCF Bioaccumulation Factor – the likelihood that a substance will accumulate in biological tissue.

BFRIP Brominated Flame Retardants Industry Panel

CONEG US Coalition of North Eastern Governors program developed in an effort to reduce the amount of heavy metals in packaging and packaging components that are sold or distributed throughout the US. Specifically,

http://www.nicnas.gov.au/


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the law is designed to phase out the use and presence of mercury, lead, cadmium and hexavalent chromium in packaging. http://www.coneg.org/

DSL/NDSL The Domestic Substances List (DSL) and the Non-Domestic Substances List (NDSL) were created in accordance with the Canadian Environmental Protection Act (CEPA) by Environment Canada. The DSL defines "existing" substances for the purposes of implementing CEPA and is the sole basis for determining whether a substance is "existing" or "new" to Canada. The NDSL specifies substances, other than those on the DSL, that were in world commerce, but not in Canada, and is based on the US Environmental Protection Agency's (EPA's) 1985 inventory compiled for the Toxic Substances Control Act (TSCA).

EC50 Effect Concentration – the concentration of a substance in a medium which causes an observable effect in 50% of a group of test animals.

ECL South Korean Existing Chemicals List

ENCS The ENCS is the list of Existing and New Chemical Substances, which regulates chemical substances that are either manufactured or imported in Japan. http://stneasy.cas.org/dbss/chemlist/encs.html

HPLC High Performance Liquid Chromatography

IARC The International Agency for Research on Cancer (IARC) is part of the World Health Organization. IARC's mission is to coordinate and conduct research on the causes of human cancer, the mechanisms of carcinogenesis, and to develop scientific strategies for cancer control. http://www.iarc.fr/

KESI Korea Existing Substances Inventory

LD50, LC50

LD stands for "Lethal Dose". LD50 is the amount of a material, given all at once, which causes the death of 50% (one half) of a group of test animals. The LD50 is one way to measure the short-term poisoning potential (acute toxicity) of a material. LC stands for "Lethal Concentration". LC values usually refer to the concentration of a chemical in air but in environmental studies it can also mean the concentration of a chemical in water.

For inhalation experiments, the concentration of the chemical in air that kills 50% of the test animals in a given time (usually four hours) is the LC50 value

NZloC

NOEC

NOEL

The New Zealand Inventory of Chemicals

No Observed Effect Concentration

No Observed Effect Level

NTP The National Toxicology Program in the US was established to coordinate toxicological testing programs, strengthen the science base in toxicology; develop and validate improved testing methods; and provide information

http://www.coneg.org/

http://www.ec.gc.ca/

http://stneasy.cas.org/dbss/chemlist/encs.html

http://www.who.ch/

http://www.iarc.fr/


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about potentially toxic chemicals to health regulatory and research agencies, the scientific and medical communities, and the public. http://ntp-server.niehs.nih.gov/

PBT Persistent, Bioaccumulative & Toxic

PICCS The Philippine Inventory of Chemicals and chemical substances (PICCS) is a list of all existing chemicals and chemical substances used, sold, distributed, imported, processed, manufactured, stored, exported, treated or transported in the Philippines. http://www.emb.gov.ph/chemicals.html

Pow The Octanol-water partition coefficient is the ratio of the concentration of a chemical in Octanol and in water at equilibrium and at a specified temperature.

REACH Registration, Evaluation and Authorization of Chemicals. European program of registration and evaluation of new and existing chemicals. europa.eu.int/comm/enterprise/chemicals/chempol/whitepaper/reach.htm

TSCA The Toxic Substances Control Act gives the US EPA the ability to track the 75,000 industrial chemicals currently produced or imported into the United States. TSCA has a public (non-confidential) section and confidential section http://www.epa.gov/region5/defs/html/tsca.htm

UL-94 Underwriters Laboratory, Inc., an independent, non-profit product safety testing and certification organization. The details of UL-94 can be found at http://www.boedeker.com/bpi-ul94.htm

WAF Water Accommodated Fraction

Prepared by:

Sarit Lifshitz, PhD

Regulatory Affairs Manager – Development Products

Health, Environment and Regulatory Affairs

http://ntp-server.niehs.nih.gov/

http://www.emb.gov.ph/chemicals.html

http://www.epa.gov/region5/defs/html/tsca.htm

http://www.boedeker.com/bpi-ul94.htm

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