PINK Crosslinked Alkyl Acrylates · 2020. 2. 29. · Memorandum To: CIR Expert Panel Members and...

PINK

Crosslinked Alkyl Acrylates

CIR EXPERT PANEL MEETING

JUNE 27-28, 2011

Ad

min

istrative

Memorandum

To: CIR Expert Panel Members and Liaisons From: Monice M. Fiume MMF Senior Scientific Analyst/Writer Date: June 3, 2011 Subject: Tentative Report on Crosslinked Alkyl Acrylates as Used in Cosmetics Included is the draft tentative report on the Crosslinked Alkyl Acrylates as Used in Cosmetics. At the March meeting, the Panel issued an insufficient data announcement asking for impurity data, specifically referring to the amount of residual benzene present. These data have been received, and the amount of residual benzene that has been found is included in the report. During discussion of this issue at the March meeting, the question of clarification of the amount of benzene allowed by the European Commission was raised. Benzene cannot be present as a constituent of other substances, or in mixtures, in concentrations equal to, or greater than 0.1% by weight. California’s Proposition 65 limits benzene exposure from a product to 6.4 µg/day for oral exposure and 13 µg/day for inhalation exposure. CIR is aware that International Nomenclature Committee Ingredient (INCI) monographs are in process for additional crosslinked alkyl acrylates. At this meeting, the Panel should consider whether the conclusion should be worded so that it extends to those ingredients as they are added to the International Cosmetic Ingredient Dictionary. If so, direction should be provided regarding monomer and crosslinking agents that would fall under the purview of that conclusion. The following are included in the data tab:

1. Product Information: Acrylates/Vinyl Neodecanoate Crosspolymer (Aculyn 38 Polymer) and Acrylates/Steareth-20 Methacrylate Crosspolymer (Aculyn 88 Polymer). (Memo from the Council dated May 3, 2011)

2. Further Information: Benzene Impurity in Acrylates/C10-30 Alkyl Acrylates Crosspolymer. (Memo from the Council dated May 4, 2011);

3. Acrylates/C10-30 Alkyl Acrylate Crosspolymer: Potential contamination with benzene. (Memo from the Council dated May 9, 2011.)

4. Cosmetics – CosIng [Cosmetics Directive (v. 1)] for benzene; 5. Council comments on the draft report that was reviewed at the March meeting (memo dated Feb

28, 2011); 6. FDA raw data.

The following CIR reports are provided online at http://www.cir-safety.org/jun11.shtml:

1. Final report on the safety assessment of acrylates copolymer and 33 related cosmetic ingredients (2002);

2. Final report on the safety assessment of methacrylic acid (2005); and 3. Final report on the safety assessment of methacrylate ester monomers used in nail

enhancement products (2005).

CROSSLINKED ALKYL ACRYLATES

December 23, 2010: SLR Issued March 3-4, 2011: Draft Report The following unpublished data were submitted by the Council, following the announcement of the SLR, and are included in the draft report:

1. Information on Sodium Acrylates Crosspolymer-2. Memo dated Nov. 30, 2010. a. Sumitomo Seika. 2010 Cosmetic Grade: AQUAKEEP 10SH-NFC (Sodium Acrylates

Crosspolymer-2) b. Sumitomo Seika. 2010. Material safety data sheet: AQUAKEEP 10SH-NFC (Sodium

Acrylates Crosspolymer-2) 2. Information on Acrylates/Vinyl Isodecanoate Crosspolymer. Memo dated Dec. 14, 2010

a. 3V Sigma. 2010. Stabylen 30 (Acrylates/Vinyl Isodecanoate Copolymer): Toxicological Summary Review.

3. Specification information on Acrylates/C10-30 Alkyl Acrylates Crosspolymer. Memo dated Dec. 15, 2010.

4. HRIPTs on Products Containing Acrylates/C10-30 Alkyl Acrylate Crosspolymer. Memo dated Jan. 11, 2011.

a. Consumer Product Testing Co. 2009. Repeated insult patch test of a body lotion containing 0.15% Acrylates/C10-30 Alkyl Acrylate Crosspolymer. Experiment Reference Number: C09-1 109.01.

b. Consumer Product Testing Co. 2010. Repeated insult patch test of a foot cream containing 0.6% Acrylates/C10-30 Alkyl Acrylate Crosspolymer. Experiment Reference Number: C10-0602.01.

5. Specifications for Allyl Methacrylates Crosspolymer. Memo dated Jan, 13, 2011. 6. Updated concentration of use by FDA product category: Acrylate Crosspolymer Ingredients. Memo

dated Jan. 28, 2011. At the meeting, the Panel issued an insufficient data announcement requesting impurity data for the crosspolymers, particularly with respect to the amount of residual benzene that may be present. June 27-28, 2011: Tentative Report The following unpublished data were submitted by the Council and added to the report:

1. Dow Chemical Company. 2011. ACULYN 88 Polymer (Acrylates/Steareth-20 Methacrylate Crosspolymer)Global Cosmetic Dossier. Submitted by the Council on May 3, 2011.)

2. Dow Chemical Company. 2011. ACULYN 38 Polymer (Acrylates/Vinyl Neodecanoate Cross-polymer) Global Cosmetic Dossier. Submitted by the Council on May 3, 2011.)

3. Personal Care Products Council. 2011. Benzene impurity in acrylates/C10-30 alkyl acrylate crosspolymer.

Distributed for Comment Only -- Do Not Cite or Quote

CIR Panel Book Page 1

April 7, 2011 – Searched using SciFinder

History April 7, 2011 2:18 PM Explore references by research topic: crosslinked polymers initiated, resulting in 2 candidates April 7, 2011 2:19 PM Explore references by research topic: acrylate crosspolymer initiated, resulting in 2 candidates Explore complete Candidates Selected 110 references were found containing the concept "acrylate crosspolymer". Explore results Answer set 45 created with 108 answers from CAPLUS 2 answers from MEDLINE April 7, 2011 2:20 PM Explore references by research topic: acrylate crosspolymer initiated, resulting in 2 candidates Limiters Book, Preprint, Report, Journal, Review Explore complete Candidates Selected 8 references were found containing the concept "acrylate crosspolymer". Explore results Answer set 46 created with 6 answers from CAPLUS 2 answers from MEDLINE Detailed display from Answer set 46 of Development of a new cosmetic active for safe skin brightening Detailed display from Answer set 46 of the properties of lecithin and lecithin-liposome containing emulsions, emulsified with crosslinked acrylic acid-alkyl acrylate crosspolymer. Keep Me Posted profile 'acrylates crosspolymers' created from Answer set 46 Exported 1 reference answer from Answer set 46 in 'RIS' format as "acrylates crosspolymer.ris" April 7, 2011 2:24 PM Explore references by research topic: methacrylic crosspolymer initiated, resulting in 2 candidates Limiters Book, Preprint, Clinical Trial, Report, Journal, Review Explore complete Candidates Selected 4 references were found containing the concept "methacrylic crosspolymer". Explore results Answer set 47 created with 4 answers from CAPLUS Detailed display from Answer set 47 of Aculyn 88 rheology modifier Detailed display from Answer set 47 of AculynT 88 rheology modifier and laponite clay Detailed display from Answer set 47 of Rheological effects with a hydrophobically modified polymer Exported 1 reference answer from Answer set 47 in 'RIS' format as "methacrylate crosspolymer.ris" April 7, 2011 2:27 PM Explore references by research topic: methacrylic crosspolymer initiated, resulting in 2 candidates Limiters Book, Preprint, Clinical Trial, Report, Journal, Review Explore complete Candidates Selected 4 references were found containing the concept "methacrylic crosspolymer". Explore results Answer set 48 created with 4 answers from CAPLUS Keep Me Posted profile 'Methacrylate Crosspolymer' created from Answer set 48 April 7, 2011 2:39 PM Explore substances by ID: acrylates/C10-30 Alkyl Acrylate Crosspolymer, 26794-61-6, 74464-10-1, Acrylates/ethylhexyl acrylate crosspolymer, acrylates/ethylhexyl acrylate/glycidyl methacrylate crosspolymer, 50657-38-0, acrylates/steareth-20 methacrylate crosspolymer, acrylates/vinyl isodecanoate crosspolymer, acrylates/vinyl neodecanoate crosspolymer, 779327-42-3, 182212-41-5, butyl acrylate/glycol diemethacrylate crosspolymer, C8-22 acrylates/methacrylic acid crosspolymer, glycol diemethacrylate/vinyl alcohol crosspolymer, lauryl methacrylate/glycol dimethacrylate crosspolymer, lauryl methacrylate/sodium methacrylate crosspolymer, acrylates/C12-13 alkyl methacrylates/methoxyethyl acrylate



crosspolymer, methacrylic acid/PEG-6 methacrylate crosspolymer, PEG/PPG-5/2 methacrylate/methacrylic acid crosspolymer, potassium acrylates/C10-30 alkyl acrylate crosspolymer, sodium acrylates/C10-30 alkyl acrylate crosspolymer, sodium acrylates crosspolymer-2, sodium acrylates/vinyl isodecanoate crosspolymer, stearyl/lauryl methacrylate crosspolymer initiated Explore complete Explore results Answer set 49 created with 5 answers from REGISTRY Saved 5 substance answers from Answer set 49 as 'Some Acrylates Crosspolymers' Retrieve reference information in 5 substances of Answer set 49 Answer set 50 created with 257 answers from CAPLUS Saved 257 reference answers from Answer set 50 as 'All Acrylates Crosspolymer Listings' Keep Me Posted profile 'Acrylates Crosspolymer Substances' created from Answer set 50 Refine Answer set 50 by document type Book, Clinical Trial, Conference, Journal, Preprint, Report, Review Answer set 51 created with 137 answers from CAPLUS Saved 137 reference answers from Answer set 51 as 'Acrylates Crosspoly Substances by Doc Type' Copyright © 2011 American Chemical Society. All Rights Reserved. Copyright © 1994-2011 Sun Microsystems, Inc. All Rights Reserved. (Java runtime environment) Copyright © 2011, Yahoo! Inc. All Rights Reserved. (YUI Base, Fonts, Reset CSS) Copyright © 2005-2011, The Dojo Foundation. All Rights Reserved Copyright © 2011, Exadel, Inc. All Rights Reserved. (JBoss RichFaces) Copyright © 2002 InfoChem GmbH. All Rights Reserved. (InfoChem’s reaction classification program CLASSIFY) CAplus SM: Copyright © 2011 American Chemical Society. All Rights Reserved. (The U.K. patent material in this product/service is U.K. Crown copyright and is made

available with permission. Copyright © Crown Copyright. The French (FR) patent material in this product/service is made available from Institut National de la Propriete

Industrielle (INPI).)

CAS REGISTRY SM: Copyright © 2011 American Chemical Society. All Rights Reserved. (Some records contain information from GenBank ® . See also: Benson D.A.,

Karsch-Mizarachi I., Lipman D.J., Ostel J., Rapp B.A., Wheeler D.L. Genbank. Nucl. Acids Res. 28(1):15-18 (2000). Property values tagged with IC are from the

ZIC/VINITI data file provided by InfoChem.) CAS Registry is a service mark of the American Chemical Society. GenBank is a registered trademark of the U.S. Library of

Medicine.

CASREACT ® : Copyright © 2011 American Chemical Society. All Rights Reserved. CASREACT contains reactions from CAS and from: ZIC/VINITI database (1974-

1999) provided by InfoChem; INPI data prior to 1986; Biotransformations database compiled under the direction of Professor Dr. Klaus Kieslich; organic reactions,

portions copyright 1996-2006 John Wiley & Sons, Ltd., John Wiley and Sons, Inc., Organic Reactions Inc., and Organic Synthesis Inc. Reproduced under license. All

Rights Reserved. CHEMCATS ® : Copyright © 2011 American Chemical Society. All Rights Reserved. Chemical supplier information is supplied on an "as is" basis. Full information

regarding substance availability, price, etc., is provided when you request supplier information. CHEMLIST ® : Copyright © 2011 American Chemical Society. All Rights Reserved.

MEDLINE ® : is produced by the U.S. National Library of Medicine. MEDLINE is a registered trademark of the U.S. National Library of Medicine.

KEEP ME POSTED RESULTS reviewed weekly



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Search Terms (ACRYLATES AND ALKYL AND ACRYLATE AND CROSSPOLYMER) OR 503867-23-0 OR (ACRYLIC AND ACID AND ALKYL AND METHACRYLATE AND COPOLYMER) OR (ACRITAMER AND (501ED OR 505ED)) OR (AQUPEC AND HV) OR (CARBOPOL AND (2020 OR 1342 OR 1382) AND POLYMER) OR (CARBOPOL AND ULTREZ AND (20 OR 21) AND POLYMER) OR (PEMULEN AND (TR-1 OR TR-2) AND POLYMER) OR (TEGO AND CARBOMER) (ACRYLATES AND CROSSPOLYMER) OR 26794-61-6 OR 74464-10-1 OR (PROPENOIC AND ACID AND (METHYL OR BUTYL) AND ESTER AND (COPOLYMER OR POLYMER)) OR (ETHYLENE AND DIMETHACRYLATE AND (ISOBUTYL OR METHYL) AND (POLYMER OR COPOLYMER)) OR (BUTYL AND METHACRYLATE AND *ETHYLENE AND DIMETHACRYLATE AND (COPOLYMER OR POLYMER)) OR (ETHANEDIOL AND METHYL AND METHACRYLATE AND (POLYMER OR COPOLYMER)) OR 937245-97-1 OR 1034390-08-3 OR 1042425-25-1 OR 66988-53-2 OR 108772-06-1 OR 66231-58-1 OR 66231-62-7 OR 37211-40-8 OR 141255-82-5 OR 138454-61-2 OR 73928-89-9 OR 144610-95-7 OR 86438-61-1 OR 219531-90-5 AND (GANZPEARL (GBX OR GME OR GMH OR GMP)) (ACRYLATES AND (ETHYLHEXYL OR (ETHYL AND HEXYL)) AND ACRYLATE AND CROSSPOLYMER) OR (TECHNOPOLYMER AND (ACP OR ACX)) (ACRYLATES AND (ETHYLHEXYL OR (ETHYL AND HEXYL)) AND ACRYLATE AND GLYCIDYL AND METHACRYLATE AND CROSSPOLYMER) OR (ACRIT AND SE) (ACRYLATES AND (PEG OR (POLYETHYLENE AND GLYCOL)) AND DIMETHACRYLATE AND CROSSPOLYMER) OR 50657-38-0 OR (COSMO AND PEARL) (ACRYLATES AND STEARETH AND METHACRYLATE AND CROSSPOLYMER) OR (ACULYN AND POLYMER) (ACRYLATES AND VINYL AND ISODECANOATE AND CROSSPOLYMER) OR 191808-02-3 OR 362523-28-2 (ACRYLATES AND VINYL AND NEODECANOATE AND CROSSPOLYMER) OR CUSTOPOLY OR STABYLEN (ALLYL AND METHACRYLATE AND GLYCOL AND DIMETHACRYLATE AND CROSSPOLYMER) OR 779327-42-3 (ALLYL AND METHACRYLATES AND CROSSPOLYMER) OR 182212-41-5 OR 286962-86-5 OR (ALLYL AND METHACYLATE AND DIMETHACRYLATE AND (POLYMER OR COPOLYMER)) OR (POLYPORE OR (POLY AND PORE)) (BUTYL AND ACRYLATE AND GLYCOL AND DIMETHACRYLATE AND CROSSPOLYMER) OR (MATSUMOTO AND MICROSPHERE) ALKYL AND ACRYLATES AND METHACRYLIC AND ACID AND CROSSPOLYMER (GLYCOL AND DIMETHACRYLATE AND VINYL AND ALCOHOL AND CROSSPOLYMER) OR POROSORP (LAURYL AND METHACRYLATE AND GLYCOL AND DIMETHACRYLATE AND CROSSPOLYMER) OR (POLYTRAP AND ADSORBER) (LAURYL AND METHACRYLATE AND SODIUM AND METHACRYLATE AND CROSSPOLYMER) OR SOFCARE (ACRYLATES AND ALKYL AND METHACRYLATES AND METHOXYETHYL AND ACRYLATE AND CROSSPOLYMER) OR DIAHOLD METHACRYLIC AND ACID AND (PEG OR (POLYETHYLENE AND GLYCOL)) AND METHACRYLATE AND CROSSPOLYMER ((PEG OR (POLYETHYLENE AND GLYCOL)) AND (PPG OR (POLYPROPYLENE AND GLYCOL)) AND METHACRYLATE AND METHACRYLIC AND ACID AND CROSSPOLYMER) OR (TECHPOLMER AND SERIES) POTASSIUM AND ACRYLATES AND ALKYL AND ACRYLATE AND CROSSPOLYMER SODIUM AND ACRYLATES AND ALKYL AND ACRYLATE AND CROSSPOLYMER (SODIUM AND ACRYLATES AND CROSSPOLYMER) OR (AQUA AND KEEP) SODIUM AND ACRYLATES AND VINYL AND ISODECANOATE AND CROSSPOLYMER (STEARYL AND LAURYL AND METHACRYLATE AND CROSSPOLYMER) OR SOFCARE (ACRYLATE OR ACRYLATES) AND CROSSPOLYMER



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Tran

scripts

Full Panel Meeting – March 2011 – Crosslinked Alkyl Acrylates

19 Going on to the next Green Book, and

20 that's the acrylate crosspolymers, Dr. Marks

21 presenting.

22 DR. MARKS: A scientific literature




76

1 review for these cosmetic ingredients were issued

2 in December of last year. Our team reviewed the

3 available data. This is the first time we saw it,

4 and we moved to issue a tentative report that

5 these ingredients are safe as used in cosmetics.

6 DR. BERGFELD: Second or comments?

7 DR. BELSITO: Comment?

8 DR. BERGFELD: Yes, go ahead.

9 DR. BELSITO: We were struck on page 3

10 or Panel Book page 9 by the benzine impurities in

11 carbachol 1342. The specifications state that it

12 can contain 0.5 percent max of residual benzine.

13 Monice was nice enough to pull a material safety

14 data sheet on carbachol 1342, and it indicates

15 that to -- it can be produced at 0.1 percent

16 maximum as benzine -- as required by Canada, the

17 EU, and Korea with no further information there.

18 But this is only from one manufacturer.

19 So, we had actually thought that we

20 would like to go insufficient on these acrylate

21 crosspolymers at this time to get clarification

22 regarding the level of benzine. Dr. Bailey had




77

1 indicated that that was perhaps an old

2 manufacturing method that was no longer applicable

3 to the current way that these cross-linked

4 acrylate polymers are produced. But this is the

5 first time we're seeing it. So, we would like to

6 go insufficient for impurities, specifically

7 benzine.

8 DR. BERGFELD: Tom?

9 DR. SLAGA: I agree that would be

10 worthwhile doing.

11 DR. MARKS: I withdraw our team's

12 motion. And we'll second the motion of Dr.

13 Belsito's team.

14 DR. BERGFELD: To go insufficient? John

15 Bailey?

16 DR. BAILEY: Why can't we go with

17 Monice's find on the MSDS sheet, which was.01

18 percent, right?

19 DR. BELSITO: 0.1.

20 DR. BAILEY: 0.1.

21 MS. FIUME: For the EU. It didn't give

22 for the U.S. For the U.S., the main impurity




78

1 specification says.5 max with a footnote from EU,

2 Canada, and Korea. So that.5 max is sort of

3 hanging out there in the air, unless it's

4 addressed in a different manner.

5 DR. BAILEY: But if the panel issues a

6 tentative report that restricts benzine impurities

7 to 0.1 percent, then it's not hanging in the air

8 anymore.

9 DR. BELSITO: You know, we certainly

10 could do that. I mean, the highest level of use

11 is 6 percent in an eye care product. So that's

12 the highest. So, I don't -- I'm not a benzine

13 toxicologist, so I throw that out. So.1 percent

14 benzine in the product, maximum use at 6 percent

15 is -- does anyone perceive that that would be a

16 problem?

17 If not, then hopefully we can get the

18 data to support that and we can go ahead with the

19 safe as used conclusion.

20 DR. BERGFELD: Ron Hill?

21 DR. HILL: Yes, I wanted to raise one

22 more while we were on the subject of impurities.




79

1 On same page of the book, under impurities. The

2 last sentence in the first section says the

3 residual monomer content of acrylates, blah, blah,

4 blah, blah, is typically less than 2,500 ppm

5 acrylic acid and 500 ppm residual ester. So, it

6 has the word "typically." And I had a note that I

7 wrote here that said, we really need this

8 information for all the acrylates because acrylate

9 esters are not something we want to be having

10 dermally absorbed in high concentrations, I think.

11 And we didn't really have that.

12 So, from -- I wondered if anybody else

13 had that same concern.

14 DR. MARKS: I thought we had addressed

15 that. We were going to address it in a

16 discussion, we didn't get to editorial comments.

17 But the -- would be monomer impurities, and that

18 they've been addressed in previous CIR reports.

19 DR. HILL: Okay, I think that's the way

20 it was dealt with, yes. I just --

21 DR. MARKS: So that was going to be in

22 the discussion. But if we still go back to how




80

1 are we going to move forward, and the -- Don, you

2 made the motion to insufficient. Do we want to

3 change that? Our team made a motion to safe. Do

4 we want to do a safe with a limit of benzine?

5 DR. BELSITO: I think --

6 DR. BERGFELD: Either way, you have to

7 withdraw the motion.

8 DR. BELSITO: I didn't make the motion.

9 DR. BERGFELD: Yes, you did.

10 Insufficient was the motion. And Jim was

11 seconding it.

12 DR. BELSITO: Okay.

13 DR. BERGFELD: No one seconded his --

14 DR. BELSITO: No, Dr. Marks' initial

15 motion was safe as used.

16 DR. BERGFELD: Nobody seconded.

17 DR. BELSITO: Oh, okay. Someone

18 seconded mine?

19 DR. MARKS: Yes, I did.

20 DR. BELSITO: Oh, good. Okay.

21 (Laughter) Whoa, okay. So, again,

22 I throw it -- it's not my area of




81

1 expertise. I'm telling you that

2 they -- in Europe, they can limit

3 to 0.1. We don't have any

4 information as to how they came up

5 with that magic number, though the

6 maximum concentration of use is

7 limited here, 6 percent in eye

8 products.

9 So those of you who know about benzine

10 toxicity, if you're prepared to do the math today

11 and sign off on it, I'm comfortable with it. In

12 terms of skin sensitization, yadda, yadda, yadda,

13 I'm comfortable. I can't comment on benzine

14 toxicity at that level.

15 DR. SLAGA: Can't we --

16 DR. BERGFELD: Tom.

17 DR. SLAGA: -- look at the data,

18 continue with this motion but get the European

19 data -- the EU data and look at why they came up

20 with.1?

21 I mean, first thought -- you know, 6

22 percent of.1 is very, very small and more likely




82

1 would have no carcinogenic or any other effect.

2 But they probably already made the calculation.

3 And why don't we just look at it?

4 DR. BELSITO: So, do you want to go safe

5 as used when benzine impurity in the material is

6 less than.1, or do you want to go insufficient --

7 DR. SLAGA: Insufficient until we get

8 comparison --

9 DR. BELSITO: I'm fine --

10 DR. SLAGA: -- and see what kind of

11 calculations they made.

12 DR. BELSITO: I'm fine either way. I

13 think there are probably no safety issues, so

14 delaying the final on this report -- I think,

15 don't think --

16 DR. SLAGA: Right --

17 DR. BELSITO: -- it's going to be a big

18 deal.

19 DR. BERGFELD: Ron Shank?

20 DR. SHANK: So, your motion is --

21 DR. BELSITO: Insufficient for

22 impurities, specifically benzine.




83

1 DR. SHANK: -- insufficient for -- and

2 what do you want? Is --

3 DR. BELSITO: I want to know what --

4 DR. SHANK: How much is in there or how

5 much --

6 DR. BELSITO: How much is in there, and

7 I want some benzine toxicity brought in. I want

8 information as to why the Europeans decided to

9 regulate it at.1. Where they got that information

10 that allowed them to set that limit.

11 DR. SHANK: Okay.

12 DR. BERGFELD: Ron Hill, okay? Dan?

13 DR. LIEBLER: Yes, I like that approach.

14 DR. BERGFELD: Paul? Curt?

15 DR. KLAASSEN: Yes.

16 DR. BERGFELD: How about John Bailey?

17 DR. BAILEY: You know, I hate to

18 continue this on for another meeting, but I think

19 it's a reasonable request and we'll certainly do

20 our best to get the information.

21 DR. BERGFELD: Thank you. So, we have a

22 motion. We had a second. Any other discussion?




84

1 Seeing none -- yes, Monice.

2 MS. FIUME: I just want to clarify. So

3 it's an insufficient data announcement --

4 DR. BELSITO: Right.

5 DR. BERGFELD: Call for the question.

6 All those in favor, raise your hands. Thank you,

7 unanimous.



Dr. Belsito’s Team – March 2011 – Crosslinked Alkyl Acrylates

12 Anything else? Hearing nothing else,

13 the next one we're looking at would be acrylate

14 cross-polymers. Now, you were going to hand out a

15 hard copy of something that you had e-mailed to

16 us, is that correct, Monice?

17 MS. FIUME: Yeah. Table 1 was

18 corrected. There was a structure that was

19 missing, and there was a structure that was

20 incorrect. We've just redone the entire table.

21 You might --

22 DR. BELSITO: Sure.




44

1 MS. FIUME: And then also -- sorry.

2 DR. BELSITO: I looked at this.

3 MS. FIUME: I have about 16 of these.

4 Does anyone else need a copy? And then for you,

5 Dr. Belsito. I updated the data profile. The one

6 in the bag matched what came in with wave 2.

7 They're sort of hard to see, but the X is in red.

8 DR. BELSITO: Yes, yes.

9 MS. FIUME: Here's the updated

10 information for wave 2.

11 DR. BELSITO: Right, which is mainly all

12 dermal, and a --

13 MS. FIUME: Little bit monomer.

14 DR. BELSITO: -- little bit of monomer

15 content.

16 MS. FIUME: I only made one -- I have a

17 couple of copies if anyone else would like one.

18 DR. BELSITO: Okay. And when I looked

19 at the changes in table 1, they didn't really seem

20 -- I mean, it was just really more editorial

21 corrections than anything of substance. Is that a

22 good, correct assumption?




45

1 MS. FIUME: Look at the -- the one

2 structure was incorrect, and my structure was

3 missing. But it was more substance. We were

4 e-mailing it to Dr. Liebler electronically, so I

5 wanted to make sure you were included.

6 DR. BELSITO: Oh, thank you. Okay, so

7 the acrylate cross-polymers -- this is the first

8 time we're looking at the report. We've

9 previously looked at acrylate copolymers and found

10 them to be safe as used when formulated to avoid

11 skin irritation. The cross-polymers theoretically

12 should be even safer, because they're going to be

13 even larger molecules with less chance of

14 penetration and less reactive monomer content, and

15 the cross-polymers we're looking at probably

16 number about 20. They're listed on page 1 of the

17 book or page 7 of the Panel Book.

18 And beyond that, I really had no

19 substantive comments. I was comfortable with the

20 report. I thought it was very well put together.

21 We got a whole wave of second data dealing with

22 skin irritation and sensitization, and that was




46

1 all negative. So, I really had no comments on

2 this report. I love that little circular

3 structure, the theoretical magnified view of the

4 cross-linked --

5 MS. FIUME: (inaudible) having a chemist

6 on (inaudible).

7 DR. LIEBLER: We did that.

8 DR. BELSITO: I don't have a clue how

9 you would do that, but I thought it was

10 phenomenal.

11 DR. LIEBLER: Yeah, I wanted to also

12 second that, because I think that was a very

13 effective way to portray the chemical nature of

14 these above and beyond just the structure that

15 would be on the table, and it worked very nicely

16 also in the silylates report as well. So, this is

17 a nice innovation. It really helps to bring the

18 chemistry to the non-chemist audience I think

19 better, so nice idea.

20 DR. SNYDER: Can I add one question on

21 the impurities on page 3?

22 DR. KLAASSEN: Yes, the benzene?




47

1 DR. SNYDER: Yeah, the benzene. So, we

2 recognize that a product can -- one product does

3 have residual benzene, and we do have leave-on in

4 the baby/infant use, so is that an issue?

5 DR. BELSITO: Where are you, Paul, on --

6 DR. SNYDER: Carbopol 1342, the product

7 specification states that the acrylates C10 to C30

8 -- acrylate cross-polymer continue --

9 DR. BELSITO: 0.5 percent max.

10 MR. SNYDER: Okay.

11 MS. FIUME: And the baby product is.2

12 percent use.


14 MS. FIUME: In that entire product,

15 leave-on is.0002 to 5 percent. But the baby

16 product is.2.


18 DR. SNYDER: All right.

19 DR. BELSITO: Is that okay?

20 DR. SNYDER: Yeah, I mean, I just wanted

21 to point it out and make sure that we considered

22 it. I mean, is there anything in the manufacture




48

1 that other ones would contain higher levels than

2 that?

3 MS. FIUME: I haven't included anything

4 that I either found through industry or MSDS that

5 had residual levels, and that's why I broke it out

6 by trade name, because they did have different

7 amounts. Even though it was the same ingredient,

8 the trade names did have different specifications.

9 DR. KLAASSEN: Well, where did you find

10 this up to 5 percent?

11 DR. BELSITO: 0.5.

12 DR. KLAASSEN: Did you say 5 percent

13 someplace else?

14 MS. FIUME: Oh, the max leave-on use is

15 percent.

16 DR. KLAASSEN: Oh, the max leave-on use,

17 okay, not the amount of benzene.

18 DR. BELSITO: No. Well, is this

19 something that we need to put into the discussion?

20 DR. SNYDER: I think so.

21 DR. KLAASSEN: Yes.

22 DR. SNYDER: I think so.




49

1 DR. KLAASSEN: Yes, I noted it also.

2 DR. BELSITO: And how would you address

3 that?

4 DR. SNYDER: That we noted it in the

5 method of manufacture that benzene can be an

6 impurity in that process based on the information

7 that we have that it's at a low level in the

8 product and at the low exposure rates that is not

9 a concern, I guess, or something along that line

10 saying --

11 DR. BELSITO: Well, how specific do you

12 want to be about not a concern? I mean, so we're

13 saying -- are we saying it shouldn't contain more

14 than 0.5 crystal benzene?

15 DR. SNYDER: Well, I actually queried to

16 say should we limit the amount of benzene. I

17 don't know what we've done in -- with been benzene

18 in other reports, because I have that tagged as

19 have we limited benzene in other --

20 DR. BELSITO: I don't remember ever

21 specifically discussing a limit on benzene. I

22 don't.




50

1 MS. FIUME: Yeah, I can't recall off the

2 top of my head.

3 DR. SNYDER: I don't recall it either.

4 I'm checking the report on sodium

5 dodecylbenzenesulfonate to see if we did anything.

6 You know, up above there it said that when they

7 make these cross-polymers, they can make them in

8 apple acetate cycle hexane mixture or may also be

9 polymerized in benzene. So, some of them might

10 not have any.

11 DR. ANDERSEN: When I think a question

12 that while wouldn't specifically be directed but

13 the producer of the material should be aware that

14 the question has come up, and while 0.5 percent

15 may be the maximum, what's the normal expected

16 level, and if that is what I would think would be

17 significantly lower than that they just put a max

18 to cover the possibility, then that gives some

19 more information.

20 DR. BELSITO: Well, I guess, you know,

21 if we're going to -- I mean, we obviously -- the

22 issue is raised. We obviously feel it needs to go




51

1 in the discussion. I think from my point of view,

2 and again this is not my area of expertise --

3 benzene toxicity applied to the skin. If we're

4 going to say that it shouldn't contain more than

5 0.5 percent, it would seem to me that we would

6 have to have a rationale as to why it couldn't,

7 why we're limiting it at 0.5, because maybe it

8 could be 1 percent, you know? Maybe it could be

9 2.5.

10 So, I guess the question becomes we're

11 obviously concerned that at some point benzene

12 could be an issue. But what's that point, and

13 since we can either table it to get to that point,

14 give a specific -- and that's not going to happen

15 -- or if we say, you know, safe as used in the

16 current yadda, yadda, yadda, does that mean that

17 the assumption is it won't contain more than 0.5

18 percent benzene max? I mean, we don't have all of

19 the manufacturers here.

20 MS. FIUME: I found what I could find on

21 the internet.





52

1 DR. ANDERSEN: Yeah. Perhaps we could

2 provide some additional clarification on this.

3 This is a report from 15 years ago. Benzene is an

4 industrial solvent for purposes of polymerization

5 and is, you know, somewhat old style, so let us

6 see if we can provide some guidance. But we were

7 also aware of the report that they have

8 established a maximum for this particular grade of

9 0.5 percent, but that seems like a lot.

10 DR. KLAASSEN: Yeah, it might not even

11 be used anymore.

12 DR. BELSITO: Okay, so then looking at

13 these acrylate cross-polymers, I mean, essentially

14 safe as used but we need to deal with this benzene

15 in some fashion, and so do we table it to hear

16 back from industry about current methods of

17 manufacture? Does a "safe as used" -- does that

18 mean that we're assuming there would be no more

19 than 0.5 percent benzene? Because if we start

20 getting into specifics in the discussion about

21 that, then I think we need to justify why we put

22 that limit, and we don't have the data to do that.




53

1 DR. SNYDER: Well, benzene is not an

2 insignificant toxicant.


4 DR. SNYDER: I mean it's -- and so -- I

5 mean, I think that we have information that it is

6 an impurity, and in one product it can -- you

7 know, they say it maxes at.05 percent. But,

8 again, we also have --

9 DR. BELSITO: 0.5.

10 DR. SNYDER: 0.5 percent. And we also

11 have information, though, that it is used in a

12 polymerization, or has been historically used in a

13 polymerization. So, I think this --

14 DR. BELSITO: Then maybe we should table

15 it and hear what industry has to say about current

16 methods of manufacture? I mean, because that's --

17 I mean, basically if there's no benzene or if

18 every product on the market is less than 0.5

19 percent, we're comfortable going ahead with "safe

20 as is," is that correct?

21 DR. SNYDER: Correct.

22 DR. KLAASSEN: Right.




54

1 DR. BELSITO: But right now we don't

2 know that. We have one company saying their max

3 is 0.5, but we don't know who the manufacturers

4 are, and we're not prepared to do a risk

5 assessment on benzene.

6 DR. KLAASSEN: I suggest we wait for

7 this information.

8 DR. SNYDER: I concur.

9 DR. ANDERSEN: There's two ways of

10 waiting -- passively waiting and aggressively

11 waiting. (Laughter) The aggressive stance would

12 be to issue an insufficient data announcement to

13 -- for clarification of benzene levels in these

14 products period. We just -- that's what you need

15 to know.

16 DR. BELSITO: I'm an aggressive guy.

17 Let's go with that if you're comfortable. I mean,

18 insufficient, further information on levels of

19 benzene.

20 DR. ANDERSEN: I mean, it's -- you would

21 expect that you will get a response. So, it's not

22 like it's sending it to insufficient limbo, and




55

1 once you have the information, you can easily

2 issue the safety assessment as a tentative the

3 next time we meet.

4 DR. KLAASSEN: Fine.

5 DR. BELSITO: I like that better than

6 tabling, yeah. Puts a time limit on it. Okay,

7 good.

8 So, then, Dan, you comfortable with

9 that?

10 DR. LIEBLER: Yeah, I am.

11 DR. BELSITO: We're going to go

12 insufficient, further information about levels of

13 benzene and the acrylate cross-polymers.

14 Otherwise, once we get that if the information is

15 less than.5 percent, we'll go ahead with the safe

16 as used.

17 DR. SNYDER: I have another question.

18 So, the inhalation data. So, we go through our

19 respiratory boilerplate, and I quite didn't know

20 how to correlate with -- we have known industrial

21 exposure limits. So, it is respirable, and so how

22 does -- it comes up in another report, too, where




56

1 we actually have inhalation data where they

2 actually dosed animals and it was -- it did have

3 an effect. And so the use of the boilerplate

4 usually says "in the absence of data," but could

5 -- we have data that says it is respirable -- I'm

6 kind of conflicted there as to what does that --

7 how are we dealing with that or --

8 DR. ANDERSEN: I think, Paul, the issue

9 of respirable/not respirable really relates more

10 to the class of products called cosmetics. As

11 aerosols are produced in the cosmetics industry,

12 they are not blockbuster particles but they're

13 bigger than what's respirable in general, and we

14 simply capture that. I don't have any question

15 that the technology exists to make smaller

16 particles, which would be respirable, but you

17 aren't going to find it in cosmetics. And so

18 there's been limits established for respiratory

19 levels, and that's fine. They wouldn't have been

20 needed for cosmetics.


22 DR. SNYDER: I have one editorial




57

1 suggestion on report page 2 right under the

2 virtual -- well, virtual molecule structure. It

3 says, "Due to the multitude of possible reaction

4 conditions" -- this is under chemistry and

5 structure, a definition and structure -- "Due to

6 multitude of possible reaction conditions and

7 methods, the properties of a single ingredient"

8 blah-blah-blah. And then the sentence -- two

9 sentences after that, "Nonetheless, the polymers

10 in this group share the same lack of chemical

11 activity." These are really discussions of

12 properties. So, they should be moved down under

13 "Physical and Chemical Properties." And I

14 actually reworded the sentence about the polymers

15 having a lack of chemical reactivity to read, "The

16 polymers in this group share a general lack of

17 chemical reactivity that renders them nearly

18 impervious to degradation." So, this is very

19 clearly outlined in my annotated version.

20 DR. BELSITO: Anything else?

21 DR. ANDERSEN: No.

22 DR. BELSITO: Okay, so we're going




58

1 "Insufficient, for further information" on the

2 benzene content, residual benzene content.



Dr. Marks Team – March 2011

255

1 DR. MARKS: "After penetration" --

2 delete. Okay. Acrylate Cross Polymers.

3 Let's go to acrylate cross polymers,

4 Green Book, titled "Crosslinked Alkyl Acrylates."

5 And then we got another electronic transmission of

6 changes in the Table 1, "Definitions, Functions,

7 Structures."

8 This is the first time we've seen this

9 report, the first time for us to review these

10 cosmetic ingredients. So we have the draft report

11 in front of us.

12 And I'll ask the old team, Tom and Ron,

13 are there any needs from your vantage point? And,

14 also -- I think I have that.

15 MS. FIUME: Okay.

16 DR. MARKS: I printed it out. Thanks.

17 MS. FIUME: I will give you this. This

18 is just the updated data profile. The red is what

19 was new.

20 DR. MARKS: Oh, okay. Thank you.

21 DR. SHANK: I have no data needs.

22 DR. SLAGA: Same here. It's a very




256

1 stable -- probably even more so than the original

2 document on just the (inaudible).

3 DR. MARKS: So we would issue a

4 tentative report "safe?"

5 DR. SLAGA: Yep.

6 DR. SHANK: Right.

7 DR. MARKS: I saw no issues. And --

8 okay. Safe. Shall we move on without Ron Hill

9 being here?

10 DR. SHANK: (Inaudible).

11 DR. MARKS: Yes, I agree. This would

12 actually be good armor in warfare?

13 DR. SHANK: Yes -- oh.

14 DR. MARKS: So one thing I highlighted

15 on page 74, it is used in baby products. There's

16 no -- again, it doesn't raise any issues from that

17 point of view. It's used in baby lotions, oils,

18 powders and creams. That -- still -- safe.

19 DR. SHANK: Well, I think in the

20 "Discussion," we should have discussion that the

21 monomers could be impurities, but the monomers

22 have already been reviewed by the panel? And we




257

1 should wait for Dr. Hill?

2 DR. MARKS: Yes -- will do. They've

3 already been addressed in previous CIR reports.

4 And, obviously, they were addressed as

5 being safe, or else we would be concerned about

6 the monomers' being present.

7 DR. SHANK: Well, the maximum

8 use-concentration --

9 DR. MARKS: Right.

10 DR. SHANK: -- for the polymers is

11 (inaudible). So the un-reacted monomer's going to

12 be small.

13 DR. MARKS: Right. So, Ron, we've

14 already decided that we have enough data, and we

15 can issue a tentative report with a "safe"

16 conclusion. And this is for the crosslinked --

17 DR. HILL: Yes.

18 DR. MARKS: -- alkyl acrylates. But we

19 didn't want to finalize that until we got your

20 input. We didn't want you to be surprised

21 tomorrow when I moved to make this --

22 DR. HILL: No, I think that's where I




258

1 came to. I'm just trying to remember if there

2 were any --

3 DR. MARKS: Monomer impurities are

4 addressed in previous -- so that would be in the

5 discussion. Yes.

6 DR. HILL: I think most of my things in

7 here were all editorial. So --

8 DR. MARKS: Okay.

9 DR. BERGFELD: May I ask a question?

10 Some of the special tox studies were not here. If

11 you're using the monomer studies, is that

12 adequate? The genotox, the reproductive? You

13 know, there's nothing on this group, crosslinked

14 acrylates.

15 DR. SHANK: These won't be absorbed.

16 DR. BERGFELD: So they won't be

17 absorbed. So that's -- you don't need that.

18 So you'll put that in the discussion, as

19 well?

20 DR. MARKS: Yes.

21 DR. BERGFELD: Okay. So they've very

22 big.




259

1 DR. HILL: Who was the report writer

2 here?

3 MS. FIUME: I am.

4 DR. HILL: Okay. Yes, I have quite a

5 bit of -- it falls in the category of editorial

6 things. But in the structures table, and --

7 MS. FIUME: Oh, I just gave you a new

8 structures table --

9 DR. HILL: You gave me a new --

10 MS. FIUME: -- that has a corrected

11 structure, and one that was missing.

12 DR. HILL: Well, there are quite a few

13 places where I made notations concerning the

14 structures. And it doesn't affect anything in

15 terms of conclusion. And it's probably, in many

16 cases, traceable to dictionary errors. But -- so

17 --

18 DR. MARKS: Okay. So tomorrow I'll move

19 to issue a tentative report with a "safe as used"

20 conclusion. And the discussion will say that

21 these ingredients are not absorbed, hence the lack

22 of some of the data points needed. And that the




260

1 monomer impurities have been addressed in previous

2 CIR reports.

3 DR. HILL: The only other question I had

4 was will Table 5 -- it is intended that Table 5

5 will be maintained in the final report? I'm

6 hoping yes.

7 MS. FIUME: Yes, Table 5 will replace

8 that "Dermal Irritation and Sensitization" -- the

9 text will be replaced by Table 5.

10 DR. HILL: Okay. But Table 5 is planned

11 for the final report?

12 MS. FIUME: Yes.

13 DR. HILL: Yes? Great.



Rep

ort

Tentative Report

Crosslinked Alkyl Acrylates as used in Cosmetics

June 27, 2011

All interested persons are provided 60 days from the above date to comment on this Tentative Report and to identify additional published data that should be included or provide unpublished data which can be made public and included. Information may be submitted without identifying the source or the trade name of the cosmetic product containing the ingredient. All unpublished data submitted to CIR will be discussed in open meetings, will be available at the CIR office for review by any interested party and may be cited in a peer-reviewed scientific journal. Please submit data, comments, or requests to the CIR Director, Dr. F. Alan Andersen.

The 2010 Cosmetic Ingredient Review Expert Panel members are: Chair, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Director is F. Alan Andersen, Ph.D. This report was prepared by Monice Fiume, Scientific Analyst/Writer; and Bart Heldreth, Ph.D., Chemist.

© Cosmetic Ingredient Review 1101 17th Street, NW, Suite 412 ◊ Washington, DC 20036-4702 ◊ ph 202.331.0651 ◊ fax 202.331.0088 ◊

[email protected]



ii

TABLE OF CONTENTS

Abstract ............................................................................................................................................................................................................ 1

Introduction ...................................................................................................................................................................................................... 1

Chemistry ......................................................................................................................................................................................................... 2

Definition and Structure ............................................................................................................................................................................... 2

Physical and Chemical Properties ................................................................................................................................................................ 2

Method of Manufacture ............................................................................................................................................................................... 3

Impurities and Residual Monomer or Solvent ............................................................................................................................................. 3

Use .................................................................................................................................................................................................................... 4

Cosmetic ...................................................................................................................................................................................................... 4

Non-Cosmetic .............................................................................................................................................................................................. 5

Toxicokinetics .................................................................................................................................................................................................. 5

Effect on Skin Permeation ........................................................................................................................................................................... 5

Toxicological studies ........................................................................................................................................................................................ 5

Single Dose (Acute) Toxicity ...................................................................................................................................................................... 5

Dermal .................................................................................................................................................................................................... 5

Oral ......................................................................................................................................................................................................... 5

Inhalation ................................................................................................................................................................................................ 6

Repeated Dose Toxicity ............................................................................................................................................................................... 6

Inhalation ................................................................................................................................................................................................ 6

Reproductive and Developmental Toxicity ...................................................................................................................................................... 6

Genotoxicity ..................................................................................................................................................................................................... 6

Carcinogenicity ................................................................................................................................................................................................. 6

Irritation and Sensitization ................................................................................................................................................................................ 6

Skin Irritation and Sensitization ................................................................................................................................................................... 7

Mucosal Irritation ........................................................................................................................................................................................ 7

Alternative Studies .................................................................................................................................................................................. 7

Non-Human ............................................................................................................................................................................................ 7

Industrial Exposure Limits................................................................................................................................................................................ 8

Summary .......................................................................................................................................................................................................... 8

Draft Discussion ............................................................................................................................................................................................... 9

Tables ............................................................................................................................................................................................................. 10

Table 1. Definitions, functions, and structures .......................................................................................................................................... 10

Table 2. Chemical and physical properties ............................................................................................................................................... 23

Table 3a. Monomers used to create crosslinked alkyl acrylates ................................................................................................................ 24

Table 3b. Crosslinker compounds and initiators used in manufacture of acrylate crosspolymers ............................................................ 24

Table 4a. Frequency and concentration of use according to duration and type of exposure ..................................................................... 25

Table 4b. Ingredients Not Reported to be Used ........................................................................................................................................ 26

Table 5. Dermal irritation and sensitization – alternative, non-human, and human .................................................................................. 27

Table 6. Relevant summary information on components .......................................................................................................................... 31

References ...................................................................................................................................................................................................... 38



1

ABSTRACT

The CIR Expert Panel assessed the safety of crosslinked alkyl acrylates as used in cosmetics. The 23 crosslinked alkyl acrylates included in this safety assessment have a number of functions in cosmetic formulations, including use as absorbents, film formers, emulsion stabilizers, viscosity increasing agents, suspending agents, binders, and/or skin conditioning agents. The Panel reviewed available animal and clinical data, as well as information from previous CIR reports on monomer components; because data were not available for the individual ingredients, and because residual monomer may be present, the Panel extrapolated from previous reports to support safety. The Panel concluded that crosslinked alkyl acrylates… [to be determined at the Panel meeting].

INTRODUCTION

This draft report includes information relevant to the safety of 23 crosslinked alkyl acrylates as used in cosmetic

formulations. These crosslinked polymers consist of co-monomers of at least one of: acrylic acid, sodium acrylate, meth-

acrylic acid, or alkyl acrylate that share chemical properties, including a general lack of chemical reactivity. The ingredients

included in this group are:

Acrylates/C10-30Alkyl Acrylate Crosspolymer Acrylates/C12-13 Alkyl Methacrylates/Methoxyethyl Acrylate Crosspolymer Acrylates Crosspolymer Acrylates/Ethylhexyl Acrylate Crosspolymer Acrylates/Ethylhexyl Acrylate/Glycidyl Methacrylate Crosspolymer Acrylates/PEG-4 Dimethacrylate Crosspolymer Acrylates/Steareth-20 Methacrylate Crosspolymer Acrylates/Vinyl Isodecanoate Crosspolymer Acrylates/Vinyl Neodecanoate Crosspolymer Allyl Methacrylate/Glycol Dimethacrylate Crosspolymer Allyl Methacrylates Crosspolymer Butyl Acrylate/Glycol Dimethacrylate Crosspolymer C8-22 Alkyl Acrylates/Methacrylic Acid Crosspolymer Glycol Dimethacrylate/Vinyl Alcohol Crosspolymer Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer Lauryl Methacrylate/Sodium Methacrylate Crosspolymer Methacrylic Acid/PEG-6 Methacrylate Crosspolymer PEG/PPG-5/2 Methacrylate/Methacrylic Acid Crosspolymer Potassium Acrylates/C10-30 Alkyl Acrylate Crosspolymer Sodium Acrylates Crosspolymer-2 Sodium Acrylates/C10-30 Alkyl Acrylate Crosspolymer Sodium Acrylates/Vinyl Isodecanoate Crosspolymer Stearyl/Lauryl Methacrylate Crosspolymer

These ingredients can function in cosmetics as absorbents, film formers, emulsion stabilizers, viscosity increasing

agents, suspending agents, binders, or skin conditioning agents.

In 2002, the Cosmetic Ingredient Review (CIR) published the Final Report on the Safety Assessment of Acrylates

Copolymer and 33 Related Cosmetic Ingredients.1 The Panel concluded that those ingredients were safe for use in cosmetics

when formulated to avoid skin irritation. While copolymers are polymers synthesized from two or more different monomers,

crosspolymers are polymers that are crosslinked (i.e. individual polymer chains are connected by bridging molecules

[crosslinking agents]). Crosslinked polymers are generally less chemically reactive and less soluble (if not totally insoluble)

than their respective non-crosslinked counterparts.

Due to the paucity of published safety and toxicity data on these ingredients, this draft report includes summary

information included in technical data sheets, ingredient specification sheets, and material safety data sheets (MSDSs); this

information is identified as such. Also included at the end of this report is a table (Table 6), which provides a brief summary

of relevant data that exist for a number of the monomer components.



2

CHEMISTRY

Definition and Structure

Crosslinked alkyl acrylates are crosslinked polymers in which the co-monomers consist of at least one of the follow-

ing: acrylic acid, sodium acrylate, methacrylic acid, or alkyl acrylate. Whereas polymers consisting purely of acrylic acid are

often referred to as “carbomers,” copolymers comprised of mixtures of acrylic acid and alkyl acrylate monomers may some-

times be referred to as “alkyl carbomers.” In that vein, most of the ingredients in this report could be classified as cross-

linked alkyl carbomers. For example, dodecyl (C12 alkyl) acrylate, acrylic acid, and methacrylic acid could be copolymer-

ized and crosslinked with diallyl sucrose to form an acrylates/C10-30 alkyl acrylate crosspolymer with the internal structure:

O

OH

OH

O

OH

O

OHHO

HO

OO

OO

O

HO

O

OO

O

OH

Theoretical magnifiedviewof thecrosslinkednetwork inapolymerbeadofAcrylates/ C10-30AlkylAcrylateCrosspolymer.

H3C

Accordingly, although all of the monomers and crosslinking agents may be the same, two polymers with very

different physical properties may share the same name under INCI conventions. The definitions and structures of the

ingredients included in this review are provided in Table 1.

Physical and Chemical Properties

The available physical and chemical property information is provided in Table 2. The properties of a single

ingredient, such as the above crosspolymer, can vary from a highly swellable, soft material to an unswellable, very hard

material because of the multitude of possible reaction conditions and methods involved in the manufacture of these polymers.

The nature of these ingredients is highly dependent on the identity of the alcohol radicals of these acrylate esters (e.g., the

stearyl and lauryl groups of stearyl/lauryl methacrylate crosspolymer).2 Acrylate crosspolymers that correspond to one INCI

name often have many trade names, and production processes may vary for different trade name products bearing the same

INCI name. Since the products may have different properties, the trade name is included in parenthesis when available.

The polymers in this group share a general lack of chemical reactivity that renders them nearly impervious to

degradation. These ingredients are essentially insensitive to solar ultraviolet light (UV) degradation, as the primary UV

absorption of acrylics is at a lower wavelength.



3

Method of Manufacture

Crosslinked alkyl acrylates are typically produced via free-radical, head-to-tail chain-propagation polymerization.2

The most common method is the emulsion method, but bulk and solution methods are also used. The marked variability in

the identity of monomers and crosslinking agents, the ratio of co-monomers, the order of addition of co-monomers, the level

of crosslinking, and other reaction conditions in the polymerization process can significantly alter the polymeric structure and

properties of the product.3 Additionally, post-synthesis, mechanical processing of these products can also significantly affect

the consistency of these ingredients. These variables will likely differ from vendor to vendor, and possibly even from batch

to batch.

Table 3a lists the monomers used to create these crosspolymers (based on INCI definition), and Table 3b names the

crosslinking compounds and initiators used.4

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

According to a trade product technical data sheet, acrylates/C10-30 alkyl acrylate crosspolymer (as Pemulen) is

polymerized in an ethyl acetate-cyclohexane mixture.5 Another source reports that acrylates/C10-30 alkyl acrylate cross-

polymer may be polymerized in benzene.6 A third supplier reports that acrylates/C10-30 alkyl acrylate crosspolymer is

polymerized in n-hexane.7

Acrylates/Steareth-20 Methacrylate Crosspolymer

Acrylates/steareth-20 methacrylate crosspolymer (as Aculyn 88 polymer) is manufactured by an emulsion polymeri-

zation process.8

Acrylates/Vinyl Isodecanoate Crosspolymer

Acrylates/vinyl isodecanoate crosspolymer (as Stabylen 30) is produced synthetically by a free radical polymeriza-

tion.9

Acrylates/Vinyl Neodecanoate Crosspolymer

Acrylates/vinyl neodecanoate crosspolymer (as Aculyn 38 polymer) is manufactured by an emulsion polymerization

process.10

Impurities and Residual Monomer or Solvent


According to product specification sheets from one company, acrylates/C10-30 alkyl acrylate crosspolymer can con-

tain (total) residual solvent (ethyl acetate + cyclohexane) at a maximum of 0.45% (Carbopol 1382; Carbopol Ultrez 20; Car-

bopol Ultrez 21)11-13 or 0.5% (Pemulen TR1; Pemulen TR2; Carbopol ETD 2020).14-16 Another supplier, that uses n-hexane

as a solvent, reported that the maximum residual solvent in the polymer is 0.2% n-hexane.7

As Carbopol 1342, the product specifications state that acrylates/C10-30 alkyl acrylate crosspolymer can contain

0.5% (max.) residual benzene.17 A supplier reported that analysis of 40 lots of Carbopol 1342 indicated that the average level

of benzene was 0.25%, and the level ranged from 0.04-0.41% benzene.18 (According to the European Commission Cosme-

tics Directive, benzene cannot be present as a constituent of other substances, or in mixtures, in concentrations equal to, or

greater than 0.1% by weight.19 California’s Proposition 65 limits benzene exposure from a product to 6.4 µg/day for oral

exposure and 13 µg/day for inhalation exposure.18)

One source stated that residual monomer content of acrylates/C10-30 alkyl acrylate crosspolymer (trade name not

provided) is typically less than 0.25% acrylic acid and less than 0.5% residual ester (C10-30 alkyl acrylate),6 while another

stated that acrylic acid monomer is <0.1%.20



4

Acrylates Crosspolymer

One source reported that acrylates crosspolymer contained <0.005% methyl methacrylate and <0.005% butyl

acrylate,21 and another reported 0.005% (max) of methyl methacrylate, ethylene methacrylate, and isobutyl methacrylate, and

that acrylates crosspolymer did not contain residual solvents or preservatives.22

Acrylates /Steareth-20 Methacrylate Crosspolymer

The composition of acrylates/vinyl neodecanoate crosspolymer (as Aculyn 88 polymer) is stated as 28.0-30.0%

acrylates/vinyl neodecanoate crosspolymer , <0.01% residual monomer, 70.0-72.0% solvent (water), and 0.195% (max)

sodium benzoate.8 According to actual analytical specifications, the amount of residual ethyl methacrylate present is

≤0.0001%.


The residual acrylic acid monomer content of acrylates/vinyl isodecanoate crosspolymer (Stabylen 30) is reported to

be <0.05% by weight.9


The composition of acrylates/vinyl neodecanoate crosspolymer (as Aculyn 38 polymer) is stated as 28.0-30.0%

acrylates/vinyl neodecanoate crosspolymer, <0.1% residual monomer, and 70.0-72.0% solvent (water).10 According to actual

analytical specifications, the amount of residual ethyl acrylate present was ≤0.0001%.

Another source reported the residual monomer level of acrylates/vinyl neodecanoate crosspolymer is <0.01%.23

Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer

The residual monomer levels of lauryl methacrylate/glycol dimethacrylate crosspolymer are <0.01% lauryl meth-

acrylate and <0.01 ppm ethylene glycol dimethacrylate.24 Lauryl methacrylate/glycol dimethacrylate crosspolymer has a re-

sidual solvent level of ≤0.1% isopropanol. The ingredient can contain up to 2% adsorbed water.

Sodium Acrylates Crosspolymer-2

The maximum amount of residual monomer content of in sodium acrylates crosspolymer-2 (Aqua Keep 10SH-NFC)

is 0.02%.25

USE

Cosmetic

Crosslinked alkyl acrylates have a number of functions in cosmetic formulations, including use as absorbents, film

formers, emulsion stabilizers, viscosity increasing agents, suspending agents, binders, and/or skin conditioning agents.4

Acrylates/C10-30 alkyl acrylate crosspolymer functions as a primary emulsifier in oil-in-water emulsions.5 Voluntary Cos-

metic Registration Program (VCRP) data obtained in 2011,26 and concentration of use information received in response to a

survey conducted by the Personal Care Products Council,27 indicate that 11 of the 23 crosslinked alkyl acrylates named in this

report currently are used in cosmetic formulations. Acrylates/C10-30 alkyl acrylate crosspolymer has the greatest number of

uses, with 1696 reported; 1365 of those uses are in leave-on products. Acrylates crosspolymer, acrylates/vinyl isodecanoate

crosspolymer, acrylates/vinyl neodecanoate crosspolymer, allyl methacrylates crosspolymer, lauryl methacrylate/glycol

dimethacrylate crosspolymer, lauryl methacrylate/sodium methacrylate crosspolymer, and sodium acrylates/C10-30 alkyl

acrylate crosspolymer are all used in less than 75 formulations.

The highest concentration of use reported in leave-on products is 6% acrylates/ethylhexyl acrylate crosspolymer,

and the highest concentration of use reported in rinse-off products is 5% acrylates/C10-30 alkyl acrylate crosspolymer.

Frequency and concentration of use data are provided in Table 4a. The ingredients not reported to be used are listed in Table

4b.



5

Products containing some crosslinked alkyl acrylates may be applied to baby skin, used near the eye area or mucous

membranes, or could possibly be ingested or inhaled. Since some of the crosslinked alkyl acrylates are reported to be in

products that could be inhaled, and effects on the lungs that may be induced by aerosolized products containing these

ingredients are of concern. The particle size of aerosol hair sprays and in pump hair sprays is around 38 µm and >80 µm,

respectively, and is large compared to respirable particle sizes (≤10 µm). Therefore, because of their size, most aerosol

particles are deposited in the nasopharyngeal region and are not respirable.

All of the ingredients included in this review, with the exception of acrylates/C12-13 alkyl methacrylates methoxy-

ethyl acrylate crosspolymer and methacrylic acid/PEG-6 methacrylate crosspolymer, are listed in the European Union

inventory of cosmetic ingredients.28 The two ingredients that are not included in the EU inventory are in the process of being

named and will be added once that process is complete.29

Non-Cosmetic

Acrylic ester polymers are used in coatings, textiles, adhesives, and paper manufacture.2

TOXICOKINETICS

Published toxicokinetics, absorption, distribution, metabolism, and excretion data were not found for the

crosspolymers. Large polymeric structures, however, such as cross-linked alkyl acrylates generally are not absorbed through

the skin. Toxicokinetics data on some of the monomers are provided in Table 6.

Effect on Skin Permeation


A topical formulation vehicle that included acrylates/C10-30 alkyl acrylate crosspolymer (Pemulen TR-2), in

combination with PEG 400 and carbomer, reduced the permeation of N,N-diethyl-m-toluamide (DEET) through skin.31

Evaluations were made in vitro using excised rat skin and in vivo using Beagle dogs.

TOXICOLOGICAL STUDIES

To aid in the evaluation of the safety of these crosspolymers, Table 6 provides a brief summary of relevant data on a

number of monomer components. (This summary is not intended to be an all-encompassing review of these monomers.)

Single Dose (Acute) Toxicity

Dermal


According to an industry MSDS, the dermal LD50 of acrylates/C10-30 alkyl acrylate crosspolymer (as Pemulen

TR1) in rabbits is >2.0 g/kg.32


The oral LD50 of acrylates/vinyl neodecanoate crosspolymer (as Aculyn 38 polymer) in rabbits is >5.0 g/kg.10

Oral


According to an industry MSDS, the oral LD50 of acrylates/C10-30 alkyl acrylate crosspolymer (as Pemulen TR1) in

rats is >10 g/kg.32 Another source provided information from an MSDS, stating that the oral LD50 in rats is >2 g/kg.20


The oral LD50 acrylates/vinyl isodecanoate crosspolymer (as Stabylen 30) in rats is >2 g/kg body wt.33


The oral LD50 of acrylates/vinyl neodecanoate crosspolymer (as Aculyn 38 polymer) in rats is >5.0 g/kg.10



6


According to an industry MSDS, the oral LD50 of sodium acrylates crosspolymer-2 (as Aqua Keep 10SH-NFC) in

rats is >2 g/kg.34

Inhalation

Acrylates/Vinyl Neodecanoate Crosspolymers

The inhalation LC50 of acrylates/vinyl neodecanoate crosspolymer (as Aculyn 38 polymer) in rats is >16,340 mg/m3

air (1 h).10

Repeated Dose Toxicity

Inhalation


In an industry MSDS for acrylates/C10-30 alkyl acrylate crosspolymers (as Pemulen TR-1), a 2-yr inhalation study

in which rats were exposed to a respirable, water-absorbent sodium polyacrylate dust is described under toxicological

information. Lung effects such as inflammation, hyperplasia, and tumors, were observed.32 There were no observed adverse

effects at exposures of 0.05 mg/m3.

REPRODUCTIVE AND DEVELOPMENTAL TOXICITY

Published reproductive and developmental toxicity data were not found. Reproductive and developmental toxicity

data on some of the monomers are provided in Table 6.

GENOTOXICITY

Genotoxicity data on some of the monomers are provided in Table 6.


Acrylates/C10-30 alkyl acrylate crosspolymer, tested at 156-500 µg/plate in dimethyl sulfoxide, was not mutagenic

in an Ames assay with Salmonella typhimurium TA98 and TA100.20 It is not stated directly, but it appears that the studies

were performed with and without metabolic activation.

Acrylates/Steareth-20 Methacrylate Crosspolymer

The acrylic copolymer of acrylates/steareth-20 methacrylate crosspolymer (as Aculyn 88 polymer) was not muta-

genic in an Ames test, with or without metabolic activation.8 (GLP study; details not provided.)


The acrylic copolymer of acrylates/vinyl neodecanoate crosspolymer (as Aculyn 38 polymer) was not mutagenic in

an Ames test, with or without metabolic activation.10 (GLP study; details not provided.)


According to an industry MSDS, sodium acrylates crosspolymer-2 (as Aqua Keep 10SH-NFC) was negative in an

Ames test using S. typhimurium TA98, TA100, TA1535, and TA1537 and Escherichia coli WP2uvrA.34

CARCINOGENICITY

Published carcinogenicity studies were not found. Carcinogenicity data on some of the monomers are provided in

Table 6.

IRRITATION AND SENSITIZATION

Irritation and sensitization data on some of the monomers are provided in Table 6.



7

Skin Irritation and Sensitization

Dermal irritation and sensitization studies, using alternative methods and non-human and human test populations,

are presented in Table 5.

The non-human studies reported no to slight irritation and weak sensitization with acrylates/C10-30 alkyl acrylate

crosspolymer, no irritation with acrylates crosspolymer and acrylates/vinyl neodecanoate crosspolymer, and no irritation or

sensitization with sodium acrylates crosspolymer-2. The human studies, performed using the crosspolymer or formulations

containing the crosspolymer, reported that acrylates/C10-30 alkyl acrylate, acrylate, acrylates/ethylhexyl acrylate,

acrylates/vinyl isodecanoate, acrylates/vinyl neodecanoate, and lauryl methacrylate/glycol dimethacrylate crosspolymers are

not dermal irritants or sensitizers. The only exception was a weak irritant response noted during an intensified Shelanski

human repeated insult patch test (HRIPT) with acrylates/C10-30 alkyl acrylate crosspolymer.

Mucosal Irritation

Alternative Studies


The EYE-TEX alternative method was used to predict the in vivo ocular irritation classification of acrylates/vinyl

isodecanoate crosspolymer (as Stabylen 30).33 The results obtained in a standard volume-response study using samples of

≤100 µl test material corresponded to a Draize ocular irritation classification of non-irritant.

Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer

The EpiOcular Human Cell Construct (MTT assay), was used to assess the potential ocular irritation of a face

powder containing 1% lauryl methacrylate/glycol dimethacrylate crosspolymer.35 The ET50 (duration of exposure resulting in

a 50% decrease in MTT conversion) of the test material was >1440 min, which was the maximum exposure time. (As a

reference point, the ET50 of the positive control, 0.3% Triton X-100, was 16.3 min.)

Non-Human


The ocular irritation potential of acrylates/C10-30 alkyl acrylate crosspolymer (as Carbopol ETD) was evaluated

using groups of 3 albino rabbits.36 The test material, undiluted and as a 1% neutralized solution (pH 6.9-7.0), was instilled

into the conjunctival sac of one eye of each rabbit per group; the contralateral eyes served as a control. The eyes were not

rinsed. The undiluted test material produced slight to moderate corneal and conjunctival irritation which cleared by day 7.

Slight iridal and conjunctival irritation was observed with the 1% solution. All signs of irritation cleared with 72 h.

In other studies using the same procedure, the ocular irritation potential of acrylates/C10-30 alkyl acrylate cross-

polymer (as Carbopol Ultrez 20 and as Carbopol Ultrez 21) was evaluated using groups of 3 rabbits.37,38 The test material

was evaluated undiluted and as a 5% dilution in distilled water. The undiluted test material produced moderate corneal

irritation and conjunctival irritation which cleared by day 21. (The maximum mean score (MMS) was 37.7/110.) Moderate

conjunctival irritation (MMS 9.3/110) was observed with the 5% solution, which was classified as a minimal irritant.

The ocular irritation potential of acrylates/C10-30 alkyl acrylate crosspolymer (as Pemulen) was evaluated by

instilling 0.021 g of the test article into the conjunctival sac of one eye of 9 New Zealand White (NZW) rabbits.39 The

contralateral eyes were untreated and served as the control. At 30 sec post-instillation, both eyes of 3 rabbits were rinsed; the

eyes of the other 6 rabbits were not rinsed. The eyes were examined for irritation for up to 72 h following dosing. “Signifi-

cant” ocular irritation was observed in 3 of the 6 unrinsed eyes. At 24 h after instillation, corneal opacity was observed in 3

and iritis in one unrinsed eye; minimal conjunctivitis was seen in all 6 unrinsed eyes. These observations were resolved by

72 h. “Less severe responses” were observed in the rinsed eyes. Iritis was observed in one and conjunctivitis in 3 of the



8

rinsed eyes at 24 h after dosing. At 48 h after dosing, conjunctivitis was observed in one rinsed eye. Based on the observa-

tions made for the unrinsed eyes, this product was considered a “borderline irritant.”

Acrylates Crosspolymer

The ocular irritation potential of acrylates crosspolymer was evaluated by instilling 0.1 ml of the test material, at a

concentration of 50% in olive oil, into the conjunctival sac of one eye of 3 Japanese white rabbits.21 The Draize score was

1.3. (Additional details were not provided.)


According to an industry MSDS, sodium acrylates crosspolymer-2 (as Aqua Keep 10SH-NFC) is not an ocular

irritant in rabbits, and it is not a vaginal mucosa irritant in dogs.34

INDUSTRIAL EXPOSURE LIMITS


According to an industry MSDS, no exposure limits have been established for acrylates/C10-30 alkyl acrylate cross-

polymer.32 However, the industry-recommended permissible exposure limits for respirable polyacrylate dusts is 0.05 mg/m3.

Breathing of dust may cause coughing, mucous production, and shortness of breath.


According to an industry MSDS, the exposure limit for respirable sodium acrylates crosspolymer-2 dust (particle

size <10 µm) is of 0.05 mg/m3.34

SUMMARY

The crosslinked alkyl acrylates are crosslinked polymers that consist of co-monomers of acrylic acid, sodium

acrylate, methacrylic acid, and/or alkyl acrylate, and they share chemical properties, including a general lack of chemical

reactivity. Crosslinked alkyl acrylates are typically produced via free-radical, head-to tail chain-propagation polymerization.

Ethyl acetate + cyclohexane, water, and benzene are all named as solvents. Because of the manner in which these polymers

are created and the mixture of monomers and cross-linking agents that can be used, two polymers that have the same INCI

name can have very different physical consistencies. Residual monomer and/or solvent may be present in the cosmetic

ingredient.

Crosslinked alkyl acrylates have a number of functions in cosmetic formulations, including use as absorbents, film

formers, emulsion stabilizers, viscosity increasing agents, suspending agents, binders, and/or skin conditioning agents. In

2011, it was reported that acrylates/C10-30 alkyl acrylate crosspolymer was used in 1696 cosmetic formulations; 1365 of

those uses are in leave-on products. According to industry data, acrylates/ethylhexyl acrylate crosspolymer had the highest

concentration of use in a leave-on product at 6%; the highest concentration of use reported in rinse-off products was 5%

acrylates/C10-30 alkyl acrylate crosspolymer.

Toxicokinetic data were not found in the published literature. Little toxicity data were available; the acute dermal

and oral toxicity data that were found indicated that these ingredients are not very toxic. The little genotoxicity data that

were available reported negative results in Ames tests. Carcinogenicity data were not found in the published literature.

Studies using rabbits or guinea pigs reported no irritation to slight irritation and weak sensitization with

acrylates/C10-30 alkyl acrylate crosspolymer, no irritation with acrylates crosspolymer and acrylates/vinyl neodecanoate

crosspolymer, and no irritation or sensitization with sodium acrylates crosspolymer-2. Human studies, performed using the

crosspolymer or formulations containing the crosspolymer, reported that acrylates/C10-30 alkyl acrylate, acrylate,

acrylates/ethylhexyl acrylate, acrylates/vinyl isodecanoate, acrylates/vinyl neodecanoate, and lauryl methacrylate/glycol



9

dimethacrylate crosspolymers are not dermal irritants or sensitizers. The only exception was a weak irritant response noted

during an intensified Shelanski human repeated insult patch test (HRIPT) with acrylates/C10-30 alkyl acrylate crosspolymer.

Mucosal irritation studies using alternative non-animal test systems with acrylates/vinyl isodecanoate crosspolymer

and a formulation containing 1% lauryl methacrylate/glycol dimethacrylate crosspolymer indicated that these compounds are

not likely ocular irritants. In studies using rabbits, undiluted acrylates/C10-30 alkyl acrylate crosspolymer produced minimal

to moderate irritation, and was considered a borderline irritant in unrinsed rabbit eyes. Acrylates crosspolymer, at 50% in

olive oil, and sodium acrylates crosspolymer-2 did not appear to be ocular irritants in rabbit eyes.

DRAFT DISCUSSION

Very little published data were available on the crosslinked alkyl acrylates. Two fundamental questions were

considered: (1) would large polymeric structures applied to the skin result in any systemic exposure; and (2) would there be

residual monomers present that might be absorbed?

The Panel noted that these crosslinked alkyl acrylates are macromolecules that are not expected to pass through the

stratum corneum of the skin. Since significant dermal absorption is not expected, data regarding reproductive and develop-

mental toxicity, genotoxicity, carcinogenicity, etc. are not relevant because there would be no exposure that could produce

these endpoints were these ingredients to be used in topically applied cosmetics.

The Panel noted that cosmetic products containing these ingredients are reportedly used around the eyes, on the lips,

and on other mucous membranes. Thus, crosslinked alkyl acrylates could be absorbed systemically through the relatively

moist, very thin stratum cornea of the conjunctiva, lips and other mucous membranes, and through ingestion when applied to

the lips. However, the Panel noted that any absorption through healthy intact mucous membranes is likely to be not signifi-

cant, primarily because of the relatively large molecular sizes and chemically inert nature of the polymers. Absorption of the

polymers and their residual monomers in cosmetic products also would be limited after application to the lips or eye area

based on the relatively small fractions of the applied products that might be inadvertently ingested or make direct contact

with the conjunctiva. The Panel indicated that confidence in these assumptions would be bolstered by data from well-con-

ducted absorption/penetration studies on, for example, mucous membranes, tape-stripped skin, or the gastrointestinal tract.

Additionally, the CIR Expert Panel has reviewed previously available data on certain of the monomers, and informa-

tion on others was provided to the Panel for use in evaluating the crosspolymers. Taking in to consideration the low amount

of residual monomer in the crosspolymers and the low use concentration of the polymers themselves (maximum of 6%), the

Panel was not concerned that they residual monomer would result in adverse effects. . For example, a worst case for benzene

as an impurity would be 0.5% (max. impurity level) times 6% (max. use concentration of ingredient) for a final level of

0.003% of benzene in a cosmetic formulation. Such a trace amount presents no safety issues. Again, the Panel did caution

that care should be taken to minimize the amount of residual benzene.

Certain of these crosslinked alkyl acrylates are used in cosmetic products that may be inhaled during their use. In

practice, however, the particle sizes produced by cosmetic sprays are typically not respirable.



10

TABLES

Table 1. Definitions, functions, and structures

Ingredient/CAS No. Definition Reported Function(s) Formula/Structure Acrylates/ C10-30 Alkyl Acrylate Crosspolymer

a copolymer of C10-30 alkyl acrylate and one or more monomers of acrylic acid, methacrylic acid or one of their simple* esters crosslinked with an allyl (2-propenyl) ether of sucrose or an allyl ether of pentaerythritol

Emulsion Stabilizer; Viscosity Increasing Agent – Aq.; Viscosity Increasing Agent - NonAq.

* According to the International Cosmetic Ingredient Dictionary and Handbook nomenclature conventions, “simple,” as used herein, is “described as simple alkyls ranging from C1 to C4 (linear or branched).”



11


Ingredient/CAS No. Definition Reported Function(s) Formula/Structure Acrylates/ C12-13 Alkyl Meth-acrylates/ Methoxyethyl Acrylate Crosspolymer

a copolymer of C12-13 alkyl methacrylates, methoxyethyl acrylate, and one or more monomers of acrylic acid, methacrylic acid or one of their simple esters, crosslinked with vinyloxazoline

hair fixative

O

O

H2C

O

O

RH2C

O

O

R'H2C

CH3

R = hydrogen or a "simple" alkyl chainR' = a 12 or 13 carbon alkyl chain

Crosslinked with:

OCH3

vinyloxazolineO

N

Copolymer of:

Acrylates Crosspolymer 26794-61-6 (when R is butyl) 74464-10-1 (when R is isobutyl)

a copolymer of acrylic acid, methacrylic acid or one of its simple esters, cross-linked with glycol dimethacrylate

Absorbent



12


Ingredient/CAS No. Definition Reported Function(s) Formula/Structure Acrylates/ Ethylhexyl Acrylate Crosspolymer

a copolymer of 2-ethylhexylacrylate and one or more monomers of acrylic acid, methacrylic acid or one of their simple esters, crosslinked with ethylene glycol dimethacrylate

Binder



13


Ingredient/CAS No. Definition Reported Function(s) Formula/Structure Acrylates/ Ethylhexyl Acrylate/ Glycidyl Methacrylate Cross-polymer

a copolymer of 2-ethylhexyl acrylate, glycidyl methacrylate and one or more monomers consisting of acrylic acid, methacrylic acid or one of their simple esters, crosslinked with triethylene glycol dimethacrylate

Film Former

O

O

H2C

O

O

RH2C

O

O

RH2C

CH3

R = hydrogen or a "simple" alkyl chain

Copolymer of:

Crosslinked with:

CH3

CH3

CH3

H2C

O

O

O

O

O

CH3

CH2

O

O

CH3

H2C

O

O

Acrylates/ PEG-4 Dimethacrylate Crosspolymer 50657-38-0

a copolymer of one or more monomers of acrylic acid, methacrylic acid or one of their simple esters crosslinked by PEG-4 dimethacrylate

Film Former



14


Ingredient/CAS No. Definition Reported Function(s) Formula/Structure Acrylates/ Steareth-20 Methacrylate Crosspolymer

a copolymer of steareth-20 methacrylate and one or more monomers consisting of acrylic acid, methacrylic acid or one of their simple esters, crosslinked with an allyl ether of pentaerythritol or an allyl ether of trimethylolpropane

Film Former; Suspending Agent – Non-Surfactant



15


Ingredient/CAS No. Definition Reported Function(s) Formula/Structure Acrylates/ Vinyl Isodecanoate Crosspolymer

a copolymer of the ester of vinyl isodeca-noate and one or more monomers of acrylic acid, methacrylic acid or one of their simple esters crosslinked with poly-alkenyl polyether

Emulsion Stabilizer; Sus-pending Agent – Non-Surfac-tant; Viscosity Increasing Agent - Aq.



16


Ingredient/CAS No. Definition Reported Function(s) Formula/Structure Acrylates/ Vinyl Neodecanoate Crosspolymer

a copolymer of vinyl neodecanoate and one or more monomers of acrylic acid, methacrylic acid or one of their simple esters crosslinked with an allyl ether of trimethylolpropane or pentaerythritol

Emulsion Stabilizer; Film Former; Viscosity Increasing Agent - Aq.

Allyl Methacrylate/Glycol Dimeth-acrylate Crosspolymer 779327-42-3

a highly crosslinked polymer of allyl methacrylate and ethylene glycol dimeth-acrylate (diisopropyl peroxydicarbonate initiated)

Oral Care Agent; Skin Protectant; Skin-Conditioning Agent - Emollient; Skin-Conditioning Agent – Misc.



17


Ingredient/CAS No. Definition Reported Function(s) Formula/Structure Allyl Methacrylates Crosspolymer 182212-41-5

a copolymer of allyl methacrylate crosslinked with ethylene glycol dimethacrylate

Emulsion Stabilizer; Opacifying Agents; Viscosity Increasing Agent – NonAq.

Butyl Acrylate/ Glycol Dimeth-acrylate Crosspolymer

a homopolymer of butyl acrylate cross-linked with ethylene glycol dimethacrylate

Absorbent; Film Former

C8-22 Alkyl Acrylates/ Methacrylic Acid Crosspolymer

a copolymer of C8-22 alkyl acrylate and methacrylic acid crosslinked with hexanediol diacrylate

Film Former; Hair Fixative; Hair-Waving/ Straightening Agent



18


Ingredient/CAS No. Definition Reported Function(s) Formula/Structure Glycol Dimethacrylate/ Vinyl Alcohol Crosspolymer

vinyl alcohol and ethylene glycol dimethacrylate

Film Former

Lauryl Methacrylate/Glycol Di-methacrylate Crosspolymer

a crosslinked copolymer of lauryl meth-acrylate and ethylene glycol dimethacryl-ate monomers

Film Former; Hair Fixative

Lauryl Methacrylate/Sodium Meth-acrylate Crosspolymer

a copolymer of lauryl methacrylate and sodium methacrylate crosslinked with ethylene glycol dimethacrylate.

Slip Modifier; Surface Modifier



19


Ingredient/CAS No. Definition Reported Function(s) Formula/Structure Methacrylic Acid/PEG-6 Methacrylate Crosspolymer

a copolymer of methacrylic acid and PEG-6 methacrylate crosslinked with polyethyl-ene glycol dimethacrylate

film former.

wherein “n” is variable

PEG/PPG-5/2 Methacrylate/Meth-acrylic Acid Crosspolymer

a copolymer of methacrylic acid and polyethylene glycol, polypropylene glycol methacrylate containing an average of 5 moles of ethylene oxide and 2 moles of propylene oxide, crosslinked with ethylene glycol dimethacrylate

Film Former



20


Ingredient/CAS No. Definition Reported Function(s) Formula/Structure Potassium Acrylates/ C10-30 Alkyl Acrylate Crosspolymer

the potassium salt of Acrylates/C10-30 Alkyl Acrylate Crosspolymer.

Film Former


the sodium salt of a copolymer of acrylic acid, methacrylic acid or one or more of its simple esters crosslinked with ethylene diglycidyl ether

Absorbent



21


Ingredient/CAS No. Definition Reported Function(s) Formula/Structure Sodium Acrylates/ C10-30 Alkyl Acrylate Crosspolymer

the sodium salt of Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Film Former



22


Ingredient/CAS No. Definition Reported Function(s) Formula/Structure Sodium Acrylates/ Vinyl Iso-decanoate Crosspolymer

the sodium salt of Acrylates/Vinyl Iso-decanoate Crosspolymer.

Emulsion Stabilizer; Sus-pending Agent - Non-Surfactant; Viscosity Increasing Agent – Aq.

O

O

R'H2C

O

O

R'H2C

CH3

R = isododecyl (branched, 12 carbon chain)R' = H or a "simple" alkyl group (the sodium salt is formed post-polymerization)

Copolymer of:

Crosslinked with a "polyalkenyl polyether." One example of such could be:

R"O

R"O

OR"

OR"

R" = hydrogen or 2-propenyl, wherein at least two R" groups are 2-propenyl

CH3

H3C

O

O CH2

one example of an "iso"

Stearyl/ Lauryl Methacrylate Crosspolymer

a copolymer of lauryl methacrylate and stearyl methacrylate crosslinked with ethylene glycol dimethacrylate

Skin-Conditioning Agent - Misc.

References4,6,40



23

Table 2. Chemical and physical properties

Property Description Reference Acrylates/C10-30 Alkyl Acrylate Crosspolymer

appearance white powder; 11-17 odor slightly acetic 11-17

activity, as supplied approximately 100% active 6 molecular weight >500,000 Daltons 6 solubility swells in water 32 pH ~2.5 – 3 at 1% in water32 heavy metals content 10 ppm (max), under all trade names 11-17 specific gravity 1.4 (at 20°C) 32 particle size (as tested by one source) 2-7 µm 20 bulk density <0.24 kg/l; <2 lb/gal 32

Acrylates Crosspolymer particle size (as tested by one source) 18-22 µm 21 heavy metal content lead, 10 ppm (max)

arsenic, 2 ppm (max)

22

Acrylates/Steareth-20 Methacrylate Crosspolymer appearance (Aculyn 88 polymer) milk-white fluid 8 solids content (Aculyn 88 polymer) 28.0-30.0% by wt 8 heavy metal content (Aculyn 88 polymer) iron, 1.028 ppm

zinc, 0.082 ppm

pH (Aculyn 88 polymer) 3.30-4.30 8

Acrylates/Vinyl Isodecanoate Crosspolymer molecular weight 24,400 Daltons (avg; <1% by weight is <1000 Daltons) 9

Acrylates/Vinyl Neodecanoate Crosspolymer appearance (Aculyn 38 polymer) milk-white fluid 10 solids content (Aculyn 38 polymer) 28.0-30.0% by weight 10 activity, as supplied 29% solids in 71% water 23 heavy metal content (Aculyn 38 polymer) copper, 0.2 ppm

iron, 0.5 ppm zinc, 1.2 ppm

10

pH (as Aculyn 38 polymer) 2.10-3.20 10 Allyl Methacrylates Crosspolymer

appearance fine white powder 41,42 solubility insoluble 41,42

refractive index 1.517-1.519 1.511-1.513

41 42

particle size (by laser diffraction) 5-15 µm 15-25 µm

41 42

bulk density 0.03 g/cc 41,42 water adsorption oleophilic (hydrophobic)

dual: hydrophilic and oleophilic

42

Sodium Acrylates Crosspolymer-2 appearance white powder 25 odor odorless 34 solubility swells in water 34 pH 6-8 34 particle size approx. 20 µm 25 bulk density 0.75-0.95 g/ml 34 stability stable at room temperature 34



24

Table 3a. Monomers used to create crosslinked alkyl acrylates acrylic acid acrylic acid, simple esters (simple alkyls ranging from C1 to C4, linear or branched , i.e., methyl, ethyl, propyl, and butyl esters, including branched versions: isopropyl, isobutyl, sec-butyl, and tert-butyl esters) butyl acrylate C8-22 alkyl acrylate 2-ethylhexyl acrylate glycidyl methacrylate lauryl methacrylate methacrylic acid methacrylic acid, simple esters (simple alkyls ranging from C1 to C4, linear or branched , i.e., methyl, ethyl, propyl, and butyl esters, including branched versions: isopropyl, isobutyl, sec-butyl, and tert-butyl esters) PEG-6 methacrylate PEG/PPG-5/2 sodium methacrylate steareth-20 methacrylate stearyl methacrylate vinyl alcohol vinyl isodecanoate, ester of vinyl neodecanoate Table 3b. Crosslinker compounds and initiators used in manufacture of acrylate crosspolymers allyl methacrylate ethylene diglycidyl ether glycol dimethacrylate hexanediol diacrylate PEG-4 dimethacrylate pentaerythritol, allyl ether polyalkenyl polyether polyethylene glycol dimethacrylate sucrose, allyl ether triethylene glycol dimethacrylate trimethylolpropane, allyl ether diisopropyl peroxydicarbonate (initiator)



25

Table 4a. Frequency and concentration of use according to duration and type of exposure

# of Uses26 Conc of Use (%)27 # of Uses26 Conc of Use (%)27 # of Uses26 Conc of Use (%)27

Acrylates/C10-30 Alkyl Acrylate

Crosspolymer Acrylates Crosspolymer Acrylates/Ethylhexyl Acrylate Crosspolymer

Totals* 1696 0.0002-5 2 0.1-4 NR 4-6

Duration of Use

Leave-On 1365 0.0002-5 2 0.1-4 NR 4-6

Rinse Off 313 0.002-5 NR 0.3-0.8 NR NR

Diluted for Use 18 1 NR NR NR NR

Exposure Type

Eye Area 132 0.003-2 NR 0.8 NR 6

Possible Ingestion 3 0.5 NR 4 NR NR Inhalation 39 0.03-2 NR NR NR NR

Dermal Contact 1594 0.0002-3 2 0.1-4 NR 4-6

Deodorant (underarm) 1 0.001 NR NR NR NR

Hair - Non-Coloring 77 0.1-2 NR NR NR NR Hair-Coloring 11 0.4-5 NR NR NR NR

Nail 9 0.1-5 NR NR NR NR

Mucous Membrane 90 0.002-3 NR NR NR NR

Bath Products 18 1 NR NR NR NR Baby Products 10 0.2 NR NR NR NR

Acrylates/Steareth-20 Methacrylate

Crosspolymer Acrylates/Vinyl Isodecanoate

Crosspolymer Acrylates/Vinyl Neodecanoate

Crosspolymer Totals* NR 0.1-2 33 0.2-0.5 10 2 Duration of Use Leave-On NR 0.1-2 25 0.3-0.5 4 NR

Rinse Off NR 1 8 0.2-0.5 4 2

Diluted for Use NR NR NR NR 2 2

Exposure Type

Eye Area NR NR NR NR NR NR Possible Ingestion NR NR NR NR NR NR

Inhalation NR NR NR NR NR NR

Dermal Contact NR 0.1-1 33 0.2-0.5 10 2

Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR 2 NR NR NR NR

Hair-Coloring NR NR NR NR NR NR

Nail NR NR NR NR NR NR

Mucous Membrane NR 1 NR NR 4 2 Bath Products NR NR NR NR 2 2

Baby Products NR NR NR NR NR NR

Allyl Methacrylates Crosspolymer Lauryl Methacrylate/Glycol

Dimethacrylate Crosspolymer Lauryl Methacrylate/Sodium

Methacrylate Copolymer Totals* 48 0.003-2 63 0.06-3 1 0.004-4

Duration of Use

Leave-On 44 0.003-2 56 0.06-3 1 0.1-4 Rinse Off 4 0.1 7 0.2-3 NR 0.004-0.1 Diluted for Use NR NR NR NR NR NR

Exposure Type

Eye Area 4 0.003-0.8 9 0.1-3 NR NR Possible Ingestion 16 0.04-0.2 8 0.06-2 NR NR

Inhalation 1 NR NR NR NR NR

Dermal Contact 47 0.003-2 61 0.06-3 1 0.004-4

Deodorant (underarm) NR NR 1 0.3 NR NR Hair - Non-Coloring NR NR NR NR NR NR

Hair-Coloring NR NR NR NR NR NR

Nail NR NR 1 NR NR NR

Mucous Membrane NR NR NR NR NR NR Bath Products NR NR NR NR NR NR

Baby Products NR NR NR NR NR NR * Because each ingredient may be used in cosmetics with multiple exposure types, the sum of all exposure types my not equal the sum of total uses. NR – no reported uses



26

Table 4a. Frequency and concentration of use according to duration and type of exposure (continued)

# of Uses26 Conc of Use (%)27 # of Uses26 Conc of Use (%)27 # of Uses26 Conc of Use (%)27

Sodium Acrylates/C10-30 Alkyl Acrylate

Crosspolymer Sodium Acrylates Crosspolymer-2

# of Uses26 Conc of Use (%)27 # of Uses26 Conc of Use (%)27

Totals* 6 NR NR 0.8

Duration of Use

Leave-On 6 NR NR 0.8 Rinse Off NR NR NR NR

Diluted for Use NR NR NR NR

Exposure Type

Eye Area NR NR NR NR

Possible Ingestion NR NR NR NR

Inhalation 1 NR NR NR Dermal Contact 6 NR NR 0.8

Deodorant (underarm) NR NR NR NR

Hair - Non-Coloring NR NR NR NR

Hair-Coloring NR NR NR NR Nail NR NR NR NR

Mucous Membrane NR NR NR NR

Bath Products NR NR NR NR

Baby Products NR NR NR NR

* Because each ingredient may be used in cosmetics with multiple exposure types, the sum of all exposure types my not equal the sum of total uses. NR – no reported uses

Table 4b. Ingredients Not Reported to be Used

Acrylates/C12-13 Alkyl Methacrylates/Methoxyethyl Acrylate Crosspolymer Acrylates/Ethylhexyl Acrylate/Glycidyl Methacrylate Crosspolymer Acrylates/PEG-4 Dimethacrylate Crosspolymer Allyl Methacrylate/Glycol Dimethacrylate Crosspolymer Butyl Acrylate/Glycol Dimethacrylate Crosspolymer C8-22 Alkyl Acrylates/Methacrylic Acid Crosspolymer Glycol Dimethacrylate/Vinyl Alcohol Crosspolymer Methacrylic Acid/PEG-6 Methacrylate Crosspolymer PEG/PPG-5/2 Methacrylate/Methacrylic Acid Crosspolymer Potassium Acrylates/C10-30 Alkyl Acrylate Crosspolymer Sodium Acrylates/Vinyl Isodecanoate Crosspolymer Stearyl/Lauryl Methacrylate Crosspolymer



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su

bje

cts

“inte

nsi

fied

” S

hel

ansk

i HR

IPT

; te

st m

ater

ial w

as

app

lied

to a

1”

x 1

” p

atch

w

eak

irrit

ant

resp

on

se; n

ot a

sen

sitiz

er

du

ring

ind

uct

ion

, fai

nt

or

mo

der

ate

eryt

he

ma

was

ob

serv

ed o

nce

for

9 s

ubje

cts

and

tw

ice

for

2 s

ub

ject

s; a

t ch

alle

nge

, fa

int

eryt

he

ma

was

ob

serv

ed o

nce

for

3 s

ubje

cts

39

bo

dy

lotio

n w

ith 0

.15

%

Acr

ylat

es/C

10

-30

Alk

yl

Acr

ylat

e C

ross

po

lym

er

0.2

g

10

7 su

bje

cts

tes

t m

ater

ial w

as a

pp

lied

to a

1”

x 1

” ab

sorb

ent

pad

and

al

low

ed t

o v

ola

tize

for

seve

ral m

in;

sem

i-occ

lusi

ve

pat

ch;

24 h

app

lica

tion

s m

ade

3 x

/wk

for

3 w

k;

chal

len

ge w

as a

pp

lied

afte

r 2

wks

no

t a

der

mal

irrit

ant

or

sen

sitiz

er

44

crè

me

with

0.6

0%

A

cryl

ates

/C1

0-3

0 A

lkyl

A

cryl

ate

Cro

ssp

oly

mer

0.2

g

51

su

bje

cts

test

mat

eria

l was

ap

plie

d t

o a

1”

x 1

” ab

sorb

ent p

ad a

nd

al

low

ed t

o v

ola

tize

for

seve

ral m

in;

sem

i-occ

lusi

ve

pat

ch;

24 h

sem

i-occ

lusi

ve p

atch

es a

pp

lied

3 x

/wk

for

3

wk;

ch

alle

nge

was

ap

plie

d a

fter

2 w

ks

no

t a

der

mal

irrit

ant

or

sen

sitiz

er

45

Acr

ylat

es C

ross

poly

mer

Acr

ylat

es C

ross

po

lym

er

15

µl;

30%

in o

live

oil

20

su

bje

cts

sin

gle

24

-h o

cclu

sive

pat

ch

no

t an

irrit

ant

acco

rdin

g to

Jap

anes

e cr

iteria

21

eye

lotio

n w

ith 0

.75

%

Acr

ylat

es C

ross

po

lym

er

un

dilu

ted

46

su

bje

cts

HR

IPT

with

occ

lusi

ve p

atch

n

ot

an ir

ritan

t or

sen

sitiz

er

46

skin

cle

anse

r w

ith 0

.8%

A

cryl

ates

Cro

ssp

oly

mer

1

% a

q.

dilu

tion

60

su

bje

cts

HR

IPT

with

occ

lusi

ve p

atch

n

ot

an ir

ritan

t or

sen

sitiz

er

46

lipst

ick

with

4%

Acr

ylat

es

Cro

ssp

oly

mer

0

.2 g

8

5 s

ub

ject

s H

RIP

T w

ith o

cclu

sive

pat

ch

no

t an

irrit

ant

or s

ensi

tizer

47

Acr

ylat

es/E

thyl

hexy

l Acr

ylat

e C

ross

poly

mer

faci

al s

un

scre

en w

ith

6.8

565

% A

cryl

ates

/Eth

yl-

hex

yl A

cryl

ate

Cro

ssp

oly

mer

un

dilu

ted

60

0 su

bje

cts

mo

difi

ed D

raiz

e R

IPT

with

ten

48

-h in

duct

ion

pat

ches

u

sin

g 0

.5 in

squ

are

occ

lusi

ve p

atch

es;

the

first

ch

alle

nge

w

as

app

lied

afte

r a

2-w

k n

on

-tre

atm

ent

per

iod

; an

ad

di-

tiona

l ch

alle

nge

ap

plic

atio

n w

as m

ade

1 w

k a

fter

the

first

ch

alle

nge

ap

plic

atio

n

no

evi

den

ce o

f prim

ary

irrita

tion

, ski

n

fatig

ue,

or

sen

sitiz

atio

n

48

Acr

ylat

es/S

tear

eth-

20 M

etha

cryl

ate

Cro

sspo

lym

er

the

acry

lic c

op

oly

mer

of

Acu

lyn

88

Pol

ymer

(t

rad

enam

e)

no

t st

ated

n

ot

stat

ed

21

-day

cu

mu

lativ

e irr

itatio

n s

tud

y (G

CP

) n

o ir

ritat

ion

or

sen

sitiz

atio

n 8



Tab

le 5

. D

erm

al ir

ritat

ion

and

sen

sitiz

atio

n –

alte

rnat

ive

stu

die

s, n

on

-hu

man

, an

d h

um

an (

con

tinu

ed)

29

Tes

t Art

icle

C

once

ntra

tion/

Dos

e T

est P

opul

atio

n P

roc ed

ure

Res

ults

R

efer

ence

the

acry

lic c

op

oly

mer

of

Acu

lyn

88

Pol

ymer

(t

rad

enam

e)

no

t st

ated

n

ot

stat

ed

HR

IPT

(G

CP

)

no

irrit

atio

n o

r se

nsi

tizat

ion

8

Acr

ylat

es/V

inyl

Iso

deca

noat

e C

ross

poly

mer

as S

tab

ylen

30

(tr

aden

ame)

0

.5-2

.5%

aq

. 2

5 s

ub

ject

s K

ligm

an t

est

(ad

diti

on

al d

etai

ls w

ere

no

t pro

vid

ed)

no

t an

irrit

ant

or s

ensi

tizer

33

Acr

ylat

es/V

inyl

Neo

deca

noat

e C

ross

poly

mer

the

acry

lic c

op

oly

mer

of

Acu

lyn

38

Pol

ymer

(t

rad

enam

e)

no

t st

ated

n

ot

stat

ed

21

-day

cu

mu

lativ

e irr

itatio

n s

tud

y (G

CP

)

at m

ost

, a

mild

irrit

ant w

ith u

nfo

rmu

late

d

po

lym

er a

nd

und

er w

ors

e-ca

se c

on

diti

on

s

10

the

acry

lic c

op

oly

mer

of

Acu

lyn

38

Pol

ymer

(t

rad

enam

e)

no

t st

ated

n

ot

stat

ed

HR

IPT

(G

CP

)

no

t an

irrit

ant

or s

ensi

tizer

10

bat

h c

rèm

e w

ith 2

% A

cry-

late

s/V

inyl

Neo

dec

ano

ate

Cro

ssp

oly

mer

1%

aq

. di

lutio

n 1

08

sub

ject

s H

RIP

T;

24-h

occ

lusi

ve p

atch

es a

pp

lied

3x/

wk

for

3

wks

; 2

4-h

ch

alle

nge

afte

r a

2-w

k n

on-

trea

tmen

t p

erio

d;

(siz

e o

f pat

ch w

as n

ot

pro

vid

ed)

no

t an

irrit

ant

or s

ensi

tizer

49

bat

h c

rèm

e w

ith 2

% A

cry-

late

s/V

inyl

Neo

dec

ano

ate

Cro

ssp

oly

mer

1%

aq

. di

lutio

n 1

09

sub

ject

s H

RIP

T;

24-h

occ

lusi

ve p

atch

es a

pp

lied

3x/

wk

for

3

wks

; 2

4-h

ch

alle

nge

afte

r a

2-w

k n

on-

trea

tmen

t p

erio

d;

(siz

e o

f pat

ch w

as n

ot

pro

vid

ed)

no

t an

irrit

ant

or s

ensi

tizer

50

bu

bble

bat

h w

ith 2

% A

cry-

late

s/V

inyl

Neo

dec

ano

ate

Cro

ssp

oly

mer

1%

aq

. di

lutio

n 1

08

sub

ject

s H

RIP

T;

24-h

occ

lusi

ve p

atch

es a

pp

lied

3x/

wk

for

3

wks

; 2

4-h

ch

alle

nge

afte

r a

2-w

k n

on-

trea

tmen

t p

erio

d;

(siz

e o

f pat

ch w

as n

ot

pro

vid

ed)

no

t an

irrit

ant

or s

ensi

tizer

51

bat

h g

el w

ith 2

% A

cry-

late

s/V

inyl

Neo

dec

ano

ate

Cro

ssp

oly

mer

1%

aq

. di

lutio

n 1

08

sub

ject

s H

RIP

T;

24-h

occ

lusi

ve p

atch

es a

pp

lied

3x/

wk

for

3

wks

; 2

4-h

ch

alle

nge

afte

r a

2-w

k n

on-

trea

tmen

t p

erio

d;

(siz

e o

f pat

ch w

as n

ot

pro

vid

ed)

no

t an

irrit

ant

or s

ensi

tizer

52

bat

h p

rod

uct

with

2%

Acr

y-la

tes/

Vin

yl N

eod

ecan

oat

e C

ross

po

lym

er

1%

aq

. di

lutio

n 1

06

sub

ject

s H

RIP

T;

24-h

occ

lusi

ve p

atch

es a

pp

lied

3x/

wk

for

3

wks

; 2

4-h

ch

alle

nge

afte

r a

2-w

k n

on-

trea

tmen

t p

erio

d;

(siz

e o

f pat

ch w

as n

ot

pro

vid

ed)

no

t an

irrit

ant

or s

ensi

tizer

53

bat

h fo

am w

ith 2

% A

cry-

late

s/V

inyl

Neo

dec

ano

ate

Cro

ssp

oly

mer

1%

aq

. di

lutio

n 1

06

sub

ject

s H

RIP

T;

24-h

occ

lusi

ve p

atch

es a

pp

lied

3x/

wk

for

3

wks

; 2

4-h

ch

alle

nge

afte

r a

2-w

k n

on-

trea

tmen

t p

erio

d;

(siz

e o

f pat

ch w

as n

ot

pro

vid

ed)

no

t an

irrit

ant

or s

ensi

tizer

54

bat

h fo

am w

ith 2

% A

cry-

late

s/V

inyl

Neo

dec

ano

ate

Cro

ssp

oly

mer

1%

aq

. di

lutio

n 1

06

sub

ject

s (s

am

e su

bje

cts

as

abo

ve)

HR

IPT

; 24

-h o

cclu

sive

pat

ches

ap

plie

d 3

x/w

k fo

r 3

w

ks;

24

-h c

hal

len

ge a

fter

a 2

-wk

no

n-tr

eatm

ent

per

iod

; (s

ize

of p

atch

was

no

t p

rovi

ded

)

no

t an

irrit

ant

or s

ensi

tizer

55

bat

h fo

am w

ith 2

% A

cry-

late

s/V

inyl

Neo

dec

ano

ate

Cro

ssp

oly

mer

1%

aq

. di

lutio

n 1

06

sub

ject

s (s

am

e su

bje

cts

as

abo

ve)

HR

IPT

; 24

-h o

cclu

sive

pat

ches

ap

plie

d 3

x/w

k fo

r 3

w

ks;

24

-h c

hal

len

ge a

fter

a 2

-wk

no

n-tr

eatm

ent

per

iod

; (s

ize

of p

atch

was

no

t p

rovi

ded

)

no

t an

irrit

ant

or s

ensi

tizer

56

bu

bble

bat

h w

ith 2

% A

cry-

late

s/V

inyl

Neo

dec

ano

ate

Cro

ssp

oly

mer

1%

aq

. di

lutio

n 1

07

sub

ject

s H

RIP

T;

24-h

occ

lusi

ve p

atch

es a

pp

lied

3x/

wk

for

3

wks

; 2

4-h

ch

alle

nge

afte

r a

2-w

k n

on-

trea

tmen

t p

erio

d;

(siz

e o

f pat

ch w

as n

ot

pro

vid

ed)

no

t an

irrit

ant

or s

ensi

tizer

57



Tab

le 5

. D

erm

al ir

ritat

ion

and

sen

sitiz

atio

n –

alte

rnat

ive

stu

die

s, n

on

-hu

man

, an

d h

um

an (

con

tinu

ed)

30

Tes

t Art

icle

C

once

ntra

tion/

Dos

e T

est P

opul

atio

n P

roc ed

ure

Res

ults

R

efer

ence

L

aury

l Met

hacr

ylat

e/G

lyco

l Dim

etha

cryl

ate

Cro

sspo

lym

er

face

po

wd

er w

ith 1

% L

aur-

yl M

eth

acry

late

/Gly

col D

i-m

eth

acry

late

Cro

ssp

oly

mer

0.2

g

10

4 su

bje

cts

HR

IPT

; 24

-h o

cclu

sive

pat

ches

ap

plie

d 3

x/w

k fo

r 3

w

ks;

24

-h c

hal

len

ge a

fter

a 1

0-1

5 d

ay n

on

-tre

atm

ent

per

iod;

(si

ze o

f pat

ch w

as n

ot p

rovi

ded

)

no

t an

irrit

ant

or s

ensi

tizer

58

exfo

liato

r cr

eam

w

ith 2

.6%

La

ury

l Met

hac

ryla

te/G

lyco

l D

imet

hac

ryla

te C

ross

-p

oly

mer

0.2

g

61

9 su

bje

cts

HR

IPT

with

ten

24

h o

cclu

sive

ap

plic

atio

ns

of a

¾”

x ¾

” p

atch

; 24

-h c

hal

len

ge a

fter

a 2

-wk

no

n-t

reat

men

t p

erio

d; r

ech

alle

nge

was

per

form

ed

on

2 s

ubje

cts

usi

ng

sem

i-occ

lusi

ve a

nd

op

en r

epet

itive

ap

plic

atio

n

no

t an

irrit

ant

or s

ensi

tizer

af

ter

chal

len

ge,

on

e su

bje

ct h

ad m

od

erat

e (a

t 2

4 h

) an

d m

ild (

at 7

2 h

) er

yth

em

a a

nd

ed

e-m

a, a

nd

on

e su

bje

ct h

ad b

arel

y p

erce

ptib

le

eryt

he

ma

at 7

2 h

; th

ese

resu

lts w

ere

no

t re

pro

duci

ble

at

rech

alle

nge

59



T

able

6. R

elev

ant s

umm

ary

info

rmat

ion

on c

ompo

nent

s

Mon

omer

Com

pone

nt

Par

amet

er E

valu

ated

O

utco

me

R

efer

ence

Acr

ylic

Aci

d

To

xico

kin

etic

s D

erm

al:

rad

ioac

tivity

was

rec

ove

red

mo

stly

in t

he

skin

tra

p,

and

then

in e

xpire

d C

O2

Ora

l: I

n n

um

ero

us

stud

ies

usi

ng

rats

,, t

he

do

se w

as p

rimar

ily e

xcre

ted

in e

xpire

d ai

r in

mo

st c

ases

; el

imin

atio

n w

as

gen

eral

ly r

apid

; up

take

an

d e

limin

atio

n a

pp

eare

d to

be

bip

has

ic;

abso

rptio

n a

nd

exc

retio

n w

ere

also

rap

id in

mic

e

Inh

alat

ion

: R

ats

wer

e e

xpo

sed

to

acr

ylic

aci

d v

ia in

hal

atio

n; m

ost

of t

he

rad

ioac

tivity

wa

s fo

un

d in

the

hea

d a

nd

snou

t, w

ith r

elat

ivel

y la

rge

am

ou

nts

als

o re

cove

red

in t

he

upp

er r

esp

irato

ry t

ract

1

T

oxi

colo

gica

l Stu

die

s S

ingl

e D

ose

- D

erm

al:

LD

50 –

295

to

950

mg/

kg in

rab

bits

Ora

l: L

D 50

– 2

100

to 3

200

mg/

kg in

rab

bits

an

d ra

ts;

pro

duce

d g

astr

ic le

sio

ns

In

hal

atio

n:

LC50

– 3

600

mg/

m3 in r

ats

1

Rep

eate

d D

ose

– D

erm

al:

4%

pro

du

ced

toxi

c ef

fect

s in

mic

e in

a 1

3-w

k st

ud

y

Ora

l: to

xic

effe

cts

wer

e o

bse

rve

d in

rat

s in

a 9

0-d

ay d

rinki

ng

wat

er s

tud

y w

ith d

ose

s o

f ≤7

50

mg/

kg a

nd

in a

90

-day

ga

vage

stu

dy

in r

ats

do

ses

with

15

0 0

r 3

75 m

g/kg

; st

om

ach

lesi

on

s w

ere

no

t o

bse

rved

in a

12

-mo

s d

rinki

ng

stud

y w

ith

rats

Inh

alat

ion:

nas

al le

sio

ns

wer

e o

bse

rved

in r

ats

and

mic

e in

4-d

ay,

2-w

k, 2

0-d

ay,

and

13

-wk

stu

die

s

1

R

epro

duct

ive

and

D

evel

op

men

tal T

oxi

city

O

ral:

did

no

t pro

du

ce t

erat

oge

nic

effe

cts

in r

ats;

did

affe

ct b

od

y w

eig

hts

an

d s

om

e o

rgan

wei

ghts

in th

e p

aren

tal a

nim

als

Inh

alat

ion

: no

t te

rato

gen

ic o

r em

bry

oto

xic

in r

ats;

did

pro

du

ce m

ater

nal

to

xici

ty

1

G

eno

toxi

city

ge

no

toxi

c in

mo

use

lym

ph

om

a as

says

, an

d in

an

in v

itro

cyt

oge

net

ic a

ssa

y; n

ot

gen

oto

xic

or

mu

tage

nic

in A

mes

tes

ts,

un

sch

edu

led

DN

A s

ynth

esis

(U

DS

) as

say,

mic

ron

ucl

eus

assa

y, in

viv

o t

ran

sfo

rmat

ion

ass

ay,

Ch

ines

e h

amst

er o

vary

(C

HO

)/H

GP

RT

, in

viv

o c

yto

gen

etic

ass

ay,

Dro

sop

hila

tes

t, o

r m

ous

e d

om

inan

t le

thal

ass

ay

1

C

arci

no

gen

icity

D

erm

al:

in o

ne

stud

y, 4

% in

ace

ton

e w

as a

co

mp

lete

bu

t w

eak

carc

ino

gen

in m

ice;

in a

no

ther

, 1

% w

as

no

t ca

rcin

oge

nic

in

mic

e

Ora

l: n

ot c

arci

no

gen

ic in

rat

s w

hen

giv

en in

drin

kin

g w

ater

P

aren

tera

l: n

ot

carc

ino

gen

ic w

hen

inje

cted

su

bcu

tan

eou

sly

(s.c

.) t

o m

ice

IA

RC

Eva

luat

ion

: no

ep

idem

iolo

gica

l dat

a re

leva

nt

to c

arci

no

gen

icity

wer

e av

aila

ble

; n

o e

xper

imen

tal d

ata

rele

van

t to

ca

rcin

oge

nic

ity w

ere

avai

lab

le; no

t cl

ass

ifia

ble a

s to

its

carc

inog

en

icity

to

hum

an

s (G

roup

3)

1

60

Ir

ritat

ion

and

Sen

sitiz

atio

n S

kin

: 4

% w

as ir

ritat

ing

to t

he

skin

of m

ice

M

uco

sal:

a 1

% s

olu

tion

cau

sed

sig

nifi

can

t in

jury

to

th

e ra

bbit

eye

1

Met

hyl A

cryl

ate

T

oxi

coki

net

ics

Der

mal

: I

n g

uin

ea p

igs

exp

ose

d d

erm

ally

to

met

hyl

[2

,3-

14C

]acr

ylat

e, r

adio

activ

ity w

as s

een

in t

he

s.c.

tis

sues

an

d

thro

ugh

out

the

bod

y O

ral:

th

e d

ose

was

prim

arily

exc

rete

d in

exp

ired

air;

elim

inat

ion

was

rap

id (

rats

)

61

T

oxi

colo

gica

l Stu

die

s S

ingl

e D

ose

- O

ral;

pro

du

ced

gas

tric

lesi

on

s 1

Rep

eate

d D

ose

– O

ral:

not

to

xic

wh

en g

iven

ora

lly t

o r

ats

(det

ails

no

t pro

vid

ed)

1

R

epro

duct

ive

and

D

evel

op

men

tal T

oxi

city

In

hal

atio

n:

did

no

t pro

du

ce t

erat

ogen

ic o

r re

pro

du

ctiv

e ef

fect

s in

rat

s 1

G

eno

toxi

city

ge

no

toxi

c in

mo

use

lym

ph

om

a an

d c

hro

mo

som

al a

ber

ratio

n a

ssa

ys;

po

sitiv

e in

on

e an

d n

egat

ive

in tw

o m

icro

nu

cleu

s te

sts;

no

t m

uta

gen

ic o

r ge

no

toxi

c in

an

Am

es,

S

alm

onella/

mic

roso

me,

liq

uid

incu

bat

ion,

mo

no

laye

r, s

usp

ensi

on

, or

AS

52

/XR

PT

ass

ay

1



Tab

le 6

. R

elev

ant

sum

mar

y in

form

atio

n o

n c

om

pon

ents

(co

ntin

ued

)

32

Mon

omer

Com

pone

nt

Pa r

amet

er E

valu

ated

O

utco

me

R

efer

ence

C

arci

no

gen

icity

In

hal

atio

n:

not

carc

ino

gen

ic to

rat

s IA

RC

Eva

luat

ion

: no

ep

idem

iolo

gica

l dat

a re

leva

nt

to t

he

carc

ino

gen

icity

; in

ad

equ

ate

evi

den

ce in e

xper

imen

tal a

nim

als;

n

ot

cla

ssifi

able

as

to it

s ca

rcin

oge

nic

ity t

o h

um

an

s (G

rou

p 3

)

1

61

Eth

yl A

cryl

ate

T

oxi

coki

net

ics

Ora

l: t

he

do

se w

as p

rimar

ily e

xcre

ted

in e

xpire

d ai

r; e

limin

atio

n w

as r

apid

(ra

ts)

1

T

oxi

colo

gica

l Stu

die

s S

ingl

e D

ose

-

Ora

l; p

rodu

ced

gas

tric

lesi

on

s 1

Rep

eate

d D

ose

– O

ral:

2-w

k st

udy

in r

ats

with

do

sin

g vi

a ga

vage

or

drin

kin

g w

ater

; g

astr

ic le

sio

ns

wer

e o

bse

rved

, p

rimar

ily in

th

e fo

rest

om

ach

; in

a 1

3-w

k ga

vag

e st

ud

y, d

ose

s o

f ≤2

00

mg/

kg p

rod

uce

d le

sion

s in

th

e fo

rest

om

ach

of r

ats

In

hal

atio

n: n

o n

asal

lesi

on

s w

ere

ob

serv

ed in

a 1

-mo

nth

stu

dy

usi

ng

rats

an

d m

ice;

nas

al le

sio

ns

we

re o

bse

rved

in r

ats

in a

12

-wk

stu

dy;

sto

mac

h le

sio

ns

wer

e n

ot

ob

serv

ed in

a 2

-yr

drin

kin

g st

ud

y w

ith r

ats

or

a 2

-yr

cap

sule

stu

dy

with

do

gs

1

R

epro

duct

ive

and

D

evel

op

men

tal T

oxi

city

In

hal

atio

n:

not

emb

ryo

toxi

c o

r fe

toto

xic

in r

ats;

mat

ern

al t

oxi

city

wa

s o

bse

rved

1

G

eno

toxi

city

ge

no

toxi

c in

a m

ou

se ly

mp

ho

ma

and

ch

rom

oso

mal

ab

erra

tion

ass

ay;

ind

uce

d c

hro

mo

som

al m

alse

gre

gatio

n a

nd

mito

tic

reco

mb

inat

ion

usi

ng S

. cer

evis

iae

; p

osi

tive

in o

ne

and

neg

ativ

e in

on

e m

icro

nu

cleu

s as

say;

no

t m

uta

gen

ic o

r ge

no

toxi

c in

an

Am

es,

Sa

lmon

ella/

mic

roso

me,

liqu

id in

cub

atio

n,

mo

nola

yer,

ch

rom

oso

mal

, s

iste

r ch

rom

atid

exc

han

ge (

SC

E),

or

Dro

soph

ila a

ssa

y

1

C

arci

no

gen

icity

D

erm

al:

tes

ted

und

ilute

d, n

ot c

arci

no

gen

ic t

o m

ice

O

ral:

in c

orn

oil,

car

cin

oge

nic

in m

ale

and

fem

ale

rats

an

d m

ice

In

hal

atio

n:

not

carc

ino

gen

ic in

mic

e IA

RC

Eva

luat

ion

: no

ep

idem

iolo

gica

l dat

a re

leva

nt

to t

he

carc

ino

gen

icity

; su

ffic

ien

t evi

den

ce in

exp

erim

enta

l an

imal

s;

po

ssib

ly c

arc

inog

en

ic to

hu

man

s (G

rou

p 2

B)

1

62

But

yl A

cryl

ate

T

oxi

coki

net

ics

Ora

l: t

he

do

se w

as p

rimar

ily e

xcre

ted

in e

xpire

d ai

r (r

ats)

1

T

oxi

colo

gica

l Stu

die

s S

ingl

e D

ose

Ora

l; p

rod

uce

d g

astr

ic le

sio

ns

1

Rep

eate

d D

ose

– O

ral:

not

to

xic

wh

en g

iven

ora

lly t

o r

ats

(det

ails

no

t pro

vid

ed)

In

hal

atio

n:

toxi

city

was

ob

serv

ed

in r

ats

and

ham

ster

s u

po

n 3

6-h

exp

osu

res;

nas

al le

sio

ns

wer

e o

bse

rved

in r

ats

in a

1

3-w

k st

ud

y

1

R

epro

duct

ive

and

D

evel

op

men

tal T

oxi

city

In

hal

atio

n:

no t

oxi

c ef

fect

s w

ere

seen

with

25

pp

m;

hig

h c

once

ntr

atio

ns

had

toxi

c ef

fect

s o

n t

he

fetu

ses

and

dam

s 1

G

eno

toxi

city

p

osi

tive

in o

ne

and

neg

ativ

e in

one

ch

rom

oso

mal

ab

erra

tion

ass

ay;

no

t m

uta

gen

ic o

r ge

no

toxi

c in

an

Am

es,

Sa

lmon

ella/

mic

roso

me,

liq

uid

incu

bat

ion

, UD

S,

mic

ron

ucl

eus,

or

in v

itro

tran

sfo

rmat

ion

ass

ay

1

C

arci

no

gen

icity

D

erm

al:

1%

wa

s n

ot

carc

ino

gen

ic in

mic

e

Inh

alat

ion

: no

t ca

rcin

oge

nic

to r

ats

IAR

C E

valu

atio

n:

no e

pid

emio

logi

cal d

ata

rele

van

t to

th

e ca

rcin

oge

nic

ity;

ina

dequ

ate

evi

den

ce in e

xper

imen

tal a

nim

als;

n

ot

cla

ssifi

able

as

to it

s ca

rcin

oge

nic

ity t

o h

um

an

s (G

rou

p 3

)

1

63



Tab

le 6

. R

elev

ant

sum

mar

y in

form

atio

n o

n c

om

pon

ents

(co

ntin

ued

)

33

Mon

omer

Com

pone

nt

Pa r

amet

er E

valu

ated

O

utco

me

R

efer

ence

2-E

thyl

hexy

l Acr

ylat

e T

oxi

coki

net

ics

Ora

l: t

he

do

se w

as p

rimar

ily e

xcre

ted

in e

xpire

d ai

r; e

limin

atio

n w

as r

apid

(ra

ts)

1

R

epro

duct

ive

and

D

evel

op

men

tal T

oxi

city

In

hal

atio

n:

did

no

t pro

du

ce t

erat

ogen

ic o

r re

pro

du

ctiv

e ef

fect

s in

rat

s 1

G

eno

toxi

city

ge

no

toxi

c in

a m

ou

se ly

mp

ho

ma

forw

ard

mu

tatio

n a

ssa

y w

ith m

eta

bo

lic a

ctiv

atio

n;

equ

ivo

cally

gen

oto

xic

in m

uta

tion

an

d a

ber

ratio

ns

assa

ys;

wea

kly

mu

tage

nic

in S

CE

an

d U

DS

ass

ays

; n

ot m

uta

gen

ic o

r ge

not

oxi

c in

a m

icro

bia

l mu

tage

n

test

, A

me

s te

st,

ma

mm

alia

n c

ell t

ran

sfo

rmat

ion

ass

ay,

mic

ron

ucl

eus

test

, m

on

ola

yer

or

susp

ensi

on a

ssa

y, C

HO

ass

ay,

or

in v

ivo

cyt

oge

nic

ass

ay

1

C

arci

no

gen

icity

D

erm

al:

car

cin

oge

nic

wh

en a

pp

lied

to

mic

e –

th

e ca

rcin

oge

nic

res

po

nse

ma

y h

ave

bee

n a

sso

ciat

ed w

ith t

he

seve

re s

kin

irr

itatio

n in

du

ced

by

the

chem

ical

T

este

d b

y sk

in a

pp

licat

ion

in t

hre

e ex

per

imen

ts in

mic

e; it

incr

ease

d t

he

inci

den

ce o

f sq

uam

ou

s-ce

ll ca

rcin

om

as

of t

he

skin

in 2

ex

per

imen

ts a

nd

of m

alig

nan

t m

elan

om

as in

on

e ex

per

imen

t; in

th

e th

ird e

xper

imen

t, in

a d

iffer

ent

stra

in o

f m

ice,

no

in

crea

se s

kin

tu

mo

r in

cid

ence

was

see

n w

ith o

r w

itho

ut s

ub

sequ

ent

app

licat

ion

of 1

2-0

-tet

rad

ecan

oyl

ph

orb

ol

13

-ace

tate

IA

RC

Eva

luat

ion

: ina

deq

uate

evi

den

ce in h

um

ans

for

carc

ino

gen

icity

; limite

d e

vid

en

ce in

exp

erim

enta

l an

imal

s;

no

t cl

ass

ifia

ble a

s to

its

carc

inog

en

icity

to

hu

ma

ns

(Gro

up

3)

1

64

Ir

ritat

ion

and

Sen

sitiz

atio

n D

erm

al -

No

n-H

um

an:

sen

sitiz

atio

n w

as o

bse

rved

wh

en g

uin

ea-p

igs

wer

e tr

eate

d w

ith 2

-eth

ylh

exyl

acr

ylat

e in

Fre

und

’s

com

ple

te a

dju

van

t

Hu

man

: in

a p

rovo

cativ

e te

st w

ith 2

43

pat

ient

s w

ith a

h

isto

ry o

f ex

po

sure

to

(m

eth

)acr

ylat

es,

no

ne

of t

he

pat

ient

s w

ere

sen

sitiz

ed w

ith p

atch

es c

ont

ain

ing

0.1

-0.5

% 2

-eth

ylh

exyl

acr

ylat

e

64

1

Pol

yacr

ylic

Aci

d

An

imal

To

xico

log

y S

ingl

e D

ose

- O

ral:

LD 50

– 2

500

mg/

kg in

rat

s 1

C

IR C

on

clu

sion

(20

02)

safe

as

used

whe

n fo

rmul

ated

to a

void

ski

n ir

rita

tion

1

Sod

ium

Pol

yacr

ylat

e A

nim

al T

oxi

colo

gy

Sin

gle

Do

se –

Ora

l: L

D 50 -

>4

0 g

/kg

in r

ats

for

a 1

5%

so

lutio

n 1

R

epro

duct

ive

and

D

evel

op

men

tal T

oxi

city

d

id n

ot c

ause

rep

rod

uct

ive

effe

cts

in r

ats

1

G

eno

toxi

city

n

ot

geno

toxi

c in

an

Am

es a

ssa

y, a

pla

te t

est,

a m

ou

se ly

mp

ho

ma

ass

ay,

ch

rom

oso

mal

ab

erra

tion

ass

ays

, a

UD

S a

ssa

y, o

r an

in v

ivo

mo

use

mic

ron

ucl

eus

assa

y

1

Ir

ritat

ion

and

Sen

sitiz

atio

n D

erm

al –

No

n-H

um

an:

no

t an

irrit

ant

to r

abb

it sk

in

H

um

an:

not

an

irrit

ant o

r se

nsi

tizer

M

uco

sal:

the

grea

test

to

lera

ted

co

nce

ntr

atio

ns

wer

e 1

3-2

0%

for

unrin

sed

an

d 2

0-3

0%

for

rinse

d r

abb

it ey

es;

in a

n

irrita

nt-

thre

sho

ld t

est,

2%

was

th

e gr

eate

st c

on

cen

trat

ion

that

did

not

pro

du

ce ir

ritat

ion

in r

abb

it ey

es

1

C

IR C

on

clu

sion

(20

02)

safe

as

used

whe

n fo

rmul

ated

to a

void

ski

n ir

rita

tion

1



Tab

le 6

. R

elev

ant

sum

mar

y in

form

atio

n o

n c

om

pon

ents

(co

ntin

ued

)

34

Mon

omer

Com

pone

nt

Pa r

amet

er E

valu

ated

O

utco

me

R

efer

ence

Met

hacr

ylic

Aci

d

To

xico

kin

etic

s re

adily

ab

sorb

ed t

hro

ugh

the

mu

cou

s m

em

bra

nes

of t

he

lun

gs a

nd

gast

roin

test

inal

tra

ct o

f an

d th

e sk

in,

and

is r

ead

ily

dis

trib

ute

d to

all

maj

or

tissu

es

65

A

nim

al T

oxi

colo

gy

Sin

gle

Do

se –

Der

mal

: r

epo

rted

LD

50 v

alu

es r

ange

d fr

om

50

0-1

243

mg/

kg f

or

rab

bits

Ora

l: r

epo

rted

LD 50

val

ues

ran

ged

fro

m 8

27

-160

0 m

g/kg

fo

r m

ice

, 2

77-2

260

mg/

kg f

or

rats

, an

d 2

80-1

200

mg/

kg f

or

rab

bits

Inh

alat

ion:

re

port

ed L

C 50 v

alu

es w

ere

36

57 p

pm

in m

ice,

13

50

ppm

/4 h

in r

ats,

and

25

22 p

pm

/1 h

in r

abb

its

65

Rep

eate

d D

ose

– O

ral:

no

sign

s of

to

xici

ty in

a s

ho

rt-t

erm

stu

dy

In

hal

atio

n: n

ose

and

eye

irrit

atio

n a

nd w

eigh

t lo

ss in

rat

s w

ith 5

exp

osu

res

to 1

300

pp

m;

onl

y re

na

l co

nge

stio

n in

rat

s w

ith 2

0 e

xpo

sure

s to

300

pp

m;

in a

2-w

k st

ud

y, r

epea

ted

do

ses

of ≥

10

0 pp

m c

ause

d r

eact

ion

s in

rat

s, o

f ≥5

00

pp

m

cau

sed

rea

ctio

ns

in m

ice,

an

d 1

000

pp

m k

illed

all

rats

an

d m

ice;

in a

90

-day

stu

dy,

res

pira

tory

effe

cts

wer

e se

en in

rat

s an

d m

ice

exp

ose

d t

o 3

00

ppm

– c

yto

me

galy

of r

enal

tu

bul

ar e

pith

eliu

m w

as o

bse

rved

in >

50

% o

f te

st m

ale

mic

e

65

R

epro

duct

ive

and

D

evel

op

men

tal T

oxi

city

In

hal

atio

n:

no r

epro

duct

ive

or

dev

elo

pm

enta

l effe

cts

In V

itro:

ad

vers

e ef

fect

s w

ere

seen

with

exp

osu

re o

f rat

em

bry

os

65

G

eno

toxi

city

p

osi

tive

in a

DN

A c

ell-b

ind

ing

assa

y; n

egat

ive

in a

n A

mes

tes

t 65

C

arci

no

gen

icity

it

was

rep

ort

ed t

hat

IA

RC

rev

iew

ed m

eth

acry

lic a

cid

, b

ut d

id n

ot p

rep

are

a m

on

ogr

aph

bec

ause

inad

equ

ate

dat

a w

ere

avai

lab

le

65

Ir

ritat

ion

and

Sen

sitiz

atio

n D

erm

al –

No

n-H

um

an:

co

rro

sive

to

rab

bit

and

gui

nea

pig

ski

n; i

n a

gu

inea

pig

max

imiz

atio

n s

tud

y, it

was

diff

icu

lt to

d

eter

min

e if

ob

serv

ed r

eact

ion

s w

ere

hyp

erse

nsi

tivity

or

irrita

tion

; gu

inea

pig

s w

ere

no

t se

nsi

tized

in 3

oth

er s

tud

ies

Mu

cosa

l: c

ause

d se

vere

co

rnea

l, iri

dal

, an

d c

onju

nct

ival

effe

cts

in r

abb

its in

on

e st

udy;

in a

n in

hal

atio

n s

tud

y, 5

6,9

16

pp

m w

as c

orr

osi

ve t

o r

abb

it ey

es

65

C

linic

al U

se

neg

ativ

e re

sults

wer

e re

po

rted

in a

nu

mb

er o

f pat

ch t

ests

of p

atie

nts

alle

rgic

to

met

hyl

met

hac

ryla

te a

nd

to w

ork

ers

exp

ose

d t

o a

cryl

ates

65

D

iscu

ssio

n I

tem

s th

e P

anel

was

co

nce

rned

with

th

e ex

tre

me

corr

osi

vity

; a

pre

sen

tatio

n d

emo

nst

rate

d th

at a

tra

ined

pro

fess

ion

al c

ou

ld

app

ly t

he

acid

to

the

nai

l with

out

exp

osu

re t

o th

e sk

in, b

ut th

is c

oul

d n

ot b

e d

emo

nst

rate

d fo

r re

tail

con

sum

ers;

du

e to

co

nce

rns

that

inh

alat

ion

co

uld

affe

ct t

he

resp

irato

ry t

ract

, an

d th

e na

il te

chn

icia

n c

ou

ld b

e su

bje

cted

to in

crea

sed

ex

po

sure

in a

co

mm

erci

al s

ettin

g, t

he

NIO

SH

-rec

om

men

ded

exp

osu

re li

mit

of 2

0 p

pm

as

a tim

e-w

eigh

ted

ave

rag

e co

nce

ntr

atio

n s

houl

d n

ot b

e ex

cee

ded

; th

e C

onsu

mer

Pro

du

ct S

afet

y C

om

mis

sio

n r

ule

req

uire

s ch

ild-r

esis

tan

t p

acka

gin

g fo

r liq

uid

hou

seh

old

pro

duct

s co

ntai

nin

g >

5%

met

hac

rylic

aci

d (

wt

to v

ol)

65

C

IR C

on

clu

sion

(20

05)

safe

as

used

as

a na

il pr

imer

by

trai

ned

prof

essi

onal

s; in

suff

icie

nt d

ata

for

reta

il us

e by

con

sum

ers

65

Met

hyl M

etha

cryl

ate

T

oxi

coki

net

ics

can

be

abso

rbed

thro

ugh

the

skin

of h

um

ans

66

A

nim

al T

oxi

colo

gy

Rep

eate

d D

ose

- O

ral:

ch

ron

ic e

xpo

sure

to

≤4

00 p

pm

did

no

t ca

use

tu

mo

rs in

ham

ster

s o

r ra

ts

67

R

epro

duct

ive

and

D

evel

op

men

tal T

oxi

city

In

hal

atio

n:

no e

ffect

on

feta

l dev

elo

pm

ent

in m

ice

or

rats

; 66

G

eno

toxi

city

ge

no

toxi

c in

a c

hro

mo

som

al a

ber

ratio

n, S

CE

, an

d m

ou

se ly

mp

ho

ma

assa

y; n

ot

mu

tage

nic

in a

S

alm

onella

/mic

roso

me

or

liqu

id in

cub

atio

n a

ssa

y

1



Tab

le 6

. R

elev

ant

sum

mar

y in

form

atio

n o

n c

om

pon

ents

(co

ntin

ued

)

35

Mon

omer

Com

pone

nt

Pa r

amet

er E

valu

ated

O

utco

me

R

efer

ence

C

arci

no

gen

icity

O

ral:

not

car

cin

oge

nic

in a

drin

kin

g st

ud

y u

sin

g ra

ts

Inh

alat

ion

: no

t ca

rcin

oge

nic

in m

ice

or

rats

IA

RC

: in

ad

equ

ate

evi

den

ce in h

uman

s fo

r ca

rcin

oge

nic

ity; ev

iden

ce s

ug

gest

ing

lack

of c

arc

inog

en

icity

in e

xper

imen

tal

anim

als;

no

t cl

ass

ifiab

le a

s to

its

carc

ino

gen

icity

in h

um

an

s (G

rou

p 3

)

66

Ir

ritat

ion

and

Sen

sitiz

atio

n D

erm

al –

No

n-H

um

an:

sen

sitiz

ing

at 2

5%

in g

uin

ea p

igs;

min

imu

m in

du

ctio

n c

once

ntr

atio

n w

as 1

M;

was

a w

eak

con

tact

alle

rgen

in a

loca

l lym

ph

no

de

assa

y

Hu

man

: t

he

freq

uen

cy o

f po

sitiv

e re

actio

ns

am

on

g al

l pat

ien

ts to

met

hyl

met

hac

ryla

te w

as

7/2

2; t

he fr

equ

ency

o

f p

osi

tive

reac

tion

s am

on

g p

atie

nts

with

art

ifici

al n

ails

was

1/1

0

68

Eth

yl M

etha

cryl

ate

G

eno

toxi

city

n

ot

mu

tage

nic

in a

Sa

lmon

ella

/mic

roso

me

assa

y; g

eno

toxi

city

in a

mo

use

lym

ph

om

a ce

ll as

say

was

co

nsi

der

ed li

kely

du

e to

a c

last

oge

nic

mec

han

ism

1

Ir

ritat

ion

and

Sen

sitiz

atio

n D

erm

al –

Hu

man

: t

he

freq

uen

cy o

f po

sitiv

e re

actio

ns

amo

ng

all p

atie

nts

tes

ted

was

14

/22

; T

he

freq

uen

cy o

f po

sitiv

e re

actio

ns

amo

ng

pat

ien

ts w

ith a

rtifi

cial

nai

ls w

as 7

/11

(6

4%

),

68

D

iscu

ssio

n I

tem

s (T

his

ingr

edie

nt

was

rev

iew

ed fo

r its

use

nai

l en

han

cem

ent

pro

du

cts.

) t

he

Pan

el w

as c

on

cern

ed w

ith t

he

stro

ng

sen

sitiz

a-tio

n an

d cr

oss

- o

r co

-rea

ctiv

ity p

oten

tial o

f met

hac

ryla

tes;

ho

wev

er d

ata

wer

e su

bm

itted

th

at in

dic

ated

th

ere

wo

uld

be

little

mo

no

mer

ava

ilab

le fo

r ex

po

sure

to

the

skin

; ge

not

oxi

city

dat

a in

dica

ted

th

e so

me

met

hac

ryla

tes

cou

ld p

rodu

ce

chro

mo

som

e d

am

age;

th

e P

anel

res

tric

ted

met

hac

ryla

tes

to t

he

nai

l, an

d th

ey m

ust

no

t co

me

in c

on

tact

with

ski

n;

initi

al

con

cern

that

exo

ther

ms

crea

ted

fro

m t

he

rap

id p

oly

mer

izat

ion

of t

he m

on

om

ers

cou

ld d

ama

ge t

he

nai

l wer

e al

levi

ated

67

C

IR C

on

clu

sion

(20

05)

safe

as

used

in n

ail e

nhan

cem

ent p

rodu

cts

whe

n sk

in c

onta

ct is

avo

ided

; pr

oduc

ts c

onta

inin

g th

is in

gred

ient

sho

uld

be a

ccom

pani

ed w

ith d

irec

tions

to a

void

ski

n co

ntac

t, be

caus

e of

the

sens

itizi

ng p

oten

tial o

f m

etha

cryl

ates

67

But

yl M

etha

cryl

ate

A

nim

al T

oxi

colo

gy

Sin

gle

Do

se –

Der

mal

: 1

0 c

c/kg

did

not

cau

se m

ort

ality

in r

abb

its, b

ut a

cute

der

mal

irrit

atio

n w

as r

epo

rted

; on

e LD

50

valu

e o

f >2

00

0 m

g/kg

in r

abb

its w

as

rep

ort

ed;

the

LD50

in g

uin

ea p

igs

was

>2

0 m

l/kg

O

ral;

rep

ort

ed o

ral L

D 50 v

alu

es in

rat

s ra

nge

d fr

om

>

20

00 to

>

20,0

00

mg/

kg

In

hal

atio

n: r

epo

rted

LC 50

val

ue

wa

s 2

8,4

69 m

g/m3 r

ats;

67

Rep

eate

d D

ose

– O

ral:

in r

ats,

the

NO

ELS

wer

e 2

0 m

g/kg

/da

y in

a 2

8-d

ay s

tud

y, 3

0

(mal

es)

and

300

(fe

mal

es)

mg/

kg/d

ay

in a

45

-day

stu

dy,

an

d <

30

(m

ales

) an

d 3

0 (

fem

ales

) m

g/kg

/da

y in

a 5

0-d

ay s

tud

y

Inh

alat

ion:

ca

use

d u

pper

airw

ay

irrita

tion

in a

28

-day

stu

dy

in r

ats

– th

e N

OE

L w

as 1

80

1 m

g/m

3

67

R

epro

duct

ive

and

D

evel

op

men

tal T

oxi

city

O

ral:

a d

ecre

ase

in c

orp

ora

lute

a an

d im

pla

nta

tion

s w

as r

epo

rted

in r

ats;

th

e p

aren

tal N

OA

EL

s w

ere

10

00 a

nd 3

00

mg/

kg/d

ay

for

mal

es a

nd

fem

ales

, re

spec

tivel

y In

hal

atio

n:

thre

sho

ld c

on

cen

trat

ion

for

emb

ryo

toxi

c an

d t

erat

oge

nic

effe

cts

in r

ats

was

0.1

mg/

m3 ;

slig

ht

feto

toxi

city

was

re

po

rted

in r

ats

exp

ose

d to

≤1

200

pp

m o

n d

ays

6-2

0 o

f ges

tatio

n

67

G

eno

toxi

city

n

ot

mu

tage

nic

in m

ulti

ple

Am

es

test

s w

ith o

r w

itho

ut

met

abo

lic a

ctiv

atio

n;

was

mu

tage

nic

to

S

alm

one

lla t

yph

imu

rium

TA

15

38

with

met

abo

lic a

ctiv

atio

n in

on

e st

udy

67

Ir

ritat

ion

and

Sen

sitiz

atio

n D

erm

al -

N

on

-Hu

man

: a

ver

y st

ron

g se

nsi

tizer

in o

ne

stud

y u

sin

g gu

inea

pig

s; c

on

sid

ered

a m

od

erat

e se

nsi

tizer

in

ano

ther

stu

dy

usi

ng

guin

ea p

igs;

in a

few

stu

die

s, a

sen

sitiz

atio

n r

eact

ion

was

no

t pro

du

ced

H

um

an:

1%

cau

sed

1 p

osi

tive

reac

tion

in 1

2 s

ubje

cts

in a

Dra

ize

con

tact

sen

sitiz

atio

n s

tud

y; in

pro

voca

tive

test

ing,

1%

el

icite

d p

osi

tive

reac

tion

s to

pat

ch t

ests

M

uco

sal:

mild

ly ir

ritat

ing

to r

abbi

t ey

es

67



Tab

le 6

. R

elev

ant

sum

mar

y in

form

atio

n o

n c

om

pon

ents

(co

ntin

ued

)

36

Mon

omer

Com

pone

nt

Pa r

amet

er E

valu

ated

O

utco

me

R

efer

ence

D

iscu

ssio

n I

tem

s (T

his

ingr

edie

nt

was

rev

iew

ed fo

r its

use

nai

l en

han

cem

ent

pro

du

cts.

) t

he

Pan

el w

as c

on

cern

ed w

ith t

he

stro

ng

sen

sitiz

a-tio

n an

d cr

oss

- o

r co

-rea

ctiv

ity p

oten

tial o

f met

hac

ryla

tes;

ho

wev

er d

ata

wer

e su

bm

itted

th

at in

dic

ated

th

ere

wo

uld

be

little

mo

no

mer

ava

ilab

le fo

r ex

po

sure

to

the

skin

; ge

not

oxi

city

dat

a in

dica

ted

th

e so

me

met

hac

ryla

tes

cou

ld p

rodu

ce

chro

mo

som

e d

am

age;

th

e P

anel

res

tric

ted

met

hac

ryla

tes

to t

he

nai

l, an

d th

ey m

ust

no

t co

me

in c

on

tact

with

ski

n;

initi

al

con

cern

that

exo

ther

ms

crea

ted

fro

m t

he

rap

id p

oly

mer

izat

ion

of t

he m

on

om

ers

cou

ld d

ama

ge t

he

nai

l wer

e al

levi

ated

67

C

IR C

on

clu

sion

(20

05)

safe

as

used

in n

ail e

nhan

cem

ent p

rodu

cts

whe

n sk

in c

onta

ct is

avo

ided

; pr

oduc

ts c

onta

inin

g th

is in

gred

ient

sho

uld

be a

ccom

pani

ed w

ith d

irec

tions

to a

void

ski

n co

ntac

t, be

caus

e of

the

sens

itizi

ng p

oten

tial o

f m

etha

cryl

ates

67

Isob

utyl

Met

hacr

ylat

e

An

imal

To

xico

log

y S

ingl

e D

ose

– D

erm

al:

th

e re

por

ted

der

mal

LD

50 w

as >

20

ml/k

g in

gu

inea

pig

s

Ora

l: r

epo

rted

LD 50

valu

es in

rat

s ra

nge

d fr

om

>5

00

0 to

12

,80

0 m

g/kg

Inh

alat

ion:

50

% o

f m

ice

die

d a

fter

exp

osu

re t

o 29

.74

mg/

l fo

r 2

89 m

inu

tes;

was

co

nsi

der

ed a

to

xic

(bu

t no

t hig

hly

to

xic)

su

bst

ance

by

inh

alat

ion

exp

osu

re

67

G

eno

toxi

city

n

ot

mu

tage

nic

in m

ulti

ple

Am

es

test

s w

ith o

r w

itho

ut

met

abo

lic a

ctiv

atio

n 67

Ir

ritat

ion

and

Sen

sitiz

atio

n D

erm

al -

H

um

an:

1%

cau

sed

no

po

sitiv

e re

actio

n in

11

subj

ects

in a

co

nta

ct s

ensi

tizat

ion

stu

dy;

in p

rovo

cativ

e te

stin

g,

1%

elic

ited

po

sitiv

e re

actio

ns

to p

atch

tes

ts

Mu

cosa

l: m

ildly

irrit

atin

g to

rab

bit

eyes

67

D

iscu

ssio

n I

tem

s (T

his

ingr

edie

nt

was

rev

iew

ed fo

r its

use

nai

l en

han

cem

ent

pro

du

cts.

) t

he

Pan

el w

as c

on

cern

ed w

ith t

he

stro

ng

sen

sitiz

a-tio

n an

d cr

oss

- o

r co

-rea

ctiv

ity p

oten

tial o

f met

hac

ryla

tes;

ho

wev

er d

ata

wer

e su

bm

itted

th

at in

dic

ated

th

ere

wo

uld

be

little

mo

no

mer

ava

ilab

le fo

r ex

po

sure

to

the

skin

; ge

not

oxi

city

dat

a in

dica

ted

th

e so

me

met

hac

ryla

tes

cou

ld p

rodu

ce

chro

mo

som

e d

am

age;

th

e P

anel

res

tric

ted

met

hac

ryla

tes

to t

he

nai

l, an

d th

ey m

ust

no

t co

me

in c

on

tact

with

ski

n;

initi

al

con

cern

that

exo

ther

ms

crea

ted

fro

m t

he

rap

id p

oly

mer

izat

ion

of t

he m

on

om

ers

cou

ld d

ama

ge t

he

nai

l wer

e al

levi

ated

67

C

IR C

on

clu

sion

(20

05)

safe

as

used

in n

ail e

nhan

cem

ent p

rodu

cts

whe

n sk

in c

onta

ct is

avo

ided

; pr

oduc

ts c

onta

inin

g th

is in

gred

ient

sho

uld

be a

ccom

pani

ed w

ith d

irec

tions

to a

void

ski

n co

ntac

t, be

caus

e of

the

sens

itizi

ng p

oten

tial o

f m

etha

cryl

ates

67

Laur

yl M

etha

cryl

ate

A

nim

al T

oxi

colo

gy

Sin

gle

Do

se –

Ora

l: n

o r

ats

dose

d w

ith

≤2

1.5

ml/k

g C

12

-C18

met

hac

ryla

te m

on

om

ers

die

d

In

hal

atio

n:

the

RD 50

was

39

00

mg/

m3 in m

ice

67

Rep

eate

d D

ose

– In

hal

atio

n: n

ot to

xic

to r

ats

in a

20

-day

stu

dy

67

Ir

ritat

ion

and

Sen

sitiz

atio

n D

erm

al –

No

n-H

um

an:

str

ong

sen

sitiz

er in

gui

nea

pig

s 67

D

iscu

ssio

n I

tem

s (T

his

ingr

edie

nt

was

rev

iew

ed fo

r its

use

nai

l en

han

cem

ent

pro

du

cts.

) t

he

Pan

el w

as c

on

cern

ed w

ith t

he

stro

ng

sen

sitiz

a-tio

n an

d cr

oss

- o

r co

-rea

ctiv

ity p

oten

tial o

f met

hac

ryla

tes;

ho

wev

er d

ata

wer

e su

bm

itted

th

at in

dic

ated

th

ere

wo

uld

be

little

mo

no

mer

ava

ilab

le fo

r ex

po

sure

to

the

skin

; ge

not

oxi

city

dat

a in

dica

ted

th

e so

me

met

hac

ryla

tes

cou

ld p

rodu

ce

chro

mo

som

e d

am

age;

th

e P

anel

res

tric

ted

met

hac

ryla

tes

to t

he

nai

l, an

d th

ey m

ust

no

t co

me

in c

on

tact

with

ski

n;

initi

al

con

cern

that

exo

ther

ms

crea

ted

fro

m t

he

rap

id p

oly

mer

izat

ion

of t

he m

on

om

ers

cou

ld d

ama

ge t

he

nai

l wer

e al

levi

ated

67

C

IR C

on

clu

sion

(20

05)

safe

as

used

in n

ail e

nhan

cem

ent p

rodu

cts

whe

n sk

in c

onta

ct is

avo

ided

; pr

oduc

ts c

onta

inin

g th

is in

gred

ient

sho

uld

be a

ccom

pani

ed w

ith d

irec

tions

to a

void

ski

n co

ntac

t, be

caus

e of

the

sens

itizi

ng p

oten

tial o

f m

etha

cryl

ates

67



Tab

le 6

. R

elev

ant

sum

mar

y in

form

atio

n o

n c

om

pon

ents

(co

ntin

ued

)

37

Mon

omer

Com

pone

nt

Pa r

amet

er E

valu

ated

O

utco

me

R

efer

ence

PE

G-4

Dim

etha

cryl

ate

An

imal

To

xico

log

y S

ingl

e D

ose

– D

erm

al:

th

e LD 5

0 w

as

>3

g/k

g in

rat

s

Ora

l: L

D 50

wa

s >

50

00

mg/

kg in

rat

s

67

G

eno

toxi

city

n

ot

mu

tage

nic

in m

ulti

ple

Am

es

test

s w

ith o

r w

itho

ut

met

abo

lic a

ctiv

atio

n;

wea

kly

po

sitiv

e in

a m

ou

se ly

mp

ho

ma

cell

assa

y w

ith m

etab

olic

act

ivat

ion

67

C

arci

no

gen

icity

D

erm

al:

no

incr

ease

in s

kin

or

visc

eral

tu

mo

rs in

an

80

-wk

stu

dy

67

Ir

ritat

ion

and

Sen

sitiz

atio

n D

erm

al -

N

on

-Hu

man

: m

od

erat

e se

nsi

tizer

in g

uin

ea p

igs;

no

t a

sen

sitiz

er in

on

e st

ud

y M

uco

sal:

min

imal

ly ir

ritat

ing

to r

abb

it ey

es

67

D

iscu

ssio

n I

tem

s (T

his

ingr

edie

nt

was

rev

iew

ed fo

r its

use

nai

l en

han

cem

ent

pro

du

cts.

) t

he

Pan

el w

as c

on

cern

ed w

ith t

he

stro

ng

sen

sitiz

a-tio

n an

d cr

oss

- o

r co

-rea

ctiv

ity p

oten

tial o

f met

hac

ryla

tes;

ho

wev

er d

ata

wer

e su

bm

itted

th

at in

dic

ated

th

ere

wo

uld

be

little

mo

no

mer

ava

ilab

le fo

r ex

po

sure

to

the

skin

; ge

not

oxi

city

dat

a in

dica

ted

th

e so

me

met

hac

ryla

tes

cou

ld p

rodu

ce

chro

mo

som

e d

am

age;

th

e P

anel

res

tric

ted

met

hac

ryla

tes

to t

he

nai

l, an

d th

ey m

ust

no

t co

me

in c

on

tact

with

ski

n;

initi

al

con

cern

that

exo

ther

ms

crea

ted

fro

m t

he

rap

id p

oly

mer

izat

ion

of t

he m

on

om

ers

cou

ld d

ama

ge t

he

nai

l wer

e al

levi

ated

67

C

IR C

on

clu

sion

(20

05)

safe

as

used

in n

ail e

nhan

cem

ent p

rodu

cts

whe

n sk

in c

onta

ct is

avo

ided

; pr

oduc

ts c

onta

inin

g th

is in

gred

ient

sho

uld

be a

ccom

pani

ed w

ith d

irec

tions

to a

void

ski

n co

ntac

t, be

caus

e of

the

sens

itizi

ng p

oten

tial o

f m

etha

cryl

ates

67



38

REFERENCES

1. Andersen FA (ed). Final report on the safety assessment of acrylates copolymer and 33 related cosmetic ingredients. Int J

Toxicol. 2002;21:(Suppl 3):1-50.

2. Kirk-Othmer Concise Encyclopedia of Chemical Technology. 4th ed. NY: Wiley, 1999.

3. Sojka, M. and Matushek, M. New polymer technology for skin oil adsorbers and controlled release. Cosmet.Toiletries. 1999;114:(Mar):83-86, 88.

4. Gottschalck T.E. and Bailey, J. E. eds. International Cosmetic Ingredient Dictionary and Handbook. Washington, DC: Personal Care Products Council, 2010.

5. Lubrizol. Introducing PemulenTM polymeric emulsifiers. TDS 114. http://www.lubrizol.com/PersonalCare/Products/Pemulen/TDS.html. 2002. Date Accessed 12-7-2010.

6. Personal Care Products Council. Specification information on acrylates/C10-30 alkyl acrylate crosspolymer. 2-28-2011. Unpublished data; originally submitted by the Council on December 15, 2010, corrected version submittedon Feb. 28, 2011. (1 p) Available from CIR.

7. Personal Care Products Council. Acrylates/C10-30 Alkyl Acrylate Crosspolymer: Potential contamination with benzene. 5-9-2011. Unpublished data submitted by the Council on May 9, 2011. (1 p).

8. Dow Chemical Company. ACULYNTM 88 Polymer (Acrylates/Steareth-20 Methacrylate Crosspolymer) Global Cosmetic Dossier. Version 10. 5-2-2011. Unpublished data submitted by the Council on May 3. (12 pp).

9. Personal Care Products Council. Molecular weight, residual monomer data, and method of manufacture on acrylates/vinyl isododecanoate crosspolymer. 12-14-2010. Unpublished data submitted by the Council on Dec 14, 2010. (1 p) Available from CIR.

10. Dow Chemical Company. ACULYNTM 38 Polymer (Acrylates/Vinyl Neodecanoate Crosspolymer) Global Cosmetic Dossier. Version 5. 5-2-2011. Unpublished data submitted by the Council on May 3, 2011. (12 pp).

11. Lubrizol. Carbopol® 1382 Polymer (alkyl/C10-30 alkyl acrylate crosspolymer) product specifications. http://www.lubrizol.com/PersonalCare/Products/Carbopol/Carbopol1382.html. 7-17-1997. Date Accessed 12-7-2010.

12. Lubrizol. Carbopol Ultrez 21 Polymer (acrylates/C10-30 alkyl acrylate crosspolymer) product specifications. http://www.lubrizol.com/PersonalCare/Products/Carbopol/CarbopolUltrez21.html. 9-16-2003. Date Accessed 12-7-2010.

13. Lubrizol. Carbopol® Ultrez 20 polymer (acrylates/C10-30 alkyl acrylate copolymer) product specifications. http://www.lubrizol.com/PersonalCare/Products/Carbopol/CarbopolUltrez20.html. 10-26-2006. Date Accessed 12-7-2010.

14. Lubrizol. PemulenTM TR-1 Polymeric Emulsifier (acrylates/C10-30 alkyl acrylate crosspolymer) product specifications. http://www.essentialingredients.com/spec/Pemulen%20TR-1.pdf. 1997. Date Accessed 12-7-0010.

15. Lubrizol. PemulenTM TR-2 Polymeric Emulsifier (acrylates/C10-30 alkyl acrylate crosspolymer) product specifications. http://www.lubrizol.com/PersonalCare/Products/Pemulen/PemulenTR-2.html. 1997. Date Accessed 12-7-2010.

16. Lubrizol. Carbopol® ETD 2020 polymer (acrylates/C10-30 alkyl acrylate crosspolymer) product specifications. http://www.lubrizol.com/PersonalCare/Products/Carbopol/CarbopolETD2020.html. 2001. Date Accessed 12-7-2010.

17. Lubrizol. Carbopol® 1342 Polymer (acrylates/C10-30 alkyl acrylate crosspolymer) product specifications. http://www.lubrizol.com/PersonalCare/Products/Carbopol/Carbopol1342.html. 7-17-1997. Date Accessed 12-7-2010.

18. Personal Care Products Council. Benzene impurity in acrylates/C10-30 alkyl acrylate crosspolymer. 5-4-2011. Unpublishe data submitted by the Council on May 4, 2011. (1 p).

19. European Commission. European Commission CosIng Cosmetics Directive (v.1); Annex II/47 - benzene. http://ec.europa.eu/consumers/cosmetics/cosing/index.cfm?fuseaction=search.details&id=28884. 2009. Date Accessed 5-3-0011.



39

20. Personal Care Products Council. Memo introducing summaries of an MSDS acute oral toxicity study, guinea pig sensitization data, an Ames assay, and a human single insult patch test, performed in 2010, on acrylate/C10-30 alkyl acrylate crosspolymer. 2-11-2011. Unpublished data submitted by the Council on Feb. 11, 2011. (2 pp) Available from CIR.

21. Personal Care Products Council. Memo introducing summaries of a dermal irritation study, ocular irritation study, and a human single insult patch test, performed in 2004, on acrylates crosspolymer. 2-11-2011. Unpublished data submitted by the Council on Feb. 11, 2011. (2 pp) Available from CIR.

22. Personal Care Products Council. Memo introducting an HRIPT of a lipstick containing 4% acrylates crosspolymer. 2-22-2011. Unpublished data submitted by the Council on Feb 22, 2011. (1 p) Available from CIR.

23. Personal Care Products Council. Memo introducting HRIPTs on bubble bath and bath and shower foam containing 2% acrylates/vinyl neodecanoate crosspolymer. 2-4-2011. Unpublished data submitted by the Council on Feb. 4, 2011. (1 p) Available from CIR.

24. Personal Care Products Council. Memo introducing studies ona face powder containing 1% lauryl methacrylate/glycol dimethacrylate crosspolymer (product tested as used). 2-7-2011. Unpublished data submitted by the Council on Feb. 7, 2011. (1 p) Available from CIR.

25. Sumitomo Seika. Cosmetic grade AquaKeep 10SH-NFC (Sodium Acrylates Crosspolymer-2). 11-24-2010. Unpublished data submitted by the Personal Care Products Council on Nov. 30, 2010. (1 p). Available from CIR.

26. Food and Drug Administration (FDA). Frequency of use of cosmetic ingredients. FDA Database. 2011. Washington, DC: FDA.Updated Feb 25.

27. Personal Care Products Council. Updated concentration of use by FDA product category: Acrylates Crosspolymer Ingredients. 1-28-2011. Unpublished data submitted by the Council on Jan. 28, 2011. (5 pp) Available from CIR.

28. European Commission. European Commission Health and Consumers Cosmetics - Cosing - Database. http://ec.europa.eu/consumers/cosmetics/cosing/. 2010. Date Accessed 11-30-2010.

29. Personal Care Products Council. Comments on the Scientific Literature Review on Crosslinked Alkyl Acrylates. 2011. Memorandum received from the Personal Care Products Council on Jan 20, 2011. (2 pp) Available from CIR.

30. Amidon GE, Peck GE, Block LH, Moreton RC, Katdare A, Lafaver R, and Sheehan C. Proposed New USP General Information Chapter, Excipient Performance (1059). http://www.usp.org/pdf/EN/USPNF/Vol33No7Stimuli.pdf. 2007.

31. Qiu, H., Mccall, J. W., and Jun, H. W. Formulation of topical insect repellent N,N-diethyl-m-toluamide (DEET): Vehicle effects on DEET in vitro skin permeation. International Journal of Pharmaceutics (Amsterdam). 1998;163:(1-2):167-176.

32. Lubrizol. Material safety data sheet for Pemulen (TM) TR-1 NF Polymer (acrylates/C10-30 alkyl acrylate crosspolymer). http://online.lubrizol.com/msds/MSDSDisplay.aspx?L=941&c=1942&p=PEM1005. 11-20-2010. Date Accessed 12-9-2010.

33. 3V Sigma. Toxicological summary review on acrylates/vinyl isododecanoate crosspolymer. 2010. Unpublished data submitted by the Council on Dec 14, 2010. (3 pp) Available from CIR.

34. Sumitomo Seika Chemicals Co. Material safety data sheet on Aqua Keep 10SH-NFC (Sodium Acrylates Crosspolymer-2). 1-11-2010. Unpublished data submitted by the Personal Care Products Council on Nov. 30, 2010. (5 pp). Available from CIR.

35. Institute for In Vitro Sciences, Inc. Topical application ocular irritation screening assay using the epiocular human cell construct on a facepowder containing 1% lauryl methacrylate/glycol dimethacrylate crosspolymer. Study no. 09AC65, 03AA05.015001. Laboratory project no. 5463. 4-20-2009. Unpublished data submittd by the Council on Feb. 7, 2011. (10 pp) Available from CIR.

36. Lubrizol. Carbopol® ETD polymer (acrylates/C10-30 alkyl acrylate crosspolymer) toxicology studies. TOX-003. http://www.lubrizol.com/PersonalCare/Products/Carbopol/CarbopolETD2020.html. 1996. Date Accessed 12-7-2010.

37. Lubrizol. Carbopol® Ultrez 21 polymer (acrylates/C10-30 alkyl acrylate crosspolymer) toxicology studies. TOX-023. http://www.lubrizol.com/PersonalCare/Products/Carbopol/CarbopolUltrez21.html. 7-10-2002. Date Accessed 12-7-2010.



40

38. Lubrizol. Carbopol® Ultrez 20 polymer (acrylates/C10-30 alkyl acrylate crosspolymer) toxicology studies. TOX-080. http://www.lubrizol.com/PersonalCare/Products/Carbopol/CarbopolUltrez20.html. 2-5-2004. Date Accessed 12-7-2010.

39. Lubrizol. Toxicology/regulatory/health, safety & environmenal studies of Pemulen polymer emulsifiers. TOX-007. http://www.lubrizol.com/PersonalCare/Products/Pemulen/PemulenTR-2.html. 7-15-2003. Date Accessed 12-7-2010.

40. CAS Registry Online Database. 2010.

41. CosPharm Inc. Product characeteristics of Poly-Pore L200 (Allyl Methacrylates Crosspolymer). http://www.cospharm.com/chemdal/p1200.htm. 2011. Date Accessed 1-19-2011.

42. CosPharm Inc. Product characteristics of Poly-Pore E200 (Allyl Methacrylates Crosspolymer). http://www.cospharm.com/chemdal/pe200.htm. 2011. Date Accessed 1-19-2011.

43. Personal Care Products Council. Comments on the draft report on crosslinked alkyl acrylates prepared for the March 3-4, 2011 CIR Expert Panel meeting. 2-28-2011. Submitted by the Council on FEb. 28, 2011. (1 p) Available from CIR.

44. Consumer Product Testing Co. Final report on a repeated insult patch test of a body lotion containing 0.15% acrylates/C10-30 alkyl acrylate crosspolymer. Exp. Ref. No. C09-1109.01. 5-1-2009. Unpublished data submitted by the Council on Jan 11, 2011. (9 pp) Available from CIR.

45. Consumer Product Testing Co. Final report on a repeated insult patch test on a crème to powder foot crème containing 0.60% acrylates C10-30 alkyl acrylate crosspolymer. Exp. Ref. No. C10-0602.01. 2010. Unpublished data submitted by the Council on Jan 11, 2011. (7 pp) Available from CIR.

46. Personal Care Products Council. Summaries of HRIPTs on products containing acrylates crosspolymer. 2-7-2011. Unpublished data submitted by the Council on Feb. 7, 2011. (1 p) Available from CIR.

47. Consumer Product Testing Co. Repeated insult patch test of a lipstick containing 4% acrylates crosspolymer. Experiment Ref. nO. c07-3553.01. 2007. Unpublished data submitted by the Council on Feb. 22, 2011. (13 pp) Available from CIR.

48. Orentreich Research Corporation. Predictive patch test study on a face powder + SPF containing 6.8565% acryaltes/ethylhexyl acrylate crosspolymer. 2005. Unpublished data received from the Council on Feb. 8, 2011. (27 pp) Available from CIR.

49. Clinical Research Laboratories, Inc. Final report of a repeated insult patch test on a bath creme containing 2% acrylates/vinyl neodecanoate crosspolymer. CRL study no. CRL81207-15. 8-3-2007. Unpublished data received from the Council on Feb. 4, 2011. (13 pp) Available from CIR.

50. Clinical Research Laboratories, Inc. Final report of a repeated insult patch test on a bath creme containing 2% acrylates/vinyl neodecanoate crosspolymer. CRL study no. CRL148107-4. 12-21-2007. Unpublished data received from the Council on Feb. 4, 2011. (13 pp) Available from CIR.

51. Clinical Research Laboratories, Inc. Final report of a repeated insult patch test on a bubble bath formulation containing 2% acrylates/vinyl neodecanoate crosspolymer. CRL study no. CRL62208-14. 7-11-2008. Unpublished data received from the Council on Feb. 4, 2011. (13 pp) Available from CIR.

52. Clinical Research Laboratories, Inc. Final report of a repeated insult patch test on a bath gel containing 2% acrylates/vinyl neodecanoate crosspolymer. CRL study no. CRL69608-15. 8-1-2008. Unpublished data received from the Council on Feb. 4, 2011. (13 pp) Available from CIR.

53. Clinical Research Laboratories, Inc. Final report of a repeated insult patch test on a bath product containing 2% acrylates/vinyl neodecanoate crosspolymer. CRL study no. CRL75208-6. 8-8-2008. Unpublished data received from the Council on Feb. 4, 2011. (13 pp) Available from CIR.

54. Clinical Research Laboratories, Inc. Final report of a repeated insult patch test on a bath and shower foam containing 2% acrylates/vinyl neodecanoate crosspolymer. CRL study no. CRL43409-8. 7-10-2009. Unpublished data received from the Council on Feb. 4, 2011. (13 pp) Available from CIR.




41


57. Clinical Research Laboratories, Inc. Final report of a repeated insult patch test on a bubble bath formulation containing 2% acrylates/vinyl neodecanoate crosspolymer. CRL study no. CRL31010-15. 6-11-2010. Unpublished data received from the Council on Feb. 4, 2011. (13 pp) Available from CIR.

58. TKL Research. Summary report on a repeated insult patch rest of a face powder containing 1% lauryl methacrylate/glycol dimethacrylate crosspolymer. TKL study no. DS102909-9. 5-20-2009. Unpublished data submittd by the Council on Feb. 7, 2011. (19 pp) Available from CIR.

59. Orentreich Research Corporation. Repeated insult patch test of an exfoliating facial mask containing 2.6% lauryl methacrylate/glycol dimethacrylate crosspolymer. 9-17-2008. Unpublished data submittd by the Council on Feb. 8, 2011. (33 pp) Available from CIR.

60. International Agency for Research on Cancer. Acrylic acid. http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-60.pdf. 1987. Date Accessed 1-21-2011.

61. International Agency for Research on Cancer. Methyl acrylate. http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-104.pdf. 1987. Date Accessed 1-21-2011.

62. International Agency for Research on Cancer. Ethyl acrylate. http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-99.pdf. 1987. Date Accessed 1-21-2011.

63. International Agency for Research on Cancer. n-Butyl acrylate. http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-14.pdf. 1987. Date Accessed 1-21-2011.

64. International Agency for Research on Cancer. 2-Ethylhexyl acrylate. http://monographs.iarc.fr/ENG/Monographs/vol60/mono60-19.pdf. 1994. Date Accessed 1-21-2011.

65. Andersen FA (ed). Final report on the safety assessment of methacrylic acid. Int J Toxicol. 2005;24:(Suppl 5):33-51.

66. International Agency for Research on Cancer. Methyl methacrylate. http://monographs.iarc.fr/ENG/Monographs/vol60/mono60-18.pdf. 1994. Date Accessed 1-21-2011.

67. Andersen FA (ed). Final report of the safety assessment of methacylate ester monomers used in nail enhancement products. Int J Toxicol. 2005;24:(Suppl 5):53-100.

68. Becker LC, Berfgeld WF, Belsito DV, Klaassen CD, Liebler DC, Hill RA, Marks JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final report of the CIR Expert Panel on the safety assessment of polymethyl methacrylate (PMMA), methyl methacrylate crosspolymer, and methyl methacrylate/glycol dimethacrylate crosspolymer. 11-15-2010. Available from CIR, 1101 17th St, NW, Ste 412, Washington, DC 20036 www.cir-safety.org.



ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 1 01A - Baby ShampoosACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 6 01B - Baby Lotions, Oils, Powders, and CreamsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 3 01C - Other Baby ProductsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 1 02A - Bath Oils, Tablets, and SaltsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 7 02B - Bubble BathsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 10 02D - Other Bath PreparationsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 13 03B - EyelinerACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 1 03C - Eye ShadowACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 60 03D - Eye LotionACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 12 03E - Eye Makeup RemoverACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 5 03F - MascaraACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 41 03G - Other Eye Makeup PreparationsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 2 04B - PerfumesACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 36 04E - Other Fragrance PreparationACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 4 05A - Hair ConditionerACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 1 05B - Hair Spray (aerosol fixatives)ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 19 05F - Shampoos (non-coloring)ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 34 05G - Tonics, Dressings, and Other Hair Grooming AidsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 1 05H - Wave SetsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 17 05I - Other Hair PreparationsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 1 06F - Hair Lighteners with ColorACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 9 06G - Hair BleachesACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 1 06H - Other Hair Coloring PreparationACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 8 07C - FoundationsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 3 07E - LipstickACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 5 07F - Makeup BasesACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 9 07I - Other Makeup PreparationsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 3 08B - Cuticle SoftenersACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 2 08C - Nail Creams and LotionsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 4 08G - Other Manicuring PreparationsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 56 10A - Bath Soaps and DetergentsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 1 10B - Deodorants (underarm)ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 1 10C - DouchesACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 33 10E - Other Personal Cleanliness ProductsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 65 11A - Aftershave LotionACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 2 11D - Preshave Lotions (all types)ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 2 11E - Shaving CreamACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 18 11G - Other Shaving Preparation ProductsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 131 12A - CleansingACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 234 12C - Face and Neck (exc shave)ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 244 12D - Body and Hand (exc shave)ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 366 12F - MoisturizingACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 61 12G - NightACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 22 12H - Paste Masks (mud packs)ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 7 12I - Skin FreshenersACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 104 12J - Other Skin Care PrepsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 9 13A - Suntan Gels, Creams, and LiquidsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 13 13B - Indoor Tanning PreparationsACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 8 13C - Other Suntan Preparations

ACRYLATES CROSSPOLYMER 2 12C - Face and Neck (exc shave)

ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER 1 11D - Preshave Lotions (all types)ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER 7 12A - CleansingACRYLATES/VINYL ISODECANOATE CROSSPOLYMER 3 12C - Face and Neck (exc shave)ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER 5 12D - Body and Hand (exc shave)ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER 12 12F - MoisturizingACRYLATES/VINYL ISODECANOATE CROSSPOLYMER 2 12G - NightACRYLATES/VINYL ISODECANOATE CROSSPOLYMER 3 12J - Other Skin Care Preps

ACRYLATES/VINYL NEODECANOATE CROSSPOLYMER 1 02B - Bubble BathsACRYLATES/VINYL NEODECANOATE CROSSPOLYMER 1 02D - Other Bath Preparations



ACRYLATES/VINYL NEODECANOATE CROSSPOLYMER 1 10A - Bath Soaps and DetergentsACRYLATES/VINYL NEODECANOATE CROSSPOLYMER 3 10E - Other Personal Cleanliness ProductsACRYLATES/VINYL NEODECANOATE CROSSPOLYMER 3 12F - MoisturizingACRYLATES/VINYL NEODECANOATE CROSSPOLYMER 1 12J - Other Skin Care Preps

ALLYL METHACRYLATES CROSSPOLYMER 3 03C - Eye ShadowALLYL METHACRYLATES CROSSPOLYMER 1 03F - MascaraALLYL METHACRYLATES CROSSPOLYMER 1 04E - Other Fragrance PreparationALLYL METHACRYLATES CROSSPOLYMER 1 07A - Blushers (all types)ALLYL METHACRYLATES CROSSPOLYMER 2 07B - Face PowdersALLYL METHACRYLATES CROSSPOLYMER 16 07E - LipstickALLYL METHACRYLATES CROSSPOLYMER 1 07F - Makeup BasesALLYL METHACRYLATES CROSSPOLYMER 1 07I - Other Makeup PreparationsALLYL METHACRYLATES CROSSPOLYMER 2 12A - CleansingALLYL METHACRYLATES CROSSPOLYMER 5 12C - Face and Neck (exc shave)ALLYL METHACRYLATES CROSSPOLYMER 4 12F - MoisturizingALLYL METHACRYLATES CROSSPOLYMER 1 12G - NightALLYL METHACRYLATES CROSSPOLYMER 2 12H - Paste Masks (mud packs)ALLYL METHACRYLATES CROSSPOLYMER 7 12J - Other Skin Care PrepsALLYL METHACRYLATES CROSSPOLYMER 1 13B - Indoor Tanning Preparations

LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER1 03B - EyelinerLAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER6 03C - Eye ShadowLAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER1 03F - MascaraLAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER1 03G - Other Eye Makeup PreparationsLAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER2 07A - Blushers (all types)LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER8 07B - Face PowdersLAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER20 07C - FoundationsLAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER8 07E - LipstickLAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER3 07I - Other Makeup PreparationsLAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER1 08G - Other Manicuring PreparationsLAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER1 10B - Deodorants (underarm)LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER4 12A - CleansingLAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER1 12C - Face and Neck (exc shave)LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER2 12F - MoisturizingLAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER1 12G - NightLAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER3 12H - Paste Masks (mud packs)

LAURYL METHACRYLATE/SODIUM METHACRYLATE CROSSPOLYMER 1 12F - Moisturizing

SODIUM ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 1 04E - Other Fragrance PreparationSODIUM ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 1 11A - Aftershave LotionSODIUM ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 4 12F - Moisturizing



Personal Care Products CouncilCommitted to Safety,Quality & Innovation

Memorandum

TO: F. Alan Andersen, Ph.D.Director - COSMETIC INGREDIENT REVIEW (CIR)

FROM: John Bailey, Ph.D.Industry Liaison to the CIR Expert Panel

DATE: May3,2011

SUBJECT: Product Information: Acrylates/Vinyl Neodecanoate Crosspolymer (AculynTM 38Polymer) and Acrylates/Steareth-20 Methacrylate Crosspolymer (AculynTM 88 Polymer)

The Dow Chemical Company. 2011. AculynTM 38 Polymer (Acrylates/Vinyl NeodecanoateCrosspolymer) Global Cosmetic Dossier.

The Dow Chemical Company. 2011. AculynTM 88 Polymer (Acrylates/Steareth-20 MethacrylateCrosspolymer) Global Cosmetic Dossier.

11011 7th Street, N.W, Suite 3OO Washington, D.C. 20036-4702 202.331.1770 202.331.1969 (fax) www.personalcarecouncil.org



ACULYNTM 88 Polymer

: Global Cosmetic Dossier

Version: 10

Date: 2 May2011

The Dow Chemical CompanySpring House Technical Center727 Norristown RdP0 Box 904Spring House, PA 19477

® TM of The Dow Chemical Company (“Dow’) or an affiliated company of Dow

This information in this document is considered accurate and reliable as of the date appearing above and is presented ingood faith. Because use conditions and applicable laws may differ from one location to another and may change withtime, Recipient is responsible for determining whether the information in this document is appropriate for recipient’s use.Since Dow has no control over how this information may be ultimately used, all liability is expressly disclaimed and Dowassumes no obligation or liability therefore. No warranty, express or implied, is given nor is freedom from any patentowned by Dow or others to be inferred.

Page 1 ofl2



ACULYNTM 88 Polymer Global Regulatory Dossier

Table of Contents

Contents

IDENTIFICATION 3

COMPOSITION 3

REGULATORY STATUS 4Global Inventory Status 4Cosmetic Approvals 5REACH Statement 5

CERTIFICATIONS 6Raw Material Origin Certification 6Kosher/Ha/al Certification 6Allergens Certification 6CA Prop6S Certification 6Residual Solvent Statement 6Fragrance Materials Certification 7Endocrine Disruptor Certification 7CMR Certification 7Impurities Statement 7Clean Water Act Toxic Pollutant List Certification 7Clean AirAct Certification 7Irradiation Certification 7RoHS Directive 2002/95/EC Certification 8ShelfLife Certification 8Manufacturing Location Certification 8

SPECIFICATIONS 9Certificate ofAnalysis (COA) Specifications 9Microbiological Specifications on the COA 9

ANALYTICAL 10Residual Monomer 10Heavy Metals 10By-Products and Impurities 10

TOXICOLOGY 11Overall evaluation 11Acute Toxicity Profile 11Sensitization Toxicityprofile 11Genetic Toxicity Profile 11Human Toxicity Profile 11Animal Testing Statement 11Environmental Fate Profile 12Biodegradation 12

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IDENTIFICATION

Trade Name: ACULYNTM 88 Polymer

INCI Name: Acrylates/Steareth-20 Methacrylate Crosspolymer

CAS Registry Number: 220431-82-3

Physical Form: Liquid

Function: Hair Fixative

COMPOSITION

The composition shown below is representative of what is listed in Section 2 of the US MSDS.The minimum and maximum values presented in this table do not necessarily represent productspecifications. Please see the “Specifications” section for the actual product specifications.

Acrylates/Steareth-20MethacrylateCrosspolymerResidual monomers

KeyIngredient

220431-82-3 28.0

CONSTITUENT CAS# Mm. Max. Function * Feedstock

__________________

% Origin30.0

Water 7732-18-5

Synthetic

Sodium Benzoate 532-32-1 I 0.195 Preservative Synthetic

<100.0 ppm Carryover Synthetic70.0 72.0 Solvent Municipal

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REGULATORY STATUS

Global Inventory Status

Country Inventory I Registration StatusAustralian Inventory of Chemical Substances

Delayed3Australia(AICS)

Canada Domestic Substances List (DSL) Complies1China Chemical Inventory Complies by PolymerChina

Exemption6European European Inventory of Existing Chemical

Exempt2Union Substances (EINECS)

JapanMinistry of International Trade and Industry

Exempt2(MITI)Korea Korean Existing Chemical Substances (KECL) Delayed3

PhilippinesPhilippines Inventory of Chemicals and

Complies1Chemical Substances (PICCS)United States Toxic Substances Control Act Inventory (TSCA) Exempt2

1 Complies — All components of the product comply with the respective inventory.

2 Exempt - In Europe, the polymer in this product meets the definition of a polymer and is exempt from listingon the EINECS inventory. All other components of this product comply. In the United States, this product isexempt from TSCA if used only in cosmetic applications. In Japan, this product is allowed in cosmeticapplications only.

Delayed - Rohm and Haas Company, A Wholly Owned Subsidiary of The Dow Chemical Company, hassubmitted a notification on an intentional component in this product and has received permission to import ormanufacture in the applicable country. However, this intentional component will not be added to thecountry’s inventory until some time in the future.

Does Not Comply — One or more components of the product do not comply with the respective inventory.Restrictions on volume limits may apply.

We have reviewed the composition of product and conclude that none of the components, as described onour Material Safety Data Sheet (MSDS), are subject to any reporting requirements associated with rules ororders under Sections 4, 5, 6, 7, and 12b of TSCA.

6 Complies by Polymer Exemption — The polymer component complies by valid polymer exemption. All othercomponents of the product comply with the respective inventory.

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Cosmetic Approva/s

European UnionComplies with Council Directive 76/768/EEC and its 7th Amendment.

JapanPermitted for use in cosmetic applications.

United StatesAllowed for use in cosmetic applications. ACULYNTM 88 Polymer has been reviewed bythe Cosmetic Ingredient Review Panel in the broad context of acrylate copolymers. Anassessment of these Acrylates copolymers was published in a CIR Panel report onDecember 21,1999.

KoreaPermitted for use in general cosmetic applications

AustraliaPermitted for use in general cosmetic applications

REACH Statement

We are committed to meeting our legal obligations under REACH as a manufacturer! importer /downstream user. We have pre-registered the substances in ACULYNTM 88 Polymer as requiredunder REACH. We currently intend to register these substances by the required registrationdeadline based on the import volume of our importing EU legal entity.

The polymer in ACULYNTM 88 Polymer is exempt from the registration obligations under REACHas long as the monomers comprising the polymer at >2% by weight are registered. We have preregistered and currently intend to register the required monomers that we import into the EU inthe polymer component of ACULYNTM 88 Polymer. We have also confirmed that our upstreammonomer suppliers have pre-registered and currently intend to register the monomers comprisingthe personal care polymers that we manufacture in the EU. We do not anticipate an interruption insupply due to REACH.

ACULYNTM 88 Polymer does not contain any of the substances currently on the Substances ofVery High Concern (SVHC) list at 0.1% (as defined in EU Regulation 1907/2006 and listed onthe first candidate list published on October 28 2008 by the European Chemical Agency). We donot anticipate any components of this product to be added to the candidate list for authorization.

Based on the criteria defined in EU Regulation 1907/2006 (Annex XIII), ACULYNTM 88 Polymerdoes not contain any persistent, bioaccumulative and toxic substances (PBT), any verypersistent, very bioaccumulative and very toxic substances (vPBT)..

Please note, that the obligation to pre-register and register under REACH belongs to the entitywhich manufacturers or imports a substance into the EU at >1 MT per year. Therefore, pleaseconsider whether you have any REACH obligation if you import substances into the EU. We referyou to http//echa.europa.eu to help you determine the relevant registration obligations for yourproducts.

We also encourage you to visit our REACH website www.reachdow.com where you will be ableto find and download the most recent REACH related documents on our products.

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CERTIFICATIONS

Raw Material Origin Certification

With regards to Bovine Spongiform Encephalopathy (BSE) and Transmissible SpongiformEncephalopathy (TSE), we do not intentionally add, nor would we expect any component ofACULYNTM 88 Polymer to be derived from bovine, ovine, caprine, porcine or related ingredientsof animal origin. This product is derived from materials of synthetic, petrochemical and/or mineralorigins. The manufacturing equipment for the product is not used for the manufacture of productsof animal origin or products containing ingredients of animal origin. This product is not stored withproducts of animal origin or products containing ingredients of animal origin. To the best of ourknowledge, none of the raw materials used to produce ACULYNTM 88 Polymer are derived fromgenetically modified organism sources.

Kosher/Ha/al Certification

With regards to Halal and Kosher status, ACULYNTM 88 Polymer is free of wheat, oat, barley orrye derivatives. Although this product has not been officially certified by a Rabbinical or Islamiccouncil, we believe this product is judged to be “pareve” within the framework of the Jewishdefinition and permitted under Muslim standards. We are disclosing above information, to thebest of knowledge based upon data from our raw material suppliers and our manufacturingprocess. Please note that we do not test any of the raw materials used in the product for thepresence of the above mentioned substances.

Allergens Certification

ACULYNTM 88 Polymer does not contain any of the eight major food allergens (milk, eggs, fish,shellfish, tree nuts, peanuts, wheat and/or soybeans) or proteins as listed in the FALCPA of 2004and in FDA Guidance Sec.550.250 and does not contact these food allergen during themanufacturing process. ACULYNTM 88 Polymer does not contain any of the 26 allergeningredients as defined in the 7th Amendment of the European Cosmetics Directive (2003/1 5/EC).ACULYNTM 88 Polymer is gluten-free.

CA Prop65 Certification

To the best of our knowledge, ACULYNTM 88 Polymer does not contain any contaminants or byproducts known to the State of California to cause cancer or reproductive toxicity as listed underthe Proposition 65 State Drinking Water and Toxic Enforcement Act, with the possible exceptionof residual ethyl acrylate which may be present at a level up to a maximum of 1.0 ppm.

Residual So/vent Statement

None of the Class 1, Class 2, and Class 3 Residual Solvents specified in USP General Chapter<467> effective on 1 JUL 2008 are used in the manufacture of ACULYNTM 88 Polymer. Anyavailable analyses of organic volatile impurities are listed in the ANALYTICAL section of thisdocument.

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Fragrance 4/later/a/s CertificationACULYNTM 88 Polymer does not contain any fragrance materials.

Endocrine Disruptor Certification

To the best of our knowledge, ACULYNTM 88 Polymer does not contain any potential endocrinedisruptors.

CMI? Certification

No substances classified as Carcinogenic, Mutagenic or toxic for Reproduction, of category 12,and 3 under Annex Ito Directive 67/548/EEC are intentionally used in the manufacture ofACULYNTM 88 Polymer.

Impurities Statement

To the best of our knowledge, ACULYNTM 88 Polymer does not contain dioxin, glycol ethers,asbestos, organotin compounds, phthalates, azo dyes, acrylamide, nonyl phenol ethoxylates, oralkyl phenol ethoxylates. These substances are not intentionally added and are not expected tobe generated during the manufacturing process. We do not expect these substances to bepresent in the raw materials used to produce ACULYNTM 88 Polymer.

Clean WaterAct Toxic Pollutant List Certification

To the best of our knowledge, ACULYNTM 88 Polymer does not contain any components thatare listed on the Clean Water Act Toxic Pollutant List in 40 CFR 401.15.

Clean Air Act Certification

To the best of our knowledge, with regards to the Clean Air Act, Section 112(b), ACULYNTM 88Polymer does not contain any Hazardous Air Pollutants (HAP5) at or above 0.1%.

To the best of our knowledge, ACULYNTM 88 Polymer does not contain any components that arelisted on the Clean Air Act Sec. 602 Class I and II Ozone Depleting Substances List (40 CFR 82).

Irradiation CertificationACULYNTM 88 Polymer does not contain materials that have been irradiated nor are the polymersthemselves irradiated at any stage in the manufacturing process.

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RoHS Directive 2002/95/EC Certification

Directive 20021951EC on the restriction of the use of certain hazardous substances in electricaland electronic equipment requires that electrical and electronic equipment placed on the EUmarket does not contain lead, mercury, cadmium, hexavalent chromium, polybrominatedbiphenyl, polybrominated biphenyl ether.

Although ACULYNTM 88 Polymer does not fall in the scope of this directive, it can be used as araw material in the manufacture of some components of electrical and electronic equipment.

We hereby confirm that in the manufacture of ACULYNTM 88 Polymer, we do not intentionally usepolybrominated biphenyl or polybrominated biphenyl ether. Based upon data from our rawmaterial suppliers and knowledge of the manufacturing process, we have no reason to believethat these substances are present.

Heavy metals analyses of ACULYNTM 88 Polymer by Inductively Coupled Plasma MassSpectroscopy (ICPIMS) showed that lead, mercury, and cadmium are not present with a Limit ofDetection of less than 1 part per billion (ppb). Hexavalent chromium was not analyzed, but it isnot expected to be found at greater than trace levels.

She/fLife Certification

The shelf life for ACULYNTM 88 Polymer is 600 days (20 months) from the date of manufactureprovided on the Certificate of Analysis (COA) for each batch lot.

Manufacturing Location CertificationACULYNTM 88 Polymer is manufactured by an emulsion polymerization process for the NorthAmerican, European, Latin American, and Asian markets by Dow at 3100 State Rd, Croydon, PAUSA 19021.

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SPECIFICATIONS

Certificate ofAnalysis (COA) Specifications

Appearance, as-is Milk-white fluid, free of visible impurities

Solids content, % by wt. 28.00 — 30.00

(Dry 0.6 gram at 150CC for20 minutes in a forced draft oven.)

pH

Viscosity, as is, cps(Brookfield L V, spindle #2, 30rpm, 25CC)

Viscosity, solubilized, cps

Residual Ethyl Acrylate, ppm

Turbidity, solubilized, NTU

FTIR Identity

Method ResultsAerobic Plate Count < 100 CFU/g LAbsence of Candida albicans in 1 gAbsence of Gram Negative BacteriaAbsence of Staphylococcus aureus in I g

3.30 —4.30

50, maximum

1800-5000

1.0, maximum

35, maximum

Conforms to reference

Microbiological Specifications on the COA

PassPassPassPass

Page 9 of 12 5/2/2011




ANALYTICAL

Residual Monomer

I[.]b]q—I e].i1iiI.1il

I Ethyl acrylate I 140-88-5 I 1 ppm I specification

Heavy Metals

Metals were determined by Inductively Coupled Plasma Mass Spectroscopy (ICPIMS). All valuesare in parts per billion.

— L_=-. — .x—I—A- in — ii i.fl i — atttLJ. 4Antimony No detect 50.0Arsenic No detect 50.0Barium No detect 50.0

Beryllium No detect 50.0Cadmium No detect 50.0Chromium No detect 50.0

Cobalt No detect 50.0Copper No detect 50.0

Iron 1028 50.0Lead No detect 50.0

Magnesium No detect 50.0Manganese No detect 50.0Molybdenum No detect 50.0

Mercury No detect 50.0Nickel No detect 50.0

Selenium No detect 50.0Silver No detect 50.0

Thallium No detect 50.0Vanadium No detect 50.0Zirconium No detect 50.0

Zinc 82 50.0

By-Products and Impurities

Impurity CAS-No. Results (ppm) Limit of Detection(ppm)

I 1.4-Dioxane I 123-91-1 No Detect 0.5

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TOXICOLOGY

Overall evaluation

The acrylic co-polymer in ACULYNTM 88 Polymer was tested in number of non-clinical and clinicaltests to evaluate potential hazards associated with handling and use of the material. Some testswere conducted with a material that varied slightly in monomer composition and percent solidshowever; there are no marked differences in these materials.

Acute Toxicity Profile

Oral LD5O—ratDermal LD5O — rabbitEye irritation — rabbitSkin irritation — rabbit

>5 g/kg — non toxic>5 g/kg — non toxicNon irritatingNon irritating

YesYesYesYes

Sensitization Toxicity profile

Sensitization data for a compositionally similar acrylic co-polymer are below:

I Sensitization, Guinea pig Non sensitizer I Yes

Genetic Toxicity Profile

ft1k[. :1T1l*.

I Ames Test Non mutagenic with and without metabolic activation I Yes

Human Toxicity Profile

Test/Species Results GCP21-day cumulative irritation Non sensitizing and non-irritating YesHRIPT Non sensitizing and non-irritating I YesHRIPT: human repeated insult patch test

Animal Testing Statement

To the best of our knowledge, ACULYNTM 88 Polymer has not been tested in animals.

Acute toxicity data for a comDositionallv similar

______—

4JI[eI.VJ

Test/Species Results GLPiier are below:

Page 11 of 12 5/2/2011




Environmental Fate Profile

Environmental fate data for a compositionally similar acrylic co-polymer are below:

Test/Species Results GLPDaphnia magna EC5O —48 hrNOEC—48 hr

>1000 mgIL — non toxic *

1000 malLRainbow Trout LC5O —96 hr >1000 rng/L — non toxic * YesNOEC — 96 hr 1000 mg/LBluegill Sunfish LC5O —96 hr >1000 mg/L — non toxic * YesNOEC — 96 hr 1000 mg/L

* US EPA TSCA Criteria

Biodegradation

Acrylic polymers are generally stable materials and can almost be considered inert’ in theenvironment. These materials do not readily decompose or biodegrade in the environment. Whilethese polymers are non-biodegradable, they are bioeliminable. In other words, they are removedfrom environmental compartments where they could be available to aquatic organisms. Theremoval process is via rapid sorption to sediment, suspended solids and organic matter. Thisprocess makes the polymers less bioavailable thereby reducing toxicity further. Typically themolecular weight of these emulsion polymers is such that it precludes uptake by aquaticorganisms and thus bioaccumulation is highly unlikely. The emulsion polymers are also generallynon-toxic to activated sludge waste water systems and are considered bioeliminable in wastewater treatment plants (via sorption to biosolids).

David J. RandazzoProduct StewardHome and Personal CareThe Dow Chemical CompanyTel: 215-641-7265Fax: 215-619-1654E-mail: [email protected]

For additional information please contact:Dow Customer Information Group800-447-4369 - Toll free989-832-1542 - Toll [email protected] - Email

2 May 2011

Page 12 of 12 5/2/2011

es



ACULYNTM 38 Polymer

Global Cosmetic Dossier

Version: 5

Date: 2 May2011

Dow

The Dow Chemical CompanySpring House Technical Center727 Norristown RdP0 Box 904Spring House, PA 19477

Trademark of The Dow Chemical Company (‘Dow) or an affiliated company of Dow

This information in this document is considered accurate and reliable as of the date appearing above and is presented ingood faith. Because use conditions and applicable laws may differ from one location to another and may change withtime, Recipient is responsible for determining whether the information in this document is appropriate for recipients use.Since Dow has no control over how this information may be ultimately used, all liability is expressly disclaimed and Dowassumes no obligation or liability therefore. No warranty, express or implied, is given nor is freedom from any patentowned by Dow or others to be inferred.

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Table of Contents

ContentsIDENTIFICATION 3

COMPOSITION 3

REGULATORY STATUS 4Global Inventory Status 4Cosmetic Approvals 5REACH Statement 5

CERTIFICATIONS 6Raw Material Origin Certification 6Kosher/Halal Certification 6Allergens Certification 6CA Prop65 Certification 6Residual Solvent Statement 6Fragrance Materials Certification 7Endocrine Disruptor Certification 7CMR Certification 7Impurities Statement 7Clean Water Act Toxic Pollutant List Certification 7Clean Air Act Certification 7Irradiation Certification 7RoHS Directive 2002/95/EC Certification 8SheffLife Certification 8Manufacturing Location Certification 8

SPECIFICATIONS 9Certificate ofAnalysis (COA) Specifications 9Microbiological Specifications on the COA 9

ANALYTICAL 10Residual Monomer 10Heavy Metals 10By-Products and Impurities 10

TOXICOLOGY 11Overall evaluation 11Acute Toxicity Profile I IGenetic Toxicity Profile IIHuman Toxicity Profile 11Animal Testing Statement 11Environmental Fate Profile 12Biodegradation 12

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IDENTIFICATION

Trade Name: ACULYNTM 38 Polymer

INCI Name: Acrylates/Vinyl Neodecanoate Crosspolymer

CAS Registry Number: 905594-44-7

Physical Form: Liquid

Function: Rheology Modifier

COMPOSITIONThe composition shown below is representative of what is listed in Section 2 of the US MSDS.The minimum and maximum values presented in this table do not necessarily represent productspecifications. Please see the ‘Specifications” section for the actual product specifications.

Acry inylNeodecanoateCrosspolymerResidual monomersWater

2.D 3u.u Icey SyntheticIngredient

<0.1 Carryover Synthetic. 7732-18-5 70.0 72.0 Solvent Municipal

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ACULYNTM 38 Polymer Global Regulatory DossIer

REGULATORY STATUS

Global Inventory Status

I.f111TTiv IIn’L]nTi’lIj!TUU[’].Australian Inventory of Chemical Substances

Complies1Australia(AICS)

Canada Domestic Substances List (DSL) Complies1China Chemical Inventory Complies by PolymerChina

Exemption6European European Inventory of Existing Chemical

Exempt2Union Substances (EINECS)

JapanMinistry of International Trade and Industry

Exempt2(MITI)Korea Korean Existing Chemical Substances (KECL) Complies1

Philippines Inventory of Chemicals andComplies1Philippines

Chemical Substances (PICCS)United States Toxic Substances Control Act Inventory (TSCA) Exempt2

1 Complies — All components of the product comply with the respective inventory.

2 Exempt - In Europe, the polymer in this product meets the definition of a polymer and is exempt from listingon the EINECS inventory. All other components of this product comply. In the United States, this product isexempt from TSCA if used only in cosmetic applications. In Japan, this product is allowed in cosmeticapplications only.

Delayed - Rohm and Haas Company, A Wholly Owned Subsidiary of The Dow Chemical Company, hassubmitted a notification on an intentional component in this product and has received permission to import ormanufacture in the applicable country. However, this intentional component will not be added to thecountry’s inventory until some time in the future.

Does Not Comply — One or more components of the product do not comply with the respective inventory.Restrictions on volume limits may apply.

We have reviewed the composition of product and conclude that none of the components, as described onour Material Safety Data Sheet (MSDS), are subject to any reporting requirements associated with rules ororders under Sections 4, 5, 6, 7, and 12b of TSCA.

6 Complies by Polymer Exemption — The polymer component complies by valid polymer exemption. All othercomponents of the product comply with the respective inventory.

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Cosmetic Approva/s

European UnionComplies with Council Directive 76/768/EEC and its 7th Amendment.

JapanPermitted for use in cosmetic applications.

United StatesAllowed for use in cosmetic applications. ACULYNTM 38 Polymer has been reviewed bythe Cosmetic Ingredient Review Panel in the broad context of acrylate copolymers. Anassessment of these Acrylates copolymers was published in a CIR Panel report onDecember 21,1999.

KoreaPermitted for use in general cosmetic applications

AustraliaPermitted for use in general cosmetic applications

REACH Statement

We are committed to meeting our legal obligations under REACH as a manufacturer / importer /downstream user. We have pre-registered the substances in ACULYNTM 38 Polymer as requiredunder REACH. We currently intend to register these substances by the required registrationdeadline based on the import volume of our importing EU legal entity.

The polymer in ACULYNTM 38 Polymer is exempt from the registration obligations under REACHas long as the monomers comprising the polymer at >2% by weight are registered. We have preregistered and currently intend to register the required monomers that we import into the EU inthe polymer component of ACULYNTM 38 Polymer. We have also confirmed that our upstreammonomer suppliers have pre-registered and currently intend to register the monomers comprisingthe personal care polymers that we manufacture in the EU. We do not anticipate an interruption insupply due to REACH.

ACULYNTM 38 Polymer does not contain any of the substances currently on the Substances ofVery High Concern (SVHC) list at 0.1% (as defined in EU Regulation 1907/2006 and listed onthe first candidate list published on October 28 2008 by the European Chemical Agency). We donot anticipate any components of this product to be added to the candidate list for authorization.

Based on the criteria defined in EU Regulation 1907/2006 (Annex XIII), ACULYNTM 38 Polymerdoes not contain any persistent, bioaccumulative and toxic substances (PBT), any verypersistent, very bioaccumulative and very toxic substances (vPBT)..

Please note, that the obligation to pre-register and register under REACH belongs to the entitywhich manufacturers or imports a substance into the EU at >1MT per year. Therefore, pleaseconsider whether you have any REACH obligation if you import substances into the EU. We referyou to http://echa.europa.eu to help you determine the relevant registration obligations for yourproducts.

We also encourage you to visit our REACH website www.reach.dow.com where you will be ableto find and download the most recent REACH related documents on our products.

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CERTIFICATIONS

Raw Material Origin Certification

With regards to Bovine Spongiform Encephalopathy (BSE) and Transmissible SpongiformEncephalopathy (TSE), we do not intentionally add, nor would we expect any component ofACULYNTM 38 Polymer to be derived from bovine, ovine, caprine, porcine or related ingredientsof animal origin. This product is derived from materials of synthetic, petrochemical and/or mineralorigins. The manufacturing equipment for the product is not used for the manufacture of productsof animal origin or products containing ingredients of animal origin. This product is not stored withproducts of animal origin or products containing ingredients of animal origin. To the best of ourknowledge, none of the raw materials used to produce ACULYNTM 38 Polymer are derived fromgenetically modified organism sources.

Kosher/Ha/al Certification

With regards to Halal and Kosher status, ACULYNTM 38 Polymer is free of wheat, oat, barley orrye derivatives. Although this product has not been officially certified by a Rabbinical or Islamiccouncil, we believe this product is judged to be “pareve” within the framework of the Jewishdefinition and permitted under Muslim standards. We are disclosing above information, to thebest of knowledge based upon data from our raw material suppLiers and our manufacturingprocess. Please note that we do not test any of the raw materials used in the product for thepresence of the above mentioned substances.

Allergens Certification

ACULYNTM 38 Polymer does not contain any of the eight major food allergens (milk, eggs, fish,shellfish, tree nuts, peanuts, wheat and/or soybeans) or proteins as listed in the FALCPA of 2004and in FDA Guidance Sec.550.250 and does not contact these food allergen during themanufacturing process. ACULYNTM 38 Polymer does not contain any of the 26 allergeningredients as defined in the 7th Amendment of the European Cosmetics Directive (2003/15/EC).ACULYNTM 38 Polymer is gluten-free.

CA Prop65 Certification

To the best of our knowledge, ACULYNTM 38 Polymer does not contain any contaminants or byproducts known to the State of California to cause cancer or reproductive toxicity as listed underthe Proposition 65 State Drinking Water and Toxic Enforcement Act, with the possible exceptionof residual ethyl acrylate which may be present at a level up to a maximum of 1.0 ppm.

Residual Solvent Statement

None of the Class 1, Class 2, and Class 3 Residual Solvents specified in USP General Chapter<467> effective on 1 JUL 2008 are used in the manufacture of ACULYNTM 38 Polymer. Anyavailable analyses of organic volatile impurities are listed in the ANALYTICAL section of thisdocument.

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Fragrance Materials CertificationACULYNTM 38 Polymer does not contain any fragrance materials.

Endocrine Disruptor Certification

To the best of our knowledge, ACULYNTM 38 Polymer does not contain any potential endocrinedisruptors.

CMR Certification

No substances classified as Carcinogenic, Mutagenic or toxic for Reproduction, of category 1,2,and 3 under Annex Ito Directive 67/548/EEC are intentionally used in the manufacture ofACULYNTM 38 Polymer.

Impurities Statement

To the best of our knowledge, ACULYNTM 38 Polymer does not contain dioxin, glycol ethers,asbestos, organotin compounds, phthalates, azo dyes, acrylamide, nonyl phenol ethoxylates, oralkyl phenol ethoxylates. These substances are not intentionally added and are not expected tobe generated during the manufacturing process. We do not expect these substances to bepresent in the raw materials used to produce ACULYNTM 38 Polymer.

Clean WaterAct Toxic Pollutant List Certification

To the best of our knowledge, ACULYNTM 38 Polymer does not contain any components thatare listed on the Clean Water Act Toxic Pollutant List in 40 CFR 401.15.

Clean Air Act Certification

To the best of our knowledge, with regards to the Clean Air Act, Section 112(b), ACULYNTM 38Polymer does not contain any Hazardous Air Pollutants (HAP5) at or above 0.1%.

To the best of our knowledge, ACULYNTM 38 Polymer does not contain any components that arelisted on the Clean Air Act Sec. 602 Class I and II Ozone Depleting Substances List (40 CFR 82).

Irradiation CertificationACULYNTM 38 Polymer does not contain materials that have been irradiated nor are the polymersthemselves irradiated at any stage in the manufacturing process.

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RoHS Directive 2002/95/EC Certification

Directive 2002/95/EC on the restriction of the use of certain hazardous substances in electricaland electronic equipment requires that electrical and electronic equipment placed on the EUmarket does not contain lead, mercury, cadmium, hexavalent chromium, polybrominatedbiphenyl, polybrominated biphenyl ether.

Although ACULYNTM 38 Polymer does not fall in the scope of this directive, it can be used as araw material in the manufacture of some components of electrical and electronic equipment.

We hereby confirm that in the manufacture of ACULYNTM 38 Polymer, we do not intentionally usepolybrominated biphenyl or polybrominated biphenyl ether. Based upon data from our rawmaterial suppliers and knowledge of the manufacturing process, we have no reason to believethat these substances are present.

Heavy metals analyses of ACULYNTM 38 Polymer by Inductively Coupled Plasma MassSpectroscopy (ICP/MS) showed that lead, mercury, and cadmium are not present with a Limit ofDetection of less than 1 part per billion (ppb). Hexavalent chromium was not analyzed, but it isnot expected to be found at greater than trace levels.

She/fLife Certification

The shelf life for ACULYNTM 38 Polymer is 600 days (20 months) from the date of manufactureprovided on the Certificate of Analysis (COA) for each batch lot.

Manufacturing Location CertificationACULYNTM 38 Polymer is manufactured by an emulsion polymerization process for the NorthAmerican, European, Latin American, and Asian markets by Dow at 3100 State Rd, Croydon, PAUSA 19021.

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SPECIFICATIONS

Certificate ofAnalysis (COA) Specifications

Appearance, as-is Milk-white fluid, free of visible impurities

Solids content, % by wt. 28.00 - 30.00

(Dry 0.6 gram at 150”C for20 minutes in a forced draft oven.)

pH 2.10—3.20

Viscosity, as is, cps 150, maximum(Brookfield L V, spindle #1, 60 rpm, 25CC)

Viscosity, neutralized, cps 2000 - 6000

Gel particles on 150 micron screen, ppm 50, maximum

Gel particles on 45 micron screen

after passing through 150 micron screen, ppm 50, maximum

Residual Ethyl Acrylate, ppm 1.0, maximum

FTIR Identity Conforms to reference

Microbiological Specifications on the COA

Method ResultsAerobic Plate Count < 100 CFU/g PassAbsence of Candida albicans in 1 g PassAbsence of Gram Negative Bacteria PassAbsence of Staphylococcus aureus in 1 g Pass

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ANALYTICAL

Residual Monomer

• [‘ pK.] .iJ.1 [. ‘] it’l I1WN[.]. ‘]

Ethyl acrylate 140-88-5 1 ppm I specification

Heavy Metals

Metals were determined by Inductively Coupled Plasma Emission Spectroscopy.

Metal CAS-No. Results (ppm) Limit of Detection(ppm)

Arsenic 7440-3-2 No detect U.1Cadmium 7440-43-9 No detect 0.1Cobalt 7440-48-4 No detect 0.1Chromium 7440-47-3 No detect 0.1Copper 7440-50-8 0.2 0.1Iron 7439-89-6 0.5 0.1Mercury 7439-97-6 No detect 0.1Nickel 7440-02-0 No detect 0.1Lead 7439-92-1 No detect 0.1Zinc 7440-66-6 1.2 0.1

By-Products and Impurities

Impurity CAS-No. Results (ppm) Limit of Detection(ppm)

I 1 4-Dioxane I 123-91-1 I No Detect 0.5

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TOXICOLOGY

Overall evaluation

The acrylic co-polymer in ACULYNTM 38 Polymer was tested in number of non-clinical and clinicaltests to evaluate potential hazards associated with handling and use of the material. Some testswere conducted with a material that varied slightly in monomer composition and percent solidshowever; there are no marked differences in these materials.

Acute Toxicity Profile

Acute toxicity data for a compositionally similar acrylic co-polymer are below:

Ir IT1IOral LD5O, rat > 5.0 g/kg non-toxic NoDermal LD5O, > 5.0 g/kg non-toxic NorabbitEye irritation, Non irritating (EEC, US) NorabbitSkin irritation, Non irritating (EEC, US) YesrabbitInhalation LC5O — >16.34 mg/L air, lh Norat

Genetic Toxicity Profile

It 1k ;1l* CIII Ames Test Non mutagenic with and without metabolic activation Yes

Human Toxicity Profile

Test Results GCPHuman Repeated Insult Non-sensitizing and non-irritating YesPatch Test (HRIPT)21-day Cumulative At most a mild irritant with unformulated YesIrritation polymer under worse case conditions

Animal Testing Statement

To the best of our knowledge, ACULYNTM 38 Polymer has not been tested in animals.

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Environmental Fate Profile

Environmental fate data for a compositionally similar acrylic co-polymer are below:

Test Results GLPDaphnia magna LC5O —48 hr 1000 mgIL, low concern * YesDaphnia magna NOEC —48 hr 600 mg/LFathead minnow LC5O —96 hr 1000 mg/L, low concern * YesFathead minnow NOEC — 96 hr 600 mgIL

Biodegradation

Acrylic polymers are generally stable materials and can almost be considered ‘inert’ in theenvironment. These materials do not readily decompose or biodegrade in the environment. Whilethese polymers are non-biodegradable, they are bioeliminable. In other words, they are removedfrom environmental compartments where they could be available to aquatic organisms. Theremoval process is via rapid sorption to sediment, suspended solids and organic matter. Thisprocess makes the polymers less bioavailable thereby reducing toxicity further. Typically themolecular weight of these emulsion polymers is such that it precludes uptake by aquaticorganisms and thus bioaccumulation is highly unlikely. The emulsion polymers are also generallynon-toxic to activated sludge waste water systems and are considered bioeliminable in wastewater treatment plants (via sorption to biosolids).

David J. RandazzoProduct StewardHome and Personal CareThe Dow Chemical CompanyTel: 215-641-7265Fax: 215-619-1654E-mail: [email protected]

For additional information please contact:Dow Customer Information Group800-447-4369 - Toll free989-832-1542 - Toll [email protected] - Email

2 May 2011

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Persona Care ‘Products CounciCommitted to Safety,Quality & Innovation

TO:

FROM:

DATE:

Memorandum

F. Alan Andersen, Ph.D.Director - COSMETIC INGREDIENT REVIEW (CIR)

dR Science and Support Committee of the Personal Care Products Council

May 4, 2011

SUBJECT: Further Information: Benzene Impurity in Acrylates/C10-30 Alkyl AcrylatesCrosspolymer

Although the supplier indicates that the trade name material (Carbopol 1342 polymer) under the INCIname Acrylates/C10-30 Alkyl Acrylates Crosspolymer has a maximum benzene content of 0.5% (5000ppm), analysis of each lot indicates the actual benzene levels are well under the 0.5% limit. Analysisfor benzene in the last 40 lots of Carbopol 1342 indicated:

Average: 2464 ppmStandard Deviation: 939Range:

The supplier indicates that the typical usage rate of Carbopol 1342 polymer in cosmetic products is0.3%, with all uses they are aware of at less than 1%.

Formulators that sell products in California must also comply with California’s Proposition 65 whichlimits benzene exposure from a product to 6.4 microg/day for oral exposure and 13 microg/day forinhalation exposure. If use of a product results in exposure to benzene greater than the limits,Proposition 65 requires the products to include warning labels.

11011 7th Street, N.W., Suite 300 Washington, D.C. 20036-4702 202.331.1770 202.331.1969 (fax) www.personalcarecouncil.org

445 - 4059 ppm (3 of the 40 lots were <1000 ppm)



Personal Care Products CounciCommitted to Safety,

ua ty nnovation

Memorandum

TO: F. Alan Andersen, Ph.D.Director - COSMETIC INGREDIENT REVIEW (Cifi)

FROM: John Bailey, Ph.D.Industry Liaison to the CW Expert Panel

DATE: May9,2011

SUBJECT: Acrylates/C1O-30 Alkyl Acrylate Crosspolymer: Potential Contamination with Benzene

Presperse LLC wanted to be certain that the CIR Expert Panel knows that not all AcrylateslClO-30Alkyl Acrylate Crosspolymer is polymerized in benzene. The AcrylateslClo-30 Alkyl AcrylateCrosspolymer Presperse LLC supplies is polymerized in n-hexane. The maximum residual solvent inthe polymer they supply is 0.2% n-hexane.

11011 7th Street, N.W, Suite 300 Washington, D.C. 20036-4702 202.331.1770 202.331.1969 (fax) www.personalcarecouncil.org



Substance: Benzene

(*) Not in the annexes of the Directive/Regulation as published in the Official Journal of the European Union

Substance Benzene

CAS # 71-43-2

EINECS/ELINCS # 200-753-7

INN/ISO/AN

Cosmetic Directive 76/768/EEC

Application Date: 27/03/1978 (the date fixed by the Directive as from which Member States shall ensure that cosmetic products which fail to comply with the

modifications are not placed on the market)

Withdrawal Date: 27/09/1979 (the date fixed by the Directive as from which Member States shall ensure that cosmetic products which fail to comply with the

modification are not sold or disposed of to the final consumer)

Other Directives/Regulations 552/2009 - as a constituent of other substances, or in mixtures, in concentrations equal to, or greater than 0.1% by weight

Annex/Part,Ref # II/47

SCCS opinions

Chemical/IUPAC Name

Identified INGREDIENTS or

substances e.g.

(*) Anthracene oil, anthracene paste, anthracene fraction, if it contains > 0.1% w/w benzene

(*) Anthracene oil, anthracene paste, carbazole fraction, if it contains > 0.1% w/w benzene

(*) Anthracene oil, anthracene paste, distn. lights, if it contains > 0.1% w/w benzene

(*) Aromatic hydrocarbons, C6-10, acid-treated, neutralized, if it contains > 0.1% w/w benzene

(*) Aromatic hydrocarbons, C6-10, C8-rich, if it contains > 0.1% w/w benzene

(*) Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived, if it contains > 0.1% w/w benzene

(*) Aromatic hydrocarbons, C7-12, C8-rich, if it contains > 0.1% w/w benzene

(*) Aromatic hydrocarbons, C7-8, dealkylation products, distn. residues, if it contains > 0.1% w/w benzene

(*) Aromatic hydrocarbons, C8, catalytic reforming-derived, if it contains > 0.1% w/w benzene

(*) Aromatic hydrocarbons, C8-10, if it contains > 0.1% w/w benzene

(*) Aromatic hydrocarbons, C8-9, hydrocarbon resin polymn. by-product, if it contains > 0.1% w/w benzene

(*) Aromatic hydrocarbons, C9-12, benzene distn., if it contains > 0.1% w/w benzene

(*) Benzol forerunnings (coal), if it contains > 0.1% w/w benzene

(*) Distillates (coal tar), benzole fraction, BTX-rich, if it contains > 0.1% w/w benzene

(*) Distillates (coal tar), benzole fraction, distn. residues, if it contains > 0.1% w/w benzene

(*) Distillates (coal tar), light oils, acid exts., if it contains > 0.1% w/w benzene

(*) Distillates (coal tar), light oils, alk. exts., if it contains > 0.1% w/w benzene

(*) Distillates (coal tar), light oils, if it contains > 0.1% w/w benzene

(*) Distillates (coal tar), light oils, neutral fraction, if it contains > 0.1% w/w benzene

(*) Distillates (coal tar), naphthalene oil crystn. mother liquor, if it contains > 0.1% w/w benzene

(*) Distillates (coal tar), naphthalene oils, acid exts., if it contains > 0.1% w/w benzene

(*) Distillates (coal tar), naphthalene oils, alk. exts., if it contains > 0.1% w/w benzene

(*) Distillates (coal tar), naphthalene oils, if it contains > 0.1% w/w benzene

(*) Distillates (coal tar), naphthalene oils, indole-methylnaphthalene fraction, if it contains > 0.1% w/w benzene

(*) Distillates (coal tar), naphthalene oils, methylnaphthalene fraction, if it contains > 0.1% w/w benzene

(*) Distillates (coal tar), naphthalene oils, naphthalene-free, alk. exts., if it contains > 0.1% w/w benzene

(*) Distillates (coal tar), naphthalene oils, naphthalene-low, if it contains > 0.1% w/w benzene

(*) Distillates (coal), coal tar-residual pyrolysis oils, naphthalene oils, if it contains > 0.1% w/w benzene

(*) Distillates (coal), coke-oven light oil, naphthalene cut, if it contains > 0.1% w/ww benzene

(*) Distillates (coal), liq. solvent extn. primary, if it contains > 0.1% w/w benzene

(*) Distillates (coal), solvent extn. hydrocracked hydrogenated middle, if it contains > 0.1% w/w benzene

(*) Distillates (coal), solvent extn. hydrocracked middle, if it contains > 0.1% w/w benzene

(*) Distillates (coal), solvent extn. hydrocracked, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), alkene-alkyne manuf. pyrolysis oil, mixed with high-temp. coal tar, indene fraction, if it

contains > 0.1% w/w benzene (*) Distillates (petroleum), C3-5, 2-methyl-2-butene-rich, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), C6-rich, if it contains > 0.1 % w/w benzene

(*) Distillates (petroleum), C7-9, C8-rich, hydrodesulfurized dearomatized, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), catalytic reformed depentanizer, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), catalytic reformed hydrotreated light, C8-12 arom. fraction, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), catalytic reformed straight-run naphtha overheads, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), depentanizer overheads, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), heat-soaked steam-cracked naphtha, C5-rich, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), heavy arom., if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), hydrotreated heavy naphtha, deisohexanizer overheads, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), hydrotreated middle, intermediate boiling, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), light arom., if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), light distillate hydrotreating process, low-boiling, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), light straight-run gasoline fractionation stabilizer overheads, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), light thermal cracked, debutanized arom., if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), naphtha steam cracking-derived, hydrotreated light arom., if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), naphtha steam cracking-derived, solvent-refined light hydrotreated, if it contains > 0.1% w/w

benzene (*) Distillates (petroleum), naphtha unifiner stripper, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), naphtha-raffinate pyrolyzate-derived, gasoline-blending, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), polymd. steam-cracked petroleum distillates, C5-12 fraction, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), steam-cracked, C5-10 fraction, mixed with light steam-cracked petroleum naphtha C5 fraction,

Cosmetics - CosIng [Cosmetics Directive (v.1)] 05/05/2011 16:24Distributed for Comment Only -- Do Not Cite or Quote


if it contains > 0.1% w/w benzene (*) Distillates (petroleum), steam-cracked, C5-12 fraction, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), steam-cracked, C8-12 fraction, polymd., distn. lights, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), straight-run light, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), thermal cracked naphtha and gas oil, C5-dimer-contg., if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), thermal cracked naphtha and gas oil, extractive, if it contains > 0.1% w/w benzene

(*) Distillates (petroleum), thermal cracked naphtha and gas oil, if it contains > 0.1% w/w benzene

(*) Extract oils (coal), acidic, tar-base free, if it contains > 0.1% w/w benzene

(*) Extract oils (coal), coal tar residual pyrolysis oils, naphthalene oil, distn. residues, if it contains > 0.1% w/w benzene

(*) Extract oils (coal), coal tar residual pyrolysis oils, naphthalene oils, if it contains > 0.1% w/w benzene

(*) Extract oils (coal), coal tar-residual pyrolysis oils, naphthalene oil, redistillate, if it contains > 0.1% w/w benzene

(*) Extract oils (coal), tar base, collidine fraction, if it contains > 0.1% w/w benzene

(*) Extract oils (coal), tar base, if it contains > 0.1% w/w benzene

(*) Extract residues (coal tar), benzole fraction alk., acid ext., if it contains > 0.1% w/w benzene

(*) Extract residues (coal), benzole fraction alk., acid ext., if it contains > 0.1% w/w benzene

(*) Extract residues (coal), light oil alk., acid ext., indene fraction, if it contains > 0.1% w/w benzene

(*) Extract residues (coal), low temp. coal tar alk., if it contains > 0.1% w/w benzene

(*) Extract residues (coal), naphthalene oil, alk., if it contains > 0.1% w/w benzene

(*) Extract residues (coal), naphthalene oil, alk., naphthalene-low, if it contains > 0.1% w/w benzene

(*) Extract residues (coal), tar oil alk., if it contains > 0.1% w/w benzene

(*) Extract residues (coal), tar oil alk., naphthalene distn. residues, if it contains > 0.1% w/w benzene

(*) Extracts (petroleum), catalytic reformed light naphtha solvent, if it contains > 0.1% w/w benzene

(*) Extracts (petroleum), cold-acid, C4-6, if it contains > 0.1% w/w benzene

(*) Extracts (petroleum), heavy naphtha solvent, clay-treated, if it contains > 0.1% w/w benzene

(*) Extracts, coal tar oil alk., if it contains > 0.1% w/w benzene

(*) Gasoline, C5-11, high-octane stabilized reformed, if it contains > 0.1% w/w benzene

(*) Gasoline, coal solvent extn., hydrocracked naphtha, if it contains >0.1% w/w benzene

(*) Gasoline, if it contains > 0.1% w/w benzene

(*) Gasoline, natural, if it contains > 0.1% w/w benzene

(*) Gasoline, pyrolysis, debutanizer bottoms, if it contains > 0.1% w/w benzene

(*) Gasoline, pyrolysis, hydrogenated, if it contains > 0.1% w/w benzene

(*) Gasoline, straight-run, topping-plant, if it contains > 0.1% w/w benzene

(*) Gasoline, vapor-recovery, if it contains > 0.1% w/w benzene

(*) Hydrocarbon oils, arom., mixed with polyethylene and polypropylene, pyrolyzed, light oil fraction, if it contains >

0.1% w/w benzene (*) Hydrocarbon oils, arom., mixed with polyethylene, pyrolyzed, light oil fraction, if it contains > 0.1% w/w benzene

(*) Hydrocarbon oils, arom., mixed with polystyrene, pyrolyzed, light oil fraction, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C2-6, C6-8 catalytic reformer, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C3-11, catalytic cracker distillates, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C3-6, C5-rich, steam-cracked naphtha, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C4-11, naphtha-cracking, arom.-free, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C4-12, naphtha-cracking, hydrotreated, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C4-6, depentanizer lights, arom. hydrotreater, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C5-11, non-aroms.-rich, reforming light fraction, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C5-rich, dicyclopentadiene-contg., if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C5-rich, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C6-11, hydrotreated, dearomatized, if it contains >0.1% w/w benzene

(*) Hydrocarbons, C6-7, naphtha-cracking, solvent-refined, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C6-8, hydrogenated sorption-dearomatized, toluene raffination, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C6-rich, hydrotreated light naphtha distillates, solvent-refined, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C7-12, C=>9-arom.-rich, reforming heavy fraction, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C8-11, naphtha-cracking, toluene cut, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C8-12, catalytic cracker distillates, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C8-12, catalytic cracking, chem. neutralized, sweetened, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C8-12, catalytic-cracking, chem. neutralized, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C9-12, hydrotreated, dearomatized, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, C>=5, C5-6-rich, if it contains > 0.1% w/w benzene

(*) Hydrocarbons, hydrotreated light naphtha distillates, solvent-refined, if it contains > 0.1% w/w benzene

(*) Light oil (coal), coke-oven, if it contains > 0.1% w/w benzene

(*) Ligroine, if it contains > 0.1% w/w benzene

(*) Naphtha (coal), solvent extn. hydrocracked, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), acid-treated, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), arom.-contg., if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), C4-12 butane-alkylate, isooctane-rich, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), catalytic cracked light distd., if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), catalytic dewaxed, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), catalytic reformed light, arom.-free fraction, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), catalytic reformed, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), chemically neutralized heavy, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), chemically neutralized light, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), clay-treated full-range straight-run, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), clay-treated light straight-run, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), full-range alkylate, butane-contg., if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), full-range alkylate, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), full-range coker, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), full-range reformed, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), full-range straight-run, if it contains > 0.1% w/w benzene



(*) Naphtha (petroleum), heavy alkylate, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), heavy catalytic cracked, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), heavy catalytic cracked, sweetened, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), heavy catalytic reformed, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), heavy hydrocracked, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), heavy steam-cracked, hydrogenated, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), heavy straight run, arom.-contg., if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), heavy straight-run, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), heavy thermal cracked, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), hydrodesulfurized full-range coker, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), hydrodesulfurized full-range, if it contains >0.1% w/w benzene

(*) Naphtha (petroleum), hydrodesulfurized heavy, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), hydrodesulfurized light, dearomatized, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), hydrodesulfurized light, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), hydrodesulfurized thermal cracked light, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), hydrotreated heavy, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), hydrotreated light steam-cracked, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), hydrotreated light, cycloalkane-contg., if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), hydrotreated light, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), isomerization, C6-fraction, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), isomerization, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), light alkylate; low boiling point modified naphtha H P

(*) Naphtha (petroleum), light catalytic cracked sweetened, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), light catalytic cracked, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), light catalytic reformed, arom.-free, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), light catalytic reformed, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), light heat-soaked, steam-cracked, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), light hydrocracked, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), light steam-cracked arom., if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), light steam-cracked, debenzenized, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), light steam-cracked, debenzenized, thermally treated, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), light steam-cracked, hydrogenated, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), light steam-cracked, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), light steam-cracked, thermally treated, if it contains >0.1% w/w benzene

(*) Naphtha (petroleum), light straight-run, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), light thermal cracked, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), light thermal cracked, sweetened, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), light, C5-rich, sweetened, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), light, sweetened, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), solvent-refined heavy, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), solvent-refined light, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), steam-cracked middle arom., if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), sweetened light, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), sweetened, if it contains > 0.1% w/w benzene

(*) Naphtha (petroleum), unsweetened, if it contains > 0.1% w/w benzene

(*) Naphtha, if it contains > 0.1% w/w benzene

(*) Natural gas (petroleum), raw liq. mix, if it contains > 0.1% w/w benzene

(*) Natural gas condensates (petroleum), if it contains > 0.1% w/w benzene

(*) Natural gas condensates, if it contains > 0.1% w/w benzene

(*) Petroleum products, hydrofiner-powerformer reformates, if it contains > 0.1% w/w benzene

(*) Phenols, ammonia liquor ext., if it contains > 0.1% w/w benzene

(*) Phenols, C9-11, if it contains > 0.1% w/w benzene

(*) Pyridine, alkyl derivs., if it contains > 0.1% w/w benzene

(*) Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts., if it contains > 0.1% w/w

benzene (*) Raffinates (petroleum), reformer, Lurgi unit-sepd., if it contains > 0.1% w/w benzene

(*) Residual oils (petroleum), deisobutanizer tower, if it contains > 0.1% w/w benzene

(*) Residues (coal tar), anthracene oil distn., if it contains > 0.1% w/w benzene

(*) Residues (petroleum), butane splitter bottoms, if it contains > 0.1% w/w benzene

(*) Residues (petroleum), C6-8 catalytic reformer, if it contains > 0.1% w/w benzene

(*) Residues (petroleum), steam-cracked light, arom., if it contains > 0.1% w/w benzene

(*) Solvent naphtha (coal), if it contains > 0.1% w/w benzene

(*) Solvent naphtha (petroleum), hydrotreated light naphthenic, if it contains > 0.1% w/w benzene

(*) Solvent naphtha (petroleum), light aliph., if it contains > 0.1% w/w benzene

(*) Solvent naphtha (petroleum), light arom., hydrotreated, if it contains > 0.1% w/w benzene

(*) Solvent naphtha (petroleum), light arom., if it contains > 0.1% w/w benzene

(*) Stoddard solvent, if it contains > 0.1% w/w benzene

(*) Tar acids, 3,5-xylenol fraction, if it contains > 0.1% w/w benzene

(*) Tar acids, brown-coal gasification, if it contains > 0.1% w/w benzene

(*) Tar acids, brown-coal, C2-alkylphenol fraction, if it contains > 0.1% w/w benzene

(*) Tar acids, brown-coal, crude, if it contains > 0.1% w/w benzene

(*) Tar acids, coal, crude, if it contains > 0.1% w/w benzene

(*) Tar acids, cresylic, if it contains > 0.1% w/w benzene

(*) Tar acids, cresylic, residues, if it contains > 0.1% w/w benzene

(*) Tar acids, cresylic, sodium salts, caustic solns., if it contains > 0.1% w/w benzene

(*) Tar acids, distn. residues, if it contains > 0.1% w/w benzene

(*) Tar acids, ethylphenol fraction, if it contains > 0.1% w/w benzene



(*) Tar acids, methylphenol fraction, if it contains > 0.1% w/w benzene

(*) Tar acids, polyalkylphenol fraction, if it contains > 0.1% w/w benzene

(*) Tar acids, residues, distillates, first-cut, if it contains > 0.1% w/w benzene

(*) Tar acids, xylenol fraction, if it contains > 0.1% w/w benzene

(*) Tar bases, coal, aniline fraction, if it contains > 0.1% w/w benzene

(*) Tar bases, coal, collidine fraction, if it contains > 0.1% w/w benzene

(*) Tar bases, coal, crude, if it contains > 0.1% w/w benzene

(*) Tar bases, coal, distn. residues, if it contains > 0.1% w/w benzene

(*) Tar bases, coal, lutidine fraction, if it contains > 0.1% w/w benzene

(*) Tar bases, coal, picoline fraction, if it contains > 0.1% w/w benzene

(*) Tar bases, coal, quinoline derivs. fraction, if it contains > 0.1% w/w benzene

(*) Tar bases, coal, toluidine fraction, if it contains > 0.1% w/w benzene

(*) Tar bases, quinoline derivs., if it contains > 0.1% w/w benzene

(*) Tar oils, brown-coal, if it contains > 0.1% w/w benzene

(*) Tar oils, coal, if it contains > 0.1% w/w benzene

(*) Tar oils, coal, low-temp., if it contains > 0.1% w/w benzene

Note

Current Version v.1



Personal Care iProducts CouncilCommitted to Safety,Quality & Innovation

Memorandum

TO: F. Alan Andersen, Ph.D.Director - COSMETIC INGREDIENT REWEW (Cifi)


DATE: February 28, 2011

SUBJECT: Comments on the Draft Report on Crosslinked Alkyl Acrylates Prepared for the March3-4, 2011 CIR Expert Panel Meeting

p.5 - Please revise the following sentence that does not make sense. “This summary is not intended tobe brief and not an all-encompassing review of these monomers.”

p.5 - Why is a study on sodium polyacrylate dust being presented under the heading Acrylates/C10-130Alkyl Acrylate Crosspolymer?

p.6, 8 - It is not clear why some HR]PT studies are presented in the skin irritation section and someHRIPTs are presented in the dermal irritation section.

p.8 - Where is the Summary section of this report?p.15, Table 1 - What is meant by “Crosslinked with some crosslinking agent”?p.17, Table 1 - Is the structure for ethylene glycidyl ether correct? It looks the same as glycol

dimethacrylate.p.20, Table 2 - See the attached corrected memo. The MW of Acrylates/C10-30 Alkyl Acrylates

Crosspolymer should be >500,000 rather than >50,000.p.21, Table 3b - In this table, would be helpful to state that ethylene glycol dimethacrylate and glycol

dimethacrylate are two names for the same compound.p.24-30, Table 5 - For every entry, this table should include the species and some indication of dose

(the lowest dose resulting in an effect is the most important). What type of effects (systemic ordermal) were observed in the 13-week dermal mouse study of acrylic acid? In the RepeatedDose rat study of butyl methacrylate, did they really treat 30 males and 300 females? Whatconcentration (or dose) of Lauryl Methacrylate was a strong sensitizer in guinea pigs?

Wave 2’, Table 5 - Carbopol ETD and Pemulen were tested without dilution - subtracting moisture andresidual solvent this is >97.5% (this has been confirmed by the supplier).




Personal Care Products CounciCommitted to Safety,Quality & Innovation

Memorandum

TO: F. Alan Andersen, Ph.D.Director - COSMETIC INGREDIENT REVIEW (CIR)


DATE: December 15, 2010 (molecular weight corrected February 28, 2011)

SUBJECT: Specification Information on Acrylates/C10-30 Alkyl Acrylates Crosspolymer

Molecular Weight: >500,000 DaltonsResidual monomer: typically less than 2500 ppm acrylic acid; less than 500 ppm residual

ester (C 10-30 Alkyl Acrylate)Method of manufacture: similar to the methods described in the “Carbomer” CIR report.

Manufactured via precipitation polymerization in solvent(s) (mostof the products are polymerized in a co-solvent mixture of ethylacetate and cyclohexane; one is polymerized in benzene)

Total residual solvent: less than 0.5%Supplied: as a powder, approximately 100% active




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