PINK Crosslinked Alkyl Acrylates CIR EXPERT PANEL MEETING JUNE 27-28, 2011

122 Pages·2011·1.83 MB·English

PINK

Crosslinked Alkyl Acrylates

CIR EXPERT PANEL MEETING
JUNE 27-28, 2011
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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).
Distributed for Comment Only -- Do Not Cite or Quote
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.

CIR Panel Book Page 1
April 7, 2011 – Searched using SciFinder
Distributed for Comment Only -- Do Not Cite or Quote

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

CIR Panel Book Page 2
crosspolymer, methacrylic acid/PEG-6 methacrylate crosspolymer, PEG/PPG-5/2 methacrylate/methacrylic acid
Distributed for Comment Only -- Do Not Cite or Quote
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'
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KEEP ME POSTED RESULTS reviewed weekly

CIR Panel Book Page 3
Distributed for Comment Only -- Do Not Cite or Quote
A 6
IFR 12- 0
OSH 2-6 0
NI 1
TC 0
O 0
FDA FUS 12-6-1 0
A
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NTP 12-6 0
IARC 12/1 info on monomer
SIDS 11-30 0
CE-OC 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
ET
EU CCP 1-23 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
S 1
EU NR* NR NR NR NR NR NR NR NR NR NR NR NR NR NR 0 0 NR NR NR NR NR NR
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NLM oxline-ubmed 11-16-113 23 0 0 0 0 0 0 0 380 11 0 0 1 0 0 0 0 0 0 3 0 0 7
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date searched Acrylates/C10-30 Alkyl 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 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 (Acrylate OR Acrylates) AND Crosspolymer *NR – not restricted References Ordered Whit - 13 papers (11-19-10)

CIR Panel Book Page 4
Search Terms
Distributed for Comment Only -- Do Not Cite or Quote

(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

CIR Panel Book Page 5
Distributed for Comment Only -- Do Not Cite or Quote
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Crosslinked Al Acrylates/C10-30Alkyl Acrylate Crosspolymer Acrylates/C12-13 Alkyl Methacrylates/Methoxyethyl Acrylate CrossAcrylates 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 Acrylic Acid Methyl Acrylate Ethyl Acrylate Butyl Acrylate 2-Ethylhexyl Acrylate Polyacrylic Acid Sodium Polyacrylate Methacrylic Acid Methyl Methacrylate Ethyl Methacrylate Butyl Methacrylate Isobutyl Methacrylate Lauryl Methacrylate PEG-4 Dimethacrylate *“X” indicates that data were available in a category for the ingr

CIR Panel Book Page 6
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