GREEN Crosslinked Alkyl Acrylates · 2. Final report on the safety assessment of methacrylic acid;...

GREEN

Crosslinked Alkyl Acrylates

CIR EXPERT PANEL MEETING

MARCH 3-4, 2011

Memorandum

To: CIR Expert Panel Members and Liaisons From: Monice M. Fiume MMF Senior Scientific Analyst/Writer Date: February 10, 2011 Subject: Crosslinked Alkyl Acrylates as Used in Cosmetics – Draft Report Included is the draft report on the Crosslinked Alkyl Acrylates as Used in Cosmetics. The Scientific Literature Review was issued on December 23, 2010. You may recall that the CIR has previously issued a final report on Acrylates Copolymers. The Panel concluded that those ingredients are safe for use in cosmetics when formulated to avoid skin irritation. The crosspolymers are different from the copolymers in that, 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 (cross-linking agents). Crosslinked polymers are generally less chemically reactive and less soluble (if not totally insoluble) than their respective non-crosslinked counterparts. Little published data were available on the Acrylates Crosspolymers. To aid in your review, Table 5 of the report provides relevant information on monomer components. Also, for your use, the following CIR reports are available at http://www.cir-safety.org/mar11.shtml:

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

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

enhancement products. Unpublished data submitted by the Council, listed below by submission date, are included in Tab 3 of this report.

1. Information on Sodium Acrylates Crosspolymer-2. Memo dated Nov. 30, 2010.

http://www.cir-safety.org/mar11.shtml�

http://www.cir-safety.org/mar11.shtml�

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.

Panel Book Page 1

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Reported Use

Monomer Content

Animal Tox – Acute, Derrmal

Animal Tox – Acute, Oral

Animal Tox, Acute, Inhalation

Animal Tox – Rptd Dose, Dermal

Animal Tox, Rptd Dose, Oral

Animal Tox – Rptd Dose, Inhalaiton

Repro/Dev Tox

Genotoxicity

Carcinogeni-city

Dermal Irr/Sens

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Panel Book Page 2

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Panel Book Page 3

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

Panel Book Page 4

Draft Report

Crosslinked Alkyl Acrylates as Used in Cosmetics

March 4, 2011 The 2011 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; Ronald A Hill, 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, Senior Scientific Analyst/Writer.

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

[email protected]

Panel Book Page 5

ii

TABLE OF CONTENTS

Introduction ....................................................................................................................................................................................................................................... 1 Chemistry .......................................................................................................................................................................................................................................... 1

Definition and Structure .............................................................................................................................................................................................................. 1 Physical and Chemical Properties ............................................................................................................................................................................................... 2 Method of Manufacture ............................................................................................................................................................................................................... 2 Analytical Methods ...................................................................................................................................................................................................................... 3 Impurities ..................................................................................................................................................................................................................................... 3

Use ..................................................................................................................................................................................................................................................... 3 Cosmetic ...................................................................................................................................................................................................................................... 3 Non-Cosmetic .............................................................................................................................................................................................................................. 4

Toxicokinetics ................................................................................................................................................................................................................................... 4 Effect on Skin Permeation ........................................................................................................................................................................................................... 4

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

Dermal .................................................................................................................................................................................................................................... 5 Oral ......................................................................................................................................................................................................................................... 5

Repeated Dose Toxicity ............................................................................................................................................................................................................... 5 Inhalation ................................................................................................................................................................................................................................ 5

Reproductive and Developmental Toxicity ...................................................................................................................................................................................... 5 Genotoxicity ...................................................................................................................................................................................................................................... 5 Carcinogenicity ................................................................................................................................................................................................................................. 5 Irritation and Sensitization ................................................................................................................................................................................................................ 6

Skin Irritation ............................................................................................................................................................................................................................... 6 Alternative Studies ................................................................................................................................................................................................................. 6 Non-Human ............................................................................................................................................................................................................................ 6 Human .................................................................................................................................................................................................................................... 6

Mucosal Irritation ........................................................................................................................................................................................................................ 7 Alternative Studies ................................................................................................................................................................................................................. 7 Non-Human ............................................................................................................................................................................................................................ 7

Sensitization ................................................................................................................................................................................................................................. 7 Non-Human ............................................................................................................................................................................................................................ 7 Human .................................................................................................................................................................................................................................... 8

Industrial Exposure Limits ................................................................................................................................................................................................................ 8 Tables ................................................................................................................................................................................................................................................ 9

Table 1. Definitions, functions, and structures .......................................................................................................................................................................... 9 Table 2. Chemical and physical properties .............................................................................................................................................................................. 20 Table 3a. Monomers used to create crosslinked alkyl acrylates ............................................................................................................................................. 21 Table 3b. Crosslinked components .......................................................................................................................................................................................... 21 Table 4a. Frequency and concentration of use according to duration and type of exposure .................................................................................................. 22 Table 4b. Ingredients Not Reported to be Used ...................................................................................................................................................................... 23 Table 5. Relevant summary information on monomer components ....................................................................................................................................... 24

References ....................................................................................................................................................................................................................................... 31

Panel Book Page 6

1

INTRODUCTION

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

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

methacrylic acid, or alkyl acrylate and 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 information

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

identified as such. Also included at the end of this report is a table providing a brief summary of relevant data that exist for a

number of the monomer components.

CIR is aware that International Nomenclature Committee Ingredient (INCI) monographs are in process for

additional crosslinked alkyl acrylates, and these ingredients will be added to this report once the monographs are complete.

CHEMISTRY

Definition and Structure

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

acrylic acid, sodium acrylate, methacrylic acid, or alkyl acrylate. Whereas polymers comprised purely of acrylic acid are

Panel Book Page 7

2

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 an internal structure

such as the following:

O

OH

OH

O

OH

O

OHHO

HO

OO

OO

O

HO

O

OO

O

OH

Theoretical magnified view of the crosslinkednetwork in a polymer bead of Acrylates / C10-30 Alkyl Acrylate Crosspolymer.

H3C

Due to the multitude of possible reaction conditions and methods involved in the manufacture of these polymers, 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. Accordingly, although all of the monomers and crosslinking agents may be the same, two

polymers with very different physical consistencies may share the same name under international nomenclature of cosmetic

ingredients (INCI) conventions. Nonetheless, the polymers in this group share the same lack of chemical reactivity in that

they are nearly impervious to degradation. 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 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 often have many trade names that correspond to one

INCI name, and under each trade name, the production process may vary. Since the products may have different properties,

the trade name is included in parenthesis when available.

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

absorption of acrylics is at a lower wavelength.

Method of Manufacture

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

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

Panel Book Page 8

3

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

induced crosslinking, and the multitude of other reaction conditions in the polymerization process can significantly alter the

polymeric structure and properties of the resultant 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 definition), and Table 3b names the

crosslinked components and any initiators.4

Acrylates/C10-30 Alkyl Acrylates Crosspolymer

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

erized in an ethyl acetate-cyclohexane mixture.5 However, another source reports that acrylates/C10-30 alkyl acrylates cross-

polymer (trade name not provided) may also be polymerized in benzene.6

Acrylates/Vinyl Isododecanoate Crosspolymer

Acrylates/vinyl isodecanoate crosspolymer (Stabylen 30) is produced via a synthetic chemical reaction by free

radical polymerization.7

Analytical Methods

Analysis of these acrylates crosspolymers can be carried out by scanning electron microscopy, differential scanning

calorimetry, ultraviolet/visible spectrophotometry, fourier transform infrared spectrophotometry, and dynamic light

scattering.8

Impurities

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

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

contain a maximum of 0.45 (Carbopol 1382; Carbopol Ultrez 20; Carbopol Ultrez 21)9-11 or 0.5% (Pemulen TR1; Pemulen

TR2; Carbopol ETD 2020)12-14 (total) residual solvent (ethyl acetate + cyclohexane). As Carbopol 1342, the product specifi-

cations state that acrylates/C10-30 alkyl acrylate crosspolymer can contain 0.5% (max.) residual benzene.15 Additionally,

under all these listed trade names, the product specifications state a maximum of 10 ppm heavy metals is allowed.9-15 The

residual monomer content of acrylates/C10-30 alkyl acrylate crosspolymer (trade name, not provided) is typically less than

2500 ppm acrylic acid and less than 500 ppm residual ester (C10-30 alkyl acrylate).6

Acrylates/Vinyl Isodecanoate Crosspolymer

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

be <0.05% by weight.7

Sodium Acrylates Crosspolymer-2

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

200 ppm (max).16

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 2010,17 and concentration of use information received in response to a

survey conducted by the Personal Care Products Council, 18 indicate that 11 of the 23 crosslinked alkyl acrylates named in

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

number of uses, with 1606 reported; 1282 of those uses are in leave-on products. Use of products containing this ingredient

could result in exposure to baby skin, to the eye area or mucous membranes, possible ingestion, or possible inhalation.

Lauryl methacrylate/glycol dimethacrylate crosspolymer has 63 reported uses, while acrylates crosspolymer, acrylates/vinyl

isodecanoate crosspolymer, acrylates/vinyl neodecanoate crosspolymer, allyl methacrylates crosspolymer, lauryl

methacrylate/sodium methacrylate crosspolymer, and sodium acrylates/C10-30 alkyl acrylate crosspolymer are all used in

less than 50 formulations.

The highest concentration of use reported is 6% Acrylates/Ethylhexyl Acrylate Crosspolymer. The maximum re-

ported concentrations of use of the other 10 in-use ingredients range from 0.5-5%. A trade article reported that experimental

emulsions contained 0.2-0.6 wt % acrylates/C10-30 alkyl acrylate crosspolymer (Pemulen TR-1).19 Frequency and concen-

tration of use data are provided in Table 4a. The ingredients not reported to be used are listed in Table 4b.

Acrylates/C10-30 alkyl acrylate crosspolymer and sodium acrylates/C10-30 alkyl acrylate crosspolymer are used in

products that may be inhaled, and effects on the lungs that may be induced by aerosolized products containing this ingredient

are of concern. The aerosol properties that determine deposition in the respiratory system are particle size and density. The

parameter most closely associated with deposition is the aerodynamic diameter, da, defined as the diameter of a sphere of unit

density possessing the same terminal settling velocity as the particle in question. In humans, particles with an aerodynamic

diameter of ≤ 10µm are respirable. Particles with a da from 0.1 - 10µm settle in the upper respiratory tract and particles with

a da < 0.1 µm settle in the lower respiratory tract.20,21

Particle diameters of 60-80 µm and ≥80 µm have been reported for anhydrous hair sprays and pump hairsprays,

respectively.22 In practice, aerosols should have at least 99% of their particle diameters in the 10 – 110 µm range and the

mean particle diameter in a typical aerosol spray has been reported as ~38 µm.23 Therefore, 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.24 These 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.25

Non-Cosmetic

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


Acrylates/C10-30 alkyl acrylate crosspolymer is used as a suspending and/or viscosity-increasing agent in pharma-

ceutical formulations.26

TOXICOKINETICS

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

crosspolymers. Toxicokinetics data on some of the monomers are provided in Table 5.

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.27

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

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5

TOXICOLOGICAL STUDIES

To aid in the evaluation of the safety of these crosspolymers, Table 5 presents relevant data on a number of

monomer components. This summary is not intended to be brief and not 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 (Pemulen TR1)

in rabbits is >2000 mg/kg.28

Oral


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

rats is >10,000 mg/kg.28


The oral LD50 in the rat of acrylates/vinyl isodecanoate crosspolymer (Stabylen 30) is >2000 mg/kg body wt.29


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

is >2000 mg/kg.30

Repeated Dose Toxicity

Inhalation


According to an industry MSDS, in a 2-yr inhalation study in which rats were exposed to a respirable, water-

absorbent sodium polyacrylate dust, lung effects such as inflammation, hyperplasia, and tumors, were observed.28 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 5.

GENOTOXICITY

Genotoxicity data on some of the monomers are provided in Table 5.


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

Ames test using Salmonella typhimurium TA98, TA100, TA1535, and TA1537 and Escherichia coli WP2uvrA.30

CARCINOGENICITY

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

Table 5.

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IRRITATION AND SENSITIZATION

Irritation and sensitization data on some of the monomers are provided in Table 5.

Skin Irritation

Alternative Studies


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

isodecanoate crosspolymer (Stabylen 30).29 The results obtained in a standard volume-response study using samples of ≤100

ml test material corresponded to a Draize dermal irritation classification of non-irritant.

Non-Human

Acrylates/C10-30 Alkyl Acrylates Crosspolymer

The dermal irritation potential of acrylates/C10-30 alkyl acrylate crosspolymer (Carbopol 1382; Pemulen) was

evaluated by applying a 0.5 g dose of the test article for 24 h under a semi-occlusive patch to an intact and an abraded site on

6 New Zealand White rabbits.31,32 After 24 h, the patch was removed and the site wiped. At 1 h after patch removal, very

slight erythema was observed at most of the intact and abraded sites; no irritation was seen at 72 h after dosing. The calcu-

lated primary irritation index (PII) was 0.42/8, and the test compound was considered to have negligible irritation potential.

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

3 rabbits.33 The test material was applied for 4 h under a semi-occlusive patch to the intact skin of each animal as 0.5 g of

dry powder or 0.5 ml of 1% neutralized solution (pH 6.9-7.0). The test site was wiped upon patch removal. Very slight

erythema and edema, which were observed with application of undiluted test material, subsided by day 7. The undiluted pol-

ymer was considered a non-irritant to a slight irritant (PII 0.0-1.5), and the 1% solution was considered a non-irritant to a

very slight irritant, to rabbit skin (PII 0.0-0.1).

In another study using the same procedure, the dermal irritation potential of acrylates/C10-30 alkyl acrylate cross-

polymer (Carbopol Ultrez 20; Carbopol Ultrez 21) was evaluated using 3 rabbits.34,35 The test material was applied as 0.5 g

of dry powder, moistened with 0.5 ml distilled water. The test material produced mild skin irritation (PII 0.3).


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

in rabbits.30

Human


A human repeated insult patch test (HRIPT) was completed on 107 subjects for a body lotion that contained 0.15%

acrylates/C10-30 alkyl acrylate crosspolymer.36 Approximately 0.2 g of the test material, or an amount sufficient to cover the

contact surface, was applied to a 1” x 1” absorbent pad, and the material was allowed to volatize for several minutes. The

semi-occlusive patch was applied to the upper back of each subject for 24 h, 3 times/wk, for 3 wks. The challenge was

performed after a 2 wk non-treatment period. No visible skin reactions were observed, and a formulation containing 0.15%

acrylates/C10-30 alkyl acrylate crosspolymer was not a dermal irritant or sensitizer.

A similar study was completed on 51 subjects for a crème that contained 0.60% acrylates/C10-30 alkyl acrylate

crosspolymer.37 Again, no visible skin reactions were observed, and a formulation containing 0.60% acrylates/C10-30 alkyl

acrylate crosspolymer was not a dermal irritant or sensitizer.

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According to an industry MSDS, sodium acrylates crosspolymer-2 (Aqua Keep 10SSH-NFC) is not a dermal irritant

in humans.30

Mucosal Irritation

Alternative Studies


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

isodecanoate crosspolymer (Stabylen 30).29 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.

Non-Human


The ocular irritation potential of acrylates/C10-30 alkyl acrylate crosspolymer (Carbopol 1382; Pemulen) was

evaluated by instilling 0.021 g of the test article into the conjunctival sac of one eye of 9 New Zealand White rabbits.31,32 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

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.”

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

groups of 3 albino rabbits.33 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 another study using the same procedure, the ocular irritation potential of acrylates/C10-30 alkyl acrylate cross-

polymer (Carbopol Ultrez 20; Carbopol Ultrez 21) was evaluated using groups of 3 rabbits.34,35 The test material was evalu-

ated 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, and it was classified as a minimal irritant.


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

in rabbits, and it is not a vaginal mucosa irritant in dogs.30

Sensitization

Non-Human


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

guinea pigs.30

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Human


The sensitization potential of acrylates/C10-30 alkyl acrylate crosspolymer (Carbopol 1382; Pemulen) was evaluat-

ed with 54 subjects in an “intensified version” of the Shelanski human repeated insult patch test (HRIPT).31,32 The test article

was impregnated into strips of surgical gauze, and a moistened patch containing a 1” x 1” square was applied to a site on the

back of each subject. Faint or moderate erythema was observed once for 9 subjects and twice for 2 subjects; no effects were

observed in the other 43 subjects. These induction results indicated a weak irritant response. During challenge, faint ery-

thema was observed one time for 3 of 53 subjects. The test product was not a skin sensitizer.

HRIPTs were conducted with acrylates/C10-30 alkyl acrylate crosspolymer. One study used 100 subjects (Carbopol

ETD)33 and another study used 111 subjects (Carbopol Ultrez 20; Carbopol Ultrez 21).34,35 In both studies, the polymer was

applied evenly over a 2 cm x 2 cm gauze pad that was moistened with distilled water just prior to application. In the study

using 111 subjects, 150 mg of a 10% distilled water paste was tested. During induction, the patch was applied for 4 consecu-

tive days of wks 1-3. After a 1-wk non-treatment period, the challenge was performed by making 4 applications to a

previously untested site. The polymers were not irritants or sensitizers.


A Kligman test was conducted using 25 subjects to determine the irritation and sensitization potential of 0.5-2.5%

aq. acrylates/vinyl isodecanoate crosspolymer(Stabylen 30) .29 No irritation or sensitization was reported. (No additional

details were provided.)

INDUSTRIAL EXPOSURE LIMITS


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

crosspolymer.28 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 ..30

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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 ether of sucrose or an allyl ether of pentaerythritol

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

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

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Table 1. Definitions, functions, and structure (continued)

10

Ingredient/CAS No. Definition Reported Function(s) Formula/Structure 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

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

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

s

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11

Ingredient/CAS No. Definition Reported Function(s) Formula/Structure 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

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

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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.

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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.

s

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

a copolymer of allyl methacrylate crosslinked with glycol dimethacrylate

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

Butyl Acrylate/ Glycol Dimeth-acrylate Crosspolymer

a homopolymer of butyl acrylate cross-linked with 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

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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

H2C

Copolymer of:

(Crosslinker)

CH3

CH2

O

O

CH3

H2C

O

O

O

O

CH3

Lauryl Methacrylate/Sodium Meth-acrylate Crosspolymer

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

Slip Modifier; Surface Modifier

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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 glycol dimethacrylate

Film Former

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17

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

Sodium Acrylates Crosspolymer-2 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

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18

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

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19

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

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

Emulsion Stabilizer; Suspend-ing Agent - Non-Surfactant; Viscosity Increasing Agent – Aq.

Stearyl/ Lauryl Methacrylate Cross-polymer

a copolymer of stearyl methacrylate and lauryl methacrylate crosslinked with ethy-lene glycol dimethacrylate

Skin-Conditioning Agent - Misc.

References4,6,38

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20

Table 2. Chemical and physical properties

Property Description


appearance white powder; 9-15

odor slightly acetic9-15

activity as supplied approximately 100% active6

molecular weight >50,000 Daltons6

solubility swells in water28

pH ~2.5 – 3 at 1% in water28

specific gravity 1.4 (at 20°C)28

bulk density <0.24 kg/l; <2 lb/gal 28


molecular weight 24,400 Daltons (avg; <1% by weight is <1000 Daltons)7

Allyl Methacrylates Crosspolymer

appearance fine white powder39,40

solubility insoluble39,40

refractive index 1.517-1.51939 1.511-1.51340

particle size (by laser diffraction) 5-15 µm39 15-25 µm40

bulk density 0.03 g/cc39,40

water adsorption oleophilic (hydrophobic)39 dual: hydrophilic and oleophilic40


appearance white powder16

odor odorless30

solubility swells in water30

pH 6-830

particle size approx. 20 µm 16

bulk density 0.75-0.95 g/ml 30

stability stable at room temperature30

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21

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, containing an avg of 5 moles ethylene oxide and 2 moles propylene oxide sodium methacrylate steareth-20 methacrylate stearyl methacrylate vinyl alcohol vinyl isodecanoate, ester of vinyl neodecanoate Table 3b. Crosslinked components allyl methacrylate ethylene diglycidyl ether ethylene glycol dimethacrylate 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)

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

Acrylates/C10-30 Alkyl Acrylate

Crosspolymer Acrylates Crosspolymer

Acrylates/Ethylhexyl Acrylate Crosspolymer

# of Uses17 Conc of Use (%)18 # of Uses17 Conc of Use (%)18 # of Uses17 Conc of Use (%)18

Totals* 1606 0.0002-5 2 0.1-4 NR 4-6

Duration of Use

Leave-On 1282 0.0002-5 2 0.1-4 NR 4-6

Rinse Off 324 0.002-5 NR 0.3-0.8 NR NR

Exposure Type

Eye Area 130 0.003-2 NR 0.8 NR 6

Possible Ingestion 3 0.5 NR 4 NR NR

Inhalation 30 0.03-2 NR NR NR NR

Dermal Contact 1491 0.0002-3 2 0.1-4 NR 4-6

Deodorant (underarm) 1 0.001 NR NR NR NR

Hair - Non-Coloring 84 0.1-2 NR NR NR NR

Hair-Coloring 19 0.4-5 NR NR NR NR

Nail 6 0.1-5 NR NR NR NR

Mucous Membrane 84 0.002-3 NR NR NR NR

Bath Products 13 1 NR NR NR NR

Baby Products 11 0.2 NR NR NR NR

Acrylates/Steareth-20 Methacrylate

Crosspolymer Acrylates/Vinyl Isodecanoate

Crosspolymer Acrylates/Vinyl Neodecanoate

Crosspolymer

# of Uses17 Conc of Use (%)18 # of Uses17 Conc of Use (%)18 # of Uses17 Conc of Use (%)18,41

Totals NR 0.1-2 30 0.2-0.5 10 2 Duration of Use Leave-On NR 0.1-2 20 0.3-0.5 7 NR

Rinse Off NR 1 10 0.2-0.5 3 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 30 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

# of Uses17 Conc of Use (%)18 # of Uses17 Conc of Use (%)18 # of Uses17 Conc of Use (%)18 Totals 41 0.003-2 63 0.06-3 1 0.004-4

Duration of Use

Leave-On 38 0.003-2 46 0.06-3 1 0.1-4 Rinse Off 3 0.1 7 0.2-3 NR 0.004-0.1

Exposure Type

Eye Area 5 0.003-0.8 8 0.1-3 NR NR

Possible Ingestion 17 0.04-0.2 8 0.06-2 NR NR

Inhalation NR NR NR NR NR NR

Dermal Contact 40 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

Panel Book Page 28

23

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

Sodium Acrylates/C10-30 Alkyl Acrylate

Crosspolymer Sodium Acrylates Crosspolymer-

2

# of Uses17 Conc of Use (%)18 # of Uses17 Conc of Use (%)18

Totals* 3 NR NR 0.8

Duration of Use

Leave-On 3 NR NR 0.8 Rinse Off 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 3 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

Panel Book Page 29

T

able

5.

Rel

evan

t sum

mar

y in

form

atio

n on

mon

omer

com

pone

nts

Mon

omer

Com

pone

nt

Par

amet

er E

valu

ated

O

utc

ome

Ref

eren

ce

Acr

ylic

Aci

d T

oxic

okin

etic

s D

erm

al:

radi

oact

ivity

was

rec

over

ed m

ostly

in th

e sk

in tr

ap, a

nd th

en in

exp

ired

CO

2 O

ral:

In

num

erou

s st

udie

s us

ing

rats

,, th

e do

se w

as p

rim

aril

y ex

cret

ed in

exp

ired

air

in m

ost c

ases

; eli

min

atio

n w

as

gene

rall

y ra

pid;

upt

ake

and

elim

inat

ion

appe

ared

to b

e bi

phas

ic; a

bsor

ptio

n an

d ex

cret

ion

wer

e al

so r

apid

in m

ice

Inha

lati

on:

Rat

s w

ere

expo

sed

to a

cryl

ic a

cid

via

inha

lati

on; m

ost o

f th

e ra

dioa

ctiv

ity

was

fou

nd in

the

head

and

sno

ut,

wit

h re

lati

vely

larg

e am

ount

s al

so r

ecov

ered

in th

e up

per

resp

irat

ory

trac

t

1

T

oxic

olog

ical

Stu

dies

S

ingl

e D

ose

- D

erm

al:

LD

50 –

295

to 9

50 m

g/kg

in r

abbi

ts

Ora

l : L

D50

– 2

100

to 3

200

mg/

kg in

rab

bits

and

rat

s; p

rodu

ced

gast

ric

lesi

ons

Inh

alat

ion:

LC

50 –

360

0 m

g/m

3 in r

ats

1

Rep

eate

d D

ose

– D

erm

al:

4% p

rodu

ced

toxi

c ef

fect

s in

mic

e in

a 1

3-w

k st

udy

Ora

l: to

xic

effe

cts

wer

e ob

serv

ed in

rat

s in

a 9

0-da

y dr

inki

ng w

ater

stu

dy w

ith

dose

s of

≤75

0 m

g/kg

and

in a

90-

day

gava

ge s

tudy

in r

ats

dose

s w

ith

150

0r 3

75 m

g/kg

; sto

mac

h le

sion

s w

ere

not o

bser

ved

in a

12-

mos

dri

nkin

g st

udy

wit

h ra

ts

Inh

alat

ion:

nas

al le

sion

s w

ere

obse

rved

in r

ats

and

mic

e in

4-d

ay, 2

-wk,

20-

day,

and

13-

wk

stud

ies

1

R

epro

duct

ive

and

Dev

elop

men

tal T

oxic

ity

Ora

l : d

id n

ot p

rodu

ce te

rato

geni

c ef

fect

s in

rat

s; d

id a

ffec

t bod

y w

eigh

ts a

nd s

ome

orga

n w

eigh

ts in

the

pare

ntal

ani

mal

s In

hala

tion

: no

t ter

atog

enic

or

embr

yoto

xic

in r

ats;

did

pro

duce

mat

erna

l tox

icit

y

1

G

enot

oxic

ity

geno

toxi

c in

mou

se ly

mph

oma

assa

ys, a

nd in

an

in v

itro

cyt

ogen

etic

ass

ay; n

ot g

enot

oxic

or

mut

agen

ic in

Am

es te

sts,

un

sche

dule

d D

NA

syn

thes

is (

UD

S)

assa

y, m

icro

nucl

eus

assa

y, in

viv

o tr

ansf

orm

atio

n as

say,

Chi

nese

ham

ster

ova

ry

(CH

O)/

HG

PR

T, i

n vi

vo c

ytog

enet

ic a

ssay

, Dro

soph

ila

test

, or

mou

se d

omin

ant l

etha

l ass

ay

1

C

arci

noge

nici

ty

Der

mal

: in

one

stu

dy, 4

% in

ace

tone

was

a c

ompl

ete

but w

eak

carc

inog

en in

mic

e; in

ano

ther

, 1%

was

not

car

cino

geni

c in

mic

e O

ral:

not

car

cino

geni

c in

rat

s w

hen

give

n in

dri

nkin

g w

ater

Pa

rent

eral

: no

t car

cino

geni

c w

hen

inje

cted

sub

cuta

neou

sly

(s.c

.) to

mic

e IA

RC

Eva

luat

ion :

no

epid

emio

logi

cal d

ata

rele

vant

to c

arci

noge

nici

ty w

ere

avai

labl

e; n

o ex

peri

men

tal d

ata

rele

vant

to

carc

inog

enic

ity

wer

e av

aila

ble;

not

cla

ssif

iabl

e as

to it

s ca

rcin

ogen

icit

y to

hum

ans

(Gro

up 3

)

1

42

Ir

rita

tion

and

Sen

siti

zati

on

Ski

n: 4

% w

as ir

rita

ting

to th

e sk

in o

f m

ice

Muc

osal

: a

1% s

olut

ion

caus

e si

gnif

ican

t inj

ury

to th

e ra

bbit

eye

1

Met

hyl

Acr

ylat

e T

oxic

okin

etic

s D

erm

al:

In g

uine

a pi

gs e

xpos

ed d

erm

ally

to m

ethy

l [2,

3-14

C]a

cryl

ate,

rad

ioac

tivi

ty w

as s

een

in th

e s.

c. ti

ssue

s an

d th

roug

hout

the

body

O

ral:

the

dose

was

pri

mar

ily

excr

eted

in e

xpir

ed a

ir; e

lim

inat

ion

was

rap

id (

rats

)

43

T

oxic

olog

ical

Stu

dies

S

ingl

e D

ose

- O

ral;

pro

duce

d ga

stri

c le

sion

s 1

Rep

eate

d D

ose

– O

ral :

not

toxi

c w

hen

give

n or

ally

to r

ats

(det

ails

not

pro

vide

d)

1

R

epro

duct

ive

and

Dev

elop

men

tal T

oxic

ity

Inha

lati

on:

did

not p

rodu

ce te

rato

geni

c or

rep

rodu

ctiv

e ef

fect

s in

rat

s 1

G

enot

oxic

ity

geno

toxi

c in

mou

se ly

mph

oma

and

chro

mos

omal

abe

rrat

ion

assa

ys; p

osit

ive

in o

ne a

nd n

egat

ive

in tw

o m

icro

nucl

eus

test

s; n

ot m

utag

enic

or

geno

toxi

c in

an

Am

es, S

alm

onel

la/m

icro

som

e, li

quid

incu

bati

on, m

onol

ayer

, sus

pens

ion,

or

AS

52/X

RP

T a

ssay

1

Panel Book Page 30

Tab

le 5

. R

elev

ant s

umm

ary

info

rmat

ion

on m

onom

er c

ompo

nent

s (c

onti

nued

)

25

Mon

omer

Com

pone

nt

Par

amet

er E

valu

ated

O

utc

ome

Ref

eren

ce

C

arci

noge

nici

ty

Inha

lati

on:

not c

arci

noge

nic

to r

ats

IAR

C E

valu

atio

n: n

o ep

idem

iolo

gica

l dat

a re

leva

nt to

the

carc

inog

enic

ity;

inad

equa

te e

vide

nce

in e

xper

imen

tal a

nim

als;

no

t cla

ssif

iabl

e as

to it

s ca

rcin

ogen

icit

y to

hum

ans

(Gro

up 3

)

1

43

Eth

yl A

cryl

ate

Tox

icok

inet

ics

Ora

l : th

e do

se w

as p

rim

arily

exc

rete

d in

exp

ired

air

; eli

min

atio

n w

as r

apid

(ra

ts)

1

T

oxic

olog

ical

Stu

dies

S

ingl

e D

ose

- O

ral;

pro

duce

d ga

stri

c le

sion

s 1

Rep

eate

d D

ose

– O

ral :

2-w

k st

udy

in r

ats

wit

h do

sing

via

gav

age

or d

rink

ing

wat

er; g

astr

ic le

sion

s w

ere

obse

rved

, pr

imar

ily in

the

fore

stom

ach;

in a

13-

wk

gava

ge s

tudy

, dos

es o

f ≤2

00 m

g/kg

pro

duce

d le

sion

s in

the

fore

stom

ach

of r

ats

Inh

alat

ion:

no

nasa

l les

ions

wer

e ob

serv

ed in

a 1

-mon

th s

tudy

usi

ng r

ats

and

mic

e; n

asal

lesi

ons

wer

e ob

serv

ed in

rat

s in

a 1

2-w

k st

udy;

sto

mac

h le

sion

s w

ere

not o

bser

ved

in a

2-y

r dr

inki

ng s

tudy

wit

h ra

ts o

r a

2-yr

cap

sule

stu

dy w

ith

dogs

1

R

epro

duct

ive

and

Dev

elop

men

tal T

oxic

ity

Inha

lati

on:

not e

mbr

yoto

xic

or f

etot

oxic

in r

ats;

mat

erna

l tox

icit

y w

as o

bser

ved

1

G

enot

oxic

ity

geno

toxi

c in

a m

ouse

lym

phom

a an

d ch

rom

osom

al a

berr

atio

n as

say;

indu

ced

chro

mos

omal

mal

segr

egat

ion

and

mit

otic

re

com

bina

tion

usi

ng S

. cer

evis

iae;

pos

itiv

e in

one

and

neg

ativ

e in

one

mic

ronu

cleu

s as

say;

not

mut

agen

ic o

r ge

noto

xic

in

an A

mes

, Sal

mon

ella

/mic

roso

me,

liqu

id in

cuba

tion

, mon

olay

er, c

hrom

osom

al ,

sist

er c

hrom

atid

exc

hang

e (S

CE

), o

r D

roso

phil

a as

say

1

C

arci

noge

nici

ty

Der

mal

: te

sted

und

ilut

ed, n

ot c

arci

noge

nic

to m

ice

Ora

l: i

n co

rn o

il, c

arci

noge

nic

in m

ale

and

fem

ale

rats

and

mic

e In

hala

tion

: no

t car

cino

geni

c in

mic

e IA

RC

Eva

luat

ion :

no

epid

emio

logi

cal d

ata

rele

vant

to th

e ca

rcin

ogen

icit

y; s

uffi

cien

t evi

denc

e in

exp

erim

enta

l ani

mal

s;

poss

ibly

car

cino

geni

c to

hum

ans

(Gro

up 2

B)

1

44

Bu

tyl A

cryl

ate

Tox

icok

inet

ics

Ora

l: th

e do

se w

as p

rim

aril

y ex

cret

ed in

exp

ired

air

(ra

ts)

1

T

oxic

olog

ical

Stu

dies

S

ingl

e D

ose

Ora

l ; p

rodu

ced

gast

ric

lesi

ons

1

Rep

eate

d D

ose

– O

ral :

not

toxi

c w

hen

give

n or

ally

to r

ats

(det

ails

not

pro

vide

d)

Inh

alat

ion:

tox

icit

y w

as o

bser

ved

in r

ats

and

ham

ster

s up

on 3

6-h

exp

osur

es; n

asal

lesi

ons

wer

e ob

serv

ed in

rat

s in

a

13-w

k st

udy

1

R

epro

duct

ive

and

Dev

elop

men

tal T

oxic

ity

Inha

lati

on:

no to

xic

effe

cts

wer

e se

en w

ith

25 p

pm; h

igh

conc

entr

atio

ns h

ad to

xic

effe

cts

on th

e fe

tuse

s an

d da

ms

1

G

enot

oxic

ity

posi

tive

in o

ne a

nd n

egat

ive

in o

ne c

hrom

osom

al a

berr

atio

n as

say;

not

mut

agen

ic o

r ge

noto

xic

in a

n A

mes

, Sa

lmon

ella

/mic

roso

me,

liqu

id in

cuba

tion

, UD

S, m

icro

nucl

eus,

or

in v

itro

tran

sfor

mat

ion

assa

y

1

C

arci

noge

nici

ty

Der

mal

: 1%

was

not

car

cino

geni

c in

mic

e In

hala

tion

: no

t car

cino

geni

c to

rat

s IA

RC

Eva

luat

ion :

no

epid

emio

logi

cal d

ata

rele

vant

to th

e ca

rcin

ogen

icit

y; in

adeq

uate

evi

denc

e in

exp

erim

enta

l ani

mal

s;

not c

lass

ifia

ble

as to

its

carc

inog

enic

ity

to h

uman

s (G

roup

3)

1

45

Panel Book Page 31

Tab

le 5

. R

elev

ant s

umm

ary

info

rmat

ion

on m

onom

er c

ompo

nent

s (c

onti

nued

)

26

Mon

omer

Com

pone

nt

Par

amet

er E

valu

ated

O

utc

ome

Ref

eren

ce

2-E

thyl

hex

yl A

cryl

ate

Tox

icok

inet

ics

Ora

l : th

e do

se w

as p

rim

arily

exc

rete

d in

exp

ired

air

; eli

min

atio

n w

as r

apid

(ra

ts)

1

R

epro

duct

ive

and

Dev

elop

men

tal T

oxic

ity

Inha

lati

on:

did

not p

rodu

ce te

rato

geni

c or

rep

rodu

ctiv

e ef

fect

s in

rat

s 1

G

enot

oxic

ity

geno

toxi

c in

a m

ouse

lym

phom

a fo

rwar

d m

utat

ion

assa

y w

ith

met

abol

ic a

ctiv

atio

n; e

quiv

ocal

ly g

enot

oxic

in m

utat

ion

and

aber

rati

ons

assa

ys; w

eakl

y m

utag

enic

in S

CE

and

UD

S as

says

; not

mut

agen

ic o

r ge

noto

xic

in a

mic

robi

al m

utag

en

test

, Am

es te

st, m

amm

alia

n ce

ll tr

ansf

orm

atio

n as

say,

mic

ronu

cleu

s te

st, m

onol

ayer

or

susp

ensi

on a

ssay

, CH

O a

ssay

, or

in v

ivo

cyto

geni

c as

say

1

C

arci

noge

nici

ty

Der

mal

: ca

rcin

ogen

ic w

hen

appl

ied

to m

ice

– th

e ca

rcin

ogen

ic r

espo

nse

may

hav

e be

en a

ssoc

iate

d w

ith

the

seve

re s

kin

irri

tati

on in

duce

d by

the

chem

ical

T

este

d by

ski

n ap

plic

atio

n in

thre

e ex

peri

men

ts in

mic

e; it

incr

ease

d th

e in

cide

nce

of s

quam

ous-

cell

carc

inom

as o

f th

e sk

in in

2 e

xper

imen

ts a

nd o

f m

alig

nant

mel

anom

as in

one

exp

erim

ent;

in th

e th

ird

expe

rim

ent,

in a

dif

fere

nt s

trai

n of

m

ice,

no

incr

ease

ski

n tu

mor

inci

denc

e w

as s

een

wit

h or

wit

hout

sub

sequ

ent a

ppli

cati

on o

f 12

-0-t

etra

deca

noyl

phor

bol

13-a

ceta

te

IAR

C E

valu

atio

n: i

nade

quat

e ev

iden

ce in

hum

ans

for

carc

inog

enic

ity; l

imite

d ev

iden

ce in

exp

erim

enta

l ani

mal

s; n

ot

clas

sifi

able

as

to it

s ca

rcin

ogen

icit

y to

hum

ans

(Gro

up 3

)

1

46

Ir

rita

tion

and

Sen

siti

zati

on

Der

mal

- N

on-H

uman

: se

nsit

izat

ion

was

obs

erve

d w

hen

guin

ea-p

igs

wer

e tr

eate

d w

ith

2-et

hylh

exyl

acr

ylat

e in

Fre

und’

s co

mpl

ete

adju

vant

H

uman

: in

a p

rovo

cati

ve te

st w

ith

243

pati

ents

wit

h a

his

tory

of

expo

sure

to (

met

h)ac

ryla

tes,

non

e of

the

pati

ents

wer

e se

nsit

ized

wit

h pa

tche

s co

ntai

ning

0.1

-0.5

% 2

-eth

ylhe

xyl a

cryl

ate

46

1

Pol

yacr

ylic

Aci

d

Ani

mal

Tox

icol

ogy

Sing

le D

ose

- O

ral:

LD

50 –

250

0 m

g/kg

in r

ats

1

C

IR C

oncl

usio

n sa

fe a

s us

ed w

hen

form

ulat

ed to

avo

id s

kin

irri

tati

on

1

Sod

ium

Pol

yacr

ylat

e A

nim

al T

oxic

olog

y Si

ngle

Dos

e –

Ora

l: L

D50

- >

40 g

/kg

in r

ats

for

a 15

% s

olut

ion

1

R

epro

duct

ive

and

Dev

elop

men

tal T

oxic

ity

did

not c

ause

rep

rodu

ctiv

e ef

fect

s in

rat

s 1

G

enot

oxic

ity

not g

enot

oxic

in a

n A

mes

ass

ay, a

pla

te te

st, a

mou

se ly

mph

oma

assa

y, c

hrom

osom

al a

berr

atio

n as

says

, a U

DS

ass

ay, o

r an

in v

ivo

mou

se m

icro

nucl

eus

assa

y

1

Ir

rita

tion

and

Sen

siti

zati

on

Der

mal

– N

on-H

uman

: no

t an

irri

tant

to r

abbi

t ski

n H

uman

: no

t an

irri

tant

or

sens

itiz

er

Muc

osal

: th

e gr

eate

st to

lera

ted

conc

entr

atio

ns w

ere

13-2

0% f

or u

nrin

sed

and

20-3

0% f

or r

inse

d ra

bbit

eye

s; in

an

irri

tant

-thr

esho

ld te

st, 2

% w

as th

e gr

eate

st c

once

ntra

tion

that

did

not

pro

duce

irri

tati

on in

rab

bit e

yes

1

C

IR C

oncl

usio

n sa

fe a

s us

ed w

hen

form

ulat

ed to

avo

id s

kin

irri

tati

on

1

Panel Book Page 32

Tab

le 5

. R

elev

ant s

umm

ary

info

rmat

ion

on m

onom

er c

ompo

nent

s (c

onti

nued

)

27

Mon

omer

Com

pone

nt

Par

amet

er E

valu

ated

O

utc

ome

Ref

eren

ce

Met

hacr

ylic

Aci

d T

oxic

okin

etic

s re

adil

y ab

sorb

ed th

roug

h th

e m

ucou

s m

embr

anes

of

the

lung

s an

d ga

stro

inte

stin

al tr

act o

f a

nd th

e sk

in, a

nd is

rea

dily

di

stri

bute

d to

all

maj

or ti

ssue

s

47

A

nim

al T

oxic

olog

y Si

ngle

Dos

e –

Der

mal

: re

port

ed L

D50

val

ues

rang

ed f

rom

500

-124

3 m

g/kg

for

rab

bits

O

ral:

rep

orte

d L

D50

val

ues

rang

ed f

rom

827

-160

0 m

g/kg

for

mic

e, 2

77-2

260

mg/

kg f

or r

ats,

and

280

-120

0 m

g/kg

for

ra

bbit

s I

nhal

atio

n: r

epor

ted

LC

50 v

alue

s w

ere

3657

ppm

in m

ice,

135

0 pp

m/4

h in

rat

s, a

nd 2

522

ppm

/1 h

in r

abbi

ts

47

Rep

eate

d D

ose

– O

ral:

no

sign

s of

toxi

city

in a

sho

rt-t

erm

stu

dy

Inh

alat

ion:

nos

e an

d ey

e ir

rita

tion

and

wei

ght l

oss

in r

ats

wit

h 5

expo

sure

s to

130

0 pp

m; o

nly

rena

l con

gest

ion

in r

ats

wit

h 20

exp

osur

es to

300

ppm

; in

a 2-

wk

stud

y, r

epea

ted

dose

s of

≥10

0 pp

m c

ause

d re

acti

ons

in r

ats,

of ≥5

00 p

pm

caus

ed r

eact

ions

in m

ice,

and

100

0 pp

m k

ille

d al

l rat

s an

d m

ice;

in a

90-

day

stud

y, r

espi

rato

ry e

ffec

ts w

ere

seen

in r

ats

and

mic

e ex

pose

d to

300

ppm

– c

ytom

egal

y of

ren

al tu

bula

r ep

ithe

lium

was

obs

erve

d in

>50

% o

f te

st m

ale

mic

e

47

R

epro

duct

ive

and

Dev

elop

men

tal T

oxic

ity

Inha

lati

on:

no r

epro

duct

ive

or d

evel

opm

enta

l eff

ects

In

Vit

ro:

adve

rse

effe

cts

wer

e se

en w

ith

expo

sure

of

rat e

mbr

yos

47

G

enot

oxic

ity

posi

tive

in a

DN

A c

ell-

bind

ing

assa

y; n

egat

ive

in a

n A

mes

test

47

C

arci

noge

nici

ty

it w

as r

epor

ted

that

IA

RC

rev

iew

ed m

etha

cryl

ic a

cid,

but

did

not

pre

pare

a m

onog

raph

bec

ause

inad

equa

te d

ata

wer

e av

aila

ble

47

Ir

rita

tion

and

Sen

siti

zati

on

Der

mal

– N

on-H

uman

: co

rros

ive

to r

abbi

t and

gui

nea

pig

skin

; in

a gu

inea

pig

max

imiz

atio

n st

udy,

it w

as d

iffi

cult

to

dete

rmin

e if

obs

erve

d re

acti

ons

wer

e hy

pers

ensi

tivi

ty o

r ir

rita

tion

; gui

nea

pigs

wer

e no

t sen

siti

zed

in 3

oth

er s

tudi

es

Muc

osal

: ca

used

sev

ere

corn

eal,

irid

al, a

nd c

onju

ncti

val e

ffec

ts in

rab

bits

in o

ne s

tudy

; in

an in

hala

tion

stu

dy, 5

6,91

6 pp

m w

as c

orro

sive

to r

abbi

t eye

s

47

C

lini

cal U

se

nega

tive

resu

lts

wer

e re

port

ed in

a n

umbe

r of

pat

ch te

sts

of p

atie

nts

alle

rgic

to m

ethy

l met

hacr

ylat

e an

d to

wor

kers

ex

pose

d to

acr

ylat

es

47

D

iscu

ssio

n It

ems

the

Pane

l was

con

cern

ed w

ith

the

extr

eme

corr

osiv

ity;

a p

rese

ntat

ion

dem

onst

rate

d th

at a

trai

ned

prof

essi

onal

cou

ld

appl

y th

e ac

id to

the

nail

wit

hout

exp

osur

e to

the

skin

, but

this

cou

ld n

ot b

e de

mon

stra

ted

for

reta

il c

onsu

mer

s; d

ue to

co

ncer

ns th

at in

hala

tion

cou

ld a

ffec

t the

res

pira

tory

trac

t, an

d th

e na

il te

chni

cian

cou

ld b

e su

bjec

ted

to in

crea

sed

expo

sure

in a

com

mer

cial

set

ting

, the

NIO

SH

-rec

omm

ende

d ex

posu

re li

mit

of 2

0 pp

m a

s a

tim

e-w

eigh

ted

aver

age

conc

entr

atio

n sh

ould

not

be

exce

eded

; the

Con

sum

er P

rodu

ct S

afet

y C

omm

issi

on r

ule

req

uire

s ch

ild-

resi

stan

t pac

kagi

ng

for

liqu

id h

ouse

hold

pro

duct

s co

ntai

ning

>5%

met

hacr

ylic

aci

d (w

t to

vol)

47

C

IR C

oncl

usio

n sa

fe a

s u

sed

as a

nai

l pri

mer

by

trai

ned

pro

fess

ion

als;

insu

ffic

ien

t dat

a fo

r re

tail

use

by

con

sum

ers

47

Met

hyl

Met

hac

ryla

te

Tox

icok

inet

ics

can

be a

bsor

bed

thro

ugh

the

skin

of

hum

ans

48

A

nim

al T

oxic

olog

y R

epea

ted

Dos

e -

Ora

l: c

hron

ic e

xpos

ure

to ≤

400

ppm

did

not

cau

se tu

mor

s in

ham

ster

s or

rat

s 49

R

epro

duct

ive

and

Dev

elop

men

tal T

oxic

ity

Inha

lati

on:

no e

ffec

t on

feta

l dev

elop

men

t in

mic

e or

rat

s;

48

G

enot

oxic

ity

geno

toxi

c in

a c

hrom

osom

al a

berr

atio

n, S

CE

, and

mou

se ly

mph

oma

assa

y; n

ot m

utag

enic

in a

Sal

mon

ella

/mic

roso

me

or

liqu

id in

cuba

tion

ass

ay

1

Panel Book Page 33

Tab

le 5

. R

elev

ant s

umm

ary

info

rmat

ion

on m

onom

er c

ompo

nent

s (c

onti

nued

)

28

Mon

omer

Com

pone

nt

Par

amet

er E

valu

ated

O

utc

ome

Ref

eren

ce

C

arci

noge

nici

ty

Ora

l: n

ot c

arci

noge

nic

in a

dri

nkin

g st

udy

usin

g ra

ts

Inha

lati

on:

not c

arci

noge

nic

in m

ice

or r

ats

IAR

C:

inad

equa

te e

vide

nce

in h

uman

s fo

r ca

rcin

ogen

icit

y; e

vide

nce

sugg

esti

ng la

ck o

f car

cino

geni

city

in e

xper

imen

tal

anim

als;

not

cla

ssif

iabl

e as

to it

s ca

rcin

ogen

icit

y in

hum

ans

(Gro

up 3

)

48

Ir

rita

tion

and

Sen

siti

zati

on

Der

mal

– N

on-H

uman

: se

nsit

izin

g at

25%

in g

uine

a pi

gs; m

inim

um in

duct

ion

conc

entr

atio

n w

as 1

M; w

as a

wea

k co

ntac

t all

erge

n in

a lo

cal l

ymph

nod

e as

say

Hum

an:

the

freq

uenc

y of

pos

itiv

e re

acti

ons

amon

g al

l pat

ient

s to

met

hyl m

etha

cryl

ate

was

7/2

2; th

e fr

eque

ncy

of

posi

tive

rea

ctio

ns a

mon

g pa

tient

s w

ith

artif

icia

l nai

ls w

as 1

/10

50

Eth

yl M

eth

acry

late

G

enot

oxic

ity

not m

utag

enic

in a

Sal

mon

ella

/mic

roso

me

assa

y; g

enot

oxic

ity

in a

mou

se ly

mph

oma

cell

ass

ay w

as c

onsi

dere

d li

kely

due

to

a c

last

ogen

ic m

echa

nism

1

Ir

rita

tion

and

Sen

siti

zati

on

Der

mal

– H

uman

: th

e fr

eque

ncy

of p

ositi

ve r

eact

ions

am

ong

al p

atie

nts

test

ed w

as 1

4/22

; The

fre

quen

cy o

f po

siti

ve

reac

tion

s am

ong

pati

ents

wit

h ar

tifi

cial

nai

ls w

as 7

/11

(64%

),

50

D

iscu

ssio

n It

ems

(Thi

s in

gred

ient

was

rev

iew

ed f

or it

s us

e na

il e

nhan

cem

ent p

rodu

cts.

) th

e Pa

nel w

as c

once

rned

wit

h th

e st

rong

se

nsit

izat

ion

and

cros

s- o

r co

-rea

ctiv

ity p

oten

tial o

f m

etha

cryl

ates

; how

ever

dat

a w

ere

subm

itte

d th

at in

dica

ted

ther

e w

ould

be

litt

le m

onom

er a

vail

able

for

exp

osur

e to

the

skin

; bec

ause

gen

otox

icit

y da

ta in

dica

ted

the

som

e m

etha

cryl

ates

co

uld

prod

uce

chro

mos

ome

dam

age,

the

Pane

l res

tric

ted

met

hacr

ylat

es to

the

nail,

and

it m

ust n

ot c

ome

in c

onta

ct w

ith

skin

; ini

tial

con

cern

that

exo

ther

ms

crea

ted

from

the

rapi

d po

lym

eriz

atio

n of

the

mon

omer

s co

uld

dam

age

the

nail

wer

e al

levi

ated

49

C

IR C

oncl

usio

n sa

fe a

s us

ed in

nai

l enh

ance

men

t pro

duct

s w

hen

skin

con

tact

is a

void

ed;

prod

uct

s co

nta

inin

g th

is in

gred

ien

t sho

uld

be

acc

ompa

nie

d w

ith

dir

ectio

ns

to a

void

ski

n c

onta

ct, b

ecau

se o

f th

e se

nsi

tizin

g po

ten

tial

of

met

hac

ryla

tes

49

Bu

tyl M

eth

acry

late

A

nim

al T

oxic

olog

y Si

ngle

Dos

e –

Der

mal

: 10

cc/

kg d

id n

ot c

ause

mor

tali

ty in

rab

bits

, but

acu

te d

erm

al ir

rita

tion

was

rep

orte

d; o

n e

LD

50

valu

e of

>20

00 m

g/kg

in r

abbi

ts w

as r

epor

ted;

the

LD

50 in

gui

nea

pigs

was

>20

ml/

kg

Ora

l ; r

epor

ted

ora

l LD

50 v

alue

s in

rat

s ra

nged

fro

m >

2000

to >

20,0

00 m

g/kg

I

nhal

atio

n: r

epor

ted

LC

50 v

alue

s w

ere

4910

ppm

, 29

mg/

ml,

and

28,4

69 m

g/m

3 rat

s;

Rep

eate

d D

ose

– O

ral :

in

rats

, the

NO

EL

S w

ere

20 m

g/kg

/day

in a

28-

day

stud

y, 3

0 (

mal

es)

and

300

(fem

ales

) m

g/kg

/day

in a

45-

day

stud

y, a

nd <

30 (

mal

es)

and

30 (

fem

ales

) m

g/kg

/day

in a

50-

day

stud

y I

nhal

atio

n: c

ause

d up

per

airw

ay ir

rita

tion

in a

28-

day

stud

y in

rat

s –

the

NO

EL

was

180

1 m

g/m

3

49

R

epro

duct

ive

and

Dev

elop

men

tal T

oxic

ity

Ora

l: a

dec

reas

e in

cor

pora

lute

a an

d im

plan

tati

ons

was

rep

orte

d in

rat

s; th

e pa

rent

al N

OA

EL

s w

ere

1000

and

300

m

g/kg

/day

for

mal

es a

nd f

emal

es, r

espe

ctiv

ely

Inha

lati

on:

thre

shol

d co

ncen

trat

ion

for

embr

yoto

xic

and

tera

toge

nic

effe

cts

in r

ats

was

0.1

mg/

m3 ; s

ligh

t fet

otox

icit

y w

as

repo

rted

in r

ats

expo

sed

to ≤

1200

ppm

on

days

6-2

0 of

ges

tati

on

49

G

enot

oxic

ity

not m

utag

enic

in m

ulti

ple

Am

es te

sts

wit

h or

wit

hout

met

abol

ic a

ctiv

atio

n; w

as m

utag

enic

to S

alm

onel

la ty

phim

uriu

m

TA

1538

wit

h m

etab

olic

act

ivat

ion

in o

ne s

tudy

49

Ir

rita

tion

and

Sen

siti

zati

on

Der

mal

- N

on-H

uman

: a

very

str

ong

sens

itiz

er in

one

stu

dy u

sing

gui

nea

pigs

; con

side

red

a m

oder

ate

sens

itiz

er in

an

othe

r st

udy

usin

g gu

inea

pig

s; in

a f

ew s

tudi

es, a

sen

sitiz

atio

n re

actio

n w

as n

ot p

rodu

ced

Hum

an:

1% c

ause

d 1

posi

tive

rea

ctio

n in

12

subj

ects

in a

Dra

ize

cont

act s

ensi

tiza

tion

stu

dy; i

n pr

ovoc

ativ

e te

stin

g, 1

%

elic

ited

posi

tive

reac

tion

s to

pat

ch te

sts

Muc

osal

: m

ildl

y ir

rita

ting

to r

abbi

t eye

s

49

Panel Book Page 34

Tab

le 5

. R

elev

ant s

umm

ary

info

rmat

ion

on m

onom

er c

ompo

nent

s (c

onti

nued

)

29

Mon

omer

Com

pone

nt

Par

amet

er E

valu

ated

O

utc

ome

Ref

eren

ce

D

iscu

ssio

n It

ems

(Thi

s in

gred

ient

was

rev

iew

ed f

or it

s us

e na

il e

nhan

cem

ent p

rodu

cts.

) th

e Pa

nel w

as c

once

rned

wit

h th

e st

rong

se

nsit

izat

ion

and

cros

s- o

r co

-rea

ctiv

ity p

oten

tial o

f m

etha

cryl

ates

; how

ever

dat

a w

ere

subm

itte

d th

at in

dica

ted

ther

e w

ould

be

litt

le m

onom

er a

vail

able

for

exp

osur

e to

the

skin

; bec

ause

gen

otox

icit

y da

ta in

dica

ted

the

som

e m

etha

cryl

ates

co

uld

prod

uce

chro

mos

ome

dam

age,

the

Pane

l res

tric

ted

met

hacr

ylat

es to

the

nail,

and

they

mus

t not

com

e in

con

tact

w

ith

skin

; ini

tial

con

cern

that

exo

ther

ms

crea

ted

from

the

rapi

d po

lym

eriz

atio

n of

the

mon

omer

s co

uld

dam

age

the

nail

w

ere

alle

viat

ed

49

C

IR C

oncl

usio

n sa

fe a

s us

ed in

nai

l enh

ance

men

t pro

duct

s w

hen

skin

con

tact

is a

void

ed;

prod

uct

s co

nta

inin

g th

is in

gred

ien

t sho

uld

be

acc

ompa

nie

d w

ith

dir

ectio

ns

to a

void

ski

n c

onta

ct, b

ecau

se o

f th

e se

nsi

tizin

g po

ten

tial

of

met

hac

ryla

tes

49

Isob

uty

l Met

hac

ryla

te

Ani

mal

Tox

icol

ogy

Sing

le D

ose

– D

erm

al:

the

repo

rted

der

mal

LD

50 w

as >

20 m

l/kg

in g

uine

a pi

gs

Ora

l : r

epor

ted

LD

50va

lues

in r

ats

rang

ed f

rom

>50

00 to

12,

800

mg/

kg

Inh

alat

ion:

50%

of

mic

e di

ed a

fter

exp

osur

e to

29.

74 m

g/l f

or 2

89 m

inut

es; w

as c

onsi

dere

d a

toxi

c (b

ut n

ot h

ighl

y to

xic)

sub

stan

ce b

y in

hala

tion

exp

osur

e

49

G

enot

oxic

ity

not m

utag

enic

in m

ulti

ple

Am

es te

sts

wit

h or

wit

hout

met

abol

ic a

ctiv

atio

n 49

Ir

rita

tion

and

Sen

siti

zati

on

Der

mal

- H

uman

: 1%

cau

sed

no p

osit

ive

reac

tion

in 1

1 su

bjec

ts in

a c

onta

ct s

ensi

tiza

tion

stu

dy; i

n pr

ovoc

ativ

e te

stin

g,

1% e

licit

ed p

ositi

ve r

eact

ions

to p

atch

test

s M

ucos

al:

mil

dly

irri

tatin

g to

rab

bit e

yes

49

D

iscu

ssio

n It

ems

(Thi

s in

gred

ient

was

rev

iew

ed f

or it

s us

e na

il e

nhan

cem

ent p

rodu

cts.

) th

e Pa

nel w

as c

once

rned

wit

h th

e st

rong

se

nsit

izat

ion

and

cros

s- o

r co

-rea

ctiv

ity p

oten

tial o

f m

etha

cryl

ates

; how

ever

dat

a w

ere

subm

itte

d th

at in

dica

ted

ther

e w

ould

be

litt

le m

onom

er a

vail

able

for

exp

osur

e to

the

skin

; bec

ause

gen

otox

icit

y da

ta in

dica

ted

the

som

e m

etha

cryl

ates

co

uld

prod

uce

chro

mos

ome

dam

age,

the

Pane

l res

tric

ted

met

hacr

ylat

es to

the

nail,

and

they

mus

t not

com

e in

con

tact

w

ith

skin

; ini

tial

con

cern

that

exo

ther

ms

crea

ted

from

the

rapi

d po

lym

eriz

atio

n of

the

mon

omer

s co

uld

dam

age

the

nail

w

ere

alle

viat

ed

49

C

IR C

oncl

usio

n sa

fe a

s us

ed in

nai

l enh

ance

men

t pro

duct

s w

hen

skin

con

tact

is a

void

ed;

prod

uct

s co

nta

inin

g th

is in

gred

ien

t sho

uld

be

acc

ompa

nie

d w

ith

dir

ectio

ns

to a

void

ski

n c

onta

ct, b

ecau

se o

f th

e se

nsi

tizin

g po

ten

tial

of

met

hac

ryla

tes

49

Lau

ryl M

eth

acry

late

A

nim

al T

oxic

olog

y Si

ngle

Dos

e –

Ora

l: n

o ra

ts d

osed

wit

h ≤2

1.5

ml/

kg C

12-C

18 m

etha

cryl

ate

mon

omer

s di

ed

Inh

alat

ion :

the

RD

50 w

as 3

900

mg/

m3 in

mic

e

49

Rep

eate

d D

ose

– In

hala

tion

: not

toxi

c to

rat

s in

a 2

0-da

y st

udy

49

Ir

rita

tion

and

Sen

siti

zati

on

Der

mal

– N

on-H

uman

: st

rong

sen

siti

zer

in g

uine

a pi

gs

49

D

iscu

ssio

n It

ems

(Thi

s in

gred

ient

was

rev

iew

ed f

or it

s us

e na

il e

nhan

cem

ent p

rodu

cts.

) th

e Pa

nel w

as c

once

rned

wit

h th

e st

rong

se

nsit

izat

ion

and

cros

s- o

r co

-rea

ctiv

ity p

oten

tial o

f m

etha

cryl

ates

; how

ever

dat

a w

ere

subm

itte

d th

at in

dica

ted

ther

e w

ould

be

litt

le m

onom

er a

vail

able

for

exp

osur

e to

the

skin

; bec

ause

gen

otox

icit

y da

ta in

dica

ted

the

som

e m

etha

cryl

ates

co

uld

prod

uce

chro

mos

ome

dam

age,

the

Pane

l res

tric

ted

met

hacr

ylat

es to

the

nail,

and

they

mus

t not

com

e in

con

tact

w

ith

skin

; ini

tial

con

cern

that

exo

ther

ms

crea

ted

from

the

rapi

d po

lym

eriz

atio

n of

the

mon

omer

s co

uld

dam

age

the

nail

w

ere

alle

viat

ed

49

C

IR C

oncl

usio

n sa

fe a

s us

ed in

nai

l enh

ance

men

t pro

duct

s w

hen

skin

con

tact

is a

void

ed;

prod

uct

s co

nta

inin

g th

is in

gred

ien

t sho

uld

be

acc

ompa

nie

d w

ith

dir

ectio

ns

to a

void

ski

n c

onta

ct, b

ecau

se o

f th

e se

nsi

tizin

g po

ten

tial

of

met

hac

ryla

tes

49

Panel Book Page 35

Tab

le 5

. R

elev

ant s

umm

ary

info

rmat

ion

on m

onom

er c

ompo

nent

s (c

onti

nued

)

30

Mon

omer

Com

pone

nt

Par

amet

er E

valu

ated

O

utc

ome

Ref

eren

ce

PE

G-4

Dim

eth

acry

late

A

nim

al T

oxic

olog

y Si

ngle

Dos

e –

Der

mal

: th

e L

D50

was

>3

g/kg

in r

ats

Ora

l : L

D50

was

>50

00 m

g/kg

in r

ats

49

G

enot

oxic

ity

not m

utag

enic

in m

ulti

ple

Am

es te

sts

wit

h or

wit

hout

met

abol

ic a

ctiv

atio

n; w

eakl

y po

siti

ve in

a m

ouse

lym

phom

a ce

ll as

say

wit

h m

etab

olic

act

ivat

ion

49

C

arci

noge

nici

ty

Der

mal

: no

incr

ease

in s

kin

or v

isce

ral t

umor

s in

an

80-w

k st

udy

49

Ir

rita

tion

and

Sen

siti

zati

on

Der

mal

- N

on-H

uman

: m

oder

ate

sens

itize

r in

gui

nea

pigs

; not

a s

ensi

tizer

in o

ne s

tudy

M

ucos

al:

min

imal

ly ir

rita

ting

to r

abbi

t eye

s

49

D

iscu

ssio

n It

ems

(Thi

s in

gred

ient

was

rev

iew

ed f

or it

s us

e na

il e

nhan

cem

ent p

rodu

cts.

) th

e Pa

nel w

as c

once

rned

wit

h th

e st

rong

se

nsit

izat

ion

and

cros

s- o

r co

-rea

ctiv

ity p

oten

tial o

f m

etha

cryl

ates

; how

ever

dat

a w

ere

subm

itte

d th

at in

dica

ted

ther

e w

ould

be

litt

le m

onom

er a

vail

able

for

exp

osur

e to

the

skin

; bec

ause

gen

otox

icit

y da

ta in

dica

ted

the

som

e m

etha

cryl

ates

co

uld

prod

uce

chro

mos

ome

dam

age,

the

Pane

l res

tric

ted

met

hacr

ylat

es to

the

nail,

and

they

mus

t not

com

e in

con

tact

w

ith

skin

; ini

tial

con

cern

that

exo

ther

ms

crea

ted

from

the

rapi

d po

lym

eriz

atio

n of

the

mon

omer

s co

uld

dam

age

the

nail

w

ere

alle

viat

ed

49

C

IR C

oncl

usio

n sa

fe a

s us

ed in

nai

l enh

ance

men

t pro

duct

s w

hen

skin

con

tact

is a

void

ed;

prod

uct

s co

nta

inin

g th

is in

gred

ien

t sho

uld

be

acc

ompa

nie

d w

ith

dir

ectio

ns

to a

void

ski

n c

onta

ct, b

ecau

se o

f th

e se

nsi

tizin

g po

ten

tial

of

met

hac

ryla

tes

49

Panel Book Page 36

31

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. International Cosmetic Ingredient Dictionary and Handbook. Washington, DC:

Personal Care Products Council, 2010. 5. Lubrizol.Introducing PemulenTM polymeric emulsifiers. TDS 114. 2002.

http://www.lubrizol.com/PersonalCare/Products/Pemulen/TDS.html. Accessed 12-7-2010. 6. Personal Care Products Council. Specification information on acrylates/C10-30 alkyl acrylate crosspolymer. 12-15-

2010. Unpublished data submitted by the Council on December 15, 2010. (1 p). 7. 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).

8. Kim, T. H., Ko, Y. S., and Kwon, Y. K. Preparation and characterization of colored electronic ink nanoparticles by high temperature-assisted dyeing for electrophoretic displays. J Nanosci.Nanotechnol. 2006;6:(11):3450-3454.

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

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

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

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

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

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

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

16. 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 upon request.

17. Food and Drug Administration (FDA). Frequency of use of cosmetic ingredients. FDA Database. 2010. Washington, DC: FDA.Updated May 4.

18. 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 Jan28, 2011. (5 pp).

19. Castañeda, J. Y., Amjad, Z., and Rouse, W. M. Polymeric emulsifier-based conditioning skin lotions. Cosmet.Toiletries. 1991;106:(Dec):41-45.

20. James AC, Stahlhofen W, Rudolf G, 0, and et al. Deposition of inhaled particles. Annals of the ICRP. 1994;24:(1-3):231-232.

21. Oberdorster G, Oberdorster E, and Oberdorster J. Nanotoxicology: An emerging discipline evolving from studies of ultrafine particles. Environ Helath Perspect. 2005;113:(7):823-839.

22. Bower D. Unpublished information on hair spray particle size provided at the September 9, 1999 CIR Expert Panel meeting. 1999.

23. Johnson MA. The influence of particle size. Spray Technology and Marketing. 2004;November:24-27. 24. European Commission.European Commission Health and Consumers Cosmetics - Cosing - Database. 2010.

http://ec.europa.eu/consumers/cosmetics/cosing/. Accessed 11-30-2010. 25. 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).

Panel Book Page 37

32

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

27. 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.

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

29. 3V Sigma. Toxicological summary review on acrylates/vinyl isododecanoate crosspolymer. 2010. Unpublished data submitted by the Council on Dec 14, 2010. (3 pp).

30. 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 upon request.

31. Lubrizol.Carbopol® 1382 Polymer (acrylates/C10-30 alkyl acrylate crosspolymer) toxicology studies. TOX-002. 1993. http://www.lubrizol.com/PersonalCare/Products/Carbopol/Carbopol1382.html. Accessed 12-7-2010.

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

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

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

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

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

37. 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).

38. CAS Registry Online Database. 2010. 39. CosPharm Inc.Product characeteristics of Poly-Pore L200 (Allyl Methacrylates Crosspolymer). 2011.

http://www.cospharm.com/chemdal/p1200.htm. Accessed 1-19-2011. 40. CosPharm Inc.Product characteristics of Poly-Pore E200 (Allyl Methacrylates Crosspolymer). 2011.

http://www.cospharm.com/chemdal/pe200.htm. Accessed 1-19-2011. 41. Personal Care Products Council. Concentration of use by FDA product category: Acrylate Crosspolymer

ingredients. 1-5-2011. Unpublished data submitted by the Council on Jan 5, 2011. (5 pp). 42. International Agency for Research on Cancer.Acrylic acid. 1987.

http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-60.pdf. Accessed 1-21-2011. 43. International Agency for Research on Cancer.Methyl acrylate. 1987.

http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-104.pdf. Accessed 1-21-2011. 44. International Agency for Research on Cancer.Ethyl acrylate. 1987.

http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-99.pdf. Accessed 1-21-2011. 45. International Agency for Research on Cancer.n-Butyl acrylate. 1987.

http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-14.pdf. Accessed 1-21-2011. 46. International Agency for Research on Cancer.2-Ethylhexyl acrylate. 1994.

http://monographs.iarc.fr/ENG/Monographs/vol60/mono60-19.pdf. Accessed 1-21-2011. 47. Andersen FA (ed). Final report on the safety assessment of methacrylic acid. Int J Toxicol. 2005;24:(Suppl 5):33-51. 48. International Agency for Research on Cancer.Methyl methacrylate. 1994.

http://monographs.iarc.fr/ENG/Monographs/vol60/mono60-18.pdf. Accessed 1-21-2011. 49. 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. 50. 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

Panel Book Page 38

33

crosspolymer. 11-15-2010. Available from CIR, 1101 17th St, NW, Ste 412, Washington, DC 20036 www.cir-safety.org.

Panel Book Page 39

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 CW Expert Panel

DATE: January 20, 2011

SUBJECT: Comments on the Scientific Literature Review on Crosslinked Alkyl Acrylates

p.1 - Will literature searches be completed for those monomers which have not yet been reviewed byCIR? Searches on the monomers limited to dermal effects (especially sensitization) would beuseful. Also consider summarizing the information in the CIR report on the AcrylateCopolymers (which includes Sodium Polyacrylate [a study on this compound is presented onp.5 of this SLR]) in this report.

p.1 - Monograph proofs for Acrylates/C12-13 Alkyl Methacrylates/Methoxyethyl AcrylateCrosspolymer and Methacrylic AcidJPEG-6 Methacylate Crosspolymer are attached. These twoingredients are on the On-Line listed as monograph development in progress.

p.2 - In the Physical and Chemical Properties section, it would be helpful to state that these are largemolecules with reported molecular weights generally much larger than 1000 Daltons.

p.3 - In the first paragraph, please change “sodium acrylates/C10-30 allyl acrylate crosspolymer” to“sodium acrylates/C 10-30 alkyl acrylate crosspolymer”.

p.4. - It would be helpful to state why Acrylates/C12-13 Alkyl Methacrylates Methoxyethyl AcrylateCrosspolymer and Methacrylic AcidIPEG-6 Methacrylate Crosspolymer are not yet listed in theEuropean Union inventory of cosmetic ingredients. These are new ingredients that are justreceiving a name. When the naming process is complete, they will be added to the EuropeanUnion inventory.

p.4 - Please provide a rational as to why dermal penetration data are needed for such large molecules.Generally, substances >1000 Daltons are not considered to penetrate the skin. If molecularweights of the substances are less than 1000 Daltons, then dermal penetration data would behelpful.

p.6 - The doses used in the EYE-TEX assay of Acrylates/Vinyl Isododecanoate Crosspolymer were100 p.1 (not 100 ml).

p.8 - It should be made clear that respirable dusts are considered to be particles < 10 1iM in size. MAKstands for maximum admissible concentration.

p.9-20 - Table 1 - Please provide a reference(s) for this table. Is there something in theFormulalStructure column? It does not appear in the pdf file or when the report is printed.

1101 17th Street, N.W, Suite 30O Washington, D.C. 20036-4702 202.331.1770 202.331.1969 (fax) www.personalcarecouncil.org Panel Book Page 40

p.10, Table 1 - Where did the two CAS numbers listed under Acrylates Crosspolymer come from?ChemiD indicates that 26794-61-6 is for 2-propenoic acid, 2-methyl-, 1,1’-(1,2-ethandiyl) ester,polymer with butyl 2-methyl-2-propenoate, and does not appear to be appropriate for AcrylatesCrosspolymer.

p.14, Table 1 - Why is “highly crosslinked” in bold text in the definition of Allyl Methacrylate/GlycolDimethacrylate Crosspolymer?

Second p.11 - Where did “peroxydicarbonate (initiator)” come from as it is not mentioned in theMethods of Manufacture section.

2

Panel Book Page 41

01/19/2011

Monograph Proof-A-

25229: ACRYLATES/C12-13 ALKYLMETHACRYLATES/METHOXYETHYLACRYLATE CROSSPOLYMER

INCI Monograph ID: 25229

Flags: ReadyToPublish

Definition: Acrylates/C1 2-13 AIkylMethacrylates/Methoxyethyl AcrylateCrosspolymer is a copolymer of C12-13 alkylmethacrylates, methoxyethyl acrylate, andone or more monomers of acrylic acid,methacrylic acid or one of their simple esters,crosslinked with vinyloxazoline.

Chemical Class: C942- Synthetic Polymers

Reported Function: F420- Hair Fixative

Ingredient Source: Synthetic

Trade Name:N97207- Diahold A-403 (Si 397- Mitsubishi

Chem)

-M

25230: METHACRYLIC ACID/PEG-6METHACRYLATE CROSSPOLYMER

INCI Monograph ID: 25230

Flags: UnderDevelopment

Definition: Methacrylic Acid/PEG-6Methacrylate Crosspolymer is a copolymer ofmethacrylic acid and PEG-6 methacrylatecrosslinked with polyethyene glycoldimethacrylate. Monograph development inprogress.

Chemical Class: C942- Synthetic Polymers

Reported Function: F340- Film Former

Ingredient Source: Synthetic

Trade Name Mixtures:N97208- Nabion Anti-Wrinkle Complex

LabO2 (S9202- Nabion Co.)N97209- Nabion Whitening Complex LabOl

(S9202- Nabion Co.)

International Cosmetic Ingredient Dictionary and Handbook Monograph Proof • 1 Panel Book Page 42

Personal Care Products CouncilCommitted to Safety,

ua ity nnovation

Memorandum

TO: F. Alan Andersen, Ph.D.Director - COSMETIC LNGRED]ENT REWEW (CIR)


DATE: November 30, 2010

SUBJECT: Information on Sodium Acrylates Crosspolymer-2

Sumitomo Seika. 2010. Cosmetic Grade: AQUAKEEP 1OSH-NFC (Sodium Acrylates Crosspolymer2).

Sumitomo Seika. 2010. Materia safety data sheet: AQUAKEEP 1OSH-NFC (Sodium AcrylatesCrosspolymer-2).

11011 7th Street, N.W., Suite 3O0 Washington, D.C. 20036-4702 202.331.1770 202.331.1969 (fax) www.personalcarecouncil.org Panel Book Page 43

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Panel Book Page 44

AQUA KEEP IOSH-NFC, 2500-61-0-02E, 11 Jan. 2010, 115

MATERIAL SAFETY DATA SHEET

1. PRODUCT & COMPANY IDENTIFICATION C-oPRODUCTNAME AQUAKEEP10SH-NFCNAME OF SUPPLIER SUMITOMO SEIKA CHEMICALS CO., LTD. SuperAbsorbent Polymers DivisionADDRESS OF SUPPLIER The Sumitomo Building 4-5-33 Kitahama, Chuo-ku, Osaka, 541-0041, JapanTELEPHONE NUMBER +81-6-6220-8532TELEFAX NUMBER +81-6-6220-8578EMERGENCY TELEPHONE

Asia Pacific except China ÷65-633-44-177 (CARECHEM24, Singapore)+86-10-5100-3039 (CARECHEM24, Beijing, China)+44-208-762-8322 (CARECHEM24, UK)+961-3-487-287 (CARECHEM24, Lebanon)800-424-9300 (CHEMTREC, USA)

GHS ClassificationHAZARD CLASSFLAMMABLE SOLIDSSELF-REACTIVE SUBSTANCES AND MIXTURESPYROPHORIC SOLIDS

SELF-HEATING SUBSTANCES AND MIXTURESSUBSTANCES AND MIXTURES WHICH, IN CONTACTWITH WATER, EMIT FLAMMABLE GASES

OXIDIZING SOLIDSORGANIC PEROXIDES

ACUTE TOXICITY - ORALACUTE TOXICITY — SKINSKIN CORROSION/IRRITATION

EYE DAMAGE/IRRITATION

SENSITIZATION — RESPIRATORY AND SKINGERM CELL MUTAGENICITYSPECIFIC TARGET ORGAN SYSTEMIC TOXICITY

(REPEATED EXPOSURE)HAZARDOUS TO THE AQUATIC ENVIRONMENT(CHRONIC HAZARD)

OTHER CLASSES

SYMBOL

CATEGORYNot classified

Not classifiedNot classified

Not classified

Not classified

Category 5Not classifiedNot classifiedNot classifiedNot classifiedNot classifiedCategory 2(Liver)

Category 4

“Not applicable” or “Of no classification”

PICTOGRAM

SIGNAL WORDHAZARD STATEMENT

RESPONSE

WarningMay be harmful if swallowedCaused damage to organs (liver) through prolonged or repeated exposureMay cause long lasting harmful effects to aquatic lifeAvoid release to the environment.Call a doctor if you feel unwell.Do not breathe dust.Products become slippery when it absorbs the water.Disposal should be done in accordance with local, state or national legislations.

China

Europe, Israel & Americas except USA

Middle East & AfricaUSA

2. HAZARDS IDENTIFICATIONTHE MOST IMPORTANT HAZARD At high temperature: Thermal decomposition can give toxic products.AND EFFECTS PHYSICAL AND (CO, CO2)CHEMICAL HAZARDS In the presence of an ignition source: Dust can explosive mixture with air.

Caused damage to organs (liver) through prolonged or repeatedexposure.

Not classified

Not classified

Panel Book Page 45


3. COMPOSITION/INFROMATION ON INGREDIENTS

CHEMICAL/MIXTURECHEMICAL NAMECHEMICAL FORMULA

4. FIRST-AID MEASURESINHALAIONSKIN CONTACTEYE CONTACT

INGESTION

INDICATIONADVICE FOR FIRST-AID

PERSON

ADVICE FOR DOCTOR

5. FIRE-FIGHTING MEASURESEXTINGUISHING MEDIAPROHIBITED MEDIASPECIFIC HAZARD

FOR FIRE-FIGHTING

SPECIFIC EQUIPMENT FORTHE FIREFIGHTERS

MIXTUREAcrylic Acid Polymer Sodium Salt, Additives(C H 2-C H),-(C H 2-C H)

Remove to fresh air. Rinse out with gargles and seek medical attention.Immediately flush skin with copious amount of water.Immediately flush eyes with copious amount of waterand week medical attentionRemove contact lenses, if present and easy to do.Remove AQUA KEEP as much as possible that can be taken out from themouth. Seek doctor immediately.If the victim is conscious, induce vomiting and rinse his mouth thoroughlywith plenty of water.Choking, nausea, and stomachache.Ware effective dust mask.Remove AQUA KEEP as much as possible, because it is hard to treat whenAQUA KEEP absorbs the water.Let the victim take an enough rest,

Water, Dry Powder, Carbon dioxide(C02), Foam.NoneIn the presence of an ignition source: Dust can form explosive mixture withAir (in an enclosed space).Temperature above 200°C: Thermal decomposition can give toxic products,Organic derivatives, Carbon monoxides.Fight a fire from windward if possible.Move the container to the safety area if possible.Sprinkle the container and its surroundings with water if not possible tomove.Wear protective clothing, safety goggles and self-contained breathingapparatus.

6. ACCIDENTALRELEASE MEASURESPERSONAL PRECAUTIONS : Avoid contact with skin and eyes.

Prohibit inhalation of dust.ENVIRONMENTAL : Products become slippery when it absorb the water.

PRECAUTIONS : Do not release into environment.Do not let the product enter into drains.

METHODS FOR CLEANINGRECOVERY

DISPOSALADVICE TO PREVENT

SECONDARY DISASTER

Collect product by mechanical means.Do not rinse with water that makes the ground slippery.Moist product : Absorb the remainder with an inert absorbent material.Wear protective clothing, safety goggles and effective mask to prevent thedust from contacting eye and skin.Destroy the product by incineration.Products become slippery when it absorb the water.

COOH COONaCHEMICAL NATURE FORMULA CAS No.

Acrylic Acid Polymer Sodium Salt — 9003-04-7n-Heptane C7H16 142-82-5Silicon dioxide SiO2 7631-86-9Water H2O —

Panel Book Page 46

AQUA KEEP IOSH-NFC, 2500-61-0-02E, 11 Jan. 2010, 3/5

7. HANDLING AND STORAGEHANDLING

TECHNICAL : Avoid dust forming.MEASURES : Storage and handling precautions applicable to products:

Dust forming, forming explosive mixtures with air (In the presence of anignition source:Ensure appropriate exhaust and ventilation at machinery and at placeswhere dust can be generated (Do not recycle permanently dust-laidenair).

PREVENTION OF : Wear suitable chemical resistant gloves, safety goggles, dust mask andEXPLOSURE other clothing.

Use only in the well ventilated area.PREVENTION OF FIRE : Keep away from heat, sparks, flame and all other ignition sources.

AND EXPLOSIONVENTILATION : Local and general ventilation and cleaning after Dust forming.NOTICE : Do not handle roughly, such as dropping, shocking, and dragging etc.

Products become slippery when it absorb the water.STORAGE

TECHNICAL ADVICE : Avoid the humidity ,especially the contact the water directly.STORAGE CONDITION : Keep container tightly closed.

Keep container in cool.Protect from direct sunlight.Store protected from moisture.Keep away from heat and sources of ignition.Provide electrical earthing of equipment and electrical equipment usable inexplosive atmosphere.

RECOMMENDED : The material must be watertightPACKAGING

8. EXPOSURE CONTROL I PERSONAL PROTECTIONPROTECTIVE PROVISIONS Ensure sufficient air exchange and / or exhaust in work areas

(Do not permanently recycle dust-laiden air)CONTROL PARAMETERS

EXPOSURE LIMIT : 0.05mg/rn3(MAK, 2005) (respirable dust : particle size <lOu m)Not listed (OSHA, 2004)Not listed (ACGIH, 2005)

TECHNICAL ADVICE : Dust collector should be installed to improve the working environment.PERSONAL PROTECTIVE

EQUIPEM ENTRESPIRATORY : Effective dust muskHAND GlovesEYE : Safety glasses I gogglesSKIN AND BODY : Non-skid bootsSPECIFIC HYGIENE Avoid contact with skin and eyes.

MEASURES Prohibit inhalation of dust9. PHYSICAL AND CHEMICAL PROPERTIES

PHYSICAL STATE : SolidFORM : Granular powderCOLOUR : WhiteODOR : OdorlessBULK DENSITY 0.75 to 0.95 g/mlpH :6to8FLASH POINT Not relevantAUTO IGNITION Above 400°C

TEM PERATU RESOLUBILTY IN WATER : Swells in waterDUST LOWER : 600g/m3

EXPLOSION LIMITELECTRICAL RESISTIVITY : 1.6 x 1011QmDUST MINIMUM : No explosion ; The energy is lower than l000mJ at 800 to 2000g/m3.

IGNITION ENERGY

Panel Book Page 47

AQUA KEEP IOSH-NFC, 2500-61-0-02E, 11 Jan. 2010, 4/5

1 0. PHYSICAL HAZARD (STABILITY AND REACTIVITY)STABILITY : Stable in room temperature.

Thermal decomposition will start above about 200°C.Products become slippery when it absorb the water.HAZARD IN SPECIAL

CONDITIONCONDITIONS TO AVOID

MATERIAL TO AVOIDHAZARDOUS

DECOMPOSITIONPRODUCTS

1 1 .TOXICOLOGICAL INFORMATION 1)

ACUTE TOXICITYIRRITATION I

CORROSIVENESSSKIN IRRITATIONSKIN CORROSIVENESSEYE IRITATIONVAGINAL MUCOSA

IRITATIONSKIN CONTACT

SENSITISATIONMUTAGENICITY

CARCINOGEN ICITYTOXIC TO REPRODUCTIONSPECIFIC TARGET ORGAN

SYSTEMIC TOXICITY(SINGLE EXPOSURE)

ASPIRATION TOXICITYSYMPTOMS OF

EXPLOSURE

Oral rat LD50 >2,000m g 1kg

Not irritant (Human, Rabbit)None(Rabbit)None(Rabbit)None(Dog)

Not sensitizing(Guinea Pig)

AMES test is negative, using Salmonella typhimurium (TA 98, TA100,TA1 535 and TA1 537) and Escherichia coli (WP2uvrA)

:Nodata:Nodata

No data

No dataDust may cause eye, nasal, or bronchial irritation.

1 2 .ECOLOGICAL INFORMATIONPERSISTENCE

I DEGRADABILITY

1 3 .DISPOSAL CONSIDERATIONSDISPOSAL OF PRODUCT

DISPOSAL OF PACKAGE

1 4.TRANSPORT INFORMATIONADR/ RIDIMDGIATASPECIFIC MEASURE

1 5 .REGULATORY INFORMATIONSAFETY DATA SHEETS

DANGEROUSPREPARATIONS

INVENTORIES

R-phrase 2)

HS code

Not biodegradable

Disposal should be done in accordance with local, state or nationallegislations.Disposal should be done after package is empty.

Not regulatedNot regulatedNot regulatedBe careful for falling or damage in loading.Avoid to contact with water.Avoid to shipment with the strong odoriferous things.

D.91/1 55/EEC amended by D.93/112/EEC (Dangerous substance andpreparations)

D.88/379/EEC amended by D.93/1 8/EEC (3rdATP)

Not classified as dangerous.TSCA(USA) : ConformsEINECS(EU): ConformsENCS(JPN) ConformsR52/53

Keep away from heat and sources of ignition.Store protected from moistureNone.Thermal decomposition gives toxic products

organic vapors, carbon monoxide

H41 3

Panel Book Page 48


1 6. OTHER INFORMATIONRECOMMENDED USE Super absorbent polymers

Aqueous fluid absorbentREFERENCES 1) Data of contracted laboratory

2) Directives, 67/548/EEC and 1999145/EC

With regard to Regulatory, it is user’s responsibility to investigate if the product complies with their countryor region’s laws or regulations.

The information relates to this specific product. It will not be valid if the product is used with any otherproducts or in any process.

It is user’s responsibility to determine the suitability and completeness of this information for user’sparticular purpose such as user’s commodity and/or usage shown below:

1) Where AQUA KEEP 1 OSH-NFC contacts with food directly.2) Where AQUA KEEP 1 OSH-NFC contacts with food via the water absorbed in AQUA KEEP 1 OSH-NFC.3) Where AQUA KEEP 1 OSH-NFC causes ingestion and contacts with eye directly.4) Where AQUA KEEP 1OSH-NFC causes accidental ingestion.

Panel Book Page 49

Personal Carei Products CouncilCommitted to Safety,Quality & Innovation

Memorandum

TO: F. Alan Andersen, Ph.D.Director - COSMETIC 1NGREDIENT REVIEW (Cifi)

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

DATE: December 14, 2010

SUBJECT: Information on Acrylates/Vinyl Isodecanoate Crosspolymer

Molecular Weight: Number average molecular weight 24,400 Daltons (<1% by weight is<1,000 Daltons)

Residual monomer: residual acrylic acid monomer content <0.05% by weightMethod of manufacture: synthetic chemical reaction by free radical polymerization

3V Sigma. 2010. Stabylen 30 (Acrylates/Vinyl Isodecanoate Crosspolymer): Toxicological SummaryReview.

1101 17th Street, N.W., Suite 3OO Washington, D.C. 20036-4702 202.331.1770 202.331.1969 (fax) www.personakarecouncil.org Panel Book Page 50

Cos’5pdywe/e h

iTh1 L SPA.

STABYLEN® 30: TOXICOLOGICAL SUMMARY REVIEW

V Acute Oral Toxicity: LD50 (oraL, rat):> 2.0 Ik bodyweight - (assumption based on a chemicaLcompound sharing a close chemical structure)

V Acute “in vitro” Dermat Irritation (tested according to SKIN-TEX® validated alternativemethod): Non- irritant (rabbit): Summary Report Attached

V Acute “in vitro” Ocular Irritation (tested according to EYE-TEX® validated alternativemethod): Non- irritant (rabbit): Summary Report Attached

EYETEX® AND SKINTEX® STUDIES REPORT

STUDY CENTRE: ROPAK LABORATOIRES EUROPE (now IN-VITRO INTERNATIONAL) -GENNEVILLIERS- FRANCE

The EYETEX and SKINTEX assays are standardised and quantitative in vitro acute ocular and dermatirritation tests which utilise changes of relevant macromolecules, upon exposure to chemicals andformuLations, to predict in vivo irritancy and toxicity endpoints.

The EYETEX test provides significant advances over the in vivo Draize test method. The DRAIZE eyeirritation assay has been criticised because of the large variability of results obtained fromdifferent laboratories that have analysed the same specimens, The variability is attributed to thefact that the assay is highly infLuenced by the size of the test group, the extent of the observationand subjective nature of irritation1.

The SKINTEX is the first well defined prototype assay system representing the use of targetmacromolecules or macromolecuLar structures relevant to in vivo pathways, structures, or events inthe skin to predict in vivo toxic effects of chemicals and formulations. The SKINTEX systemprovides significant advances over the in vivo Draize test method. The applicability of irritation orsensitisation evaluation based on the visual assessment of reactions in animals has been a source ofcontroversy for many years. Levels of skin damage are judged by observation, a procedure that haslong been noted as highly subjective and unreLiable, Leading to problems of interlaboratoryvariability and calling the accuracy of the data into question2.

By contrast,the EYETEX and SKINTEX tests have been found to be highly reproducible and morequantitative than the Draize test.

To perform the EYETEX test, each of the test samples is applied to a semi-permeable cellulosemembrane which comes into contact with the EYETEX reagent. The EYETEX reagent, an organisedprotein matrix which mimics the rabbit cornea, is a lyophilised powder containing globulin’s,albumin’s, mucopolysaccharides and lipids, along with buffer salts. The powder is reconstituted bythe addition of the EYETEX water. The samples are incubated for 24 hours at 25 ± 1 °C.

The sampLes react directly with the organised protein matrix reagent to produce turbidity. Theturbidity is measured in OpticaL density (OD) UNITS on the Jenway 6060 Colorimeter at 400 nm. Thechange in OD can be quantified and scored for the prediction of ocular irritation.

The SKINTEX assay is a standardised and quantitative in vitro acute dermal irritation test methodbased on a two-compartment biomacromolecular model. To perform the assay, the test sample isapplied to and is absorbed by or permeates a semi-permeable membrane coated with a keratincollagen matrix cross linked to a dye. The sample also reacts directLy with a highly ordered

1 Panel Book Page 51

7/JIJ

globulin and dermaL protein reagent which undergoes conformational changes when challenge witha chemical irritant, The turbidity and dye release caused by the sample are measured in opticaldensity units via a colorimeter at 470 nm. The changes in CD can be quantified and scored for theprediction of dermaL irritation.

A caLibration curve is constructed based on a standard set of Calibrators with known in vivo results.An CD reading for a test sampLe is read versus the calibration curve and the in vivo equivalentscale.

Based on this scoring system predicted irritation classes can be assessed. The testing proceduresfollowed are published in IN VITRO INTERNATIONAL’s DIRECTIONS for USE manuals.

The results of the EYETEX AND SKINTEX analysis performed on STABYLEN 30 sampLes provided apredicted in vivo classification for the test sample in terms of potential to cause ocular and dermalirritations.

Initially, a standard voLume-response study was performed with the EYETEX Upright membraneAssay (UMA) method. The following volumes of neat sampLe were applied for analysis: 10,20,30,50and 100 t I: This investigation clearly demonstrated that at 100 t I, the highest Qualified Dose,STABYLEN 30 proves to be NON IRRITANT based on the EYETEX Draize equivalent (EDE) scoringsystem.

A similar volume-response study was performed with the SKINTEX Human response assay (HRA)method. The results clearly demonstrated that the sample is NON IRRITANT based on the HumanEquivalency scoring system. -

In summary, EYETEX and SKINTEX test systems could be successfulLy employed to classify the ocuLarand dermal irritation potentials of this sample.

1 “Evaluation of a system for assessing ocular toxicity of Surfactants and Surfactants-based formulations” presentedat the 25th World Congress on Surfactants (Barcelona, Spain), pp.533-545 (1994)

2 “In vitro methods to predict dermal toxicity”, In vitro TOXICOLOGY, pp.47-55 (1994)


7/V/! \

V VilVh V SRA.

HUMAN

TOXICITY DATA

“IRRITATION AND SENSITIZATION POTENTIAL STUDY IN HEALTHY VOLUNTEERS” performed atthe University of PAVIA School of Medicine, Dermatological Clinics, PAVIA ITALY, directed by Prof.G. RABBIOSI.

The study was conducted on 25 healthy volunteers (males and females, age interval 19-63)and symptoms were scored according to a pre-determined table after visual assessment ofsymptoms such as papules, vesicles, itching, burning and stinging.

Aqueous solutions containing the test article ranged in concentration between 0.5 and 2.5%. No irritation was detected. Sensitisation was evaluated using the Kligman test. No signs ofsensitisation were detectable in the study population.

R. VILLA, Pharm. D.** (Electronically signed)

3V SIGMA S.p.A., R& D DepartmentBoard Certified Toxicologist


TO:

‘Products Counci

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

Committed to Safety,Quality & Innovation

FROM:

DATE:

John Bailey, Ph.D.Industry Liaison to the Cifi Expert Panel

December 15, 2010

SUBJECT: Specification Information on Acrylates/C10-30 Alkyl Acrylates Crosspolymer

Molecular Weight:Residual monomer:

Method of manufacture:

Total residual solvent:Supplied:

>50,000 Daltonstypically less than 2500 ppm acrylic acid; less than 500 ppm residualester (C10-30 Alkyl Acrylate)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)

less than 0.5%as a powder, approximately 100% active

1101 17th Street, N.W., Suite 300 Washington, D.C. 20036-4702 202.331.1770 202.331.1969 (fax) www.personalccirecouncil.org

Persona Care

Memorandum

Panel Book Page 54

Personal Care Products CouncilCommitted to Safety,

ua ity nnovation

Memorandum




SUBJECT: HRIPTs on Products Containing Acrylates/C10-30 Alkyl Acrylate Crosspolymer

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.

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.

11011 7th Street, N.W., Suite 3O0 Washington, D.C. 20036-4702 202.331.1770 202.331.1969 (fax) www.personalcarecouncil.org Panel Book Page 55

Consumer Product Testing Co.‘iST. O75

FINAL REPORT

CLIENT:

A

ATrENTION:Licensed Cosmetologist

TEST: Repeated Insult Patch TestProtocolNo.: LOl

TEST MATERIAL: Body Lotion

1\cEXPERIMENT /

REFER1NCE NUMBER; C09-1 109.01 cD- ,A\0\

Reviewed by: Richard R. Eisenberg, M.D.Medical DirectorBoard Certified Dermatologist

Approved by: Joyai RA.Executive Vice President, Clinical Evaluations

Report Date:

________

This reprI is submitted fr the exclusive use of The person, partnership, or corporation to whom ft is addressed, and niThor the report nor the

name of these Laboratories not any member of its staff, may be used in cnnoc1lon with the advertising or sale of any product or process

without written authorization

70 New [hitch Lane • Fairfield. New Jersey 07004-2514 • (973) 808-7 I 11 • Fax 973) 808-7234-

Panel Book Page 56

Consumer Product Testing Co.Est 975

QUALITY ASSURANCE UNIT STATEMENT

Study No,: C09-l 109.01

The objective of the Quality Assurance Unit (QAU) is to monitor the conduct and reporting of clinical

laboratory studies. These studies have been performed with adherence to the applicable ICH GuidelineE6 for Good Clinical Practice and requirements provided for in 21 CFR parts 50 and 56 and inaccordance to standard operating procedures and applicable protocols. The QAU maintains copies ofstudy protocols and standard operating procedures and has inspected this study. All data pertinent to thisstudy will be stored in the Consumer Product Testing Company archive, unless specified otherwise, inwriting by the Sponsor.

Quality Assurance personnel involved:

Quality Assurance Date

The representative signature of the Quality Assurance Unit signifies that this study has been performedin accordance with standard operating procedures and study protocol as well as government regulationsregarding such procedures and protocols.

70 New Dutch Lane • Fairfield, New Jersey 07004-2514 (973) 808-7111 • Fax (973) 808-7234

Clinical • Toxicology • Analytical Chemistry Microbiology

Panel Book Page 57

C0Jl 09.01Page 3

Objective: To determine by repetitive epidermal contact the potential of a test materialto induce primary or cumulative irritation and/or allergic contactsensitization.

Participants: One hundred fifteen (115) qualified subjects, male and female, ranging in agefrom 16 to 77 years, were selected for this evaluation. One hundred seven(107) subjects completed this study. The remaining subjects discontinuedtheir participation for various reasons, none of which were related to theapplication of the test material.

Inclusion Criteria: a. Male and female subjects, age 6 and over.b, Absence of any visible skin disease whichmight be confused with a kin

reaction from the test material.e. Prohibition of use of topical or systemic steroids and/or antihistamines

for at least seven days prior to study initiation.d. Completion of a Medical History form and the understanding and

signing of an Informed Consent form.e. Considered reliable and capable of following directions.

Exclusion Criteria: a. Ill health.b. Under a doctor’s care or taking medication(s) which could influence the

outcome of the study.c. Females who are pregnant or nursing.d. A history of adverse reactions to cosmetics or other personal care

products.

Test Material: Body Lotion-

Study Schedule: Panel # Initiation Date Completion Date

20090070 March 9, 2009 April 16, 200920090073 March 16, 2009 April 23, 2009

aWith parental or guardian consent

Panel Book Page 58

C09-l 109.01Page 4

Methodology: The upper back between the scapulae served as the treatment area.Approximately 0.2 g of the test material, or an amount sufficient to cover thecontact surface, was applied to the 1’ x I absorbent pad portion of a clearadhesive dressing and allowed to volatilize for several minutes. This wasthen applied to the appropriate treatment site to form a semi-occlusive patch.

Induction Phase:

Patches were applied three (3) times per week (e.g., Monday, Wednesday,and Friday) for a total of nine (9) applications. The site was marked to ensurethe continuity of patch application. Following supervised removal andscoring of the first Induction patch, participants were instructed to remove allsubsequent Induction patches at home, twenty-four hours after application.The evaluation of this site was made again just prior to re-application. If aparticipant was unable to report for an assigned test day, one (1) makeup daywas permitted. This day was added to the Induction period.

With the exception of the first supervised Induction Patch reading, if any Lestsite exhibited a moderate (2-level) reaction during the Induction Phase,application was moved to an adjacent area, Applications were discontinuedfor the remainder of this test phase, if a moderate (2-level) reaction wasobserved on this new test site. Applications would also be discontinued ifmarked (3-level) or severe (4-level) reactivity was noted.

Rest periods consisted of twenty-four hours following each Tuesday andThursday removal, and forty-eight hours following each Saturday removal.

Challenge Phase;

Approximately two (2) weeks after the final Induction patch application, aChallenge patch was applied to a virgin test site adjacent to the originalInduction patch site, following the same procedure described for Induction.The patch was removed and the site scored at the clinic twenty-four andseventy-two hours post-application.

Panel Book Page 59

C09-1 109M1Page5

Methodology(continued): Evaluation Criteria (Erythema and additional Dermal Seguelac):

0 No visible skin reaction E = Edema0.5 / + = Barely perceptible D = Dryness

1 Mild S = Staining2 = Moderate P = Papules3 = Marked V = Vesicles4 Severe B = Bullac

U = UlcerationSp = Spreading

Erythema was scored numerically according to this key. If present, additionalDermal Sequelae were indicated by the appropriate letter code and anumerical value for severity.

Results: The results of each participant are appended (Table I).

Observations remained within normal limits throughout the test interval.

Subject demographics are presented in Table 2.

Summary: Under the conditions of this study, test material, Bpdy Lotion‘ did not indicate a potential for dermal irritation or

allergic contact sensitization.

Panel Book Page 60

Table 1Panel #20090070

C09-1 109.01Page 6

Body Lotion-E

ndividuaI Results

Virgin Challenge

Subject -— —---------------Induotion Phase—--------------—-———------- Site

Number 24*hr 1 2 3 4 5 6 - 7 8 9 24*1w 72hr

1 0 0 0 0

2 0 0 0 0

5

6

7

89

10ii1213

140

0

0 0 0 0

0 0 0 0

0 0 0 0

0 0 0 0

o o 0 0

0 0 0 0

0 0 0 0

0 0 0 0

0 0 0 0 0 0

o o 0 0 0 0

0

0000

0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0

00000

00

0 0

0 0

0 0

o 0

0 0 0 U

3 0 0 0 0 0 0 0 0 0 0

4 0 0 0 0 0 0 0 0 0 0

0 0 0 0 0 0 0 0

— * —----DID NOT COMPLETE STUDY

DID NOT COMPLETE STUDY

0 0 0 0 0 0 0 0

0 0 0 0 0 0 0

0 0 0 0 0 0 0

0 0 0 0 0 9 0

0 0 0 0 0 0 0

o 0 0 0 0 0 0

0 0 0 0 0 0 0

0 0 0 0 0 0 0 0

------———- DID NOT COMPLETE STUDY

—- —----DID NOT COMPLETE STUDY

0 0 0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

1516

171819

20

21

22

2324

25

0 0

0

000

0

0

0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

26 0 0 0 0 0 0 0 0 0 0

27 0 0 0 0 00 0 0 0 0

28 0 0 0 0 0 0 0 0 0 0

29 0 0 0 0 0 0 0 0 0 0

24* = Supervised removai of I Induction and Challenge Patch

Panel Book Page 61

Body Lotion-

C09-I 109M1Page 7

Virgin ChaliengeSubject ———-—---——-————InductionPhase--———————-—-——— SiteNumber 24*hr 1 2 3 4 5 6 7 8 9 24*hr 72 hr

30 0 0 0 0 0 0 0 0 0 0 0 031 0 0 0 0 0 0 0 0 0 0 .0 032. 0 .0 0. 0 0 0 0 0 .0 0 0 033 0 0 0 0 0 0 0 0 0 0 0 034 0 0 0 0 0 0 0 0 0 0 0 035 0 0 0 0 0 0 0 0 0 0 0 036 0 0 0 0 0 0 0 0 0 0 0 0

37 0 0 0. 0 0 0 0 0 0 0 0 0

38 0 0 0 0 0 0 0 0 0 0 0 0

39 0 0 0 0 0 0 0 0 .0 0 0 040 0 0 0 0 0 0 0 0 0 0 0 041 0 0 0 0 0 0 0 0 0 0 0 042 ‘0 0 0 0 0 0 0 0 0 0 0 0

43 0 0 0 0 0 0 0 0 0 0 0 044 + 0 .0 00 0 0 0 0 0 0 0

45 0 0 0 0 0 0 0 0 0 0 0 0

46 0 0 0 0 0 0 0 0 0 0 0 0

47 0 0 0 0 0 0 0 0 0 0 0 0

48 0 0 0 0 0 0 0 0 0 0 0 049 00 0 0 0 0 0 0 0 0 0 050 0 0 0 0 0 0 0 0 0 0 0 051 0 0 0 0 0 0 0 0 0 0 0 052 0 0 0 0 0 0 0 0 0 0 0 0

53 0 0 0 0 0 0 0 0 0 0 0 0

54 0 0 0 0 0 0 0 0 0 0 0 0

55 0 0 0 0 0 0 0 0 0 0 0 0

56 0 0 0 0 0 0 0 0 0 0 0 0

57 0 0 0 0 0 0 0 0 0 0 0 0

58 0 0 0 0 0 0 0 0 0 0 —DNC-59 0 0 0 0 0 0 0 0 9 0 0 0

24* Supervised removal of 1 Induction and Challenge Patch

Table 1(continued)

Panel #20090070

Individual Results

Panel Book Page 62

Table I(continued)

Panel #20090073

Individual Results

C09-1 109.01Page 8

Body Lotion-

Virgin ChallengeSubject — ——--—Induction Phase --- SiteNumber 24*hr 1 2 3 4 5 6 7 8 9 24*hr 72 hr

0 0 0 0 0 0 0 0 0 0 0 02 0 0 0 0 0 0 0 0 0 0 0 03 0 0 0 0 0 0 0 0 0 0 0 04 0 0 0 0 0 0 0 0 00 0 05 0 0 0 0 0 0 0 0 0 0 0 06 0 0 0 0 0 0 0 0 0 0 0 07 0 0 0 0 0 0 0 0 0 0 0 08 0 0 0 0 0 0 0 0 0 0 0 09 0 0 0 0 0 0 0 0 0 0 0 010 0 0 0 0 0 0 0 0 0 0 0 011 0 0 0 0 0 0 0 0 0 0 0 012 0 -—-- —----------------DID NOT COMPLETE STUDY—----—---—--------—---13 0 0 0 0 0 0 0 0 0 0 0 014 0 0 0 0 0 0 0 0 0 0 0 015 0 0 0 0 0 0 0 0 0 0 0 016 0 0 0 0 0 0 0 0 0 0 0 017 0 0 0 0 0 0 0 0 0 0 0 018 0 0 0 0 0 0 0 0 0 0 019 0 0 0 0 0 0 0 0 0 0 0 020 0 0 0 0 0 0. 0 0 0 0 0 021 0 0 0 0 0 0 0 0 0 0 0 022 0 0 0 0 0 om 0 0 0 0 0 0

23 0 0 0 0 0 0 0 0 0 0 0 024 0 0 0 0 0 0 0 0 0 0 0 025 0 0 0 0 0 0 0 0 0 0 0 026 0 0 0 0 0 0 0 0 0 0 0 027 0 0 0 0 0 0 0 0 0 0 0 0

28 0 0 0 0 0 0 DID NOT COMPLETE STUDY29 0 0 0 0 0 0 0 0 0 0 0 0

24* Supervised removal of l Induction and Challenge Patch- Subject not present for supervised removal.

m Additional makeup day granted at the discretion of th clinic supervisor

Panel Book Page 63

Table 1(continued)

Panel #20090073

Individual Results

C09-1 109.01Page 9

Virgin ChaHengeSubject --—-------—------— Induction Phase— —

—-- SiteNumber 24*hr 1 2 3 4 5 6 7 8 9 24*hr 72 hr

30 031 032 033 034 035 036

37 0

o 0

0 00 0

0 0

o o0 0o 0o ao 0o 0

Body Lotion

0 0 0 0 0 0 0 0 0o 0 0 0 0 M 0 0 00 0 0 0 0 0 0 0 00 0 0 0 0 0 0 0 00 0 0 0 0 0 0 0 0o 0 0 0 0 0 0 0 0o 0 0 0 0 0 0 0 0o a o 0 0 0 0 0 0

38 0 0. 0 0 0 0 0 0 0 039 0 0 0 0 0 0 0 0 0 040 0 0 0 0 0 0 0 0 0 0 0 041 0 0 0 0 0 0 0 0 DID NOT COMPLETE STUDY42 0 0 0 0 0 0 0 0 0 0 0 043 0 0 0 0 0 0 0 0 0 0 0 044 0 0 0 o 0 0 0 0 0 0 0 045 0 0 0 0 0 0 0 0 0 0 0 046 0 0 0 0 0 0 0 0 0 0 0 047. 0 0 0 0 0 0 0 0 0 0 0 048 0 0 a o 0 0 0 a a 0 0 049 0 0 0 0 0 0 0 0 0 0 0 050 0 0 0 0 0 0 0 0 0 0 0 051 0 0 0 0 0 0 0 0 0 0 0 052 0 0 0 0 0 0 0 0 0 0 0 053 0 0 0 0 0 0 0 0 0 0 0 054 00 0 0 0 0 0 0 0 0 0 055 0 0 0 0 0 0 0 0 0 0 0 056 0 0 0 0 0 0 0 0 0 0 0 0

24* Supervised removal of 1 ‘ Induction and Challenge Patch

Panel Book Page 64

Consumer Product Testing Co.EST i$7

FINAL REPORT

CLIENT: -.

ATTENTIONLicensed Cosmetologist

TEST: Repeated Insult Patch TestProtocolNo. 1.01

TEST MATERIAL: Crème to Powder Foot Crème

1\ \c/EXPERIMENTREFERENCE NUMBER: C10-0602.01

CIReviewed by: Richard R. Eisenberg, M.D.

Medical DirectorBoard Certified Dermatologist

Approved by: Michael Caswell, Ph.D., C.C.R.C.. C.C.R.A.Director, Clinical Evaluations

-4c1yfApproved by: y rank RN.

x utive Vice President, Clinical Evaluations

This reporl is submiltud tot tho xctusLe use ot t,e person, partneiship or corperstkm to whom it is addressed, and neither the report nor tilename ot these Laboratories nor any meniber of its ataf, may be used in connection with the advertisisg or sale of any product or processwithout written authorization

70 New Dutch Lttte Fiirftek1, Ncw Jersey 07OO42514 • (973) 8O87S I • Fax {973) 8Ut7234

Panel Book Page 65

Consumer Product Testing Co.t!ST. j975

QUALITY ASSURANCE UNIT STATEMENT

Study Number: Cl 0-0602.01

The Consumer Product Testing Company, Incorporated (CPTC) Quality Assurance Unit (QAU) isresponsible for monitoring the conduct, content and reporting of all clinical laboratory studies that areconducted at CPTC.

This study has been conducted in accordance with ICR Guideline E6 for Good Clinical Practice, therequirements of 21 CFR Parts 50 and 56, other applicable regulations, CPTC Standard OperatingProcedures, and the approved Study Protocol.

The CPTC QAU has reviewed all data, records, and documents relating to this study and also this FinalReport. The following QAU representative signature certifies that all data, records, and documentsrelating to this study and also this Final Report have been reviewed and are deemed to be acceptable, andthe study confonns to all of the requirements as indicated above.

/te

70 New Dutch Lane • Fairfield, New Jersey 07004-2514 • (973) 808-71 1 1 • Fax (973) 808-7234Clinical • Toxicology ‘ Ana1yica1 Chemistry Microbiology

Representative

Panel Book Page 66

Ci0-0602.0lPage 3 of 9

Objective: To determine by repetitive epidermal contact the potential of a test materialto induce primary or cumulative irritation and/or allergic contactsensitization.

Participants: Fifty-six (56) qualified subjects, male and female, ranging in agc from 17 to70 years, were selected for this evaluation. Fifty-one (51) subjects completedthis study. The remaining subjects discontinued their participation forvarious reasons, none of which were related to the application of the testmaterial.

Inclusion Criteria: a. Male and female subjects, age 16a and over.b. Absence of any visible skin disease which might be confused with a skin

reaction from the test material.c. Prohibition of use of topical or systemic steroids and/or antihistamines

for at least seven days prior to study initiation.d. Completion of a Medical History form and the understanding and

signing of an Informed Consent form,e. Considered reliable and capable of following directions.

Exclusion Criteria: a. Ill health.b. Under a doctors care or taking medication(s) which could influence the

outcome of the study.c. Females who are pregnant or nursing.d. A history of adverse reactions to cosmetics or other personal care

products.

Test Material: Crème to Powder Foot Crème

Study Schedule: Panel # Initiation Date Completion Date

20100066 February 17, 2010 March 26, 2010

With parental or guardian consent

Panel Book Page 67

C 10-0602.01Page 4 of 9

Methodology: The upper back between the scapulae served as the treatment area.Approximately 0.2 g of the test material, or an amount sufficient to cover thecontact surface, was applied to the I” x 1” absorbent pad portion of a clearadhesive dressing and allowed to volatilize for several minutes. This wasthen applied to the appropriate treatment site to form a semi-occlusive patch.

Induction Phase:

Patches were applied three (3) times per week (e.g., Monday, Wednesday.and Friday) for a total of nine (9) applications. The site was marked to ensurethe continuity of patch application. Following supervised removal andscoring of the first Induction patch, participants were instructed to remove allsubsequent Induction patches at home, twenty-four hours after application.The evaluation of this site was made again just prior to re-application. If aparticipant was unable to report for an assigned test day, one (1) makeup daywas permitted. This day was added to the Induction period. It was noted thatdue to inclement weather, numerous subjects were unable to report asscheduled, They were instructed to report on the following test day.

With the exception of the first supervised Induction Patch reading, if any testsite exhibited a moderate (2-level) reaction during the Induction Phase,application was moved to an adjacent area. Applications were discontinuedfor the remainder of this test phase, if a moderate (2-level) reaction wasobserved on this new test site. Applications would also be discontinued ifmarked (3-level) or severe (4-level) reactivity was noted.

Rest periods consisted of twenty-four hours following each Tuesday andThursday removal, and forty-eight hours following each Saturday removal,

Challenge Phase:

Approximately two (2) weeks after the final Induction patch application, aChallenge patch was applied to a virgin test site adjacent to the originalInduction patch site, following the same procedure described for induction.The patch was removed and the site scored at the clinic twenty-four andseventy-two hours post-application.

Panel Book Page 68

C1O..0602.O1Page 5 of9

Methodology(continued) Evaluation Criteria (Erythenia and additional Dermal Seguelae):

o = No visible skin reaction £ Edema0.5 Barely perceptible P = Dryness

1 Mild S Staining2 = Moderate P = Papules3 Marked V = Vesicles4 Severe B = BulIac

U — UlcerationSp = Spreading

Erythema was scored numerically according to this key. If present, additionalDermal Sequelae were indicated by the appropriate letter code aid anumerical value for severity.

Results: The results of each participant are appended (Table 1).

Observations remained negative throughout the test interval.

Subject demographics are presented in Table 2.

Summary: Under the conditions of this study, test material, Crème to Powder FootCrème did not indicate a potential fordermal irritation or allergic contact sensitization.

Panel Book Page 69

Table IPanel #20100066

C10-06020IPage 6 of 9

Individual Results

Crème to Powder Foot Crème —

Virgin ChallengeSubject - —.--4nduction Phae----—-------——-—--—---- SiteNumber 24*hr 1 2 3 4 5 6 7 8 9 24*hr 72 hr

1 0 0

2 0 03 0 04 0 0

5 0 06 0 07 0 0

8 0 09 0 010 0 011 0 012 0 0

13 0 014 0 0

15 0 016 0 017 0 018 0 0

19 0 0

20 0 021 0 022 0 0

23 0 0

24 0 0

25 0 026 0 027 0 0

28 0 029 0 0

0 0 ow 00 o O 0o o ow o0 0 ow oo o ow oo 0 ow oo o ow 0o 0 ow oo o ow oo o ow oo o ow 0o o ow o0 o ow oo a o a

o ow o0 0 ow 0o 0 0w

o o ow oo o ow oo o ow oo o ow 0o 0 ow 0o a ow 0o a o oo o ow ao 0 ow oo o ow oo a o” 0

o 0 0 0

o 0 0 00 0 0 0

o o 0 0o 0 0 0o a o ao o 0 0o 0 0 0o 0 0 00 0 0 0

o a a 0o o 0o 0 0 0o o 0 0o o 0 0o 0 0 0

o 0 0 0o o 0 0o 0 0 0o o 0 0o o 0 0o a o 00 0 0 0

o 0 0 00 0 0 0

0 0 0 0

o o 0 ow

o o 0 0

-DID NOT COMPLETE STUDY-

o oo o0 00 00 0o 00 0o oo 0

0 00 00 0o 0o ao o-—-DNC—

0 ao ao 0

o oo 00 0o 0

o oo 0o DNC

0 0o 0

24* = Supervised removal of 1 Induction and challenge PatchW = Inclement weather. Subject unable to report as scheduled

DNC = Did not complete study- = Observation omitted. Subject unable to report, as scheduled

Panel Book Page 70

Table I(continued)

Panel #20100066

Individual Results

C 10-0602.01Page 7 of 9

Crème to Powder Foot Crème —

Virgin ChallengeSubject —---——------—-—----—--Induction Phase--——-----------—---—-—— SiteNumber 24*hr 1 2 3 4 5 6 7 8 9 24*hr 72 hr

30 0 0 0 0 ow 0 0 0 0 0 0 031 0 0 0 0 ow 0 0 0 0 0 0 032 0 0 0 0 0 0 0 0 0 0 033 0 0 0 0 ow o 0 0 0 0 0 034 0 0 0 Ow 0 0 0 0 0 ow 0 035 0 0 0 0 0” 0 0 0 0 0 0 036 0 0 0 ow 0 0 0 0 0 0 0 037 0 0 0 0 Ow 0 0 0 0 0 0 038 0 0 0 0 0” 0 0 0 0 0 0 039 0 0 0 0 ow —--DID NOT COMPLETE STUDY------—--—40 0 0 0 0 0”' 0 0 0 0 0 0 041 0 0 0 0 Ow 0 0 0 0 0 0 042 0 0 0 0 ow 0 0 0 0 0 0 043 0 0 0 0 ow o 0 0 0 0 0 044 0 0 0 0 ow o 0 0 0 0 0 045 0 0 0 a ow 0 0 0 0 0 0 0*46 0 0 0 0 0”' 0 0 0 0 0 0 047 0 0 0 o ow 0 0 0 0 0 0 048 0 0 0 0 Ow 0 0 0 049 0 0 0 o 0W o 0 0 0 0 050 0 0 0 0 0”' 1) 0 0 0 0 0 051 0 0 0 o ow 0 0 0 0 0 0 052 0 0 0 0 O’ 0 0 0 0 0 0 053 0 0 0 o 1jW 0 0 0 0 0 0 054 0 0 0 0”' 0 0 0 0 0 W o 055 0 0 0 ow 0 0.0 0 o o o56 0 0 0 0 0”' 0 0 0 0 0 0 0

24’ Supervised removal of 1 Induction and Challenge PatchW = Inclement weather. Subject unable to report as scheduled

DNC Did not complete study*

= Observations recorded 96 hours post challenge application. Subjectunable to report, as scheduled,

-w No reading taken, subject unable to report due to inclement weather.

Panel Book Page 71


Memorandum




SUBJECT: Specifications for Allyl Methacrylates Crosspolymer

Specifications for Allyl Methacrylates Crosspolymer can be found on the internet athttp://www . cospharm.comlchemdal/pe200 . htm andhttp:/Iwww .cospharm.comlchemdal/p1200.htm

1101 17th Street, N.W., Suite 3OO Washington, D.C. 20036-4702 202.331.1770 202.331.1969 (fax) www.personalcarecouncil.org Panel Book Page 72


Memorandum




SUBJECT: Updated Concentration of Use by FDA Product Category: Acrylate CrosspolymerIngredients

11011 7th Street, N.W., Suite 30O Washington, D.C. 20036-4702 202.331.1770 202.331.1969 (fax) www.personalcarecouncil.org Panel Book Page 73

Concentration of Use by FDA Product CategoryAcrylates/C1O-30 Alkyl Acrylate Crosspolynier, Acrylates Crosspolymer, Acrylates/Ethyihexyl Acrylate

Crosspolymer, Acrylates/Ethylhexyl Acrylate/Glycidyl Methacrylate Crosspolymer, AcrylatesfPEG-4Dimethacrylate Crosspolymer, Acrylates/Steareth-20 Methacrylate Crosspolymer, Acrylates/Vinyl

Isodecanoate Crosspolymer, Acrylates/Vinyl Neodecanoate Crosspolymer, Allyl Methacrylate/GlycolDimethacrylate Crossolymer, Allyl Methacrylates Crosspolymer, Butyl Acrylate/Glycol Dimethacrylate

Crosspolymer, C8-22 Alkyl Acrylates/Methacrylic Acid Crosspolymer, Glycol Dimethacrylate/Vinyl AlcoholCrosspolymer, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Lauryl Methacrylate/Sodium

Methacrylate Crosspolymer, Acrylates/C12-13 Alkyl MethacrylatesfMethoxyethyl Acrylate Crosspolymer,Methacrylic AcidJPEG-6 Methacrylate Crosspolymer, PEG/PPG-512 Methacrylate/Methacrylic Acid

Crosspolymer, Potassium Acrylates/C1O-30 Alkyl Acrylate Crosspolymer, Sodium Acrylates/C1O-30 AlkylAcrylate Crosspolymer, Sodium Acrylates Crosspolymer-2, Sodium Acrylates/Vinyl Isodecanoate

Crosspolymer and StearyilLauryl Methacrylate Crosspolymer*

Ingredient Product Category Concentration ofUse

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Baby lotions, oils, powder and creams 0.2%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Bath oils, tablets and salts 1%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Bubble baths 1%

Acrylates/Cl0-30 Alkyl Acrylate Crosspolymer Other bath preparations 1%

Acrylates/C 10-30 Alkyl Acrylate Crosspolymer Eyeliner 0.03-0.4%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Eye shadow 0.05-2%

Acrylates!C10-30 Alkyl Acrylate Crosspolymer Eye lotion 0.2-0.6%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Eye makeup remover 0.1-0.6%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Mascara 0.003%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Colognes and toilet waters 0.03-0.2%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Perfumes 0.3%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Powders (dusting and talcum) 0.1%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Other fragrance preparations 0.2-0.7%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Hair conditioners 0.1-0.4%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Hair sprays (aerosol fixatives) 2%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Shampoos (noncoloring) 0.2-2%

Acrylates!C10-30 Alkyl Acrylate Crosspolymer Tonics, dressings and other hair 0.2-2%grooming aids

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Other hair preparations (noncoloring) 0.6%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Hair dyes and colors (all types 0.4%requiring caution statement and patch

Page 1 of 5

Panel Book Page 74

test)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Hair color sprays (aerosol) 2%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Hair bleaches 5%

Acrylates/Cl0-30 Alkyl Acrylate Crosspolymer Other hair coloring preparations 0.6%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Blushers (all types) 3%

Acrylates!C10-30 Alkyl Acrylate Crosspolymer Face powders 0.0002%

Acrylates/C 10-30 Alkyl Acrylate Crosspolymer Foundations 0.03-0.3%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Lipstick 0.5%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Makeup bases 0.1-0.3%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Cuticle softeners 1-5%

Acrylates!C10-30 Alkyl Acrylate Crosspolymer Nail creams and lotions 0.1-0.8%

Acrylates!C10-30 Alkyl Acrylate Crosspolymer Nail polish and enamel 1%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Bath soaps and detergents 0.002-2%

Acrylates/Cl0-30 Alkyl Acrylate Crosspolymer Deodorants (underarm) 0.00 1%

Acrylates/Cl0-30 Alkyl Acrylate Crosspolymer Other personal cleanliness products 2-3%

Acrylates!C10-30 Alkyl Acrylate Crosspolymer Aftershave lotions 0.2-0.8%

Acrylates!C10-30 Alkyl Acrylate Crosspolymer Shaving cream (aerosol, brushless and 1-2%lather)

Acrylates!C10-30 Alkyl Acrylate Crosspolymer Other shaving preparations 0.9%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Skin cleansing (cold creams, cleansing 0.2-2%lotions, liquids and pads)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Face and neck creams, lotions and 0.1-2%powders

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Body and hand creams, lotions and 0.08-2%powders

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Body and hand sprays 0.2-0.5%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Moisturizing creams, lotions and 0.2-1%powders

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Night creams, lotions and powders 0.1-2%

Acrylates/Cl0-30 Alkyl Acrylate Crosspolymer Paste masks (mud packs) 0.1-1%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Skin fresheners 0.7%

Acrylates!C10-30 Alkyl Acrylate Crosspolymer Other skin care preparations’ 0.2-0.8%

Page 2 of 5

Panel Book Page 75

Acrylates/Cl0-30 Alkyl Acrylate Crosspolymer Suntan gels, creams and liquids 0.2-0.5%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Indoor tanning preparations 0.1-0.6%

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Other suntan preparations 0.4-0.5%

Acrylates Crosspolymer Eye lotion 0.8%

Acrylates Crosspolymer Face powders 2%

Acrylates Crosspolymer Foundations 0.1-0.6%

Acrylates Crosspolymer Lipstick 4%

Acrylates Crosspolymer Makeup bases 0.5%

Acrylates Crosspolymer Skin cleansing (cold creams, cleansing 0.8%lotions, liquids and pads)

Acrylates Crosspolymer Face and neck creams, lotions and 0.3-0.5%powders

Acrylates Crosspolymer Night creams, lotions and powders 0.3%

Acrylates Crosspolymer Paste masks (mud packs) 0.3%

Acrylates[Ethylhexyl Acrylate Crosspolymer Eye shadow 6%

Acrylates/Ethylhexyl Acrylate Crosspolymer Foundations 5%

AcrylatesfEthylhexyl Acrylate Crosspolymer Other makeup preparations 4%

Acrylates/Steareth-20 Methacrylate Tonics, dressings and other hair 2%Crosspolymer grooming aids

Acrylates/Steareth-20 Methacrylate Bath soaps and detergents 1%Crosspolymer

Acrylates/Steareth-20 Methacrylate Face and neck creams, lotions and 0.1%Crosspolymer powders

Acrylates/Vinyl Isodecanoate Crosspolymer Skin cleansing (cold creams, cleansing 0.2-0.5%lotions, liquids and pads)

Acrylates/Vinyl Isodecanoate Crosspolymer Face and neck creams, lotions and 0.5%powders

Acrylates/Vinyl Isodecanoate Crosspolymer Body and hand creams, lotions and 0.4%powders

Acrylates/Vinyl Isodecanoate Crosspolymer Night creams, lotions and powders 0.3%

Acrylates/Vinyl Isodecanoate Crosspolymer Suntan gels, creams and liquids 0.4%

Acrylates/Vinyl Isodecanoate Crosspolymer Other suntan preparations 0.4%

Acrylates/Vinyl Neodecanoate Crosspolymer Bubble baths 2%

Page 3 of 5

Panel Book Page 76

Acrylates/Vinyl Neodecanoate Crosspolymer Other personal cleanliness products 2%

Allyl Methacrylates Crosspolymer Eye shadow 0.003-0.2%

Allyl Methacrylates Crosspolymer Eye lotion 0.8%

Allyl Methacrylates Crosspolymer Mascara 0.2%

Allyl Methacrylates Crosspolymer Face powders 0.3-0.8%

Allyl Methacrylates Crosspolymer Foundations 0.3-2%

Allyl Methacrylates Crosspolymer Lipstick 0.04-0.2%

Allyl Methacrylates Crosspolymer Other makeup preparations 0.07%

Allyl Methacrylates Crosspolymer Skin cleansing (cold creams, cleansing 0.1%lotions, liquids and pads)

Allyl Methacrylates Crosspolymer Face and neck creams, lotions and 2%powders

Allyl Methacrylates Crosspolymer Night creams, lotions and powders 0.2%

Allyl Methacrylates Crosspolymer Skin fresheners 1%

Allyl Methacrylates Crosspolymer Other skin care preparations 0.2%

Lauryl Methacrylate/Glycol Dimethacrylate Eyeliner 0.2%Crosspolymer

Lauryl Methacrylate/Glycol Dimethacrylate Eye shadow 0.1-3%Crosspolymer

Lauryl Methacrylate/Glycol Dimethacrylate Blushers (all types) 0.2%Crosspolymer

Lauryl Methacrylate/Glycol Dimethacrylate Face powders 0.1-1%Crosspolymer

Lauryl Methacrylate/Glycol Dimethacrylate Foundations 0.1-2%Crosspolymer

Lauryl Methacrylate/Glycol Dimethacrylate Lipstick 0.06-2%Crosspolymer

Lauryl Methacrylate/Glycol Dimethacrylate Other makeup preparations 0.7-2%Crosspolymer

Lauryl Methacrylate/Glycol Dimethacrylate Deodorants (underarm) 0.3%Crosspolymer

Lauryl Methacrylate/Glycol Dimethacrylate Skin cleansing (cold creams, cleansing 0.4-3%Crosspolymer lotions, liquids and pads)

Lauryl Methacrylate/Glycol Dimethacrylate Depilatories 0.2%Crosspolymer

Page 4 of 5

Panel Book Page 77

Lauryl Methacrylate/Glycol Dimethacrylate Face and neck creams, lotions and 0.2-1%Crosspolymer powders

Lauryl Methacrylate/Glycol Dimethacrylate Body and hand creams, lotions and 2%Crosspolymer pwoders

Lauryl Methacrylate/Glycol Dimethacrylate Paste masks (mud packs) 1%Crosspolymer

Lauryl Methacrylate/Glycol Dimethacrylate Other skin care preparations 3%Crosspolymer

Lauryl Methacrylate/Sodium Methacrylate Skin cleansing (cold creams, cleansing 0.004-0.1%Crosspolymer lotions, liquids and pads)

Lauryl Methacrylate/Sodium Methacrylate Face and neck creams, lotions and 0.1-4%Crosspolymer powders

Methyl Methacrylate/Glycol Dimethacrylate Eye shadow 0.009%Crosspolymer

Methyl Methacrylate/Glycol Dimethacrylate Blushers (all types) 1%Crosspolymer

Methyl Methacrylate/Glycol Dimethacrylate Face powders 1%Crosspolymer

Methyl Methacrylate/Glycol Dimethacrylate Foundations 0.3-0.4%Crosspolymer

Methyl Methacrylate/Glycol Dimethacrylate Lipstick 0.4%Crosspolymer

Methyl Methacrylate/Glycol Dimethacrylate Makeup bases 0.3%Crosspolymer

Methyl Methacrylate/Glycol Dimethacrylate Other makeup preparations 1%Crosspolymer

Methyl Methacrylate/Glycol Dimethacrylate Face and neck creams, lotions and 0.5%Crosspolymer powders

Sodium Acrylates Crosspolymer-2 Body and hand creams, lotions and 0.8%powders

*Ingredients found in the title but not found in the table were included in the concentration of use survey, but no useswere reported.‘0.6%, 0.8% in rinse-off skin care products

Information collected in 2010Table prepared January 5, 2011

Table updated January 28, 2011 (Acrylates/C10-30 Alkyl Acrylate Crosspolymer: lowered low concentration Indoortanning preparations, added low concentration Other suntan preparations; Acrylates/Vinyl Isodecanoate

Crosspolymer:added Other suntan preparations)

Page 5 of 5

Panel Book Page 78

ACRYLATES CROSSPOLYMER 12C - Face and Neck (exc 2

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 01B - Baby Lotions, Oils, 7ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 01C - Other Baby Product 4ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 02A - Bath Oils, Tablets, a 1ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 02B - Bubble Baths 2ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 02D - Other Bath Prepara 10ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 03B - Eyeliner 14ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 03C - Eye Shadow 3ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 03D - Eye Lotion 55ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 03E - Eye Makeup Remov 15ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 03F - Mascara 6ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 03G - Other Eye Makeup 37ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 04B - Perfumes 1ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 04E - Other Fragrance Pre 28ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 05A - Hair Conditioner 3ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 05B - Hair Spray (aerosol 1ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 05F - Shampoos (non-col 20ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 05G - Tonics, Dressings, 41ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 05H - Wave Sets 1ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 05I - Other Hair Preparatio 18ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 06D - Hair Shampoos (co 7ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 06F - Hair Lighteners with 1ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 06G - Hair Bleaches 10ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 06H - Other Hair Coloring 1ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 07B - Face Powders 1ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 07C - Foundations 7ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 07E - Lipstick 3ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 07F - Makeup Bases 3ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 07I - Other Makeup Prepa 8ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 08B - Cuticle Softeners 2ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 08C - Nail Creams and Lo 1ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 08G - Other Manicuring P 3ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 10A - Bath Soaps and De 53ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 10B - Deodorants (undera 1ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 10D - Feminine Deodoran 1ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 10E - Other Personal Clea 30ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 11A - Aftershave Lotion 57ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 11D - Preshave Lotions (a 2ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 11E - Shaving Cream 3ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 11G - Other Shaving Prep 21ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 12A - Cleansing 120ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 12C - Face and Neck (exc 216ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 12D - Body and Hand (exc 246ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 12F - Moisturizing 322ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 12G - Night 58ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 12H - Paste Masks (mud 24ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 12I - Skin Fresheners 7ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 12J - Other Skin Care Pre 95ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 13A - Suntan Gels, Cream 11ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 13B - Indoor Tanning Prep 16ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER 13C - Other Suntan Prepa 9

ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER 11D - Preshave Lotions (a 1ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER 12A - Cleansing 9ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER 12C - Face and Neck (exc 2ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER 12D - Body and Hand (exc 2ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER 12F - Moisturizing 11ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER 12G - Night 2ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER 12J - Other Skin Care Pre 3

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ACRYLATES/VINYL NEODECANOATE CROSSPOLYMER 02B - Bubble Baths 1ACRYLATES/VINYL NEODECANOATE CROSSPOLYMER 02D - Other Bath Prepara 1ACRYLATES/VINYL NEODECANOATE CROSSPOLYMER 10A - Bath Soaps and De 1ACRYLATES/VINYL NEODECANOATE CROSSPOLYMER 10E - Other Personal Clea 3ACRYLATES/VINYL NEODECANOATE CROSSPOLYMER 12F - Moisturizing 3ACRYLATES/VINYL NEODECANOATE CROSSPOLYMER 12J - Other Skin Care Pre 1

ALLYL METHACRYLATES CROSSPOLYMER 03C - Eye Shadow 4ALLYL METHACRYLATES CROSSPOLYMER 03F - Mascara 1ALLYL METHACRYLATES CROSSPOLYMER 07A - Blushers (all types) 1ALLYL METHACRYLATES CROSSPOLYMER 07B - Face Powders 3ALLYL METHACRYLATES CROSSPOLYMER 07E - Lipstick 17ALLYL METHACRYLATES CROSSPOLYMER 12A - Cleansing 1ALLYL METHACRYLATES CROSSPOLYMER 12C - Face and Neck (exc 3ALLYL METHACRYLATES CROSSPOLYMER 12D - Body and Hand (exc 1ALLYL METHACRYLATES CROSSPOLYMER 12F - Moisturizing 3ALLYL METHACRYLATES CROSSPOLYMER 12H - Paste Masks (mud 2ALLYL METHACRYLATES CROSSPOLYMER 12J - Other Skin Care Pre 5

LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSS03B - Eyeliner 1LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSS03C - Eye Shadow 5LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSS03F - Mascara 1LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSS03G - Other Eye Makeup 1LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSS07A - Blushers (all types) 2LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSS07B - Face Powders 8LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSS07C - Foundations 21LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSS07E - Lipstick 8LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSS07I - Other Makeup Prepa 3LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSS08G - Other Manicuring P 1LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSS10B - Deodorants (undera 1LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSS12A - Cleansing 4LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSS12C - Face and Neck (exc 1LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSS12F - Moisturizing 2LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSS12G - Night 1LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSS12H - Paste Masks (mud 3

LAURYL METHACRYLATE/SODIUM METHACRYLATE CROSSPOL12F - Moisturizing 1

SODIUM ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYME 04E - Other Fragrance Prepa 1SODIUM ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYME 11A - Aftershave Lotion 1SODIUM ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYME 12F - Moisturizing 1

Panel Book Page 80

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