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 Unpublished data submitted by the Council, listed below by submission date, are included in Tab 3 of this report.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.
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
Cros
slin
ked
Alk
yl A
cryl
ates
Dat
a P
rofi
le*
– M
arch
20
11
– W
rite
r, M
onic
e Fi
um
e
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
Ocular Irritaton
Acry
late
s/C1
0-30
Alky
l Acr
ylat
e Cr
ossp
olym
er
x x
x x
x
x
x Ac
ryla
tes/
C12-
13 A
lkyl
Met
hacr
ylat
es/M
etho
xyet
hyl A
cryl
ate
Cros
spol
ymer
Acry
late
s Cro
sspo
lym
er
x
Ac
ryla
tes/
Ethy
lhex
yl A
cryl
ate
Cros
spol
ymer
x
Acry
late
s/Et
hylh
exyl
Acr
ylat
e/Gl
ycid
yl M
etha
cryl
ate
Cros
spol
ymer
Acry
late
s/PE
G-4
Dim
etha
cryl
ate
Cros
spol
ymer
Acry
late
s/St
eare
th-2
0 M
etha
cryl
ate
Cros
spol
ymer
x
Acry
late
s/Vi
nyl I
sode
cano
ate
Cros
spol
ymer
x
x
x x
Acry
late
s/Vi
nyl N
eode
cano
ate
Cros
spol
ymer
x
x
Ally
l Met
hacr
ylat
e/Gl
ycol
Dim
etha
cryl
ate
Cros
spol
ymer
Ally
l Met
hacr
ylat
es C
ross
poly
mer
x
Buty
l Acr
ylat
e/Gl
ycol
Dim
etha
cryl
ate
Cros
spol
ymer
C8-2
2 Al
kyl A
cryl
ates
/Met
hacr
ylic
Aci
d Cr
ossp
olym
er
Gl
ycol
Dim
etha
cryl
ate/
Viny
l Alc
ohol
Cro
sspo
lym
er
La
uryl
Met
hacr
ylat
e/Gl
ycol
Dim
etha
cryl
ate
Cros
spol
ymer
x
Laur
yl M
etha
cryl
ate/
Sodi
um M
etha
cryl
ate
Cros
spol
ymer
x
Met
hacr
ylic
Aci
d/PE
G-6
Met
hacr
ylat
e Cr
ossp
olym
er
PE
G/PP
G-5/
2 M
etha
cryl
ate/
Met
hacr
ylic
Aci
d Cr
ossp
olym
er
Po
tass
ium
Acr
ylat
es/C
10-3
0 Al
kyl A
cryl
ate
Cros
spol
ymer
Sodi
um A
cryl
ates
Cro
sspo
lym
er-2
x
x
x
x
x x
Sodi
um A
cryl
ates
/C10
-30
Alky
l Acr
ylat
e Cr
ossp
olym
er
x
So
dium
Acr
ylat
es/V
inyl
Isod
ecan
oate
Cro
sspo
lym
er
St
eary
l/La
uryl
Met
hacr
ylat
e Cr
ossp
olym
er
M
onom
ers
Acry
lic A
cid
x x
x x
x x
x x
x x
x M
ethy
l Acr
ylat
e
x
x
x
x x
Ethy
l Acr
ylat
e
x
x
x
x x
Buty
l Acr
ylat
e
x
x
x
x x
2-Et
hylh
exyl
Acr
ylat
e
x
x x
x
Poly
acry
lic A
cid
x
So
dium
Pol
yacr
ylat
e
x
x
x
x x
Met
hacr
ylic
Aci
d
x
x x
x
x x
x x
x x
Met
hyl M
etha
cryl
ate
x
x x
x x
Et
hyl M
etha
cryl
ate
x
x
Bu
tyl M
etha
cryl
ate
x x
x
x x
x x
x
x Is
obut
yl M
etha
cryl
ate
x x
x
x
x
x La
uryl
Met
hacr
ylat
e
x x
x
x
PEG-
4 Di
met
hacr
ylat
e
x
x
x x
x
*“X
” in
dica
tes t
hat d
ata
wer
e av
aila
ble
in a
cat
egor
y fo
r the
ingr
edie
nt
Panel Book Page 2
Cr
ossl
inke
d A
lkyl
Acr
ylat
es –
wri
ter,
Mon
ice
Fium
e
NLM
ST
N
EU
FD
A
#
uses
co
nc
data
To
xlin
e-Pu
bmed
M
isc
NLM
Be
il-st
ein
Regi
s-tr
y Ko
s-m
et
Nap
ra-
lert
RT
ECS
NTI
S M
erck
EU
SC
CP
ECE-
TOC
SID
S IA
RC
NTP
EA
FUS
OTC
N
IOSH
IF
RA
date
sea
rche
d
11
-16-
10
11
-23
11
-23
11-3
0 12
/1
12-6
12
-6-1
0 12
-6
12-6
A
cryl
ates
/C10
-30
Alk
yl A
cryl
ate
Cros
spol
ymer
13
0
1
0
N
R*
0 0
0
info
on
m
ono
mer
0
0 0
0 0
Acr
ylat
es C
ross
poly
mer
23
1
3
0
N
R 0
0 A
cryl
ates
/Eth
ylhe
xyl A
cryl
ate
Cros
spol
ymer
0
0
0
0
NR
0 0
Acr
ylat
es/E
thyl
hexy
l Acr
ylat
e G
lyci
dyl M
etha
cryl
ate
Cros
spol
ymer
0
0
0
0
NR
0 0
Acr
ylat
es/P
EG-4
Dim
etha
cryl
ate
Cros
spol
ymer
0
0
1
0
NR
0 0
Acr
ylat
es/S
tear
eth-
20 M
etha
cryl
ate
Cros
spol
ymer
0
0
0
0
NR
0 0
Acr
ylat
es/V
inyl
Isod
ecan
oate
Cro
sspo
lym
er
0 0
1
0
N
R 0
0 A
cryl
ates
/Vin
yl N
eode
cano
ate
Cros
spol
ymer
0
0
0
0
NR
0 0
Ally
l Met
hacr
ylat
e/G
lyco
l Dim
etha
cryl
ate
Cros
spol
ymer
0
0
1
0
NR
0 0
Ally
l Met
hacr
ylat
es C
ross
poly
mer
41
380
4
2
0
NR
0 0
Buty
l Acr
ylat
e/G
lyco
l Dim
etha
cryl
ate
Cros
spol
ymer
11
0
0
0
N
R 0
0 C8
-22
Alk
yl A
cryl
ates
/Met
hacr
ylic
Aci
d Cr
ossp
olym
er
0 0
0
0
N
R 0
0 G
lyco
l Dim
etha
cryl
ate/
Viny
l Alc
ohol
Cro
sspo
lym
er
0 0
0
0
N
R 0
0 La
uryl
Met
hacr
ylat
e/G
lyco
l Dim
etha
cryl
ate
Cros
spol
ymer
1
0
0
0
NR
0 0
Laur
yl M
etha
cryl
ate/
Sodi
um M
etha
cryl
ate
Cros
spol
ymer
0
0
0
0
NR
0 0
Acr
ylat
es/C
12-1
3 A
lkyl
Met
hacr
ylat
es/M
etho
xyet
hyl
Acr
ylat
e Cr
ossp
olym
er
0 0
0
0
0
0 0
Met
hacr
ylic
Aci
d/PE
G-6
Met
hacr
ylat
e Cr
ossp
olym
er
0 0
0
0
0
0 0
PEG
/PPG
-5/2
Met
hacr
ylat
e/M
etha
cryl
ic A
cid
Cros
spol
ymer
0
0
0
0
NR
0 0
Pota
ssiu
m A
cryl
ates
/C10
-30
Alk
yl A
cryl
ate
Cros
spol
ymer
0
0
0
0
NR
0 0
Sodi
um A
cryl
ates
/C10
-30
Alk
yl A
cryl
ate
Cros
spol
ymer
0
0
0
0
NR
0 0
Sodi
um A
cryl
ates
Cro
sspo
lym
er-2
3
0
0
0
NR
0 0
Sodi
um A
cryl
ates
/Vin
yl Is
odec
anoa
te C
ross
poly
mer
0
0
0
0
NR
0 0
Stea
ryl/
Laur
yl M
etha
cryl
ate
Cros
spol
ymer
0
0
0
0
NR
0 0
(Acr
ylat
e O
R A
cryl
ates
) AN
D C
ross
poly
mer
7
0
0
*N
R –
not r
estr
icte
d R
efer
ence
s O
rder
ed
Whi
t - 1
3 pa
pers
(11-
19-1
0)
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 "
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
Panel Book Page 9
4
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
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
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
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
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
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
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
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
Acrylates/Vinyl Isodecanoate Crosspolymer
The oral LD50 in the rat of acrylates/vinyl isodecanoate crosspolymer (Stabylen 30) is >2000 mg/kg body wt.29
Sodium Acrylates Crosspolymer-2
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
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
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.
Sodium Acrylates Crosspolymer-2
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.
Panel Book Page 11
6
IRRITATION AND SENSITIZATION
Irritation and sensitization data on some of the monomers are provided in Table 5.
Skin Irritation
Alternative Studies
Acrylates/Vinyl Isodecanoate Crosspolymer
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).
Sodium Acrylates Crosspolymer-2
According to an industry MSDS, sodium acrylates crosspolymer-2 (Aqua Keep 10SH-NFC) is not a dermal irritant
in rabbits.30
Human
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
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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7
Sodium Acrylates Crosspolymer-2
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
Acrylates/Vinyl Isodecanoate Crosspolymer
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
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
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.
Sodium Acrylates Crosspolymer-2
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
Sodium Acrylates Crosspolymer-2
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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8
Human
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
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.
Acrylates/Vinyl Isodecanoate Crosspolymer
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
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
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.
Sodium Acrylates Crosspolymer-2
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
Panel Book Page 14
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
Panel Book Page 15
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
Panel Book Page 16
Table 1. Definitions, functions, and structure (continued)
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
Panel Book Page 17
Table 1. Definitions, functions, and structure (continued)
12
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.
Panel Book Page 18
Table 1. Definitions, functions, and structure (continued)
13
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
Panel Book Page 19
Table 1. Definitions, functions, and structure (continued)
14
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
Panel Book Page 20
Table 1. Definitions, functions, and structure (continued)
15
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
Panel Book Page 21
Table 1. Definitions, functions, and structure (continued)
16
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
Panel Book Page 22
Table 1. Definitions, functions, and structure (continued)
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
Panel Book Page 23
Table 1. Definitions, functions, and structure (continued)
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
Panel Book Page 24
Table 1. Definitions, functions, and structure (continued)
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
Panel Book Page 25
20
Table 2. Chemical and physical properties
Property Description
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
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
Acrylates/Vinyl Isodecanoate Crosspolymer
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
Sodium Acrylates Crosspolymer-2
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)
Panel Book Page 27
22
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).
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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)
FROM: John Bailey, Ph.D.Industry Liaison to the CW Expert Panel
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
AQUA KEEP IOSH-NFC, 2500-61-0-02E, 11 Jan. 2010, 215
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
AQUA KEEP IOSH-NFC, 2500-61-0-02E, 11 Jan. 2010, 515
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)
2 Panel Book Page 52
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
3 Panel Book Page 53
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
TO: F. Alan Andersen, Ph.D.Director - COSMETIC INGREDIENT REVIEW (CIR)
FROM: John Bailey, Ph.D.Industry Liaison to the CIR Expert Panel
DATE: January 11, 2011
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
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 13, 2011
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
Personal Care Products CouncilCommitted to Safety,Quality & Innovation
Memorandum
TO: F. Alan Andersen, Ph.D.Director - COSMETIC INGREDIENT REVIEW (CIR)
FROM: John Bailey, Ph.D.Industry Liaison to the CIR Expert Panel
DATE: January 28, 2011
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
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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)
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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
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