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Scientific Literature Review for Public Comment , Release Date: January 14, 2016 ; Panel Meeting Date: March 31-April 1, 2016
The 2016 Cosmetic Ingredient Review Expert Panel members are: Chair, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Director is Lillian J. Gill, D.P.A. This report was prepared by Lillian C. Becker, Scientific Analyst/Writer.
Safety Assessment of Acryloyldimethyltaurate Polymers as Used in Cosmetics
SUMMARY
This is a review of the available scientific literature and unpublished data provided by industry relevant to assessing the safety of 22 acryloyldimethyltaurate polymers as used in cosmetics. This group of ingredients is composed of homopolymers, copolymers, and crosslinked polymers, the monomers of which are at least partially composed of acryloyldimethyltaurate monomers. The functions of these ingredients include dispersing agent – nonsurfactant, emulsion stabilizers, opacifying agent, and viscosity increasing agents – aqueous. According to the VCRP survey data received in 2015, hydroxyethyl acrylate/sodium acryloyl dimethyl taurate copolymer is reported to be used in 438 formulations, including 412 leave-on products, 24 rinse-off products, and 2 products used in the bath. The next highest reported uses are for acrylamide/sodium acryloyldimethyltaurate copolymer (236) and ammonium polyacryloyldimethyl taurate (230). All other in-use ingredients are reported to be used in 149 or few products. The results of a concentration of use survey conducted by the Council in 2015 indicate hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer has the highest reported maximum concentration of use; it is reported to be used at up to 4.3% in depilatories (a rinse-off product) and up to 3.6% in eyeliner and eye shadow (leave-on products). The reported maximum concentrations of use for the remaining ingredients range from 0.015%-3% for leave-on products and 0.078%-3.2% in rinse-off products.The acute dermal LD50 for acrylamide /sodium acryloyldimethyltaurate/acrylic acid copolymer was reported to be >5000 mg/kg in rats. The acute oral LD50 for acrylamide/sodium acryloyl dimethyltaurate/acrylic acid copolymer was reported to be >5000 mg/kg in rats. The acute oral LD50 values for ammonium ayloyl dimethyltaurate/carboxyethyl acrylate crosspolymer, ammonium acryloyldimethyltaurate/VP copolymer and hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer were reported to be >2000 mg/kg in rats. Acrylamide/sodium acryloyldimethyltaurate/acrylic acid copolymer, ammonium acryloyl dimethyltaurate/carboxyethyl acrylate crosspolymer, ammonium acryloyldimethyltaurate/VP copolymer, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, and sodium acrylate/acryloyldimethyltaurate/dimethylacrylamide crosspolymer were not mutagenic in bacterial reverse mutation assays. Acrylamide/sodium acryloyldimethyltaurate/acrylic acid copolymer, ammonium acryloyldimethyltaurate/carboxyethyl acrylate crosspolymer, and ammonium acryloyldimethyltaurate/VP copolymer were not irritating to rabbit skin at 100%. Hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer was not irritating in a human assay. In ocular irritation assays acrylamide/sodium acryloyldimethyltaurate/acrylic acid copolymer, ammonium acryloyldimethyltaurate/carboxyethyl acrylate crosspolymer, and ammonium acryloyldimethyltaurate/VP copolymer were not irritating or only slightly irritating in rabbit eyes. Hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer was not an ocular irritant in an in vitro assay. Sodium acrylate/acryloyldimethyltaurate/ dimethylacrylamide crosspolymer (<2.25%) was not predicted to be irritating in a HET-CAM assay. In a Buehler Test, ammonium acryloyldimethyltaurate/carboxyethyl acrylate crosspolymer was not sensitizing to guinea pigs at 25%. Ammonium acryloyldimethyltaurate/VP copolymer was not sensitizing to guinea pigs. Acrylamide/sodium acryloyldimethyltaurate/acrylic acid copolymer and sodium acrylate/acryloyldimethyltaurate/ dimethylacrylamide crosspolymer were not sensitizing in HRIPTs. Hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer was not sensitizing in a human sensitization assay.
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The Cosmetic Ingredient Review was established in 1976 by the industry trade association (then the Cosmetic, Toiletry, and Fragrance Association, now the Personal Care Products Council), with the support of the U.S. Food and Drug Administration and the Consumer Federation of America. Although funded by the Council, CIR and the review process are independent from the Council and the cosmetics industry. CIR operates under a set of procedures.
General policy and direction are given by a 7-member Steering Committee chaired by the President and CEO of the Council, with a dermatologist representing the American Academy of Dermatology, a toxicologist representing the Society of Toxicology, a consumer representative representing the Consumer Federation of America, an industry scientist (the current chair of the Council's CIR Committee), Chair of the CIR Expert Panel, and the Council’s Executive Vice President for Science.