Ethyl Ester of PVM/MA Copolymer and Butyl Ester of PVM/MA Copolymer are polymers consisting of the partial ethyl ester and butyl ester, respectively, of the polycarboxylic resin formed from vinyl methyl ether and maleic anhydride. These esters are used in cosmetic formulations as film formers and hair fixatives. Ethyl Ester and Butyl Ester of PVM/MA Copolymer had oral LD50s for rats of >25.6 g/kg. Butyl Ester of PVM/MA Copolymer was not toxic in a short-term oral toxicity study. Neither ester was toxic in subchronic inhalation animal studies and were neither ocular or dermal primary irritants. Neither was a skin irritant, sensitizer, or photosensitizer when assayed in human volunteers. Butyl Ester of PVM/MA Copolymer was not mutagenic in a mouse forward mutation assay with or without metabolic activation, and was inactive in an unscheduled DNA Synthesis assay. This ingredient was weakly active in the in vitro transformation of Balb/3T3 cells assay. On the basis of the animal and clinical data presented in this report, it is concluded that Ethyl Ester of PVM/MA Copolymer and Butyl Ester of PVM/MA Copolymer are safe in a neutralized form as cosmetic ingredients in the present practices of use.
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