Amended final safety assessment of polyvinyl acetate

Abstract

The polymer Polyvinyl Acetate (PVAc) is used in cosmetics as a binder, emulsion stabilizer, and hair fixative. Current reported uses are limited to a few eye makeup formulations. As used in cosmetic formulations, PVAc is an emulsion containing 55 to 60% resin. The Cosmetic Ingredient Review (CIR) Expert Panel had previously published a review of the safety of this ingredient in J Am Coll Toxicol (1992:11:465-74) concluding that the available data were not sufficient to support safety. The report included mutagenesis and carcinogenesis studies with negative findings. Data from pregnant rabbits indicated that PVAc was not transferred to the fetus, even when administered by the i.v. route, suggesting that present cosmetic use practices preclude any reproduction or developmental toxicity hazard to humans. Composition and impurities data and human skin irritation and sensitization data, however, were not available. Data received since that assessment include the nature of the ingredient as used in cosmetics, the identity of many of the impurities, and the test results of human exposure to aqueous emulsions containing ≤50% PVAc. Less than 2 ppm of arsenic and <20 ppm of heavy metals reportedly will be in a typical emulsion. The clinical testing of an aqueous emulsion with 50% PVAc produce no irritation or sensitization. Based on the recent information, this ingredient is found to be safe for use as a cosmetic ingredient in the present practices of use.