Final Report On the Safety Assessment of Polyvinyl Alcohol

Abstract

Polyvinyl Alcohol is a synthetic alcohol used as a binder, film former, and viscosity increasing agent in a wide range of cosmetic formulations at concentrations up to 13%. Typical molecular weights range from 25,000 to 300,000. The acute oral LD50 in rats is reported to be >10 g/kg in one study and >21.5 g/kg in another. Dermal exposures of 5 and 13 weeks (the latter using 13% Polyvinyl Alcohol) produced no significant effects in rats. Various organ lesions and hypertension were noted in rats following repeated subcutaneous or intravenous dosing. Central nervous system depression and anemia, followed by renal damage, was seen in beagle dogs given daily intravenous injections of Polyvinyl Alcohol for a week. Several studies tested the carcinogenicity of subcutaneous implants of Polyvinyl Alcohol sponges or powder. Although the majority of these studies were positive, tumors were localized to the site of implantation. In another study in which Polyvinyl Alcohol was used as the vehicle for another agent and tested itself as the vehicle control, Polyvinyl Alcohol had no effect on the incidence of histiocytic sarcoma. Although no data were available assessing the reproductive or developmental toxicity, these endpoints were not considered to be likely with external exposure to this polymer. Polyvinyl Alcohol was not an ocular irritant in animal or clinical studies, nor was it a sensitizer. Some evidence of dermal irritation in animal and clinical studies was seen, but in the clinical studies it was not considered clinically significant. Based on these data, it was concluded that Polyvinyl Alcohol is safe as used in cosmetic formulations.