Evaluation of the toxicity of polyvinylacetate phthalate in experimental animals.

Polyvinylacetate phthalate (PVAP) is used in the pharmaceutical industry as an ingredient in coating systems for oral solid dosage forms and in inks for monogramming capsules. PVAP has been evaluated in both sexes of several species in a number of toxicological studies including acute, repeated dosing, subchronic, chronic and reproductive and developmental. The acute oral toxicity is low in rats and mice (LD(50) > 8000 mg/kg body weight), although it appears to be more toxic in the dog. The gastrointestinal tract appears to be the target organ and effects seen (irritation, laxation, colitis with erosions and submucosal fibrosis in the dog and ulcers, polyps, and cecal wall thickening in rats) were dose dependent. There were no consistent treatment-related adverse effects on reproductive performance or development (not teratogenic). The no-observed-adverse-effect levels (NOAELs) ranged from 100 mg/kg body weight/day in the rabbit developmental toxicity study, to 500 mg/kg body weight/day in 24 month rat and dog studies, to 1000 mg/kg body weight/day in a one-generation reproduction study in the rat.