title: Review of the oral toxicity of polyvinyl alcohol (PVA).
abstract: Polyvinyl alcohols (PVA) (CAS no. 9002-89-5) are synthetic polymers used in a wide range of industrial, commercial, medical and food applications. The purpose of this review, this critical evaluation of the available information on PVA, is to support the safety of PVA as a coating agent for pharmaceutical and dietary supplement products. All the available information on PVA gleaned from a comprehensive search of the scientific literature were critically evaluated. Orally administered PVA is relatively harmless. The safety of PVA is based on the following: (1) the acute oral toxicity of PVA is very low, with LD(50)s in the range of 15-20 g/kg; (2) orally administered PVA is very poorly absorbed from the gastrointestinal tract; (3) PVA does not accumulate in the body when administered orally; (4) PVA is not mutagenic or clastogenic; and (5) NOAELs of orally administered PVA in male and female rats were 5000 mg/kg body weight/day in the 90-day dietary study and 5000 mg/kg body weight/day in the two-generation reproduction study, which was the highest dose tested. A critical evaluation of the existing information on PVA supports its safety for use as a coating agent for pharmaceutical and dietary supplement products.
authors.affiliation: Colorcon, 415 Moyer Boulevard, West Point, PA 19486, USA. cdemerlis@colorcon.com
authors.forename: C C
authors.initials: CC
authors.lastname: DeMerlis
authors.forename: D R
authors.initials: DR
authors.lastname: Schoneker
mesh_terms: D000284:Administration, Oral; D000818:Animals; D019587:Dietary Supplements / Q000633:toxicity; D005260:Female; D006801:Humans; D007408:Intestinal Absorption; D007928:Lethal Dose 50; D008297:Male; D009152:Mutagenicity Tests; D019055:No-Observed-Adverse-Effect Level; D011142:Polyvinyl Alcohol / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000633:toxicity*; D012098:Reproduction / Q000187:drug effects*; D012449:Safety; D014018:Tissue Distribution
chemical_list: D011142:Polyvinyl Alcohol