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.