Effects of polyvinyl alcohol administered in the diet to rats on fertility, early embryonic development, growth and development

PVA was administered in the diet to male and female Sprague-Dawley rats (26/sex/group) at doses of 0, 2000, 3500 and 5000 mg/kg/day for two generations. The study design assessed gonadal function, estrous cycle, mating behavior, conception, gestation, parturition, lactation, weaning, and growth and development of F(1) and F(2) offspring. Parental rats were treated for 70 days prior to mating, throughout mating, gestation and lactation until sacrifice. Clinical observations, body weights and feed consumption were recorded routinely. Dietary concentrations were adjusted for each sex on a weekly basis except during gestation and lactation, to provide the intended mg/kg/day PVA levels. Pups were weighed routinely and weaned at 21 days of age prior to selection for the next generation. Unformed stool was noted predominately at the 3500 and 5000 mg/kg/day levels in P(0) and F(1) parental Animals. This finding was attributed to the high levels of PVA being fed and subsequently excreted in the stool. Slight decreases in the mean body weights of P(0) males were noted at 2000 and 5000 mg/kg/day. Feed consumption was elevated at the 3500 and 5000 mg/kg/day doses in both generations but not during either lactation period. These increases generally were observed in a dose-related manner (g/kg/day), as a result of the large amount of PVA being consumed to maintain the caloric intake necessary for normal growth. There were no effects of PVA on P(0), F(1) male or female reproductive performance or pup survival, growth, organ weights, and macroscopic or microscopic observations at doses of 2000, 3500 and 5000 mg/kg/day. Therefore the no-observed-effect level (NOAEL) is 5000 mg/kg/day for both parental and offspring in this reproductive study.