Evaluation of developmental neurotoxicity of polysorbate 80 in rats.

The developmental neurotoxicity of polysorbate 80 (PS80) was evaluated in rats. Crl:CD(SD) rats were given drinking water containing PS80 at 0, 0.018, 0.13, 1.0, or 7.5% (0, 0.035, 0.245, 1.864, or 16.783ml/kgbw/day) on day 0 of pregnancy through day 21 after delivery. Pregnant rats were allowed to deliver spontaneously. Potential adverse effects of pre- and post-natal exposure on the development and function of the nervous system in offspring of rats given PS80 were examined. Maternal body weight was lowered at 7.5%. Number of pups born was lowered at 7.5%. There were no compound-related effects on locomotor activity of offspring on postnatal days (PNDs) 14-15, 17-18, 20-21 and 33-37. No compound-related changes were found in developmental landmarks, sexual maturation, or reflex responses. Although decreased rate of avoidance responses was noted on PNDs 23-27 in male and female offspring at 7.5%, no compound-related changes were found in performance in the conditioned avoidance response on PNDs 60-67. Histopathological examinations of the brain revealed no toxicological changes. Lowered body weight was observed in male and female offspring at 7.5%. The NOAEL in this study was considered to be 1.0% (1.864ml/mg/kgbw/day).