Subchronic Toxicity Study of 1,3-Propanediol Administered Orally to Rats

Abstract

1,3-Propanediol was a specialty chemical that, due to a novel manufacturing process, is now commercially available in large quantities. Its subchronic toxicity has been evaluated in rats, with special emphasis on potential male reproductive effects. 1,3-Propanediol in deionized water was administered orally by gavage to three groups of 10 male and 10 female Crl:CD(SD)BR rats for a period of 90 consecutive days. Dosage levels were 100, 300, and 1000 mg/kg/day, and a control group received water at a constant volume of 10 ml/kg/day. All animals survived to the scheduled necropsy, and there were no effects on the clinical condition of the animals, body weights, body weight gains, food consumption or organ weights. There were no effects on hematology or serum chemistry parameters. Spermatogenic endpoints were unaffected in all treated males. No treatment-related changes were observed on macroscopic or microscopic examinations of selected organs. Under the conditions of the study, the no-observed-effect level (NOEL) for systemic toxicity of 1,3-propanediol administered orally via gavage to male and female rats for 90 consecutive days was 1000 mg/kg/day, the highest dose tested.