Toxicology and Carcinogenesis Studies of Scopolamine Hydrobromide Trihydrate (CASNo. 6533-68-2) in F344/N Rats and B6C3F1 Mice (Gavage Studies)

摘要

Scopolamine hydrobromide trihydrate is used in ophthalmic preparations and as apreanesthetic sedative. Its major use is in transdermal patches for the treatment of motion sickness. Scopolamine hydrobromide trihydrate was selected for study because of considerable human exposure resulting from its use in prescription and over-the-counter preparations. Scopolamine was a suspect carcinogen because it contains an aliphatic epoxide moiety which may act as a biological alkylating agent. Male and female F344/N rats and B6C3F1 mice received scopolamine hydrobromide trihydate (89% pure) in distilled water by gavage for 16 days, 14 weeks, or 2 years. Genetic toxicology studies were conducted in Salmonella typhimurium cultured Chinese hamster ovary cells, and mouse peripheral blood erythrocytes.