Toxicology and Carcinogenesis Studies of Gamma-Butyrolactone (CAS NO. 96-48-0) inF344/N Rats and B6C3F1 Mice (Gavage Studies)

摘要

Toxicology and carcinogenesis studies were conducted by administering gamma-butyrolactone in corn oil by gavage to groups of F344/N rats and B6C3F1 mice of each sex. Daily doses were 0, 112, and 225 mg/kg for male rats; 0, 225, and 450 mg/kg for female rats; and 0, 262, and 525 mg/kg for male and female mice for a period of 2 years. Under the conditions of the 2-year gavage studies, there was no evidence of carcinogenic activity of gamma-butyrolactone in male F344/N rats given 112 or 225 mg/kg or in female F344/N rats given 225 or 450 mg/kg in corn oil. There was equivocal evidence of carcinogenic activity of gamma-butyrolactone in male B6C3F1 mice based on marginally increased incidences of adrenal medulla pheochromocytomas and hyperplasia in the low-dose group. The sensitivity of the study in male mice to detect a carcinogenic effect was reduced by the low survival of the high-dose group associated with fighting. There was no evidence of carcinogenic activity of gamma-butyrolactone in female B6C3F1 mice given 262 or 525 mg/kg in corn oil.