Toxicology and Carcinogenesis Studies of Diphenhydramine Hydrochloride (Cas No. 147-24-0) in F344/N Rats and B6C3F1 Mice (Feed Studies)

摘要

Two-year toxicology and carcinogenesis studies were conducted by feeding diets containing 0, 313, or 625 ppm diphenhydramine hydrochloride to groups of 50 male rats for 103 weeks. Diets containing 0, 156, or 313 ppm were fed to groups of 50 female rats and 48 or 50 male and 50 female mice for 103 (female rats and female mice) or 105 (male mice) weeks. Under the conditions of these 2-year feed studies, there was equivocal evidence of carcinogenic activity of diphenhydramine hydrochloride for male F344/N rats, based on marginally increased incidences of uncommon brain neoplasms (astrocytomas or gliomas) and of alveolar/bronchiolar neoplasms. There was equivocal evidence of carcinogenic activity for female F344/N rats, based on a marginal increase in the incidence of pituitary gland adenomas. There was no evidence of carcinogenic activity for male or female B6C3F1 mice fed diets containing 156 or 313 ppm diphenhydramine hydrochloride.