Collaborative work on evaluation of ovarian toxicity. 16) Effects of 2 or 4 weeks repeated dose studies and fertility study of Chlorpromazine hydrochloride in rats.

In order to examine potential ovarian toxicity in 2 weeks or 4 weeks repeated-dose studies and a fertility study, chlorpromazine hydrochloride (CPZ) was administered orally to Crl:CD(SD) female rats at dosage levels of 0, 3, 10 and 30 mg/kg/day. In the repeated-dose studies, ovarian weights were decreased at > or = 10 mg/kg in the 4 weeks study and an increase in large atretic follicles was observed histopathologically at > or = 3 mg/kg and > or = 10 mg/kg in the 2 and 4 weeks studies, respectively. In addition, decreased uterine weights and/or atrophic findings in the uterus and vagina at 30 mg/kg and > or = 10 mg/kg, mucification in the vaginal epithelium and alveolar hyperplasia in the mammary gland at > or = 3 mg/kg and > or = 10 mg/kg were seen in the 2 and 4 weeks studies, respectively.