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Flutamide, a nonsteroidal antiandrogen, was administered orally to 8-week (for the 2 week study) and 6-week-old (for the 4 week study) male Crj:CD(SD) rats at dose levels of 0 mg/kg, 60 mg/kg and 200 mg/kg daily for 2 weeks or 4 weeks in order to determine whether a 2 week treatment period is sufficient for detection of drug effects on the male reproductive system. Flutamide treatment for 4 weeks resulted in decreased organ weights of the epididymides and prostate, decreased sperm counts and Leydig cell proliferation in the testes at 60 mg/kg and 200 mg/kg. Decreased sperm motility and histological lesions in the seminiferous tubules were observed at 200 mg/kg. Flutamide treatment for 2 weeks decreased organ weight of epididymides and prostate and caused Leydig cell proliferation in the testes at 60 mg/kg and 200 mg/kg. Decreased sperm counts and sperm motility, and histological lesions in seminiferous tubules were observed at 200 mg/kg. The results of this study showed that 2 weeks treatment with flutamide causes histological lesions of testes and disorders of sperm parameters similar to those observed with 4 weeks treatment, indicating that 2 weeks treatment is sufficient for detection of effects of flutamide on the male reproductive system.

journal of toxicological sciences

COLLABORATIVE WORK TO EVALUATE TOXICITY ON MALE REPRODUCTIVE ORGANS BY REPEATED DOSE STUDIES IN RATS : 5)EFFECTS OF REPEATED DOSES OF FLUTAMIDE FOR 2 AND 4 WEEKS