COLLABORATIVE WORK TO EVALUATE TOXICITY ON MALE REPRODUCTIVE ORGANS BY REPEATED DOSE STUDIES IN RATS : 8)EFFECTS OF DAILY SUBCUTANEOUS ADMINISTRATION OF RESERPINE ON SPERMATOGENESIS FOR 2 AND 4 WEEKS

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概要

• 論文の詳細を見る

• To obtain information on the validity and the limitations of 2-weeks repeated-dose toxicity studies to detect effects on the male genital organs of rats, reserpine was administered daily at 0.05 and 0.1 mg/kg by subcutaneous injection to Crj:CD(SD)IGS male rats for 2 and 4 weeks (2-weeks and 4-weeks studies). In the 2-weeks study, suppression of body weight gain was observed in the reserpine 0.1 mg/kg group. In the 4-weeks study, suppression of body weight gain and a decrease in prostate weight were observed in ne reserpine 0.1 mg/kg group. Slight to moderate retention of step 19 spermatids in the seminiferous tubules (stages IX-XI) was observed in a few animals of both the reserpine 0.05 and 0.1 mg/kg groups in both the 2- and 4-weeks studies. However, seminiferous tubule atrophy with degeneration of germ sells was observed sporadically not only in the reserpine groups but also in the control group, and this change might have been the cause of the spermatid retention. Therefore, we were unable to reach a clear conclusion with regard to whether it is possible to detect reserpine toxicity on spermatogenesis in rats after 2-weeks administration.

• 日本トキシコロジー学会の論文
• 2000-10-25

著者

• Kawamura Nobuyuki

  European Federation of Pharmaceutical Industries and Associations

• Takeshita Shuji

  Drug Safety Evaluation Lead Optimizaion Drug Innovation & Approval Divistion Aventis Pharma Ltd.

• Kawamura Naohisa

  Research Department Saitama Daiichi Pharmaceutical Co. Ltd.

• Tsutsumi Shunsuke

  Drug Development Research Laboratories, Pharma Research and Development Division, Hoechst Japan Limi

• KAWAMURA Nobuyuki

  Drug Safety Evaluation, Lead Optimization, Drug Innovation & Approval Division, Aventis Pharma Ltd.

• Tsutsumi S.

  日本製薬工業協会

関連論文

• Safety assessment of biopharmaceuticals : Japanese perspective on ICH S6 guideline maintenance
• CURRENT OPINION : SAFETY EVALUATION OF DRUG METABOLITES IN DEVELOPMENT OF PHARMACEUTICALS
• Effects of pyridoxine on the male fertility.
• EFFECTS OF PYRIDOXINE ON MALE FERTILITY (<SPECIAL ISSUE>TESTICULAR TOXICITY)
• COMPARISON OF POULTICE-TYPE AND TAPE-TYPE PATCHES CONTAINING KETOPROFEN ON HUMAN SKIN IRRITATION
• P-83 Collaborative work for evaluation of toxicity on male reproductive organs by repeated dose studies in rats : Effects of daily subcutaneous administration of reserpine on spermatogenesis for 2 and 4 weeks(Proceedings of the 27th Annual Meeting)
• COLLABORATIVE WORK TO EVALUATE TOXICITY ON MALE REPRODUCTIVE ORGANS BY REPEATED DOSE STUDIES IN RATS : 8)EFFECTS OF DAILY SUBCUTANEOUS ADMINISTRATION OF RESERPINE ON SPERMATOGENESIS FOR 2 AND 4 WEEKS

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