Reproductive Toxicity Study of DA-125, A New Anthracycline Anticancer Agent: (II) Fertility Study in Rats

새로운 안트라사이클린계 항암제 DA-125의 생식독성연구: (II) 랫트 수태능력시험

  • 정문구 (한국화학연구소 안전성연구부) ;
  • 김종춘 (한국화학연구소 안전성연구부) ;
  • 김원배 (동아제약 주식회사 연구소) ;
  • 노정구 (한국화학연구소 안전성연구부)
  • Published : 1994.04.01

Abstract

DA-125, a new anthracycline antitumor antibiotic, was at dose levels of 0, 0.03, 0.1 and 0.3 mg/kg/day administered intravenously to Sprague-Dawley male rats from premating to mating period and to females from premating to early gestation period. Effects of test agent on general findings and reproductive performance of parent animals and embryonic development were examined. No treatment-related changes in clinical signs, body weight, food consumption and necropsy findings were observed in all groups of both sexes. At 0.3 mg/kg, a decrease in the weight of spleen was found only in male rats. Mating performance and fertility of parent animals were not adversely affected by all doses tested. Fl fetuses showed no changes related to treatment of DA-125, except that at 0.3 mg/kg, an increase in the resorption rate was seen. The results show that the no effect dose levels (NOELS) for general toxicity of parent animals and fetal development are 0.1 mg/kg/day and NOELS for reproductive capability are over 0.3 mg/kg/day.

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