SODIUM N-[2-[4-(2, 2-DIMETHYLPROPIONYLOXY)PHENYLSULFONYLAMINO]BENZOYL]AMINOACETATE TETRAHYDRATE(ONO-5046・Na)の生殖発生毒性試験(第2報)ラットにおける静脈内投与による出生前および出生後の発生ならびに母動物の機能に関する試験

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Prenatal and postnatal toxicity of sodium N-[2-[4-(2, 2-dimethylpropionyloxy)phenylsulfonylamino]benzoyl]aminoacetate tetrahydrate(ONO-5046・Na), a novel inhibitor of human neutrophil elastase, was studied in Sprague-Dawley(SD)rats. ONO-5046・Na was injected intravenously at doses of 0, 18.75, 37.5 and 75 mg/kg/day to pregnant rats from day 7 of pregnancy to day 20 after delivery. All pregnant rats were allowed to deliver naturally for postnatal examination of their offspring. No adverse effects on dams were observed in clinical signs, body weigth change, food consumption, pregnant, delivery or lactating performances. ONO-5046・Na did not'affect the postnatal development of offspring, including birth index, survival index, physical and functional development, motor activity, emotionality, learning ability and reproductive performance. From these, results, it is considered that the NOAEL of ONO-5046・Na is 75 mg/kg/day for dams and their offspring.
日本トキシコロジー学会の論文
1998-07-28