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[Toxicity study of sodium N-[2-[4-(2,2-dimethylpropionyloxy) phenylsulfonylamino] benzoyl] aminoacetate tetrahydrate (ONO-5046.Na) (4). 6-month repeated dose intravenous toxicity study in rats with 1-month recovery test]. 1998
K Yamaguchi, and
Y Aze, and
K Shimizu, and
Y Shichino, and
H Oku, and
H Mori, and
K Shinomiya, and
H Ueda, and
Y Suzuki, and
H Oida, and
K Nishibata, and
M Tanaka, and
Y Yanagizawa, and
T Nanba, and
K Nishiyama, and
H Yonezawa, and
T Fujita
Fukui Institute of Safety Research, ONO Pharmaceutical Co., Ltd., Japan.
A 6-month repeated dose toxicity study with 1-month recovery test of sodium N-[2-[4-(2,2-dimethylpropionyloxy) phenylsulfonylamino] benzoyl] aminoacetate tetrahydrate (ONO-5046.Na), a novel neutrophil elastase inhibitor, was conducted in Sprague-Dawley (SD) rats. The rats of both sexes were administered ONO-5046.Na intravenously at a daily dose of 0 (vehicle control), 18.75, 37.5 or 75 mg/kg. ONO-5046.Na did not affect clinical signs, body weight, food consumption, opthalmology, urinalysis, hematology, blood chemistry, organ weight, necropsy or histopathology at any dose. These results indicate that the NOAEL of ONO-5046.Na in rats is 75 mg/kg/day for both sexes in this study.
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