[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].
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.
Fukui Institute of Safety Research, ONO Pharmaceutical Co., Ltd., Japan.
K
K
Yamaguchi
Y
Y
Aze
K
K
Shimizu
Y
Y
Shichino
H
H
Oku
H
H
Mori
K
K
Shinomiya
H
H
Ueda
Y
Y
Suzuki
H
H
Oida
K
K
Nishibata
M
M
Tanaka
Y
Y
Yanagizawa
T
T
Nanba
K
K
Nishiyama
H
H
Yonezawa
T
T
Fujita
D000818:Animals; D001772:Blood Cell Count / Q000187:drug effects; D005260:Female; D005998:Glycine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000633:toxicity; D006321:Heart / Q000187:drug effects; D007275:Injections, Intravenous; D008168:Lung / Q000187:drug effects; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D051381:Rats; D017207:Rats, Sprague-Dawley; D015842:Serine Proteinase Inhibitors / Q000008:administration & dosage / Q000633:toxicity*; D013449:Sulfonamides / Q000008:administration & dosage / Q000633:toxicity*; D013997:Time Factors; D001743:Urinary Bladder / Q000187:drug effects
D015842:Serine Proteinase Inhibitors; D013449:Sulfonamides; C069195:sivelestat; D005998:Glycine