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J Toxicol Sci ; 23 Suppl 3: 457-82, 1998 Jul.
Article in Japanese | MEDLINE | ID: mdl-9760406

ABSTRACT

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.


Subject(s)
Glycine/analogs & derivatives , Serine Proteinase Inhibitors/toxicity , Sulfonamides/toxicity , Animals , Blood Cell Count/drug effects , Female , Glycine/administration & dosage , Glycine/toxicity , Heart/drug effects , Injections, Intravenous , Lung/drug effects , Male , No-Observed-Adverse-Effect Level , Organ Size/drug effects , Rats , Rats, Sprague-Dawley , Serine Proteinase Inhibitors/administration & dosage , Sulfonamides/administration & dosage , Time Factors , Urinary Bladder/drug effects
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