Toxicity study of sodium N-[2-[4-(2,2-dimethylpropionyloxy) phenylsulfonylamino] benzoyl] aminoacetate tetrahydrate (ONO-5046·Na) (2) 4- week repeated dose intravenous toxicity study in rats with 4-week recovery test

Abstract

A 4-week repeated dose toxicity study with 4-week 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 and saline control), 18.75, 37.5, 75 or 150 mg/kg. ONO-5046·Na did not affect clinical signs, body weight, food consumption, ophthalmology, urinalysis, hematology, blood chemistry, organ weights, necropsy or histopathology at any dose. These results indicate that the NOAEL of ONO- 5046·Na in rats is 150 mg/kg/day for both sexes in this study.