薬理と治療

Abstract

The toxicity of the test substance, a water chestnut extract, was evaluated in male and female Sprague–Dawley（Crl: CD（SD））rats by repeated oral administration for 90 days. Three groups of 10 male and 10 female rats were used per group: 600 and 1200 mg/kg/day, and a control group. During the treatment period, general and detailed observations, functional tests, body weight and food intake measurements, ophthalmologic examinations, and urinalysis were performed. At the end of the treatment period, hematological examinations, blood biochemical tests, necropsy, organ weights, and histopathological examinations were performed. 　　No deaths occurred in either male or female group during the observation period. In the general condition, stools colored with the test substance were observed sporadically in males and females receiving 600 mg/kg/day or more, and post–dose drooling was observed sporadically in males and females receiving 1200 mg/kg/day during the observation period. 　　No toxicological changes were observed during detailed condition monitoring, functional examination, body weight, food intake, ophthalmological examination, urinalysis, hematological examination, hematological biochemical examination, organ weights, necropsy, and histopathological examination. 　　The NOAEL of 1200 mg/kg/day for both males and females was determined to be the nontoxic dose（NOAEL）after repeated oral administration of water chestnut extract for 90 days under the conditions of this study.（Jpn Pharmacol Ther 2023；51：633‒42）