LyophilizedB. subtilisZB183 Spores: 90-Day Repeat Dose Oral (Gavage) Toxicity Study In Wistar Rats

Appala Naidu. B, Kamala Kannan,D. P. Santhosh Kumar, John W.K. Oliver,Zachary D. Abbott

Journal of Toxicology(2019)

引用 0|浏览0
暂无评分
摘要
AbstractA 90-day repeated-dose oral toxicological evaluation was conducted according to GLP and OECD guidelines on lyophilized spores of the novel genetically modified strainB. subtilisZB183. Lyophilized spores at doses of 109, 1010, and 1011CFU/kg body weight/day were administered by oral gavage to Wistar rats for a period of 90 consecutive days.B.SubtilisZB183 had no effects on clinical signs, mortality, ophthalmological examinations, functional observational battery, body weights, body weight gains and food consumption in both sexes. There were no test item-related changes observed in haematology, coagulation, urinalysis, thyroid hormonal analysis, terminal fasting body weights, organ weights, gross pathology and histopathology. A minimal increase in the plasma albumin level was observed at 1010and 1011CFU/kg/day doses without an increase in total protein in males or females and was considered a non-adverse effect. The “No Observed Adverse Effect Level (NOAEL)” is defined at the highest dose of 1011CFU/kg body weight/day for lyophilizedB.SubtilisZB183 Spores under the test conditions employed.
更多
查看译文
AI 理解论文
溯源树
样例
生成溯源树,研究论文发展脉络
Chat Paper
正在生成论文摘要