冻干ZB183孢子：在Wistar大鼠中进行的90天重复剂量口服（灌胃）毒性研究。
Lyophilized ZB183 Spores: 90-Day Repeat Dose Oral (Gavage) Toxicity Study in Wistar Rats.
作者信息
Appala Naidu B, Kannan Kamala, Santhosh Kumar D P, Oliver John W K, Abbott Zachary D
机构信息
Department of Safety Assessment, Eurofins Advinus Limited, Post Box No. 5813, Plot Nos. 21 & 22 Peenya II Phase, Bengaluru 560 058, India.
ZBiotics Company, 181 2nd St., San Francisco, CA 94105, USA.
出版信息
J Toxicol. 2019 Nov 3;2019:3042108. doi: 10.1155/2019/3042108. eCollection 2019.
A 90-day repeated-dose oral toxicological evaluation was conducted according to GLP and OECD guidelines on lyophilized spores of the novel genetically modified strain ZB183. Lyophilized spores at doses of 10, 10, and 10 CFU/kg body weight/day were administered by oral gavage to Wistar rats for a period of 90 consecutive days. ZB183 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 10 and 10 CFU/kg/day doses without an increase in total protein in males or females and was considered a nonadverse effect. The "No Observed Adverse Effect Level (NOAEL)" is defined at the highest dose of 10 CFU/kg body weight/day for lyophilized ZB183 Spores under the test conditions employed.
根据GLP和经合组织指南，对新型转基因菌株ZB183的冻干孢子进行了为期90天的重复剂量口服毒理学评估。以10⁶、10⁷和10⁸CFU/kg体重/天的剂量，通过口服灌胃法连续90天给予Wistar大鼠冻干孢子。ZB183对两性的临床体征、死亡率、眼科检查、功能观察组合、体重、体重增加和食物消耗均无影响。在血液学、凝血、尿液分析、甲状腺激素分析、末次禁食体重、器官重量、大体病理学和组织病理学方面，未观察到与受试物相关的变化。在10⁷和10⁸CFU/kg/天剂量下，观察到雄性或雌性大鼠血浆白蛋白水平有轻微升高，但总蛋白未增加，这被认为是一种非不良反应。在所采用的试验条件下，冻干ZB183孢子的“未观察到不良反应水平（NOAEL）”定义为最高剂量10⁸CFU/kg体重/天。
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