Adgyl Lifesciences Private Limited (Formerly Department of Safety Assessment, Eurofins Advinus Limited), Bengaluru, Karnataka, India.
ZBiotics Company, San Francisco, California, USA.
J Appl Toxicol. 2024 Dec;44(12):1874-1885. doi: 10.1002/jat.4677. Epub 2024 Aug 21.
The novel genetically modified probiotic Bacillus subtilis ZB423 was assessed in a 90-day repeated-dose oral toxicity study adhering to Good Laboratory Practice (GLP) and Organization for Economic Cooperation and Development (OECD) guidelines. Spray-dried spores at a concentration of 1.1E12 CFU/g were administered at doses of 130, 260, and 519 mg/kg body weight/day correlating to 1.43 × 10, 2.86 × 10, and 5.71 × 10 CFU/kg/day, respectively, by oral gavage to Wistar rats for a period of 90 consecutive days. Results showed no toxicologically relevant findings for B. subtilis ZB423 from measured parameters. The no observed adverse effect level (NOAEL) of B. subtilis ZB423 is 519 mg/kg body weight/day corresponding to 5.71 × 10 CFU/kg/day for lyophilized B. subtilis ZB423 spores under the test conditions employed.
新型基因改良益生菌枯草芽孢杆菌 ZB423 进行了为期 90 天的重复剂量经口毒性试验，该试验符合良好实验室规范（GLP）和经济合作与发展组织（OECD）的指导原则。采用喷雾干燥孢子，浓度为 1.1E12 CFU/g，以 130、260 和 519mg/kg 体重/天的剂量通过口服灌胃给予 Wistar 大鼠，分别相当于 1.43×10、2.86×10 和 5.71×10 CFU/kg/天，连续 90 天。结果表明，枯草芽孢杆菌 ZB423 的各项测量参数均无毒性相关发现。枯草芽孢杆菌 ZB423 的未观察到不良作用水平（NOAEL）为 519mg/kg 体重/天，相当于试验条件下冻干枯草芽孢杆菌 ZB423 孢子的 5.71×10 CFU/kg/天。
