Ngo Nguyen Quynh Anh, Nguyen Huong Thi, Dam Xuan Thanh, Bui Dinh Nhi, Minh Thi Thao
Center for Pharmaceutical Research and Business, Hai Duong Central College of Pharmacy, 324 Nguyen Luong Bang, Hai Duong City 170000, Vietnam.
Faculty of Biotechnology, Hanoi University of Pharmacy, 13-15 Le Thanh Tong, Ha Noi City 100000, Vietnam.
Toxicol Res (Camb). 2024 Sep 24;13(5):tfae152. doi: 10.1093/toxres/tfae152. eCollection 2024 Oct.
This study investigated the acute and repeated 28-day dose toxicity profiles of M31, isolated from children's feces, in Swiss rats and New Zealand rabbits. To investigate acute toxicity, rats were given varied doses of M31 (1 × 10 CFU/mL, 3 × 10 CFU/mL, and 5 × 10 CFU/mL) orally once daily for 14 days, in accordance with OECD recommendations No. 423. To evaluate toxicity, rabbits were given either a low dosage (1 × 10 CFU/mL) or a high dose (5 × 10 CFU/mL) during a 28-day period using the OECD Test Guideline 407 protocol. Neither death nor significant abnormalities were observed in the rats during the experiment. The microscopic examination of key organs revealed no substantial changes in organ morphology. Furthermore, analyses of serum biochemistry and hematological parameters did not reveal any treatment-associated variations. In sum, these findings suggest that the oral intake of M31 at concentrations up to 5 × 10 CFU/mL for 28 days poses no discernible risks.
本研究调查了从儿童粪便中分离出的M31对瑞士大鼠和新西兰兔的急性毒性及28天重复给药毒性特征。为研究急性毒性,按照经合组织(OECD)第423号建议,大鼠每天口服一次不同剂量的M31(1×10 CFU/mL、3×10 CFU/mL和5×10 CFU/mL),持续14天。为评估毒性,根据OECD测试指南407方案,在28天期间给兔子低剂量(1×10 CFU/mL)或高剂量(5×10 CFU/mL)的M31。实验期间大鼠未出现死亡或明显异常。对关键器官的显微镜检查未发现器官形态有实质性变化。此外,血清生化和血液学参数分析未发现任何与治疗相关的差异。总之,这些结果表明,连续28天口服浓度高达5×10 CFU/mL的M31没有明显风险。