Bacillus coagulans SNZ 1969 is a rod-shaped, slightly acidophilic, gram-positive, spore forming and highly resilient bacteria. B. coagulans SNZ 1969 has GRAS (Generally Recognized As Safe) status for use as a probiotic in foods (US FDA number GRN-597). The present study was aimed to assess the safety of a proprietary strain Bacillus coagulans SNZ 1969 by conducting acute and sub-acute 28 days repeated dose oral toxicity studies in Wistar Rats. In the acute toxicity study, the rats were orally fed with 2000 mg/kg body weight (BW) (5 × 1011 CFU/g) of B. coagulans SNZ 1969 as a single dose to determine the LD50 values. In the sub-acute repeated dose toxicity study, six groups of experimental rats received 250, 500, 1000 mg/kgBW/day (5 × 1011 CFU/g) of the test item for 28 consecutive days. The control animals received only water. Four groups of rats were sacrificed after 28 days and the remaining two groups were kept as recovery groups and sacrificed after 42 days. The results of these study indicate that there were no treatment related changes in any of the parameters studied i.e. clinical signs, body weight, food intake, urinalysis, hematological examinations, clinical biochemistry, gross pathology and histopathology after 28 days of repeated administration. Based on the results it was concluded that the LD50 of Bacillus coagulans SNZ 1969 is more than 2000 mg/kg body weight and the NOAEL derived from this study was 1000 mg/kg/day for 28 days, this corresponds to the 5 × 1011 CFU/kg.

中文翻译：

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凝结芽孢杆菌SNZ 1969在Wistar大鼠中的安全性评估。

凝结芽孢杆菌SNZ 1969是一种杆状，稍嗜酸，革兰氏阳性，芽孢形成和高弹性细菌。凝结芽孢杆菌SNZ 1969具有GRAS（一般公认安全）状态，可作为食品中的益生菌使用（美国FDA编号GRN-597）。本研究旨在通过在Wistar大鼠中进行急性和亚急性28天重复剂量口服毒性研究来评估专有芽孢杆菌凝结芽孢杆菌SNZ 1969的安全性。在急性毒性研究中，给大鼠口服单剂量2000毫克/千克体重（BW）（5×1011 CFU / g）的凝结芽孢杆菌SNZ 1969，以确定其LD50值。在亚急性重复剂量毒性研究中，六组实验大鼠连续28天接受250、500、1000 mg / kgBW /天（5×1011 CFU / g）的测试项目。对照动物仅接受水。28天后处死四组大鼠，其余两组作为恢复组并在42天后处死。这些研究的结果表明，重复给药28天后，在所研究的任何参数（即临床体征，体重，食物摄入，尿液分析，血液学检查，临床生化，总体病理学和组织病理学）中均没有与治疗相关的变化。根据结果​​得出结论，凝结芽孢杆菌SNZ 1969的LD50大于2000 mg / kg体重，本研究得出的NOAEL为1000 mg / kg / day，持续28天，相当于5×1011 CFU /公斤。这些研究的结果表明，重复给药28天后，在所研究的任何参数（即临床体征，体重，食物摄入，尿液分析，血液学检查，临床生化，总体病理学和组织病理学）中均没有与治疗相关的变化。根据结果​​得出结论，凝结芽孢杆菌SNZ 1969的LD50大于2000 mg / kg体重，本研究得出的NOAEL为1000 mg / kg / day，持续28天，相当于5×1011 CFU /公斤。这些研究的结果表明，重复给药28天后，在所研究的任何参数（即临床体征，体重，食物摄入，尿液分析，血液学检查，临床生化，总体病理学和组织病理学）中均没有与治疗相关的变化。根据结果​​得出结论，凝结芽孢杆菌SNZ 1969的LD50大于2000 mg / kg体重，本研究得出的NOAEL为1000 mg / kg / day，持续28天，相当于5×1011 CFU /公斤。