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Bacillus coagulans is a lactic acid, spore-forming gram-positive bacteria that has the potential of probiotic benefits. To evaluate the toxicological profiles of Bacillus coagulans strain SANK70258 (active element of LACRISTM-S), a 90-day oral gavage dose study was conducted in rats. The microbe was administered by oral gavage to 6-week old Crl:CD(SD) rats (10 males and 10 females/ group) for 90 days at dose levels of 0, 500, 1000, and 2000 mg/kg/day. According to the results, no deaths occurred in either males or females, and no treatment-related changes were observed in any clinical sign including a detailed observation with functional observational battery (FOB), functional test, motor activity, body weight, food consumption, ophthalmoscopy, urinalysis, hematology, blood chemistry, organ weight, necropsy or histopathology. In conclusion, Bacillus coagulans strain SANK70258 had no subchronic toxicity in rats and the no-observed-adverse-effect-level (NOAEL) was judged to be greater than 2000 mg (about 1 × 1012 CFU)/kg/day. The microbe is harmless and can be used as a probiotic.

Safety assessment of probiotic bacteria, <i>Bacillus coagulans </i>strain SANK70258, in rats