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One-year chronic oral toxicity with combined reproduction toxicity study of a novel probiotic, Bacillus coagulans, as a food ingredient

Food and Chemical Toxicology, 2011, 49: 1174-1182

J.R. Endres, I. Qureshi, T. Farber, J. Hauswirth, G. Hirka, I. Pasics, and A.G. Schauss

Abstract

Some strains of Bacillus coagulans can survive extremes of heat, stomach acid and bile acids, to which commonly consumed probiotics are susceptible. A toxicological safety assessment was published in 2009 on a proprietary preparation of B. coagulans – GanedenBC30 – a novel probiotic. It was concluded that GanedenBC30 is safe for chronic human consumption based upon scientific procedures, supported by a safe history of use (Endres et al., 2009).

A one-year chronic oral toxicity study combined with a one-generation reproduction study was conducted to further investigate safety of long-term consumption. The one-year study of GanedenBC30 administered to male and female HsdBrlHan: Wistar rats in their diet showed no signs of toxicity at the highest dose tested. The conclusion from the reproduction toxicity study is that administration of GanedenBC30 in the diet caused no signs of toxicity in the parental generation (male or female) nor the F1 offspring. Using the lowest NOEL of 1948 mg/kg concluded at the end of the 1-year feeding study, a 100-fold safety factor, a test article concentration of 6.88 × 1010 CFU (colony forming units) per gram, and an average 70 kg human, it is determined that GanedenBC30 is safe for chronic consumption at up to 9.38 × 1010 CFUs per day.

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