Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5854340 | Food and Chemical Toxicology | 2011 | 9 Pages |
Abstract
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 Ã 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 Ã 1010 CFUs per day.
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Authors
J.R. Endres, I. Qureshi, T. Farber, J. Hauswirth, G. Hirka, I. Pasics, A.G. Schauss,