Safety evaluation of a proprietary food-grade, dried fermentate preparation of Saccharomyces cerevisiae.

Abstract	A safety evaluation was performed for EpiCor, a product produced by a proprietary fermentation process using Saccharomyces cerevisiae. Studies included the following assays: bacterial reverse mutation, mouse lymphoma cell mutagenicity, mitogenicity assay in human peripheral lymphocytes, and a cytochrome P450 ([CYP] CYP1A2 and CYP3A4) induction assessment as well as 14-day acute, 90-day subchronic, and 1-year chronic oral toxicity studies in rats. No evidence of genotoxicity or mitogenicity was seen in any of the in vitro or in vivo studies. The CYP assessment showed no interactions or inductions. No toxic clinical symptoms or histopathological lesions were observed in the acute, subchronic, or chronic oral toxicity studies in the rat. Results of the studies performed indicate that EpiCor does not possess genotoxic activity and has a low order of toxicity that is well tolerated when administered orally. The no observable adverse effect level (NOAEL) was 1500 mg/kg body weight (bw)/d for the 90-day study and 800 mg/kg bw/d for the 1 year study, for the highest doses tested.
Authors	Alexander G Schauss, R Glavits, John Endres, Gitte S Jensen, Amy Clewell
Journal	International journal of toxicology (Int J Toxicol) 2012 Jan-Feb Vol. 31 Issue 1 Pg. 34-45 ISSN: 1092-874X [Electronic] United States
PMID	22222580 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
Chemical References	Food Additives Cytochrome P-450 CYP1A2 Cytochrome P-450 CYP3A CYP3A4 protein, human
Topics	Animals Cell Proliferation (drug effects) Cells, Cultured Cytochrome P-450 CYP1A2 (metabolism) Cytochrome P-450 CYP3A (metabolism) Dietary Supplements (toxicity) Female Fermentation Food Additives (toxicity) Hepatocytes (enzymology) Humans Lymphocytes (cytology, drug effects) Male Mice Mutagenicity Tests No-Observed-Adverse-Effect Level Rats Rats, Sprague-Dawley Saccharomyces cerevisiae Salmonella typhi (drug effects, genetics)

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