Safety evaluation of a proprietary food-grade, dried fermentate preparation of Saccharomyces cerevisiae.
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.
Natural and Medicinal Products Division, AIBMR Life Sciences, South Meridian, Puyallup, WA, USA. alex@aibmr.com
Alexander G
AG
Schauss
R
R
Glavits
John
J
Endres
Gitte S
GS
Jensen
Amy
A
Clewell
D000818:Animals; D049109:Cell Proliferation / Q000187:drug effects; D002478:Cells, Cultured; D019388:Cytochrome P-450 CYP1A2 / Q000378:metabolism; D051544:Cytochrome P-450 CYP3A / Q000378:metabolism; D019587:Dietary Supplements / Q000633:toxicity*; D005260:Female; D005285:Fermentation; D005503:Food Additives / Q000633:toxicity*; D022781:Hepatocytes / Q000201:enzymology; D006801:Humans; D008214:Lymphocytes / Q000166:cytology / Q000187:drug effects; D008297:Male; D051379:Mice; D009152:Mutagenicity Tests; D019055:No-Observed-Adverse-Effect Level; D051381:Rats; D017207:Rats, Sprague-Dawley; D012441:Saccharomyces cerevisiae; D012485:Salmonella typhi / Q000187:drug effects / Q000235:genetics
D005503:Food Additives; D019388:Cytochrome P-450 CYP1A2; D051544:Cytochrome P-450 CYP3A; C510163:CYP3A4 protein, human