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

2012-01
International journal of toxicology 31(1)

PubMed: 22222580
DOI: 10.1177/1091581811425195

Study Design

Population: rats
Methods: bacterial reverse mutation, mouse lymphoma cell mutagenicity, mitogenicity assay in human peripheral lymphocytes, and a cytochrome P450 (CYP1A2 and CYP3A4) induction assessment as well as 14-day acute, 90-day subchronic, and 1-year chronic oral toxicity studies

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.

Research Insights

Supplement	Dose	Health Outcome	Effect Type	Effect Size	Source
Saccharomyces cerevisiae	—	No Adverse Effects	Neutral	Small	View source No toxic clinical symptoms or histopathological lesions were observed in the acute, subchronic, or chronic oral toxicity studies in the rat.
Saccharomyces cerevisiae	—	No CYP1A2 or CYP3A4 Interaction	Neutral	Small	View source The CYP assessment showed no interactions or inductions.
Saccharomyces cerevisiae	—	No Cytochrome P450 Induction	Neutral	Small	View source The CYP assessment showed no interactions or inductions.
Saccharomyces cerevisiae	—	No Observed Toxicity	Neutral	Small	View source No toxic clinical symptoms or histopathological lesions were observed in the acute, subchronic, or chronic oral toxicity studies in the rat.
Saccharomyces cerevisiae	—	Reduced Genotoxicity	Neutral	Small	View source No evidence of genotoxicity or mitogenicity was seen in any of the in vitro or in vivo studies.