title: Safety assessment of EPA-rich oil produced from yeast: Results of a 90-day subchronic toxicity study.
abstract: The safety of eicosapentaenoic acid (EPA) oil produced from genetically modified Yarrowia lipolytica yeast was evaluated following 90 days of exposure. Groups of rats received 0 (olive oil), 98, 488, or 976 mg EPA/kg/day, or GRAS fish oil or deionized water by oral gavage. Rats were evaluated for in-life, neurobehavioral, anatomic and clinical pathology parameters. Lower serum cholesterol (total and non-HDL) was observed in Medium and High EPA and fish oil groups. Lower HDL was observed in High EPA and fish oil males, only at early time points. Liver weights were increased in High EPA and Medium EPA (female only) groups with no associated clinical or microscopic pathology findings. Nasal lesions, attributed to oil in the nasal cavity, were observed in High and Medium EPA and fish oil groups. No other effects were attributed to test oil exposure. Exposure to EPA oil for 90 days produced no effects at 98 mg EPA/kg/day and no adverse effects at doses up to 976 mg EPA/kg/day. The safety profile of EPA oil was comparable to that of GRAS fish oil. These results support the use of EPA oil produced from yeast as a safe source for use in dietary supplements.
authors.affiliation: DuPont Haskell Global Centers for Health and Environmental Sciences, E. I. duPont de Nemours & Company, 1090 Elkton Road, Newark, DE 19711-3507, USA. susan.a.mackenzie@usa.dupont.com
authors.forename: Susan A
authors.initials: SA
authors.lastname: MacKenzie
authors.forename: Leigh A
authors.initials: LA
authors.lastname: Belcher
authors.forename: Greg P
authors.initials: GP
authors.lastname: Sykes
authors.forename: Steven R
authors.initials: SR
authors.lastname: Frame
authors.forename: Pushkor
authors.initials: P
authors.lastname: Mukerji
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Gillies
mesh_terms: D000818:Animals; D001835:Body Weight; D002784:Cholesterol / Q000097:blood; D019963:Clinical Chemistry Tests; D015118:Eicosapentaenoic Acid / Q000633:toxicity*; D005227:Fatty Acids / Q000097:blood; D005260:Female; D005395:Fish Oils / Q000633:toxicity; D005502:Food / Q000633:toxicity; D006403:Hematologic Tests; D008099:Liver / Q000187:drug effects; D008297:Male; D009821:Oils / Q000633:toxicity*; D051381:Rats; D017207:Rats, Sprague-Dawley; D018570:Risk Assessment; D013997:Time Factors; D018675:Toxicity Tests / Q000379:methods*; D015003:Yeasts
chemical_list: D005227:Fatty Acids; D005395:Fish Oils; D009821:Oils; D002784:Cholesterol; D015118:Eicosapentaenoic Acid