By Stephen Daniells, 16-Sep-2010
The safety of an EPA-rich oil from genetically modified yeast is “comparable to that of GRAS fish oil”, says a new study from DuPont.
Results of a 90-day rat study with eicosapentaenoic acid (EPA)-rich oil produced from GM Yarrowia lipolytica yeast produced no adverse effects at doses up to 976 mg EPA per kilogram of body weight per day, according to findings published in Regulatory Toxicology and Pharmacology.
“Exposure to EPA oil produced no test substance-related effects on body weight or nutritional parameters, neurobehavioral parameters, clinical or ophthalmological observations, hematology or urinalysis parameters or microscopic pathology at any tested dose,” wrote researchers from DuPont, led by Susan MacKenzie.
“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,” they added.
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Regul Toxicol Pharmacol. 2010 Sep 6. [Epub ahead of print]Safety assessment of EPA-rich oil produced from yeast: Results of a 90-day subchronic toxicity study.
Mackenzie SA, Belcher LA, Sykes GP, Frame SR, Mukerji P, Gillies PJ.
DuPont Haskell Global Centers for Health and Environmental Sciences, E. I. duPont de Nemours & Company, 1090 Elkton Road, Newark, DE 19711-3507, USA.
The safety of eicosapentaenoic acid (EPA) oil produced from genetically modified Yarrowia lipolytica yeast was evaluated following 90days of exposure. Groups of rats received 0 (olive oil), 98, 488, or 976mg 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 90days produced no effects at 98mg EPA/kg/day and no adverse effects at doses up to 976mg 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.