Genotoxicity evaluation of a fish oil concentrate containing Very Long Chain Fatty Acids

Very long chain fatty acids (VLCFAs) are lipids found in fish with a chain length longer than C22. They represent a minor lipid fraction composing of less than 1% of the total lipid. EPAX® EVOLVE 05 is a concentrate of VLCFAs providing roughly 10 times the amount found in fish. Here we report genotoxocity studies performed in cell culture and using a rat model. No genotoxicity was noted in a bacterial reverse mutation test (AMES test). An in vitro micronucleus assay was negative with a 4-hr test item incubation but a 24-hr incubation resulted in a positive signal. This prompted further study using an in vivo Sprague Dawley rat model. Test item exposure was demonstrated by plasma measurements from Sprague Dawley rats with peak absorption at 2-4 h post administration, as expected for fatty acids. The micronucleus assay showed no genotoxicity for fish oil containing VLCFAs. Together, the data shows that VLCFAs up to the test dose of 1200 mg/kg b.w. do not show genotoxicity.