1. Toxicological evaluation of a fish oil concentrate containing Very Long Chain Fatty Acids.
- Author
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Tobin, Derek, Svensen, Harald, Shanmugasundaram, Devanand, Ruyter, Bente, Stoknes, Iren, and Dornish, Michael
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FISH oils , *FATTY acids , *SPRAGUE Dawley rats , *LIVER enzymes , *THYROID hormone receptors , *URINALYSIS , *ASPARTATE aminotransferase - Abstract
Very long chain fatty acids (VLCFA) have a chain length ≥24 carbons. Fish contain low levels of these fatty acids. A commercial oil called EPAX® Evolve 05 with an up-concentration of VLCFAs of approximately 10 times, has been developed as a dietary supplement by Epax Norway AS. A series of toxicological studies were performed using mice and rats to determine the safety and toxicity of repeat dosing with a gavage administered VLCFA formulation. The results suggest transient lipid accumulation in kidneys and liver. Lipid accumulation was seen with the test item and with the soya control but was not dose related. Liver and kidney lipid accumulation, whilst present in 14- day repeat dose study, was absent in a 90-day rat study. No treatment-effect was seen in urine analysis in any of the studies. No treatment-related effects were seen with a functional observation battery, ophthalmological examination, haematology, urine analysis, oestrus cycle, thyroid hormones, organ weight, or histopathology. In the 90-day study the liver enzymes ALP, AST and ALT were statistically significantly increased with test item but within control values. There were no associated histological findings in the liver suggesting there was no toxic effect and the normalisation of values for all liver enzymes in the recovery groups suggests an adaptive response rather than a prevailing toxic response. The no-observed-adverse-effect level (NOAEL) was determined as 1200 mg VLCFA/kg b.w./day. • An oil (EPAX EVOLVE 05) containing Very Long Chain Fatty Acids (VLCFA) was tested. • Toxicity was assessed with 14, 28, and 90-day repeat dose studies. • No adverse effects were noted up to a dose of 1200 mg/kg bw/day in a 90-day rat study. • NOAEL was defined as 1200 mg VLCFA/kg bw/day in Sprague Dawley rats. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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