Concentrated DHA Ethyl Ester (DHA-EE) was administered to beagle dogs at dose levels 150, 1000 and 2000 mg/kg bw/day by oral gavage in this 9-month study.
DHA-EE was well tolerated; clinical findings of occasional reddened areas and dry flaky skin were observed at doses ≥1000 mg/kg bw/day in both sexes.
Test article-related changes in hematology parameters were limited to decreases in reticulocyte count in the high-dose males.
DHA-EE administration resulted in dose-related reductions in cholesterol and triglyceride levels in both sexes.
The no-observed-adverse-effect level (NOAEL) of DHA-EE was established at 2000 mg/kg bw/day for both genders.