THANE(WEST), India—The safety of the eye health ingredientLutemax 2020™ (from OmniActive Health Technologies), which is comprised of lutein and zeaxanthin from marigold flowers (Tagetes erecta L,) has been confirmed by tests on toxicity and mutagenic effects on the ingredient at various dose levels. Results of the testing were published online ahead of print inFood and Chemical Toxicology.
An acute toxicity study in rats revealed no lethality at a dose of 2,000 mg/kg of bodyweight (BW) Lutemax 2020. In the subchronic toxicity study, Wistar rats (10/sex/group) were administered (gavage) Lutemax 2020 at dose levels of 0, 4, 40 and 400 mg/kg bw/day for 90 days. Lutemax administration did not result in any toxicologically significant treatment-related changes in clinical observations, ophthalmic examinations, body weights, body weight gains, feed consumption, and organ weights. Further, researchers found no toxicologically relevant results in urinalysis, hematology or clinical biochemistry parameters at the end of the treatment or recovery period; terminal necropsy did not reveal any treatment-related gross or histopathology findings.
Similarly, mutagenicity testing of Lutemax in Salmonella typhimurium did not reveal any genotoxicity. Also, the researchers determined the no observed-adverse-effect level (NOAEL) for Lutemax as 400 mg/kg bw/day, the highest dose tested.