Lutein and zeaxanthin carotenoids linked to lower risk of cataracts and age‑related macular degeneration were evaluated in Lutemax 2020, a marigold-derived concentrate enriched with lutein, zeaxanthin and the meso‑isomer. Acute testing in rats found no lethality at 2000 mg/kg. In a 90‑day subchronic study, Wistar rats given 0, 4, 40 or 400 mg/kg/day showed no treatment‑related adverse effects: clinical exams, ophthalmic checks, body weights, food intake, organ weights, urinalysis, hematology, clinical chemistry, and necropsy/histopathology were comparable to controls. Salmonella mutagenicity assays were negative. The no observed‑adverse‑effect level (NOAEL) was 400 mg/kg/day, the highest dose tested, supporting a favorable preclinical safety profile for Lutemax 2020.