Safety evaluation of zeaxanthin concentrate (OmniXan™): Acute, subchronic toxicity and mutagenicity studies

• Zeaxanthin (OmniXanTM) was investigated for its subchronic toxicity and mutagenic effects.
• In the 90-day study, no adverse effects of zeaxanthin were noted at doses up to 400 mg/kg bw/day.
• In Ames assay, no mutagenic effects of zeaxanthin preparation were noted.
• The no observed-adverse-effect level (NOAEL) for zeaxanthin was 400 mg/kg bw/day.
• No adverse effects of product containing 67% lutein and 13.5% zeaxanthin were noted in a previous similar study.

The available evidence suggests a beneficial effect of zeaxanthin against the progression of age-related macular degeneration (AMD). The objective of the present study was to investigate potential adverse effects of OmniXan™, a RR-zeaxanthin (65%) enriched product obtained from paprika (Capsicum annum fruits) in subchronic toxicity and mutagenicity studies. The oral LD50 of OmniXanTM in rats was greater than 2000 mg/kg body weight (bw)/day. For the subchronic toxicity study, Wistar rats (10/sex/group) were gavaged daily with zeaxanthin concentrate at doses of 0, 4, 40 and 400 mg/kg bw/day for 90-days. No treatment related clinical signs and mortalities observed. Similarly, no treatment related toxicologically significant changes in body weight, feed consumption; ophthalmoscopic examination, neurological examination, hematology, urine analysis and organ weights were observed. Statistically significant changes observed in some clinical chemistry parameters were considered toxicologically and biologically insignificant and nonadverse. Macroscopic and microscopic examinations did not reveal treatment-related abnormalities. The results of mutagenicity testing using Salmonella typhimurium did not reveal any genotoxicity. The no observed-adverse-effect level (NOAEL) for zeaxanthin concentrate (OmniXanTM) was determined as 400 mg/kg bw/day, the highest dose tested. The findings of this subchronic toxicity and mutagenicity studies support safety of zeaxanthin concentrate.