Safety assessment of lutein and zeaxanthin (Lutemax™ 2020): Subchronic toxicity and mutagenicity studies |
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Authors: | R Ravikrishnan Shraddha Rusia G Ilamurugan Ulhas Salunkhe Jayant Deshpande J Shankaranarayanan ML Shankaranarayana Madhu G Soni |
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Institution: | aRCC Laboratories India Pvt. Ltd., Genome Valley, Shameerpet, Hyderabad 500 078, AP, India;bOmniActive Health Technologies Ltd., A 131, Road 23, Wagle Estate, Thane West 400 607, India;cSoni and Associates Inc., 973, 37th Place, Vero Beach, FL 32960, USA |
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Abstract: | Lutein and zeaxanthin, naturally occurring carotenoids, have shown to reduce the risk of cataracts and age-related macular degeneration. Lutemax™ 2020 is a lutein and zeaxanthin (including meso-isomer) enriched product obtained from Marigold flowers (Tagetes erecta L). The objective of the present study was to investigate adverse effects, if any, of Lutemax 2020™ in acute and subchronic toxicity, and mutagenicity studies. In acute toxicity study in rats no lethality was noted at 2000 mg Lutemax 2020™/kg body weight (bw). In the subchronic study, Wistar rats (10/sex/group) were administered (gavage) lutein/zeaxanthin concentrate at dose levels of 0, 4, 40 and 400 mg/kg bw/day for 90-days. Compared with the control group, administration of lutein/zeaxanthin concentrate 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. No toxicologically relevant findings were noted 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. The results of mutagenicity testing in Salmonella typhimurium did not reveal any genotoxicity. The no observed-adverse-effect level (NOAEL) for lutein/zeaxanthin concentrate was determined as 400 mg/kg bw/day, the highest dose tested. |
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Keywords: | Abbreviations: ALP alkaline phosphatase ALT alanine aminotransferase AST aspartate aminotransferase FDA food and drug administration ICH international conference on harmonization NOAEL no-observed-adverse-effect level OECD organization for economic co-operation and development |
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