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

Ravi, Kondle; Reddy, Kandula Ravindra; Shankaranarayanan, J.; Deshpandé, Jayant V.; Juturu, Vijaya; Soni, Madhu G.

doi:10.1016/j.fct.2014.06.015

Cited by 14 publications

(9 citation statements)

References 20 publications

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“…In a recent publication of safety studies of the zeaxanthin concentrate OmniXan, RR-zeaxanthin 65% enriched product obtained from paprika [ 60 ], there was no indication of genotoxicity. In the 13-week rat toxicity study, the highest dosage in terms of concentrate was 400 mg/kg bw/day and this was considered the NOAEL.…”

Section: Summary and Discussionmentioning

confidence: 99%

Zeaxanthin: Review of Toxicological Data and Acceptable Daily Intake

Edwards¹

2016

Journal of Ophthalmology

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Zeaxanthin is a nutritional carotenoid with a considerable amount of safety data based on regulatory studies, which form the basis of its safety evaluation. Subchronic OECD guideline studies with mice and rats receiving beadlet formulations of high purity synthetic zeaxanthin in the diet at dosages up to 1000 mg/kg body weight (bw)/day, and in dogs at over 400 mg/kg bw/day, produced no adverse effects or histopathological changes. In developmental toxicity studies, there was no evidence of fetal toxicity or teratogenicity in rats or rabbits at dosages up to 1000 or 400 mg/kg bw/day, respectively. Formulated zeaxanthin was not mutagenic or clastogenic in a series of in vitro and in vivo tests for genotoxicity. A 52-week chronic oral study in Cynomolgus monkeys at doses of 0.2 and 20 mg/kg bw/day, mainly designed to assess accumulation and effects in primate eyes, showed no adverse effects. In a rat two-generation study, the NOAEL was 150 mg/kg bw/day. In 2012, this dosage was used by EFSA (NDA Panel), in association with a 200-fold safety factor, to propose an Acceptable Daily Intake equivalent to 53 mg/day for a 70 kg adult. The requested use level of 2 mg/day was ratified by the EU Commission.

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Section: Summary and Discussionmentioning

confidence: 99%

Zeaxanthin: Review of Toxicological Data and Acceptable Daily Intake

Edwards¹

2016

Journal of Ophthalmology

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“…Moreover in these studies, the results of zeaxanthin mutagenicity testing in the Salmonella typhimurium model did not reveal any genotoxicity [70] [27] [71], and neither in Escherichia coli [71]. In the same way, lutein was not genotoxic in Drosophila melanogaster genetic model [15].…”

Section: Discussionmentioning

confidence: 96%

Role of Zucchini and Its Distinctive Components in the Modulation of Degenerative Processes: Genotoxicity, Antigenotoxicity, Cytotoxicity and Apoptotic Effects

Martínez-Valdivieso¹,

Font²,

Fernández-Bedmar³

et al. 2017

Preprint

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Zucchini (Cucurbita pepo subsp. pepo) is a seasonal vegetable with high nutritional and medical value. Many useful properties of this fruit are attributed to its bioactive compounds. Zucchini fruits ("Yellow" and "Light Green" varieties) and four distinctive components (lutein, β-carotene, zeaxanthin and dehydroascorbic acid)were selected. Firstly it was determinated the lutein, β-carotene, zeaxanthin and dehydroascorbic acid content in these fruits and then, in order to measure the safety and suitability of their use different assays were carried out: (i) Genotoxicity and antigenotoxicity tests to determine the safety and DNA-protection against hydrogen peroxide; (ii) cytotoxicity and (iii) DNA fragmentation assay to evaluate the proapoptotic effect. Results showed that: (i) all the substances were non-genotoxic, (ii) all the substances were antigenotoxic except the highest concentration of lutein, (iii) "Yellow" Zucchini epicarp and mesocarp exhibited the highest cytotoxic activity (IC50 > 0.1 mg/mL and 0.2 mg/mL, respectively) and iv) "Light Green" Zucchini skin and pulp induced internucleosomal DNA fragmentation . To sump up, Zucchini fruit could play a positive role in human health and nutrition due to this fruit and its components were safe, able to inhibit significantly the H2O2-induced damage and exhibit antiproliferative and proapoptotic properties toward HL60 tumour cells. The information generated from this research should take into account to select potential accessions for breeding programs purposes.

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“…A systematic risk assessment of lutein supplements in placebo-controlled intervention trials indicate that lutein is safe up to 20 mg/day; however these levels are not sufficient to draw confident conclusions on long-term safety (107). Although some experimental safety data are available for lutein and zeaxanthin (107–109), further trials are warranted to evaluate the chronic use of high-dose supplementation, especially in specific populations such as pregnant women, infants and premature newborns. Further studies in experimental animal models are clearly needed to understand the molecular and physiological mechanisms of maternal-fetal transfer and milk incorporation of xanthophylls in relation to the maternal dietary intake of these carotenoids.…”

Section: Discussionmentioning

confidence: 99%

Lutein, zeaxanthin and mammalian development: Metabolism, functions and implications for health

Giordano

Quadro

2018

Archives of Biochemistry and Biophysics

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It is now widely accepted that nutrition during critical periods in early development, both pre- and postnatal, may have lifetime consequences in determining health or onset of major diseases in the adult life. Dietary carotenoids have shown beneficial health effects throughout the life cycle due to their potential antioxidant properties, their ability to serves as precursors of vitamin A and to the emerging signaling functions of their metabolites. The non-provitamin A carotenoids lutein and zeaxanthin are emerging as important modulators of infant and child visual and cognitive development, as well as critical effectors in the prevention and treatment of morbidity associated with premature births. This review provides a general overview of lutein and zeaxanthin metabolism in mammalian tissues and highlights the major advancements and remaining gaps in knowledge in regards to their metabolism and health effects during pre- and early post-natal development. Furthering our knowledge in this area of research will impact dietary recommendation and supplementation strategies aimed at sustaining proper fetal and infant growth.

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

Cited by 14 publications

References 20 publications

Zeaxanthin: Review of Toxicological Data and Acceptable Daily Intake

Zeaxanthin: Review of Toxicological Data and Acceptable Daily Intake

Role of Zucchini and Its Distinctive Components in the Modulation of Degenerative Processes: Genotoxicity, Antigenotoxicity, Cytotoxicity and Apoptotic Effects

Lutein, zeaxanthin and mammalian development: Metabolism, functions and implications for health

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