Safety evaluation of zeaxanthin concentrate (OmniXan™): acute, subchronic toxicity and mutagenicity studies. 2014

K B Ravi, and K R Raghunatha Reddy, and J Shankaranarayanan, and Jayant V Deshpande, and Vijaya Juturu, and Madhu G Soni
BIONEEDS, Devarahosahally, NH-4, Sompura Hobli, Nelamangala Taluk, Bangalore Rural District 562111, Karnataka, India.

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 OmniXan(TM) in rats was greater than 2000 mg/kgbody 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 (OmniXan(TM)) 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.

UI MeSH Term Description Entries
D007928 Lethal Dose 50 The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population. LD50,Dose 50, Lethal
D008297 Male Males
D009152 Mutagenicity Tests Tests of chemical substances and physical agents for mutagenic potential. They include microbial, insect, mammalian cell, and whole animal tests. Genetic Toxicity Tests,Genotoxicity Tests,Mutagen Screening,Tests, Genetic Toxicity,Toxicity Tests, Genetic,Genetic Toxicity Test,Genotoxicity Test,Mutagen Screenings,Mutagenicity Test,Screening, Mutagen,Screenings, Mutagen,Test, Genotoxicity,Tests, Genotoxicity,Toxicity Test, Genetic
D009929 Organ Size The measurement of an organ in volume, mass, or heaviness. Organ Volume,Organ Weight,Size, Organ,Weight, Organ
D010936 Plant Extracts Concentrated pharmaceutical preparations of plants obtained by removing active constituents with a suitable solvent, which is evaporated away, and adjusting the residue to a prescribed standard. Herbal Medicines,Plant Extract,Extract, Plant,Extracts, Plant,Medicines, Herbal
D002212 Capsicum A plant genus of the family SOLANACEAE. The hot peppers yield CAPSAICIN, which activates VANILLOID RECEPTORS. Several varieties have sweet or pungent edible fruits that are used as vegetables when fresh and spices when the pods are dried. Bell Pepper,Cayenne Pepper,Chili Pepper,Chilli Pepper,Green Pepper,Jalapeno Pepper,Paprika,Pimiento,Red Pepper,Capsicum annuum,Cayenne,Chile Pepper,Hot Pepper,Sweet Pepper,Bell Peppers,Cayenne Peppers,Chile Peppers,Chili Peppers,Chilli Peppers,Green Peppers,Hot Peppers,Jalapeno Peppers,Pepper, Bell,Pepper, Cayenne,Pepper, Chile,Pepper, Chili,Pepper, Chilli,Pepper, Green,Pepper, Hot,Pepper, Jalapeno,Pepper, Red,Pepper, Sweet,Peppers, Bell,Peppers, Cayenne,Peppers, Chile,Peppers, Chili,Peppers, Chilli,Peppers, Green,Peppers, Hot,Peppers, Jalapeno,Peppers, Red,Peppers, Sweet,Red Peppers,Sweet Peppers
D004249 DNA Damage Injuries to DNA that introduce deviations from its normal, intact structure and which may, if left unrepaired, result in a MUTATION or a block of DNA REPLICATION. These deviations may be caused by physical or chemical agents and occur by natural or unnatural, introduced circumstances. They include the introduction of illegitimate bases during replication or by deamination or other modification of bases; the loss of a base from the DNA backbone leaving an abasic site; single-strand breaks; double strand breaks; and intrastrand (PYRIMIDINE DIMERS) or interstrand crosslinking. Damage can often be repaired (DNA REPAIR). If the damage is extensive, it can induce APOPTOSIS. DNA Injury,DNA Lesion,DNA Lesions,Genotoxic Stress,Stress, Genotoxic,Injury, DNA,DNA Injuries
D004305 Dose-Response Relationship, Drug The relationship between the dose of an administered drug and the response of the organism to the drug. Dose Response Relationship, Drug,Dose-Response Relationships, Drug,Drug Dose-Response Relationship,Drug Dose-Response Relationships,Relationship, Drug Dose-Response,Relationships, Drug Dose-Response
D005260 Female Females
D005638 Fruit The fleshy or dry ripened ovary of a plant, enclosing the seed or seeds. Berries,Legume Pod,Plant Aril,Plant Capsule,Aril, Plant,Arils, Plant,Berry,Capsule, Plant,Capsules, Plant,Fruits,Legume Pods,Plant Arils,Plant Capsules,Pod, Legume,Pods, Legume

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