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Ninety-day oral toxicity study of lycopene from Blakeslea trispora in rats

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Author: Jonker, D. · Kuper, C.F. · Fraile, N. · Estrella, A. · Rodríguez Otero, C.
Type:article
Date:2003
Institution: TNO Voeding
Source:Regulatory Toxicology and Pharmacology, 3, 37, 396-406
Identifier: 237137
doi: doi:10.1016/S0273-2300(03)00013-8
Keywords: Toxicology · Toxicology and Applied Pharmacology · Diet · Lycopene · NOEL · Oral · Subchronic toxicity · Wistar rat · lycopene · animal experiment · animal tissue · article · blood examination · body weight · calculation · clinical chemistry · clinical observation · cognition · dietary intake · female · food intake · functional assessment · fungal biomass · histopathology · male · motor activity · nonhuman · ophthalmoscope · organ weight · priority journal · rat · urinalysis · Administration, Oral · Animals · Antioxidants · Behavior, Animal · Biomass · Body Weight · Carotenoids · Chemistry, Clinical · Diet · Dose-Response Relationship, Drug · Female · Hematologic Tests · Male · Motor Activity · Mucorales · No-Observed-Adverse-Effect Level · Rats · Rats, Wistar · Blakeslea trispora · Helianthus · Rattus norvegicus

Abstract

Lycopene, as a suspension in sunflower oil (20% w/w), was tested for subchronic toxicity by administration at dietary concentrations of 0, 0.25, 0.50, and 1.0% to groups of 20 male and 20 female Wistar rats for a period of 90 days. The lycopene examined in this study was derived from a fungal biomass (Blakeslea trispora). Lycopene intake was calculated to be 0, 145, 291, and 586mg/kg body weight/day in control through high-dose males and 0, 156, 312, and 616mg/kg body weight/day in control through high-dose females. The results from this study do not provide any evidence of toxicity of lycopene at dietary levels up to 1.0% as demonstrated by the findings of clinical observations, neurobehavioral observations, motor activity assessment, body weight and food consumption measurements, ophthalmoscopic examinations, hematology, clinical chemistry, urinalysis, organ weights, gross pathology, or histopathology. The No-Observed-Effect Level (NOEL) was 1.0% in the diet, the highest dietary concentration tested. © 2003 Elsevier Science (USA). All rights reserved.