The safety of β-carotene from Yarrowia lipolytica

Crystalline beta-carotene from genetically modified Yarrowia lipolytica is an alternative source of beta-carotene for use as a nutritional supplement. To support the use of beta-carotene from Y. lipolytica as a food ingredient, the genotoxic and subchronic toxicity potential of this compound was determined. Genotoxicity was examined using Salmonella typhimurium and Escherichia coli (Ames test), a chromosomal aberration assay in Chinese Hamster Ovary WBL cells, and the micronucleus test in CD-1 mice. All three assays showed no significant results due to beta-carotene from Y. lipolytica. In a subchronic toxicity study in SD rats, beta-carotene from Y. lipolytica was administered by oral gavage for 13 weeks at 0, 125, 250 or 500 mg/kg per day. Adverse effects were not observed following clinical, clinical pathology and gross- and histopathological evaluations of dosed rats; thus, the no-observed-adverse effect level (NOAEL) for beta-carotene from Y. lipolytica was 500 mg/kg, the highest dose used in the study. In conclusion, beta-carotene derived from Y. lipolytica was shown in genotoxicity models and a standard rat subchronic rat study to have a safety profile similar to that of the current commercial products (synthetic and natural) with no unexpected finding attributable to the alternative source. (C) 2013 Elsevier Ltd. All rights reserved.