title: The safety of β-carotene from Yarrowia lipolytica.
abstract: Crystalline β-carotene from genetically modified Yarrowia lipolytica is an alternative source of β-carotene for use as a nutritional supplement. To support the use of β-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 β-carotene from Y. lipolytica. In a subchronic toxicity study in SD rats, β-carotene from Y. lipolytica was administered by oral gavage for 13weeks at 0, 125, 250 or 500mg/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 β-carotene from Y. lipolytica was 500mg/kg, the highest dose used in the study. In conclusion, β-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.
authors.affiliation: Microbia, Inc., 60 Westview Street, Lexington, MA 02421, USA. Electronic address: daniel.grenfell-lee@dsm.com.
authors.forename: Daniel
authors.initials: D
authors.lastname: Grenfell-Lee
authors.affiliation: Microbia, Inc., 60 Westview Street, Lexington, MA 02421, USA. Electronic address: samuel.zeller@unilever.com.
authors.forename: Samuel
authors.initials: S
authors.lastname: Zeller
authors.affiliation: Nucro-Technics, 2000 Ellesmere Rd #16, Toronto, ON M1H 2W4, Canada. Electronic address: Cardoso@nucro-technics.com.
authors.forename: Renato
authors.initials: R
authors.lastname: Cardoso
authors.affiliation: Nucro-Technics, 2000 Ellesmere Rd #16, Toronto, ON M1H 2W4, Canada. Electronic address: pucaj@nucro-technics.com.
authors.forename: Kresimir
authors.initials: K
authors.lastname: Pucaj
mesh_terms: D000818:Animals; D016466:CHO Cells; D006224:Cricetinae; D003412:Cricetulus; D004305:Dose-Response Relationship, Drug; D009152:Mutagenicity Tests; D030821:Plants, Genetically Modified; D051381:Rats; D017207:Rats, Sprague-Dawley; D059550:Toxicity Tests, Subchronic; D025062:Yarrowia / Q000737:chemistry* / Q000235:genetics; D019207:beta Carotene / Q000008:administration & dosage* / Q000633:toxicity
chemical_list: D019207:beta Carotene
keywords: Genotoxicity; Subchronic; Toxicity; Yarrowia lipolytica; β-Carotene