Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5856539 | Regulatory Toxicology and Pharmacology | 2015 | 10 Pages |
Abstract
l-Fucose is a natural monosaccharide present in mammals where it is found predominantly as an O-glycosidically linked component of glycoproteins, glycolipids, and oligosaccharides. It is also present in its free form in human breast milk (human milk monosaccharide). l-Fucose plays important roles in the development of the immune and nervous systems and is involved in cognitive function and memory formation. The human-identical milk monosaccharide l-fucose is therefore proposed for use in infant formulas to better simulate the free saccharides present in human breast milk. As part of the safety evaluation of l-fucose, a subchronic dietary toxicity study preceded by an in utero phase was conducted in Sprague-Dawley rats. l-Fucose was without maternal toxicity or compound-related adverse effects on female reproduction and general growth and development of offspring at a maternal dietary level up to 1%, equivalent to a dose of 1655 mg/kg body weight (bw)/day. During the subchronic phase, no compound-related adverse effects were observed in first generation rats at dietary levels of up to 1% (highest level tested), corresponding to doses of 516 and 665 mg/kg bw/day in males and females, respectively. l-Fucose was non-genotoxic in a series of in vitro genotoxicity/mutagenicity tests. These results support the safe use of l-fucose in infant formula and as a food ingredient at levels equivalent to those present in human breast milk.
Keywords
USDAMCHNaN3OECD2-aminoanthraceneCBPIMMSFOBNeu5AcL-fucosePNDNOAELGLP9-AAHMOs2-NF2-AA2-nitrofluorene9-AminoacridineDMSOUS FDAHMMsArachidonic aciddocosahexaenoic acidHuman milk oligosaccharidesFunctional observational batteryGood Laboratory PracticeARADHADimethyl sulfoxidegestation daypost-natal dayOrganisation for Economic Co-operation and Developmentsodium azideSubchronic toxicityGenotoxicityInfant formulamean corpuscular hemoglobinmethyl methanesulfonateICHfirst generationno-observed-adverse-effect levelParentalUS Department of Agriculturebody weightInternational Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Related Topics
Life Sciences
Environmental Science
Health, Toxicology and Mutagenesis
Authors
Sharon S.H. Choi, Barry S. Lynch, Nigel Baldwin, Emily W. Dakoulas, Shambhu Roy, Carey Moore, Bjorn A. Thorsrud, Christoph H. Röhrig,