Safety evaluation of a mixture of the human-identical milk oligosaccharides 2'-fucosyllactose and difucosyllactose
| Autor: | Marta H. Mikš, Kirt R. Phipps, Barry Lynch, Nigel Baldwin, Jessica Flaxmer, Christoph H. Röhrig, Ben Gilby, Alica Šoltésová |
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| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Male In vitro genotoxicity Biology Toxicology medicine.disease_cause Compositional difference 03 medical and health sciences Ingredient chemistry.chemical_compound 0404 agricultural biotechnology 2'-Fucosyllactose medicine Animals Humans Food science Sexual Maturation chemistry.chemical_classification No-Observed-Adverse-Effect Level Milk Human Mutagenicity Tests Fructooligosaccharide Toxicity Tests Subchronic Infant Newborn 04 agricultural and veterinary sciences General Medicine Oligosaccharide 040401 food science Rats 030104 developmental biology Infant formula chemistry Female Trisaccharides Genotoxicity Food Science |
| Zdroj: | Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association. 120 |
| ISSN: | 1873-6351 |
| Popis: | Human milk oligosaccharides (HMOs) are endogenous indigestible carbohydrates representing the largest compositional difference between human breastmilk and infant formula (IF). Two major HMOs in human breastmilk are 2′-fucosyllactose (2′-FL) and difucosyllactose (DFL); commercial IF can be supplemented with manufactured structurally identical versions of HMOs [known as human-identical milk oligosaccharides (HiMOs)] to better replicate the composition of human milk. As 2′-FL and DFL are always found together in human milk, a mixture of these HiMOs (2′-FL/DFL) has been proposed for use in IF and as a food ingredient. Safety assessment of 2′-FL/DFL included conduct of in vitro genotoxicity tests and a subchronic oral toxicity study. In the subchronic study, 2′-FL/DFL (8:1 ratio) was administered to neonatal rats at doses up to 5000 mg/kg body weight (bw)/day, once daily for 90 days, followed by a 4-week recovery period. A concurrent reference control group received 5000 mg/kg bw/day of an oligosaccharide already used in IF (fructooligosaccharide), for direct comparison with the high-dose 2′-FL/DFL group. No evidence of genotoxicity was observed. In the absence of compound-related adverse effects in the 90-day study, 5000 mg/kg bw/day was established as the no-observed-adverse-effect-level. These results support the use of 2′-FL/DFL in IF and as a food ingredient. |
| Databáze: | OpenAIRE |
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