Safety assessment of the biotechnologically produced human-identical milk oligosaccharide 3-Fucosyllactose (3-FL)
| Autor: | M.W. Himmelstein, P. Tenning, O. Hasselwander, P. Sarela, J. Pitt, Jason M. Roper, A. Lim, R. Mukherjea, M. Chan, Pushkor Mukerji, C. Gibson, A. Myhre |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_treatment
Oligosaccharides CHO Cells Pharmacology Biology Toxicology 03 medical and health sciences 0404 agricultural biotechnology Immune system Cricetulus In vivo medicine Animals Humans 030304 developmental biology 0303 health sciences No-Observed-Adverse-Effect Level Dose-Response Relationship Drug Milk Human Mutagenicity Tests Prebiotic 04 agricultural and veterinary sciences General Medicine 040401 food science Genetically modified organism Rats Infant formula Micronucleus test Toxicity Micronucleus Food Science Biotechnology |
| Zdroj: | Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association. 134 |
| ISSN: | 1873-6351 |
| Popis: | 3-Fucosyllactose (3-FL), a highly abundant complex carbohydrate in human breast milk, functions as a prebiotic promoting early microbial colonization of the gut, increasing pathogen resistance and modulating immune responses. To investigate potential health benefits, 3-FL was produced by fermentation using a genetically modified E. coli K12 strain. The safety assessment of 3-FL included acute oral toxicity, in vitro and in vivo assessment of genetic toxicity, and a subchronic rodent feeding study. 3-FL was not acutely toxic at 5000 mg/kg bw, and there was no evidence of genetic toxicity in the bacterial reverse mutation test and chromosomal aberration assay. There was a repeatable statistically-significant trend in the 4-h S9-activated test conditions in the in vitro micronucleus assay; the confirmatory in vivo mouse micronucleus study was negative at all doses. Dietary subchronic exposure of rats to 3-FL (5% and 10%) did not produce any statistical or biologically-relevant differences in growth, food intake or efficiency, clinical observations, or clinical or anatomic pathology changes at average daily intakes of 5.98 and 7.27 g/kg bw/day for males and females, respectively. The weight of evidence from these studies support the safe use of 3-FL produced using biotechnology as a nutritional ingredient in foods. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect