Safety assessment of the biotechnologically produced human-identical milk oligosaccharide 3-Fucosyllactose (3-FL).

Safety assessment of the biotechnologically produced human-identical milk oligosaccharide 3-Fucosyllactose (3-FL). Food Chem Toxicol. 2019 Sep 15;:110818 Authors: Pitt J, Chan M, Gibson C, Hasselwander O, Lim A, Mukerji P, Mukherjea R, Myhre A, Sarela P, Tenning P, Himmelstein MW, Roper JM Abstract 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, 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/da...
Source: Food and Chemical Toxicology - Category: Food Science Authors: Tags: Food Chem Toxicol Source Type: research