Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8551132 | Regulatory Toxicology and Pharmacology | 2018 | 32 Pages |
Abstract
We performed a series of toxicity studies on the safety of 6â²-sialyllactose (6â²-SL) sodium salt as a food ingredient. 6â²-SL sodium salt, up to a maximum dose of 5000 μg/plate, did not increase the number of revertant colonies in five strains of Salmonella typhimurium in the presence or absence of S9 metabolic activation. A chromosomal aberration assay (using Chinese hamster lung cells) found no clastogenic effects at any concentration of 6â²-SL sodium salt in the presence or absence of S9 metabolic activation. An in vivo bone marrow micronucleus test in Kunming mice showed no clastogenic activities with 6â²-SL sodium salt doses up to 2000â¯mg/kg body weight (bw). In an acute toxicity study, the mean lethal dose of 6â²-SL sodium salt was greater than 20â¯g/kg bw in rats. In a 13-week subchronic toxicity investigation, no effects were found at doses up to 5.0â¯g/kg bw of 6â²-SL sodium salt in food consumption, body weight, clinical signs, blood biochemistry and hematology, urinalysis, or ophthalmic and histological macroscopic examination of organs. The no-observed-adverse-effect level (NOAEL) was 5.0â¯g/kgâ¯bw/day in rats.
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Authors
Rit Bahadur Gurung, Dae Hee Kim, Lila Kim, Albert W. Lee, Zhenhua Wang, Yonglin Gao,