Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8551417 | Regulatory Toxicology and Pharmacology | 2018 | 8 Pages |
Abstract
The safety of 3â²-sialyllactose (3â²-SL) sodium salt was evaluated by testing for gene mutations, in vivo and in vitro clastogenic activity, and animal toxicity in beagle dogs and rats. The results of all mutagenicity and genotoxicity tests were negative, indicating that 3â²-SL does not have any mutagenic or clastogenic potential. The mean lethal dose (LD50) of 3â²-SL sodium salt was well above 20â¯g/kg body weight (bw) in rats. A dose escalation acute toxicity study in Beagle dogs also indicated no treatment-related abnormalities. Subsequent 28-day and 90-day toxicity studies in Sprague- Dawley (SD) rats involved dietary exposure to 500, 1,000, and 2000â¯mg/kg bw of 3â²-SL sodium salt and a water (vehicle) control. There were no treatment-related abnormalities on clinical observations, body weight, food consumption, behavior, hematology, clinical chemistry, organ weights, relative organ weights, urinalysis parameters, or necropsy and histopathological findings. The No Observed Adverse Effect Level (NOAEL) of 3â²-SL sodium salt was determined to be higher than 2000â¯mg/kgâ¯bw/day in an oral subchronic toxicity study in rats, indicating that the substance is an ordinary carbohydrate with the lowest toxicity rating. Results confirm that 3â²-SL sodium salt has a toxicity profile similar to other non-digestible carbohydrates and naturally occurring human milk oligosaccharides (HMOs) and support its safety for human consumption in foods.
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Authors
Daehee Kim, Rit Bahadur Gurung, Wonmin Seo, Albert W. Lee, Jinsuk Woo,