Abstract

Toxicology studies were conducted to evaluate the safety of chondroitin sulfate oligosaccharide (CSO) produced by the enzymatic hydrolysis of shark cartilage by a bacterial lyase. Although the safety of chondroitin sulfate, which is used as a dietary supplement, has been investigated, no safety studies have been conducted on CSO. CSO was evaluated in bacterial reverse mutagenesis, mammalian cell gene mutation using mouse lymphoma cells, in vivo mammalian erythrocyte micronucleus assays, and a ninety-day repeated dose oral toxicity study in rats. The study showed that CSO was not genotoxic. The No Observed Adverse Effect Level (NOAEL) was determined to be 4,000 mg/kg bw/day, the highest dose tested.

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