Genotoxicity and 90-day oral toxicity of a monk fruit (Siraitia grosvenorii) mogroside preparation (>=95% mogrosides) produced by microbial fermentation

Abstract

Here we report genotoxicity and 90-day oral toxicity evaluations of a high-purity, fermentation-derived mogroside preparation rich in mogroside V, the principal sweetener of monk fruit (Siraitia grosvenorii). The test article ([≥]95% total mogrosides, 70.3% mogroside V) is produced by a modified Escherichia coli from glucose, offering a higher-purity alternative to traditional monk fruit extracts. The test article was non-mutagenic in a bacterial reverse mutation test (OECD TG 471) and non-clastogenic in an in vitro human lymphocyte micronucleus test (OECD TG 487), up to the maximum recommended concentration. In the 90-day study (OECD TG 408), the test article was given by daily oral gavage at 0, 500, 1000, and 2000 mg/kg body weight/day to Sprague-Dawley rats. There were no deaths and no test article-related effects on clinical signs, ophthalmology, functional observational battery, body weight, food consumption, clinical pathology, thyroid hormones, oestrous cyclicity, or sperm parameters. Minor liver-weight increases lacking any clinical chemistry or histopathological correlates were determined to be non-adverse. No effects were seen on testis weight, sperm endpoints, or spermatogenesis. All other statistically significant differences were minor and considered incidental. The no-observed-adverse-effect level (NOAEL) was 2000 mg/kg body weight/day, the highest dose tested, supporting its safety as a food ingredient.