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

This report examines the genotoxicity and 90-day oral toxicity of a monk fruit-derived mogroside preparation, which is rich in mogroside V and produced via microbial fermentation. The substance, containing at least 95% total mogrosides with 70.3% mogroside V, is an alternative to traditional monk fruit extracts due to its higher purity.

In tests, the preparation showed no mutagenic effects in a bacterial reverse mutation test and no clastogenic effects in an in vitro human lymphocyte micronucleus test up to its maximum recommended concentration.

Further investigation was conducted in a 90-day study, where the preparation was administered orally to Sprague-Dawley rats at doses of 0, 500, 1000, and 2000 mg/kg body weight per day. The study revealed no deaths and no test article-related adverse effects on clinical signs, ophthalmology, functional behavioral assessments, body weight, food intake, clinical chemistry, thyroid hormones, oestrous cyclicity, or sperm parameters.

Although minor increases in liver weight were observed, these were deemed non-adverse as they lacked any clinical chemistry or histopathological signs.

No adverse effects were noted on testis weight, sperm endpoints, or spermatogenesis. All statistically significant differences observed were considered minor and incidental. Based on these findings, the no-observed-adverse-effect level (NOAEL) was determined to be 2000 mg/kg body weight per day, the highest dose tested. This NOAEL supports the safety of the preparation as a potential food ingredient.