Genotoxicity and 90-day oral toxicity of a monk fruit (Siraitia grosvenorii) mogroside preparation (>=95% mogrosides) produced by microbial fermentation
- 1Manus Bio, Inc.
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.
Related
- Mechanistic insights on mogrosides as bifunctional regulators of metabolic reprogramming and immune modulation in tumor microenvironment
- Mogroside V regulates autophagy through AMPK/mTOR pathway to ameliorate cigarette smoke-induced acute lung injury.
- Research Progress on Genotoxicity and Molecular Mechanisms of Environmental Endocrine Disruptors
- Saccharin-Enabled Oral Formulation, Biopharmaceutics and Early Genotoxicity Assessment of the PPARγ Antagonist T0070907
- Advancing genotoxicity assessment with transcriptomic biomarkers: from 2D to 3D HepaRG spheroid models
BibTeX
@misc{santos2026genotoxicity,
title = {{Genotoxicity and 90-day oral toxicity of a monk fruit (Siraitia grosvenorii) mogroside preparation (>=95% mogrosides) produced by microbial fermentation}},
author = {C. N. S. Santos and S. S. M and S. M. Paneliya and M. Pawluk and S. A and V. S. P. Chaturvedula},
howpublished = {bioRxiv},
year = {2026},
month = sep,
doi = {10.64898/2026.09.04.749478},
url = {https://www.biorxiv.org/content/10.64898/2026.09.04.749478v1},
note = {CC BY-NC-ND},
}
RIS
TY - UNPB
TI - Genotoxicity and 90-day oral toxicity of a monk fruit (Siraitia grosvenorii) mogroside preparation (>=95% mogrosides) produced by microbial fermentation
AU - C. N. S. Santos
AU - S. S. M
AU - S. M. Paneliya
AU - M. Pawluk
AU - S. A
AU - V. S. P. Chaturvedula
PY - 2026
DA - 2026/09/04
PB - bioRxiv
DO - 10.64898/2026.09.04.749478
UR - https://www.biorxiv.org/content/10.64898/2026.09.04.749478v1
AB - 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.
ER -