Evaluation of the acute, sub-chronic and chronic oral toxicity, genetic toxicity, and safety of a Lomens-P0.

Extracts of Hordeum vulgare and Chrysanthemum zawadskii, two traditional herbal medicines, have long been used to treat women's diseases. Our previous studies have confirmed that these extracts could help relieve the symptoms of premenstrual syndrome by inhibiting prolactin release. A mixture of these natural products was named Lomens-P0. In this study, we conducted three genotoxicity tests (bacterial reverse mutation, mammalian chromosome aberration, and mammalian erythrocyte micronucleus studies) and four oral toxicity tests (single-dose, 2-week repeated-dose, and 13-week repeated-dose studies in rodents, and a single-dose dose-escalation toxicity study in a non-rodent model) to confirm the potential toxicity and safety of Lomens-P0. The results of this series of tests indicated Lomens-P0 did not induce genotoxicity, and the NOAEL for the rodent was 2000 mg/kg BW/day. Similarly, no toxic effects were evident in the single-dose-escalation study in the non-rodent model. In conclusion, we confirmed that Lomens-P0 might have potential utility as a raw material for nutraceuticals and natural medicines. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s43188-021-00090-5. © Korean Society of Toxicology 2021.