Background: Evaluation of genotoxic potential is essential for reducing carcinogenic risk and for assessing the safety of newly developed pharmaceutical products, traditional herbal medicines, and health supplements. Such evaluation plays an important role in protecting human health. Therefore, in Mongolia, it is necessary to investigate the safety of domestically produced pharmaceutical preparations, natural products, and traditional medicines on a scientific basis in accordance with international standards; to develop and implement national policies and standards; to introduce and localize appropriate methodologies; to protect human health; to prevent cancer, hereditary diseases, and longterm adverse effects; and to promote the rational use of medicines. Aim: To investigate the mutagenic properties of an herbal combination preparation in vitro and its genotoxic effects in vivo. Materials and Methods: Extracts were prepared from Dasiphora fruticosa, Cynara scolymus, and Rosa acicularis, and a herbal combination preparation was formulated in specific proportions. Mutagenicity was evaluated according to OECD Guideline 471 (Bacterial Reverse Mutation Test) using the Salmonella typhimurium TA100 strain under both S9 (-) and S9 (+) conditions with the Muta-Chromoplate™ assay. The combination preparation was tested at concentrations of 5, 2.5, 1.25, 0.625, 0.3125, and 0.1562 mg/mL in 96 wells, and reverse-mutated bacterial colonies were assessed by counting the number of wells that changed color from purple to yellow. In addition, using the IPHASE Biosciences kit, the preparation was tested at doses of 5, 2.5, 1.25, 0.625, 0.3125, and 0.1562 mg/plate on Salmonella typhimurium TA100 and TA98 strains under both S9 (-) and S9 (+) conditions. After incubation, the number of bacterial colonies formed was counted and compared with that of the positive control group. Genotoxicity was assessed according to OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test) by evaluating the numbers of polychromatic erythrocytes (PCEs), normochromatic erythrocytes (NCEs), and micronucleated polychromatic erythrocytes in the bone marrow of BALB/c mice. Result: In the study using the Muta-Chromoplate™ assay, bacterial colonies were observed at doses ranging from 5.0 to 0.1562 mg/mL of the herbal combination preparation. However, compared with the positive control group (aminoanthracene), the number of bacterial colonies was significantly lower (p<0.05). In the study using the IPHASE Biosciences kit, 30–154 bacterial colonies were observed in Salmonella typhimurium TA98 and TA100 strains under S9 (-/+) conditions at doses ranging from 5.0 to 0.156 mg/plate, which was approximately threefold lower than that observed in the positive control groups. In the positive control group treated with cyclophosphamide, the number of micronucleated polychromatic erythrocytes was increased. Conclusion The herbal combination preparation showed no mutagenic activity in either of the two mutation detection assays using Salmonella typhimurium TA98 and TA100 strains under S9 (-/+) conditions. In addition, it showed no genotoxic effect in the micronucleus assay.