Abstract: Objective Ames test, Chromosome aberration test and mouse bone marrow micronucleus test were used to evaluate the genotoxicity risk of xueshuantong injection. Methods Ames test, Five strains of bacteria including TA97, TA98, TA100, TA102 and TA1535 were exposed to xueshuantong injection at concentrations of 128.0, 320.0, 800.0, 2 000.0 and 5 000.0 μg/plate by plate incorporation ,with and without S9 respectively. Chromosome aberration test, CHL cells were exposed to xueshuantong injection for 4 h (with and without S9) or 24 h (without S9) at concentrations of 125, 250 and 500 μg·mL^-1. The number of cells with structural and numerical aberrations in 300 metaphase cells in each group was counted under oil lens. Mouse bone marrow micronucleus test, KM mice were dosed with 104.3 , 208.6 and 417.2 mg·kg^-1 by intravenous injection of xueshuantong injection for two days, and the bone marrow samples were collected at 24 h after the last treatment.The number of immature erythrocytes per animal were scored , and the proportion of immature among total erythrocytes was determined for each animal by counting erythrocytes for bone marrow. Results Compared with the concurrent solvent control, the mean number of revertant colonies in each group increased less than once. Compared with the concurrent solvent control, there was no significant difference in the rate of structural aberration and numerical aberration caused by xueshuantong injection (P>0.05). At 24 h post-administration of xueshuantong injection, there was no significant difference in the average micronucleated polychromatic erythrocyte rate in each group compared with the solvent control (P>0.05). Conclusion The genotoxicity evaluation result of xueshuantong injection is negative under the test conditions.

Key words: xueshuantong injection, genotoxic, Ames assay, CHL cells chromosome aberration test, PCE, micronucleus assay