OBJECTIVE: To study the genotoxicity and reproductive toxicity of new hypoglycemic compound G004. METHODS: The genotoxicity of G004 was investigated by Ames trial (reverse mutation test of Salmonella typhimurium mutant), CHL cell (Chinese hamster lung fibroblasts) chromosomal aberration test and mice bone marrow micronucleus test. In embryo-fetal development toxicity test, pregnant rats were given medicine intragastrically during 6-15 days of pregnancy (G004 dose of 100, 300, 900 mg/kg). The effects of G004 on body weight and food intake of pregnant rats, embryo formation and fetal rat growth and development were investigated to evaluate reproductive toxicity of G004. RESULTS: The negative genotoxicity results were obtained in Ames trial, CHL cell chromosomal aberration test and mice bone marrow micronucleus test. In respect of reproductive toxicity, there was no obvious toxic reaction in pregnant rats of G004 different dose groups, and rat embryos developed normally in G004 100, 300 mg/kg groups. Only resorption number increased and rat embryos developed slowly in 900 mg/kg group. CONCLUSIONS: G004 shows no obvious genotoxicity. When the doses are not more than 900 mg/kg, G004 has no toxic effect on rat; when the doses are not more than 300 mg/kg, G004 has no teratogenic effect on rat offspring.