Abstract: BACKGROUND AND AIM: To evaluate the safety of the compound of lycopene and soybean isoflavone in order to provide some toxicological data for its application. MATERIALS AND METHODS: Acute toxicity test、bone marrow cell micronucleus test、mice sperm abnormality test、Ames test were conducted in accordance with the ＂Technical Standards for Testing & Assessment of Health Food＂. RESULTS: Acute toxicity test of oral dosing showed LD50>10.0 g/kg in mice. Salmonella typhimurium/mammals microsomal enzyme test and micronucleus test of bone marrow cells showed that the compound was safe without mutagenesis. No toxicity was observed in sperm shape abnormality test in mice. CONCLUSION: The compound of lycopene and soybean isoflavone is a non-toxic、 non-mutagenic preparation.