目的　鲨鱼肝油胶丸系鲨鱼肝之提取物 ,为判定其对人体健康是否产生危害 ,特进行了安全性毒理学评价。方法　采用急性毒性试验、Ames试验、小鼠骨髓微核实验、微小鼠精子畸形试验和 30天喂养试验对鲨鱼肝油胶丸急性毒性、致突变性及亚慢性毒性进行了研究。结果　鲨鱼肝油胶丸属实际无毒级物质 ,致突变试验结果为阴性 ,初步估计最大无作用剂量大于 5 0 0g/kg体重 ,相当于人体推荐量的 10 0倍。结论　根据试验结果 ,判定其为安全性食品 Objective shark liver oil capsules shark liver extract, in order to determine whether it is harmful to human health, especially the safety of toxicology assessment. Methods The acute toxicity, mutagenicity and subchronic toxicity of shark Liver Oil Capsule were studied by acute toxicity test, Ames test, micronucleus test of mouse bone marrow, micro-mouse sperm abnormality test and 30-day feeding test. Results Shark liver oil capsule is an actual non-toxic substances, mutagenicity test results were negative, the initial estimated maximum non-effect dose greater than 500 g / kg body weight, equivalent to 10 times the recommended amount of human body. Conclusions According to the test results, it is judged as safe food