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本实验测定了富马酸二甲酯(DMF)的急性毒性和蓄积性毒性,并选用了三种体内和体外的短期测试系统,对其致突变性进行了试验。实验结果表明,DMF对雌、雄小鼠经口LD_(50)分别为1190和1180mg/kg,属于低毒。根据蓄积系数法测定了蓄积毒性。当死亡率为50%时,雌、雄动物蓄积系数K值都大于5,所以DMF蓄积性低。在Ames试验中,DMF未呈现致突变性。在体内试验中,DMF未引起小鼠骨髓多染红细胞微核率和小鼠精子畸形率的增加,在三项致突变试验中DMF未呈现致突变活性。
The acute toxicity and accumulative toxicity of dimethyl fumarate (DMF) were determined in this experiment. Three kinds of short-term in vitro and in vivo test systems were selected to test their mutagenicity. The experimental results showed that the oral LD_ (50) of DMF in female and male mice were 1190 and 1180 mg / kg, respectively, which belonged to low toxicity. Accumulation toxicity was determined by the accumulation coefficient method. When the mortality rate is 50%, female and male animal’s accumulation coefficient K value is greater than 5, so DMF accumulates low. DMF did not show mutagenicity in the Ames test. In vivo, DMF did not cause micronuclei in mouse bone marrow polychromatic erythrocytes and mouse sperm deformity rate increase, in the three mutagenic test DMF did not show mutagenic activity.