转乙肝抗原蛋白基因苜蓿毒理学安全性的研究

Study on Toxicology Safety of Alfalfa Transformated with HBV Antigen Protein Gene

目的对转乙肝抗原蛋白基因苜蓿进行安全性评价试验研究,为其进一步研发提供依据。方法采用急性毒性试验、遗传毒性试验(包括V79细胞基因突变试验、Ames试验、小鼠骨髓细胞微核试验、小鼠精子畸形试验)对转乙肝抗原蛋白基因苜蓿进行系统的安全性研究。结果转乙肝抗原蛋白基因苜蓿最大耐受剂量>10.0 g.kg?1,属实际无毒级。V79细胞基因突变试验、Ames试验、小鼠骨髓细胞微核试验、小鼠精子畸形试验结果均为阴性。结论转乙肝抗原蛋白基因苜蓿属实际无毒类物质,在本试验条件下无致基因突变和染色体畸变作用。

OBJECTIVE To evaluate the safety of alfalfa transformated with HBV antigen protein gene （ATHAPG） for its further research. METHODS Systematic safety was evaluated by acute toxicity and genotoxicity experiments including V79/HGPRT gene mutation test, mice bone marrow micro-nuclear test, Ames test and mice sperm abnormality test. RESULTS The maximal tolerance dose was higher than 10.0 g.kg-1, all genetic toxicity tests were negative. CONCLUSION ATHAPG is an actually non-toxic substance. ATHAPG has no mutagenic effects under the experimental conditions.