采用体内碱性彗星试验检测两种聚醚醚酮材料的遗传毒性

doi:10.3969/j.issn.1004-616x.2022.05.010

Abstract

Abstract: OBJECTIVE: An in vivo mammalian alkaline comet test was used to detect genotoxicity of two kinds of polyether ether ketone materials,and to develop the method for genotoxicity evaluation of medical devices.METHODS: Two polyether ether ketone materials were extracted with 0.9% sodium chloride injection (SC) and cottonseed oil (CSO) into rats,and used as the test solution.SC and CSO were prepared the same way and served as the negative controls.Methyl methanesulfonate (MMS) was used as positive control.70 SD rats (half males and half females) received two treatments at 24 h intervals.The SC and MMS groups of rats received treatments through intravenous injection at a dose of 10 mL/kg.The CSO group received treatments through intraperitoneal injection at a dose of 5 mL/kg.All rats were sacrificed at 3 h after the last treatments.Their livers and kidneys were weighed and histopathological examined.Single-cell suspensions were prepared from liver,kidney and peripheral blood for the alkaline comet assay which determined DNA damage via% tail DNA,tail moments and Olive tail moments.RESULTS: Under the conditions of this study,the liver and kidney coefficients of the test solution and the MMS positive control group showed no statistically significant differences compared with the SC and CSO negative control groups,respectively.The shape and structure of the liver and kidney of all rats were normal without obvious histopathological changes.There were statistically significant differences in the% tail DNA,tail moment and Olive tail moment in the MMS positive control group (P<0.01) and there were no statistically significant differences in the two polyether ether ketone materials groups (P>0.05) compared with the SC and CSO negative control groups.CONCLUSION: The method of in vivo alkaline comet assay for genotoxicity of medical devices was successfully tested.The two polyether ether ketone materials were considered unable to induce DNA strand breakage in the rat liver under the conditions of this study.

Key words: in vivo alkaline comet assay, medical device, methyl methanesulfonate, genotoxicity, polyether ether ketone materials

CLC Number:

Q355

SUN Lingxiao, LIU Xiangdong, LIU Zengxiang, WANG Luanluan, ZHU Fuyu, SUN Xiaoxia, LIU Chenghu. Application of an in vivo alkaline comet assay in genotoxicity of two polyether ether ketone materials[J]. Carcinogenesis, Teratogenesis & Mutagenesis, 2022, 34(5): 388-394,399.

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Application of an in vivo alkaline comet assay in genotoxicity of two polyether ether ketone materials

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