Carcinogenesis, Teratogenesis & Mutagenesis ›› 2023, Vol. 35 ›› Issue (5): 387-391.doi: 10.3969/j.issn.1004-616x.2023.05.010

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Genotoxicity evaluation of biodegradable patches using the micronucleus test in peripheral blood of mice

WANG Guowei1, SUN Xiaoxia1, CHE Guoxi1, GAI Xiaoxiao1, QU Qiujin1, WANG Yan1, WANG Xiaofei1, DU Xiaodan2, LIU Chenghu1   

  1. 1. Shandong Institute of Medical Device and Pharmaceutical Packing Inspection/NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, Jinan 250101, Shandong;
    2. National Institutes for Food and Drug Control, Beijing 102629, China
  • Received:2023-05-23 Revised:2023-09-05 Published:2023-10-13

Abstract: OBJECTIVE:Based on flow cytometry,genotoxicity of biodegradable patch was investigated by studying the induction of micronuclei in peripheral reticulocytes (MN-RET) and mature erythrocytes (MN-NCE) in mice under different administration conditions. METHODS: For the short-term administration condition, mice were intraperitoneally injected with vehicle control,test solution,and cyclophosphamide solution (25,50 mg/kg) once a day for 3 days. Then,peripheral blood samples were collected,and the micronucleus were detected by flow cytometry. For the long-term administration condition, mice were continuous administrated for 14 days. Then,peripheral blood samples were collected,and spleens were enucleated. Micronucleus frequencies as well as splenic cell apoptosis were detected by flow cytometry. In addition, spleens were histopathologically examined after hematoxylin-eosin staining (HE). RESULTS: There was no significant differences in the percentage of MN-RET and MN-NCE in both treatment and control groups under the two different administration conditions (P> 0.05). In addition, there was no significant difference in the apoptosis rate of spleen cells between the two groups (P>0.05),and there were no significant pathological changes in the spleen tissue. On the other hand, significant and positive results were observed with the cyclophosphamide groups. CONCLUSION: The micronucleus test results show that the biodegradable patches had no potential genotoxic risk. In addition,the selection and analysis of MN-RET and MN-NCE in mouse peripheral blood under different dosing cycle conditions was useful in detecting genotoxic risk of chemicals.

Key words: flow cytometry, micronucleus test, genotoxicity, biodegradable patches

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