中国结合医学杂志（英文版）Chinese Journal of Integrative Medicine

Author Name	Affiliation	E-mail
ZHANG Qian-qian, LI Qiang, DONG Lin
JIN Hong-tao	1. New Drug Safety Evaluation Center, Institute of Materia Medica, Chinese Academy of Medical Sciences, Beijing (100050), China 2. Beijing Union-GeniousPharmaceutical Technology Ltd., Beijing (100176), China	jinhongtao@imm.ac.cn

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Abstract:

Objective: To assess the genotoxicity and embryotoxicity of bicyclol methyl ether (BME), the main impurity in bicyclol. Methods: Five concentrations of BME (0.5, 5, 50, 500 and 5000 μ g/plate) were used in the Ames test to detect gene mutation. In the chromosome aberration test, Chinese hamster lung cells were used to detect chromosomal aberration of BME (15, 30, 60, 120 μ g/mL) with or without S9 mixture. Embryotoxicity test was also conducted to determine any embryotoxicity of BME (7.5, 22.5, 67.5 μ g/L) using zebrafish embryos. Results: No significant differences were observed in the Ames test and the chromosome aberration test in the BME groups compared with the vehicle control group. The zebrafish embryos toxicity test also showed no embryo development toxicity of BME, including hatching rate, body length, pericardial area and yolk sac area. Conclusions: Bicyclol methyl ether has no genotoxicity in vitro and embryotoxicity in zebrafish embryos, and the impurity in bicyclol is qualified.