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Chin J Integr Med. 2018 Sep 22. doi: 10.1007/s11655-018-2553-x. [Epub ahead of print]

Genotoxicity and Embryotoxicity Study of Bicyclol Methyl Ether, Main Impurity in Bicyclol.

Author information

1
New Drug Safety Evaluation Center, Institute of Materia Medica, Chinese Academy of Medical Sciences, Beijing, 100050, China.
2
Beijing Union Pharmaceutical Factory, Beijing, 100026, China.
3
Beijing Union-Genious Pharmaceutical Technology Ltd., Beijing, 100176, China.
4
New Drug Safety Evaluation Center, Institute of Materia Medica, Chinese Academy of Medical Sciences, Beijing, 100050, China. jinhongtao@imm.ac.cn.
5
Beijing Union-Genious Pharmaceutical Technology Ltd., Beijing, 100176, China. jinhongtao@imm.ac.cn.

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 μg/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 μg/mL) with or without S9 mixture. Embryotoxicity test was also conducted to determine any embryotoxicity of BME (7.5, 22.5, 67.5 μg/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.

KEYWORDS:

Ames test; bicyclol methyl ether; chromosome aberration test; embryotoxicity; genotoxicity; zebrafish

PMID:
30242590
DOI:
10.1007/s11655-018-2553-x

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