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

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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 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.

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Authors and Affiliations

  1. New Drug Safety Evaluation Center, Institute of Materia Medica, Chinese Academy of Medical Sciences, Beijing, 100050, China

    Qian-qian Zhang, Wan-fang Li, Ai-ping Wang, Jin-feng Wei & Hong-tao Jin

  2. Beijing Union Pharmaceutical Factory, Beijing, 100026, China

    Qiang Li

  3. Beijing Union-Genious Pharmaceutical Technology Ltd., Beijing, 100176, China

    Lin Dong, Chao Li, Ai-ping Wang, Jin-feng Wei & Hong-tao Jin

Authors
  1. Qian-qian Zhang
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  2. Qiang Li
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  3. Lin Dong
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  4. Wan-fang Li
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  5. Chao Li
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  6. Ai-ping Wang
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  7. Jin-feng Wei
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  8. Hong-tao Jin
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Contributions

Zhang QQ, Dong L carried out the experiments and wrote the paper; Li Q, Li WF help sampling the test article and detection of HPLC; Li C, Wang AP, Wei JF supervised and directed the project; Jin HT as the corresponding author reviewed and revised the entire manuscript.

Corresponding author

Correspondence to Hong-tao Jin.

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Zhang, Qq., Li, Q., Dong, L. et al. Genotoxicity and Embryotoxicity Study of Bicyclol Methyl Ether, Main Impurity in Bicyclol. Chin. J. Integr. Med. 25, 743–749 (2019). https://doi.org/10.1007/s11655-018-2553-x

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  • DOI: https://doi.org/10.1007/s11655-018-2553-x

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