CSⅡ 약침의 포유류 배양세포 염색체이상 시험

In vitro Mammalian Chromosomal Aberration Test of CSⅡ-YAKCHIM

Objectives : This study evaluated the potential related CSⅡ-YAKCHIM on chromosomal aberrations in Chinese Hamster Lung (CHL/IU) cells to provide the safety evidence of CSⅡ-YAKCHIM. Methods : In order to determine the high dose levels of the main study, the cell growth inhibition study was conducted. The high dose was selected at 5,000 μg/mL and it was sequentially diluted to produce lower dose levels of 39.1, 78.1, 156, 313, 625, 1,250 and 2,500 μg/mL. As a result, the cell growth inhibition was below 50% at all dose levels when compared with negative control value in the short time treatments without and with metabolic activation and the continuous treatment without metabolic activation. Therefore, the dose levels of the main study were selected as 1,250, 2500, and 5,000 μg/mL (short time treatment and continuous treatment). Also, the negative and positive control groups were used. Results : As a result of the main study, the frequency of cells with chromosome aberrations was less than 5% in the short time treatments without and with metabolic activation and the continuous treatment without metabolic activation. Also, there was no statistically significant differences when compared to that in the negative control group. In the positive control group, the frequency of cells with structural chromosomal aberrations was more than 10% and statistically significantly increased compared to that in the negative control group. Conclusions : Based on the results of this study, CSⅡ-YAKCHIM did not exhibited the chromosome aberrations under the conditions of this study.