세균을 이용한 CSⅡ 약침의 복귀돌연변이 시험

Bacterial Reverse Mutation Test of CSⅡ-YAKCHIM

Objectives : This study was designed to determine the mutagenic potential of CSⅡ-YAKCHIM, manufactured from Brassicae Semen, Raphani Semen, Persicae Semen, and Carthami Fructus extract, using histidine requiring Salmonella typhimurium (TA98, TA100, TA1535, and TA1537) and tryptophan requiring Escherichia coli (WP2uvrA(pKM101)) strains. Methods : In order to determine the dose levels of the main study, the dose range finding study was conducted. The high dose was selected at 5,000 μg/plate and it was sequentially diluted by the geometric ratio of 4 to 1,250, 313, 78.1 and 19.5 μg/plate. As a result, the growth inhibition and deposition by the CSⅡ-YAKCHIM was not evident at any dose levels in the absence and presence of metabolic activation. Therefore, the dose levels of the main study were selected as 5,000, 2,500, 1,250, 625, and 313 μg/plate. Also, the negative and positive control groups were used. Results : As a result of the main study, the mean number of revertant colonies was less than twice when compared to the negative control values at all dose levels of the test substance in the presence and absence of metabolic activation, without dose-related increase. In the positive control group, the number of revertant colonies was markedly increased when compared to that of the negative control group. Conclusions : Based on the results of this study, the test substance, CSⅡ-YAKCHIM, did not exhibit any indications of mutagenic potential under the conditions of this study.