CJ-50005 (A형 간염백신)에 대한 유전독성시험 = Mutagenicity Tests on CJ-50005 (Hepatitis A Vaccine)

다국어 초록 (Multilingual Abstract)

CJ-50005 is an inactivated whole virus vaccine derived from hepatitis A virus (HM175) grown in human MRC-5 diploid fibroblasts cell culture. In order to evaluate the mutagenic potential of CJ-50005, 3 sets of mutagenicity tests were performed. In the reverse mutation test using Salmonella typhimurium TA1535, TA1537, TA98, TA100 and TA102, CJ-50005 did not increase the number of revertants at any concentration tested in this study (2.8, 1.4, 0.7, 0.35 and 0.175 ㎍/plate). CJ-50005, at concentrations of 2.8, 1.4 and 0.7 ㎍/ml, did not increase the number of cells having structural or numerical chromosome aberration in cytogenic test using Chinese Hamster Lung cells. In mouse micronucleus test, no significant increase in the occurrence of micronucleated polychromatic erythrocytes was observed in ICR male and female mice intraperitoneally administered with CJ-50005 at the doses of 25, 12.5 and 6.25 ㎍/kg. These results indicate that CJ-50005 has no mutagenic potential in these in vitro and in vivo systems.