연구논문 : 유전독성 대체시험법(in vitro소핵시험)의 국내검증시험연구

This validation study was performed to introduce and set up the in vitro micronucleus test, as an alternative to the existing chromosome aberration test, in the test facilities in Korea, and to establish the competence of each facility to perform the in vitro micronucleus test independently. The 10 coded substances, including 6 positive and 4 negative in genotoxicity assay, were tested. Six facilities were divided into two subgroups, A and B. Three coded positive compounds and two negative compounds were sent to each test facility. The compounds were tested according to the facility`s GLP system. In group A, positive results were obtained from testing of the three positive compounds, and negative results were obtained from testing of the two negative compounds in all three facilities. In group B, positive results were also obtained from testing of the three positive compounds, and negative results were obtained from testing of the two negative compounds in all three facilities. For the Urethane, an in vitro equivocal compound tested by group B, negative results were obtained. These results suggested that the compound may be effectively activated only in in vivo environment. The results show that the six test facilities are capable of performing the in vitro micronucleus test independently and producing consistent results.