Genotoxicity studies on sertaconazole.

A series of 6 studies has been performed to evaluate the potential genotoxic effect of 7-chloro-3-[1-(2,4-dichlorophenyl)-2-(1H- imidazol-1-yl)ethoxy-methyl]benzo[b]thiophene (sertaconazole, FI 7045, CAS 99592-32-2). From these studies, the reverse mutation assay on Salmonella typhimurium, sex-linked recessive lethal mutations on Drosophila and genetic mutations in cultured mammal cells allowed to study the genetic mutations in prokaryotes and eukaryotes. In vitro and in vivo chromosomal aberrations were studied using human lymphocytes cytogenetic test, micronucleus test and sister chromatid exchange test. The results obtained in these studies, which are complemented one another, demonstrated that sertaconazole did not induce any signs of promutagenic, mutagenic or clastogenic activity or interference with the chromosomal segregation process.