Evaluation of Genotoxicity of CVA1020 through Ames and in Vitro Chromosomal Aberration Tests

The aim of the present study was to assess the mutagenic potential of CVA1020 using the bacterial reverse mutation assay (Ames test) with bacteria and in vitro chromosomal aberration test with mammalian cells. In the reverse mutation test, Salmonella typhimurium TA 98, TA100, TA1535 and TA1537 and Escherichia coli [WP2 (uvrA)] were used with the dose range from 0.0015 to 0.16 μg/plate in triplicates with and without S9 activation. In the chromosomal aberration test with mammalian cells, a Chinese hamster lung fibroblast cell line (CHL/IU) in culture was used at dose levels 0.34, 0.69, 1.37, 2.75 and 5.50 mg/mL in the absence and presence of the metabolic activation. CVA1020 induced no significant increases in the number of revertants in any of the strains at the dose levels where antibacterial effects were not noted with and without metabolic activation. CVA1020 did not induce increase in the incidence of cells with chromosomal aberration or those with genome mutation (polyploidy) in any of the strains irrespective of the absence or presence of metabolic activation. Thus, based on these results it is concluded that CVA1020 does not have mutagenic potential.