Evaluation of Genotoxicity of CSE1034 by Ames and In vitro Chromosomal Aberration Tests

Purpose: To evaluate the genotoxicity of CSE1034, a novel antibiotic adjuvant entity, using bacterial reverse mutation assay (Ames test) and in vitro chromosomal aberration test. Methods: Reverse mutation test was carried out using four strains of Salmonella typhimurium (TA 98, TA100, TA1535 and TA1537) and one strain of E. coli [WP2 (uvrA)], while chromosomal aberration test was done with cultured Chinese hamster lung (CHL) cells. Reverse mutation test was carried out in a dose range of 0.0015 to 0.16 μg/plate in triplicate with and without S9 activation. Results: No significant increases in the number of revertants were observed at the dose levels where antibacterial effects were not noted. CSE1034 caused no increase in the number of chromosomal aberrants at dose levels of 0.34, 0.69, 1.37, 2.75 and 5.50 mg/ml in the absence and presence of metabolic activation. Conclusion: Based on the above observations, it can be concluded that CSE1034 has no mutagenic activity.