Mutagenicity evaluation of glutaraldehyde in a battery of in vitro bacterial and mammalian test systems

Abstract

Glutaraldehyde was evaluated for genotoxicity using a battery of four in vitro test systems: the Salmonella/microsome assay, the Chinese hamster ovary cell/hypoxanthine-guanine phosphoribosyltransferase (CHO/HGPRT) gene mutation system, the sister-chromatid exchange test with Chinese hamster ovary cells, and measurements of unscheduled DNA synthesis in primary rat-hepatocyte cultures. No significant, dose-related increases in the various end-points were produced by glutaraldehyde in tests with or without the addition of a rat-liver metabolic activation system (S-9 mix) or with the cell-mediated activation of the hepatocyte test system. A range of concentrations which spanned cytotoxic to non-cytotoxic doses was evaluated in each test system and marked cytotoxicity was typically noted at micromolar concentrations. Within a range of biologically active concentrations, glutaraldehyde did not produce significant genotoxic effects with the assays and conditions used for these studies.