Studies on potential mutagenic and genotoxic activity of Setarud

Background: Setarud (IMOD™) is a new herbal drug that has demonstrated immunemodulating activity in preliminary investigations. The aim of this study was to evaluate thepotential of mutagenicity and genotoxic properties of Setarud following the guidelines ofthe Organization for Economic Co-operation and Development (OECD) for the Testing ofChemicals.Methods: Ames Salmonella/mammalian microsome mutagenesis assay was used toevaluate the ability of the drug and its metabolites to induce mutation in Salmonella testerstrains. Setarud was applied in concentrations of 0.1-1000 μg/dish. The effect of the drugmetabolites which were formed in the presence of rat liver microsomal fraction S9 wasinvestigated using complete and incomplete microsomal activation mixtures, separately.Induction of dominant lethal mutations in spermatogenic stem cells of male mice was alsoassessed.Results: In the Ames test, the drug preparation did not cause a significant increase in thenumber of revertant bacterial colonies as compared with negative control meaning thatSetarud within the tested range did not exhibit mutagenic activity. The level of postimplantationlosses and as a result the number of lethal mutations in germ cells at differentstages of spermatogenesis in mice treated with Setarud was not statistically higher than thatof control.Conclusion: Under experimental conditions which were employed, the drug was notmutagenic or genotoxic.