Investigations of genotoxic activity of the antimicrobial/antiviral agent FS-1 in rodents by means of the micronucleus and the comet assays

Background: FS-1 is a complex of iodine and synthesized polysaccharides and it is very effective against a number of microbe and virus strains. The aim of the study was to evaluate possible genotoxic properties of FS-1. Methods: The compound was studied in rat and mouse bone marrow micronucleus (MN) assay and the comet assay in murine peripheral blood leukocytes, hepatocytes, and kidney cells. Two treatment protocols were applied, namely acute and subacute ones. In the first protocol, the compound was administered orally once and in subacute treatment two times, 24 h apart. The animals were sacrificed 24 h after the last treatment, and appropriate cells were used to assess DNA damage and MN induction. Results: In none of the tests (MN and comet assays) significant increase compared with respective negative controls was observed. Conclusion: The fact that the compound neither induces DNA damage in various organs of mice nor is effective in the induction of MN in bone marrow cells of rats and mice is important for future genotoxicity studies of FS-1, which can be used in clinical medicine after additional testing of safety for humans.