| MUTAGENICITY
Bacterial mutation test (Ames test) IQB-9320.HCl at concentrations ranging up to 5.000 mg/plate was added to plates of bacterial histidine dependent auxotrophic mutants of Salmonella typhimurium (strains TA 1535, TA 1537, TA 98 and TA 100) and of a tryptophan dependent mutant of Escherichia coli (strain CM891). Two independent mutation tests were performed in the presence and absence of liver preparations from Aroclor 1254-induced rats (S9 mix). The first was a standard plate incorporation assay, the second involved a pre-incubation stage. No evidence of mutagenic activity
was seen at any dose level of IQB-9302.HCl in either mutation test. The
concurrent positive controls demonstrated the sensitivity of the assay
and the metabolising activity of the liver preparation
Conclusion: In the preliminary mutagenicity tests on bacteria, IQB-9302 with and without hepatic microsomal activation was found to be inactive A complete set of mutagenicity tests have been planned to further evaluate mutagenic potential of IQB-9302 in compliance with Regulatory Guidelines. These are:
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