The purpose of this study is to evaluate the mutagenic potential of the test substance or its metabolites by measuring its ability to induce back mutations at selected loci of several strains in the presence and absence of microsomal enzymes. This test system has been shown to detect a diverse group of chemical mutagens. The ability to induce mutation is indicative of a chemical's genotoxic potential.
The test substance (Liver No. 1™) was tested in 5 separate tester strains in the presence and absence of Aroclor-induced rat liver microsomal enzymes. The assay was performed in two phases using the plate incorporation method. The first phase was used to establish the dose range for the mutagenicity assay. The second phase was used to evaluate the mutagenicity of the test substance.
The results of the first phase indicated that neither precipitate nor appreciable toxicity was observed. In the second phase, no positive responses were observed with any of the tester strains in the presence and absence of microsomal enzymes prepared from Aroclor-induced rat liver. In addition, precipitate but no appreciable toxicity was observed.
In conclusion, the results indicated that under the conditions of this study, test substance (Liver No. 1™) did not produce a positive response in the AMES assay.