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EC number: 831-973-7 | CAS number: 147116-67-4
The objective of this study was to determine the potential of Maropitant base (CJ-11,972) and/or its metabolites to induce reverse mutations at the histidine locus in several strains of Salmonella typhimurium (S. typhimurium; TA98, TA100, TA1535, and TA1537), and at the tryptophan locus of Escherichia coli (E. coli) strain WP2uvrA in the presence or absence of an exogenous mammalian metabolic activation system (S9). The study procedures described in this report were based on the most recent OECD and EC guidelines. Batch 334115 of the test item was a white to off-white powder with a purity of 99.9%. The vehicle of the test item was dimethyl sulfoxide. In the dose-range finding test, the test item was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. The test item precipitated on the plates at the top dose level of 5000 μg/plate. Cytotoxicity, as evidenced by a decrease in the number of revertants, reduction of the bacterial background lawn and/or the presence of microcolonies, was observed in tester strain TA100 at dose levels of 164 μg/plate and upwards and in tester strain WP2uvrA at dose levels of 1600 μg/plate and upwards. Results of this dose-range finding test were reported as part of the first mutation assay. Based on the results of the dose-range finding test, the test item was tested in the first mutation assay at the concentration ranges of 0.54 to 164 µg/plate in tester strain TA1537 (absence and presence of 5% (v/v) S9-mix)) and tester strain TA98 (absence of S9-mix) and at the concentration ranges of 0.54 to 500 µg/plate in the tester strains TA1535 (absence and presence of S9-mix) and TA98 (presence of S9-mix). The test item did not precipitate on the plates at this dose level. Cytotoxicity, as evidenced by a decrease in the number of revertants, reduction of the bacterial background lawn and/or the presence of microcolonies, was observed in all tester strains in the absence and presence of S9-mix. In a follow-up experiment of the assay with additional parameters, the test item was tested up to concentrations of 500 µg/plate in the absence and presence of 10% (v/v) S9-mix in the tester strains TA1535, TA1537, TA98, TA100 and up to 5000 µg/plate in tester strainWP2uvrA in the absence and presence of 10% (v/v) S9-mix. The test item precipitated on the plates at the dose levels of 1500 and 1000 µg/plate and upwards in the absence and presence of S9-mix, respectively. Cytotoxicity, as evidenced by a decrease in the number of revertants, reduction of the bacterial background lawn and/or the presence of microcolonies, was observed in all tester strains in the absence and presence of S9-mix. Maropitant base (CJ-11,972) did not induce a significant dose-related increase in the number of revertant (His+ ) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+ ) colonies in the tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in a follow-up experiment. The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. In conclusion, based on the results of this study it is concluded that Maropitant base (CJ11,972) is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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