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EC number: 689-267-8 | CAS number: 501925-98-0
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The purpose of this study was to evaluate the test substance for mutagenic activity (gene mutation) in bacteria without and with the addition of a mammalian metabolic activation system as originally described by AMES et al. (1973, 1975) and revised by MARON and (1983).
The test substance was examined in the 5 Salmonella typhimuriumstrains TA98, TA100, TA102, TA1535 and TA1537 in two independent experiments, each carried out without and with metabolic activation (a microsomal preparation derived from Aroclor 1254-induced rat liver). The first experiment was carried out as a plate incorporation test and the second as a preincubation test.
The test item wascompletely dissolved indimethylsulfoxide (DMSO).The vehicle served as the negative control.
The test item was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain TA100. Ten concentrations ranging from 0.316 to 5000 µg test item /plate were tested. No signs of cytotoxicity were noted up to the top concentration of 5000 µg/plate. Hence, 5000 µg test item /plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test.
Six concentrations ranging from 31.6 to 5000 µg test item /plate were employed in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation.
No signs of cytotoxicity were noted up to the top concentration of 5000 µg test item/plate inthe plate incorporation test and in the preincubation test, each carried out without and with metabolic activation in all test strains.
No increase in revertant colony numbers as compared with control counts was observed for the test item, tested up to aconcentration of 5000 µg/plate,in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively (plate incorporation and preincubation test).
The positive control items showed a significant increase in the number of revertant colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system.
In conclusion, under the present test conditions, the test substance tested up to a concentration of 5000 µg/plate caused no mutagenic effect in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
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