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EC number: 618-832-3 | CAS number: 92263-41-7
The purpose of this in vitro reverse gene mutation test is to identify agents that cause mutations in bacteria cells thus providing information on possible health hazards for the test material and serve as a rational basis for risk assessment to the genotoxic potential of the test item in man.
The investigations for mutagenic potential were performed using Salmonella typhimurium tester strains TA 98, TA 100, TA 102, TA 1535 and TA 1537, and Escherichia coli WP2 uvrA pkM101. The plate incorporation test with and without addition of liver S9 mix from Aroclor 1254-pretreated rats was used. Two independent experimental series were performed for all strains. In the series with S9 mix, 10 % or 30 % S9 in the S9 mix were used inn the 1st and 2nd series, respectively.
The test material was dissolved in acetone and tested at concentrations ranging from 5.00 to 500 µg/plate. Precipitation of the test material on the agar plates occurred at concentrations larger/equal 250 µg/plate. Toxicity to the bacteria was not observed.
Daunomycin, N-ethyl-N'-nitro-N-nitroso-guanidine, 9-aminoacridine and cumene hydroperoxide served as strain specific positive control compounds in the absence of S9 mix. 2-Aminoanthracene and benzo[a]pyrene were used for testing the bacteria and the activity of the S9 mix. Each treatment with the substances used as positive controls led to a clear increase in revertant colonies, thus showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used.
No increase in revertant colonies was obtained after treatment with the test material up to the highest concentrations investigated, thus showing the absence of mutagenic potential in vitro with and without external metabolizing system.
With and without addition of S9 mix as the external metabolizing system, the test material was not mutagenic under the experimental conditions described.
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