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EC number: 606-647-0
CAS number: 208338-50-5
The test material was not genotoxic in an Bacterial Mutagenicity Assay
(Ames test) with and without metabolic activation.
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
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 20 % S9 in
the S9 mix were used in the 1st or 2nd series, respectively.
The test material was dissolved in acetone and tested at concentrations
ranging from 5.00 to 5000 µg/plate. Precipitation of the test material
on the agar plates occurred at concentrations >=500 or 1580 µg/plate,
depending upon the experimental condition tested. 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.
With and without addition of S9 mix as the external metabolizing system,
the test material was not mutagenic under the experimental conditions
The in vitro study was GLP compliant and of high quality (Klimisch 1).
Therefore, the results are applicable to humans.
The test material must not be classified with regard to genetic toxicity.
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