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EC number: 278-145-6
CAS number: 75234-41-2
# culture was not continued as a minimum of only four analysable
concentrations is required
The test item Acid Brown 425 was assessed for its potential to
induce gene mutations at the HPRT locus using V79 cells of the Chinese
The study was performed in two independent experiments, using
identical experimental procedures. In the first experiment the treatment
period was 4 hours with and without metabolic activation. The second
experiment was performed with a treatment time of 4 hours with and 24
hours without metabolic activation.
The cell cultures were evaluated at the following concentrations:
concentration in the experimental parts without metabolic activation was
limited by cytotoxicity of the test item. Precipitation at the end of
treatment, visible to the unaided eye, was not observed.
effects, indicated by a relative cloning efficiency I of less than 50%
compared to the corresponding solvent control in both parallel cultures,
occurred in experiment I at 1400 µg/mL and above without and at 4200
µg/mL and above with metabolic activation. In experiment II cytotoxic
effects were noted at 1400 µg/mL and above without and at 5600 µg/mL and
above with metabolic activation.
No relevant and reproducible increase in mutant colony numbers/106cells
was observed in the main experiments up to the maximum concentration.
The threshold of three times the mutation frequency of the corresponding
solvent control was reached in the first culture of the second
experiment with metabolic activation at 5600 µg/mL. The range of the
historical solvent control data (3.4 - 36.6 mutant colonies/106cells)
was also exceeded at this concentration (61.0 mutant colonies/106cells).
This isolated increase was judged as biologically irrelevant however, as
the threshold was not reached in the parallel culture under identical
experimental conditions and there was no dose dependent increase as
indicated by the lacking statistical significance.
In the second experiment the mutation frequency slightly exceeded
the historical range of solvent controls at 700 µg/mL in culture I with
metabolic activation (41.9 mutant colonies/106cells).
However, the induction factor did not exceed the threshold of three
times the corresponding solvent control and statistical analysis showed
that there was no dose dependent increase. Therefore, the increase was
judged as biologically irrelevant.
A linear regression analysis (least squares) was performed to
assess a possible dose dependent increase of the mutation frequency. No
significant dose dependent trend of the mutation frequency indicated by
a probability value of <0.05 was determined in any of the experimental
In both experiments of this study (with and without S9 mix) the
range of the solvent controls was from 16.8 up to 35.5 mutants per 106cells;
the range of the groups treated with the test item was from 8.1 to 61.0
mutants per 106cells.
EMS(150 µg/mL) and DMBA (1.1 µg/mL) were used as positive controls
and showed a distinct increase of induced mutant colonies.
The hazard of gene mutation was
determined in mammalian cells (V79) in vitro with the following result:
not mutagenic. The study included several repeats with and without
The test item did not induce gene
mutations in 2 standard Ames tests in salmonella typhimurium or
escherichia coli. An analogous substance did not induce gene mutations
in Salmonella typhimurium with and without metabolic activation by
syrian hamster liver S9-mix.
Chromosomal aberrations were determined after in vitro incubation of
human lymphocytes. No hazard was identified.
In conclusion the test item is considered not mutagenic in in-vitro test
The test item did not induce gene
mutations in bacteria and mammalian cells and did not provoke chromosomal
aberrations in human lymphocytes.
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