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EC number: 225-803-5
CAS number: 5089-22-5
The study was run according to OECD
guideline 471 using histidine-requiring auxotroph strains of Salmonella
typhimurium (Salmonella typhimurium TA98, TA100, TA1535 and TA1537), and
the tryptophan-requiring auxotroph strain of Escherichia coli
(Escherichia coli WP2 uvrA) in the presence and absence of a post
mitochondrial supernatant (S9) prepared from rat livers.
The study included a preliminary
solubility test, a preliminary concentration range finding test
(informatory toxicity test applying the plate incorporation method), an
initial mutation test (plate incorporation test), and a confirmatory
mutation test (pre-incubation test).
Based on the results of the solubility
test and the concentration range finding test, the test item was
suspended/dissolved in dimethyl sulfoxide (DMSO) and the following
concentrations were prepared and investigated in the initial and
confirmatory mutation tests in the absence and presence of exogenous
±S9: 1600; 500; 160; 50; 16; 5 and 1.6
The test item limited solubility and
non-toxicity were taken into consideration and the maximum test
concentration was in all strains 1600 µg/plate.
In the initial and confirmatory mutation
test precipitate was noticed on the plates in all examined strains at
the concentrations of 1600 and 500 µg/plate in the absence ( S9) and at
1600 µg/plate in the presence of exogenous metabolic activation (+S9),
after about 48 hours incubation. The obtained precipitate did not
interfere with the scoring of the colonies and background lawn
development in any case.
In the performed experiments, inhibitory
effect of the test item on bacterial growth was not observed. All of the
noticed lower revertant colony numbers (when compared to the revertant
colony numbers of the corresponding solvent control) remained in the
range of the biological variability of the applied test system and the
background lawn development was not affected in any case.
The revertant colony numbers of solvent
control (dimethyl sulfoxide) plates with and without S9 mix demonstrated
the characteristic mean number of spontaneous revertants that was in
line with the corresponding historical control data ranges.
The reference mutagen treatments (positive
controls) showed the expected, biological relevant increases (more than
3-fold increase) in induced revertant colonies and the number of
revertants fell in the corresponding historical control ranges, thereby
meeting the criteria for the positive control in all experimental
phases, in all tester strains.
No biologically relevant increases were
observed in revertant colony numbers of any of the five test strains
following treatment with test item at any concentration level, either in
the presence or absence of metabolic activation (S9 mix) in the
Under the experimental conditions applied,
the test item did not induce gene mutations in the genome of the strains
of Salmonella typhimurium TA98, TA100, TA1535 and TA1537 and of
Escherichia coli WP2 uvrA.
In conclusion, the test item has no
mutagenic activity on the applied bacterium tester strains under the
test conditions used in this study.
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