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EC number: 203-004-2
CAS number: 102-08-9
The objective of this study was to
evaluate the potential of the test item to induce reverse mutation in Salmonella
The study was performed according to
the international guidelines (OECD No. 471 and Council Regulation (EC)
No. 440/2008 of 30 May 2008, Part B13/14 p. 248) and in compliance with
the principles of Good Laboratory Practice.
The first experiment (with and without
S9 mix) and the second experiment without S9 mix were performed
according to the direct plate incorporation method, contrary to the
second, third and fourth experiments with S9 mix, which were performed
according to the pre-incubation method (60 minutes, 37°C).
Five strains of bacteria Salmonella
typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 102 were used.
Each strain was exposed to six dose-levels of the test item (three
plates/dose-level). After 48 to 72 hours of incubation at 37°C, the
revertant colonies were scored.
The evaluation of the toxicity was
performed on the basis of the observation of the decrease in the number
of revertant colonies and/or a thinning of the bacterial lawn.
The test item was dissolved in
The number of revertants for the
vehicle and positive controls met the acceptance criteria. The study was
therefore considered to be valid.
Since the test item was found poorly
soluble in the preliminary test, the choice of the highest dose-level
was based on the level of precipitate, according to the criteria
specified in the international guidelines.
Experiments without S9 mix
The selected treatment-levels were
78.13, 156.3, 312.5, 625, 1250 and 2500 µg/plate for the first and
A moderate to strong precipitate was
observed in the Petri plates when scoring the revertants at dose-levels
>= 1250 µg/plate.
In the first experiment, a moderate
toxicity (thinning of the bacterial lawn) was noted at dose-levels of
1250 µg/plate in the strains TA 1535 and TA 1537, and at 2500 µg/plate
in the TA 100 strain.
In the second experiment, a moderate
toxicity (thinning of the bacterial lawn) was noted at 2500 µg/plate in
the TA 98 strain.
No noteworthy toxicity was noted
towards the strain TA 102 in either experiment.
The test item did not induce any
noteworthy increase in the number of revertants, in any of the five
Experiments with S9 mix
In the first experiment performed
using the direct plate incorporation method, a moderate to strong
precipitate was observed in the Petri plates when scoring the revertants
at dose-levels >= 1250 µg/plate.
Using the pre-incubation method, a
moderate to strong precipitate was observed in the Petri plates when
scoring the revertants at dose-levels >=1250 µg/plate, except for the
strains TA 100 and TA 1537 in the second experiment where a moderate
precipitate was observed at 1250 µg/plate only. In the
fourth experiment, a strong toxicity (decrease in the number of
revertants) was noted at 2500 µg/plate towards the strain TA 1537.
No noteworthy toxicity was noted
towards the other strains used.
Noteworthy increases in the number of
revertants were noted at 2500 µg/plate in the strains TA 1535, TA 1537
and TA 100 in the second experiment performed with S9 mix. These
increases exceeded the threshold of 2-fold the vehicle control (2.6-fold
the vehicle control for the strain TA 100) and of 3-fold the vehicle
control (up to 30.3-fold the vehicle control for the strains TA 1535 and
TA 1537). Two additional experiments were performed using the same
experimental conditions (pre-incubation method) and a closer range of
dose-levels to check the reproducibility and therefore the reliability
of these increases. In these experiments, no increases in the number of
revertants were noted at any of the dose-levels tested. Thus, the
increases noted in the second experiment were not reproducible in two
additional independent experiments. Consequently, they were not
considered as biologically relevant.
The test item did not show any
mutagenic activity in the bacterial reverse mutation test with Salmonella
typhimurium, in the presence or in the absence of a rat metabolizing
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