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EC number: 935-411-2
CAS number: -
The objective of this study was to
evaluate the potential of the test item to induce reverse mutations in Salmonella
The study was performed according to
the international guidelines (OECD No. 471 and Commission Directive No.
B.13/14) and in compliance with the principles of Good Laboratory
A preliminary toxicity test was
performed to define the dose levels of the test item, diluted in
dimethylsulfoxide (DMSO), to be used for the mutagenicity experiments.
The test item was then tested in two independent experiments, both with
and without a metabolic activation system, the S9 mix, prepared from a
liver post-mitochondrial fraction (S9 fraction) of rats induced with
Treatments were performed according to
the direct plate incorporation method except for the second experiment
with S9 mix, which was performed according to the pre-incubation method
(60 minutes, 37°C).
Five strains of bacteria Salmonella
typhimurium were used: TA 1535, TA 1537, TA 98, TA 100 and TA 102.
Each strain was exposed to at least 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.
Thetreatment of the TA 1537 strain in
the second experiment with and without S9 mix was performed at the test
Since the test item was found poorly
soluble in the final treatment medium in the preliminary test and toxic
only at dose levels close to the highest recommended one (i.e. 5000 µg/plate),
the selection of the highest dose level to be used in the main
experiments was based on the level of emulsion or was 5000 µg/plate,
according to the criteria specified in the international guidelines.
The mean number of revertants for the
vehicle and positive controls met the acceptance criteria. Also, there
were six analysable dose levels for each strain and test condition. The
study was therefore considered to be valid.
The selected dose levels were:
20.6, 61.7, 185.2, 555.6 and 1666.7 µg/plate for the five strains in
both mutagenicity experiments without S9 mix, except for the TA 1537
strain in the second experiment,
61.7, 185.2, 555.6, 1666.7 and 5000 µg/plate for the five strains in
both mutagenicity experiments with S9 mix, except for the TA 1537 strain
in the second experiment,
20.6, 61.7, 185.2, 555.6, 1666.7 and 5000 µg/plate for the TA 1537
strain in the second experiment with and without S9 mix.
A moderate to strong emulsion and/or
precipitate was observed in the Petri plates when scoring the revertants
at dose levels =555.6
µg/plate in both experiments with and without S9 mix.
No noteworthy toxicity was noted at
any dose levels, in any strains or test conditions.
The test item did not induce any
noteworthy increase in the number of revertants, in any of the five
strains, in either experiment with or without S9 mix. These results met
thus the criteria of a negative response.
Under the experimental conditions of
this study, the test item did not show any mutagenic activity in the
bacterial reverse mutation test with Salmonella typhimurium strains,
either in the presence or absence of a rat liver metabolizing system.
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