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EC number: 264-140-6
CAS number: 63429-28-7
See the attached document for information on
tables of results
In a reverse gene mutation assay performed
according to the OECD test guideline No. 471 and in compliance with GLP,
Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and
Escherichia coli strain WP2 uvrA- were exposed to test material diluted
in dimethyl sulphoxide both in the presence and absence of metabolic
activation system (10% liver S9 in standard co-factors). The dose range
for the range-finding test (Experiment 1) was predetermined and was 1.6
to 5350 µg/plate. The experiment was repeated on a separate day
(pre-incubation method) using fresh cultures of the bacterial strains
and fresh test item formulations. The dose range was amended following
the results of the range-finding test and an abandoned second experiment
and was 0.5 to 5330 µg/plate. Negative, vehicle (dimethyl sulphoxide)
and positive control groups were also included in mutagenicity tests.
The vehicle control plates gave counts of
revertant colonies within the normal range. All of the positive control
chemicals used in the test induced marked increases in the frequency of
revertant colonies, both with or without metabolic activation. Thus, the
sensitivity of the assay and the efficacy of the S9-mix were validated.
The maximum dose level of the test item in
the first experiment was 5350 μg/plate. There was no visible reduction
in the growth of the bacterial background lawn at any dose level, either
in the presence or absence of metabolic activation, in the first
mutation test (plate incorporation method) and consequently a similar
maximum dose level was used in the second mutation test.
However, in the second mutation test
(pre-incubation method) the test item induced a visible reduction in the
growth of the bacterial background lawns of TA100, TA1535 and TA1537 in
both the absence and presence of S9-mix, initially from 1599 μg/plate.
No toxicity was noted to Escherichia coli strain WP2uvrA and Salmonella
strain TA98. The sensitivity of the bacterial tester strains to the
toxicity of the test item varied slightly between strain type, exposures
with or without S9-mix and experimental methodology. No test item
precipitate was observed on the plates at any of the doses tested in
either the presence or absence of S9-mix.
There were no toxicologically significant
increases in the frequency of revertant colonies recorded for any of the
bacterial strains, with any dose of the test item, either with or
without metabolic activation in Experiment 1 (plate incorporation
method). Similarly, no significant increases in the frequency of
revertant colonies were recorded for any of the bacterial strains, with
any dose of the test item, either with or without metabolic activation
in Experiment 2 (pre-incubation method). A small, statistically
significant increase in TA98 revertant colony frequency was observed in
the absence of S9-mix at 5350 μg/plate in Experiment 1. This increase
was considered to be of no biological relevance because there was no
evidence of a dose-response relationship or reproducibility.
Furthermore, the individual revertant colony counts at 5350 μg/plate
were within the in-house historical untreated/vehicle control range for
the tester strain and the fold increase was only 1.4 times the
concurrent vehicle control.
Under the test condition, test material is
not mutagenic with and without metabolic activation in S. typhimurium
(strains TA1535, TA1537, TA98 and TA100) and E.coli WP2 uvrA- according
to the criteria of the Annex VI of the of the Regulation (EC) No.
This study is considered as acceptable and
satisfies the requirement for reverse gene mutation endpoint.
7.6/1: Summary of genotoxicity tests
Test / Guideline
K, rel. 1
TA 1535, TA 1537, TA 98,
E. coli WP2
Up to limit concentration
-S9 : non mutagenic
+S9 : non mutagenic
mutation Assay (Test n° 1):
Reverse mutation Assay (Ames test) was performed according to OECD
guideline No. 471 with the substance (See Table 7.6/1). No significant
increases in the frequency of revertant colonies were recorded for any
of the bacterial strains under the test condition, with any dose of the
substance, either in the presence or absence of metabolic activation.
The substance does not induce gene mutations in bacteria whereas all
positive control chemicals (with and without metabolic activation)
induced significant increase of colonies. The substance is therefore
considered as non-mutagenic according to the Ames test.
material has no harmonized classification for human health according to
the Regulation (EC) No. 1272/2008 including ATP6.
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