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EC number: 309-066-8
CAS number: 99811-75-3
Table 7.6.1/2. Mutagenic and cytotoxic effect of the test material.
Test concentration range
Lowest mutagenic concentration (µg/plate)
1.5 - 5000
See the attached document for more information on tables of results.
reverse gene mutation assay performed according to the OECD test
guideline No. 471 and in compliance with GLP, Salmonella typhimurium
strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain
WP2uvrA were treated with the test item diluted in DMSO both in the
presence and absence of metabolic activation system (10% liver S9 in
standard co-factors) using the plate incorporation method in two
independent experiments. The dose range for Experiment 1 was 1.5 to
5000 mg/plate in all the tester strains, with and without S9-mix. The
dose range for Experiment 2 was 50 to 5000 µg/plate in all the tester
strains, with and without S9-mix, based on the results of expriment 1.
(dimethyl sulphoxide) and positive control groups were also included in
item was cytotoxic in Salmonella strains TA1535 and TA1537 at 5000
μg/plate and from 1500 μg/plate in Experiments 1 and 2, respectively, in
both the presence and absence of metabolic activation (S9-mix). No
toxicity was noted to Salmonella strains TA100 and TA98 and Escherichia
coli strain WP2uvrA. No test item precipitate was observed on the plates
at any of the doses tested in either the presence or absence of S9-mix.
experiments 1 and 2, small but toxicologically significant increases in
the revertant colony frequency of TA100, TA1535 (absence and presence of
S9-mix) and WP2uvrA (absence of S9-mix only) at the upper test item dose
Experiment 2, a clear dose-related response in WP2uvrA frequency between
1000 and 5000 μg/plate in the absence of S9-mix was noted. The increases
over the concurrent vehicle control for this strain were 2.5 times at
1500 μg/plate, 4.1 times at 3000 μg/plate and 4.7 times at 5000 μg/plate
(mean numbers). Furthermore, the individual revertant colony counts at
3000 and 5000 μg/plate exceeded the in-house historical control range
for the bacterial tester strain. Any excursions outside the maxima
ranges, particularly when reproducibility is apparent (5000 μg/plate in
Experiments 1 and 2), must be considered to be evidence of a biological
response. There was no evidence of a response with WP2uvrA dosed in the
presence of S9-mix, this lack of activity may be due to partial
inhibition following metabolic activation.
responses were also noted to TA100 (1.5 times at 5000 μg/plate in the
absence of S9-mix
and 1.4 times at 5000 μg/plate in the presence of S9-mix) ) and TA1535
(1.6 times at 1000
μg/plate and 3.0 times at 1500 μg/plate in the absence of S9-mix. 1.8
times at 500 and 1500
μg/plate, 2.0 at 1000 μg/plate - in the presence of S9-mix), although
there was a slight shift in toxicity to TA1535 in the second mutation
test with weakened lawns initially noted at 1500 μg/plate compared to
5000 μg/plate in the first mutation test.
increase in TA98 revertant colony frequency was also noted at and above
3000 μg/plate (absence of S9-mix) in the second mutation test, however
this increase was non-reproducible over the two experiments.
(dimethyl sulphoxide) control plates gave counts of revertant colonies
the normal range. A small number of vehicle control revertant colony
counts for TA100 and TA1535 (dosed in the absence or presence of S9-mix
after the first mutation test) and TA1537 (dosed in the presence of
S9-mix in the second mutation test) were either just below or above the
historical control ranges. These counts were still considered acceptable
as the other vehicle and untreated control counts were within expected
range and each tester strain responded very well with the respective
positive controls in both the presence and absence of S9-mix. All of the
positive control chemicals used in the test induced marked increases in
the frequency of revertant colonies thus confirming the activity of the
S9-mix and the sensitivity of the bacterial strains.
test conditions, test material is mutagenic with and without metabolic
activation in S. typhimurium (strains TA 1535, TA 1537, TA 98 and TA
100) and E. coli WP2 uvr A according to the Annex VI of the Regulation
(EC) No. 1272/2008 (CLP).
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