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EC number: 807-754-7
CAS number: 89929-57-7
Prior to use, the master strains were
checked for characteristics, viability and spontaneous reversion rate
(all were found to be satisfactory). The amino acid supplemented top
agar and the S9-mix used in both experiments was shown to be sterile.
The test item formulation was also shown to
a reverse gene mutation assay performed according to the OECD test
guideline No. 471 and in compliance with GLP, Salmonella
TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA
were treated with the test item using the Ames pre-incubation method
(under anaerobic conditions) at up to eight dose levels, in triplicate,
both with and without the addition of a rat liver homogenate
metabolizing system (10% liver S9 in standard co-factors). The dose
range for the range-finding test (Experiment 1) was predetermined and
was 1.5 to 5000 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 ranged between 0.15 and 500 μg/plate, depending
on bacterial strain type and presence or absence of S9-mix. Seven test
item dose levels were selected in Experiment 2 in order to achieve both
four non-toxic dose levels and the toxic limit of the test item. Negative,
vehicle (dimethyl sulphoxide) and positive control groups were also
included in mutagenicity tests.
vehicle (dimethyl sulphoxide) 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.
maximum dose level of the test item in the first experiment was selected
as the maximum recommended dose level of 5000 μg/plate. The test item
induced a visible reduction in the growth of the bacterial background
lawns of all of the tester strains in the absence of S9-mix, initially
from 150 μg/plate (TA100, TA1535 and TA1537) and 500 μg/plate (TA98 and
WP2uvrA). In the presence of S9-mix, weakened lawns were noted to
all of the tester strains from 500 μg/plate. Consequently, the toxic
limit of the test item was employed in the second mutation test. Main
test results once again showed a visible reduction in the growth of the
bacterial background lawns of all of the tester strains in the absence
of S9-mix, initially from 150 μg/plate (TA100, TA1535, TA98 and TA1537)
and 500 μg/plate (WP2uvrA). In the presence of S9-mix,
weakened lawns were noted to all of the tester strains from 500
μg/plate. No test item precipitate was observed on the plates at any of
the doses tested in either the presence or absence of S9-mix.
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
both experiments. Small, statistically significant increases in TA100
revertant colony frequency were observed (presence of S9-mix) at 15 and
50 μg/plate in the main test. These increases were 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 15 and 50 μg/plate were within the in-house historical
untreated/vehicle control range for the tester strain and the fold
increase was only 1.2 times the concurrent vehicle control.
the test condition, test item 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 Regulation (EC) No. 1272/2008 (CLP) and to the
study is considered as acceptable and satisfies the requirement for
reverse gene mutation endpoint.
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