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EC number: 700-748-4
CAS number: 1226911-69-8
The test item formulation and S9-mix used in
this experiment were both shown to be sterile.
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.
Tables: cf Attached background material.
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, ST 01 C 11, using both the Ames
plate incorporation and pre-incubation methods at seven dose levels, in
triplicate, both with and without the addition of a rat liver homogenate
metabolising system (10% liver S9 in standard co-factors). The dose
range for the range-finding test was determined in a preliminary
toxicity assay and ranged between 0.15 and 500 μg/plate, depending on
bacterial strain type and presence or absence of S9-mix. The experiment
was repeated on a separate day (pre-incubation method) using the same
dose range, fresh cultures of the bacterial strains and test item
formulations. Additional dose levels and an expanded dose range were
selected in each experiment 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.
item caused a visible reduction in the growth of the bacterial
background lawns of all of the tester strains, initially from 150
μg/plate after employing plate incorporation methodology (range-finding
test) and from 15 μg/plate following the pre-incubation method (main
test). 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. The test item was tested up
to the toxic limit. A test item precipitate (light and oily in
appearance) was observed at 5000 μg/plate. The test item was tested up
to the toxic limit in the range-finding and main tests, therefore, this
observation was only noted in the preliminary toxicity test.
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 or exposure method.
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-.
study is considered as acceptable and satisfies the requirement for
reverse gene mutation endpoint.
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