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EC number: 230-603-6
CAS number: 7216-56-0
a reverse gene mutation assay in bacteria, performed according to
Guideline OECD 471 and in compliance with GLP, Salmonella typhimurium strains
TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA
were exposed to the test item diluted in acetone at the
1 – Plate Incorporation Method
typhimurium strains TA 98, TA
100, TA 1535, TA 1537.
coli WP2uvrA (with and without S9 mix): 1.5, 5,
15, 50, 150, 500, 1500 and 5000 μg/plate.
2 – Pre-Incubation Method
typhimurium strains TA 98, TA
100, TA 1535, TA 1537 (with and without S9 mix): 0.15, 0.5, 1.5, 5, 15,
50, 150, 500 and 1500 μg/plate.
WP2uvrA (with and without S9 mix): 0.5, 1.5, 5, 15, 50, 150, 500, 1500
and 5000 μg/plate.
activation system used in this test S9 mix (10% v/v S9 fraction): S9
microsomal fraction was pre-prepared from male rats induced with
phenobarbital/β-naphthaflavone. Negative control, vehicle and
positive control groups were also included in mutagenicity tests.
the first mutation test (plate incorporation method) the test item
induced a visible reduction in the growth of the bacterial background
lawns of all of the Salmonella strains in both the absence and
presence of S9-mix from 500 μg/plate. No toxicity was noted to E.
coli strain WP2uvrA. Consequently, the same maximum dose
level (5000 μg/plate) or the toxic limit was employed in the second
mutation test depending on bacterial strain type. The test item induced
a stronger toxic response in the second mutation test, after
implementation of the pre-incubation method, with weakened bacterial
background lawns noted in the absence of S9-mix from 15 μg/plate (all Salmonella
strains) and 150 μg/plate (WP2uvrA). In the presence of
S9-mix, weakened bacterial background lawns were noted to all of the Salmonella
strains, initially from 150 μg/plate (TA1535 and TA100) and 1500
μg/plate (TA98 and TA1537). No toxic response was noted for E.
coli strain WP2uvrA dosed in the presence of S9-mix. 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. A test item precipitate (globular
in appearance) was observed under a low power microscope at 5000
μg/plate after the first mutation test (plate incorporation method).
However, there was no evidence of a precipitate in the second mutation
test after employing the pre-incubation modification.
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
(S9-mix) in Experiment 1 (plate incorporation method). Similarly, no
toxicologically 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 (S9-mix)
in Experiment 2 (pre-incubation method). Statistically significant
increases in revertant colony frequency were observed in both the first
and second mutation tests to TA1535, however these increases were
considered to have no biological relevance because weakened bacterial
background lawns were also noted. Therefore the responses are considered
false and due to additional histidine being available to His- bacteria
allowing these cells to undergo several additional cell divisions and
presenting as non-revertant colonies.
vehicle control plates (acetone) 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 test item is not considered as mutagenic in these bacterial systems.
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