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EC number: 211-989-5
CAS number: 732-26-3
Table 1: Summary of Experiment 1
± S9 Mix
Mean number of colonies/plate
Base-pair Substitution Type
Mean no. colonies/plate
= sodium azide
= 4-nitroquinoline N-oxide
Table 2: Summary of Experiment 2
± S9 Mix
= sodium azide
= Congo red
The mutagenic activity of the test material was evaluated in a bacterial
reverse mutation assay conducted in accordance with the standardised
guidelines OECD 471 and EU Method B.13/14 under GLP conditions.
The test material dissolved in dimethyl sulfoxide was tested with four
histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537,
TA98 and TA100) and with a tryptophan-requiring strain of Escherichia
coli (WP2uvrA). The test was performed in two independent experiments in
the presence and absence of metabolic activation (rat liver S9-mix
induced by Aroclor 1254). Experiment 1 was performed using the plate
incorporation method and Experiment 2 was performed using the
A dose range finding study was performed as part of Experiment 1; the
test material was initially tested up to concentrations of 5000 μg/plate
in the strains TA100 and WP2uvrA in the direct plate assay. The test
material precipitated on the plates at dose levels of 1600 μg/plate and
upwards. The bacterial background lawn was not reduced at any of the
concentrations tested and no biologically relevant decrease in the
number of revertants was observed.
In the rest of the first mutation experiment, the test material was
tested up to concentrations of 1600 μg/plate in the strains TA1535,
TA1537 and TA98. The test material precipitated on the plates at the top
dose of 1600 μg/plate. The bacterial background lawn was not reduced at
any of the concentrations tested and no biologically relevant decrease
in the number of revertants was observed.
In the second mutation experiment, the test material was tested up to
concentrations of 1600 μg/plate in all tester strains in the
pre-incubation assay. The test material precipitated on the plates at
the top dose of 1600 μg/plate. Cytotoxicity, as evidenced by a decrease
in the number of revertants, was only observed in tester strain TA1537
in the absence of S9-mix at the highest tested concentration.
The test material did not induce a significant dose-related increase in
the number of revertant (His+) colonies in each of the four tester
strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant
(Trp+) colonies in tester strain WP2uvrA both in the absence and
presence of S9-metabolic activation. These results were confirmed in an
independently repeated experiment.
Acceptable responses were obtained for the negative and positive
control materials, indicating that the test conditions were adequate and
that the metabolic activation system functioned properly.
Under the conditions of this study, the test material was determined to
be non-mutagenic in both the presence and absence of metabolic
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