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EC number: 949-790-7
CAS number: -
In the dose-range finding study, the test
item was initially tested up to concentrations of 5000 µg/plate in the
strains TA100 and WP2uvrA in the direct plate assay. Esacure 3644
precipitated on the plates at dose levels of 512 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. Results of this dose-range finding
test were reported as part of the first mutation assay.
In the first mutation experiment, the test
item was tested up to concentrations of 1600 µg/plate in the strains
TA1535, TA1537 and TA98. The test item precipitated on the plates at
the top dose level 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 item was tested up to concentrations of 1600 µg/plate in the
tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA in the
pre-incubation assay. The test item precipitated on the plates at the
top dose of 1600 μg/plate, except in tester strains TA1535 and TA98 in
the absence of S9-mix where precipitate was observed at dose levels of
512 and 164 µg/plate and upwards, respectively. Cytotoxicity, as
evidenced by a reduction of the bacterial background lawn was observed
in tester strains TA1535, TA1537, TA98 and TA100 in the absence of
S9-mix. No toxicity was observed in tester strains TA1535, TA1537, TA98
and TA100 in the presence of S9-mix and in tester strain WP2uvrA in the
absence and presence of S9-mix.
The negative and strain-specific positive
control values were within the laboratory historical control data ranges
indicating that the test conditions were adequate and that the metabolic
activation system functioned properly.
The test item 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 a follow-up experiment.
Based on the results of this study it is
concluded that Esacure 3644 is not mutagenic in the Salmonella
typhimurium reverse mutation assay and in the Escherichia coli reverse
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