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EC number: 948-912-6
CAS number: -
Toxicity test / range finding test
Six concentrations ranging from 20.6 to
5000 µg/plate were tested with strain S. typhimurium TA 100 to determine
the highest concentration to be used in the mutagenicity assay. The
experiments were performed with and without microsomal activation. The
numbers of revertant colonies were not reduced. Normal back-ground
growth was observed at all concentrations. The test material exerted no
toxic effect on the growth of the bacteria . From the results obtained,
the highest concentration suitable for the mutagenicity test was
selected to be 5000 µg/plate without and with activation.
Mutagenicity test, original experiment
In the experiment performed without and
with metabolic activation, treatment with test substance did not lead to
an increase in the incidence of histidine-prototrophic mutants in
comparison with the negative control.
Mutagenicity test, confirmatory
In the experiment carried out without
metabolic activation, again none of the tested concentrations led to an
increase in the incidence of histidineprototrophic mutants by comparison
with the negative control.
In the experiment performed with
activation on strain TA 102, a marginal increase in the number of
back-mutants was observed at the concentrations of 1666.7 and 5000
µg/ml. Since no such effects were registered in the original experiment
conducted on this strain, the latter finding is not attributed to a
mutagenic action of the test material. The marginal increase in the
number of revertant counts probably may be due to spontaneously
occurring back-mutants. Again, no effect was seen with the other
In the mutagenicity tests without and with
metabolic activation, normal back-ground growth was observed. The
numbers of revertant colonies was not reduced. The test material exerted
no toxic effect on the growth of the bacteria. The various mutagens,
promutagens, sterility checks, sensitivity and resistance tests, etc.,
employed to ensure the test system was acceptable, all produced results
within our established limits.
The test was conducted to detect gene
mutations induced by test substance or its metabolites in
histidine-requiring strains of Salmonella typhimurium.
The concentration range of test substance
was determined in a preliminary toxicity test . Thus, it was tested for
mutagenic effects without and with metabolic activation at five
concentrations in the range of 61.7 to 5000 µg/plate. An independent
repetition of the experiments was performed with the same
In the toxicity/range finding test, no
toxic effect of the test material on the growth of the bacteria was
observed with or without metabolic activation.
In the original mutagenicity test, none of
the tested concentrations led to an increase in the incidence of
histidine-prototrophic mutants by comparison with the negative control
both with and without metabolic activation.
Similarly, in the confirmatory
mutagenicity test, no mutagenic effects were noted both without and with
In the mutagenicity tests without and with
metabolic activation, normal background growth was observed. The number
of revertant colonies was not reduced. The test substance exerted no
toxic effect on the growth of the bacteria.
Overall, test substance and its
metabolites did not exhibit a mutagenic potential under test conditions.
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