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EC number: 940-783-4
CAS number: -
The test item was tested for potential
mutagenic activity using the Bacterial Reverse Mutation Assay.
The experiments were carried out using
histidine-requiring auxotroph strains of Salmonella typhimurium
(Salmonella typhimurium TA98, TA100, TA1535 and TA1537) and the
tryptophan-requiring auxotroph strain of Escherichia coli (Escherichia
coli WP2 uvrA) in the presence and absence of a post mitochondrial
supernatant (S9 fraction) prepared from the livers of
The study included a Preliminary
Compatibility Test, a Preliminary Range Finding Test (Informatory
Toxicity Test), an Initial Mutation Test (Plate Incorporation Method)
and a Confirmatory Mutation Test (Pre-Incubation Method).
Based on the available information, the test
item was formulated in DMSO. Concentrations of 5000; 2500; 1000; 316;
100; 31.6 and 10 μg/plate were examined in the Range Finding Test. Based
on the results of the Range Finding Test, the test item concentrations
in the Initial Mutation Test and Confirmatory Mutation Test were 5000;
1581; 500; 158.1; 50; 15.81 and 5 μg/plate.
In the Initial Mutation Test (using the
plate incorporation method) and Confirmatory Mutation Tests (using the
pre-incubation method), a clear repeatable positive effect of the test
item was obtained in Salmonella typhimurium TA1535 strain as a
dose-related increase in the number of revertants occurred and the
observed revertant colony numbers were above or near the respective
biological threshold value.
No insolubility was detected in the main
tests. Inhibitory, cytotoxicity of the test item was observed in the
Confirmatory Mutation Test in all strains at 5000 μg/plate concentration
without metabolic activation; and in Salmonella typhimurium TA98, TA100
and TA1537 strains at 5000 μg/plate concentration with metabolic
The mean values of revertant colonies of the
solvent control plates were within the historical control range, the
reference mutagens showed the expected increase in the number of
revertant colonies, the viability of the bacterial cells was checked by
a plating experiment in each test. At least five analyzable
concentrations were presented in all strains of the main tests. The
tests were considered to be valid.
The reported data of this mutagenicity assay
show (see Appendix 2 to 5) that under the experimental conditions
applied the test item induced gene mutations by base pair changes or
frameshifts in the genome of the strains used.
In conclusion, the test item had slight
mutagenic activity in Salmonella typhimurium TA1535 strain under the
test conditions of this study. No mutagenic activity was observed in the
other four examined bacterium strains under the test conditions of the
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