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EC number: 408-200-3
CAS number: 63187-91-7
The study investigates the potential of the test substance to
induce gene mutations according to the plate incorporation test using
Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA
100. The study was performed according to GLP and OECD and EU
guidelines. The assay was performed in two independent experiments,
using identical procedures, both with and without liver microsomal
activation. Each concentration, including the controls, was tested in
triplicate. The test article was tested at the following concentrations:
1.0, 10.0, 33.3, 100.0, 333.3, 1000.0 and 5000.0 µg/plate.
Distinct toxic effects, evidenced by a partial or complete
reduction in the number of revertants, occurred at higher dose levels in
experiment I and II with and without metabolic activation in nearly all
strains used. The plates incubated with the test article showed normal
background growth up to 5000.0 µg/plate with and without S9 mix in all
strains used, except in experiment II, where the background growth was
reduced in the strains TA 1537 and TA 1538 at 5000 µg/plate with and
without metabolic activation.
Up to the highest investigated dose, neither a significant and
reproducible increase of the number of revertants was found in any
strain as compared to the solvent control nor a concentration-dependent
enhancement of the revertant number exists. The presence of liver
microsomal activation did not influence these findings.
Appropriate reference mutagens were used as positive controls and
showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described
mutagenicity test and under the experimental conditions reported, the
test article did not induce point mutations by base pair changes or
frame shifts in the genome of the strains used. Therefore, the test
substance is considered to be non-mutagenic in this Salmonella
typhimurium reverse mutation assay.
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