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EC number: 700-158-7
CAS number: 1092834-40-6
Table 1: Ames Test Results of the plate
incorporation Experiment I (= Pre-Experiment):
With or without S9-Mix
Test substance concentration
Mean number of revertant colonies per plate
(average of 3 plates)
Number of colonies/plate
Table 2: Ames Test Results of the
preincubation Experiment II:
NaN3 = Sodium azide
MMS = Methyl methane sulfonate
4-NOPD = 4-nitro-o-phenylene-diamine
2-AA = 2-aminoanthracene
P = Precipitate
This study was performed to investigate the
potential of SH-1 to induce gene mutations in the plate incorporation
test (experiment I) and the pre-incubation test (experiment II) using
the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100,
Escherichia coli strain WP2 uvrA.
The assay was performed in two independent
experiments both with and without liver microsomal activation. Each
concentration, including the controls, was tested in triplicate.
The test item was tested at the following
Pre-Experiment/Experiment I: 3; 10; 33; 100;
333; 1000; 2500; and 5000 µg/plate
Experiment II: 33; 100; 333; 1000; 2500; and
The plates incubated with the test item
showed normal background growth up to 5000 µg/plate with and without
metabolic activation in both independent experiments.
No toxic effects, evident as a reduction in
the number of revertants (below the indication factor of 0.5), occurred
in the test groups with and without metabolic activation.
No substantial increase in revertant colony
numbers of any of the five tester strains was observed following
treatment with SH-1 at any dose level, neither in the presence nor
absence of metabolic activation (S9 mix). There was also no tendency of
higher mutation rates with increasing concentrations in the range below
the generally acknowledged border of biological relevance. 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 item did not induce gene mutations by base pair
changes or frameshifts in the genome of the strains used. Therefore,
SH-1 is considered to be non-mutagenic in this Salmonella typhimurium
and Escherichia coli reverse mutation assay.
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