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EC number: 407-240-9
CAS number: 159604-94-1
BLUE 10 25 964
Toxic effects, evidenced by a reduction in the number of revertants, occurred in nearly all strains with and without metabolic activation in both experiments .
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.
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 nurnber exists. The presence of liver microsomal activation did not influence these findings .
A slight increase in the revertant colonie numbers was observed in strain TA 1535 in experiment II with S9 mix at 100.0 µg/plate. This effect is considered being irrelevant as it could not be reproduced in the independent experiment. In strain TA 100 in experiment I in the presence of S9 mix a concentration-dependent enhancement was observed from 10.0 µg/plate to 1000.0 µg/plate.
At 5000.0 µg/plate the revertant number of revertant colonies decreased due to toxic effects of the test article. According to these results an additional concentration (2500.0 µg/plate) was tested in all strains in experiment Il. According to the results in experiment II the observed effects in strain TA 100 in experiment I are considered not to be relevant. They could not be reproduced.
Appropriate reference mutagens were used as positive controls and showed a distinct increase in 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 frameshifts in the genome of the strains used.
This study was performed to investigate the potential of the test item to induce gene mutations according to the plate incorporation test using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100.
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:
10.0; 100.0; 333.3; 1000.0; and 5000.0; µg/plate.
10.0; 100.0; 333.3; 1000.0; 2500.0; and 5000.0; µg/plate,
Toxic effects, evidenced by a reduction in the number of revertants, occurred in nearly all strains with and without metabolic activation in both experiments.
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.
Therefore, the test item is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
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