
The test article Fruit-Metalloenzymes DetTM AQ-53 was assessed for its potential to induce gene mutations asccording to the plate incorporations test ( experiment I ) and the pre-incubation test ( experiment II ) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in trilicate. The test article was tested at the following concentrations :
33.3; 100.0; 333.3; 1000.0; 2500.0; and 5000.0 ug/plate
No toxic effects occurred in the test groups with and without metabolic activation in experiment I and II in all strains used.
The plates incubated with the test article showed normal background growth up to 5000.0ug/plate with and without S9 mix in all strains used.
No substantial increase in revertant colony numbers of any of the five tester strains were observed following treatment with Fruit- Metalloenzymes DetTM AQ-53 at any dose level, either in the presence or 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 significance.
A slightly decrease ( 0.0001% ) in revertant colony numbers was observed in strain TA 102 at 333.3 and 1000.0 ug/plate in experiment I in the presence of metabolic activation. However, this effect is considered not to be relevant since it could not be reproduced in the normally more sensitive pre-incubation assays.
Appropriate, 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.
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