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EC number: 220-778-7
CAS number: 2896-70-0
Results for concurrent negative controls and experiments 1 and 2 with
and without metabolic activation are attached as Tables 1 - 5 below.
The genetic toxicity of 4-Oxo Tempo was examined in a bacterial reverse
mutation assay (Ames test) performed to GLP and in accordance with OECD
471 and EU method B.13/14. Salmonella Typhimurium strains TA1535, TA
1537, TA98 and TA100, along with Escherichia coli strain WP2uvrA, were
tested with and without S9 rat liver fraction metabolic activation.
A preliminary toxicity test proved the test substance to be non-toxic to
the TA100 and WP2uvrA strains tested. Two mutation
tests were performed, Experiment 1 used the plate incorporation method,
test substance concentrations of 50, 150, 500, 1500 and 5000µg/plate
were assessed. Experiment 2 was performed using the pre-incubation
method at concentrations of 1000, 1500, 2000, 3000, 4000 and 5000
μg/plate. Negative, positive and vehicle controls were also tested.
The results from Experiment 1, showed a small but statistically
significant increase in the revertant colony frequencies in the majority
of tester strains at the upper dose levels, with and without the S9 mix.
This was noted particularly in strains TA100, WP2uvrA and TA98.
The results for Experiment 2 were similar to Experiment 1, again
statistically significant increases in the revertant colony frequency
were noted for strains TA100 (presence and absence of S9 mix), WP2uvrA
and TA98 (absence of S9 mix only) at the majority of the dose levels.
At all statistically significant dose levels, a modest dose-response
relationship was observed. The responses, although small were
reproducible and in the case of TA100, noted in three separate
experiments, the preliminary toxicity test included.
The results for all control tests were considered acceptable.
The test material, 4-Oxo Tempo, was considered to be weakly mutagenic
under the conditions of the test.
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