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EC number: 252-044-7
CAS number: 34455-00-0
The mutagenic potential of the test article was evaluated in the
Bacterial Reverse Mutation Assay with S. typhimurium strains TA98,
TA100, TA1535, and TA1537 and E. coli strain WP2 uvrA in the presence
and absence of a metabolic activation system (S9-mix rat liver induced
by Phenobarbital and B-napthoflavone). The study was performed in
compliance with OECD GLP (1997). The test method was based on OECD No.
471 (1997) and EC No. 440/2008 Part B (2008). The test article was
dissolved in dimethyl sulfoxide. A dose range-finding test was performed
with concentration up to 5000 ug/plate in the absence and presence of
metabolic activation in strains TA100 and WP2uvrA. Based on the results
of the dose range finding test, the test article was dosed at
concentrations of 100, 333, 1000, 3330, and 5000 ug/plate in the TA1535,
TA1537 and TA98 strains in the presence and absence of 5% S9 mix. A
second assay was performed in all strains with the same doses in the
presence and absence of 10% S9 mix. Strain specific positive controls
and negative (vehicle) controls were tested in parallel. All treatments
were performed in triplicate. Top agar was melted and the following
solutions were added to 3 mL molten top agar: 0.1 mL of a fresh
bacterial culture (10^9 cells/mL) of one of the tester strains, 0.1 mL
of a dilution of the test material in DMSO and either 0.5 mL S9-mix (in
case of activated assays) or 0.5 mL of 0.1 M phosphate buffer (in case
of non-activated assays). The ingredients were mixed on a Vortex and the
content of the top agar tube was poured onto a selective agar
plate. After solidification, plates were inverted and incubated in the
dark at 37 ± 1.0°C for 48 ± 4 hours. After this period, revertant
colonies (His+) for S. typhimurium and (Trp+) for E. coli were counted.
In tester strain TA100 a slight reduction of the bacterial background
lawn was observed at the highest concentration tested and slight to
extreme reductions in the number of revertant colonies were observed at
the concentrations of 3330 and 5000 μg/plate in the absence and presence
of S9-mix indicating cytotoxicity. The test article did not induce a
significant dose-related increase in the number of revertant (His+)
colonies in each of the four tester strains (TA1535, TA1537, TA98 and
TA100) and in the number of revertant (Trp+) colonies in tester strain
WP2uvrA both in the absence and presence of S9-metabolic activation.
These results were confirmed in an independently repeated experiment.
All criteria for a valid test were met as described in the protocol.
Based on the results of this study it is concluded that the test article
is not mutagenic in the Salmonella typhimurium reverse mutation assay
and in the Escherichia coli reverse mutation assay with and without
metabolic activation (S9-mix).
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