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EC number: 835-273-2
CAS number: 852056-62-3
The mutagenic potential of the test item was examined in a GLP study
according to OECD GL 471 using Salmonella typhimurium tester strains TA
98, TA 100, TA 102, TA 1535 and TA 1537. The plate incorporation test
with and without addition of liver S9 mix from Aroclor 1254-pretreated
rats was used. Two independent experimental series were performed. In
the two series with S9 mix, 10 % S9 in the S9 mix was used. The test
item was dissolved in anhydrous analytical grade dimethyl sulphoxide
(DMSO) and tested at concentrations ranging from 5 - 5000 μg/plate.
In Experiment 1 treatments of all the tester strains were performed in
the absence and presence of S-9, using final concentrations at 5, 16,
50, 160, 500, 1600 and 5000 μg/plate, plus vehicle and positive
controls. Following these treatments, evidence of toxicity was observed
at 5000 μg/plate in strain TA1537 in the absence of S-9 and strain TA98
in the presence of S-9.
Experiment 2 treatments of all the tester strains were performed in the
absence and presence of S-9. The maximum test concentration of 5000
μg/plate was retained for all strains. Narrowed concentration intervals
were employed covering the range 20.48 to 5000 μg/plate, in order to
examine more closely those concentrations of the test material
approaching the maximum test concentration and considered therefore most
likely to provide evidence of any mutagenic activity. In addition, all
treatments in the presence of S-9 were further modified by the inclusion
of a pre-incubation step. In this way, it was hoped to increase the
range of mutagenic chemicals that could be detected using this assay
system. Following these treatments, no evidence of toxicity was observed.
Precipitation was observed on the test plates at concentrations of 800
μg/plate and above.
Vehicle and positive control treatments were included for all strains in
both experiments. The mean numbers of revertant colonies all fell within
acceptable ranges for vehicle control treatments, and were elevated by
positive control treatments.
Following test material treatments of all the test strains in the
absence and presence of S-9, no increases in revertant numbers were
observed that were ≥1.5 -fold (in strain TA102), ≥2 -fold (in strains
TA98 or TA100) or ≥3-fold (in strains TA1535 or TA1537) the concurrent
vehicle control. This study was considered therefore to have provided no
evidence of any test material mutagenic activity in this assay system.
With and without addition of S9 mix as the extemal metabolizing system,
the test item was not mutagenic under the experimental conditions
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