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EC number: 944-817-9
CAS number: 244626-73-1
In this in vitro assessment of the mutagenic
potential of the test item, histidine-dependent auxotrophic mutants of
Salmonella typhimurium, strains TA1535, TA1537, TA98 and TA100, and a
tryptophan-dependent mutant of Escherichia coli, strain WP2 uvrA
(pKM101), were exposed to the test material diluted in dimethyl
sulphoxide (DMSO). DMSO was also used as a vehicle control. The study
was conducted in compliance with OECD 471, EC B.13/14 and OPPTS 870.5100
test guidelines and with GLP.
Two independent mutation tests were
performed in the presence and absence of liver preparations (S9 mix)
from rats treated with phenobarbital and 5,6-benzoflavone. The first
test was a standard plate incorporation assay; the second included a
Concentrations of the test material up to,
and including, 5000 µg/plate were tested. This is the standard limit
concentration recommended in the regulatory guidelines that this assay
follows. Other concentrations used were a series ofcahalf-log10dilutions
of the highest concentration.
No signs of toxicity towards the tester
strains were observed in either mutation test following exposure to the
No evidence of mutagenic activity was seen
at any concentration of the test material in either mutation test.
The concurrent positive controls verified
the sensitivity of the assay and the metabolising activity of the liver
preparations. The mean revertant colony counts for the vehicle controls
were within or close to the current historical control range for the
It was concluded that the test material
showed no evidence of mutagenic activity in this bacterial system under
the test conditions employed.
This study is considered as acceptable and
satisfies the requirement for the bacterial gene mutation endpoint.
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