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EC number: 614-345-5
CAS number: 68155-40-8
Attached "Tables 1 to 10"
to the nature and quantity of tables it was not possible to insert them
in this section.
The study was conducted according to a
method that was designed to assess the potential mutagenicity of the
test material on the thymidine kinase, TK +/-, locus of the L5178Y mouse
lymphoma cell line. The method used meets the requirements of the OECD
(476), Method B17 of Commission Regulation (EC) No. 440/2008 of30 May
Two independent experiments were
performed. In Experiment 1, L5178Y TK +/- 3.7.2c mouse lymphoma cells
(heterozygous at the thymidine kinase locus) were treated with the test
material at eight dose levels, in duplicate, together with vehicle
(solvent) and positive controls using 4-hour exposure groups both in the
absence and presence of metabolic activation (2% S9). In Experiment 2,
the cells were treated with the test material at eight dose levels using
a 4‑hour exposure group in the presence of metabolic activation (1% S9)
and a 24‑hour exposure group in the absence of metabolic activation.
The dose range of test material was
selected following the results of a preliminary toxicity test. The dose
range for Experiment 1 was 0.31 to 10 µg/ml in the absence of metabolic
activation and 1.25 to 20 µg/ml in the presence of metabolic
activation. The dose range for Experiment 2 was 0.16 to 5 µg/ml in the
absence of metabolic activation, and 1.25 to 20 µg/ml in the presence of
The maximum dose level used was
limited by test material induced toxicity. Precipitate of test material
was not observed at any of the dose levels. The vehicle (solvent)
controls had acceptable mutant frequency values that were within the
normal range for the L5178Y cell line at the TK +/- locus. The positive
control materials induced marked increases in the mutant frequency
indicating the satisfactory performance of the test and of the activity
of the metabolising system.
The test material did not induce any
toxicologically significant dose-related increases in the mutant
frequency at any dose level, either with or without metabolic
activation, in either the first or the second experiment.
The test material was considered to be
non-mutagenic to L5178Y cells under the conditions of the test.
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