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EC number: 413-110-2
CAS number: 135861-56-2
Bacterial reverse mutation assay (Ames test):
Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and Escherichia
coli strain WP2uvrA- were treated with suspensions of the test
material using the Ames plate incorporation method at five dose levels,
in triplicate, both with and without the addition of a rat liver
homogenate metabolising system (10% liver S9 in standard co-factors).
The dose range was determined in a preliminary toxicity assay and was 50
to 5000 ug/plate in the first experiment. The experiment was repeated on
a separate day using the same dose range as experiment 1, fresh cultures
of the bacterial strains and fresh test material formulations.
The vehicle (dimethyl sulphoxide) control plates gave counts of
revertant colonies within the normal range.
All of the positive control chemicals used in the test induced marked
increases in the frequency of revertant colonies, both with and without
The test material caused no visible reduction in the growth of the
bacterial lawn at any dose level. The test material was, therefore,
tested up to the maximum recommended dose of 5000 ug/plate. A
precipitate was observed at and above 1500 ug/plate, this did not
prevent the scoring of revertant colonies.
No significant increases in the frequency of revertant colonies were
recorded for any of the bacterial strains, with any dose of the test
material, either with or without metabolic activation.
The test material was considered to be non-mutagenic under the
conditions of this test.
In vitro mammalian chromosome aberration tests:
Results from five chromosome aberration studies are available, both
conducted on the test material and on three closely related structural
Studies on test material: Results are available
from two chromosome aberration studies (one using human lymphocytes and
one using Chinese Hamster lung cells (CHL)).
In the studies using lymphocytes, the test item was considered to be
non-clastogenic to human lymphocytes in vitro.
In a test conducted to a Japanese method using CHL cells, which does not
conform to EC/OECD requirements, the
test substance induced numerical chromosomal aberrations
dose-dependently within the dose range of 125 – 500 µg/ml in the 48 h
treatment by the direct method, and 500 – 5000 µg/ml in the group
without S9 mix by the metabolic activation method, respectively. No
structural aberrations were noted in this study.
positive controls (MMC and CPA) induced evident structural chromosomal
Studies on structural analogues: Results have been
read-across from chromosome aberrations studies using CHL cells from
three structurally related analogue substances.
The three analogue substances were considered to be non-clastogenic to
CHL cells in vitro.
Mammalian cell gene mutation assay (mouse lymphoma assay):
study was conducted according to a method that was designed to assess
the potential mutagenicity of the test item on the thymidine kinase, TK
+/-, locus of the L5178Y mouse lymphoma cell line. The method was
designed to be compatible with the OECD Guidelines for Testing of
Chemicals NO.476"In Vitro Mammalian Cell Gene Mutation
Tests", Method B17 of Commission Regulation (EC) No. 440/2008 of 30 May
2008, the US EPA OPPTS 870.5300 Guideline, and be acceptable to the
Japanese METI/MHLW guidelines for testing of new chemical substances.
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 item at six 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 final concentration). In Experiment 2, the cells were treated
with the test item at six dose levels using a 4-hour exposure group in
the presence of metabolic activation (1% S9final
concentration) and a 24-hour exposure group in the absence of metabolic
dose range of test item was selected following the results of a
preliminary toxicity test and for Experiment 1 and 2 was 64.77 to
1036.25 µg/ml in both the absence and presence of metabolic activation.
maximum dose level used in the Mutagenicity Test was limited by the
formulation of the test item and the maximum achievable dose level was
1036.25 µg/ml. Precipitate of the test item was observed at and above
64.77 µg/ml in the Mutagenicity Test.
vehicle (solvent) controls had mutant frequency values that were
considered acceptable for the L5178Y cell line at the TK +/- locus.
positive control items induced marked increases in the mutant frequency
indicating the satisfactory performance of the test and of the activity
of the metabolising system.
test item 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 second experiment.
test item was considered to be non-mutagenic to L5178Y cells under the
conditions of the test.
The test substance was found to be:
- non-mutagenic in a bacterial reverse mutation assay (Ames test).
- non-mutgenic to L5178Y cells in a mouse lymphoma assay.
- non-clastogenic in in-vitro chromosome aberration studies (in CHL
cells and human lymphocytes).
In a test conducted to a Japanese method using CHL cells the
test substance induced numerical chromosomal aberrations but no
structural aberrations were noted in this study and the result is
considered to be negative. It has been assessed that the numerical
aberrations, which was noted at toxic dose levels, was most likely to be
a cytotoxic drive response on the mitotic apparatus and as no structural
aberration response was observed, not to be an indication of a true
Three structurally similar analogue substances were found to be
non-clastogenic in in-vitro chromosome aberration studies.
Based on the above, the substance has been assessed as not requiring
classification as a germ cell mutagen.
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