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EC number: 250-342-1
CAS number: 30798-32-4
The test substance is not mutagenic in
bacteria, as determined in an OECD 471 study.
Genetic toxicity in vitro
Genetic toxicity of the test substance
in vitro was tested in a GLP compliant study according to OECD 471 and
EU B.13/14. To this end, the potential of the test substance and/or its
metabolites to induce reverse mutations at the histidine locus in
several strains of Salmonella typhimurium (S. typhimurium; TA98, TA100,
TA1535, and TA1537), and at the tryptophan locus of Escherichia coli (E.
coli) strain WP2uvrA was tested in the presence or absence of an
exogenous mammalian metabolic activation system (S9). The test was
performed in two independent experiments, at first a direct plate assay
was performed and secondly a pre-incubation assay. A correction factor
of 1.49 was used to correct for the purity. The test item was dissolved
in Milli-Q water or dimethyl sulfoxide. In the dose-range finding study,
the test item was initially tested up to concentrations of 5000 μg/plate
in the strains TA100 and WP2uvrA in the direct plate assay. Next, in the
first mutation experiment, the test item was tested up to concentrations
of 5000 μg/plate in the strains TA1535, TA1537 and TA98. In both of
these tests the bacterial background lawn was not reduced at any of the
concentrations tested and no biologically relevant decrease in the
number of revertants was observed. The test item did not precipitate on
the plates at this dose level. In the second mutation experiment, the
test item was tested up to concentrations of 5000 μg/plate in the tester
strains TA1535, TA1537, TA98, TA100 and WP2uvrA in the pre-incubation
assay. The test item did not precipitate on the plates at this dose
level. Cytotoxicity, as evidenced by a reduction in the bacterial
background lawn, was only observed in tester strain TA100 in the
presence of S9-mix at the highest tested concentration. The negative and
strain-specific positive control values were within the laboratory
historical control data ranges indicating that the test conditions were
adequate and that the metabolic activation system functioned properly.
The test item 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 a follow-up
experiment. In conclusion, based on the results of this study it is
concluded that the test substance is not mutagenic in the Salmonella
typhimurium reverse mutation assay and in the Escherichia coli reverse
Based on the available information
classification for genetic toxicity is not warranted according
to EU Classification, Labelling and Packaging of Substances and
Mixtures (CLP) Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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