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EC number: 270-302-7
CAS number: 68424-43-1
The substance is considered not to induce mutagenic effects
and is therefore not classified with regards to this end point according to
the Dangerous Substance Directive (67/548/EEC) or CLP Regulation (EC) No.
1272/2008 based on the following:
A study was performed to assess the mutagenic potential
of the substance using a bacterial/microsome test system (Ames plate
incorporation method). the method conforms to OECD Guideline 471. No
significant increase in the frequency of revertant colonies was recorded
for any of the bacterial strains with any dose of the test material,
either with or without metabolic activation. the test material was found
to be non-mutagenic under the conditions of the test.
A study was conducted to assess the clastogenic potential
of the submission substance using human lymphocytes Cells. The substance
did not induce any significant increases in the frequency of cells with
aberrations in any of the treatment cases. The submission substance was
shown to be non-toxic and non-clastogenic to human lymphocytes in-vitro
in all treatment cases.
A study was conducted to assess the potential
mutagenicity of the submission substance to the thymidine kinase, TK
+/-locaus of the L5178Y mouse lymphoma cell line. The test method used
meets the requirements of OECD Guideline 476. The test material did not
induce any statistically significant or dose-related increases in the
mutant frequency at any of the dose levels, either with or without
metabolic activation, in either the first or second experiment using a
dose range where maximum exposure of the test material to the cells had
The test material was considered to be non-mutagenic to
L5178Y cells under the conditions of the test.
The above studies have all been ranked reliability 1
according to the scoring system of Klimisch et al. This ranking was
deemed appropriate because the studies were conducted to GLP and were in
compliance with agreed protocols, with no or minor deviations from
standard test guidelines and/or minor methodological deficiencies, which
do not affect the quality of relevant results.
The submission substance was found to be non-mutagenic to
bacterial cells (Ames study), mammalian cells (mouse lymphoma assay),
and non-clastogenic to mammalian cells (chromosome aberration study), so
therefore does not meet the criteria required for classification.
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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