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EC number: 251-649-3
CAS number: 33704-61-9
The ability of Cashmeran to induce
mutations was investigated in the Bacterial Reverse Mutation Assay
(Ames) by using 4 histidine-requiring strains of Salmonella typhimurium
(TA100, TA1535, TA98 and TA1537), and a tryptophan-requiring strain of
Escherichia coli (WP2 uvrA) with a pre-incubation method in the presence
and absence of a metabolic activation system (S9 mix). The study
procedures described in this reverse mutation assay were equivalent to
OECD guideline 471. Test concentrations used in the main test were as
follows: - S9 mix: 2.44, 4.88, 9.77, 19.5, 39.1 and 78.1 µg/plate; + S9
mix: 9.77, 19.5, 39.1, 78.1, 156, and 313 µg/plate.
The mutagenicity of the test compound
was judged negative because the number of revertant colonies in the test
compound treatment groups was less than twice that of each negative
control in all test strains. The number of revertant colonies in the
positive control groups were more than twice that of negative control
groups. The test results showed that the number of revertant colonies
for the negative control and the positive controls were within the range
of the historical data at Hita laboratory, indicating that the test can
be considered valid.
It is concluded that Cashmeran has no
ability to induce mutations in bacteria under the present test
Furthermore, Cashmeran was examined for its cytogenicity in the
micronucleus test (similar to OECD474) with human lymphocytes and
hepatocytes in vitro in the presence and absence of metabolic
activation. Cashmeran did not induce a significant increase in the
frequency of micronuclei in both human lymphocytes and human
hepatocytes. It is concluded that Cashmeran is not cytogenic in the
micronucleus test with human lymphocytes and with the human hepatoma
cell line Hep G2.
The test article, Cashmeran, was tested in the L5178Y TK+/- Mouse
Lymphoma Mutagenesis Assay (in accordance with OECD 476), both in the
presence and absence of exogenous metabolic activation, to investigate
its potential to induce gene mutations in mammalian cells. All of the
cloned cultures treated with Cashmeran in both the Definitive and
Confirmatory Mutation Assays had Mutant Frequencies that were similar to
that of their corresponding solvent control cultures. Therefore, under
the test conditions, Cashmeran is negative in the L5178Y TK+/- Mouse
Lymphoma Mutagenesis Assay.
Based on the available information in the dossier, Cashmeran does not
need to be classified for genotoxicity when considering the criteria
outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.
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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