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EC number: 251-718-8
CAS number: 33885-52-8
Ames test (similar to OECD TG 471): negative
In vitro micronucleus test (OECDTG487): not clastogenic or aneugenic
In vitro mouse lymphoma test (OECDTG490): not mutagenic
All in vitro genotoxicity tests are negative and therefore the substance
does not have a genotoxic mode of action.
The mutagenic activity of the substance was evaluated according to
the Japanese Guidelines for Screening Mutagenicity Testing of Chemicals
(similar to OECD 471) and according to GLP principles. The test was
performed with the pre-incubation method assay, both in the absence and
presence of S9-mix. The dose levels were selected based on observed
cytotoxicity in all strains. Adequate negative and positive controls
were included. The substance did not induce a significant dose-related
increase in the number of revertant (His+) colonies in each of the four
S. typhimurium tester strains (TA1535, TA1537, TA98, TA100) and E.coli
WP2, both in the absence and presence of S9-metabolic activation. Based
on the results of this study, it is concluded that the substance is not
mutagenic in the Salmonella typhimurium reverse mutation assay.
In vitro micronucleus test
In an in vitro micronucleus assay, cultured peripheral human lymphocytes
were exposed to different concentrations of the substance (dissolved in
ethanol), in the presence and absence of S9-mix according to OECD 487
guideline and GLP principles. In the first cytogenetic assay, the test
item was tested up to and including 50 and 100 μg/mL for a 3 hours
exposure time with a 27 hours harvest time in the absence and presence
of S9-fraction, respectively. In the second cytogenetic assay, the test
item was tested up to and including 65 μg/mL for a 24 hours exposure
time with a 24 hours harvest time in the absence of S9-mix. The highest
concentration analysed was selected based on toxicity, cytokinesis-block
proliferation index of about 55 ± 5% in both tests. Reliable positive
and negative controls were included. The substance did not induce a
statistically significant or biologically relevant increase in the
number of mono- and binucleated cells with micronuclei in the absence
and presence of S9-mix, in either of the two experiments. It is
concluded that the substance is not clastogenic or aneugenic in human
In vitro mouse lymphoma assay
The mouse lymphoma assay with the substance was conducted according to
OECD 490 guideline and GLP principles.
In the first experiment, the test item was tested up to and including
concentrations of 22.5 and 40 μg/mL in the absence and presence of
S9-mix, respectively. The incubation time was 3 hours. Relative total
growth (RTG) was 48 and 27% in the absence and presence of S9-mix,
respectively. The test item did not precipitated in the culture medium
at this dose level. In the second experiment, the test item was tested
up to and including concentrations of 22.5 μg/mL in the absence of
S9-mix. The incubation time was 24 hours. The RTG was 19%. Positive
control chemicals, methyl methanesulfonate and cyclophosphamide, both
produced significant increases in the mutation frequency. In the absence
of S9-mix, the substance did not induce a significant increase in the
mutation frequency in the first experiment. This result was confirmed in
an independent experiment with modification in the duration of
treatment. In the presence of S9-mix, the substance did not induce a
significant increase in the mutation frequency. It is concluded that the
substance is not mutagenic in the mouse lymphoma L5178Y test system.
Based on the available data, the substance does not need to be
classified for genotoxicity in accordance with the criteria outlined in
EU CLP (EC. no 1272/2008 and its amendments).
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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