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EC number: 212-133-3
CAS number: 764-99-8
The test item was tested for mutagenicity in
the Ames test and in the E. coli- reverse mutation assay both in the
standard plate test and in the preincubation test with and without the
addition of a metabolizing system obtained from rat liver (S-9 mix)
using the Salmonella strains TA 1535, TA 100, TA 1537, TA 98 and
Escherichia coli WP2 uvrA at a dose of 20-5000 µg/plate (GLP guideline
study, BASF, 1998). Positive control substances caused increases in the
number of revertants as expected, indicating proper test conditions. The
test substance showed no mutagenic effects at any dose level including
the recommended limit dose of 5000 µg/plate.
Chromosome aberration test
The test item was assessed for its potential
to induce structural chromosome aberrations in primary lymphocytes in
vitro in two independent experiments at doses of 125 - 1580 µg/ml with
and without metabolic activation (GLP guideline study, BioReliance,
2007). Under the experimental conditions reported no increased
aberration frequencies were observed by the chromosome aberration test.
Based on the findings of this in vitro mammalian chromosome aberration
test using human peripheral blood lymphocytes, the test item was
negative for the induction of structural or numerical chromosome
aberrations in both the non-activated and the S9-activated test systems.
HPRT (read across, for justification see
repeated dose toxicity)
The structural analogue
3,6,9,12-Tetraoxatetradeca-1,13-diene (CAS 765-12-8) of the test item
was tested with and without metabolic activation for mammalian gene
mutation (HGPRT locus) in Chinese hamster ovary cells (GLP guideline
study, BASF SE, 2011). The concentration range tested was up to 2100
µg/mL (without and with metabolic activation by S9-Mix). No induction of
forward mutations was observed in any of the experiments. Positive and
negative controls gave the expected results. Therefore, the structural
analogue of the test item is non-mutagenic in CHO cells (HGPRT-/+).
Mouse micronucleus test
In a GLP guideline study according to OECD
474 (BioReliance, 2007), the test item was tested for clastogenicity and
for the ability to induce spindle poison effects in ICR mice using the
micronucleus test method. The test substance, dissolved in corn oil was
administered by gavage to male and female animals at dose levels of 500
mg/kg, 1000 mg/kg and 2000 mg/kg bw body weight in a volume of 20 mL/kg
body weight. As a negative control, corn oil (the selected vehicle) was
administered to male mice by the same route, and gave frequencies of
micronucleated polychromatic erythrocytes within the historical control
range. The test item reduced the ratio of polychromatic erythrocytes to
total erythrocytes relative to the respective vehicle controls in both
sexes. Although these reductions did not occur in a dose-related manner,
they suggest that the test item was bioavailable to the bone marrow
target tissue. The test item did not produce a significant increase in
the incidence of micronucleated polychromatic erythrocytes in either sex
of any group relative to the respective vehicle control groups at either
24 or 48 hours after dose administration. Based on the observations in
this study and under the conditions described in this report, the test
item was not clastogenic in the mouse micronucleus assay.
Classification is not warranted according to
the criteria of EU Directive 67/548/EEC and EU Classification, Labelling
and Packaging of Substances and Mixtures (CLP) Regulation (EC) No
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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