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EC number: 945-518-6
CAS number: -
In vitro Gene Mutation study in
Bacteria - AMES
Negative. The substance is not mutagenic
In vitro mammalian cells Chromosome
Negative. The substance is not clastogenic
in human lymphocytes.
In vitro mammalian cell gene mutation
Test substance does not induce gene
mutation in Chinese hamster V79 cells after in vitro treatment in the
absence or presence of S9 metabolic activation.
For substances covered by Annex VIII to
REACH genetic toxicity on bacteria and two tests on in vitro mammalian
cells are required.
The tests required to fulfil the ANNEX
VIII were performed on a similar substance 01 and Similar substance 02
(read-across from supporting substance -structural analogue or
on bacteria (AMES)
The mutagenicity on bacteria was performed
following the OECD 471 and the EU B.13/B.14.
The similar substance 01 was tested in the
Salmonella typhimurium reverse mutation assay with tour histidine-
requiring strains of Salmonella typhimurium (TA1535, TA1537, TA100 and
TA98) and in the Escherichia coli reverse mutation assay with a
tryptopham requiring strain of Escherichia coli WP2uvrA in two
independent experiments, modified according to Prival and Mitchell.
The substance was tested up to
concentrations of 5000 pg/plate in the absence and presence of S9 mix.
The test item did not precipitate on the
plates at this dose level.
The bacterial background lawn was not
reduced at all concentrations tested and no decrease in the number of
revertants was observed.
The substance did not induce a
dose-related increase in the number of revertant (His*) colonies in each
of the tour tester strains (TA1535, TA1537, TA98 and TA100) and in the
number of revertant (Trpt) colonies in tester strain WP2uvrA both in the
absence and presence of S9- metabolic activation. These results were
confirmed in an independently repeated experiment.
Based on the results of this study it is
concluded that the similar substance is not mutagenic in the Salmonella
typhimurium reverse mutation assay and in the Escherichia coli reverse
on in vitro mammalian cells
The test has been performed according to
the OECD 473 and EU B10.
In the first cytogenetic assay, the
substance was tested up to 5000 pg/mL for a 3 h exposure time with a 24
h fixation time in the absence and presence of S9-mix.
In the second cytogenetic assay, the
substance was tested up to 1500 pg/mL for a 24 h and 48 h continuous
exposure time with a 24 h and 48 h fixation time in the absence of
Appropriate toxicity was reached at
these dose levels. In the presence of 1.8% (v/v) S9-fraction was tested
up to 5000 pg/ml for a 3 h exposure time with a 48 h fixation time.
The Similar substance 01 did not
induce a statistically significant or biologically relevant increase in
the number of cells with chromosome aberrations in the absence and in
the presence of S9-mix, in two independently repeated experiments.
It is concluded that this test is
valid and that the Similar substance 01 is not clastogenic in human
lymphocytes under the experimental conditions described in this report.
The GENE MUTATION IN CHINESE HAMSTER V79
CELLS OECD476- RTC Study Number: A2931.
It is concluded that the test substance
does not induce gene mutation in Chinese hamster V79 cells after in
vitro treatment in the absence or presence of S9 metabolic activation,
under the reported experimental conditions.
the read-across principle, this evaluated conclusion can be considered
valid for the genetic toxicity assessment of the substance.
Justification for Read Across is detailed in the report attached to the
IUCLID section 13.
hazard class is primarily concerned with substances that may cause
mutations in the germ cells of humans that can be transmitted to the
that are mutagenic in somatic cells may produce heritable effects if
they, or their active metabolites, have the ability to interact with the
genetic material of germ cells. Conversely, substances that do not
induce mutations in somatic cell in vivo would not be expected to be
germ cell mutagens.
the results from mutagenicity or genotoxicity tests in vitro and in
mammalian somatic and germ cells in vivo are also considered in
classifying substances and mixtures within this hazard class.
1: substances known to induce heritable mutations or to be regarded as
if they induce heritable mutations in the germ cells of humans.
Substances known to induce heritable mutations in the germ cells of
2: substances which cause concern for humans owing to the possibility
that they may induce heritable mutations in the germ cells of humans.
for heritable effects in human germ cells is made on the basis of well
conducted, sufficiently validated tests as In vitro mutagenicity tests
such as these indicated in 126.96.36.199.8:
- in vitro
mammalian chromosome aberration test;
- in vitro
mammalian cell gene mutation test;
bacterial reverse mutation tests
Similar substance 01 did not induced gene mutations in the strains in
the Salmonella typhimurium reverse mutation assay.
additional study is available, in vitro, Chromosome aberration, resulted
the Annex VIII, the missing GENE
MUTATION IN CHINESE HAMSTER V79 CELLS OECD476-RTC Study Number: A2931, the
test substance does not induce gene mutation after in vitro treatment in
the absence or presence of S9 metabolic activation, under the reported
the read-across principle, the available results are considered for the
genetic toxicity assessment of the substance.
conclusion, according to the CLP Regulation n.1272/2008 and the ECHA
Guidance R.7a, the substance is not classified as mutagenic.
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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