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EC number: -
CAS number: -
The test substance gave negative results in three in vitro
genetic toxicology tests and is therefore considered to be non-mutagenic.
mutagenicity of the test substance in bacteria was assessed using a test
method was designed to be compatible with OECD
Guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation
strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain
WP2uvrA were treated with solutions of the test substance using
both the Ames plate incorporation and pre-incubation methods at up to
eight dose levels, in triplicate, both with and without the addition of
a rat liver homogenate metabolising system (10% liver S9 in standard
co-factors) over four separate experiments (two experiments with two
further confirmatory experiments).
dose range for Experiment 1 (plate incorporation) was 1.5 to 5000 mg/plate. The
experiment was repeated on a separate day (pre-incubation method) using
a dose range that ranged between 0.15 and 5000 µg/plate, depending on
the strain type and presence or absence metabolic activation (S9). An
expanded dose range was selected in Experiment 2 in order to achieve
both four non-toxic dose levels and the toxic limit of the test item.
to differences in the results obtained in Experiments 1 and 2, a confirmatory
test (Confirmatory Test 1) was dosed at 5 to 500 µg/plate using TA1535
(in the presence of S9-mix only) under pre-incubation conditions only. A
second confirmatory experiment (Confirmatory Test 2) was dosed, again
using TA1535, with and without S9-mix and using both plate incorporation
and pre-incubation methods to confirm the difference in results obtained
in Experiment 2 and Confirmatory Test 1. The
dose range was the same as Confirmatory Test 1.
vehicle (dimethyl sulphoxide (DMSO)) control plates gave counts of
revertant colonies within the normal range. All
of the positive control chemicals used in the test induced marked
increases in the frequency of revertant colonies, both with or without
metabolic activation. Thus,
the sensitivity of the assay and the efficacy of the S9-mix were
analysis of the results of all the experiments, it was concluded that no
biologically relevant increases in the frequency of revertant colonies
were observed at any dose of the test item, either with or without
metabolic activation (S9-mix).
test item precipitate was observed on the plates at any of the doses
tested in either the presence or absence of S9-mix in any of the
experiments detailed above.
test substance was considered to be non-mutagenic under the conditions
of this test.
All the positive control chemicals
induced a demonstrable positive response (p≤0.01) and confirmed the
validity and sensitivity of the assay and the integrity of the S9-mix.
The frequency of cells with chromosome
aberrations (excluding gaps) in the vehicle control cultures were within
the current historical control data range fro the laboratory.
test item did not induce any statistically significant increases in the
frequency of cells with aberrations either in the absence or presence of
The study was conducted to assess the
potential of the test substance to cause chromosomal damage. It was
designed to meet the requirements of the following guideline: OECD
Guidelines for Testing of Chemicals N. 493 “ In Vitro Mammalian
Chromosome Aberration Test2 adopted 29 July 2016.
cultures of human lymphocytes, treated with the test item, were
evaluated for chromosome aberrations at up to four dose levels, together
with vehicle and positive controls.
this study, three exposure conditions were investigated; 4 hours
exposure in the presence of an induced rat liver homogenate metabolising
system (S9), at a 2% final concentration with cell harvest after a
20-hour expression period, 4 hours exposure in the absence of metabolic
activation (S9) with a 20-hour expression period and a 24-hour exposure
in the absence of metabolic activation.
dose levels used in the Main Experiment were selected using data from
the Preliminary Toxicity Test where the results indicated that the
maximum concentration should be limited by toxicity. The
dose levels selected for the Main Experiment were as follows:
substance did not induce any statistically significant increases in the
frequency of cells with aberrations, using a dose range that included a
dose level that induced 55±5% mitotic inhibition or greater. The
test item demonstrated marked toxicity in all three exposure groups.
positive controls all responded as expected demonstrating that the assay
was responding as expected.
substance was considered to be non-clastogenic to human lymphocytes in
The study was performed to investigate the
potential of the test substance to induce mutations at the mouse
lymphoma thymidine kinase locus using the cell line L5178Y. The method
was designed to meet the requirements of the following guidelines:
• OECD Guidelines for the Testing of
Chemicals, adopted 28 July 2015, Guideline No. 490 "In Vitro Mammalian
Cell Gene Mutation Tests using the Thymidine Kinase Gene“.
• Commission Regulation (EC) No.
440/2008 B.17: ”Mutagenicity – In vitro Mammalian Cell Gene Mutation
Test“, dated May 30, 2008.
The assay was performed in two independent
experiments, using two parallel cultures each. The first experiment was
performed with and without liver microsomal activation and a treatment
period of 4 hours. The second experiment was solely performed in the
absence of metabolic activation with a treatment period of 24 hours.
The maximum concentration in the
pre-experiment (5000 µg/mL, UVCB substance) was chosen with respect to
the OECD guideline 490. The concentration range of the main experiments
was limited by cytotoxicity of the test item.
No substantial and reproducible dose
dependent increase in mutant colony numbers was observed in both main
experiments. No relevant shift of the ratio of small versus large
colonies was observed up to the maximal concentration of the test item.
Appropriate reference mutagens, used as
positive controls, induced a distinct increase in mutant colonies and
thus, showed the sensitivity of the test system and the activity of the
metabolic activation system.
Under the conditions of the assay the test
substance did not induce gene mutations at the mouse lymphoma thymidine
kinase locus using the cell line L5178Y. Therefore, the test substance
is considered to be non-mutagenic in this mouse lymphoma thymidine
kinase locus assay using the cell line L5178Y.
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