Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 949-211-8
CAS number: -
following considerations based on the similar substance are also
applicable to the target substance. For read across justification see
the relevant document in the read across section
experimental data were available to assess the genetic toxicity in vitro
and in vivo.
mutation in bacteria
substance was mutagenic in a standard plate Ames test with and without
metabolic activation according to OECD guideline 471 (tested up to 5000μg/plate
with Salmonella typhimurium TA1535, TA 1537, TA 98 and TA 100; A
bacteriotoxic effect was not observed but a precipitation of the test
substance between 100 and 5000 µg/plate. Precipitation correlated with
mutagenic activity. The result indicated that an impurity of the test
material could have been responsible for the genotoxic effect.
second study the test substance was tested in a standard plate Ames test
with and without metabolic activation according to OECD guideline 471
(tested up to 7500μg/plate
with Salmonella typhimurium TA 100). A bacteriotoxic effect was observed
for the test substance >6000 µg/plate. The test substance was mutagenic
w/o metabolic activation in high amounts of >2000 µg/plate.
substance was again tested in a standard plate Ames test with and
without metabolic activation according to OECD guideline 471 (tested up
with Salmonella typhimurium TA1535, TA 1537, TA 1538, TA 98 and TA 100.
A bacteriotoxic effect was not observed. The test substance showed a
strain-dependent weak to moderate mutagenic effect without metabolic
activation from 2500µg/plate onward. In presence of metabolic activation
no mutagenic effect was observed for TA1535,TA1538 and TA98 and a weak
mutagenic effect for TA100 and TA1537 (>2500 µg/plate).
tests indicated a mutagenic potential of the test substance, but not in
each set-up and strain and particularly without metabolic activation.
Thus, it was indicated that metabolic systems/enzymes from mammalian
cells could detoxify the parent substance. Due to the fact that
toxicokinetic studies indicated that the test substance could already be
metabolized in the intestine, an intrasanguineous
mouse host-mediated assay
using Salmonella typhimurium TA 1535, TA98 or TA 100 was performed.
Here, the indicator bacteria were inoculated into living animals and
could subsequently be recovered from the liver and assayed for induced
genetic effects. The test substance was administered per os up to 4000
µg/kg bw in Swiss random bred rats and the effect on intravenously
injected bacteria that had been re-isolated from rat liver 3 h after
inoculation was investigated. Revertant colonies in comparison to
solvent controls were determined. The test substance showed no mutagenic
tests in bacteria are currently not available.
experimental conditions chosen in those studies, the test substance
showed some mutagenic activity in the bacterial reverse mutation test on
Salmonella typhimurium in the presence and particularly in the absence
of a metabolic activation system. A modified test system where test
substance and bacteria were processed in vivo, did not show any
mutagenic activity of the test substance.
mutation in mammalian cells
potential of the test substance to induce gene mutations at the HGPRT
locus using chinese hamster ovary cells was tested in vitro with and
without metabolic activation according to OECD guideline 476 (tested up
Cytotoxicity was observed in an intermediate concentration range around
20 µg/ml of test substance, presumably induced by inhibition of enzymes
of the S9-mix. The test substance showed no mutagenic effects on the
HGPRT locus of CHO cells.
in mammalian cells
there is no information available.
potential of the test substance to induce chromosome damage or spindle
poisoning was investigated in an OECD guideline 474 conform standard
micronucleus test study in male and female NMRI mice. Test substance was
given orally in CMC-vehicle in concentrations of 1700,3400 and 6800
mg/kg bw (>limit dose tested in acute oral toxicity study) and bone
marrow was isolated after 16,24 and 48 h. No signs of toxicity and no
pathological changes of the organs were observed in any dose groups.
Microscopic evaluation of bone-marrow derived erythrocytes showed that
the test substance did not impair erythropoeisis, did not induce any
chromosome-damaging (clastogenic) effects and did not impair chromosome
distribution in the course of mitosis.
in vivo rat hepatocyte UDS indicator test was done according to OECD
guideline 486. The test material was administered in water orally to
rats (4000,2000,1000 and 500 mg/kg bw) and 4 h later hepatocytes were
isolated, labelled with 3H-thymidine, processed and net nuclear grains
were determined via microscopic evaluation. The test substance did not
induce nuclear staining differently from vehicle control levels and no
dose-related trend was observed, thus, the test material was inactive in
the UDS-test in the dose range tested.
Short description of key information:
Gene mutation in bacteria
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 with and without
metabolic activation (Ames test, OECD 471): positive (BASF AG, 1993)
(standard plate test).
S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100 with and without
metabolic activation (Ames test, OECD 471): weakly positive (BASF AG,
1984) (standard plate test).
S. typhimurium TA 100 with and without metabolic activation (Ames test):
positive (BASF AG, 1986) (standard plate test).
S. typhimurium TA 1535, TA 100 with metabolic activation in vivo:
negative (Hazleton Laboratories America, 1986).
Gene mutation in mammalian cells
Chinese hamster ovary cells (OECD 476;BASF AG, 1992): negative
Cytogenicity in mammalian cells
No data available
Cytogenicity in vivo
In vivo micronucleus test (OECD 474; BASF AG, 1985): negative
In vivo UDS-test (OECD 486; Hazleton Laboratories America, 1988):
Endpoint Conclusion: No adverse effect observed (negative)
substance showed genotoxic reactions only in in vitro experiments using
bacteria (Ames test). In all other experiments using bacteria in vivo
(host mediated assay), mammalian cells in vitro (CHO, hamster; HGPRT
test), mammalian cells in a combined in vitro/in vivo study (UDS test)
or whole animals (in vivo micronucleus test) the test substance did not
exhibit any genetic activity.
based on the information currently available, there is no need for
classification of the test substance for mutagenic effects.
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again