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EC number: 813-604-1
CAS number: 68533-01-7
A genotoxic potential was not detected in three in vitro tests according
to OECD TGs 471, 473 and 476, respectively.
The test substance NM01 was tested for its mutagenic potential based on
the ability to induce point mutations in selected loci of several
strains of Salmonella typhimurium and Escherichia coli (TA 1535, TA 100,
TA 1537, TA 98 and E. coli WP2 uvrA), in a reverse mutation assay. A
standard plate test and a preincubation test were conducted, both with
and without metabolic activation (liver S9 mix from induced rats), and
both covering a dose range of 33 μg - 5 000 μg/plate. No precipitation
of the test substance was found with and without S9 mix. A weak
bacteriotoxic effect was occasionally observed depending on the strain
and test conditions at 5 000 μg/plate. A biologically relevant increase
in the number of his+ or trp+ revertants was not observed in the
standard plate test or in the preincubation test either without S9 mix
or after the addition of a metabolizing system.
The test item NM01, suspended in deionised water, was assessed for its
potential to induce structural chromosome aberrations in V79 cells of
the Chinese hamster in vitro in two independent experiments. In each
experimental group two parallel cultures were analysed. Per culture 100
metaphases were evaluated for structural chromosomal aberrations, except
for the positive controls in Experiment II, in the absence of S9 mix,
where only 50 metaphases were evaluated. The highest applied
concentration in this study (2100.0 μg/mL of the test item, approx. 10
mM) was chosen with regard to the molecular weight and the purity (95%
preliminary information at study start) of the test item and with
respect to the current OECD Guideline 473. Dose selection of the
cytogenetic experiment was performed considering the toxicity data and
the occurrence of test item precipitation in accordance with OECD
In Experiment II in the absence of S9 mix after 28 hours continuous
treatment clear cytotoxicity, indicated as reduced cell numbers, was
observed at the highest evaluated concentration. In all other
experimental parts no clear cytotoxicity was observed up to the highest
applied concentration. In both independent experiments, no relevant
increase in the number of cells carrying structural chromosomal
aberrations was observed after treatment with the test item. However, in
Experiment II in the presence of S9 mix one single statistically
significant increase (3.5% aberrant cells, excluding gaps), within the
range of the laboratory historical solvent control data (0.0 – 3.5 %
aberrant cells, excluding gaps) was observed after treatment with 525.0
μg/mL. No relevant increase in the frequencies of polyploid metaphases
was found after treatment with the test item as compared to the
frequencies of the controls. Appropriate mutagens were used as positive
controls. They induced statistically significant increases in cells with
structural chromosome aberrations.
The study was performed to investigate the potential of NM01 to induce
gene mutations at the HPRT locus in V79 cells of the Chinese hamster.
The assay was performed in two independent experiments, using two
parallel cultures each. The main experiments were performed with and
without liver microsomal activation and a treatment period of 4 hours.
The highest concentration of 2100 μg/mL in the pre-experiment was equal
to approximately 10 mM. Dose calculation was adjusted to preliminary
purity data at study start (>95 %). The concentration range of the main
experiments was limited by precipitation. The test item was suspended in
deionised water. No substantial and reproducible dose dependent increase
of the mutation frequency was observed up to the maximum concentration
with and without metabolic activation. Appropriate reference mutagens
(EMS and DMBA), 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.
Since a genotoxic potential was not detected in three in vitro tests
according to OECD TGs 471, 473 and 476, respectively, the classification
criteria of the CLP Regulation are not met.
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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