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EC number: 201-304-8
CAS number: 80-73-9
Bacterial reverse mutation
In a study conducted according
to OECD test guideline 471 (Japan Biological Chemistry Co. Ltd.), four
mutant strains of Salmonella Typhimurium (TA1535, TA1537, TA98, and
TA100) and one strain of Escherichia coli (WP2 uvrA) were treated with
DMI at a series of concentrations (5 µg/plate 5000 µg/plate) with and
without metabolic activation (S9 mix). No increase in the number of
revertant colonies was seen relative to the concurrent vehicle controls
in any of the strains tested at any concentration, either with or
without metabolic activation and it was concluded that DMI showed no
evidence of mutagenic activity in the bacterial system used, under the
Chromosome aberration study
A chromosomal aberration study
(Shin Nippon Biomedical Laboratories, 1997) was conducted according to
OECD test guideline 473 to assess the cytogenetic potential of DMI in
Chinese hamster CHL/IU lymphocytes. Test were carried out with and
without metabolic activation and with short a treatment time (6hr) and
with continuous treatment (24 -48hr). There was no statistically
significant increase in the cells having structural or numerical
chromosomal aberrations, regardless of the use or non-use of metabolic
activation and the length of treatment time. Based on this, it was
judged that the test substance does not possess clastogenic properties.
Mouse lymphoma study
A mouse lymphoma assay (Huntingdon Life Sciences, 2013) was conducted to
assess the mutagenic potential of DMI. The study was conducted according
to OECD guideline 476, EU guideline B17, and US EPA, Japanese, and ICH
guidelines, and in compliance with GLP. Mouse lymphoma L5178Y cells were
treated with a suspension of DMI at concentrations up to 1141 µg/mL,
with and without metabolic activation (S9 mix). No increase in mean
mutant frequencies were seen in any of the tests conducted, nor was any
reduction in relative total growth (RTG) observed. It was concluded that
DMI had not shown any mutagenic potential in this in vitro cell mutation
assay, under the experimental conditions described.
The substance has given negative results in three in vitro tests
that cover bacterial gene mutation, gene mutation in mammalian cells and
cytogenicity in mammalian cells. In accordance with Table R.7.7 -5 of
ECHA Endpoint specific guidance Chapter 7(a) Version 2.0 the substance
can therefore be regarded as not genotoxic and no further tests are
Short description of key information:
Ames: Negative with and without metabolic activation (S9 mix)
Chromosome aberration: no evidence of an increase in the frequency of
structural chromosome aberrations.
Mouse Lymphoma Assay: no evidence of mutagenic activity with or without
Endpoint Conclusion: No adverse effect observed (negative)
Three in-vitro studies (as described above) examined aspects of
the mutagenic potential of DMI. None of these studies indicated any
mutagenic potential; and so it is not necessary to classify DMI as
hazardous on the basis of mutagenic activity according to either the CLP
Regulation (Regulation (EC) 1272/2008), or the Dangerous Substances
Directive (Directive 67/548/EEC).
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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