Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Bacterial reverse mutation (Ames) assay

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 conditions employed

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.

Overall conclusion

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 required.

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 metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

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).