Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

A wealth of information on the genotoxic potential of DMS was available for the assessment, indicating that DMS is a direct acting alkylating agent. No data gap could be identified for mutagenicity.

 

Clear positive results in vitro exist for reverse mutation assays in bacteria and chromosome aberration in mammalian cells. The absence of a genotoxicity study in mammalian cells would result a formal data gap, however taking into consideration the availability of in vivo tests and several mechanistic investigations on the binding potential of DMS to DNA, this data gap could be resolved.

 

The data requirements for isolated transported intermediates do not foresee the submission of in vivo mutagenicity studies. However, the registration requirements for intermediates foresee that any available existing information on physico-chemical, human health and environmental properties of the intermediate shall be included in the registration dossier (cf. REACH regulation (EC) 1907/2006 Art. 18 (2) d). All reliable studies on mutagenicity / genotoxicity are included in the technical dossier of DMS.

 


Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

According to the data available and in accordance to the regulation (EC) 1272/2008 DMS has to be classified as mutagenic substance "Muta. 2"; H341: Suspected of causing genetic defects. This was already done by directive 67/548/EEC annex 1.