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Annex XV Dossier PROPOSAL for IDENTIFICATION of A ANNEX XV – IDENTIFICATION OF N,N-DIMETHYLACETAMIDE (DMAC) AS SVHC Annex XV dossier PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A CATEGORY 1A OR 1B CMR, PBT, vPvB OR A SUBSTANCE OF AN EQUIVALENT LEVEL OF CONCERN Substance Name(s): N,N-Dimethylacetamide (DMAC) EC Number(s): 204-826-4 CAS Number(s): 127-19-5 Submitted by: European Chemicals Agency at the request of the European Commission Version: August 2011 PUBLIC VERSION: This version does not include the confidential annexes referred to in Parts I and II. 1 ANNEX XV – IDENTIFICATION OF N,N-DIMETHYLACETAMIDE (DMAC) AS SVHC CONTENTS ABBREVIATIONS AND ACRONYMS.....................................................................................................................6 PART I..........................................................................................................................................................................9 JUSTIFICATION .........................................................................................................................................................9 1 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES .................................9 1.1 Name and other identifiers of the substance ...................................................................................................9 1.2 Composition of the substance.........................................................................................................................10 1.3 Physico-chemical properties...........................................................................................................................11 2 HARMONISED CLASSIFICATION AND LABELLING....................................................................................12 3 ENVIRONMENTAL FATE PROPERTIES...........................................................................................................13 4 HUMAN HEALTH HAZARD ASSESSMENT.....................................................................................................13 5 ENVIRONMENTAL HAZARD ASSESSMENT ..................................................................................................13 6 CONCLUSIONS ON THE SVHC PROPERTIES .................................................................................................13 6.1 CMR assessment.............................................................................................................................................13 INFORMATION ON USE, EXPOSURE, ALTERNATIVES AND RISKS...............................................................14 EXECUTIVE SUMMARY ..........................................................................................................................................14 1 MANUFACTURE, IMPORT AND EXPORT .......................................................................................................17 1.1 Manufacturing process....................................................................................................................................17 1.2 Manufacture, import and export of the substance on its own .........................................................................17 1.3 Trends.............................................................................................................................................................17 1.4 Import of the substance in mixtures................................................................................................................17 1.5 Import of the substance in articles ..................................................................................................................18 1.6 Releases from manufacture and transport.......................................................................................................18 1.6.1 Operational conditions of use and existing risk management measures..............................................18 1.6.1.1 Manufacturing process ..........................................................................................................18 1.6.1.2 Operational conditions ..........................................................................................................18 1.6.1.3 Risk management measures ..................................................................................................18 1.6.2 Releases of the substance from manufacturing ...................................................................................19 1.6.2.1 Occupational exposure ..........................................................................................................19 1.6.2.2 Environmental releases..........................................................................................................20 1.6.3 Releases of the substance from transport ............................................................................................20 1.7 Mass balance and conclusions for manufacture, import and export ...............................................................20 2 ANNEX XV – IDENTIFICATION OF N,N-DIMETHYLACETAMIDE (DMAC) AS SVHC 2 USES OF THE SUBSTANCE................................................................................................................................22 2.1 Overview of uses ............................................................................................................................................22 2.2 Use # 1 – Use as a solvent in man-made fibre production..............................................................................24 2.2.1 Functions of the substance ..................................................................................................................24 2.2.2 Applications ........................................................................................................................................24 2.2.2.1 Sectors of use and description of the supply chain................................................................25 2.2.2.2 Use in mixtures......................................................................................................................26 2.2.3 Processes involved in the production of fibres....................................................................................27 2.2.4 Residues in fibres and textiles .............................................................................................................28 2.2.5 Processes involved in the processing and reprocessing of fibres ........................................................29 2.2.6 Service life of final products ...............................................................................................................30 2.2.7 Quantities involved..............................................................................................................................30 2.3 Use #2 – Use as a solvent and intermediate in production of pharmaceuticals, agrochemicals and fine chemicals ........................................................................................................................................................30 2.3.1 Function of the substance ....................................................................................................................30 2.3.2 Applications ........................................................................................................................................31 2.3.2.1 Sectors of use and description of supply chain......................................................................32 2.3.2.2 Use in mixtures......................................................................................................................32 2.3.2.3 Processes involved ................................................................................................................32 2.3.3 Quantities involved..............................................................................................................................33 2.4 Use #3 – Use as a solvent in enamels and other coatings ...............................................................................33 2.4.1 Function of the substance ....................................................................................................................33 2.4.2 Applications ........................................................................................................................................33 2.4.2.1 Sectors of use and description of supply chain......................................................................34 2.4.2.2 Use in mixtures......................................................................................................................34 2.4.2.3 Processes involved ................................................................................................................34 2.4.2.4 Use in articles........................................................................................................................35 2.4.3 Quantities involved..............................................................................................................................35 2.5 Use #4 – Use as a solvent in production of films ...........................................................................................36 2.5.1 Function of the substance ....................................................................................................................36 2.5.2 Applications ........................................................................................................................................36
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