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Annex XV Dossier PROPOSAL for IDENTIFICATION of a SUBSTANCE AS a CATEGORY 1A OR 1B CMR, PBT, Vpvb OR a SUBSTANCE of an EQUIVALEN

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Annex XV Dossier PROPOSAL for IDENTIFICATION of a SUBSTANCE AS a CATEGORY 1A OR 1B CMR, PBT, Vpvb OR a SUBSTANCE of an EQUIVALEN ANNEX XV – IDENTIFICATION OF HYDRAZINE 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): Hydrazine EC Number(s): 206-114-9 CAS Number(s): 302-01-2 Submitted by: European Chemical Agency on request of the European Commission Version: February 2011 PUBLIC VERSION: This report does not include the Confidential Annexes referred to in Part II. 1 ANNEX XV – IDENTIFICATION OF HYDRAZINE AS SVHC CONTENTS PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A CATEGORY 1A OR 1B CMR, PBT, VPVB OR A SUBSTANCE OF AN EQUIVALENT LEVEL OF CONCERN ................................................................................7 PART I..........................................................................................................................................................................8 JUSTIFICATION .........................................................................................................................................................8 1 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES .................................8 1.1 Name and other identifiers of the substance...................................................................................................8 1.2 Composition of the substance.........................................................................................................................9 1.3 Physico-chemical properties...........................................................................................................................9 2 HARMONISED CLASSIFICATION AND LABELLING....................................................................................11 3 ENVIRONMENTAL FATE PROPERTIES...........................................................................................................12 4 HUMAN HEALTH HAZARD ASSESSMENT.....................................................................................................13 5 ENVIRONMENTAL HAZARD ASSESSMENT ..................................................................................................14 6 CONCLUSIONS ON THE SVHC PROPERTIES .................................................................................................15 6.1 PBT, vPvB assessment ...................................................................................................................................15 6.2 CMR assessment.............................................................................................................................................15 6.3 Substances of equivalent level of concern assessment. ..................................................................................15 PART II ........................................................................................................................................................................16 INFORMATION ON USE, EXPOSURE, ALTERNATIVES AND RISKS...............................................................16 1 EXECUTIVE SUMMARY.....................................................................................................................................16 1.1 Manufacture, Imports and Exports .................................................................................................................16 1.2 Uses ................................................................................................................................................................16 1.3 Releases from Manufacture and Use ..............................................................................................................17 1.4 Current Knowledge of Alternatives................................................................................................................19 2 PURITY AND DIFFERENT FORMS OF HYDRAZINE .....................................................................................21 2.1 Purity of Anhydrous Hydrazine......................................................................................................................21 2.2 Solutions of Hydrated Hydrazine ...................................................................................................................22 3 INFORMATION ON MANUFACTURE, IMPORT, EXPORT AND RELEASES FROM MANUFACTURE...22 1 ANNEX XV – IDENTIFICATION OF HYDRAZINE AS SVHC 3.1 Production Process .........................................................................................................................................22 3.1.1 The Olin Raschig Process....................................................................................................................22 3.1.2 The Atofina-PCUK (Peroxide) Process...............................................................................................23 3.1.3 The Bayer (Ketazine) Process .............................................................................................................23 3.1.4 The Hoffmann (Urea) Process.............................................................................................................24 3.2 Production Sites..............................................................................................................................................24 3.2.1 EU Production Sites ............................................................................................................................24 3.2.2 Non-EU Production Sites ....................................................................................................................24 3.3 Production Volumes .......................................................................................................................................25 3.3.1 Historical Information – Global Production........................................................................................25 3.3.2 Current EU Production........................................................................................................................25 3.4 Imports into the EU ........................................................................................................................................25 3.5 Future Trends..................................................................................................................................................25 3.6 Information on Releases from Manufacture ...................................................................................................26 3.6.1 Releases to the Environment from Manufacture .................................................................................26 3.6.1.1 Information from Literature ..................................................................................................26 3.6.1.2 Consultation Findings ...........................................................................................................26 3.6.2 Releases to the Working Environment and Occupation Exposure during Manufacture .....................26 3.6.2.1 Information from Literature ..................................................................................................26 3.6.2.2 Consultation Findings ...........................................................................................................27 4 INFORMATION ON USES OF HYDRAZINE .....................................................................................................28 4.1 Overview of Hydrazine Uses..........................................................................................................................28 4.1.1 Possible Uses referred to in Literature ................................................................................................28 4.1.2 Hydrazine Hydrate vs. Hydrazine Derivatives ....................................................................................30 4.1.3 Information on Overall Use Patterns (Tonnage) .................................................................................31 4.1.3.1 Information from Literature – Historical Information on Global Consumption....................31 4.1.3.2 Consultation Findings – Current Information on EU Consumption......................................32 4.2 Use in Syntheses.............................................................................................................................................33 4.2.1 Introduction .........................................................................................................................................33 4.2.2 Pharmaceuticals and Agrochemicals...................................................................................................33 4.2.3 Chemical Blowing Agents...................................................................................................................33 4.2.4 Polymerisation Initiators and Catalysts ...............................................................................................34 4.2.5 Crosslinking in Urethanes and Acrylics ..............................................................................................34 4.2.6 Lubricants............................................................................................................................................34 4.2.7 Nuclear Reactor Waste Treatment.......................................................................................................35 4.3 Use in Water Treatment..................................................................................................................................36
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