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Annex Xv Report ANNEX XV REPORT PROPOSAL FOR A RESTRICTION SUBSTANCE NAME(S): Chromium (VI) compounds IUPAC NAME(S): not applicable 1 EC NUMBER(S): not applicable CAS NUMBER(S): not applicable INDEX NUMBER(S): not applicable CONTACT DETAILS OF THE DOSSIER SUBMITTER: Danish Competent Authority for REACH Danish Environmental Protection Agency Strandgade 29 DK-1401 Copenhagen K [email protected] , tel.: +45 72544000 att.: Annette Orloff, Bent Horn Andersen VERSION NUMBER: MST 1.0 DATE: 19 January 2012 1 Information corrected by the dossier submitter after submission of the dossier. 1 CONTENT A. Proposal..........................................................................................................................................5 A.1 Proposed restriction(s)..........................................................................................................5 A.1.1 The identity of the substance(s) .....................................................................................5 A.1.2 Scope and conditions of the restriction ..........................................................................5 A.2 Summary of the justification................................................................................................5 A.2.1 Identified hazard and risk...............................................................................................5 A.2.2 Justification that action is required on a Community-wide basis ..................................6 A.2.3 Justification that the proposed restriction is the most appropriate Community-wide measure ....................................................................................................................................7 A.2.4 Summary ........................................................................................................................8 B. Information on hazard and risk...................................................................................................9 B.1 Identity of the substance(s) and physical and chemical properties ..................................9 B.1.1 Name and other identifiers of the substance(s) ..............................................................9 B.1.2 Composition of the substance(s) ....................................................................................9 B.1.3 Physicochemical properties............................................................................................9 B.1.4 Justification for grouping .............................................................................................10 B.2 Manufacture and uses.........................................................................................................10 B.2.1 Manufacture and import of chromium (VI) .................................................................10 B.2.2 Uses ..............................................................................................................................13 B.2.2.1 Use of chromium in leather tanning..........................................................................13 B.2.2.2 Formation of chromium (VI) in leather.....................................................................17 B.2.2.3 Other sources of chromium (VI) in leather ...............................................................20 B.2.2.4 Methods for prevention of the formation of chromium (VI) in leather.....................21 B.2.2.5 Manufacturing and trade of articles of leather ..........................................................21 B.2.2.6 Leather chemicals production and market.................................................................28 B.2.2.7 Presence of chromium (III) and chromium (VI) in articles of leather ......................29 B.2.2.8 Articles of leather that may come into prolonged contact with the skin...................32 B.2.3 Uses advised against by the registrants ........................................................................35 B.2.4 Description of targeting................................................................................................35 B.3 Classification and labelling.................................................................................................36 B.3.1 Classification and labelling in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation).............................................................................................................................37 B.3.2 Classification and labelling in classification and labelling inventory..........................38 B.4 Environmental fate properties ...........................................................................................38 B.5 Human health hazard assessment......................................................................................38 B.5.1 Toxicokinetics (absorption, metabolism, distribution and elimination).......................39 B 5.2 Acute toxicity ...............................................................................................................39 B 5.3 Irritation........................................................................................................................39 B 5.4 Corrosivity....................................................................................................................40 B 5.5 Sensitisation..................................................................................................................40 B 5.5.1 Sensitisation to chromium (VI) .................................................................................40 B 5.5.2 Sensitisation to chromium (III) .................................................................................51 B 5.6 Repeated dose toxicity..................................................................................................52 B 5.7 Mutagenicity.................................................................................................................53 B 5.8 Carcinogenicity ............................................................................................................53 B 5.9 Toxicity for reproduction .............................................................................................54 2 B 5.10 Other effects ...............................................................................................................55 B 5.11 Derivation of DNEL(s)/DMEL(s)..............................................................................55 B.6 Human health hazard assessment of physico-chemical properties.................................56 B.7 Environmental hazard assessment.....................................................................................56 B.8 PBT and vPvB assessment..................................................................................................56 B 8.1 Assessment of PBT/vPvB Properties – Comparison with the Criteria of Annex XIII.56 B 8.2 Emission Characterisation............................................................................................56 B.9 Exposure assessment ...........................................................................................................56 B.9.1 General discussion on release and exposure ................................................................56 B.9.1.1 Summary of the existing legal requirements.............................................................57 B.9.1.2 Summary of the effectiveness of the implemented operational conditions and risk management measures ...........................................................................................................60 B.9.2 Manufacturing ..............................................................................................................60 B.9.2.1 Occupational exposure ..............................................................................................60 B.9.2.2 Environmental release ...............................................................................................60 B.9.3 Formation of chromium (VI) in the production of leather ...........................................61 B.9.3.1 General information ..................................................................................................61 B.9.3.2 Exposure....................................................................................................................61 B.9.4 Other sources (for example natural sources, unintentional releases) ...........................64 B.9.5 Overall environmental exposure assessment................................................................65 B.10 Risk characterisation ........................................................................................................65 B.10.1 Formation of chromium (VI) in the production of leather .........................................65 B.10.1.1 Human health ..........................................................................................................65 B.10.1.2 Environment ............................................................................................................67 B.11 Summary on hazard and risk...........................................................................................67 C. Available information on alternatives.......................................................................................67 C.1 Identification of potential alternative substances and techniques..................................67 C.2 Assessment of techniques for the prevention of formation of chromium (VI) in leather and in articles of leather ............................................................................................................68
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