Committee for Risk Assessment (RAC) Committee for Socio-economic Analysis (SEAC) Background Document to the Opinion on the Annex XV dossier proposing restrictions on 1,4-dichlorobenzene ECHA/RAC/RES-O-0000003486-69-01/F ECHA/SEAC/[reference code to be added after the adoption of the SEAC opinion] EC NUMBER CAS NUMBER 203-400-5 106-46-7 11 April, 2013 BACKGROUND DOCUMENT TO RAC AND SEAC OPINIONS ON 1,4-dichlorobenzene Change history Revision n. Reason for change Date Prepared by 1 Background Document 12/10/2012 Dossier submitter 2 Background Document 14/10/2012 RAC Rapporteur 3 Background Document 31/01/2013 RAC Rapporteur 4 Background Document 01/03/2013 RAC RApporteur 5 Background Document 12/03/2013 RAC Rapporteur 6 Background Document 18/03/2013 SEAC Rapporteur 7 Background Document 08/04/2013 RAC Rapporteur 2 BACKGROUND DOCUMENT TO RAC AND SEAC OPINIONS ON 1,4-dichlorobenzene CONTENT A. Proposal ............................................................................................................. 3 A.1 Proposed restriction ..................................................................................... 3 A.1.1 The identity of the substance ...................................................................... 3 A.1.2 Scope and conditions of restriction ............................................................... 3 A.2 Summary of the justification ........................................................................ 5 A.2.1 Identified hazard and risk ........................................................................... 5 A.2.2 Justification that action is required on an EU-wide basis.................................. 7 A.2.3 Justification that the proposed restriction is the most appropriate EU-wide measure ........................................................................................................... 7 B. Information on hazard and risk ........................................................................ 10 B.1 Identity of the substance(s) and physical and chemical properties ............ 10 B.1.1 Name and other identifiers of the substance(s) ............................................ 10 B.1.2 Composition of the substance(s) ................................................................ 11 B.1.3 Physicochemical properties ....................................................................... 11 B.1.4 Justification for grouping .......................................................................... 13 B.2 Manufacture and uses ................................................................................. 14 B.2.1 Manufacture, import and export of a substance ........................................... 14 B.2.2 Uses ...................................................................................................... 15 B.2.3 Uses advised against by the registrants ...................................................... 19 B.2.4 Description of targeting ............................................................................ 19 B.3 Classification and labelling ......................................................................... 20 B.3.1 Classification and labelling in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) ..................................................................................................... 20 B.3.2 Classification and labelling in classification and labelling inventory ................. 22 B.4 Environmental fate properties .................................................................... 22 B.4.1 Degradation ............................................................................................ 23 B.4.2 Environmental distribution ........................................................................ 23 B 4.3 Bioaccumulation ...................................................................................... 23 B.4.4 Secondary poisoning ................................................................................ 23 B.5 Human health hazard assessment .............................................................. 23 B.5.1 Toxicokinetics (absorption, metabolism, distribution and elimination) ............. 23 B.5.1.1 Non-human information ......................................................................... 23 B.5.1.2 Human information ............................................................................... 25 B.5.1.3 Conclusions .......................................................................................... 26 B.5.2 Acute toxicity .......................................................................................... 26 B.5.2.1 Non-human information ......................................................................... 26 B.5.2.2 Human information ............................................................................... 27 B.5.2.3 Conclusion ........................................................................................... 28 B.5.3 Irritation ................................................................................................. 28 B.5.3.1 Non-human information ......................................................................... 28 B.5.3.2 Human information ............................................................................... 29 B.5.3.3 Conclusions .......................................................................................... 29 B.5.4 Corrosivity .............................................................................................. 30 B.5.5 Sensitisation ........................................................................................... 30 B.5.5.1 Non-human information ......................................................................... 30 B.5.5.2 Human information ............................................................................... 30 B.5.5.3 Conclusions .......................................................................................... 41 B 5.6 Repeated dosed toxicity ............................................................................ 41 B.5.6.6 Non-human information ......................................................................... 41 B.5.6.2 Human information ............................................................................... 46 B.5.6.3 Conclusions .......................................................................................... 47 3 BACKGROUND DOCUMENT TO RAC AND SEAC OPINIONS ON 1,4-dichlorobenzene B.5.8.1 Non-human information ......................................................................... 49 B.5.8.2 Human information ............................................................................... 51 B.5.8.3 Mode of action of the carcinogenic effects ................................................ 51 B.5.8.3 Conclusions .......................................................................................... 55 B.5.9 Toxicity for reproduction ........................................................................... 55 B.5.9.1 Non-human information ......................................................................... 55 B.5.9.2 Human information ............................................................................... 58 B.5.9.3 Conclusions .......................................................................................... 58 B.5.10 Other effects ......................................................................................... 59 B.5.10.1 Non-human information ....................................................................... 59 B.5.10.2 Human information .............................................................................. 61 B.5.10.3 Conclusions ........................................................................................ 61 B 5.11 Derivation of DNEL(s)/DMEL(s) ................................................................ 61 B.6 Human health hazard assessment of physico-chemical properties ............. 75 B.6.1 Explosivity .............................................................................................. 75 B.6.2 Flammability ........................................................................................... 75 B.6.3 Oxidising potential ................................................................................... 75 B.7 Environmental hazard assessment ............................................................. 75 B.8 PBT and vPvB assessment .......................................................................... 75 B.9 Exposure assessment ................................................................................. 75 B.9.1 General discussion on releases and exposure .............................................. 75 B.9.1.2 Summary of the relevant operational conditions (OCs) and risk management measures (RMMs) ............................................................................................ 79 B.9.2 Manufacturing ......................................................................................... 84 B.9.3 Use of 1,4-Dichlorobenzene in toilet blocks/air fresheners ............................. 84 B.9.3.1 General information .............................................................................. 84 B.9.3.2 Exposure estimation .............................................................................. 85 B.9.3.2.4 Summary of the estimated exposure levels for professional workers and consumers ...................................................................................................... 98 B.10 Risk characterisation .............................................................................