Committee for Risk Assessment (RAC) Committee for Socio-economic Analysis (SEAC) Background document to the Opinion on the Annex XV dossier proposing restriction on CADMIUM AND ITS COMPOUNDS IN ARTISTS’ PAINTS ECHA/RAC/RES-O-0000004990-69-02/F ECHA/SEAC/RES-O-0000004990-69-03/F IUPAC NAME: CADMIUM EC NUMBER: 231-152-8 (cadmium) CAS NUMBER: 7440-43-9 (cadmium) 9 March 2015 Background document to RAC and SEAC opinions on CADMIUM AND ITS COMPOUNDS IN ARTISTS’ PAINTS Table of contents PROPOSAL FOR A RESTRICTION .................................................................. 1 About this report .................................................................................................. 1 A. Proposal .................................................................................................. 3 A.1 Proposed restriction(s) .................................................................................... 3 A.1.1 The identity of the substance(s) ............................................................ 3 A.1.2 Scope and conditions of restriction ......................................................... 3 A.2 Targeting....................................................................................................... 5 A.3 Summary of the justification ............................................................................ 6 A.3.1 Identified hazard and risk ..................................................................... 6 A.3.2 Justification that action is required on a Union-wide basis ......................... 7 A.3.3 Justification that the proposed restriction is the most appropriate Union- wide measure .................................................................................. 8 B. Information on hazard and risk ............................................................... 8 B.1 Identity of the substance(s) and physical and chemical properties ........................ 8 B.1.1 Name and other identifiers of the substance(s) ........................................ 9 B.1.2 Composition of the substance(s) ........................................................... 10 B.1.3 Physicochemical properties .................................................................. 10 B.1.4 Justification for grouping...................................................................... 12 B.2 Manufacture and uses .................................................................................... 12 B.2.1 Manufacture, import and export of cadmium .......................................... 12 B.2.2 Uses .................................................................................................. 14 B.2.3 Uses advised against by the registrants ................................................. 17 B.3 Classification and labelling .............................................................................. 17 B.1.1 Classification and labelling in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) ............................................................................. 17 B.3.2 Classification and labelling in classification and labelling inventory/Industry’s self classification(s) and labelling ......................... 19 B.4 Environmental fate properties ......................................................................... 19 B.4.1 Degradation ....................................................................................... 21 B.4.2 Environmental distribution ................................................................... 21 B.4.2.1 Distribution in the aquatic environment .................................................. 21 B.4.2.2 Distribution in soil ................................................................................ 21 B.4.2.3 Adsorption/desorption .......................................................................... 22 B.4.2.4 Availability in soil of cadmium from pigments .......................................... 23 B.4.3 Bioaccumulation ................................................................................. 24 B.4.4 Secondary poisoning ........................................................................... 25 B.5 Human health hazard assessment ................................................................... 25 B.5.1 Toxicokinetics (absorption, metabolism, distribution and elimination) ........ 25 B.5.2 Acute toxicity ..................................................................................... 26 B.5.3 Irritation ............................................................................................ 26 B.5.4 Corrosivity ......................................................................................... 26 B.5.5 Sensitisation ...................................................................................... 26 B.5.6 Repeated dosed toxicity ....................................................................... 27 B.5.6.1 Lung toxicity ....................................................................................... 27 B.5.6.2 Kidney toxicity ..................................................................................... 27 B.5.6.3 Bone toxicity ....................................................................................... 28 B.5.7 Mutagenicity ...................................................................................... 36 B.5.8 Carcinogenicity ................................................................................... 36 B.5.8.1 Harmonized classification ...................................................................... 37 Background document to RAC and SEAC opinions on CADMIUM AND ITS COMPOUNDS IN ARTISTS’ PAINTS B.5.8.2 Cancer - tissues (Swedish Chemicals Agency 2011 and references therein unless indicated otherwise) .............................................................................. 37 B.5.9 Toxicity for reproduction ...................................................................... 40 B.5.9.1 Harmonized classification ...................................................................... 40 B.5.9.2 Developmental toxicity ......................................................................... 40 B.5.10 Other effects .................................................................................... 41 B.5.10.1 Overall mortality ................................................................................ 41 B.5.11 Derivation of DNEL(s)/DMEL(s) ........................................................... 41 B.6 Human health hazard assessment of physico-chemical properties ........................ 42 B.6.1 Explosivity ......................................................................................... 42 B.6.2 Flammability ...................................................................................... 42 B.6.3 Oxidising potential .............................................................................. 42 B.7 Environmental hazard assessment ................................................................... 42 B.7.1 Aquatic compartment (including sediments) ........................................... 42 B.7.2 Terrestrial compartment ...................................................................... 42 B.7.3 Atmospheric compartment ................................................................... 42 B.7.4 Microbiological activity in sewage treatment systems .............................. 42 B.7.5 Non compartment specific effects relevant for the food chain (secondary poisoning) ...................................................................................... 42 B.8 PBT and vPvB assessment .............................................................................. 43 B.8.1 Assessment of PBT/vPvB Properties – Comparison with the Criteria of Annex XIII ...................................................................................... 43 B.8.2 Emission Characterisation .................................................................... 43 B.9 Exposure assessment ..................................................................................... 43 B.9.1 General discussion on releases and exposure ......................................... 43 B.9.1.1 Summary of the existing legal requirements ........................................... 43 B.9.1.2 Summary of the effectiveness of the implemented operational conditions and risk management measures ....................................................................... 43 B.9.2 Manufacturing .................................................................................... 43 B.9.2.1 Occupational exposure ......................................................................... 43 B.9.2.2 Environmental release .......................................................................... 44 B.9.3 User Scenario –Release from usage of artists’ paints ....................................... 44 B.9.3.1 General information on releases ............................................................ 44 B.9.3.1.1 Release from usage of artists’ paints ................................................ 44 B.9.3.2 Exposure estimation ............................................................................. 49 B.9.3.2.1 Workers exposure .......................................................................... 50 B.9.3.2.2 Consumer exposure ....................................................................... 50 B.9.3.2.3 Indirect exposure of humans via the environment .............................. 50 B.9.3.2.4 Environmental exposure ................................................................