ANNEX 1 – BACKGROUND DOCUMENT TO RAC OPINION ON WHITE SPIRIT Committee for Risk Assessment RAC Annex 1 Background document to the Opinion proposing harmonised classification and labelling at Community level of white spirit Stoddard solvent 1 EC number: 232-489-3; CAS number: 8052-41-3 Naphtha (petroleum), hydrodesulphurized heavy 2 EC number: 265-185-4; CAS number: 64742-82-1 Solvent naphtha (petroleum), medium aliphatic 3 EC number: 265-191-7; CAS number: 64742-88-7 ECHA/RAC/DOC No CLH-O-0000001193-82-03/A1 ECHA/RAC/DOC No CLH-O-0000001745-71-01/A1 ECHA/RAC/DOC No CLH-O-0000000944-70-02/A1 Adopted 10 June 2011 Please, note: the original CLH proposal presented in the ECHA Public consultation included also naphtha (petroleum), solvent-refined heavy (EC No 265-095-5; CAS No 64741-92-0, white spirit type 2) and naphtha (petroleum), hydrotreated heavy (EC No 265-150-3; CAS No 64742-48-9, white spirit type 3) which were withdrawn by the dossier submitter . 1 USA term for white spirit, which corresponds to white spirit type 1 2 White spirit type 1 3 White spirit type 0 - 1 - ANNEX 1 – BACKGROUND DOCUMENT TO RAC OPINION ON WHITE SPIRIT CONTENTS 1 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES .................................9 1.1 Name and other identifiers of the substance ...................................................................................................10 1.2 Composition of the substance.........................................................................................................................11 1.3 Physico-chemical properties...........................................................................................................................16 2 MANUFACTURE AND USES..............................................................................................................................17 2.1 Manufacture....................................................................................................................................................17 2.2 Identified uses.................................................................................................................................................17 2.3 Uses advised against.......................................................................................................................................18 3 CLASSIFICATION AND LABELLING ...............................................................................................................19 3.1 Classification in Annex I of Directive 67/548/EEC and in Annex VI of Regulation (EC) no. 1272/2008.....19 3.2 Self classification(s) .......................................................................................................................................20 4 ENVIRONMENTAL FATE PROPERTIES...........................................................................................................21 4.1 Degradation ....................................................................................................................................................21 4.1.1 Stability ...............................................................................................................................................21 4.1.2 Biodegradation ....................................................................................................................................21 4.1.3 Summary and discussion of persistence ..............................................................................................21 4.2 Environmental distribution .............................................................................................................................21 4.2.1 Adsorption/desorption.........................................................................................................................21 4.2.2 Volatilisation .......................................................................................................................................21 4.2.3 Distribution modelling ........................................................................................................................21 4.3 Bioaccumulation.............................................................................................................................................21 4.3.1 Aquatic bioaccumulation.....................................................................................................................21 4.3.2 Terrestrial bioaccumulation.................................................................................................................21 4.3.3 Summary and discussion of bioaccumulation .....................................................................................21 4.4 Secondary poisoning.......................................................................................................................................21 5 HUMAN HEALTH HAZARD ASSESSMENT.....................................................................................................22 5.1 Toxicokinetics (absorption, metabolism, distribution and elimination) .........................................................23 5.2 Acute toxicity .................................................................................................................................................28 5.2.1 Acute toxicity: oral..............................................................................................................................28 5.2.2 Acute toxicity: inhalation ....................................................................................................................28 5.2.3 Acute toxicity: dermal.........................................................................................................................28 5.2.4 Acute toxicity: other routes .................................................................................................................28 5.2.5 Summary and discussion of acute toxicity ..........................................................................................28 5.3 Irritation..........................................................................................................................................................28 5.3.1 Skin .....................................................................................................................................................28 5.3.2 Eye.......................................................................................................................................................28 5.3.3 Respiratory tract ..................................................................................................................................28 2 ANNEX 1 – BACKGROUND DOCUMENT TO RAC OPINION ON WHITE SPIRIT 5.3.4 Summary and discussion of irritation..................................................................................................28 5.4 Corrosivity......................................................................................................................................................28 5.5 Sensitisation....................................................................................................................................................28 5.5.1 Skin .....................................................................................................................................................28 5.5.2 Respiratory system ..............................................................................................................................28 5.5.3 Summary and discussion of sensitisation ............................................................................................28 5.6 Repeated dose toxicity....................................................................................................................................28 5.6.1 Repeated dose toxicity: oral ................................................................................................................29 5.6.2 Repeated dose toxicity: inhalation.......................................................................................................29 5.6.3 Repeated dose toxicity: dermal ...........................................................................................................52 5.6.4 Other relevant information ..................................................................................................................52 5.6.5 Summary and discussion of repeated dose toxicity:............................................................................52 5.7 Mutagenicity...................................................................................................................................................62 5.7.1 In vitro data .........................................................................................................................................62 5.7.2 In vivo data..........................................................................................................................................62 5.7.3 Human data .........................................................................................................................................62 5.7.4 Other relevant information ..................................................................................................................62 5.7.5 Summary and discussion of mutagenicity...........................................................................................62 5.8 Carcinogenicity...............................................................................................................................................62