BACKGROUND DOCUMENT to the opinion on the Annex XV dossier proposing restrictions on Methanol Committee for Risk Assessment (RAC) Committee for Socio-economic Analysis (SEAC) Background document to the Opinion on the Annex XV dossier proposing restrictions on Methanol ECHA/RAC/RES-O-0000006324-78-01/F ECHA/SEAC/RES-O-0000001412-86-100/F EC Number CAS Number 200-659-6 67-56-1 11 March 2016 BACKGROUND DOCUMENT to the opinion on the Annex XV dossier proposing restrictions on Methanol About this document This Background Document to the opinions of RAC and SEAC is an amended version of the Annex XV restriction report submitted by Poland. The amendments include further information obtained during the public consultations and other relevant information resulting from the opinion making process. The evaluation made by RAC and SEAC of the information presented in this document can be found in their opinions and justification. Where relevant some additional assessment by the RAC and SEAC rapporteurs can be found in boxes in the document. Contents A. Proposal .................................................................................................................................................................... 5 A.1 Proposed restriction(s) ................................................................................................. 5 A.1.1 The identity of the substance ....................................................................................................................... 5 A.1.2 Scope and conditions of restriction(s) ......................................................................................................... 5 A proposal for an Annex XVII entry is given below: ..................................................................... 5 A.2 Targeting ............................................................................................................... 7 A.3 Summary of the justification .......................................................................................... 9 A.3.1 Identified hazard and risk ............................................................................................................................ 9 A.3.2 Justification that action is required on a Union-wide basis ....................................................................... 10 A.3.3 Justification that the proposed restriction is the most appropriate Union-wide measure .......................... 10 B. Information on hazard and risk ............................................................................................................................... 12 B.1 Identity of the substance(s) and physical and chemical properties ................................................ 12 B.1.1 Name and other identifiers of the substance .............................................................................................. 12 B.1.2 Composition of the substance .................................................................................................................... 13 B.1.3 Physicochemical properties ....................................................................................................................... 13 B.1.4 Justification for grouping .......................................................................................................................... 14 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 ..................................................................................................... 15 B.3 Classification and labelling .......................................................................................... 15 B.3.1 Classification and labelling in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) .............. 15 B.3.2 Classification and labelling in classification and labelling inventory/ ...................................................... 16 Industry’s self classification(s) and labelling ...................................................................................................... 16 B.4 Environmental fate properties ....................................................................................... 17 B.5 Human health hazard assessment ................................................................................... 17 B.5.1 Toxicokinetics (absorption, metabolism, distribution and elimination) .................................................... 17 B.5.1.1. Non-human information ........................................................................................................................ 17 B.5.1.2. Human information ............................................................................................................................... 20 B.5.1.3. Summary and discussion of toxicokinetics ............................................................................................ 32 B 5.2 Acute toxicity ............................................................................................................................................ 33 B.5.2.1. Non-human information ........................................................................................................................ 33 B.5.2.1.1. Acute toxicity: oral ............................................................................................................................. 33 B.5.2.1.2. Acute toxicity: inhalation ................................................................................................................... 34 B.5.2.1.3. Acute toxicity: dermal ........................................................................................................................ 35 B.5.2.1.4. Acute toxicity: other routes ................................................................................................................ 35 B.5.2.2. Human information ............................................................................................................................... 36 B.5.2.3. Summary and discussion of acute toxicity ............................................................................................ 39 B 5.3 Irritation ..................................................................................................................................................... 40 B.5.3.1. Skin ........................................................................................................................................................ 40 B.5.3.2. Eye ......................................................................................................................................................... 40 B 5.4 Corrosivity ................................................................................................................................................. 40 B 5.5 Sensitisation ............................................................................................................................................... 40 B 5.6 Repeated dosed toxicity ............................................................................................................................. 40 B.5.6.1. Non-human information ........................................................................................................................ 40 B.5.6.1.1. Repeated dose toxicity: oral ............................................................................................................... 40 B 5.7 Mutagenicity .............................................................................................................................................. 49 B 5.8 Carcinogenicity ......................................................................................................................................... 49 B 5.9 Toxicity for reproduction .......................................................................................................................... 49 B 5.10 Other effects ............................................................................................................................................ 49 B.5.10.1. Non-human information ...................................................................................................................... 49 BACKGROUND DOCUMENT to the opinion on the Annex XV dossier proposing restrictions on Methanol B.5.10.1.1. Neurotoxicity .................................................................................................................................... 49 B.5.10.1.2. Immunotoxicity ................................................................................................................................ 49 B.5.10.1.3. Specific investigations: other studies ................................................................................................ 49 B.5.10.2. Human information ............................................................................................................................. 52 B.5.10.3. Summary and discussion of other effects ............................................................................................ 56 B 5.11 Derivation of