ANNEX XV REPORT PROPOSAL FOR A RESTRICTION SUBSTANCE NAME(S): (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silanetriol and any of its mono-, di- or tri-O-(alkyl) derivatives IUPAC NAME(S): N.A. (group entry) EC NUMBER(S): N.A. (group entry) CAS NUMBER(S): N.A. (group entry) INDEX NUMBER(S): N.A. (group entry) Where X = alkyl groups or hydrogen 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 VERSION NUMBER: 20.4.2016 1 CONTENT ANNEX XV REPORT ................................................................................................................... 1 PROPOSAL FOR A RESTRICTION ...................................................................................... 1 CONTENT ........................................................................................................................................ 2 A. Proposal .................................................................................................................................... 6 A.1 Proposed restriction(s) ................................................................................................ 6 A.1.1 The identity of the substance(s) .................................................................. 6 A.1.2 Scope and conditions of the restriction .................................................... 6 A.2 Summary of the justification ..................................................................................... 8 A.2.1 Identified hazard and risk ................................................................................ 8 A.2.2 Justification that action is required on a Union-wide basis ......... 9 A.2.3 Justification that the proposed restriction is the most appropriate Union-wide measure.............................................................................. 9 A.2.4 Summary ................................................................................................................... 11 A.3 Main uncertainties ................................................................................................... 11 B. Information on hazard and risk ............................................................................... 13 B.1 Identity of the substance(s) and physical and chemical properties ............................................................................................................................................................ 13 B.1.1 Name and other identifiers of the substance(s) ............................... 13 B.1.2 Composition of the substances and mixtures ..................................... 16 B.1.3 Physicochemical properties ........................................................................... 19 B.1.4 Justification for grouping ................................................................................ 19 B.2 Manufacture and uses ................................................................................................. 19 B.2.1 Manufacture, import and export of the substances ........................ 19 B.2.1.1 Manufacture of TDFAs in the EU ............................................................... 19 B.2.1.2 Manufacture of TDFAs outside the EU..................................................... 20 B.2.1.3 Import and export of TDFAs ....................................................................... 20 B.2.2 Uses of the substances in mixtures in spray products for the general public ...................................................................................................................... 20 B.2.2.1 Formulation of mixtures to be used in spray products .................... 20 B.2.2.2 The supply chain in general ........................................................................ 23 B.2.3 Description of targeting ................................................................................... 26 B.3 Classification and labelling ....................................................................................... 26 B.3.1 Classification and labelling in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) .................................................................................... 26 B.3.2 Classification and labelling in classification and labelling inventory/ Industry’s self-classification(s) and labelling ....................... 26 B.4 Environmental fate properties ............................................................................... 27 B.5 Human health hazard assessment ....................................................................... 27 B.5.1 Toxicokinetics (absorption, metabolism, distribution and elimination) .......................................................................................................................... 27 B.5.2 Acute toxicity .......................................................................................................... 27 B.5.2.1 Acute inhalation toxicity - Animal studies ............................................. 27 B.5.2.2 Acute inhalation toxicity - Human incidents with impregnation spray products .................................................................................................................. 37 B.5.2.3 Summary of acute inhalation toxicity ..................................................... 42 2 B.5.3 Irritation .................................................................................................................. 43 B.5.3.1 Skin irritation .................................................................................................... 43 B.5.3.2 Eye irritation ...................................................................................................... 43 B.5.3.3 Respiratory irritation ...................................................................................... 43 B.5.4 Corrosivity ................................................................................................................ 43 B.5.5 Sensitisation ............................................................................................................ 43 B.5.6 Repeated dose toxicity ..................................................................................... 43 B.5.7 Mutagenicity ............................................................................................................ 44 B.5.8 Carcinogenicity ...................................................................................................... 44 B.5.9 Toxicity for reproduction ................................................................................. 44 B.5.10 Other effects......................................................................................................... 44 B.5.11 Derivation of no-effect concentration (DNEL) ................................. 44 B.6 Human health hazard assessment of physico-chemical properties 45 B.7 Environmental hazard assessment and PBT and vPvB assessment 45 B.8 Exposure assessment .................................................................................................. 45 B.8.1 General discussion on releases and exposure .................................... 45 B.8.1.1 Summary of the existing legal requirements ....................................... 46 B.8.1.2 Summary of the effectiveness of the implemented operational conditions and risk management measures ......................................................... 46 B.8.2 Manufacturing ........................................................................................................ 46 B.8.2.1 Occupational exposure .................................................................................. 46 B.8.2.2 Environmental release ................................................................................... 46 B.8.3 Use - spray application .................................................................................... 46 B.8.4 Other sources (for example natural sources, unintentional releases) ................................................................................................................................. 51 B.8.5 Overall environmental exposure assessment ..................................... 51 B.8.6 Combined human exposure assessment ................................................ 51 B.9 Risk characterisation ................................................................................................... 51 B.9.1 Use in aerosol dispensers, pump and trigger sprays ..................... 51 B.9.1.1 Human health ..................................................................................................... 51 B.9.1.2 Environment ...................................................................................................... 54 B.10 Summary on hazard and risk................................................................................ 54 C. Available information on alternatives .................................................................. 55 C.1 Identification of potential alternative substances and techniques . 55 C.2 Assessment of alternative application methods for the mixtures concerned .................................................................................................................................... 55 C.2.1 Human health risks associated with alternative application ..... 55 C.2.3 Environment risks related to alternative application methods 56 C.2.3 Availability of application methods ..........................................................