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Draft Analysis of the Most Appropriate Risk Management Option for Nickel Oxide

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Draft Analysis of the Most Appropriate Risk Management Option for Nickel Oxide DRAFT ANALYSIS OF THE MOST APPROPRIATE RISK MANAGEMENT OPTION FOR NICKEL OXIDE Substance name: Nickel oxide EC number: 215-215-7 and 234-323-5 CAS number: 1313-99-1 and 11099-02-8 Submitted by: FRANCE (Anses - French Mandated National Institute) Date: April 2014 This report is a non-confidential version that can be made publicly available. All data considered confidential by the registrants have been hidden. CONTENTS 1 Background information .................................................................................................... 4 1.1 Substance identity ........................................................................................................ 4 1.2 Classification and labelling ......................................................................................... 5 1.3 Information on the REACH registration status ........................................................... 6 1.3.1 Registration status ................................................................................................ 6 1.3.2 Registrants’ identity ............................................................................................. 6 1.4 Information on any previous risk assessment, risk reduction strategy and RMO analyses .................................................................................................................................. 8 1.4.1 Previous risk assessment carried out under Council Regulation 793/93.............. 9 1.4.2 Previous risk reduction strategy carried out under Council Regulation 793/93... 9 1.4.3 Previous RMO analysis carried out on environment by Denmark ..................... 10 1.5 Current legal requirements for nickel and nickel compounds under REACH and other EU legislations ............................................................................................................ 11 1.5.1 EU general legislations on dangerous chemicals ............................................... 11 1.5.2 EU workplace legislation regarding occupational health and safety ................. 12 1.5.3 EU legislation regarding consumer protection ................................................... 12 1 1.5.4 EU legislation regarding protection of the environment and/or covering human health safety through environmental exposure ................................................................. 13 1.5.5 Focus on current instruments setting occupational exposure limit values ......... 14 2 Uses, volumes, market picture and alternatives per main use .......................................... 16 2.1 Volumes manufactured and used in the EU .............................................................. 19 2.1.1 The data quality issue ......................................................................................... 19 2.1.2 Estimated volumes ............................................................................................. 19 2.2 Production of nickel oxide ......................................................................................... 21 2.3 Downstream uses of nickel oxide .............................................................................. 21 2.3.1 Distinction made between chemical and metallurgical nickel oxide grades ...... 21 2.3.2 Production and use of nickel oxide catalyst precursors ..................................... 23 2.3.3 Use of nickel oxide for the production of nickel based powders ....................... 38 2.3.4 Use of nickel oxide for the production of nickel-containing electronics and thermally functioning ceramics ........................................................................................ 38 2.3.5 Use of nickel oxide for the production of nickel-containing frits ...................... 39 2.3.6 Use of nickel oxide for the production of nickel-containing pigments .............. 47 2.3.7 Use of nickel oxide for the production of nickel-containing glass .................... 57 2.3.8 Use of nickel oxide for the production of of stainless steel, special steels and special alloys .................................................................................................................... 73 2.3.9 Use of nickel oxide for the production of NiZn cores and solids from nickel oxide powder .................................................................................................................... 73 2.3.10 Use of nickel oxide for the production of other nickel chemicals...................... 73 3 Risk assessment and objectives for further risk management .......................................... 75 3.1 Hazard identification ................................................................................................. 75 3.2 Risk assessment based on the REACH registration dossiers .................................... 75 3.3 Health hazard related to nickel oxide ........................................................................ 76 3.3.1 Toxicokinetics .................................................................................................... 76 3.3.2 Acute toxicity ..................................................................................................... 77 3.3.3 Irritation and corrosivity ..................................................................................... 77 3.3.4 Sensitization ....................................................................................................... 77 3.3.5 Repeated dose toxicity ....................................................................................... 78 3.3.6 Mutagenicity ....................................................................................................... 80 2 3.3.7 Carcinogenicity .................................................................................................. 81 3.3.8 Reproductive toxicity ......................................................................................... 82 3.4 Derivation of Reference Values ................................................................................ 83 3.4.1 Acute exposure ................................................................................................... 83 3.4.2 Chronic exposure ................................................................................................ 84 3.5 Exposure data and risk characterization .................................................................... 87 3.5.1 Data description .................................................................................................. 87 3.5.2 Risk characterization per GES ........................................................................... 87 3.5.3 Overall conclusion on exposure assessment and risk characterization ............ 107 3.6 Need and objectives for further risk assessment and risk management .................. 107 3.6.1 Need for further risk assessment ...................................................................... 107 3.6.2 Need for further risk management ................................................................... 108 4 Identification and assessment of current and further Risk management options ........... 109 4.1 Existing non-REACH legislations or recommendations ......................................... 110 4.1.1 EU general legislations on hazardous chemicals ............................................. 110 4.1.2 EU workplace legislation and recommendations regarding occupational health 110 4.2 Risk management measures under REACH ............................................................ 117 4.2.1 REACH Annex XVII - Restriction .................................................................. 117 4.2.2 REACH Annex XIV - Authorisation .............................................................. 140 5 Conclusions on the most appropriate (combination of) risk management option(s) ..... 162 3 DRAFT ANALYSIS OF THE MOST APPROPRIATE RISK MANAGEMENT OPTION FOR NICKEL OXIDE Substance name: Nickel oxide (nickel monoxide) EC number: 215-215-7 and 234-323-5 CAS number: 1313-99-1 and 11099-02-8 Submitted by: FRANCE (Anses - French Mandated National Institute) Date: April 2014 Nickel monoxide (NiO) belongs to the family of nickel compounds including nickel metal, nickel salts, organometallic nickel substances (etc.). More than a hundred are classified under the CLP Regulation. At least 26 nickel compounds are registered under REACH 1, 16 as full dossiers (REACH Article 10), 8 as intermediate dossiers (REACH article 18) and 2 with both full and intermediate dossiers (see Appendix 2). Additional registrations can also be expected. From those 26 nickel compounds, 6 have been selected by the French Competent Authority on the basis of Anses’s proposal for further assessment (nickel sulphate, hydroxycarbonate, dichloride, dinitrate, bis(hydrogen)phosphate and monoxide). Substances registered only as intermediates have been excluded at this stage. In a first approach, risk management option analysis (RMOA) are carried out on nickel sulphate (NiSO 4) and NiO as both salts cover substantially the majority the uses reported for nickel compounds which may facilitate extrapolation to other compounds in a potential second approach. The Nickel Institute groups nickel containing chemicals into five main classes: metallic nickel, nickel carbonyl, oxidic nickel (e.g. nickel oxides, hydroxide, silicates, carbonates, complex nickel oxides), sulfidic nickel (e.g. nickel sulfide, nickel subsulfide), and water- soluble nickel containing chemicals (e.g. nickel sulfate hexahydrate, nickel chloride hexahydrate). The group of “oxidic nickel”
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