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Echa/Rac/A77-0-0000001412-86-189/F ANNEX 1 Background Document in support of the Committee for Risk Assessment (RAC) for evaluation of limit values for nickel and its compounds in the workplace Prepared by the European Chemicals Agency ECHA/RAC/A77-0-0000001412-86-189/F 9 March 2018 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 2 ANNEX 1 - BACKGROUND DOCUMENT TO RAC OPINION ON NICKEL AND ITS COMPOUNDS Preamble The Commission, in view of the preparation of the third and fourth proposals for amendment of Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (CMD), and in line with the 2017 Commission Communication ‘Safer and Healthier Work for All’ - Modernisation of the EU Occupational Safety and Health Legislation and Policy’1, asked the advice of RAC to assess the scientific relevance of occupational exposure limits for some carcinogenic chemical substances. Therefore, the Commission made a request (8 March 20172) in accordance with Article 77 (3)(c) of the REACH Regulation, to evaluate, in accordance Directive 2004/37/EC, the following chemical compounds: 4,4'-methylenebis[2-chloroaniline] (MOCA), arsenic acid and its inorganic salts, nickel and its compounds, acrylonitrile and benzene. In support of the Commission’s request, ECHA prepared a proposal concerning occupational limit values for nickel and its compounds at the workplace. This proposal was made publically available at: ‘https://echa.europa.eu/echas-executive-director-requests- to-the-committees-previous-consultations’ on 10 October 2017 and interested parties were invited to submit comments by 7 November 2017. The Committee for Risk Assessment (RAC) developed its opinion on the basis of the proposal submitted by ECHA. During the preparation of the opinion on occupational limit values for nickel and its compounds, the ECHA proposal was further developed as the Background Document. In addition, stakeholders were able to provide comments on the RAC opinion during the evaluation process. Following adoption of an opinion on 9 March 2018, recommending an Occupational Exposure Limit for nickel and its compounds by RAC, this Background Document was amended to align it appropriately with the view of RAC. It supports the opinion of the RAC and gives the detailed grounds for the opinion3. 1 http://ec.europa.eu/social/main.jsp?langId=en&catId=148&newsId=2709&furtherNews=yes 2 https://echa.europa.eu/documents/10162/13641/ec_note_to_echa_oels_en.pdf/f72342ef-7361- 0d7c-70a1-e77243bdc5c1 3 https://echa.europa.eu/documents/10162/13579/interim_wponevaluation_oel_agreed_rac_42_en. pdf/021bc290-e26c-532f-eb3f-52527700e375 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu ANNEX 1 - BACKGROUND DOCUMENT TO RAC OPINION ON NICKEL AND ITS COMPOUNDS 3 Table of Contents LITERATURE SEARCH ...................................................................................................... 9 1. CHEMICAL AGENT IDENTIFICATION AND PHYSICO-CHEMICAL PROPERTIES ....................... 9 NICKEL ................................................................................................................ 9 NICKEL COMPOUNDS............................................................................................. 9 1.2.1 Inorganic compounds ................................................................................... 10 1.2.2 Organic compounds ..................................................................................... 10 2. EU HARMONISED CLASSIFICATION AND LABELLING - CLP (EC) 1271/2008 ........................ 10 3. CHEMICAL AGENT AND SCOPE OF LEGISLATION - REGULATED USES OF NICKEL AND ITS COMPOUNDS IN THE EU .................................................................................................. 13 DIRECTIVE 98/24/EC AND DIRECTIVE 2004/37/EC ................................................... 13 REACH REGISTRATIONS ........................................................................................ 14 AUTHORISED USES UNDER ANNEX XIV OF REACH .................................................... 15 RESTRICTED USES UNDER ANNEX XVII OF REACH .................................................... 15 PLANT PROTECTION PRODUCTS REGULATION (EC)1107/2009 .................................... 15 HUMAN AND VETERINARY MEDICINAL PRODUCTS DIRECTIVES 2001/83/EC AND 2004/28/EC RESPECTIVELY ................................................................................................ 15 BIOCIDAL PRODUCTS REGULATION (EU)528/2012 .................................................... 15 4. EXISTING OCCUPATIONAL EXPOSURE LIMITS................................................................. 15 5. OCCURRENCE, USE AND OCCUPATIONAL EXPOSURE ....................................................... 19 OCCURRENCE ....................................................................................................... 19 PRODUCTION AND USE INFORMATION .................................................................... 19 OCCUPATIONAL EXPOSURE .................................................................................... 34 5.3.1 Occupational exposure across all the main uses and production of nickel and nickel compounds .............................................................................................. 34 5.3.2 Considerations on particulate matter in order to establish size selective OEL values46 ROUTES OF EXPOSURE AND UPTAKE ....................................................................... 46 5.4.1 Worker exposure ......................................................................................... 46 5.4.2 General population ....................................................................................... 46 6. MONITORING EXPOSURE ............................................................................................. 47 EXTERNAL EXPOSURE ............................................................................................ 47 BIOMONITORING OF EXPOSURE (INTERNAL EXPOSURE) ........................................... 48 6.2.1 Background levels of nickel ........................................................................... 49 6.2.2 Occupational exposure ................................................................................. 51 6.2.2.1 Relationship between external and internal nickel exposures ................. 52 6.2.3 Biomonitoring analytical methods .................................................................. 56 7. HEALTH EFFECTS ........................................................................................................ 56 TOXICOKINETICS (ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION - ADME) 56 4 ANNEX 1 - BACKGROUND DOCUMENT TO RAC OPINION ON NICKEL AND ITS COMPOUNDS 7.1.1 Human data ................................................................................................ 56 7.1.2 Animal data ................................................................................................ 59 7.1.3 In vitro data ................................................................................................ 60 7.1.4 Further in invitro studies are reported in section 7.6.3. Toxicokinetic modelling ... 60 7.1.5 Biological monitoring .................................................................................... 61 7.1.6 Summary.................................................................................................... 61 ACUTE TOXICITY ................................................................................................... 61 7.2.1 Human data ................................................................................................ 61 7.2.2 Animal data ................................................................................................ 62 7.2.3 In vitro data ................................................................................................ 65 7.2.4 Summary.................................................................................................... 65 SPECIFIC TARGET ORGAN TOXICITY/REPEATED DOSE TOXICITY ................................ 65 7.3.1 Human data ................................................................................................ 66 7.3.2 Animal data ................................................................................................ 67 7.3.3 In vitro data ................................................................................................ 77 7.3.4 Summary.................................................................................................... 77 IRRITANCY AND CORROSIVITY ............................................................................... 77 7.4.1 Human data ................................................................................................ 77 7.4.2 Animal data ................................................................................................ 78 7.4.3 In vitro data ................................................................................................ 78 7.4.4 Summary.................................................................................................... 79 SENSITISATION .................................................................................................... 79 7.5.1 Human data ................................................................................................ 79 7.5.2 Animal data ...............................................................................................
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