Committee for Risk Assessment RAC Opinion on Arsenic acid and its inorganic salts ECHA/RAC/A77-O-0000001412-86-148/F Adopted 29 May 2017 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 2 RAC Opinion 29 May 2017 ECHA/RAC/A77-O-0000001412-86-148/F OPINION OF THE COMMITTEE FOR RISK ASSESSMENT ON THE EVALUATION OF THE OCCUPATIONAL EXPOSURE LIMITS (OELs) FOR ARSENIC ACID AND ITS INORGANIC SALTS Pursuant to Article 77(3)(c) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (the REACH Regulation), the Committee for Risk Assessment (RAC) has adopted an opinion on the evaluation of the scientific relevance of occupational exposure limits (OELs) for arsenic acid and its inorganic salts. Commission request The Commission, in view of the preparation of the third and fourth proposal for an 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, has decided to ask the advice of RAC to assess the scientific relevance of occupational exposure limits for some carcinogenic chemical substances. Therefore, the Commission has made a request (8 March 20172) in accordance with Article 77 (3)(c) of the REACH Regulation, to evaluate, in accordance with Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work (CAD) and/or Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (CMD), the following chemical compounds: 4,4'-methylenebis[2-chloroaniline] (MOCA), arsenic acid and its inorganic salts, nickel and its compounds, acrylonitrile and benzene. I PROCESS FOR ADOPTION OF THE OPINION Following a request from the European Commission, in the mandate of 15 March 20173, the Executive Director of ECHA requested RAC to draw up an opinion on the evaluation of the scientific relevance of occupational exposure limits (OELs) for arsenic acid and its inorganic salts. The aim of the opinion is to provide scientific advice in support of the Commission action on the Proposal to amend Directive 2004/37/EC (3rd wave of amendment). This advice must include a recommendation to be given to the Advisory Committee on Safety and Health at Work (ACSH) in line with the relevant OSH legislative procedures and in the format used by SCOEL in drafting its opinion. An initial proposal was prepared by the European Chemicals Agency for the consideration by RAC. The current opinion was reviewed by RAC in a written commenting round from 05 May 2017 to 23 May 2017 and at the RAC-41 meeting,. Due to imposed time constraints, the opinion was not subject to a Public Consultation. 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/10162/13641/rac_mandate_oels_en.pdf/9f9b7fb9-545a- 214c-69f0-dff5f5092174 RAC Opinion 3 II ADOPTION OF THE OPINION OF THE RAC Rapporteur, appointed by the RAC: Tiina Santonen. The RAC opinion was adopted by consensus on 29 May 2017.… 4 RAC Opinion Table of Contents RECOMMENDATION ............................................................................................ 8 SUMMARY TABLE ............................................................................................ 8 SUMMARY ..................................................................................................... 9 REPORT ............................................................................................................ 13 1. CHEMICAL AGENT IDENTIFICATION AND PHYSICO-CHEMICAL PROPERTIES .......... 13 2. EU HARMONISED CLASSIFICATION AND LABELLING - CLP (EC)1271/2008 ........... 15 3. CHEMICAL AGENT AND SCOPE OF LEGISLATION - REGULATED USES OF ARSENIC ACID AND ITS SALTS IN THE EU .......................................................................... 17 3.1 DIRECTIVE 98/24/EC AND DIRECTIVE 2004/37/EC ....................................... 17 3.2 REACH REGISTRATIONS (2010 AND 2013) .................................................. 18 3.3 AUTHORISED USES UNDER ANNEX XIV OF REACH ........................................ 19 3.4 RESTRICTED USES UNDER ANNEX XVII OF REACH ....................................... 20 3.5 PLANT PROTECTION PRODUCTS REGULATION (EC)1107/2009 ....................... 20 3.6 BIOCIDAL PRODUCTS REGULATION (EU)528/2012 ....................................... 21 4. EXISTING OCCUPATIONAL EXPOSURE LIMITS .................................................... 21 5. OCCURRENCE, USE AND OCCUPATIONAL EXPOSURE .......................................... 22 5.1 OCCURRENCE ........................................................................................... 22 5.2 PRODUCTION AND USE INFORMATION ........................................................ 23 5.3 OCCUPATIONAL EXPOSURE ........................................................................ 27 5.3.1 General exposure ............................................................................. 27 5.3.2 Occupational exposure from uses and processes relevant to arsenic acid and its compounds ................................................................................ 28 5.4 ROUTES OF EXPOSURE AND UPTAKE ........................................................... 37 5.4.1 Worker exposure .............................................................................. 37 5.4.2 General population ........................................................................... 37 6. MONITORING EXPOSURE ................................................................................. 38 6.1 EXTERNAL EXPOSURE ............................................................................... 38 6.2 BIOMONITORING OF EXPOSURE (INTERNAL EXPOSURE) ............................... 39 7. HEALTH EFFECTS ........................................................................................... 42 7.1 TOXICOKINETICS (ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION - ADME) ................................................................................................ 42 7.1.1 Human data .................................................................................... 42 7.1.2 Animal data ..................................................................................... 44 7.1.3 In vitro data .................................................................................... 44 RAC Opinion 5 7.1.4 Toxicokinetic modelling ..................................................................... 44 7.1.5 Biological monitoring ........................................................................ 45 7.2 ACUTE TOXICITY ...................................................................................... 49 7.2.1 Human data .................................................................................... 49 7.2.2 Animal data ..................................................................................... 49 7.2.3 In vitro data .................................................................................... 50 7.2.4 Summary ........................................................................................ 50 7.3 SPECIFIC TARGET ORGAN TOXICITY/REPEATED DOSE TOXICITY .................... 50 7.3.1 Human data .................................................................................... 50 7.3.2 Animal data ..................................................................................... 51 7.3.3 Summary ........................................................................................ 52 7.4 IRRITANCY AND CORROSIVITY ................................................................... 52 7.4.1 Human data .................................................................................... 52 7.4.2 Local effects on the eyes are often characterised by conjunctivitis, often in combination with facial dermatitis [82], [86] (LG, 1921; Pinto et al, 1953) .Animal data .................................................................................. 52 7.4.3 Summary ........................................................................................ 52 7.5 EXPOSURE TO ARSENIC DUSTS CAUSES IRRITATION TO THE RESPIRATORY SYSTEM AND DERMAL CONTACT CAN CAUSE IRRITATION AND DERMATITIS. SENSITISATION ................................................................................... 52 7.5.1 Human data .................................................................................... 53 7.5.2 Animal data ..................................................................................... 53 7.5.3 Summary ........................................................................................ 53 7.6 GENOTOXICITY ........................................................................................ 53 7.6.1 Human data .................................................................................... 53 7.6.2 Animal data ..................................................................................... 54 7.6.3 In vitro data .................................................................................... 54 7.6.4 Summary .......................................................................................