EU RISK ASSESSMENT – TCPP CAS 13674-84-5 European Union Risk Assessment Report TRIS(2-CHLORO-1-METHYLETHYL) PHOSPHATE (TCPP) CAS No: 13674-84-5 EINECS No: 237-158-7 RISK ASSESSMENT RAPPORTEUR IRELAND/UK EU RISK ASSESSMENT – TCPP CAS 13674-84-5 LEGAL NOTICE Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information A great deal of additional information on the European Union is available on the Internet. It can be accessed through the Europa Server (http://europa.eu.int). Cataloguing data can be found at the end of this publication Luxembourg: Office for Official Publications of the European Communities, [ECB: year] ISBN [ECB: insert number here] © European Communities, [ECB: insert year here] Reproduction is authorised provided the source is acknowledged. Printed in Italy RAPPORTEUR IRELAND/UK EU RISK ASSESSMENT – TCPP CAS 13674-84-5 TRIS(2-CHLORO-1-METHYLETHYL) PHOSPHATE (TCPP) CAS No: 13674-84-5 EINECS No: 237-158-7 RISK ASSESSMENT May 2008 Ireland (lead) and United Kingdom Rapporteur for the risk assessment of TCPP is Ireland (lead) and United Kingdom Contact point: Dr. Majella Cosgrave Chemicals Policy and Services Health and Safety Authority The Metropolitan Building James Joyce Street Dublin 1 Ireland RAPPORTEUR IRELAND/UK EU RISK ASSESSMENT – TCPP CAS 13674-84-5 Date of Last Literature Search : 28/06/2006(Environment) 28/05/2007(Human Health) Review of report by MS Technical Experts finalised: April 2007 (Environment) April 2008 (Human Health) Final report: 2008 RAPPORTEUR IRELAND/UK EU RISK ASSESSMENT – TCPP CAS 13674-84-5 FOREWORD Foreword This Draft Risk assessment Report is carried out in accordance with Council Regulation (EEC) 793/931 on the evaluation and control of the risks of “existing” substances. “Existing” substances are chemical substances in use within the European Community before September 1981 and listed in the European Inventory of Existing Commercial Chemical Substances. Regulation 793/93 provides a systematic framework for the evaluation of the risks to human health and the environment of these substances if they are produced or imported into the Community in volumes above 10 tonnes per year. There are four overall stages in the Regulation for reducing the risks: data collection, priority setting, risk assessment and risk reduction. Data provided by Industry are used by Member States and the Commission services to determine the priority of the substances which need to be assessed. For each substance on a priority list, a Member State volunteers to act as “Rapporteur”, undertaking the in-depth Risk Assessment and recommending a strategy to limit the risks of exposure to the substance, if necessary. The methods for carrying out an in-depth Risk Assessment at Community level are laid down in Commission Regulation (EC) 1488/942, which is supported by a technical guidance document3. Normally, the “Rapporteur” and individual companies producing, importing and/or using the chemicals work closely together to develop a draft Risk Assessment Report, which is then presented at a Meeting of Member State technical experts for endorsement. The Risk Assessment Report is then peer-reviewed by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) which gives its opinion to the European Commission on the quality of the risk assessment. This Draft Risk Assessment Report is currently under discussion in the Competent Group of Member State experts with the aim of reaching consensus. During the course of these discussions, the scientific interpretation of the underlying scientific information may change, more information may be included and even the conclusions reached in this draft may change. The Competent Group of Member State experts seek as wide a distribution of these drafts as possible, in order to assure as complete and accurate an information basis as possible. The information contained in this Draft Risk Assessment Report does not, therefore, necessarily provide a sufficient basis for decision making regarding the hazards, exposures or the risks associated with the priority substance. This Draft Risk Assessment Report is the responsibility of the Member State rapporteur. In order to avoid possible misinterpretations or misuse of the findings in this draft, anyone wishing to cite or quote this report is advised to contact the Member State rapporteur beforehand. 1 O.J. No L 084, 05/04/199 p.0001 – 0075 2 O.J. No L 161, 29/06/1994 p. 0003 – 0011 3 Technical Guidance Document, Part I – V, ISBN 92-827-801 [1234] RAPPORTEUR IRELAND/UK V EU RISK ASSESSMENT – TCPP CAS 13674-84-5 FOREWORD Contact Details of the Rapporteur(s) Rapporteur: Ireland (lead) and United Kingdom Contact - human health: Chemicals Policy and Services Health and Safety Authority The Metropolitan Building James Joyce Street Dublin 1 Ireland Tel: 353-1-6147000 Fax: 353-1-6147017 Contact - environment: Environment Agency Chemicals Assessment Unit Red Kite House, Howbery Park Wallingford, Oxfordshire OX10 8BD United Kingdom Email: [email protected] Fax: (+44) 01491 828 556 The human health exposure review was undertaken under contract to the rapporteur by: Workplace Environment Solutions Ltd. 69 Manchester Road Knutsford, Cheshire WA16 0LX UK The environmental exposure and property review was undertaken under contract to the rapporteur by: Peter Fisk Associates 39 Bennell’s Avenue Whitstable, Kent CT5 2HP UK Note regarding EU enlargement Work on this risk assessment began before enlargement of the EU to 27 member states in 2006. All tonnage data, and references to the ‘EU’ in this risk assessment report, therefore refer to the former EU of 15 Member States. RAPPORTEUR IRELAND/UK VI EU RISK ASSESSMENT – TCPP CAS 13674-84-5 FOREWORD Reasons for prioritisation for risk assessment Chlorinated alkyl phosphate esters (particularly TCPP) were identified as possible substitutes for pentabromodiphenyl ether in the risk reduction strategy for that substance (EC 2001). A risk assessment of this group is therefore important as that substance has now been banned from the EU market. It has since become clear, from discussion with the industry, that in the EU these chemicals are not direct replacements for pentaBDE, and that changes in TCPP consumption are linked mostly with the decline in TCEP use and increase in the market for polyurethane (PUR) generally (pers. comm., 1st March 2004). They appear to be relatively persistent substances, and there is some human health concern (the substance manufacturers have voluntarily classified TDCP as a category 3 carcinogen). Four substances in this group are listed in IUCLID, and were ranked according to the EURAM method (EU Risk Ranking Method); their priority scores (PS) are shown in Table i. Table i Priority scores of chlorinated alkyl phosphate esters Name CAS No. Aquatic Health PS PS tris(2-chloroethyl) phosphate (TCEP) 115-96-8 15.3 61.2 tris(2-chloro-1-methylethyl) phosphate (TCPP) 13674-84-5 10.5 58.1 tris[2-chloro-1-(chloromethyl)ethyl] phosphate (TDCP) 13674-87-8 42.6 39.8 2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate) (V6) 38051-10-4 34.2 39.8 Note: A priority score of 100 is the highest priority. The substance structures are shown below. Tris(2-chloroethyl) phosphate (TCEP) Tris(2-chloro-1-methylethyl) phosphate (TCPP)4 O ClCH O CH Cl Cl 2 3 OP O OP O HC CH Cl O 3 O 2 HC3 CH2Cl Cl Tris[2-chloro-1-(chloromethyl)ethyl] 2,2-Bis(chloromethyl)trimethylene phosphate (TDCP) bis(bis(2-chloroethyl)phosphate) (V6) O ClCH2 CH2Cl OP O Cl ClCH O Cl ClCH CH Cl O 2 O 2 O 2 P O O P O O Cl O CH2Cl Cl ClCH CH Cl 2 2 4 Structure shown is the main isomer present RAPPORTEUR IRELAND/UK VII EU RISK ASSESSMENT – TCPP CAS 13674-84-5 FOREWORD A previous assessment in 1995 concluded that there was insufficient exposure and hazard information to perform a risk assessment for some of these substances (KEMI 1996). V6 in particular was data poor. A 1998 OECD SIDS assessment concluded that TCPP was a low priority for further work (the environmental exposure was said to be ‘minimal’) (UNEP 1999). Nevertheless, the pentabromodiphenyl ether risk reduction strategy indicated that TCPP use is increasing owing to new technologies in both rigid and flexible foam systems. An in depth ESR assessment is a useful check of OECD conclusions. The substances TDCP, TCPP and V6 are therefore good candidates for a concurrent assessment in view of their similar use pattern and structures. Other flame retardant substances (from Environmental Health Criteria document (WHO 1998) or UK review) within this group that do not appear to be EU HPV substances are shown in Table ii. The substance with CAS number 6145-73-9 is an isomer of TCPP and is present in the commercial substance. The substance with CAS number 78-43-3 is an isomer of TDCP. Both of these CAS numbers may have in the past been erroneously applied to the respective substances. Table ii Chlorinated alkyl phosphate esters which are not EU HPV substances Name CAS No. Status Data availability Use (according to EHC) tris(2-chloro-1-propyl) phosphate 6145-73-9 LPV Poor rigid urethane foams tetrakis(2-(chloroethyl)ethylene- 33125-86-9 Believed not to be Poor “plastics” diphosphate available1 tris(2,3-dichloro-1-propyl) phosphate 78-43-3 Believed not to be Poor “plastics” available1 Note: None of these substances are commercially available as such, or produced as isolated products, by EU manufacturers. These substances are not listed as either HPV or LPV substances by the ECB. TCPP, TDCP and V6 all appear on the 4th ESR Priority List and their risk assessments have been completed by Ireland (leading the work and assessing human health) and the UK (leading on the environmental assessment).