A structured approach to Exposure Based Waiving of human health endpoints under REACH developed in the OSIRIS project

Regulatory Toxicology and Pharmacology

Volumn 62, Issue 2, 2012, Pages 231-240

  Marquart, Hans ^a   Meijster, Tim ^a   Van de Bovenkamp, Marja ^b   Ter Burg, Wouter ^b   Spaan, Suzanne ^a   Van Engelen, Jacqueline ^b  

^a TNO   (Netherlands)

^b NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

Author keywords

Consumers; Exposure Based Waiving; Integrated testing strategies; REACH; Workers

Indexed keywords

ABSORPTION; ADSORPTION; ARTICLE; DECISION TREE; EXCRETION; HEALTH HAZARD; HUMAN; METABOLISM; MOLECULAR WEIGHT; PRIORITY JOURNAL; PROTECTIVE EQUIPMENT; REPRODUCTIVE TOXICITY; RISK ASSESSMENT; RISK MANAGEMENT; SYSTEMATIC REVIEW; TOXICITY TESTING; TOXICOLOGICAL PARAMETERS;

DECISION TREES; ENDPOINT DETERMINATION; ENVIRONMENTAL EXPOSURE; GUIDELINES AS TOPIC; HUMANS; RISK ASSESSMENT; TOXICITY TESTS;

EID: 84856505771     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2011.12.010     Document Type: Article

References (21)

1. Bradbury S.P., Feijtel T.C., Van Leeuwen C.J. Meeting the scientific needs of ecological risk assessment in a regulatory context. Environ. Sci. Technol. 2004, 38(23):463A-470A.
2. Bunke, D., Schneider, K., Jäger, I., 2006. Exposure-Based Waiving. Concrete specifications of the waiving-conditions in the context of the registration procedure according to REACH. öko-Institut e.V., Freiburg (D). (last visited: 14-02-2011). http://www.oeko.de/oekodoc/287/2005-021-en.pdf.
3. Combes R., Barratt M., Balls M. An overall strategy for the testing of chemicals for human hazard and risk assessment under the EU REACH system. Altern. Lab. Anim. 2003, 31(1):7-19.
4. European Council (EC), 1998. COUNCIL DIRECTIVE 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (14th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC). Off. J. Eur. Union, L 131, 11-23.
5. European Commission (EC), 2009. COMMISSION REGULATION (EC) No. 134/2009 of 16 February 2009 amending Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XI. Off. J. Eur. Union, L 46, 3-5.
6. European Chemicals Bureau (ECB), 2003. European Union Risk Assessment Report. Hydrogen peroxide. European Commission Joint Research Centre. (Ispra, It.). EUR 20844 EN.
7. European Chemicals Agency (ECHA), 2010a. Guidance on information requirements and chemical safety assessment. Chapter R.12: use descriptor system. Version 2. European Chemicals Agency, Helsinki (Fi). (last visited 18-10-2011). http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_r12_en.pdf.
8. European Chemicals Agency (ECHA), 2010b. Guidance on information requirements and Chemical Safety Assessment Chapter R.14: occupational exposure estimation. Version 2. European Chemicals Agency, Helsinki (Fi). ?vers=27_05_10 (last visited: 18-10-2011). http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_r14_en.pdf.
9. Environmental Protection Agency (EPA), 2002. Guidance: waiver criteria for multiple-exposure inhalation toxicity studies. Office of Prevention, Pesticides and Toxic Substances. United States Environmental Protection Agency. HED SOP 2002: 01. (last visited: 31-08-2011). http://www.epa.gov/oppfead1/cb/ppdc/pria/september05/sept14minutes.pdf.
10. Escher S., Tluczkiewicz I., Batke M., Bitsch A., Melber C., Kroese D., Buist H., Mangelsdorf I. Evaluation of inhalation TTC values with the database RepDose. Regul. Toxicol. Pharmacol. 2010, 58:259-274.
11. European Union (EU), 2007. Corrigendum to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L396, 30.12.2006). Off. J. Eur. Union, L 136, 50, May 29, 2007.
12. Hollander, A., Bruinen de Bruin, Y., Vonk, A., Vermeire, T., Van de Meent, D., 2011. Exposure Based Waiving in environmental risk assessment: a tiered approach. Hum. Ecol. Risk Assess. 17 (6), 1-19. doi: 0.1080/10807039.2011.618380.
13. Kroes R., Renwick A.G., Cheeseman M., Kleiner J., Mangelsdorf I., Piersma A., Schilter B., Schlatter J., Van Schothorst F., Vos J.G., Wurtzen G. Structure-based Threshold of Toxicological Concern (TTC): guidance for application to substances present at low levels in the diet. Food Chem. Toxicol. 2004, 42:65-83.
14. OSIRIS, 2011. OSIRIS Integrated Testing Strategy tool. (last visited 17-10-2011). http://osiris.simpple.com/OSIRIS-ITS/itstool.do.
15. Richarz, A., Pauné, E., Cronin, M.T.D., Vermeire, T.G., Benfenati, E., Scheringer, M., Schüürmann, G., 2010 Integrated Testing Strategies for the risk assessment of chemicals under REACH: the OSIRIS web tool. Poster at the SETAC GLB, 6-9 September 2010, Dessau, Germany.
16. Schaafsma G., Kroese E.D., Tielemans E.L.J.P., Van de Sandt J.J.M., Van Leeuwen C.J. REACH, non-testing approaches and the urgent need for a change in mind set. Regul. Toxicol. Pharmacol. 2009, 53(1):70-80.
17. TNsG, 2008. Technical guidance document in support of the directive 98/8/EC concerning the placing of biocidal products on the market. Guidance on data requirements for active substances and biocidal products. (last visited: 31-08-2011). http://ihcp.jrc.ec.europa.eu/our_activities/health-env/risk_assessment_of_Biocides/doc/TNsG/TNsG_DATA_REQUIREMENTS/TNsG-Data-Requirements.pdf.
18. Van de Bovenkamp, M., Buist, H., 2010. The use of the Threshold of Toxicological Concern (TTC) for Exposure Based Waiving (EBW) of dermal toxicity studies under REACH. OSIRIS deliverable D3.2.6. Internal OSIRIS document.
19. Van Leeuwen, C.J., Patlewicz, G.Y., Worth, A.P., 2007. Intelligent Testing Strategies. In: Van Leeuwen, C.J., Vermeire, T.G. (Eds.), Risk assessment of chemicals: an introduction, Second edition. Springer, Dordrecht (The Netherlands). ISBN 978-1-4020-6101-1 (handbook), ISBN 978-1-4020-6102-8 (e-book).
20. Vermeire, T.G., Aldenberg, T., Dang, Z., Janer, G., De Knecht, G.A., Van Loveren, H., Peijnenburg, W.J.G.M., Piersma, A.H., Traas, T.P., Verschoor, A.J., Van Zijverden, M., Hakkert, B., 2007. Selected Integrated Testing Strategies (ITS) for the risk assessment of chemicals. Bilthoven (The Netherlands), RIVM, Report No 601050001/2007.
21. Vermeire T., Van de Bovenkamp M., De Bruin Y.B., Delmaar C., Van Engelen J., Escher S., Marquart H., Meijster T. Exposure Based Waiving under REACH. Regul. Toxicol. Pharmacol. 2010, 58(3):408-420.