Optimizing the aquatic toxicity assessment under REACH through an integrated testing strategy (ITS)

Environmental Research

Volumn 135, Issue , 2014, Pages 156-164

  Lombardo, Anna ^a   Roncaglioni, Alessandra ^a   Benfenati, Emilio ^a   Nendza, Monika ^b   Segner, Helmut ^c   Jeram, Sonja ^d   Pauné, Eduard ^e   Schüürmann, Gerrit ^f,g  

^a MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

^b Analytisches Laboratorium   (Germany)

^c UNIVERSITY OF BERN   (Switzerland)

^d NATIONAL INSTITUTE OF PUBLIC HEALTH   (Slovenia)

^e SIMPPLE SL   (Spain)

^f HELMHOLTZ CENTRE FOR ENVIRONMENTAL RESEARCH UFZ   (Germany)

^g TU BERGAKADEMIE FREIBERG   (Germany)

Author keywords

Alternative methods; Aquatic toxicity; Hazard assessment; ITS; REACH

Indexed keywords

ANIMAL WELFARE; AQUATIC ECOSYSTEM; HAZARD ASSESSMENT; PELAGIC ENVIRONMENT; PHYSICOCHEMICAL PROPERTY; TOXICITY TEST;

ALGA; AQUATIC ENVIRONMENT; AQUATIC TOXICITY; ARTICLE; COMPUTER MODEL; FISH; HAZARD; HAZARD ASSESSMENT; IN VITRO STUDY; INVERTEBRATE; NONHUMAN; PELAGIC ZONE; PHYSICAL CHEMISTRY; PREDICTION; TOXICITY; BIOCHEMICAL OXYGEN DEMAND; CHEMICAL SAFETY; CHEMISTRY; EUROPEAN UNION; GOVERNMENT REGULATION; LEGISLATION AND JURISPRUDENCE; PROCEDURES; TOXICITY TESTING; WATER POLLUTANT;

FRESH WATER; SEA WATER; WATER POLLUTANT;

BIOLOGICAL OXYGEN DEMAND ANALYSIS; CHEMICAL SAFETY; EUROPEAN UNION; FRESH WATER; GOVERNMENT REGULATION; SEAWATER; TOXICITY TESTS; WATER POLLUTANTS, CHEMICAL;

EID: 84907806877     PISSN: 00139351     EISSN: 10960953     Source Type: Journal    
DOI: 10.1016/j.envres.2014.09.002     Document Type: Article

References (45)

1. CLP: Regulation (EC No 1272)/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
2. Council Directive of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (67/548/EEC).
3. Commission Regulation (EU) No 253/2011 of 15 March 2011 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 XIII.
4. Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations.
5. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes.
6. ECHA, 2008. Guidance on Information Requirements and Chemical Safety Assessment Chapter R.10: characterization of dose [concentration]-response for environment, May 2008.
7. ECHA, 2009. Guidance in a Nutshell - Chemical Safety Assessment, September 2009.
8. ECHA, 2010. Practical Guide 10: How to Avoid Unnecessary Testing On Animals, June 2010.
9. ECHA, 2012. Guidance on the Application of the CLP Criteria, November 2012.
10. ECHA, 2012a. Guidance on Information Requirements And Chemical Safety Assessment, Chapter R.7b: Endpoint Specific Guidance, November 2012.
11. ECHA, 2012b. Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.11: PBT Assessment, November 2012.
12. EU method A.6, Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
13. Fleischer M. Testing cost and testing capacity according to the REACH requirements - results of a survey of independent and corporate GLP laboratories in the EU and Switzerland. J. Bus. Chem. 2007, 4:96-114.
14. Hartung T., Luechtefeld T., Maertens A., Kleensang A. Food for thought: integrated testing strategies for safety assessments. Altex 2013, 31:3-18.
15. Hoff D., Lehmann W., Pease A., Raimondo S., Russom C., Steeger T. Predicting the Toxicities of Chemicals to Aquatic Animal Species 2010, EPA, U.S.
16. Jeram S., Riego Sintes J., Halder M., Baraibar Fentanes J., Sokull-Klüttgen B., Hutchinson T. A strategy to reduce the use of fish in acute ecotoxicity testing of new chemical substances notified in the European Union. Regul. Toxicol. Pharmacol. 2005, 42:218-224.
17. Kwon J.H., Escher B.I. A modified parallel artificial membrane permeability assay for evaluating bioconcentration of highly lipophilic chemicals in fish. Environ. Sci. Technol. 2008, 42:1787-1793.
18. Marquart H., Meijster T., Van de Bovenkamp M., Ter Burg W., Spaan S., Van Engelen J. A structured approach to Exposure Based Waiving of human health endpoints under REACH developed in the OSIRIS project. Regul. Toxicol. Pharmacol. 2012, 62:231-240.
19. Masungi C., Borremans C., Willems B., Mensch J., van Dijck A., Augustijns P., Brewster M.E., Noppe M. Usefulness of a novel Caco-2 cell perfusion system. I. In vitro prediction of the absorption potential of passively diffused compounds. J. Pharm. Sci. 2004, 93:2507-2521.
20. Nakao K., Fujikawa M., Shimizu R., Akamatsu M. QSAR application for the prediction of compound permeability with in silico descriptors in practical use. J. Comput. Aided Mol. Des. 2009, 23:309-319.
21. Nendza M., Müller M., Wenzel A. Discriminating toxicant classes by mode of action: 4. Baseline and excess toxicity. SAR QSAR Environ. Sci. 2014, 25:393-405.
22. Nendza M., Gabbert S., Kühne R., Lombardo A., Roncaglioni A., Benfenati E., Benigni R., Bossa C., Strempel S., Scheringer M., Fernández A., Rallo R., Giralt F., Dimitrov S., Mekenyan O., Bringezu F., Schüürmann G. A comparative survey of chemistry-driven in silico methods to identify hazardous substances under REACH. Regul. Toxicol. Pharmacol. 2013, 66(3):301-314.
23. OECD, 2010. Short guidance on the threshold approach for short term fish toxicity, ENV/JM/MONO (20010)17. OECD series on testing assessment No. 126, Organisation for Economic Co-operation and Development, Paris, France.
24. OECD 105, 1995. Water Solubility. Organisation for Economic Cooperation and Development (OECD), OECD Guideline for the Testing of Chemicals No. 105, Paris, France.
25. OECD 111, 2004. Hydrolysis as a function of pH. Organisation for Economic Cooperation and Development (OECD), OECD Guideline for the Testing of Chemicals No. 111, Paris, France.
26. OECD 201, 2011. Freshwater Alga and Cyanobacteria, Growth Inhibition Test. Organisation for Economic Cooperation and Development (OECD), OECD Guideline for the Testing of Chemicals No. 201, Paris, France.
27. OECD 202, 2004. Daphnia sp., acute immobilisation test. Organisation for Economic Cooperation and Development (OECD), OECD Guideline for the Testing of Chemicals No. 202, Paris, France.
28. OECD 203, 1992. Fish, short term toxicity test. Organisation for Economic Cooperation and Development (OECD), OECD Guideline for the Testing of Chemicals No. 203, Paris, France.
29. OECD 210, 2013. Fish, Early-life Stage Toxicity Test. Organisation for Economic Cooperation and Development (OECD), OECD Guideline for the Testing of Chemicals No. 210, Paris, France.
30. OECD 211, 2012. Daphnia magna Reproduction Test. Organisation for Economic Cooperation and Development (OECD), OECD Guideline for the Testing of Chemicals No. 211, Paris, France.
31. OECD 212, 1998. Fish, Short-term Toxicity Test on Embryo and Sac-fry Stages. Organisation for Economic Cooperation and Development (OECD), OECD Guideline for the Testing of Chemicals No. 212, Paris, France.
32. OECD 215, 2000. Fish, Juvenile Growth Test. Organisation for Economic Cooperation and Development (OECD), OECD Guideline for the Testing of Chemicals No. 215, Paris, France.
33. OECD 221, 2006. Lemna sp. Growth Inhibition Test. Organisation for Economic Cooperation and Development (OECD), OECD Guideline for the Testing of Chemicals No. 221 Paris, France.
34. OECD 236, 2013. Fish Embryo Acute Toxicity (FET) Test. Organisation for Economic Cooperation and Development (OECD), OECD Guideline for the Testing of Chemicals No. 236, Paris, France.
35. OECD 301, 1992. Ready Biodegradability. Organisation for Economic Cooperation and Development (OECD), OECD Guideline for the Testing of Chemicals No. 301, Paris, France.
36. OECD 303, 2001. Simulation Test - Aerobic Sewage Treatment: 303 A: Activated Sludge Units - 303 B: biofilms. Organisation for Economic Cooperation and Development (OECD), OECD Guideline for the Testing of Chemicals No. 303, Paris, France.
37. OECD 308, 2002. Aerobic and Anaerobic Transformation in Aquatic Sediment Systems. Organisation for Economic Cooperation and Development (OECD), OECD Guideline for the Testing of Chemicals No. 308, Paris, France.
38. OECD 309, 2004. Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test. Organisation for Economic Cooperation and Development (OECD),OECD Guideline for the Testing of Chemicals No. 309, Paris, France.
39. OECD 69, 2007. Guidance document on the validation of (quantitative) structure-activity relationship [(Q)SAR] models. Organisation for Economic Cooperation and Development (OECD), OECD Environment health and safety publications, series on testing and assessment No. 69, Paris, France.
40. REACH: 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 (REAC H), 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.
41. Rovida C., Hartung T. Re-evaluation of animal numbers and costs for in vivo tests to accomplish REACH legislation requirements for chemicals - a report by the transatlantic think tank for toxicology (t4). Altex 2009, 26:187-208.
42. UK REACH Competent Authority Information Leaflet Number 18 - Minimisation of Animal Testing, January 2010.
43. Van der Jagt, K., Munn, S., Torslov, J., de Bruijnk, J., 2004. Alternative approaches can reduce the use of test animals under REACH. Addendum to the report Assessment of additional testing needs under REACH Effects of (Q)SAR, risk based testing and voluntary industry initiatives.
44. Verhaar H.J.M., van Leeuwen C.J., Hermens J.L.M. Classifying environmental pollutants. 1: Structure-activity relationships for prediction of aquatic toxicity. Chemosphere 1992, 25:471-491.
45. Wood C.M., Kelly S.P., Zhou B., Fletcher M., O'Donell M., Eletti B., Paert P. Cultured gill epithelia as models for freshwater gills. Biochim. Biophys. Acta Biomembr. 2002, 1566:72-83.