Overcoming barriers to validation of non-animal partial replacement methods/integrated testing strategies: The report of an EPAA-ECVAM workshop

Alternatives to Laboratory Animals

Volumn 37, Issue 4, 2009, Pages 437-444

  Kinsner Ovaskainen, Agnieszka ^a   Akkan, Zerrin ^b   Casati, Silvia ^a   Coecke, Sandra ^a   Corvi, Raffaella ^a   Dal Negro, Gianni ^c   De Bruijn, Jack ^d   De Silva, Odile ^e   Gribaldo, Laura ^a   Griesinger, Claudius ^a   Jaworska, Joanna ^f   Kreysa, Joachim ^a   Maxwell, Gavin ^g   McNamee, Pauline ^f   Price, Anna ^a   Prieto, Pilar ^a   Schubert, Roland ^h   Tosti, Luca ^a   Worth, Andrew ^a   Zuang, Valerie ^a  

^a JOINT RESEARCH CENTRE   (Italy)

^b CIBA GEIGY LTD   (Switzerland)

^c GSK   (Italy)

^d EUROPEAN CHEMICALS AGENCY   (Finland)

^e L ORÉAL RECHERCHE   (France)

^f PROCTER AND GAMBLE COMPANY   (United States)

^g UNILEVER RESEARCH   (United Kingdom)

^h EUROPEAN COMMISSION   (Belgium)

Author keywords

Alternative methods; Integrated testing strategies; Three Rs; Validation

Indexed keywords

ANIMAL WELFARE; APPLIED RESEARCH; CONFERENCE PAPER; COSMETIC INDUSTRY; COST BENEFIT ANALYSIS; DRUG INDUSTRY; IN VIVO STUDY; METHODOLOGY; PRIORITY JOURNAL; RELIABILITY; RISK ASSESSMENT; SIMULATION; SKIN IRRITATION; TOXICITY TESTING; VALIDATION PROCESS;

ANIMALIA;

EID: 70449637644     PISSN: 02611929     EISSN: None     Source Type: Journal    
DOI: 10.1177/026119290903700413     Document Type: Conference Paper

References (26)

1. European Commission (1991). Establishment of a European Centre for the Validation of Alternative Methods. Communication of the European Commission to Council and the European Parliament. SEC(91)1794. Brussels, Belgium: European Commission.
2. Anon. (2007). 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 (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. Official Journal of the European Union L396, 1-856.
3. Anon. (2005). REACH and the need for intelligent testing strategies. [EUR 21554 EN], 32pp. Ispra, Italy: Institute for Health and Consumer Protection, EC Joint Research Centre.
4. Anon. (2003). Directive 2003/15/EC of the European Parliament and the Council of 27 February amending Directive 76/786/EEC on the approximation of the laws of the member States relating to cosmetic products. Official Journal of the European Communities L66, 26-35.
5. Zuang, V., Alonso, M.A., Botham, P.A., Eskes, C., Fentem, J., Liebsch, M. & van de Sandt, J.J. (2005). Skin irritation and corrosion. ATLA 33, Suppl. 1, 35-46.
6. Liebsch, M., Spielmann, H., Pape, W., Krul, C., Deguercy, A. & Eskes, C. (2005). UV-induced effects. ATLA 33, Suppl. 1, 131-146.
7. Van Leeuwen, C.J., Patlewicz, G.Y. & Worth, A.P. (2007). Intelligent Testing Strategies. In Risk Assessment of Chemicals. An Introduction, 2nd edn (ed. C.J. Van Leeuwen & T.G. Vermeire), pp. 467-509. Dordrecht, The Netherlands: Springer.
8. Combes, R., Grindon, C., Cronin, M.T., Roberts, D.W. & Garrod, J. (2007). Proposed integrated decision-tree testing strategies for mutagenicity and carcinogenicity in relation to the EU REACH legislation. ATLA 35, 267-287. (Pubitemid 46883166)
9. Combes, R., Grindon, C., Cronin, M.T., Roberts, D.W. & Garrod, J.F. (2008). Integrated decision-tree testing strategies for acute systemic toxicity and toxicokinetics with respect to the requirements of the EU REACH legislation. ATLA 36, 45-63. (Pubitemid 352803007)
10. Grindon, C., Combes, R., Cronin, M.T., Roberts, D.W. & Garrod, J.F. (2007). Integrated decision-tree testing strategies for skin corrosion and irritation with respect to the requirements of the EU REACH legislation. ATLA 35, 673-682. (Pubitemid 351169739)
11. Grindon, C., Combes, R., Cronin, M.T., Roberts, D.W. & Garrod, J.F. (2007). An integrated decision-tree testing strategy for skin sensitisation with respect to the requirements of the EU REACH legislation. ATLA 35, 683-697. (Pubitemid 351169740)
12. Grindon, C., Combes, R., Cronin, M.T., Roberts, D.W. & Garrod, J.F. (2008). Integrated decision-tree testing strategies for developmental and reproductive toxicity with respect to the requirements of the EU REACH legislation. ATLA 36, 65-80.
13. Grindon, C., Combes, R., Cronin, M.T., Roberts, D.W. & Garrod, J.F. (2008). An integrated decision-tree testing strategy for eye irritation with respect to the requirements of the EU REACH legislation. ATLA 36, 81-92.
14. Grindon, C., Combes, R., Cronin, M.T., Roberts, D.W. & Garrod, J.F. (2008). An integrated decision-tree testing strategy for repeat dose toxicity with respect to the requirements of the EU REACH legislation. ATLA 36, 93-101.
15. European Chemicals Agency (2008). Guidance on Information Requirements and Chemical Safety Assessment. Helsinki, Finland: European Chemicals Agency. Available at: http://guidance.echa.europa.eu/docs/guidance-document/information- requirements-en.htm (Accessed 17.04. 09).
16. Eskes, C., Bessou, S., Bruner, L., Curren, R., Harbell, J., Jones, P., Kreiling, R., Liebsch, M., McNamee, P., Pape, W., Prinsen, M.K., Seidle, T., Vanparys, P., Worth, A. & Zuang, V. (2005). Eye irritation. ATLA, 33, Suppl. 1, 47-81.
17. Hoffmann, S., Gallegos Saliner, A., Patlewicz, G., Eskes, C., Zuang, V. & Worth, A. (2008). A feasibility study developing an integrated testing strategy assessing skin irritation potential of chemicals. Toxicology Letters 180, 9-20.
18. Basketter, D., Casati, S., Gerberick, F., Griem, P., Philips, B. & Worth, A. (2005). Skin sensitisation ATLA, 33, Suppl. 1, 83-103.
19. Aeby, P., Ashikaga, T., Diembeck, W., Eschrich, D., Gerberick, F., Kimber, I., Marrec-Fairley, M., Maxwell, G., Ovigne, J-M., Sakaguchi, H., Tailhardat, M. & Teissier, S. (2008). The COLIPA strategy for the development of in vitro alternatives: Skin sensitization. AATEX 14, 375-379.
20. OECD (2007). Guidance Document on the Validation of (Quantitative) Structure Activity Relationship [(Q)SAR] Models. ENV/JM/MONO(2007)2. OECD Series on Testing and Assessment 69, 154pp. Paris, France: Organisation for Economic Co-operation and Development.
21. Balls, M., Blaauboer, B., Brusick, D., Frazier, J., Lamb, D., Pemberton, M., Reinhardt, C., Roberfroid, M., Rosenkranz, H., Schmid, B., Spielmann, H., Stammati, A-L. & Walum, E. (1990). Report and recommendations of the CAAT/ERGATT workshop on the validation of toxicity test procedures. ATLA 18, 313-337.
22. OECD (2005). Guidance Document on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment. ENV/JM/MONO(2005)14. OECD Series on Testing and Assessment 34, 96pp. Paris, France: Organisation for Economic Co-operation and Development.
23. Balls, M., Blaauboer, B.J., Fentem, J.H., Bruner, L., Combes, R.D., Ekwall, B., Fielder, R.J., Guillouzo, A., Lewis, R.W., Lovell, D.P., Reinhardt, C.A., Repetto, G., Sladowski, D., Spielmann, H. & Zucco, F. (1995). Practical aspects of the validation of toxicity test procedures. The report and recommendations of ECVAM Workshop 5. ATLA 23, 129-147.
24. Balls, M. & Karcher, W. (1995). The validation of alternative methods. ATLA 23, 884-886.
25. Curren, R.D., Southee, J.A., Spielmann, H., Liebsch, M., Fentem, J.H. & Balls, M. (1995). The role of prevalidation in the development, validation & acceptance of alternative methods. ATLA 23, 211-217.
26. OECD (2007). Workshop on Integrated Approaches to Testing and Assessment. ENV/JM/MONO (2008)10. OECD Series on Testing and Assessment 88, 97pp. Paris, France: Organisation for Economic Co-operation and Development.