References

1 Russell, W. M. S. and Burch, R. L. (1959). The Principles of Humane Experimental Technique. Methuen, London, UK.

2 European Commission (1986). EU Directive 86/609/EEC on protection of animals used for experimental and other scientific purposes. EU DG Environment, Brussels, Belgium.

3 Bundesverband der Pharmazeutischen Industrie e.V. (BPI) (1981).

Tiere in der Arzneimittelforschung. Nutzen und Grenzen von Tierversuchen und anderen experimentellen Modellen. BPI Abt. Presse und Öffentlichkeitsarbeit, Frankfurt, Germany, 32 pp.

4 OECD (Organisation for Economic Co-operation and Development) (1982). OECD Guidelines for Testing of Chemicals. OECD Publication Office, Paris, France.

5 D'Arcy, P. F. and Harron, D. W. G. (Eds.) (1995). Proceedings of the Third International Conference on Harmonisation (ICH) Yokohama 1995. The Queens University of Belfast, Belfast, UK.

6 Balls, M., Blaauboer, B., Brusik, D., Frazier, J., Lamp, D., Pemberton, M., Reinhardt, C., Robertfroid, M., Rosenkranz, H., Schmid, B., Spielmann, H., Stammati, A. L., and Walum, E. (1990). Report and recommendations of the CAAT/ERGATT workshop on the validation of toxicity test procedures. Alt. Lab. Anim. 18, 313-337.

7 Balls, M., Botham, P. A., Bruner, L. H., and Spielmann, H. (1995). The EC/HO international validation study on alternatives to the Draize eye irritation test. Toxicol. In Vitro 9, 871-929.

8 Balls, M., Blaauboer, B. J., Fentem, J., Bruner, L., Combes, R. D., Ekwal, B., Fiedler, R. J., Guillouzo, A., Lewis, R. W., Lovell, D. P., Reinhardt, C. A.,

Repetto, G., Sladowski, D., Spielmann, H., and Zucco, F. (1995). Practical aspects of the validation of toxicity test procedures. The report and recommendations of ECVAM Workshop 5. Alt. Lab. Anim. 23, 129-147. 9 Curren, R. D., Southee, J. A., Spielmann, H., Liebsch, M., Fentem, J., and Balls, M. (1995). The role of prevalidation in the development, validation and acceptance of alternative methods. Alt. Lab. Anim. 23, 211-217.

10 National Institute of Environmental Health (NIEHS) (1997). Validation and Regulatory Acceptance of Toxicological test Methods: a report of the Ad hoc Interagency Co-ordinating Committee on the Validation of Alternative Methods. NIH Publication No. 97-3981. NIH, Research Triangle Park, USA.

11 OECD (1996). Final Report of the OECD Workshop on Harmonisation of Validation and Acceptance Criteria for Alternative Toxicological Tests Methods. OECD Publication Office, Paris, France.

12 European Commission (2000). EU Directive 2000/33/EU for the 21st Amendment of Annex V of the EU Directive 86/906/EEC for classification and labelling of hazardous chemicals: Test guideline B-40 "skin corrosivity

- in vitro method". O. J. European Communities, 8th June 2000, L136, 85-97.

13 European Commission (2000). EU Directive 2000/33/EU for the 21st Amendment of Annex V of the EU Directive86/906/EEC for classification and labelling of hazardous chemicals: Test guideline B-41 "phototoxicity

- in vitro 3T3 NRU phototoxicity test". O. J. European Communities, 8th June 2000, L136, 98-107.

14 OECD (2004). OECD guidelines for the testing of chemicals: Test Guideline 431 "In Vitro corrosivity test using human skin models". OECD Publication Office, Paris, France.

15 OECD (2004). OECD guidelines for the testing of chemicals: Test Guideline 432 "In vitro 3T3 NRU phototoxicity test". OECD Publication Office, Paris, France.

16 Spielmann, H., Balls, M., Brand, M., Döring, B., Holzhütter, H. G., Kalweit, S., Klecak, G., L'Epattenier, H., Liebsch, M., Lovell, W. W., Maurer, T., Moldenhauer, F., Moore, L., Pape, W. J. W., Pfannenbecker, U., Potthast, J., De Silva, O., Steiling, W., and Willshaw, A. (1994). EC/COLIPA project on in vitro phototoxicity testing: first results obtained with the Balb/c 3T3 cell phototoxicity assay. Toxicol. In Vitro 8, 793-796.

17 Spielmann, H., Lovell, W. W., Hölzle, E., Johnson, B. E., Maurer, T., Miranda, M., Pape, W. J. W. Sapora, O., and Sladowski, D. (1994). In vitro phototoxicity testing. The report and recommendations of ECVAM Workshop 2. Alt. Lab. Anim. 22, 314-348.

18 Spielmann, H., Balls, M., Dupuis, J., Pape, W. J. W., Pechovitch, G., de Silva, O., Holzhütter, H. G., Clothier, R., Desolle, P., Gerberick, F., Liebsch, M., Lovell, W. W., Maurer, T., Pfannenbecker, U., Potthast, J. M., Csato, M., Sladowski, D., Steiling, W., and Brantom, P. (1998). The international EU/COLIPA in vitro phototoxicity validation study: results of Phase II (blind trial); part 1: the 3T3 NRU phototoxicity test. Toxicol.

In Vitro 12, 305-327.

19 ESAC (ECVAM Scientific Advisory Committee) (1998). Statement on the scientific validity of the 3T3 NRU PT test (an in vitro test for phototoxic potential). Alt. Lab. Anim. 26, 7-8.

20 Spielmann, H., Balls, M., Dupuis, J., Pape, W. J. W., de Silva, O., Holzhütter, H. G., Gerberick, F., Liebsch, M., Lovell, W. W., and Pfannenbecker U. (1998). A study on UV filter chemicals from Annex VII of European Union Directive 76/768/EEC, in the in vitro 3T3 NRU phototoxicity test. Alt. Lab. Anim. 26, 679-708.

21 European Commission (1983). Directive 83/467EEC adapting to technical progress for the fifth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. EU DG Environment, Brussels, Belgium.

22 Gerner, I., Graetschel, G., Kahl, J., and Schlede, E. (2000). Development of a decision support system for the introduction of alternative methods into local irritation/corrosion testing strategies: development of a relational data base. Alt. Lab. Anim. 28, 11-28.

23 Gerner, I., Zinke, S., Graetschel, G., and Schlede, E. (2000). Development of a decision support system for the introduction of alternative methods into local irritancy/corrosivity testing strategies: creation of fundamental rules for a decision support system. Alt. Lab. Anim. 28, 665-698.

24 Gerner, I., Spielmann, H., Hoefer, T., Liebsch, M., and Herzler, M. (2004). Regulatory use of (Q)SARs in toxicological hazard assessment strategies. SAR QSAR Environ. Res. 15, 359-366.

25 Rorje, E. and Hulzebos, E. (2005). Evaluation of (Q)SAR for the prediction of skin irritation/corrosion potential - physico-chemical exclusion rules. European Chemicals Bureau www.ecb.jrc.eu.int, 46 pp.

Part IV

Summary and Visions

0 0

Post a comment