Validation and Regulatory Acceptance of New Carcinogenicity Tests

Toxicologic Pathology

Volumn 31, Issue 1, 2003, Pages 54-59

  Spielmann, Horst ^a  

^a FEDERAL INSTITUTE FOR RISK ASSESSMENT   (Germany)

Author keywords

Alternative tests; animal welfare; carcinogenicity; harmonization; in vitro toxicology; international guidelines; regulatory testing; toxicology; validation

Indexed keywords

ANIMAL WELFARE; CARCINOGENICITY; CONFERENCE PAPER; EUROPE; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; REGULATORY MECHANISM; TOXICITY TESTING; UNITED STATES; VALIDATION PROCESS;

ANIMAL TESTING ALTERNATIVES; ANIMALS; ANIMALS, LABORATORY; CARCINOGENICITY TESTS; DRUG INDUSTRY; GERMANY;

ANIMALIA; RODENTIA; VERTEBRATA;

EID: 0037255579     PISSN: 01926233     EISSN: None     Source Type: Journal    
DOI: 10.1080/01926230390173897     Document Type: Article

References (22)

1. Anonymous (1981). Tiere in der Arzneimittelforschung. Nutzen und Grenzen von Tierversuchen und anderen experimentellen Modellen. Bundesverband der Pharmazeutischen Industrie e.V. (BPI). BPI Abt. Presse und Öffentlichkeitsarbeit, Frankfurt, Germany.
2. Balls M., Blaauboer B., Brusik D., Frazier J., Lamp D., Pemberton M., Reinhardt C., Robertfroid M., Rosenkranz H., Schmid B., Spielmann H., Stammati AL, Walum E. (1990). Report and recommendations of the CAAT/ERGATT workshop on the validation of toxicity test procedures. ATLA 18: 313-337.
3. Balls M., Blaauboer BJ, Fentem J., Bruner L., Combes RD, Ekwal B., Fiedler RJ, Guillouzo A., Lewis RW, Lovell DP, Reinhardt CA, 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.
4. Balls M., Botham PA, Bruner LH, Spielmann H. (1995). The EC/HO international validation study on alternatives to the Draize eye irritation test. Toxicol In Vitro 9: 871-929.
5. Chen JJ, Gaylor D. (1987). Carcinogenic risk assessment: Comparison of estimated safety doses for rats and mice. Environ Health Perspect 72: 305-309.
6. Curren RD, Southee JA, Spielmann H., Liebsch M., Fentem J., Balls M. (1995). The role of prevalidation in the development, validation and acceptance of alternative methods. ATLA 23: 211-217.
7. D'Arcy PF, Harron DWG (eds) (1995). Proceedings of the Third International Conference on Harmonisation (ICH) Yokohama 1995. The Queens University of Belfast, Belfast, UK.
8. ESAC (ECVAM Scientific Advisory Committee) (1998). Statement on the scientific validity of the 3T3 NRU PT test (an in vitro test for phototoxic potential). ATLA 26: 7-8.
9. European Commission (1983). European Commission 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. Brussels, Belgium: EU DG Environment.
10. European Commission (1986). European Commission Directive 86/609/EEC on Protection of Animals Used for Experimental and other Scientific Purposes. EU DG Environment, Brussels, Belgium.
11. European Commission (2000). European Commission 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.” OJ European Communities L136: 98-107.
12. National Institute of Environmental Health (NIEHS) (1997). Validation and regulatory acceptance of toxicological test methods: A report of the ad hoc Interagency Coordinating Committee on the validation of alternative methods. NIH Publication No. 97-3981. NIH, Research Triangle Park, USA.
13. OECD (Organisation for Economic Co-operation and Development) (1982). OECD Guidelines for Testing of Chemicals. OECD Publication Office, Paris, France.
14. Oecd (1996). Final reportofthe OECD workshop on harmonisation of validation and acceptance criteria for alternative toxicological test methods. Paris, France: OECD Publication Office.
15. Oecd (2002). OECD guideline for the testing of chemicals: Draft proposal for a new guideline 431 “In vitro corrosivity test using human skin models.” OECD Publication Office, Paris, France.
16. Russell WMS, Burch RL (1959). The Principles of Humane Experimental Technique. Methuen, London, UK.
17. Schwetz B., Gaylor D. (1998). Alternative tests: Carcinogenesis as an example. Environ Health Perspect 106(Suppl 2): 467-471.
18. Spielmann H., Balls M., Brand M., Döring B., Holzhütter HG, Kalweit S., Klecak G., L'Epattenier H., Liebsch M., Lovell WW, Maurer T., Moldenhauer F., Moore L., Pape WJW, Pfannenbecker U., Potthast J., De Silva O., Steiling W., 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.
19. Spielmann H., Balls M., Dupuis J., Pape WJW, de Silva O., Holzhütter HG, Gerberick F., Liebsch M., Lovell WW, 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. ATLA 26: 679-708.
20. Spielmann H., Balls M., Dupuis J., Pape WJW, Pechovitch G., de Silva O., Holzhütter HG, Clothier R., Desolle P., Gerberick F., Liebsch M., Lovell WW, Maurer T., Pfannenbecker U., Potthast JM, Csato M., Sladowski D., Steiling W., 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.
21. Spielmann H., Lovell WW, Hölzle E., Johnson BE, Maurer T., Miranda M., Pape WJW, Sapora O., Sladowski D. (1994). In vitro phototoxicity testing. The report and recommendations of ECVAM Workshop 2. ATLA 22: 314-348.
22. Tennant RW (1998). Evaluation and validation issues in the development of transgenic mouse carcinogenicity bioassays. Environ Health Perspect 106(Suppl 2): 473-476.