The validation and acceptance of alternatives to animal testing

Toxicology in Vitro

Volumn 13, Issue 4-5, 1999, Pages 837-846

  Balls, M ^a   Fentem, J H ^a  

^a JOINT RESEARCH CENTRE   (Italy)

Author keywords

Animal testing; In vitro toxicology; Prediction model; Regulatory testing; Replacement alternatives; Toxicity testing; Validation

Indexed keywords

ANIMAL WELFARE; CONFERENCE PAPER; ETHICS; EXPERIMENTAL ANIMAL; IN VITRO STUDY; MODEL; NONHUMAN; PREDICTION; RELIABILITY; TOXICITY TESTING; TOXICOLOGY; VALIDATION PROCESS;

EID: 0032856082     PISSN: 08872333     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0887-2333(99)00067-3     Document Type: Conference Paper

References (38)

1. Archer G. No statistics, no science - let alone validation studies. ATLA. 24:1996;453-456.
2. Archer G., Balls M., Bruner L.H., Curren R.D., Fentem J.H., Holzhütter H-G., Liebsch M., Lovell D.P., Southee J.A. The validation of toxicological prediction models. ATLA. 25:1997;505-516.
3. Balls M. In vitro test validation: high-hurdling, but not pole vaulting. ATLA. 20:1992;355-357.
4. Balls M. Defined structural and performance criteria would facilitate the validation and acceptance of alternative test procedures. ATLA. 25:1997;483-484.
5. Balls M. Mechanistic approaches and the development of alternative toxicity test methods. Environmental Health Perspectives. 106:(suppl. 2):1998;453-457.
6. 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. Report and recommendations of the CAART/ERGATT workshop on the validation of toxicity test procedures. ATLA. 18:1990;339-344.
7. Balls M., Blaauboer B., 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. Practical aspects of the validation of toxicity test procedures. The report and recommendations of ECVAM workshop 5. ATLA. 23:1995;129-147.
8. Balls M., Botham P., Cordier A., Fumero S., Kayser D., Koëter H., Koundakjian P., Lindquist N.G., Meyer O., Pioda L., Reinhardt C., Rozemond H., Smyrniotis T., Spielmann H., Van Looy H., van der Venne M-T., Walum E. Report and recommendations of an international workshop on promotion of the regulatory acceptance of validated non-animal toxicity test procedures. ATLA. 18:1990;339-344.
9. Balls M., Fentem J.H. Progress toward the validation of alternative tests. ATLA. 25:1997;33-43.
10. Balls M., Karcher W. The validation of alternative test methods. ATLA. 23:1995;884-886.
11. Balls M., Spielmann H., Archer G., Bansil L., Blaauboer B., Bruner L., Combes R., Curren R., Fentem J., Holzhütter H-G., Koëter H., Liebsch M., Reinhardt C., Stokes W., Thomas H. and Wilcox N. (1999) Progress with the validation and acceptance of alternative test methods. The report and recommendations of ECVAM workshop 40. ATLA 40. In press.
12. Botham P.A., Earl L.K., Fentem J.H., Roguet R., van de Sandt J.J.M. Alternative methods for skin irritation: the current status. ECVAM Skin Irritation Task Force report 1. ATLA. 26:1998;195-211.
13. Brantom P.G., Bruner L.H., Chamberlain M., de Silva O., Dupuis J., Earl L.K., Lovell D.P., Pape W.J.W., Uttley M., Bagley D.M., Baker F.W., Bracher M., Courtellemont P., Declercq L., Freeman S., Steiling W., Walker A.P., Carr G.J., Dami N., Thomas G., Harbell J., Jones P.A., Pfannenbecker U., Southee J.A., Tcheng M., Argembeaux H., Castelli D., Clothier R., Esdaile D.J., Itigaki H., Jung K., Kasai Y., Kojima H., Kristen U., Larnicol M., Lewis R.W., Marenus K., Moreno O., Peterson A., Rasmussen E.S., Robles C., Stern M. A summary report of the COLIPA international validation study on alternatives to the Draize rabbit eye irritation test. Toxicology in Vitro. 11:1997;141-179.
14. Bruner L.H., Carr G.J., Chamberlain M., Curren R.D. Validation of alternative methods for toxicity testing. Toxicology in Vitro. 10:1996;479-501.
15. Bruner L., Carr G., Chamberlain M., Curren R.D. No prediction model, no validation study. ATLA. 24:1996;139-142.
16. Curren R.D., Southee J.A., Spielmann H., Liebsch M., Fentem J.H., Balls M. The role of prevalidation in the development, validation and acceptence of alternative methods. ATLA. 23:1995;211-217.
17. Dickens M.S., Kruszewski F.H., Gordon V.G. In vitro test validation: the winds of change. ATLA. 20:1992;563-564.
18. Statement on the scientific validity of the 3T3 NRU PT test (an in vitro test for phototoxic potential). ATLA. 26:1998;7-8.
19. Statement on the scientific validity of the rat skin transcutaneous electrical reistance test (an in vitro test for skin corrosivity). ATLA. 26:1998;275-277.
20. TM (an in vitro test for skin corrosivity). ATLA. 26:1998;278-280.
21. ECVAM (1998d) Draft Proposal for an OECD Guideline on the In vitro 3T3 NRU Phototoxicity Test, pp. 12. ECVAM, Ispra.
22. Fentem J.H., Archer G.E. B., Balls M., Botham P.A., Curren R.D., Earl L.K., Esdaile D.J., Holzhütter H-G., Liebsch M. The ECVAM international validation study on in vitro tests for skin corrosivity. 2. Results and evaluation by the Management Team. Toxicology in Vitro. 12:1998;483-524.
23. Flint O.P. In vitro test validation: a house bulit on sand. ATLA. 20:1992;196-198.
24. Frazier J.M. Scientific criteria for the validation of in vitro toxicity tests. OECD Environment Monographs. 36:1990;1-62.
25. Goldberg A. M., (ed) (1988) In Vitro Toxicology: Approaches to Validation, Alternative Methods in Toxicology. Vol. 5. pp. 251. Mary Ann Liebert, New York.
26. Goldberg A.M., Frazier J.M., Brusick D., Dickens M.S., Flint O., Gettings S.D., Hill R.N., Lipnick R.L., Renskers K.J., Bradlaw J.A., Scala R.A., Veronesi B., Green S., Wilcox N.L., Curren R.D. Framework for validation and implementation of in vitro toxicity tests: report of the Validation and Technology Transfer Committeee of the Johns Hopkins Center for Alternatives to Animal Testing. Journal of the American College of Toxicology. 12:1993;23-30.
27. Green S. In vitro test validation and regulatory animal testing: a house built on sand versus a house of cards? ATLA. 20:1992;567-570.
28. Holzhütter H-G., Archer G., Dami N., Lovell D.P., Saltelli A., Sjöstrom M. Recommendations for the application of biostatistical methods during the development and validation of alternative toxicological methods. ECVAM Biostatistics Task Force report 1. ATLA. 24:1996;511-530.
29. Holzhütter H-G., Spielmann H. The use of prediction models in validation studies: what should they predict? ATLA. 24:1996;881-884.
30. ICCVAM. (1997) Validation and Regulatory Acceptance of Toxicological Test Methods. A Report of the ad hocInteragency Coordinating Committee on the Validation of Alternative Methods. pp. 105. NIEHS, Research Triangle Park, NC.
31. Connor A. M. (1997) Barriers to regulatory acceptance. In Animal Alternatives, Welfare and Ethics. Edited by L. F. M. Van Zutphen and M. Balls, pp. 1173-1181. Elsevier, Amsterdam.
32. OECD (1996) Final Report of the OECD Workshop on Harmonization of Validation and Acceptance Criteria for Alternative Toxicological Test Methods, pp. 62. OECD, Paris.
33. Russell W. M. S. and Burch R. L. (1958) The Principles of Humane Experimental Technique, pp. 238. Methuen, London.
34. 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., Brantom P. The international EU/COLIPA in vitro phototoxicity validation study: results of Phase II (blind trial). Part 1: the 3T3 NRU phototoxicity test. Toxicology in Vitro. 12:1998;305-327.
35. Spielmann H., Balls M., Dupuis J., Pape W.J.W., de Silva O., Holzhütter H-G., Gerberick F., Liebsch M., Lovell W.W., Pfannenbecker U. A study on the phototoxic potential of UV filter chemicals from Annex VII of EU Directive 76/768/EEC in the 3T3 NRU in vitro phototoxicity test. ATLA. 26, 1998;679-705.
36. Walum E. In vitro test validation: should it obey laws, recognise uncertainty principles or follow scientific practices? ATLA. 20:1992;502-503.
37. Walum E., Clemedson C., Ekwall B. Principles for the validation of in vitro toxicology test methods. Toxicology in Vitro. 8:1994;807-812.
38. Zucco F. In vitro test validation: no room for conflict with "mechanistic" studies. ATLA. 20:1992;565-566.