Validation of alternative methods for toxicity testing

Environmental Health Perspectives

Volumn 106, Issue SUPPL. 2, 1998, Pages 477-484

  Bruner, Leon H ^a   Carr, Gregory J ^a   Curren, Rodger D ^b   Chamberlain, Mark ^c  

^a PROCTER AND GAMBLE COMPANY   (United States)

^b Microbiological Associates Inc   (United States)

^c UNILEVER RESEARCH   (United Kingdom)

Author keywords

Alternative methods; Eye irritation testing; Prediction model; Relevance; Reliability; Validation

Indexed keywords

CONFERENCE PAPER; EYE IRRITATION; PREDICTION; PRIORITY JOURNAL; RELIABILITY; TOXICITY TESTING; VALIDATION PROCESS;

EID: 0031804081     PISSN: 00916765     EISSN: None     Source Type: Journal    
DOI: 10.1289/ehp.98106477     Document Type: Conference Paper

References (72)

1. EEC. Council Directive 93/35/EEC of 14 June, 1993 amending for the 6th time Directive76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. Off J Eur Comm L151:32-36 (1994).
2. Scala RA. Theoretical approaches to validation. In:Approaches to Validation. Alternative Methods in Toxicology. Vol 5 (Goldberg AM, ed). New York: Mary Ann Liebert, 1987;1-10.
3. Frazier JM. OECD Environment Monograph No. 36:Scientific Criteria for Validation of In Vitro Toxicology Tests, 1990. Paris: Organisation for Economic Co-operation and Development, 1990.
4. Balls M, Blaauboer B, Brusick D, Frazier J, Lamb D, Pemberton M, Reinhardt C, Roberfroid M, Rosenkranz H, Schmid B, et al. Report and recommendations of the CAAT/ERGATT Workshop on the Validation of Toxicity Test Procedures. ATLA 18:313-337 (1990).
5. Balls M, Blaauboer B, Fentem JH, Bruner L, Combes RD, Ekwall B, Fielder RJ, Guillouzo A, Lewis RW, Lovell DP, et al. Practical aspects of the Validation of Toxicity Test Procedures. The report and recommendations of ECVAM Workshop 5. ATLA 23:129-147 (1995).
6. Frazier JM. Validation of in vitro models. J Am Coll Toxicol 9:355-359 (1990).
7. Frazier JM. Validation of in vitro toxicity tests. In:In Vitro Toxicity Testing:Applications to Safety Evaluations (Frazier JM, ed). New York: Marcel Dekker, 1992;245-252.
8. Frazier JM. In vitro models for toxicological research and testing. Toxicol Lett 68:73-90 (1993).
9. Frazier JM. The role of mechanistic toxicology in test methods validation. Toxicol In Vitro 8:787-791 (1994).
10. Frazier JM. Interdisciplinary approach to toxicity test development and validation. Toxicol in Vitro 9:8925-8949 (1995)
11. Goldberg AM, ed. Alternative Methods in Toxicology. Vols 1-11. New York: Mary Ann Liebert, 1983-1995.
12. Goldberg AM, Frazier JM, Brusick D, Dickens MS, Flint O, Gettings SD, Hill RN, Lipnick RL, Renskers KJ, Bradlaw JA, et al. Framework for validation and implementation of in vitro toxicity tests. In Vitro Cell Dev Biol 29A:688-692 (1993).
13. Goldberg AM, Epstein LD, Zurlo J. A modular approach to validation:a work in progress, In Vitro Toxicol 8:431-435 (1995).
14. Goldberg AM, Frazier JM. Alternatives to animals in toxicity testing. Sci Am 261:24-30 (1989).
15. Frazier, JM, Bradlaw J. Technical Report No 1:Technical Problems Associated with In Vitro Toxicity Testing Systems. Baltimore: The Johns Hopkins Center for Alternatives to Animal Testing, 1989.
16. Sehnert SS. Technical Report No 2:Structure-Activity Relationships in Predictive Toxicology. Baltimore: The Johns Hopkins Center for Alternatives to Animal Testing, 1990.
17. CAAT. Technical Report No 4:Cell Culture Systems and In Vitro Toxicity Testing:Baltimore: The Johns Hopkins Center for Alternatives to Animal Testing, 1992.
18. Frazier JF. Technical Report No 5:The International Status of Validation of In Vitro Toxicity Tests. Baltimore The Johns Hopkins Center for Alternatives to Animal Testing, 1993.
19. CAAT. Technical Report No 6:Final Scientific Reports of CAAT Grantees. Baltimore: The Johns Hopkins Center for Alternatives to Animal Testing, 1994.
20. CAAT. Technical Report No 7:Molecular and Cellular Approaches to Extrapolation for Risk Assessment. Baltimore:The Johns Hopkins Center for Alternatives to Animal Testing, 1994.
21. Clemedson C, McFarlane-Abdulla E, Andersson M, Barile FA, Calleja MC, Chesné C, Clothier R, Cottin M, Gurren R, Daniel-Szolgay E, et al. MEIC evaluation of acute systemic toxicity. Part I:Methodology of 68 in vitro toxicity assays used to test the first 30 reference chemicals. ATLA 24:251-272 (1996).
22. Clemedson C, McFarlane-Abdulla E, Andersson M, Barile FA, Calleja MC, Chesné C, Clothier R, Cottin M, Curren R, Dierickx P, et al. MEIC evaluation of acute systemic toxicity. Part II:In vitro results from 68 toxicity assays used to test the first 30 reference chemicals and a comparative cytotoxicity analysis. ATLA 24:273-311 (1996).
23. Bradlaw JA, Wilcox NL. Workshop on eye irritation testing:Practical applications of non-whole animal alternatives. Fd Chem Toxicol 35:1-11 (1997).
24. NIEHS. Validation and Regulatory Acceptance of Toxicological Test Methods:A Report of the Ad Hoc Interagency Coordinating Committee on the Validation of Alternative Methods. NIH Publ No 97-3981. Research Triangle Park, NC: National Institute of Environmental Health Sciences, 1997.
25. Curren RD, Southee JA, Spielmann H, Liebsch M, Fentem JH, Balls M. The role of prevalidation in the development, validation and acceptance of alternative methods. ATLA 23:211-217(1995).
26. Balls, M. Replacement of animal procedures:alternatives in research, education and testing. Lab Anim 28:193-211 (1994).
27. Marafante E, Smyrniotis T, Balls M. ECVAM:The European Centre for the Validation of Alternative Methods. Toxicol in Vitro 8:803-805 (1994).
28. Balls M. In vitro methods in regulatory toxicology:the crucial significance of validation. In:Toxicology in Transition (Degen GH, Seiler JP, Bentley P, eds). Archives of Toxicology, Suppl 17. Berlin/Heidelberg:pringer Verlag, 1995;155-162.
29. Balls M. Scientific validation:a crucial and unavoidable prerequisite to the acceptance of new tests and testing strategies. ATLA 23:474-479 (1995).
30. Balls M. Defining the role of ECVAM in the development, validation and acceptance of alternative tests and testing strategies. Toxicol in Vitro 9:863-869 (1995).
31. Balls M, Blaauboer BJ, eds. The validation of replacement alternative methods. In:Proceedings of the ECVAM Opening Symposium, 18 October 1994, Ispra, Italy. Toxicol in Vitro 9:789-869 (1995).
32. Balls M, Karcher W. The validation of alternative test methods. ATLA 23:884-886(1995).
33. Fentem JH, Balls M. Alternative methods in toxicological research and testing. Comments Toxicol 5:199-202 (1995).
34. Fentem JH, Prinsen MK, Spielmann H, Walum E, Botham PA. Validation - lessons learned from practical experience. Toxicol in Vitro 9:857-862 (1995).
35. Balls M, Fentem JH. Progress toward the validation o alternative tests. ATLA 25:33-43 (1997).
36. Fentem JH. ECVAM workshops:summary of conclusions and recommendations. Toxicol Ecotoxicol News 3:69-78 (1996).
37. Blaauboer BJ, Boobis AR, Castell JV, Coecke S, Groothuis GMM, Guillouzo A, Hall TJ, Hawksworth GM, Lorenzon G, Miltenburger HG, et al. The practical applicability of hepatocyte cultures in routine testing. The report and recommendations of ECVAM Workshop 1. ATLA 22:231-241 (1994).
38. Spielman, H, Lovell WW, Hölzle E, Johnson BE, Maurer T, Miranda MA, Pape WJW, Sapora O, Sladowski D. In vitro phototoxicity testing. The report and recommendations of ECVAM Workshop 2. ATLA 22:314-348 (1994).
39. Atterwill CK, Bruinink A, Drejer J, Duarte E, McFarlane Abdulla E, Meredith C, Nicotera P, Regan C, Rodriguez-Farre E, et al. In vitro neurotoxicity testing. The report and recommendations of ECVAM Workshop 3. ATLA 22:350-362 (1994).
40. Hendriksen CFM, Garthoff B, Aggerbeck H, Bruckner L, Castle P, Cussler K, Dobbelaer R, van de Donk H, van der Gun J, Lefrancois S, et al. Alternatives to animal testing in the quality control of immunobiologicals:current status and future prospects. The report and recommendations of ECVAM Workshop 4. ATLA 22:420-434 (1994).
41. Balls M, Blaauboer BJ, Fentem, JH, Bruner L, Combes RD, Ekwall B, Fielder RJ, Guillouzo A, Lewis RW, Lovell DP, et al. Practical aspects of the validation of toxicity test procedures. The report and recommendations of ECVAM Workshop 5. ATLA 23:129-147 (1995).
42. Botham PA, Chamberlain M, Barratt MD, Curren RD, Esdaile DJ, Gardner JR, Gordon VC, Hildebrand B, Lewis,RW, Liebsch M, et al. A prevalidation study on in vitro skin corrosivity testing. The report and recommendations of ECVAM Workshop 6. ATLA 23:219-255 (1995)
43. Balls M, De Klerck W, Baker F, van Beek M, Bouillon C, Bruner L, Carstensen J, Chamberlain M, Cottin M, Curren R., et al. Development and validation of non-animal tests and testing strategies:the identification of a coordinated response to the challenge and the opportunity presented by the 6th Amendment to the Cosmetics Directive (76/768/EEC). The report and recommendations of an ECVAM/CPS Workshop (ECVAM Workshop 7. ATLA 23:398-409 (1995).
44. Barratt MD, Castell JV, Chamberlain M, Combes RD, Dearden JC, Fenten JH, Gerner I, Giuliani, A, Gray TJB, Livingstone DK, et al. The integrated use of alternative approaches for predicting toxic hazard. The report and recommendations of ECVAM Workshop 8. ATLA 23:410-429 (1995).
45. Garthoff B, Hendriksen C, Bayol A, Goncalves D, Grauer A, de Leeuw R, van Noordwijk J, Pares M, Pirovano R, Rieth M, et al. Safety and efficacy testing of hormones and related products. The report and recommendations of ECVAM Workshop 9. ATLA 23:699-712 (1995).
46. Hawksworth GM, Bach PH, Dekant W, Diezi JE, Harpur E, Lock EA, MacDonald C, Morin J-P, Nagelkerke JF, Pfaller, W, et al. Nephrotoxicity testing in vitro. The report and recommendations of ECVAM Workshop 10. ATLA 23:713-727 (1995).
47. Balls M, Goldberg AM, Fentem JH, Broadhead CL, Burch RL, Festing, MFW, Frazier JM, Hendriksen CFM, Jennines M, van der Kamp MDO, et al. The three Rs:the way forward. The report and recommendations of ECVAM Workshop 11. ATLA 23:838-866 (1995).
48. Brown NA, Spielmann H, Bechter R, Flint, OP, Freeman SJ, Jelínek RJ, Koch E, Nau H, Newall DR, Palmer AK, et al. Screening chemicals for reproductive toxicity:the current alternatives. The report and recommendations of an ECVAM/ETS workshop (ECVAM Workshop 12). ATLA 23:868-882 (1995).
49. Howes D, Guy R, Hadgraft J, Heylings J, Hoeck U, Kemper, F, Mailbach H, Marty J-P, Merk H, Parra J, et al. Methods for assessing percutaneous absorption. The report and recommendations of ECVAM Workshop 13. ATLA 24:81-106 (1996).
50. Gribaldo L, Bueren J, Deldar A, Hokland P, Meredith C, Moneta, D, Mosesso P, Parchment R., Parent-Massin D, Pessina A, et al. The use of in vitro systems for evaluating haematotoxicity. The report and recommendations of ECVAM Workshop 14. ATLA 24:211-231 (1996).
51. Blaauboer BJ, Bayliss MK, Castell JV, Evelo CTA. Frazier JM, Groen K, Gülden M, Guillouzo A, Hissink AM, Houston JB, et al. The use of biokinetics and in vitro methods in toxicological risk evaluation. The report and recommendations of ECVAM Workshop 15. ATLA 24:473-497 (1996).
52. Seibert H, Balls M, Fentem JH, Bianchi V, Clothier RH, Dierickx PJ, Ekwall B, Garle MJ, GA, Hissink AM, Houston J, et al. The in vitro and the classification and labelling of chemicals. The report and recommendations of ECVAM Workshop 16. ATLA 24:499-510 (1996).
53. Svendsen O, Garthoff B, Spielmann H, Hensten-Pettersen A, Jensen JC, Kuijpers MR, Leimgruber R, Liebsch M, Müller-Lierheim WGK, Rydhög G, et al. Alternatives to the animal testing of medical devices. The report and recommendations of ECVAM Workshop 17. ATLA 24:659-669 (1996).
54. Lambré CR, Aufderheid, M, Bolton RE, Fubini B, Haagsman HP, Hext PM, Jorissen M, Landry Y, Morin J-P, Nemery B, et al. In vitro tests for respiratory toxicity. The report and recommendations of ECVAM Workshop 18. ATLA 24:671-681 (1996).
55. de Silva O, Basketter DA, Barratt MD, Corsini E, Cronin MTD, Das PK, Degwert J, Enk A, Garrigue JL, Hauser C, et al. Alternative methods for skin sensitisation testing. The report and recommendations of ECVAM Workshop 19. ATLA 24:683-705 (1996).
56. Bach PH, Vickers AEM, Fisher R, Baumann A, Brittebo E, Carlile DJ, Koster HJ, Lake BG, Salmon F, Sawyer TW, et al. The use of tissue slices for pharmacotoxicology studies. The report and recommendations of ECVAM Workshop 20. ATLA 24:893-923 (1996).
57. Schade R, Staak C, Hendriksen C, Erhard M, Hugl H, Koch G, Larsson A, Pollmann W, van Regenmortel M, Rijke E, et al. The production of avian (egg yolk) antibodies:IgY. The report and recommendations of ECVAM Workshop 21. ATLA 24:925-934 (1996).
58. Leahy DE, Duncan R, Ahr HJ, Bayliss MK, de Boer AG, Darvas F, Fentem JH, Fry JR, Hopkins R, Houston JB, Pharmacokinetics in early drug research. The report and recommendations of ECVAM Workshop 22. ATLA 25:17-31 (1997).
59. Marx U, Embleton MJ, Fischer R., Gruber FP, Hansson U, Heuer J, de Leeuw WA, Logetenberg T, Merx W, Portetelle D, et al. Monoclonal antibody production. The report and recommendations of ECVAM Workshop 23. ATLA 25:121-137 (1997).
60. Dearden JC, Barratt MD, Benigni, R, Bristol DW, Combes RD Cronin, MTD, Judson PN, Payne MP, Richard AM, Tichy M, et al. The development and validation of expert systems for predicting toxicity. The report and recommendations of an ECVAM/ECB workshop (ECVAM Workshop 24). ATLA 25:223-252 (1997).
61. Janusch A, van der Kamp MDO, Bottrill K, Grune B, Anderson DC, Ekwall B, Howald M, Kolar R, Kuiper HJD, Larson J, et al. Current status and future developments of databases on alternative methods. The report and recommendations of ECVAM Workshop 25. ATLA 25:411-422 (1997).
62. Holzhütter H-G, Archer G, Dam, N, Lovell DP, Saltelli A, Sjöström M. . Recommendations for the application of biostatistical methods during the development and validation of alternative texicological methods. ECVAM Biostatistics Task Force Report 1. ATLA 24:511-530 (1996).
63. Balls M, Botham P, Bruner LH, Spielmann H. The EC/HO International Validation Study on Alternatives to the Draize Eye Irritation Test. Toxicology in Vitro 9:871-929 (1995).
64. Spielmann H, Balls M, Brand M, Döring B, Holzhütter HG, Kalweit S, Klecak G, L'Eplattenier H, Liebsch M, Lovell WW, et al. EEC/COLIPA project on in vitro phototoxicity testing:first results obtained with a Balb/c 3T3 cell phototoxicity assay. Toxicol in Vitro 8:793-796 (1995).
65. OECD. Final Report of the OECD Workshop on Harmonization of Validation and Acceptance Criteria for Alternative Toxicological Test Methods. ENV/MC/CHEM/ TG(96)9. Paris:reanisation for Economic Co-operation and Development, 1996.
66. Bruner LH, Carr GJ, Chamberlain M, Curren RD. Validation of alternative methods for toxicity testing. Toxicol in Vitro 10:479-501 (1996).
67. Bruner L, Carr GJ, Chamberlain M, Gurren RD. No prediction model, no validation study ATLA 24:139-142 (1996).
68. Draize JH, Woodard G, Calvery HO. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J Pharmacol Exp Ther 82:377-390 (1944).
69. Weil CA, Scala A. Study of intralaboratory and inter-laboratory variability in the results of rabbit eye and skin irritation tests. Toxicol Appl Pharmacol 19:276-360(1971).
70. Brantom PG, Bruner LH, Chamberlain M, de Silva O, Dupuis J, Earl LK, Lovell DP, Pape WJW, Uttley M, et al. A summary report of the COLIPA international validation study on the alternatives to the Draize rabbit eye irritation test. Toxicol in Vitro 11:141-179 (1997).
71. Hunter WJ, Lingk W, Recht RJ. Intercomparson study on the determination of single administration toxicity in rats. J Assoc Off Analyt Chem 62:864-873 (1979).
72. 50 test. Food Chem Toxicol 28:469-482 (1990).