Validation of alternative methods for toxicity testing

Toxicology in Vitro

Volumn 10, Issue 4, 1996, Pages 479-501

  Bruner, L H ^a   Carr, G J ^a   Chamberlain, M ^b   Curren, R D ^c  

^a PROCTER AND GAMBLE COMPANY   (United States)

^b UNILEVER RESEARCH   (United Kingdom)

^c Microbiological Associates Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; EYE IRRITATION; IN VITRO STUDY; IN VIVO STUDY; MODEL; NONHUMAN; TECHNIQUE; TOXICITY TESTING;

EID: 0030218920     PISSN: 08872333     EISSN: None     Source Type: Journal    
DOI: 10.1016/0887-2333(96)00028-8     Document Type: Article

References (40)

1. Bagley D. M., Botham P. A., Gardner J. R., Holland G., Kreiling R., Lewis R. W., Stringer D. A. and Walker A. P. (1992a) Eye irritation: reference chemicals data bank. Toxicology in Vitro 6, 487-491.
2. Bagley D. M., Bruner L. H., de Silva O., Cottin M., O'Brien K. A. F., Uttley M. and Walker A. P. (1992b) An evaluation of five potential alternatives in vitro to the rabbit eye irritation test in vivo. Toxicology in Vitro 6, 275-284.
3. Balls M., Blaauboer B., Brusick D., Frazier J., Lamb D., Pemberton M., Reinhardt C., Roberfroid M., Rosenkranz H., Schmid B., Spielmann H., Stammat A.-L. and Walum E. (1990) Report and recommendations of the CAAT/ERGATT Workshop on the Validation of Toxicity Test Procedures. ATLA 18, 313-337.
4. 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. and Zucco F. (1995a) Practical Aspects of the Validation of Toxicity Test Procedures. The Report and Recommendations of ECVAM Workshop 5. ATLA 23, 129-147.
5. Balls M., Botham P. A., Bruner L. H. and Spielmann H. (1995b) The EC/HO international validation study on alternatives to the Draize eye irritation test. Toxicology in Vitro 9, 871-929.
6. Barratt M. (1995a) A quantitative structure activity relationship for the eye irritation potential of neutral organic chemicals. Toxicology Letters 80, 69-74.
7. Barratt M. D. (1995b) Quantitative structure activity relationships for skin corrosivity of organic acids, bases, and phenols. Toxicology Letters 75, 169-176.
8. Barratt M. D., Castell J. V., Chamberlain M., Combes R. D., Dearden J. C., Fentem J., Gerner I., Giuliani A., Gray T. J. B., Livingstone D., Provan W. McL., Rutten A. A. J. J. L., Verhaar H. J. M. and Zbinden P. (1995) The integrated use of alternative approaches for predicting toxic hazard. ATLA 23, 410-429.
9. Beck B. D., Calabrese E. J. and Anderson P. D. (1995) The use of toxicology in the regulatory process. In Principles and Methods of Toxicology. 3rd Ed. Edited by A. W. Hayes. pp. 19-58. Raven Press, New York.
10. Booman K. A., DeProspo J., Demetrulias J., Driedger A., Griffith J. F., Grochoski G., Kong B., McCormick W. C., North-Root H., Rozen M. G. and Sedlak R. I. (1989) The SDA alternatives programme: comparison of in vitro data with Draize test data. Journal of Toxicology - Cutaneous and Ocular Toxicology 8, 35-39.
11. Bruner L. H. (1991) Ocular irritation. In In Vitro Toxicity Testing: Applications to Safety Evaluation. Edited by J. M. Frazier. pp. 149-190. Marcel Dekker, New York.
12. Bruner L. H., Kain D. J., Roberts D. A. and Parker R. D. (1991a) Evaluation of seven in vitro alternatives for ocular safety testing. Fundamental and Applied Toxicology 17, 136-149.
13. Bruner L. H., Miller K. R., Owicki J. C., Parce J. W. and Muir V. C. (1991b) Testing ocular irritancy in vitro with the silicon microphysiometer. Toxicology in Vitro 5, 277-284.
14. Chamberlain M. and Barratt M. D. (1995) Practical applications of QSAR to in vitro toxicology illustrated by consideration of eye irritation. Toxicology in Vitro 9, 543-547.
15. Curren R. D., Southee J. A., Spielmann H., Liebsch M., Fentem J. H. and Balls M. (1995) The role of prevalidation in the development, validation and acceptance of alternative methods. ATLA 23, 211-217.
16. DeSousa D. J., Rouse A. A. and Smolon W. J. (1984) Statistical consequences of reducing the number of rabbits utilized in eye irritation testing: data on 67 petrochemicals. Toxicology and Applied Pharmacology 76, 234-242.
17. Draize J. H., Woodard G. and Calvery H. O. (1944) Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. Journal of Pharmacology and Experimental Therapy 82, 377-390.
18. Durham R. A., Sawyer D. C., Keller W. F. and Wheeler C. A. (1992) Topical ocular anesthetics in ocular irritancy testing: a review. Laboratory Animal Sciences 42, 1-7.
19. ECETOC (1992) Technical Report No. 48. Eye Irritation: Reference Chemicals Data Bank. ECETOC, Brussels.
20. Flint O. (1992) In vitro test validation: a house built on sand. ATLA 20, 196-198.
21. Frazier J. M. (1990) OECD Environment Monograph no. 36. Scientific Criteria for Validation of In Vitro Toxicology Tests. OECD, Paris.
22. Frazier J. M. (1994) The role of mechanistic toxicology in test method validation. Toxicology in Vitro 8, 787-791.
23. Frazier J. M., Gad S. C., Goldberg A. M. and McCulley J. P. (1987) Critical evaluation of alternative tests. In A Critical Evaluation of Alternatives to Acute Ocular Irritation Testing. Alternative Methods in Toxicology. Vol. 4. pp. 45-112. Edited by A.M. Goldberg. Mary Ann Liebert, New York.
24. Gautheron P., Dukic M., Alix D. and Sina F. M. (1992) The bovine corneal opacity and permeability test: an in vitro assay of ocular irritancy. Fundamental and Applied Toxicology 18, 442-449.
25. Gettings S. D., Bagley D. M., Demetrulias J. L., Dipasquale L. C., Hintze K. L., Rozen M. G., Teal J. J., Weise S. L., Chudkowski M., Marenus K. D., Pape W. J. W., Roddy M. T., Schnetzinger R., Silber P. M., Glaza S. M. and Kurtz P. J. (1991) The CTFA Evaluation Alternatives Program: an evaluation of in vitro alternatives to the Draize primary eye irritation test. (Phase I) Hydro-alcoholic formulations; (part 2) Data analysis and biological significance. In Vitro Toxicology 4, 247-288.
26. Gordon V. C., Harvell J. D. and Maibach H. I. (1994) Dermal corrosion: the CORROSITEX system: a DOT accepted method to predict corrosivity potential of test materials. Alternative Methods in Toxicology 10, 37-42.
27. Hunter W. J., Lingk W. and Recht R. (1979) Intercomparson study on the determination of single administration toxicity in rats. Journal of the Association of Official Analytical Chemists 62, 864-873.
28. Johnson N. L. and Kotz S. (1970) Continuous Univariate Distributions. Vol. 2, Chapter 23. Wiley, New York.
29. Loprieno N., Bruner L. H., Carr G. J., Chamberlain M., Cottin M., De Silva O. and Kato S. (1995) Alternatives in cosmetics testing. Toxicology in Vitro 9, 827-838.
30. North-Root H., Yackovich F., Demetrulias J., Gacula M., Jr and Heinze J. E. (1982) Evaluation of an in vitro cell toxicity test using rabbit corneal cells to predict eye irritation potential of surfactants. Toxicology Letters 14, 207-212.
31. O'Brien K. A. F., Basketter D. A., Jones P. and Dixit M. (1994) An in vitro study of the eye irritation potential of new shampoo formulations. Toxicology in Vitro 8, 257-261.
32. Official Journal of the European Communities (1994) 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. Official Journal of the European Communities L151, 32-36.
33. Osborne R. M., Perkins M. A and Roberts D. A. (1995) Development and intralaboratory evaluation of an in vitro human cell-based test to aid ocular irritancy assessments. Fundamental and Applied Toxicology 28, 139-153.
34. Reader S. J., Blackwell V., O'Hara R., Clothier R. H., Griffin G. and Balls M. (1989) A vital dye release method for assessing the short term cytotoxicity effects of chemicals and formulations. ATLA 17, 28-37.
35. Snedecor G. W. and Cochran W. G. (1980) Statistical Methods. 7th Ed. Iowa State University Press, Ames, IA.
36. Spielmann H., Balls M., Brand M., Döring B., Holzhütter H, G., Kalweit S., Klecak G., Eplattenier H. L., Liebsch M., Lovell W. W., Maurer T., Moldenhauer F., Moore L., Pape W. J. W., Pfanenbecker U., Potthast J., DeSilva O., Steiling W. and Willshaw A. (1994) EEC/COLIPA project on in vitro phtototoxicity testing: first results obtained with a Balb/c 3T3 cell phototoxicity assay. Toxicology in Vitro 8, 793-796.
37. Spielmann H., Kalweit S., Liebsch M., Wirnsberger T., Gerner I., Bertram-Neis E., Krauser K., Kreiling R., Miltenburger H. G., Pape W. and Steiling W. (1993) Validation study of alternatives to the Draize eye irritation test in Germany: cytotoxicity testing and HET-CAM test with 136 industrial chemicals. Toxicology in Vitro 7, 505-510.
38. Talsma K. M., Leach C. L., Hatoum N. S., Gibbons R. D., Roger J. C. and Garvin P. J. (1988) Reducing the number of rabbits in the Draize eye irritancy test: A statistical analysis of 155 studies conducted over 6 years. Fundamental and Applied Toxicology 10, 146-153.
39. 50 test. Food and Chemical Toxicology 28, 469-482.
40. Weil C. A. and Scala R. A. (1971) Study of intralaboratory and inter-laboratory variability in the results of rabbit eye and skin irritation tests. Toxicology and Applied Pharmacology 19, 276-360.