Ocular safety: A silent (in vitro) success story

Alternatives to Laboratory Animals

Volumn 30, Issue SUPPL. 2, 2002, Pages 69-74

  Curren, Rodger D ^a   Harbell, John W ^a  

^a Inst for In Vitro Sciences Inc ^*  (United States)

Author keywords

Alternative methods; ECVAM; Eye irritation; In vitro; Validation

Indexed keywords

ANIMAL TESTING ALTERNATIVE; ANIMAL TESTING REPLACEMENT; ANIMAL WELFARE; CONFERENCE PAPER; DRUG EFFICACY; DRUG SAFETY; DRUG TOXICITY; EYE IRRITATION; IN VITRO STUDY; NONHUMAN; PRIORITY JOURNAL; TOXICITY TESTING;

ANIMALIA;

EID: 0036975135     PISSN: 02611929     EISSN: None     Source Type: Journal    
DOI: 10.1177/026119290203002s10     Document Type: Conference Paper

References (37)

1. Draize, J.H., Woodard, G. & 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 Therapeutics 82, 377-390.
2. Weil, C.S. & Scala, R.A. (1971). Study of intra- and interlaboratory variability in the results of rabbit eye and skin irritation tests. Toxicology and Applied Pharmacology 19, 276-360.
3. Bruner, L., Carr, G., Chamberlain, M. & Curren, R. (1996). Validation of alternative methods for toxicology testing. Toxicology in Vitro 1, 479-501.
4. Freeberg, F.E., Nixon, G.A., Reer, P.J., Weaver, J.E., Bruce, R.D., Griffith, J.F. & Sanders, L.W.I. (1986). Human and rabbit eye responses to chemical insult. Fundamental and Applied Toxicology 7, 626-634.
5. Daston, G.P. & Freeberg, F.E. (1991). Ocular irritation testing. In Dermal and Ocular Toxicology: Fundamentals and Methods (ed. D.W. Hobson), pp. 509-540. Ann Arbor, MI, USA: CRC Press.
6. Balls, M., Botham, P.A., Bruner, L.H. & Spielmann, H. (1995). The EC/HO international validation study on alternatives to the Draize eye irritation test. Toxicology in Vitro 9, 871-929.
7. Balls, M., Blaauboer, B.J., 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. (1995). Practical aspects of the validation of toxicity test procedures. The report and recommendations of ECVAM workshop 5. ATLA 23, 129-147.
8. Hendriksen, C., Spieser, J.M., Akkermans, A., Balls, M., Bruckner, L., Cubler, K., Daas, A., Descamps, J., Dobblaer, R., Fentem, J.H., Halder, M.E., van der Kamp, M., Lucken, R., Milstien, J., Sesardic, D., Straughan, D. & Valadares, A. (1998). Validation of alternative methods for the potency testing of vaccines. ATLA 26, 747-761.
9. Cooper-Hannan, R., Harbell, J., Coecke, S., Balls, M., Bowe, G., Cervinka, M., Clothier, R., Hermann, F., Klahm, L.K., de Lange, J., Liebsch, M. & Vanparys, P. (1999). The principles of Good Laboratory Practice: application to in vitro toxicology studies. ATLA 27, 539-577.
10. Curren, R.D., Southee, J.A., Spielmann, H., Liebsch, M., Fentem, J.H. & Balls, M. (1995). The role of prevalidation in the development, validation and acceptance of alternative methods. ATLA 23, 211-217.
11. Holzhutter, H-G., Archer, G., Dami, N., Lovell, D.P., Saltelli, A. & Sjostrom, M. (1996). Recommendations for the application of biostatistical methods during the development and validation of alternative toxicological methods. ECVAM Biostatistics Task Force Report 1. ATLA 24, 511-530.
12. Spielmann, H., Liebsch, M. & Kalweit, S. (1996). Results of a validation study in Germany on two in vitro alternatives to the Draize eye irritation test, the HET-CAM test and the 3T3-NRU cytotoxicity test. ATLA 24, 741-858.
13. Curren, R., Bruner, L., Goldberg, A. & Walum, E. (1998). 13th meeting of the Scientific Group on Methodologies for the Safety Evaluation of Chemicals (SGOMSEC): validation and acute toxicity testing. Environmental Health Perspectives 106, 419-425.
14. Flint, O.P. (1993). Speranza per Voi Che Entrate. ATLA 21, 317-318.
15. Balls, M., Klerck, W.D., Baker, F., Van Beek, M., Bouillon, C., Bruner, L., Carstensen, J., Chamberlain, M., Cottin, M., Curren, R., Dupuis, J., Fairweather, F., Faune, U., Fentem, J.H., Fisher, C., Galli, C., Kemper, F., Knapp, A., Langly, G., Loprieno, G., Loprieno, N., Pape, W.J.W., Pechovitsch, G., Spielmann, H., Ungar, K., White, I. & Zuang, V. (1995). 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 Sixth Amendment to the Cosmetics Directive (76/768/EEC). The report and recommendations of an ECVAM/CPS workshop (ECVAM workshop 7). ATLA 23, 398-409.
16. Balls, M., Berg, N., Bruner, L.H., Curren, R.D., de Silva, O., Earl, L.K., Esdaile, D.J., Fentem, J.H., Liebsch, M., Ohno, Y., Prinsen, M.K., Spielmann, H. & Worth, A.P. (1999). Eye irritation testing: the way forward. The report and recommendations of ECVAM workshop 34. ATLA 27, 53-77.
17. Worth, A.P. & Cronin, M.T.D. (2001). The use of bootstrap resampling to assess the variability of Draize tissue scores. ATLA 29, 557-573.
18. Bruner, L., Carr, G.J., Curren, R.D. & Chamberlain, M. (1997). Validation of alternative methods for toxicity testing. Comments in Toxicology 6, 37-51.
19. Swanson, J.E. & Harbell, J. (2000). Evaluating the eye irritancy potential of ethanolic test materials with the bovine corneal opacity and permeability assay. The Toxicologist 54, 188.
20. Cater, K.C., Raabe, H.A., Mun, G.C. & Harbell, J.W. (2001). Corporate validation program for predicting eye irritation of surfactant formulations. The Toxicologist 60, 99.
21. Burdick, J., Merrill, J., Spangler, T., Moyer, G. & Harbell, J. (2002). Use of histological examination in bovine corneal opacity and permeability (BCOP) assay for assessing the ocular irritation potential of fragranced formulations. The Toxicologist 66, 1194.
22. Sina, J.F., Galer, D.M., Sussman, R.G., Gautheron, P.D., Sargent, E.V., Leong, B., Shah, P.V., Curren, R.D. & Miller, K. (1995). A collaborative evaluation of seven alternatives to the Draize eye irritation test using pharmaceutical intermediates. Fundamental and Applied Toxicology 26, 20-31.
23. Gettings, S.D., Rozen, M.G., Bagley, D.M., Casterton, P.L., Chudkowski, M.R., Curren, R.D., Demetrulias, J.L., DiPasquale, L.C., Earl, L.K., Feder, P.I., Galli, C.L., Harbell, J., Hintz, K.L., Lordo, R.A., Marenus, K.D., Moral, J., Pape, W.J.W., Re, T.A., Renskers, K.J., Rothenstein, A.S. & Tedeschi, J.P. (1996). The CTFA evaluation of alternatives programme: a summary of the results of an analysis of the performance of a series of promising alternatives to the Draize eye irritation test. In Alternatives to Animal Testing (ed. S. Lisansky, R. Macmillan & J. Dupuis), pp. 282-295. Newbury, UK: CPL Press.
24. Curren, R.D., Harbell, J.W., Raabe, H.A., Sussman, R.G. & Kimmel, T.A. (1997). The utility of a two-test in vitro battery to assess the ocular irritancy of drug intermediates. In Animal Alternatives, Welfare and Ethics (ed. L.F.M. van Zutphen & M. Balls), pp. 583-589. Amsterdam, The Netherlands: Elsevier.
25. Sina, J.F., Gautheron, P., Casterton, P., Evans, M.G., Harbell, J.W., Curren, R.D., Earl, L.K. & Bruner, L. (1998). Report from the bovine corneal opacity and permeability technical workshop. In Vitro and Molecular Toxicology 11, 315-351.
26. Lewis, R.W., McCall, J.C. & Botham, P.A. (1994). Use of an in vitro battery as a prescreen in the assessment of ocular irritancy. Toxicology in Vitro 8, 75-79.
27. Cooper, K.J., Earl, L.K., Harbell, J.W. & Raabe, H. (2001). Prediction of ocular irritancy of prototype shampoo formulations by the isolated rabbit eye (IRE) test and bovine corneal opacity and permeability (BCOP) assay. Toxicology in Vitro 15, 95-103.
28. Burton, A.B.D., York, M. & Lawrence, R.S. (1981). The in vitro assessment of severe eye irritants. Food and Cosmetics Toxicology 19, 471-480.
29. Prinsen, M.K. & Koëter, H.B.W.M. (1993). Justification of the enucleated eye test with eyes of slaughterhouse animals as an alternative to the Draize eye irritation test with rabbits. Food and Chemical Toxicology 31, 69-76.
30. Harbell, J., Raabe, H., Evans, M.G. & Curren, R. (1999). Histopathology associatedwith opacity and permeability changes in bovine corneas in vitro. The Toxicologist 48, 336.
31. Southee, J.A., McPherson, J.P., Osborne, R., Carr, G.J. & Rasmussen, E. (1999). The performance of the tissue equivalent assay using the skin ZK1200 model in the COLIPA international validation study on alternatives to the Draize eye irritation test. Toxicology in Vitro 13, 355-373.
32. Harbell, J. & Curren, R. (2001). In vitro methods for the prediction of ocular and dermal toxicity. In Handbook of Toxicology (ed. M. Derelanko & M. Hollinger), 2nd edn, pp. 114-119. Boca Raton, FL, USA: CRC Press.
33. Harbell, J., Koontz, S.W., Lewis, R.W., Lovell, D. & Acosta, D. (1997). IRAG working group 4: cell cytotoxicity assays. Food and Chemical Toxicology 35, 79-126.
34. Spielmann, H., Liebsch, M., Moldenhauer, F., Holzhütter, H-G., Bagley, D.M., Lipman, J.M., Pape, W.J.W., Miltenberger, H., deSilva, O., Hofer, H. & Steiling, W. (1997). IRAG working group 4: CAM-based assays. Food and Chemical Toxicology 35, 39-66.
35. Bagley, D.M., Cerven, D. & Harbell, J.W. (1999). Assessment of the chorioallantoic membrane vascular assay (CAMVA) in the COLIPA in vitro eye irritation validation study. Toxicology in Vitro 13, 285-293.
36. Bruner, L., Carr, G., Chamberlain, M. & Curren, R. (1996). No prediction model, no validation study. ATLA 24, 139-142.
37. Archer, G., Balls, M., Bruner, L.H., Curren, R.D., Fentem, J.H., Holzhutter, H.G., Liebsch, M., Lovell, D.P. & Southee, J.A. (1997). The validation of toxicological prediction models. ATLA 25, 505-516.