Development of a new opacitometer for the bovine corneal opacity and permeability (BCOP) assay

Toxicology in Vitro

Volumn 24, Issue 6, 2010, Pages 1854-1861

  Van Goethem, Freddy ^a   Hansen, Erik ^a   Sysmans, Marc ^a   De Smedt, Ann ^a   Vanparys, Philippe ^a   Van Gompel, Jacky ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

BCOP; Eye irritation; Opacitometer

Indexed keywords

IMIDAZOLE;

ACCURACY; ANALYTIC METHOD; ANALYTICAL EQUIPMENT; ANIMAL CELL; ANIMAL EXPERIMENT; ARTICLE; BIOMEDICAL TECHNOLOGY ASSESSMENT; BOVINE CORNEAL OPACITY AND PERMEABILITY ASSAY; CONTROLLED STUDY; EYE IRRITATION; MEASUREMENT; NONHUMAN; OPACITOMETER; PREDICTION; RELIABILITY; SCORING SYSTEM; VISUAL SYSTEM EXAMINATION;

ANIMAL TESTING ALTERNATIVES; ANIMALS; CATTLE; CORNEAL OPACITY; EPITHELIUM, CORNEAL; EQUIPMENT DESIGN; IRRITANTS; OPTICAL DEVICES; PERMEABILITY; XENOBIOTICS;

BOVINAE;

EID: 77956177038     PISSN: 08872333     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.tiv.2010.04.012     Document Type: Article

References (40)

1. Adriaens E., Dhondt M.M.M., Remon J.P. Refinement of the slug mucosal irritation test as an alternative screening test for eye irritation. Toxicology In Vitro 2005, 19:79-89.
2. Bruner L.H., Evans M.G., McPherson J.P., Southee J.A., Williamson P.S. Investigation of ingredient interactions in cosmetic formulations using isolated bovine corneas. Toxicology In Vitro 1998, 12:669-690.
3. Casterton P.L., Potts L.F., Klein B.D. A novel approach to assessing eye irritation potential using the bovine corneal opacity and permeability assay. Journal of Toxicology - Cutaneous and Ocular Toxicology 1996, 15:147-163.
4. Clayton, G.D., Clayton, F.E., 1993-1994. Pattys industrial hygiene and toxicology, fourth ed. Toxicology, vol. 2A-F. John Wiley, New York, NY, p. 1789.
5. Cooper J.A., Saracci R., Cole P. Describing the validity of carcinogen screening tests. British Journal of Cancer 1979, 39:87-89.
6. Cooper K.L., Earl L.K., Harbell J.W., Raabe H. 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 2001, 15:95-103.
7. Curren R.D., Harbell J.W. Ocular safety: a silent (in vitro) success story. ATLA 2002, 30:69-74.
8. Curren R., Evans M., Raabe H., Dobson T., Harbell J. Optimisation of the bovine cornea opacity and permeability assay: histopathology aids understanding of the EC/HO false negative materials. ATLA 1999, 27:344.
9. Draize J.H., Woodard G., Calvery H.O. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. Journal of Pharmacology and Experimental Therapeutics 1944, 82:377-390.
10. ECETOC, 1998. ECETOC Technical Report No. 48, Eye Irritation: Reference Chemicals Data Bank, second ed. ECETOC, Brussels, Belgium, p. 236.
11. ECVAM Scientific Advisory Committee, 2007. Statement on the Conclusions of the ICCVAM Retrospective Study on Organotypic In Vitro Assays as Screening Tests to Identify Potential Ocular Corrosives and Severe Irritants. http://www.ecvam.jrc.it.
12. EPA, 2003. Label Review Manual, EPA737-B-96-001, third ed. US Environmental Protection Agency, Washington, DC.
13. ESIS (European chemical Substances Information System), 2010. Classification and Labelling Information on Methyl Isobutyl Ketone. http://www.ecb.jrc.ec.europa.eu/esis.
14. Eskes, C., Bessou, S., Bruner, L., Curren, R., Harbell, J., Jones, P., Kreiling, R., Liebsch, M., McNamee, P., Pape, W., Prinsen, M.K., Seidle, T., Vanparys, P., Worth, A., Zuang V., 2005. Eye irritation. In: Eskes, C, Zuang, V (Eds), Alternative (Non-Animal) Methods for Cosmetics Testing: Current Status and Future Perspectives. ATLA 33 (Supplement 1), 47-81.
15. EU Commission Directive 2001/59/EC of 6 August 2001 Adapting to Technical Progress for the 28th 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. Official Journal of the European Communities 2001, L255:1-333.
16. EU Risk Assessment Report vol. 30 on Toluene, 2003. Publication: EUR 20539 EN. http://www.ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/REPORT/toluenereport032.pdf.
17. Federal Register Notice (vol. 72(226), pp. 65964-65965), 2007. Availability of the ICCVAM Test Method Evaluation Report on In Vitro Ocular Toxicity Test Methods for Identifying Severe Irritants and Corrosives and Final In Vitro Ocular Test Method Background Review Documents; Notice of Transmittal of ICCVAM Test Method Recommendations to Federal Agencies http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox.htm.
18. Freeberg F.E., Nixon G.A., Reer P.J., Weaver J.E., Bruce R.D., Griffith J.F., Sanders L.W. Human and rabbit eye responses to chemical insult. Fundamental and Applied Toxicology 1986, 7:626-634.
19. Gautheron P., Dukic M., Alix D., Sina J. Bovine corneal opacity and permeability test: an in vitro assay of ocular irritancy. Fundamental and Applied Toxicology 1992, 18:442-449.
20. Gautheron P., Giroux J., Cottin M., Audegond L., Morilla A.L., Mayordomo-Blanco L., Tortajada A., Haynes G., Vericat J.A., Pirovano R., Gillio Tos E., Hagemann C., Vanparys P., Deknudt G., Jacobs G., Prinsen M., Kalweit S., Spielmann H. Interlaboratory assessment of the bovine corneal opacity and permeability (BCOP) assay. Toxicology In Vitro 1994, 8:381-392.
21. Griffith J.F., Nixon G.A., Bruce R.D., Reer P.J., Bannan E.A. Dose-response studies with chemical irritants in the albino rabbit eye as a basis for selecting optimum testing conditions for predicting hazard to the human eye. Toxicology and Applied Pharmacology. 1980, 55:501-513.
22. Guillot J.P., Gonnet J.F., Clement C., Caillard L., Truhaut R. Evaluation of the ocular-irritation potential of 56 compounds. Food and Chemical Toxicology 1982, 20:573-582.
23. ICCVAM, 2005. Expert Panel Report: Evaluation of the Current Validation Status of In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants. http://www.iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocu_report.htm.
24. ICCVAM, 2006a. Current Status of In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants: Bovine Corneal Opacity and Permeability Test Method Background Review Document. http://www.iccvam.niehs.nih.gov/docs/ocutox_docs/ocubrd/bcop/bcopbrd.pdf.
25. ICCVAM, 2006b. Test Method Evaluation Report. In Vitro Ocular Toxicity Test Methods for Identifying Severe Irritants and Corrosives; NIH Publication No: 07-4517. http://iccvam.niehs.nih.gov/docs/ocutox_docs/OTeval/OTevalrpt.pdf.
26. ICCVAM, 2009. In Vitro Test Methods for Detecting Nonsevere Ocular Irritants. http://www.iccvam.niehs.nih.gov/methods/ocutox/MildMod.htm.
27. Jones P.A., Budynsky E., Cooper K.J., Decker D., Griffiths H.A., Fentem J.H. Comparative evaluation of five in vitro tests for assessing the eye irritation potential of hair-care products. ATLA-Alternatives to Laboratory Animals 2001, 29:669-692.
28. McNamee P., Hibatallah J., Costabel-Farkas M., Goebel C., Araki D., Dufour E., Hewitt N.J., Jones P., Kirst A., Le Varlet B., Macfarlane M., Marrec-Fairley M., Rowland J., Schellauf F., Scheel J. A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: eye irritation. Regulatory Toxicology and Pharmacology 2009, 54:197-209.
29. OECD OECD Guidelines for Testing of Chemicals; Test Guideline 405, Acute Eye Irritation/Corrosion (Updated Guideline, adopted 24th April 2002) 2002, Organisation for Economic Cooperation and Development, Paris, France.
30. OECD, 2009a. OECD Guidelines for Testing of Chemicals, Organisation for Economic Co-operation and Development, Test No. 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants. OECD Publishing. http://www.oecdilibrary.org/oecd/content/book/9789264076303-en.
31. OECD, 2009b. OECD Guidelines for Testing of Chemicals, Organisation for Economic Co-operation and Development, Test No. 438: Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants. OECD Publishing. http://www.oecdilibrary.org/oecd/content/book/9789264076310-en.
32. Scott L., Eskes C., Hoffmann S., Adriaens E., Alepée N., Bufo M., Clothier R., Facchini D., Faller C., Guest R., Harbell J., Hartung T., Kamp H., Varlet B.L., Meloni M., McNamee P., Osborne R., Pape W., Pfannenbecker U., Prinsen M., Seaman C., Spielmann H., Stokes W., Trouba K., Berghe C.V., Van Goethem F., Vassallo M., Vinardell P., Zuang V. A proposed eye irritation testing strategy to reduce and replace in vivo studies using Bottom-Up and Top-Down approaches. Toxicology In Vitro 2010, 24:1-9.
33. Southee, J.A., 1998. Evaluation of the Prevalidation Process. Part 2, Final Report, vol. 2. The Bovine Corneal Opacity and Permeability (BCOP) Assay. European Community Contract No. 11279-95-10F 1ED ISP GB.
34. Sugai S., Murata K., Kitagaki T., Tomita I. Studies on eye irritation caused by chemicals in rabbits 1. A quantitative structure-activity relationships approach to primary eye irritation of chemicals in rabbits. Journal of Toxicological Sciences 1990, 15:245-262.
35. Ubels J.L., Erickson A.M., Zylstra U., Kreulen C.D., Casterton P.L. Effect of hydration on opacity in the bovine corneal opacity and permeability (BCOP) assay. Journal of Toxicology - Cut and Ocular Toxicology 1998, 17:197-220.
36. Ubels J.L., Paauw J.D., Casterton P.L., Kool D.J. A redesigned corneal holder for the bovine cornea opacity and permeability assay that maintains normal corneal morphology. Toxicology In Vitro 2002, 16:621-628.
37. United Nations, 2009. Globally Harmonised System of Classification and Labelling of Chemicals (GHS). New York and Geneva (ST/SG/AC.10/30) 9. http://www.unece.org/trans/danger/publi/ghs/ghs_rev03/03files_e.html.
38. Van Goethem F., Alépée N., Adriaens E., Cappadoro M., Catoire S., De Wever B., Hansen E., Kretz S., Straube F., Wolf A., Vanparys P. Prevalidation of a new in vitro reconstituted human cornea model to assess the eye irritating potential of chemicals. Toxicology In Vitro 2006, 20:1-17.
39. Vanparys Ph., Deknudt Gh., Sysmans M., Teuns G., Coussement W., Van Cauteren H. Evaluation of the bovine corneal opacity-permeability assay as an in vitro alternative to the Draize eye irritation. Toxicology In Vitro 1993, 7:471-476.
40. Wilhelmus K.R. The Draize eye test. Survey of Ophthalmology 2001, 45:493-515.