Validation study on the Ocular Irritection® assay for eye irritation testing

Toxicology in Vitro

Volumn 28, Issue 5, 2014, Pages 1046-1065

  Eskes, Chantra ^a   Hoffmann, Sebastian ^b   Facchini, Davide ^c   Ulmer, Rich ^d   Wang, Amy ^d   Flego, Manuela ^a   Vassallo, Marco ^e   Bufo, Monica ^f   van Vliet, Erwin ^a   d'Abrosca, Federica ^c   Wilt, Nathan ^g  

^a SeCAM Services and oConsultation on Alternative Methods   (Switzerland)

^b Seh Consulting + Services   (Germany)

^c CellSystems Biotechnology   (Italy)

^d InVitro International   (United States)

^e Farcos Srl   (Italy)

^f Recordati S P A   (Italy)

^g IIVS   (United States)

Author keywords

Eye hazards; Ocular irritection ; Regulatory testing; Validation

Indexed keywords

ACRYLIC ACID; AMIDE; CHEMICAL COMPOUND; CYCLOALKENE; FUNCTIONAL GROUP; EYE PROTEIN; IRRITANT AGENT;

ARTICLE; ASSAY; CLASSIFICATION; EYE INJURY; EYE IRRITATION; HEALTH HAZARD; OCULAR IRRITECTION ASSAY; PEER REVIEW; POST HOC ANALYSIS; PREDICTION; PROSPECTIVE STUDY; RELIABILITY; REPRODUCIBILITY; RETROSPECTIVE STUDY; SENSITIVITY AND SPECIFICITY; VALIDATION STUDY; ANIMAL TESTING ALTERNATIVE; BIOASSAY; BIOLOGICAL MODEL; CORNEA; DRUG EFFECTS; EYE; METABOLISM; PROCEDURES; PROTEIN DENATURATION; TOXICITY; TOXICITY TESTING;

ANIMAL TESTING ALTERNATIVES; BIOLOGICAL ASSAY; CORNEA; EYE; EYE PROTEINS; IRRITANTS; MODELS, BIOLOGICAL; PROTEIN DENATURATION; REPRODUCIBILITY OF RESULTS; TOXICITY TESTS, ACUTE;

EID: 84901235475     PISSN: 08872333     EISSN: 18793177     Source Type: Journal    
DOI: 10.1016/j.tiv.2014.02.009     Document Type: Article

References (37)

1. Adriaens E., Barroso J., Eskes C., Hoffmann S., McNamee P., Alépée N., Bessou-Touya S., De Smedt A., de Wever B., Pfannenbecker U., Tailhardat M., Zuang V. Draize test for serious eye damage/eye irritation: importance of the endpoints evaluated with regard to UN GHS/EU CLP classification. Arch. Toxicol. 2014, 80:701-723.
2. Agresti A., Gottard A. Comment: randomized confidence intervals and the mid-p approach. Stat. Sci. 2005, 20:367-371.
3. Balls M., Botham P.A., Bruner L.H., Spielmann H. The EC/HO international validation study on alternatives to the Draize eye irritation test. Toxicol. In Vitro 1995, 9:871-929.
4. Beckeley J.H., Russel T.J., Rubin L.F. Use of the Rhesus monkey for predicting human response to eye irritants. Toxicol. Appl. Pharmacol. 1969, 15:1-9.
5. Cormier E.M., Parker R.D., Henson C., Cruze L.W., Merritt A.K., Bruce R.D., Osborne R. Determination of the intra- and inter-laboratory reproducibility of the Low Volume Eye Test and its statistical relationship to the Draize test. Reg. Tox. Pharm. 1996, 23:156-161.
6. Courtellemont P., Pannetier M., Biesse J.P., Larnicol M., Baret J.P., Breda B. Evaluation of the EYTEX system in the COLIPA eye irritation program. Toxicol. In Vitro 1999, 13:295-304.
7. EC, 2008. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on Classification, Labelling and Packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. Official Journal of the European Union L353, 1-1355.
8. ECETOC, 1998. Eye Irritation Reference Chemicals Data Bank. Technical Report n. 48 (2), European Centre for Ecotoxicology and Toxicology of Chemicals, Brussels, Belgium.
9. Freeberg F.E., Griffith J.F., Bruce R.D., Bay P.H.S. Correlation of animal test methods with human experience for household products. J. Toxicol. Cut. Ocular Toxicol. 1984, 1:53-64.
10. Gautheron P., Giroux J., Cottin M., Audegond L., Morilla A., Mayordomo-Blanco L., Tortajada A., Haynes G., Vericat J.A., Pirovano R., Tos E.G., 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. Toxicol. In Vitro 1994, 8:381-392.
11. Gershbein L.L., McDonald J.E. Evaluation of the corneal irritancy of test shampoos and detergents in various animal species. Food Cosmet. Toxicol. 1977, 15:131-134.
12. Gettings S.D., Dipasquale L.C., Bagley D.M., Casterton P.L., Chudkowski M., Curren R.D. The CTFA evaluation of alternatives program: an evaluation of in vitro alternatives to the Draize primary eye irritation test. (Phase II), oil/water emulsions. Food Chem. Toxicol. 1994, 32:943-976.
13. Gettings S.D., Lordo R.A., Hintze K.L., Bagley D.M., Casterton P.L., Chudkowski M., Curren R.D., Demetrulias J.L., DiPasquale L.C., Earl L.K., Feder P.I., Galli C.L., Glaza S.M., Gordon V.C., Janus J., Kurtz P.J., Marenus K.D., Moral J., Pape W.J.W., Renskers K.J., Rheins L.A., Roddy M.T., Rozen M.G., Tedeschi J.P., Zyracki J. The CTFA evaluation of alternatives program: an evaluation of in vitro alternatives to the Draize primary eye irritation test. (Phase III) Surfactant-based formulations. Food Chem. Toxicol. 1996, 34:79-117.
14. Gordon V.C. The scientific basis of the EYTEX system. ATLA 1992, 20:537-548.
15. 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 basis for selecting optimum testing conditions for predicting hazard to the human eye. Toxicol. Appl. Pharmacol. 1980, 55:501-513.
16. Hartung T., Bremer S., Casati S., Coecke S., Corvi R., Fortaner S., Gribaldo L., Halder M., Hoffmann S., Roi A.J., Prieto P., Sabbioni E., Scott L., Worth A., Zuang V. A modular approach to the ECVAM principles on test validity. ATLA 2004, 32:467-472.
17. Hartung T., Bruner L., Curren R., Eskes C., Goldberg A., McNamee P., Scott L., Zuang V. First alternative method validated by a retrospective weigth-of-evidence approach to replace the Draize eye test for the identification of non-irritant substances for a defined applicability domain. ALTEX 2010, 27:43-51.
18. ICCVAM, 2007. Test Method Evaluation Report on In vitro Test Methods for Identifying Ocular Severe Irritants and Corrosives. ICCVAM-NICEATM. NIH Publication n. 07-4517. (accessed 31.07.13). http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocu_tmer.htm.
19. ILSI Health and Environmental Sciences Institute Replacing the Draize eye irritation test: scientific background and research needs. J. Toxicol. Cut. Ocular Toxicol. 1996, 15:211-234.
20. Kelly C.P. EYTEX: an in vitro method of predicting ocular safety. Pharmacopeial Forum 1989, 15:4815-5824.
21. Marzulli F.N., Ruggles D.I. Rabbit eye irritation test: collaborative study. J. Ass. Off. Analyt. Chem. 1973, 56:905-914.
22. Matsukawa K., Masuda K., Kakishima H., Suzuki K., Nakagawa Y., Matsushige C., Imanishi Y., Nakamura T., Mizutani A., Watanabe R., Shingai T., Kaneko T., Hirose A., Ohno Y. Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. Toxicol. In Vitro 1999, 13:209-217.
23. OECD, 2002. Acute Eye Irritation/Corrosion. OECD Guideline for Testing of Chemicals No. 405. Organisation for Economic Co-operation and Development, Paris. (accessed 03.08.13). http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-4-health-effects_20745788.
24. OECD, 2005. Guidance Document on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment. Environmental Health and Safety Monograph Series on Testing and Assessment No. 34. (accessed 03.08.12). http://www.oecd.org/env/ehs/testing/seriesontestingandassessmentpublicationsbynumber.htm.
25. OECD, 2012a. Test Guideline 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants. OECD Guideline for the Testing of Chemicals, Paris. (accessed 03.08.13). http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-4-health-effects_20745788.
26. OECD, 2012b. Series on Testing and Assessment n. 180: Streamlined Summary Document Related to the Fluorescein Leakage (FL) test Method for the Identification of Ocular Corrosives and Severe Irritants (TG 460). Organisation for Economic Co-operation and Development, Paris. (accessed 03.08.13). http://www.oecd.org/env/ehs/testing/seriesontestingandassessmentpublicationsbynumber.htm.
27. OECD, 2013a. Test Guideline 438: Isolated Chicken Eye test method for identifying i) chemicals inducing serious eye damage and ii) chemicals not requiring classification for eye irritation or serious eye damage. OECD Guideline for the Testing of Chemicals, Paris. (accessed 03.08.13). http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-4-health-effects_20745788.
28. OECD, 2013b. Series on Testing and Assessment n. 188: Streamlined Summary Document Supporting OECD Test Guideline 438 on the Isolated Chicken Eye for Eye Irritation/Corrosion. Organisation for Economic Co-operation and Development, Paris. (accessed 03.08.13). http://www.oecd.org/env/ehs/testing/seriesontestingandassessmentpublicationsbynumber.htm.
29. OECD, 2013c. Test Guideline 437: Bovine Corneal Opacity and Permeability test method for identifying i) chemicals inducing serious eye damage and ii) chemicals not requiring classification for eye irritation or serious eye damage. OECD Guideline for the Testing of Chemicals, Paris. (accessed 03.08.13). http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-4-health-effects_20745788.
30. OECD, 2013d. Series on Testing and Assessment n. 189: Streamlined summary document supporting OECD Test Guideline 437 on the Bovine Corneal Opacity and Permeability for eye irritation/corrosion. Organisation for Economic Co-operation and Development, Paris. (accessed 03.08.13). http://www.oecd.org/env/ehs/testing/seriesontestingandassessmentpublicationsbynumber.htm.
31. OECD, 2013e. Guidelines for the Testing of Chemicals 439. In vitro Skin Irritation: Reconstructed Human Epidermis Test Method. Organisation for Economic Co-operation and Development, Paris, France. Originally adopted in 2010. (accessed 26.08.13). http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-4-health-effects_20745788.
32. Prinsen M.K. The Draize eye test and in vitro alternatives, a left-handed marriage?. Toxicol. In Vitro 2006, 20:78-81.
33. Roggeband R., York M., Pericoi M., Braun W. Eye irritation responses in rabbit and man after single applications of equal volumes of undiluted model liquid detergent products. Food Chem. Toxicol. 2000, 38:727-734.
34. Scott L., Eskes C., Hoffman S., Adriaens E., Alépée N., Bufo M., Clothier R., Facchini D., Faller C., Guest R., Hamernik K., Harbell J., Hartung T., Kamp H., Le Varlet B., Meloni M., Mcnamee P., Osborn R., Pape W., Pfannenbecker U., Prinsen M., Seaman C., Spielmann H., Stokes W., Trouba K., Vassallo M., Van den Berghe C., Van Goethem F., Vinardell P., Zuang V. A proposed Eye Irritation Testing Strategy to Reduce and Replace in vivo Studies Using Bottom-up and Top-down Approaches. Toxicol. In Vitro 2010, 24:1-9.
35. United Nations (UN), 2011. Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Fourth revised edition, UN New York and Geneva, 2011. (accessed 12.04.13). http://www.unece.org/trans/danger/publi/ghs/ghs_rev04/04files_e.html.
36. Weil C.S., Scala A. Study of intra- and inter- laboratory variability in the results of rabbit eye and skin irritation tests. Toxicol. Appl. Pharmacol. 1971, 19:276-360.
37. Wilhelmus K.R. The Draize eye test. Surv. Ophthalmol. 2001, 45:493-515.