Measuring depth of injury (DOI) in an isolated rabbit eye irritation test (IRE) using biomarkers of cell death and viability

Toxicology in Vitro

Volumn 24, Issue 2, 2010, Pages 597-604

  Jester, James V ^a   Ling, Joseph ^a   Harbell, John ^b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b MARY KAY INC   (United States)

Author keywords

Alternative Draize test; Ocular irritation; Rabbit cornea; Replacement tests

Indexed keywords

ACETIC ACID; ACETONE; BENZALKONIUM CHLORIDE; CYCLOHEXANOL; F ACTIN; HYPOCHLORITE SODIUM; PARAFLUOROANALINE; PHALLOIDIN; SODIUM HYDROXIDE; TOXIC SUBSTANCE; UNCLASSIFIED DRUG;

ANIMAL CELL; ANIMAL TISSUE; ARTICLE; CELL DEATH; CELL DISRUPTION; CELL VIABILITY; CONTROLLED STUDY; CORNEA CELL; CYTOSKELETON; CYTOTOXICITY; DISEASE SEVERITY; EPITHELIUM; EX VIVO STUDY; EYE EXAMINATION; EYE IRRITATION; HISTOPATHOLOGY; IN VIVO STUDY; NONHUMAN; STAINING; STROMA; THICKNESS; TISSUE PREPARATION;

ANIMALS; BIOLOGICAL MARKERS; CELL DEATH; CELL SURVIVAL; CORNEA; EYE; IN SITU NICK-END LABELING; IRRITANTS; ORGAN CULTURE TECHNIQUES; PHALLOIDINE; RABBITS; STAINING AND LABELING; TOXICITY TESTS;

ORYCTOLAGUS CUNICULUS;

EID: 76649129848     PISSN: 08872333     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.tiv.2009.10.010     Document Type: Article

References (37)

1. Bruner, L.H., 1992. Ocular irritation. In Vitro Toxicity Testing Applications to Safety Evaluation, Marcel Dekker, New York, pp. 149-190.
2. Cater K.C., and Harbell J.W. Prediction of eye irritation potential of surfactant-based rinse-off personal care formulations by the bovine corneal opacity and permeability (BCOP) assay. Cutan. Ocul. Toxicol. 25 (2006) 217-233
3. Cooper K.J., Earl L.K., Harbell J., and 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. Toxicol. in Vitro 15 (2001) 95-103
4. Cormier E.M., Hunter J.E., Billhimer W., May J., and Farage M.A. Correlation of animal eye data with human experience for household products. J. Toxicol. Cutan. Ocular Toxicol. 14 (1995) 197-205
5. ECVAM, 2007. ESAC 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 as determined by the USEPA, EU9R41 and UN GHS classifications in the tiered testing strategy, as part of a weight of evidence, 27 April 2007.
6. 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., and Zuang V. Eye irritation. Altern. Lab. Animal 33 Suppl. 1 (2005) 47-81
7. Essepian J.P., Wei F., Hildesheim J., and Jester J.V. Comparison of corneal epithelial wound healing rates in scrape vs. lamellar keratectomy injury. Cornea 9 (1990) 294-298
8. Freeberg F.E., Griffith J.F., Bruce R.D., and Bay P.H.S. Correlation of animal test methods with human experience for household products. J. Toxicol. Cutan. Ocular Toxicol. 1 (1984) 53-64
9. Freeberg F.E., Hooker D.T., and Griffith J.F. Correlation of animal eye data with human experience for household products. J. Toxicol. Cutan. Ocular Toxicol. 5 (1986) 115-123
10. Gettings S.D., Lordo R.A., Demetrulias J., Feder P.I., and Hintze K.L. Comparison of low-volume, Draize and in vitro eye irritation test data. I. Hydroalcoholic formulations. Food Chem. Toxicol. 34 (1996) 737-749
11. Gettings S.D., Lordo R.A., Feder P.I., and Hintze K.L. A comparison of low volume, Draize and in vitro eye irritation test data. II. Oil/water emulsions. Food Chem. Toxicol. 36 (1998) 47-59
12. Gettings S.D., Lordo R.A., Feder P.I., and Hintze K.L. A comparison of low volume, Draize and in vitro eye irritation test data. III. Surfactant-based formulations. Food Chem. Toxicol. 36 (1998) 209-231
13. Griffith J.F., Nixon G.A., Bruce R.D., Reer P.J., and 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. Toxicol. Appl. Pharmacol. 55 (1980) 501-513
14. Heywood R., and James R.W. Toward objectivity in the assessment of eye irritation. J. Soc. Cosmet. Chem. 29 (1978) 25
15. ICCVAM, 2007. Test Method Evaluation Report - In Vitro Ocular Toxicity Test Methods for Identifying Ocular Severe Irritants and Corrosives. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NEICEATM). NIH Publication No.:07-4517. .
16. Jester J.V. Extent of corneal injury as a biomarker for hazard assessment and the development of alternative models to the Draize rabbit eye test. Cutan. Ocular Toxicol. 25 (2006) 41-54
17. Jester J.V., Barry P.A., Lind G.J., Petroll W.M., Garana R., and Cavanagh H.D. Corneal keratocytes: in situ and in vitro organization of cytoskeletal contractile proteins. Invest. Ophthalmol. Vis. Sci. 35 (1994) 730-743
18. Jester J.V., Maurer J.K., Petroll W.M., Wilkie D.A., Parker R.D., and Cavanagh H.D. Application of in vivo confocal microscopy to the understanding of surfactant-induced ocular irritation. Toxicol. Pathol. 24 (1996) 412-428
19. Jester J.V., Li H.F., Petroll W.M., Parker R.D., Cavanagh H.D., Carr G.J., Smith B., and Maurer J.K. Area and depth of surfactant-induced corneal injury correlates with cell death. Invest. Ophthalmol. Vis. Sci. 39 (1998) 922-936
20. Jester J.V., Petroll W.M., Bean J., Parker R.D., Carr G.J., Cavanagh H.D., and Maurer J.K. Area and depth of surfactant-induced corneal injury predicts extent of subsequent ocular responses. Invest. Ophthalmol. Vis. Sci. 39 (1998) 2610-2625
21. Jester J.V., Molai A., Petroll W.M., Parker R.D., Carr G.J., Cavanagh H.D., and Maurer J.K. Quantitative characterization of acid- and alkali-induced corneal injury in the low-volume eye test. Toxicol. Pathol. 28 (2000) 668-678
22. Jester J.V., Li L., Molai A., and Maurer J.K. Extent of initial corneal injury as a basis for alternative eye irritation tests. Toxicol. in Vitro 15 (2001) 115-130
23. Jester J.V., Lam L., and Wahlert A. Assessing ocular irritation potential using a modified ex vivo rabbit eye test. Cutan. Ocular Toxicol. 28 (2009) 32-36
24. Le Varlet B., Alepee N., Bessou S., de Smedt A., De Wever B., Harbell J., Jones P., McNamee P., Marrec-Fairley M., Pape W., Pfannenbecker U., Schroder K., Tailhardat M., and van Goethem F. Continued developments in the COLIPA eye irritation task force strategy and program for development of in vitro methods. Altern. Animal Exp. 26 (2009) 283
25. Marzulli F.N., and Simon M.E. Eye irritation from topically applied drugs and cosmetics: precinical studies. Am. J. Optom. Arch. Am. Acad. Optom. 48 (1971) 61-79
26. Maurer J.K., Molai A., Parker R.D., Li L., Carr G.J., Petroll W.M., Cavanagh H.D., and Jester J.V. Pathology of ocular irritation with bleaching agents in the rabbit low-volume eye test. Toxicol. Pathol. 29 (2001) 308-319
27. Maurer J.K., Parker R.D., and Jester J.V. Extent of initial corneal injury as the mechanistic basis for ocular irritation: key findings and recommendations for the development of alternative assays. Regul. Toxicol. Pharmacol. 36 (2002) 106-117
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., and Scheel J. A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: eye irritation. Regul. Toxicol. Pharmacol. 54 (2009) 197-209
29. Methods, I.C.C.o.t.V.o.A., 2009. Independent Scientific Peer Review Panel Report: Evaluation of the Validation Status of Alternative Ocular Safety Testing Methods and Approaches. .
30. Moller-Pedersen T., Cavanagh H.D., Petroll W.M., and Jester J.V. Corneal haze development after PRK is regulated by volume of stromal tissue removal. Cornea 17 (1998) 627-639
31. Moller-Pedersen T., Li H.F., Petroll W.M., Cavanagh H.D., and Jester J.V. Confocal microscopic characterization of wound repair after photorefractive keratectomy. Invest. Ophthalmol. Vis. Sci. 39 (1998) 487-501
32. Rowan A.N. The future of animals in research and training. The search for alternative. Fundam. Appl. Toxicol. 4 (1984) 508-516
33. Scott, L., Eskes, C., Hoffmann, S., Adriaens, E., Alepee, 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., Goethem, F.V., Vassallo, M., Vinardell, P., Zuang, V., 2009. A proposed eye irritation testing strategy to reduce and replace in vivo studies using bottom-up and top-down approaches. Toxicol. in Vitro.
34. United Nations, 2007. Globallly Harmonized System of Classification and Labeling Chemicals (GHS) - "The Purple Book", United Nations Publications, New York, Geneva.
35. Weil C.S., and Scala R.A. Study of intra- and interlaboratory variability in the results of rabbit eye and skin irritation tests. Toxicol. Appl. Pharmacol. 19 (1971) 276-360
36. Wilson S.E., He Y.G., Weng J., Li Q., McDowall A.W., Vital M., and Chwang E.L. Epithelial injury induces keratocyte apoptosis: hypothesized role for the interleukin-1 system in the modulation of corneal tissue organization and wound healing. Exp. Eye Res. 62 (1996) 325-327
37. Zieske J.D., Guimaraes S.R., and Hutcheon A.E. Kinetics of keratocyte proliferation in response to epithelial debridement. Exp. Eye Res. 72 (2001) 33-39