Abraham, M.H., Hassanisadi, M., Jalali-Heravi, M., et al. (2003). Draize rabbit eye test compatibility with eye irritation thresholds in humans: A quantitative structure-activity relationship analysis. Toxicol. Sci. 76, 384-391.
Ahmad, S., Stewart, R., Yung, S., et al. (2007). Differentiation of human embryonic stem cells into corneal epithelial-like cells by in vitro replication of the corneal epithelial stem cell niche. Stem Cells. 25, 1145-1155.
Bagley, D.M., Waters, D. & Kong, B.M. (1994). Development of a 10-day chorioallantoic membrane vascular assay as an alternative to the Draize rabbit eye irritation test. Food Chem. Toxicol. 32, 1155-1160.
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. Toxicol. in Vitro. 13, 285-293.
Bagley, D.M., Casterton, P.L., Dressler, W.E., et al. (2006). Proposed new classification scheme for chemical injury to the human eye. Regul. Toxicol. Pharm. 45, 206-213.
Balls, M., Berg, N., Bruner, L.H., et al. (1999). Eye irritation testing: The way forward. The report and recommendations of ECVAM workshop 34. Altern. Lab. Anim. 27, 53-77.
Boulton, M. & Wride, M. (2006). Can toxicogenomics be used to identify chemicals that cause ocular injury? ALTEX. 23, Suppl., 318-320.
Buehler, E.V. & Newman, E.A. (1964). A comparison of eye irritation in monkeys and rabbits. Toxicol. Appl. Pharmacol. 6, 701-710.
Burbach, G.J., Naik, S.M., Harten, B.J., et al. (2001). Interleukin-18 expression and modulation in human corneal epithelial cells. Curr. Eye Res. 23, 64-68.
Cater, K.C. & Harbell, J.W. (2006). 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, 217-233.
Clothier, R., Orme, A., Walker, T.L., et al. (2000). Comparison of three cytotoxicity assays using the corneal HCE-T model. Altern. Lab. Anim. 28, 293-302.
Cometto-Muñiz, J.E., Cain, W.S., Abraham, M.H. & Sánchez-Moreno, R. (2007). Cutoff in detection of eye irritation from vapors of homologous carboxylic acids and aliphatic aldehydes. Neuroscience. 145, 1130-1137.
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. Toxicol. In Vitro. 15, 95-103.
Curren, R.D., Sina, J.F., Feder, P., et al. (1997). IRAG working group 5. Other assays. Interagency Regulatory Alternatives Group. Food Chem. Toxicol. 35, 127-158.
Curren, R.D. & Harbell, J.W. (1998). In vitro alternatives for ocular irritation. Environ. Health Perspect. 106, Suppl. 2, 485-492.
de Silva, O. & European Federation of the Cosmetics Industry Steering Committee on Alternatives to Animal Testing (2002). The contributions of the European cosmetics industry to the development of alternatives to animal testing: Dialogue with ECVAM and future challenges. Altern. Lab. Anim. 30, Suppl. 2, 189-193.
Debbasch, C., Ebenhahn, C., Dami, N., et al. (2005). Eye irritation of low-irritant cosmetic formulations: Correlation of in vitro results with clinical data and product composition. Food Chem. Toxicol. 43, 155-165.
Doillon, C.J., Watsky, M.A., Hakim, M., et al. (2003). A collagen-based scaffold for a tissue engineered human cornea: Physical and physiological properties. Int. J. Artif. Organs. 26, 764-773.
Doucet, O., Lanvin, M., Thillou, C., et al. (2006). Reconstituted human corneal epithelium: A new alternative to the Draize eye test for the assessment of the eye irritation potential of chemicals and cosmetic products. Toxicol. In Vitro. 20, 499-512.
Draize, J.H., Woodward, G., Calvery, H.O. (1944). Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. Exp. Ther. 82, 377-390.
Duan, X., McLaughlin, C., Griffith, M. & Sheardown, H. (2007). Biofunctionalization of collagen for improved biological response: Scaffolds for corneal tissue engineering. Biomaterials. 28, 78-88.
ECVAM. (2002). Local toxicity. Acute dermal and ocular effects. Altern. Lab. Anim. 30, Suppl. 1, 35-47.
Environmental Protection Agency (EPA). (2006). Globally Harmonized System (GHS) for Classification and Labeling of Chemicals. Available here.
Eskes, C., Bessou, S., Bruner, L., et al. (2005). Eye irritation. Altern. Lab. Anim. 33, Suppl. 1, 47-81.
Freeberg, F.E., Griffith, J.F., Bruce, R.D. & Bay, P.H.S. (1984). Correlation of animal test methods with human experience for household products. J. Toxicol. Cutaneous Ocul. Toxicol. 3, 53-64.
Friedenwald, J. S., Hughes, W. F. & Herrmann, H. (1944). Acid-base tolerance of the cornea. Arch. Ophthalmol. 31, 279-283.
Gad, S.C. & Chengelis, C.P. (1991). Acute Toxicology Testing. Academic Press, San Diego, 57-83.
Gautheron, P., Dukic, M., Alix, D. & Sina, J.F. (1992). Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam. Appl. Toxicol. 18, 442-449.
Gerner, I., Liebsch, M. & Spielmann, H. (2005). Assessment of the eye irritating properties of chemicals by applying alternatives to the Draize rabbit eye test: The use of QSARs and in vitro tests for the classification of eye irritation. Altern. Lab. Anim. 33, 215-237.
Grant, W.M. & Schuman, J.S. (1993). Toxicology of the Eye. 4th Ed. Charles C. Thomas, Springfield, IL.
Grant, R.L., Yao, C., Gabaldon, D. & Acosta, D. (1992). Evaluation of surfactant cytotoxicity potential by primary cultures of ocular tissues: I. Characterization of rabbit corneal epithelial cells and initial injury and delayed toxicity studies. Toxicol. 76, 153-176.
Griffith, M., Osborne, R., Munger, R., et al. (1999). Functional human corneal equivalents constructed from cell lines. Science. 286, 2169-2172.
Harbell, J., Koontz, S.W., Lewis, R.W., et al. (1997). IRAG working group 4: Cell cytotoxicity assays. Food Chem. Toxicol. 35, 79-126.
Huhtala, A., Alajuuma, P., Burgalassi, S., et al. (2003). A collaborative evaluation of the cytotoxicity of two surfactants by using the human corneal epithelial cell line and the WST-1 test. J. Ocul. Pharmacol. Ther. 19, 11-21.
ICCVAM. (2006). In vitro test methods for detecting ocular corrosives and severe irritants. Background Review Documents. Available here.
ILSI Technical Committee on Alternatives to Animal Testing (TCAAT). (1996). Replacing the Draize eye irritation test: Scientific background and research needs. J. Toxicol. Cutaneous Ocul. Toxicol. 15, 211-234.
Jester, J.V. (2006). Extent of corneal injury as a biomarker for hazard assessment and the development of alternative models to the Draize rabbit eye test. Cutan. Ocul. Toxicol. 25, 41-54.
Jester, J.V., Petroll, W.M., Bean, J., et al. (1998). Area and depth of surfactant-induced corneal injury predicts extent of subsequent ocular responses. Invest. Ophthalmol. Vis. Sci. 39, 2610-2625.
Jones, P.A., Budynsky, E., Cooper, K.J., et al. (2001). Comparative evaluation of five in vitro tests for assessing the eye irritation potential of hair-care products. Altern. Lab. Anim. 29, 669-692.
Kahn, C.R. & Walker, T.L. (1993). Human corneal epithelial cell lines with extended lifespan: Transepithelial permeability across membranes formed in vitro. Invest. Ophthalmol. Vis. Sci. 34, 1010.
Kahn, C.R., Young, E., Lee, I.H. & Rhim, J.S. (1993). Human corneal epithelial primary cultures and cell lines with extended life span: In vitro model for ocular studies. Invest. Ophthalmol. Vis. Sci. 34, 3429-3441.
Kruszewski, F.H., Walker, T.L., Ward, S.L. & DiPasquale, L.C. (1995). Progress in the use of human ocular tissues for in vitro alternative methods. Comments on Toxicol. 5, 203-224.
Kruszewski, F.H., Walker, T.L. & Dipasquale, L.C. (1997). Evaluation of a human corneal epithelial cell line as an in vitro model for assessing ocular irritation. Fundam. Appl. Toxicol. 36, 130-140.
Kulkarni, A.S. & Hopfinger, A.J. (1999). Membrane-interaction QSAR analysis: Application to the estimation of eye irritation by organic compounds. Pharm. Res. 16, 1245-1253.
Kulkarni, A., Hopfinger, A.J., Osborne, R., et al. (2001). Prediction of eye irritation from organic chemicals using membrane-interaction QSAR analysis. Toxicol. Sci. 59, 335-345.
Lagarto, A., Vega, R., Vega, Y., et al. (2006). Comparative study of red blood cell method in rat and calves blood as alternatives of Draize eye irritation test. Toxicol. In Vitro. 20, 529-533.
Li, Y., Liu, J., Pan, D. & Hopfinger, A.J. (2005). A study of the relationship between cornea permeability and eye irritation using membrane-interaction QSAR analysis. Toxicol. Sci. 88, 434-446.
Liao, Y., Wang, X., Zhang, L.S., et al. (2004). Study on the use of haemoglobin denaturation test as an alternative to Draize eye irritation test. Sichuan Da Xue Xue Bao Yi Xue Ban. 35, 654-657.
Lilja, J. & Forsby, A. (2004). Development of a sensory neuronal cell model for the estimation of mild eye irritation. Altern. Lab. Anim. 32, 339-343.
Lilja, J., Lindegren, H. & Forsby, A. (2007). Surfactant-induced TRPV1 activity: A novel mechanism for eye irritation? Toxicol. Sci. 99, 174-180.
Martinez, V., Corsini, E., Mitjans, M., et al. (2006). Evaluation of eye and skin irritation of arginine-derivative surfactants using different in vitro endpoints as alternatives to the in vivo assays. Toxicol. Lett. 164, 259-267.
Maurer, J.K., Parker, R.D. & Jester, J.V. (2002). 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, 106-117.
Mehling, A., Kleber, M. & Hensen, H. (2007). Comparative studies on the ocular and dermal irritation potential of surfactants. Food Chem. Toxicol. 45, 747-758.
Minami, Y., Sugihara, H. & Oono, S. (1993). Reconstruction of cornea in three-dimensional collagen gel matrix culture. Invest. Ophthalmol. Vis. Sci. 34, 2316-2324.
North-Root, H., Yackovich, F., Demetrulias, J., et al. (1982). Evaluation of an in vitro cell toxicity test using rabbit corneal cells to predict the eye irritation potential of surfactants. Toxicol. Lett. 14, 207-212.
Nussenblatt, R.B., Bron, A., Chambers, W., et al. (1998). Ophthalmologic perspectives on eye irritation testing. J. Toxicol. Cutaneous Ocul. Toxicol. 17, 103-109.
Osborne, R., Perkins, M.A. & Roberts, D.A. (1995). Development and intralaboratory evaluation of an in vitro human cell-based test to aid ocular irritancy assessments. Fundam. Appl. Toxicol. 28, 139-153.
Pape, W.J.W., Pfannenbecker, U. & Hoppe, U. (1987). Validation of the red blood cell test system as an in vitro assay for the rapid screening of irritation potential of surfactants. Mol. Toxicol. 1, 525-536.
Parnigotto, P.P., Bassani, V., Montesi, F. & Conconi, M.T. (1998). Bovine corneal stroma and epithelium reconstructed in vitro: Characterization and response to surfactants. Eye. 12, 304–310.
Pasternak, A.S. & Miller, W.M. (1995). First-order toxicity assays for eye irritation using cell lines: Parameters that affect in vitro evaluation. Fundam. Appl. Toxicol. 25, 253-263.
Pospisil, H. & Holzhütter, H.G. (2001). A compartment model to calculate time-dependent concentration profiles of topically applied chemical compounds in the anterior compartments of the rabbit eye. Altern. Lab. Anim. 29, 347-365.
Prinsen, M.K. (1996). The chicken enucleated eye test (CEET): a practical (pre)screen for the assessment of eye irritation/corrosion potential of test materials. Food Chem. Toxicol. 34, 291-296.
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 Chem. Toxicol. 31, 69–76.
Salem, H. & Katz, S.A. (2003). Part II. Development of predictive methods based on mechanisms of eye irritation at the ocular surface: Meeting industry and regulatory needs. Alternative Toxicological Methods for the New Millennium. CRC Press, Boca Raton, FL. 75-186.
Shaw, A.J., Clothier, R.H. & Balls, M. (1990). Loss of trans-epithelial impermeability of a confluent monolayer of Madin-Darby canine kidney(MDCK) cells as a determinant of ocular irritancy potential. Altern. Lab. Anim. 18, 145-151.
Shortt, A.J., Secker, G.A., Munro, P.M., et al. (2007). Characterization of the limbal epithelial stem cell niche: Novel imaging techniques permit in vivo observation and targeted biopsy of limbal epithelial stem cells. Stem Cells. 25, 1402-1409.
Sina, J.F., Gautheron, P., Casterton, P., et al. (1998). Report from the bovine corneal opacity and permeability technical workshop. In Vitro Mol. Toxicol. 11, 315–351.
Smit, E.E., Sra, S.K., Grabowski, L.R., et al. (2003). Modulation of IL-8 and RANTES release in human conjunctival epithelial cells: Primary cells and cell line compared and contrasted. Cornea. 22, 332-337.
Song, P.I., Abraham, T., Park, Y., et al. (2001). The expression of functional LPS receptor proteins CD14 and toll-like receptor 4 in human corneal cells. Invest. Ophthalmol. Vis. Sci. 42, 2867-2877.
Spielmann, H. & Liebsch, M. (2001). Lessons learned from validation of in vitro toxicity test: From failure to acceptance into regulatory practice. Toxicol. In Vitro. 15, 585-590.
Spielmann, H., Liebsch, M., Moldenhauer, F., et al. (1997). IRAG working group 4: CAMbased assays. Food Chem. Toxicol. 35, 39-66.
Stepp, M.A. & Zieske, J.D. (2005).The corneal epithelial stem cell niche. Ocul. Surf. 3, 15-26.
Stramer, B.M., Zieske, J.D., Jung, J.C., et al. (2003). Molecular mechanisms controlling the fibrotic repair phenotype in cornea: Implications for surgical outcomes. Invest. Ophthalmol. Vis. Sci. 44, 4237-4246.
Tchao, R. (1988). Trans-epithelial permeability of fluorescein in vitro as an assay to determine eye irritants. Alternative Methods in Toxicology. Vol 6 (Ed. A.M. Goldberg). Mary Ann Liebert, New York.
Tsakovska, I., Saliner, A.G., Netzeva, T., et al. (2007). Evaluation of SARs for the prediction of eye irritation/corrosion potential: Structural inclusion rules in the BfR decision support system. SAR QSAR Environ. Res. 18, 221-235.
Ubels, J.L., Ditlev, J.A., Clousing, D.P. & Casterton, P.L. (2004). Corneal permeability in a redesigned corneal holder for the bovine cornea opacity and permeability assay. Toxicol. In Vitro. 18, 853-857.
United Nations Economic Commission for Europe (UNECE). (2004). Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Part 3, Health and environmental hazards. Chapter 3.3. Serious eye damage/ irritation. Available here.
Van den Berghe, C., Guillet, M.C. & Compan, D. (2005). Performance of porcine corneal opacity and permeability assay to predict eye irritation for water-soluble cosmetic ingredients. Toxicol. In Vitro. 19, 823-830.
Van Goethem, F., Adriaens, E., Alépée, N., et al. (2006). Prevalidation of a new in vitro reconstituted human cornea model to assess the eye irritating potential of chemicals. Toxicol. In Vitro. 20, 1-17.
Wang, Y., Zhang, J., Yi, X.J. & Yu, F.S. (2004). Activation of ERK1/2 MAP kinase pathway induces tight junction disruption in human corneal epithelial cells. Exp. Eye Res. 78, 125-136.
Ward, S.L., Walker, T.L. & Dimitrijevich, S.D. (1997). Evaluation of chemically-induced toxicity using an in vitro model of human corneal epithelium. Toxicol. In Vitro. 11, 121-139.
Ward, S., Walker, T., Trocme, S., et al. (2000). A human conjunctival model for the evaluation of eye irritants. Progress in the Reduction, Refinement and Replacement of Animal Experimentation. (Eds: M. Balls, A.M. van Zeller & M.E. Halder). Elsevier Science B.V., Amsterdam. 305-317.
Ward, S.L., Gacula, Jr., M. & Edelhauser, H.F. (2003). The Human Corneal Epithelial HCE-T TEP assay for eye irritation: Scientific relevance and summary of prevalidation study results. Alternative Toxicological Methods for the New Millennium. (Eds. H. Salem & S.A. Katz). CRC Press, Boca Raton, FL. 161-186.
Weil, C.S. & Scala, R.A. (1971). Study of intra- and inter-laboratory variability in the results of rabbit eye and skin irritation test. Toxicol. Appl. Pharmacol. 19, 276-360.
Xu, K.P., Li, X.F. & Yu, F.S. (2000). Corneal organ culture model for assessing epithelial responses to surfactants. Toxicol. Sci. 58, 306-314.
Yang, W. & Acosta, D. (1994). Cytotoxicity potential of surfactant mixtures evaluated by primary cultures of rabbit corneal epithelial cells. Toxicol. Lett. 70, 309–318.
Yannariello-Brown, J., Hallberg, C.K., Häberle, H., et al. (1998). Cytokine modulation of human corneal epithelial cell ICAM-1 (CD54) expression. Exp. Eye Res. 67, 383-393.
Zieske, J.D., Mason, V.S., Wasson, M.E., et al. (1994). Basement membrane assembly and differentiation of cultured corneal cells: Importance of culture environment and endothelial cell interaction. Exp. Cell Res. 214, 621-633.
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