Anonymous. (2007). Draft Technical Guidance Document to Industry on the Information Requirements for REACH Part 2. Chapter 7.2 on Skin- and eye irritation/corrosion and respiratory irritation. p. 173-220. Website: Joint Research Center (accessed on October 30, 2007)
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. Toxicol. In Vitro. 9, 871-929.
Balls, M., Berg, N., Bruner, L.H., Curren, R., deSilva, 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. Altern. Lab. Anim. 27, 53-77.
Balls, M., Amcoff, P., Bremer, S., Casati, S., Coecke, S., Clothier, R., Combes, R., Corvi, R., Curren, R., Eskes, C., Fentem, J., Gribaldo, L., Halder, M., Hartung, T., Hoffmann, S., Schechtman, L., Scott, L., Spielmann, H., Stokes, W., Tice, R., Wagner, D. & Zuang, V. (2006). The principles of weight of evidence validation of test methods and testing strategies. Altern. Lab. Anim. 34, 1-19.
Bradlaw, J., Gupta, K., Green, S., Hill, R. & Wilcox, N. (1997). Practical application of non–whole animal alternatives: summary IRAG workshop on eye irritation. Food Chem. Toxicol. 35,175-178.
Brantom, P.G., Bruner, L.H., Chamberlain, M., Desilva, O., Dupuis, J., Earl, L.K., Lovell, D.P., Pape, W.J.W., Uttley, M., Bagley, D.M., Baker, F.W., Brachter, M., Courtellemont, P., Declercq, L., Freeman, S., Steiling, W., Walker, A.P., Carr, G.J., Dami, N., Thomas, G., Harbell, J., Jones, P.A., Pfannenbecker, U., Southee, J,A,. Tcheng, M., Argembeaux, H., Castelli, D., Clothier, R., Esdaile, D.J., Itigaki, H., Jung, K., Kasai, Y., Kojima, H., Kristen, U., Larnicol, M., Lewis, R.W., Marenus, K., Moreno, O., Peterson, A., Rasmussen, E.S., Robles, C. & Stern, M. (1997). A summary report of the COLIPA international validation study on alternatives to the Draize rabbit eye irritation test. Toxicol. In Vitro. 11, 141-179.
Christian, M.S. & Diener, R.M. (1996). Soaps and detergents - alternatives to animal eye irritation tests. J. Am. Coll. Toxicol. 15, 1-44.
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. J. Pharmacol. Exp. Ther. 82, 377-390.
EC. (2004). Manual of Decisions for Implementation of the 6th and 7th Amendments to Directive 67/548/EEC on Dangerous Substances. Updated version of July 2004 (EUR 20519). 189pp. Ispra, Italy: European Chemicals Bureau, European Commission JRC. Website: Joint Research Center (accessed on September 28, 2007).
ESAC. (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 US EPA, EU (R41) and UN GHS classifications in a tiered testing strategy, as part of a weight of evidence approach. Website: Joint Research Center (accessed on September 28, 2007).
Eskes, C., Bessou, S., Bruner, L., Curren, R., Harbell, J., Jones, P., Kreiling, R., Liebsch, M., McNamee, P., Pape, W., Prinsen, M., Seidle, T., Vanparys, P., Worth, A. & Zuang, V. (2005). Subchapter 3.3. Eye Irritation. In Alternative (Non-Animal) Methods for Cosmetics Testing: Current Status and Future Prospects (Eskes C., Zuang V. eds). Altern. Lab. Anim. 33, Suppl. 1, 47-81.
EU. (2003). Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. Official Journal of the European Union L66, 26-35.
EU. (2006). Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Official Journal of the European Union L396, 1-849.
Freeberg, F.E., Nixon, G.A., Reer, P.J., Weaver, J.E., Bruce, R.D., Griffith, J.F. & Sanders, L.W. (1986). Human and rabbit eye responses to chemical insult. Fundam. Appl. Toxicol. 7, 626-634.
Gettings, S.D., Teal, J.J., Bagley, D.M., Demetrulias, J.L., DiPasquale, L.C., Hintze, K.L., Rozen, M.G., Weise, S.L., Chudkowski, M., Marenus, K.D., Pape, W.J.W., Roddy, M., Schnetzinger, R., Silber, P.M., Glaza, S.M. & Kurtz, P.J. (1991). The CTFA evaluation of alternatives program: an evaluation of in vitro alternatives to the Draize primary eye irritation test (phase I) hydro-alcoholic formulations; (part 2) data analysis and biological significance. In Vitro Toxicol. 4, 247-288.
Gettings, S.D., Bagley, D.M., Chudlowski, M., Demetrulias, J.L., Dipasquale, L.C., Galli, C.L., Gay, R., Hintze, K.L., Janus, J., Marenus, K.D., Muscatiello, M.J., Pape, W.J.W., Renskers, K.J., Roddy, M.T. & Schnetzinger, R. (1992). Development of potential alternatives to the Draize eye test. The CTFA evaluation of alternatives program (Phase II). Review of materials and methods. Altern. Lab. Anim. 20, 164-171.
Gettings, S.D., Dipasquale, L.C., Bagley, D.M., Casterton, P.L., Chudkowski, M. & Curren, R.D. (1994). 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. 32, 943-976.
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. (1996). 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. 34, 79-117.
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. (2004). A modular approach to the ECVAM principles on test validity. Altern. Lab. Anim. 32, 467-472.
Hamernik, K., Eskes, C., Merrill, J., Choksi, N., Allen, D., Truax, J., Tice, R., Wind, M., Schechtman, L.M. & Stokes, W. (2006). ICCVAM-NICEATM-ECVAM Symposium on Mechanisms of Chemically-Induced Ocular Injury and Recovery: Current Understanding and Knowledge Gaps. ALTEX 23 Suppl, 321-323.
ICCVAM. (2006). The ICCVAM Test Method Evaluation Report on In Vitro Ocular Toxicity Test Methods for Identifying Severe Irritants and Corrosives. Website: ICCVAM (accessed on October 30, 2007).
Jones, P., Bagley, D., Faller, C., Le Varlet, B., McNamee, P., Manou, I., Pape, W., Van den Berghe, C. & Van Goethem, F. (2006). An overview of the COLIPA Eye Irritation Research Programme. ALTEX 23 Suppl, 324-325.
Lordo, R.A., Feder, P.I. & Gettings, S.D. (1999). Comparing and evaluating alternative (in vitro) tests on their ability to predict the Draize maximum average score. Toxicol. In Vitro. 13, 45-72.
OECD. (2002). OECD Guidelines for the Testing of Chemicals No. 405: Acute Eye Irritation/Corrosion. 14 pp. Paris, France: Organisation for Economic Cooperation and Development.
Ohno, Y., Kaneko, T., Inoue, T., Morikawa, Y., Yoshida, T., Fuji, A., Masuda, M., Ohno, T., Hayashi, M., Momma, J., Uchiyama, T., Chiba, K., Ikeda, N., Imanashi, Y. & Itakagaki, H. (1999). Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (1) Overview of the validation study and Draize scores for the evaluation of the tests. Toxicol. In Vitro. 13, 73-98.
Prinsen, M. (2006). The Draize Eye Test and in vitro alternatives, a left-handed marriage? Toxicol. In Vitro. 20, 78-81.
Scott, L., Eskes, C., Hoffman, S., Adriaens, E., Alepee, 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. Bottom-up and Top-down Approach: Eye Irritation Testing Strategy to Reduce and Replace in vivo studies (in preparation).
Spielmann, H., Kalweit, S., Liebsch, M., Wirnserberger, T., Gerner, I., Bertram-Neis, E., Krauser, K., Kreiling, R., Miltenburger, H.G., Pape, W. & Steiling, W. (1993). Validation study of alternatives to the Draize eye irritation test in Germany: cytotoxicity testing and HET-CAM test with 136 industrial chemicals. Toxicol. In Vitro. 7, 505-510.
Spielmann, H., Liebsch, M., Kalweit, S., Moldenhauer, F., Wirnsberger, T., Holzhuetter, H.G., Schneider, B., Glaser, S., Gerner, I., Pape, W.J.W., Kreiling, R., Krauser, K., Miltenburger, H.G., Steiling, W., Luepke, N.P., Mueller, N., Kreuzer, H., Muermann, P., Spengler, J., Betram-Neis, E., Siegemund, B. & Wiebel, F.J. (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. Altern. Lab. Anim. 24, 741-858.
Weil, C.S. & Scala, R.A. (1971). Study of intra- and interlaboratory variability in the results of rabbit eye and skin irritation tests. Toxicol. Appl. Pharm. 19, 276-360.
Worth, A.P. & Balls, M., eds. (2002). Alternative (Non-Animal) Methods for Chemicals Testing: Current Status and Future Prospects. A report prepared by ECVAM and the ECVAM working group on chemicals. Altern. Lab. Anim. 30, Suppl.1, 1-115.
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