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Alternatives to animal experiments for eye irritation

8. References

Balls, M., Botham, P. A., Bruner, L. H. and Spielmann, H.: The EC/HO international validation study on alternatives to the Draize eye irritation test. Toxicology in Vitro. 1995, 9, 871-929.

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Brantom, P. G., Bruner, L. H., Chamberlain, M. et al.: A summary report of the COLIPA international validation study on alternatives to the Draize rabbit eye irritation test. Toxicology in Vitro, 1997, 11, 141-179.

Bruner, L. H., Carr, G. J., Chamberlain, M. and Curren, R. D.: Validation of alternative methods for toxicity testing. Toxicology in Vitro, 1996, 10, 479-501.

Bruner, L. H., De Silva, O., Earl, L. K., Easty, D. L., Pape, W. J. W. and Spielmann, H.: Report on the COLIPA workshop on mechanisms of eye irritation. Alternatives to Laboratory Animals, 1998, 26, 811-820.

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Curren, R. D., Sina, J. F., Feder, P., Kruszewski, F. H., Osborne, R. and Régnier, J.-F.: Other assays. IRAG Working Group 5. Food and Chemical Toxicology, 1997, 35, 127-158.

deSilva, O.: Alternatives to eye irritation evaluation - the industry perspective. From: Lisansky, S. G., Macmillan, R. and Dupuis, J. (eds.): Alternatives to animal testing. Proceedings of an international scientific conference organised by the European Cosmetics Industry, Brussels, Belgium 1995. CPL Press, Newbury, UK, 1996, pp. 67-73.

Doucet, O., Lanvin, M. and Zastrow, L.: A new in vitro human epithelial model for assessing the eye irritating potential of formulated cosmetic products. In Vitro & Molecular Toxicology, 1998, 11, 273-283.

ECETOC (European Centre for Ecotoxicology and Toxicology of Chemicals) (1998). Eye Irritation: Reference chemicals data bank (second edition). Technical Report No. 48 (2). Brussels.

Espersen, R. J., Olsen, P., Nicolaisen, G., Jensen, B. L. and Rasmussen, E. S.: Assessment of recovery from ocular irritancy using a human tissue equivalent model. Toxicology in Vitro, 1997, 11, 81-88.

EU (1993): Directive 93/35/EEC. Official Journal of the European Communities, L 151/32, 23.6.1993.

EU Commission (1995): Development, validation and legal acceptance of alternative methods in the field of cosmetic products.

EU Commission (1996 a) Classification, packaging and labelling of dangerous substances in the European Union. Opdated version of Directive 67/548/EEC.

EU Commission (1996 b): Development, validation and legal acceptance of alternative methods in the field of cosmetic products.

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. Hydroalcoholoc formulations. Food and Chemical Toxicology,1996a 34, 737-749.

Gettings, S. D., Lordo, R. A., Hintze, K. L. et al.: 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 and Chemical Toxicology, (1996b), 34, 79-117.

Gettings, S. D., Lordo, R. A., Feder, P. I., and Hintze, K. L.: Comparison of low-volume, Draize and in vitro eye irritation test data. II. Oil/water emulsions. Food and Chemical Toxicology, (1998), 36, 47-59.

Gupta, K. C., Chambers, W. A., Green, S. et al.: An eye irritation test protocol and an evaluation and classification scheme. Food and Chemical Toxicology, 1993, 31, 117-121.

Harbell, J. W. and Curren, R.: Report from the bovine corneal opacity and permaebility technical workshop, November 3-4, 1997, Gaithersburg, MD. Assay performance. In Vitro & Molecular Toxicology, 1998, 11, 337-345.

Harbell, J. W., Koontz, S. W., Lewis, R. W., Lovell, D. and Acosta, D.: Cell cytotoxicity assays. IRAG Working Group 4. Food and Chemical Toxicology, 1997, 35, 79-126.

Hatao, M., Murakami, N. Sakamoto, K. et al.: Interlaboratory validation of in vitro eye irritation tests for cosmetic ingredients (4) Haemoglobin denaturation test. Toxicology in Vitro, 1999, 13, 125-137.

Hagino, S., Kinoshita, S., Tani, N. et al.: Interlaboratory validation of in vitro eye irritation tests for cosmetic ingredients (2) Chorioallantoic membrane tests. Toxicology in Vitro, 1999, 13, 99-113.

Klausner, M., Sennott, H. A., Breyfogle, B., Makwana, A., and Kubilis, J.: The EpiOcular prediction model: a reproducible in vitro means of assessing ocular irritancy potential. The Toxicologist, 1999, 48, 336.

Kurishita, A. Katoh, T., Ohsawa, H. et al.: Interlaboratory validation of in vitro eye irritation tests for cosmetic ingredients (5) SKIN2TMZK1100 and tissue equivalent assay. Toxicology in Vitro, 1999, 13, 139-151.

Matsukawa, K., Masuda, K., Kakishima, H. et al.: Interlaboratory validation of in vitro eye irritation tests for cosmetic ingredients (11) EYTEXTM. Toxicology in Vitro, 1999, 13, 209-217.

Ohno, Y., Kaneko, T., Inoue, T. et al.: Interlaboratory validation of in vitro eye irritation tests for cosmetic ingredients (1) Overview of the validation study and Draize scores for the evaluation of the tests. Toxicology in Vitro, 1999, 13, 73-98.

Ohuchi, J., Kasai, Y., Sakamoto, K. et al.: Interlaboratory validation of in vitro eye irritation tests for cosmetic ingredients (6) Evaluation of MATREXTM. Toxicology in Vitro, 1999, 13, 153-162.

Osborne, R., Perkins, M. A. and Roberts, D. A.: Development and intralaboratory evaluation of an in vitro human cell-based test to aid ocular irritancy assessments. Fundamental and Applied Toxicology, 1995, 28, 139-153.

Purchase, I. F. H.: Prospects for reduction and replacement alternatives in regulatory toxicology. Toxicology in Vitro, 1997, 313-319.

Rasmussen, E. S: Prospects for use of in vitro methods for assessment of human safety. National Food Agency of Denmark, 1995.

Rasmussen, E. S.: Use of reconstructed human tissue models in toxicological and pharmacological studies. Dansk Veterinærtidsskrift, 1/11, 1996, 943-948.

Sheasgreen, J. E., Kubilus, J., Sennott, H., Ogle, P. and Klausner, M.: Reproducibility and correlation of EpiOcular TM, a three-dimensional tissue culture model of human corneal epithelium. Alternatives to Laboratory Animals, 1996, 24, Special Issue, 284.

Sina, J. F. and Gautheron, P.: Report from the bovine corneal opacity and permeability technical workshop, November 3-4, 1997, Gaithersburg, MD. An historical perspective. In Vitro & Molecular Toxicology, 1998, 11, 316-326.

Southee, J. A., McPherson, J. P., Osborne, R., Carr, G. J. and Rasmussen, E.: The performance of the tissue equivalent assay using the SKIN2TM ZK1200 model in the COLIPA international validation study on alternatives to the Draize eye irritation test. Toxicology in Vitro, 1999, 13. 355-373.

Spielmann, H., Kalweit, S., Liebsch, M. et al.: Validation study of alternatives to the Draize eye irritation test in Germany: cytotoxicity testing and HET-CAM test with 136 industrial chemicals. Toxicology in Vitro, 1993, 7, 505-510.

Spielmann, H., Liebsch, M., Kalweit, S. et al.: Results of a validation study in Germany of two in vitro alternatives to the Draize eye irritation test, the HET-CAM test and the 3T3 NRU cytotoxicity test. Alternatives to Laboratory Animals, 1996, 24, 741-858.

Spielmann, H., Liebsch, M., Moldenhauer, F. et al.: CAM based assays. IRAG Working Group 2. Food and Chemical Toxicology, 1997, 35, 39-66.

Stern, M., Klausner, M., Alvarado, R., Renskers, K., and Dickens, M.: Evaluation of the EpiOcular TM tissue model as an alternative to the Draize eye irritation test. Toxicology in Vitro, 1998, 12, 455-461.

van de Sandt, J. J. M. and Rutten, A. A. J. J. L.: Differential effects of chemical irritants in rabbit and human skin organ cultures. Toxicology in Vitro, 1995, 9, 157-168.

Weil, C. S. and Scala, R. A.: Study of intra- and interlaboratory variability in the results of rabbit eye and skin irritation tests. Toxicology and Applied Pharmacology, 1971, 19, 276-360.

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