A new cell-based method for assessing the eye irritation potential of chemicals: An alternative to the Draize test

Toxicology Letters

Volumn 212, Issue 2, 2012, Pages 198-204

  Cho, Sun A ^a   An, Susun ^a   Lee, Eunyoung ^a   Shin, Kyeho ^a   Cho, Jun Cheol ^a   Lee, Tae Ryong ^a  

^a AmorePacific Corporation   (South Korea)

Author keywords

Alternative; Draize eye test; Eye irritation; HCE T

Indexed keywords

IRRITANT AGENT;

ACCURACY; ARTICLE; CELL VIABILITY; CONCENTRATION (PARAMETERS); CORRELATION ANALYSIS; DRAIZE TEST; EYE IRRITATION; HUMAN; HUMAN CELL; LABORATORY TEST; PRIORITY JOURNAL; REPRODUCIBILITY; SCORING SYSTEM; SENSITIVITY AND SPECIFICITY; T LYMPHOCYTE;

ANIMAL TESTING ALTERNATIVES; ANIMALS; CELLS, CULTURED; CORNEA; EYE; HUMANS; IRRITANTS; RABBITS; REPRODUCIBILITY OF RESULTS;

ORYCTOLAGUS CUNICULUS;

EID: 84862651922     PISSN: 03784274     EISSN: 18793169     Source Type: Journal    
DOI: 10.1016/j.toxlet.2012.05.004     Document Type: Article

References (23)

1. Becker U., Ehrhardt C., Schneider M., Muys L., Gross D., Eschmann K., Schaefer U.F., Lehr C.M. A comparative evaluation of corneal epithelial cell cultures for assessing ocular permeability. Alternatives to Laboratory Animals 2008, 36:33-44.
2. Cotovio J., Grandidier M.H., Lelièvre D., Bremond C., Amsellem C., Maloug S., Ovigne J.M., Loisel-Joubert S., Lee A.V., Minondo A.M., Capallere C., Bertino B., Alépée N., Tinois-Tessonneaud E., de Fraissinette A.B., Meunier J.R., Leclaire J. In vitro assessment of eye irritancy using the Reconstructed Human Corneal Epithelial SkinEthic HCE model: application to 435 substances from consumer products industry. Toxicology In Vitro 2010, 24:523-537.
3. Curren R.D., Harbell J.W. Ocular safety: a silent (in vitro) success story. Alternatives to Laboratory Animals 2002, 30:69-74.
4. EC Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003. Official Journal of the European Union 2003, L66:26-35.
5. EEC Commission Directive 93/21/EEC of 27 April 1993 adapting to technical EEC, 1993. Commission Directive 93/21/EEC of 27 April 1993 adapting to technical progress for the 18th time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substance, Annex IV. Official Journal of the European Communities 1993, L11OA:1-86.
6. ETETOC ECETOC Technical Report No. 48, Eye Irritation: Reference Chemicals Data Bank 1998, ECETOC, Brussels, Belgium, p. 236. second ed.
7. Hartung T., Bruner L., Curren R., Eskes C., Goldberg A., McNamee P., Scott L., Zuang V. First alternative method validated by a retrospective weight-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.
8. Hagino S., Okazaki Y., Itagaki H. An in vitro tier evaluation for the identification of cosmetic ingredients which are not ocular irritants. Alternatives to Laboratory Animals 2008, 36:641-652.
9. Gautheron P., Giroux J., Cottin M., Audegond L., Morilla A., Mayordomo-Blanco L., Tortajada A., Haynes G., Vericat J.A., Pirovano R., Gillio Tos E., 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. Toxicology In Vitro 1994, 8:381-392.
10. Kaluzhny Y., Kandárová H., Hayden P., Kubilus J., d'Argembeau-Thornton L., Klausner M. Development of the EpiOcular(TM) eye irritation test for hazard identification and labelling of eye irritating chemicals in response to the requirements of the EU cosmetics directive and REACH legislation. Alternatives to Laboratory Animals 2011, 39:339-364.
11. Matsuda S., Hisama M., Shibayama H., Itou N., Iwaki M. In vitro eye irritancy test of lauryl derivatives using the reconstructed rabbit corneal epithelium model. Toxicology In Vitro 2009, 23:555-560.
12. 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., Scheel J. A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: eye irritation. Regulatory Toxicology and Pharmacology 2009, 54:197-209.
13. OECD OECD Guidelines for Testing of Chemicals; Test Guideline 405, Acute Eye Irritation/Corrosion (Updated Guideline, adopted 24 April 2002) 2002, OECD (Organization for Economic Cooperation and Development), Paris, France.
14. Ohno Y., Kaneko T., Inoue T., Morikawa Y., Yoshida T., Fujii A., Masuda M., Ohno T., Hayashi M., Momma J., Uchiyama T., Chiba K., Ikeda N., Imanishi Y., Itakagaki H., Kakishima H., Kasai Y., Kurishita A., Kojima H., Matsukawa K., Nakamura T., Ohkoshi K., Okumura H., Saijo K., Sakamoto K., Suzuki T., Takano K., Tatsumi H., Tani N., Usami M., Watanabe R. 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. Toxicology In Vitro 1999, 13:73-98.
15. Sasaki Araki K., Ohashi Y., Sasabe T., Hayashi K., Watanabe H., Tano Y., Handa H. An SV40-immortalized human corneal epithelial cell line and its characterization. Investigative Ophthalmology and Visual Science 1995, 36:614-621.
16. Scott L., Eskes C., Hoffmann S., Adriaens E., Alepée 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. A proposed eye irritation testing strategy to reduce and replace in vivo studies using Bottom-Up and Top-Down approaches. Toxicology In Vitro 2010, 24:1-9.
17. Seomun Y., Joo C.K. Lumican induces human corneal epithelial cell migration and integrin expression via ERK 1/2 signaling. Biochemical and Biophysical Research Communications 2008, 372:221-225.
18. Takahashi Y., Koike M., Honda H., Ito Y., Sakaguchi H., Suzuki H., Nishiyama N. Development of the short time exposure (STE) test: an in vitro eye irritation test using SIRC cells. Toxicology In Vitro 2008, 22:760-770.
19. Takahashi Y., Hayashi T., Watanabe S., Hayashi K., Koike M., Aisawa N., Ebata S., Sakaguchi H., Nakamura T., Kuwahara H., Nishiyama N. Inter-laboratory study of short time exposure (STE) test for predicting eye irritation potential of chemicals and correspondence to globally harmonized system (GHS) classification. Journal of Toxicological Sciences 2009, 34:611-626.
20. Takahashi Y., Hayashi T., Koike M., Sakaguchi H., Kuwahara H., Nishiyama N. An interlaboratory study of the short time exposure (STE) test using SIRC cells for predicting eye irritation potential. Cutaneous and Ocular Toxicology 2010, 29:77-90.
21. United Nations, 2003. Globally Harmonized System of Classification and Labeling of Chemicals (GHS); New York & Geneva (ST/GT/AC. 10/3).
22. Vinardell M.P., Mitjans M. Alternative methods for eye and skin irritation tests: an overview. Journal of Pharmaceutical Sciences 2008, 97:46-59.
23. Weil C.S., 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.