A tiered approach combining the short time exposure (STE) test and the bovine corneal opacity and permeability (BCOP) assay for predicting eye irritation potential of chemicals

Journal of Toxicological Sciences

Volumn 37, Issue 2, 2012, Pages 269-280

  Hayashi, Kazuhiko ^a   Mori, Taeko ^a   Abo, Takayuki ^a   Koike, Mirei ^a   Takahashi, Yutaka ^a   Sakaguchi, Hitoshi ^a   Nishiyama, Naohiro ^a  

^a KAO CORPORATION   (Japan)

Author keywords

Alternative method; BCOP; Eye irritation; GHS; STE; Tiered approach

Indexed keywords

ALCOHOL; AMINE; AROMATIC COMPOUND; CHEMICAL COMPOUND; ESTER; HETEROCYCLIC COMPOUND; HYDROCARBON; KETONE; LACTONE; POLYOL; SURFACTANT;

ANIMAL CELL; ANIMAL CELL CULTURE; ARTICLE; BOVINE CORNEAL OPACITY AND PERMEABILITY ASSAY; CELL ASSAY; CELL VIABILITY; CLINICAL ASSESSMENT TOOL; CONTROLLED STUDY; CYTOTOXICITY; EYE IRRITATION; IN VITRO STUDY; NONHUMAN; RABBIT; SHORT TIME EXPOSURE TEST;

BOVINAE; ORYCTOLAGUS CUNICULUS;

EID: 84859361733     PISSN: 03881350     EISSN: 18803989     Source Type: Journal    
DOI: 10.2131/jts.37.269     Document Type: Article

References (17)

1. Bagley, D., Booman, K.A., Bruner, L.H., Casterton, P.L., Demetrulias, J., Heinze, J.E., Innis, J.D., McCormick, W.C., Neun, D.J., Rothenstein, A.S. and Sedlak, R.I. (1994): The SDA Alternatives Program Phase III: Comparison of in vitro data with animal eye irritation data on solvents, surfactants, oxidizing agents, and prototype cleaning products., J. Toxicol. Cutaneous Ocul. Toxicol., 13, 127-155.
2. Balls, M., Berg, N., Bruner, L.H., Curren, R.D., De Silva, O., Earl, L.K., Esdaile, D.J., Fentem, J.H., Liebsch, M., Ohno, Y., Prinsen, M.K., Spielmann, H. and Worth, A.P. (1999): Eye irritation testing: the way forward, The report and recommendations of ECVAM workshop 34., Altern. Lab. Anim., 27, 53-77.
3. Cooper, K.R., Brown, R.S. and Chang, P.W. (1982): Accuracy of blood cytological screening techniques for the diagnosis of a possible hematopoietic neoplasm in the bivalve mollusc, Mya arenaria. J. Invertebr. Pathol., 39, 281-289.
4. Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003, Official Journal of the European Union, L66, 26-35.
5. Draize, J.H., Woodard, G. and 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.
6. ECETOC (1998): Eye Irritation - Reference Chemicals Data Bank. Technical Report No. 48(2). European Centre for Ecotoxicology and Toxicology of Chemicals, Brussels.
7. 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. (2005): Alternative(non-animal) methods for cosmetics testing: current status and future prospects, 3.3. ocular irritancy. Altern. Lab. Anim., 33, 47-81.
8. Gautheron, P., Dukic, M., Alix, D. and Sina, J.F. (1992): Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam. Appl. Toxicol., 18, 442-449.
9. Hagino, S., Okazaki, Y. and Itagaki, H. (2008): An in vitro tier evaluation for the identification of cosmetic ingredients which are not ocular irritants. Altern. Lab. Anim., 36, 641-652.
10. ICCVAM-NICEATM (2006): Background Review Document: Current Status of In vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants: Bovine Corneal Opacity and Permeability Test Method. NIH Publication No. 06-4512. Research Triangle Park, NC: National Institute of Environmental Health Sciences. Available from: http://iccvam.niehs.nih.gov/docs/ocutox_docs/ocubrd/bcop/bcopbrd.pdf.
11. 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. (2009): A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: Eye irritation., Regul. Toxicol. Pharmacol., 54, 197-209.
12. Ohno, Y., Kaneko, T., Inoue, T., Morikawa, Y., Yoshida, T., Fujii, A., Matsuda, M., Ohno, T., Hayashi, M., Momma, J., Uchiyama, T., Chiba, K., Ikeda, N., Imanishi, Y., Itagaki, 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., Tutsumi, H., Tani, N., Usami, M. and Watanabe, R. (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.
13. 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., Le Varlet, B., Meloni, M., McNamee, P., Osborne, R., Pape, W., Pfannenbecker, U., Prinsen, M., Seaman, C., Spielman, H., Stokes, W., Trouba, K., Van den Berghe, C., Van Goethem, F., Vassallo, M., Vinardell, P. and Zuang, V. (2010): A proposed eye irritation testing strategy to reduce and replace in vivo studies using Bottom-Up and Top-Down approaches. Toxicol. In Vitro, 24, 1-9.
14. Takahashi, Y., Koike, M., Honda, H., Ito, Y., Sakaguchi, H., Suzuki, H. and Nishiyama, N. (2008): Development of the short time exposure (STE) test: an in vitro eye irritation test using SIRC cells., Toxicol. In Vitro, 22, 760-770.
15. Takahashi, Y., Hayashi, T., Watanabe, S., Hayashi, K., Koike, M., Aisawa, N., Ebata, S., Sakaguchi, H., Nakamura, T., Kuwahara, H. and Nishiyama, N. (2009): Inter-laboratory study of short time exposure (STE) test for predicting eye irritation potential of chemicals and correspondence to globally harmonized system (GHS) classification., J. Toxicol. Sci., 34, 611-626.
16. Takahashi, Y., Hayashi, K., Abo, T., Koike, M., Sakaguchi, H. and Nishiyama, N. (2011): The Short Time Exposure (STE) test for predicting eye irritation potential: Intra-laboratory reproducibility and correspondence to globally harmonized system (GHS) and EU eye irritation classification for 109 chemicals., Toxicol. In Vitro, 25, 1425-1434.
17. Wilhelm, K.P., Bottjer, B. and Siegers, C.P. (2001): Quantitative assessment of primary skin irritants in vitro in a cytotoxicity model: comparison with in vivo human irritation tests., Br. J. Dermatol., 145, 709-715.