Development of the epiocular™ 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

ATLA Alternatives to Laboratory Animals

Volumn 39, Issue 4, 2011, Pages 339-364

  Kaluzhny, Yulia ^a   Kandárová, Helena ^b   Hayden, Patrick ^a   Kubilus, Joseph ^a   D'Argembeau Thornton, Laurence ^a   Klausner, Mitchell ^a  

^a MATTEK CORPORATION   (United States)

^b MatTek In vitro Life Science Laboratories   (Slovakia)

Author keywords

ECVAM; EpiOcular; Eye irritation; In vitro; REACH; Reconstructed ocular tissue model; Validation

Indexed keywords

ALCOHOL; AMINE; COSMETIC; ESTER; HYDROCARBON; IRRITANT AGENT; KETONE;

ARTICLE; CELL CULTURE; CHEMICAL ANALYSIS; COSMETIC INDUSTRY; DIAGNOSTIC ACCURACY; EXPERIMENTAL MODEL; EYE IRRITATION; HAZARD ASSESSMENT; PREDICTIVE VALUE; PRIORITY JOURNAL; QUALITY CONTROL; SENSITIVITY AND SPECIFICITY; TOXICITY TESTING; VALIDATION STUDY; ANIMAL TESTING ALTERNATIVE; DRUG EFFECT; EYE; HUMAN; METHODOLOGY; PACKAGING;

ANIMALIA;

ANIMAL TESTING ALTERNATIVES; COSMETICS; EYE; HUMANS; IRRITANTS; PRODUCT LABELING; QUALITY CONTROL; TOXICITY TESTS;

EID: 80053389693     PISSN: 02611929     EISSN: None     Source Type: Journal    
DOI: 10.1177/026119291103900409     Document Type: Article

References (52)

1. European Commission (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, 11.03.2003, 26-34.
2. European Commission (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, 30.12.2006, 1-849.
3. UN Economic Commission for Europe (2002). UN Recommendations on the Transport of Dangerous Goods. Manual of Tests and Criteria, 4th edn, 440pp. Geneva, Switzerland: United Nations, Economic Commission for Europe.
4. Watt, B.E., Proudfoot, A.T. & Vale, J.A. (2004). Hydrogen peroxide poisoning. Toxicology Reviews 23, 51-57. (Pubitemid 40484572)
5. Hackett, R.B. & McDonald, T.O. (1991). Eye Irritation. In Advances in Modern Toxicology: Dermatoxicology (ed. F.N. Marzulli & H.I. Maibach), 4th edn, pp. 749-815. Washington, DC, USA: Hemisphere Publishing Corporation.
6. Fox, D.A. & Boyes, W.K. (2008). Toxic responses of the ocular and visual system. In Cassaret and Doull's Toxicology: The basic science of poisons (ed. C.D. Klaassen), 7th edn, pp. 665-697. Withby, ON, Canada: McGraw-Hill Ryerson.
7. 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. Journal of Pharmacology & Experimental Therapeutics 82, 377-390.
8. Draize, J.H. (1959). Dermal Toxicity. In Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics, pp. 46-59. Austin, TX, USA: The Association of Food and Drug Officials of the United States.
9. 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. Toxicology in Vitro 9, 871-929. (Pubitemid 26017173)
10. Weil, C.S. & Scala, R.A. (1971). Study of intra- and interlaboratory variability in the results of rabbit eye and skin irritation tests. Toxicology & Applied Pharmacology 19, 276-360.
11. Curren, R.D. & Harbell, J.W. (2002). Ocular safety: A silent (in vitro) success story. ATLA 30, Suppl. 2, 69-74. (Pubitemid 36168715)
12. European Commission (2010). Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. Official Journal of the European Union L276, 20.10.2010, 33-79.
13. OECD (2009). OECD Guideline for the Testing of Chemicals, Test No. 437. Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants, 18pp. Paris, France: Organisation for Economic Co-operation and Development. Available at: http://www.oecdilibrary.org/ docserver/download/fulltext/9743701e.pdf?expires=1307537293&id= id&accname=freeContent&checksum=7F30A8FAEE0BB485CE991AD0BE541E3A (Accessed 08.06.11).
14. OECD (2009). OECD Guideline for the Testing of Chemicals. No. 438. Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants, 18pp. Paris, France: Organisation for Economic Co-operation and Development. Available at: http://www.oecd-ilibrary.org/docserver/ download/fulltext/9743801e.pdf?expires=1307537555&id=id&accname= freeContent&checksum=8AC509AA31015260D08451061EFC3F9E (Accessed 08.06.11).
15. 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). Alternative (non-animal) methods for cosmetics testing: Current status and future prospects. ATLA 33, Suppl. 1, 47-81.
16. McCain, N.E., Binetti, R.R., Gettings, S.D. & Jones, B.C. (2002). Assessment of ocular irritation ranges of market-leading cosmetic and personal-care products using an in vitro tissue equivalent. [Abstract.] The Toxicologist 66, S-1, 243.
17. Niranjan, P., Dang, A.H., January, B.G., Gomez, C. & Harbell, J.W. (2007). Use of the EpiOcular assay for preclinical qualification of formulas for human clinical studies. [Abstract.] The Toxicologist 96, S-1, 249.
18. Yin, X.J., Dang, A.H., Gill, A., Rodriguez, C., Pham, H., Armbrister, W., Harbell, J.W. & Jones, B.C. (2009). Prediction of ocular irritation potential of surfactants-based formulations at different concentrations using the EpiOcular™ model. [Abstract.] The Toxicologist 108, S-1, 378.
19. Blazka, M., Diaco, M., Harbell, J.W., Raabe H., Sizemore, A., Wilt, N. & Bagley, D.M. (2005). EpiOcular™ human cell construct: Tissue viability and histological changes following exposure to surfactants. [Abstract.] The Toxicologist 84, S-1, 409.
20. Kandárová, H., Liebsch, M., Gerner, I., Schmidt, E., Genschow, E., Traue, D. & Spielmann, H. (2005). EpiDerm skin irritation test protocol - Assessment of the performance of the optimised test. ATLA 33, 351-367.
21. Kandárová, H., Hayden, P., Klausner, M., Kubilus, J., Kearney, P. & Sheasgreen, J. (2009). In vitro skin irritation testing: Improving the sensitivity of the EpiDerm skin irritation test protocol. ATLA 37, 671-669.
22. Gupta, K., Rispin, A., Stitzel, K., Coecke, S. & Harbell, J.W. (2005). Ensuring quality of in vitro alternative test methods: Issues and answers. Regulatory Toxicology & Pharmacology 43, 219-224. (Pubitemid 41616388)
23. Rispin, A., Stitzel, K., Harbell, J.W. & Klausner, M. (2006). Ensuring quality of in vitro alternative test methods: Current practice. Regulatory Toxicology & Pharmacology 45, 97-103.
24. 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. (1994). Interlaboratory assessment of the bovine corneal opacity and permeability (BCOP) assay. Toxicology in Vitro 8, 381-392. (Pubitemid 24219171)
25. Southee, J.A., McPherson, J.P., Osborne, R., Carr, G.J. & Rasmussen, E. (1999). The performance of the tissue equivalent assay using the Skin2 TM ZK1200 model in the COLIPA international validation study on alternatives to the Draize eye irritation test. Toxicology in Vitro 13, 355-373. (Pubitemid 29288622)
26. Swanson, J.E. & Harbell, J.W. (2000). Evaluating the eye irritancy potential of ethanolic materials with the bovine corneal opacity and permeability assay. The Toxicologist 54, 188-189.
27. Casterton, P.T., Potts, L.F. & Klein, B.D. (1996). A novel approach to assessing eye irritation potential using the bovine corneal opacity and permeability assay. Cutaneous & Ocular Toxicology 15, 147-163. (Pubitemid 26117130)
28. Amenuvor, L., Zeigler, P., Hauber, S.A., Roberts, K.N. & Powers, M.J. (2006). A human corneal epithelial culture model for evaluation of ocular irritation. [Abstract.] The Toxicologist 90, 327.
29. ECETOC (1992). Eye Irritation Reference Chemicals Data Bank. Technical Report No. 48. Brussels, Belgium: European Centre for Ecotoxicology and Toxicology of Chemicals.
30. US EPA (2011). TSCA Chemical Substance Inventory. Washington, DC, USA: US Environmental Protection Agency. Available at: http://www.epa. gov/oppt/existingchemicals/pubs/tscainventory/index.html (Accessed 08.06.11).
31. ICCVAM (2005). Bovine Corneal Opacity and Permeability (BCOP) Test Method. Accuracy and Reliability Reanalysis, Section III, 34pp. Research Triangle Park, NC, USA: National Institutes of Environmental Health Sciences. Available at: http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocudocs/ reanal/bcop.pdf (Accessed 08.06.11).
32. ICCVAM (2005). Revised Proposed Reference Substances for Optimization/Validation Studies, App endix V-B: List of Proposed Reference Substances for Validation Studies of In Vitro Test Methods for the Identification of Ocular Corrosives/Severe Irritants, 22pp. Research Triangle Park, NC, USA: National Institutes of Environmental Health Sciences. Available at: http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocudocs/reanal/AppVB.pdf (Accessed 09.06.11).
33. ICCVAM (2005). Revised Proposed Reference Substances for Optimization/Validation Studies. Appendix V-A1: Candidate Substances for the List of Proposed Reference Substances for Validation Studies of In Vitro Test Methods for the Identification of Ocular Corrosives/Severe Irritants, 34pp. Research Triangle Park, NC, USA: National Institutes of Environmental Health Sciences. Available at: http://iccvam.niehs.nih.gov/ methods/ocutox/ivocutox/ ocudocs/reanal/AppVA1.pdf (Accessed 09.06.11).
34. ICCVAM (2005). Hen's Egg Test - Chorioallantoic Membrane (HET-CAM) Accuracy and Reliability Reanalysis. Appendix IV-A: Substances Used in HET-CAM Test Method Reanalysis, 14pp. Research Triangle Park, NC, USA: National Institutes of Environmental Health Sciences. Available at: http://iccvam.niehs. nih.gov/methods/ocutox/ivocutox/ocudocs/reanal/AppIVA.pdf (Accessed 09.06.11).
35. van Goethem, F., Adriaens, E., Alepee, N., Straube, F., De Wever, B., Cappadoro, M., Catoire, S., Hansen, E., Wolf, A. & vanparys, P. (2006). Prevalidation of a new in vitro reconstituted human cornea model to assess the eye irritating potential of chemicals. Toxicology in Vitro 20, 1-17. (Pubitemid 41796438)
36. Kubilus, J., Sennott, H., Makwana, A. & Klausner, M. (1997). EpiOcular prediction model. A reproducible in vitro tissue culture means of predicting Draize scores. [Abstract.] The Toxicologist 36, S-1, 44.
37. Mosmann, T. (1983). Rapid colorimetric assay for cellular growth and survival: Application to proliferation and cytotoxicity assays. Journal of Immunological Methods 65, 55.
38. Hines, M.D., Gettings, S.D. & Jones, B.C. (2003). Evaluation of MTT metabolism as a meaningful indicator of viability in human corneal epithelial tissue models. [Abstract.] The Toxicologist 72, S-1, 156.
39. Barile, F.A. & Cardona, M. (1998). Acute cytotoxicity testing with cultured human lung and dermal cell. In Vitro Cellular & Developmental Biology, Animal 34, 631-635. (Pubitemid 29069598)
40. Evans, S.M., Casartelli, A., Herreros, E., Minnick, D.T., Day, C., George, E. & Westmoreland, C. (2001). Development of a high throughput in vitro toxicity screen predictive of high acute in vivo toxic potential. Toxicology in Vitro 15, 579-584. (Pubitemid 32889688)
41. Liebsch, M., Barrabas, C., Traue, T. & Spielmann, H. (1997). Entwicklung eines in vitro Tests auf dermale Phototoxizität in einem Modell menschlicher Epidermis (EpiDerm™). ALTEX 14, 165-174.
42. Liebsch, M., Traue, D., Barrabas, C., Spielmann, H., Upholl, P., Wilkins, S., McPherson, J.P., Wiemann, C., Kaufmann, T., Remmele, M. & Holzhütter, H-G. (2000). The ECVAM prevalidation study on the use of EpiDerm for skin corrosivity testing. ATLA 28, 371-401. (Pubitemid 30412547)
43. Fentem, J.H., Briggs, D., Chesne, C., Elliott, G.R., Harbell, J.W., Heylings, J.R., Portes, P., Roguet, R., van de Sandt, J.J. & Botham, P.A. (2001). A pre-validation study on in vitro tests for acute skin irritation: Results and evaluation by the Management Team. Toxicology in Vitro 15, 57-93. (Pubitemid 32226375)
44. Blazka, M., Harbell, J., Klausner, M., Merril, J., Kubilus, J., Kloos, C. & Bagley, D. (2003). Evaluating the ocular irritation potential of 54 test articles using the EpiOcular human tissue construct model (OCL-200). [Abstract.] The Toxicol ogist 72, S-1, 221.
45. Kaluzhny, Y., Pfannenbecker, U. & Kandarova, H. (2011). EpiOcular Eye Irritation Test (EpiOcular EIT): Standard Operating Procedure to be Used in ECVAM-COLIPA Validation Study, 56pp. Ashland, MA, USA: MatTek Corporation. [Available on request].
46. Liebsch, M., Traue, D., Barrabas, C., Spielmann, H., Gerberick, G.F., Cruse, L., Diembeck, W., Pfannenbecker, U., Spieker, J., Holzhütter, H-G., Brantom, P., Aspin, P. & Southee, J. (1999). Prevalidation of the EpiDerm™ phototoxicity test. In Alternatives to Animal Testing II (ed. D.G. Clark, S.G. Lisansky & R. Macmillan), pp. 160-167. Brussels, Belgium: COLIPA.
47. Kejlová, K., Jírová, D., Bendová, H., Kandárová, H., Weidenhoffer, Z., Kolářová, H. & Liebsch, M. (2007). Phototoxicity of bergamot oil assessed by in vitro techniques in combination with human patch tests. Toxicology in Vitro 21, 1298-1303. (Pubitemid 350030874)
48. York, M. & Steiling, W. (1998). A critical review of the assessment of eye irritation potential using the Draize rabbit eye test. Journal of Applied Toxicology 18, 233-240. (Pubitemid 28360801)
49. Wilhelmus, K.R. (2001). The Draize eye test. Survey of Ophthalmology 45, 493-515.
50. Sheasgreen, J.E., Kubilus, J., Klausner, M., Kandárová, H. & Hayden, P.J. (2010). Culture of organotypic, 3-dimensional tissue models - importance of substrate properties. [Abstract.] The Toxicologist 114, S-1, 106.
51. BéruBé, K., Pitt, A., Hayden, P., Prytherch, Z. & Job, C. (2010). Filter-well technology for advanced three-dimensional cell culture: Perspectives for respiratory research. ATLA 38, Suppl. 1, 49-65.
52. Harbell, J.W., Le Varlet, B., Marrec-Fairley, M., Kaluzhny, Y. & McNamee, P. (2009). COLIPA program on optimization of existing in vitro eye irritation assays for entry into formal validation: Technology transfer and intra/inter laboratory evaluation of EpiOcular assay for chemicals. [Abstract.] The Toxicologist 108, S-1, 79.