Eye irritation potential: Usefulness of the HET-CAM under the Globally Harmonized System of Classification and Labeling of Chemicals (GHS)

Regulatory Toxicology and Pharmacology

Volumn 59, Issue 3, 2011, Pages 471-492

  Scheel, Julia ^a   Kleber, Marcus ^b   Kreutz, Jürgen ^a   Lehringer, Elke ^a   Mehling, Annette ^b   Reisinger, Kerstin ^a   Steiling, Winfried ^a  

^a HENKEL KGAA   (Germany)

^b Department of Intellectual Capital   (Germany)

Author keywords

Classification; Draize test; Eye irritation; GHS; HET CAM; In vitro method

Indexed keywords

ACCURACY; ANIMAL EXPERIMENT; ARTICLE; CHEMOSIS; CLASSIFICATION; CONJUNCTIVAL ERYTHEMA; CONTROLLED STUDY; CORNEA OPACITY; ERYTHEMA; EUROPEAN UNION; EYE IRRITATION; GLOBALLY HARMONIZED SYSTEM OF CLASSIFICATION AND LABELING OF CHEMICALS; HEN EGG TEST CHORIOALLANTOIC MEMBRANE; IRITIS; NONHUMAN; PREDICTION; PREDICTIVE VALUE; PRIORITY JOURNAL; RABBIT; RESPONSE TIME; RETROSPECTIVE STUDY; RISK ASSESSMENT; SENSITIVITY AND SPECIFICITY; TOXICITY TESTING;

ANIMAL TESTING ALTERNATIVES; ANIMALS; CHICK EMBRYO; CHORIOALLANTOIC MEMBRANE; DATA INTERPRETATION, STATISTICAL; DATABASES, FACTUAL; IRRITANTS; RABBITS; RETROSPECTIVE STUDIES;

ORYCTOLAGUS CUNICULUS;

EID: 79952705531     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2011.02.003     Document Type: Article

References (32)

1. Balls M., Boham P.A., Bruner L.H., Spielmann H. The EC/HO international validation study on alternatives to the draize eye irritation test. Toxicol. In Vitro 1995, 9:871-929.
2. Brantom P.G., Bruner L.H., Chamberlain M., De Silva O., Dupuis J., Earl L.K., Lovell D.P., Pape W.J., Uttley M., Bagley D.M., Baker W., Bracher M., Courtellemont P., Declercq L., Freeman S., Steiling W., Walker A.P., Harbell J., Jones P.A., Pfannenbecker U., Southee J.A., Tcheng M., Argembeaux H., Castelli D., Clothier R., Esdaile D.J., Itagaki 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. A summary report of the COLIPA international validation study on alternatives to the Draize rabbit eye irritiation test. Toxicol. In Vitro 1997, 11:141-179.
3. Draize J.H., Woodard G., Calvery H.O. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. Exp. Therap. 1944, 82:377-390.
4. ECHA, Guidance on information requirements and chemical safety assessment. Chapter R.7a: Endpoint specific guidance. R.7.2.6 Integrated Testing Strategy (ITS) for irritation/corrosion., 2008, p. 223ff.
5. 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., Zuang V. Eye irritation. Altern. Lab. Anim. 2005, 33(Suppl. 1):47-81.
6. European Commission, 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.
7. European Union EU Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations, and administrative provisions relating to the classification, packaging and labeling of dangerous substances. Official J. Eur. Communities 1976, L196:1-98.
8. European Union EU Directive 2004/73/EC of 29 April 2004 adopting to technical progress for the 29th time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances. Official J. Eur. Communities 2004, L152:1-316.
9. European Union EU Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures. Official Journal of the European Union 2008, L 353:1-1354.
10. European Union, 2009. EU Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures. ECHA Reference: ECHA-09-G-02-EN, 2009, p. 245ff.
11. Gettings S.D., Dipasquale L.C., Bagley D.M., Casterton P.L., Chudkowski M., Curren R.D., Demetrulias J.L., Feder P.I., Galli C.L., Gay R., et al. 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. 1994, 32:943-976.
12. Grindon C., Combes R., Cronin M.T., Roberts D.W., Garrod J.F. An integrated decision-tree testing strategy for eye irritation with respect to the requirements of the EU REACH legislation. Altern. Lab. Anim. 2008, 36(Suppl. 1):111-122.
13. ICCVAM, 2006. Background Review Document. Current Status of in vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants: Hen's Egg Test - Chorioallantoic Membrane Test Method. Interagency Coordinating Committee on the Validation of Alternative Methods.
14. ICCVAM, 2009a. Draft Background Review Document. Current Status of in vitro Test Methods for Identifying Mild/Moderate Ocular Irritants: The Hen's Egg Test - Chorioallantoic Membrane (HET-CAM) Test Method. Interagency Coordinating Committee on the Validation of Alternative Methods.
15. ICCVAM, 2009b. Independent Scientific Peer Review Panel Report: Evaluation of the Validation Status of Alternative Ocular Safety Testing Methods and Approaches. Reserach Triangle Park, NC: National Institute of Environmental Health Sciences. Interagency Coordinating Committee on the Validation of Alternative, Methods.
16. ICCVAM, 2009c. Draft Background Review Document. Current Status of in vitro Test Methods for Identifying Mild/Moderate Ocular Irritants: The Hen's Egg Test - Chorioallantoic Membrane (HET-CAM) Test Method.
17. Jester J.V. Extent of corneal injury as a biomarker for hazard assessment and the development of alternative models to the Draize rabbit eye test. Cutan. Ocul. Toxicol. 2006, 25:41-54.
18. Knight D.J., Breheny D. Alternatives to animal testing in the safety evaluation of products. Altern. Lab. Anim. 2002, 30:7-22.
19. Maurer J.K., Parker R.D., Jester J.V. Extent of initial corneal injury as the mechanistic basis for ocular irritation: key findings and recommendations for the development of alternative assays. Regul. Toxicol. Pharmacol. 2002, 36:106-117.
20. 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. Regul. Toxicol. Pharmacol. 2009, 54:197-209.
21. OECD, 1981. Guideline for the Testing of Chemicals 405: Acute Eye Irritation/Corrosion. Adopted: 12th May 1981.
22. OECD, 1987. Guideline for the Testing of Chemicals 405: Acute Eye Irritation/Corrosion. 1st revision, adopted: 24th February 1987.
23. OECD, 2002. Guideline for the Testing of Chemicals 405: Acute Eye Irritation/Corrosion. 2nd revision, adopted: 24th April 2002.
24. OECD, 2009a Guideline for the Testing of Chemicals 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants, adopted: 7th September 2009.
25. OECD, 2009b. Guideline for the Testing of Chemicals 438: Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants, adopted 7th September 2009.
26. Schrage A., Gamer A.O., van Ravenzwaay B., Landsiedel R. Experience with the HET-CAM method in the routine testing of a broad variety of chemicals and formulations. Altern. Lab. Anim. 2010, 38:39-52.
27. 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., 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. Toxicol. In Vitro 2010, 24:1-9.
28. Spielmann H., Liebsch M., Kalweit S., Moldenhauer F., Wirnsberger T., Holzhütter H.-G., Schneider B., Glaser S., Gerner I., Pape W.J.W., Kreiling R., Krauser K., Miltenburger H.G., Steiling W., Luepke N.P., Müller N., Kreuzer H., Mürmann P., Spengler J., Bertram-Neis E., Siegemund B., Wiebel F.J. 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. 1996, 24:741-858.
29. Steiling W., Bracher M., Courtellemont P., de Silva O. The HET-CAM, A Useful in vitro Assay for Assessing the Eye Irritation Properties of Cosmetic Formulations and Ingredients. Toxicol. In Vitro 1999, 13:375-384.
30. Sterzel W., Bartnik F.G., Matthies W., Kaestner W., Kuenstler K. Comparison of two in vitro an two in vivo methods for the Measurement of Irritancy. Toxicol. In Vitro 1990, 4:698-701.
31. UN, 2009. Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Published 2003, last (3rd) revision 2009.
32. York M., Steiling W. A critical review of the assessment of eye irritation potential using the Draize rabbit eye test. J. Appl. Toxicol. 1998, 18:233-240.