A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: Eye irritation

Regulatory Toxicology and Pharmacology

Volumn 54, Issue 2, 2009, Pages 197-209

  McNamee, Pauline ^a   Hibatallah, Jalila ^b   Costabel Farkas, Margit ^c   Goebel, Carsten ^a   Araki, Daisuke ^d   Dufour, Eric ^e   Hewitt, Nicola J ^f   Jones, Penny ^g   Kirst, Annette ^h   Varlet, Béatrice Le ⁱ   Macfarlane, Martin ^g   Marrec Fairley, Monique ^j   Rowland, Joanna ^k   Schellauf, Florian ^j   Scheel, Julia ^l  

^a PROCTER AND GAMBLE COMPANY   (United States)

^b Chanel Parfums Beaute   (France)

^c JOHNSON AND JOHNSON   (United States)

^d Kanebo Cosmetics   (France)

^e L ORÉAL RECHERCHE   (France)

^f Scientific Writing Services   (Germany)

^g UNILEVER RESEARCH   (United Kingdom)

^h KAO GERMANY GMBH   (Germany)

ⁱ Links Ingénierie   (France)

^j European Cosmetic Toiletry and Perfumery Association COLIPA   (Belgium)

^k GLAXOSMITHKLINE   (United Kingdom)

^l HENKEL KGAA   (Germany)

more..

Author keywords

Alternative methods; Cosmetics; Eye irritation; Safety assessment

Indexed keywords

COSMETIC;

ANIMAL TESTING ALTERNATIVE; ANIMAL TESTING REPLACEMENT; ARTICLE; BOVINE CORNEAL OPACITY AND PERMEABILITY ASSAY; COW; DATA ANALYSIS; DECISION TREE; DIAGNOSTIC TEST; DRAIZE TEST; EYE IRRITATION; FLUORESCEIN LEAKAGE ASSAY; HEN; HEN'S EGG TEST ON CHORIOALLANTOIC MEMBRANE ASSAY; HUMAN; HUMAN EXPERIMENT; IN VIVO STUDY; INTERMETHOD COMPARISON; ISOLATED CHICKEN EYE ASSAY; ISOLATED RABBIT EYE ASSAY; NEUTRAL RED RELEASE ASSAY; NEUTRAL RED UPTAKE ASSAY; NONHUMAN; NORMAL HUMAN; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; RABBIT; RED BLOOD CELL ASSAY; VALIDATION PROCESS;

ANIMALIA; ORYCTOLAGUS CUNICULUS;

EID: 67349087330     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2009.04.004     Document Type: Article

References (66)

1. Adriaens, E., 2006. The slug mucosal irritation assay: an alternative assay for local tolerance testing. The national centre for the replacement, refinement and reduction of animals in research. Available from: .
2. Adriaens E., Bytheway H., De Wever B., Eschrich D., Guest R., Hansen E., Vanparys P., Schoeters G., Warren N., Weltens R., Whittingham A., and Remon J.P. Successful prevalidation of the slug mucosal irritation test to assess the eye irritation potency of chemicals. Toxicol. In Vitro 22 (2008) 1285-1296
3. Bagley D.M., Waters D., and Kong B.M. Development of a 10-day chorioallantoic membrane vascular assay as an alternative to the Draize rabbit eye irritation test. Food Chem. Toxicol. 12 (1994) 1155-1160
4. Bagley D.M., Cerven D., and Harbell J. Assessment of the chorioallantoic membrane vascular assay (CAMVA) in the COLIPA in vitro eye irritation validation study. Toxicol. In Vitro 13 (1999) 285-293
5. 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. Toxicol. In Vitro 9 (1995) 871-929
6. Balls, M., Berg, N., Bruner, L.H., Curren, R., deSilva, O., Earl, L.K., Esdaile, D.J., Fentem, J.H., Liebsch, M., Ohno, Y., Prinsen, M.K., Spielmann, H., Worth, A.P., 1999. Eye irritation testing: the way forward. The report and recommendations of ECVAM workshop 34. ALTA 27, 53-77.
7. Balls, M., Amcoff, P., Bremer, S., Casati, S., Coecke, S., Clothier, R., Combes, R., Corvi, R., Curren, R., Eskes, C., Fentem, J., Gribaldo, L., Halder, M., Hartung, T., Hoffmann, S., Schectman, L., Scott, L., Spielmann, H., Stokes, W., Tice, R., Wagner, D., Zuang, V. ECVAM. 2006. The principles of weight of evidence validation of test methods and testing strategies. The report and recommendations of ECVAM workshop 58. ATLA 34(6), 603-620.
8. Blazka, M.E., Harbell, J., Klausner, M., Merrill, J., Kubilus, J., Kloos, C., Bagley, D.M., 2003. Evaluating the ocular irritation potential of 54 test articles using the EpiOcular™ human tissue construct model (OCL-200). Poster presentation SOT, USA.
9. Blazka, M.E., Diaco, M., Harbell, J., Raabe, H., Sizemore, A., Wilt, N., Bagley, D.M., 2006. EpiOcular™ human cell construct: tissue viability and histological changes following exposure to surfactants. Poster presentation. 5th World Congress on Alternatives and Animal Use in the Life Sciences. Berlin, Germany.
10. Botham P.A., Earl L.K., Fentem J.H., Roguet R., and van de Sandt J.J.M. Alternative methods for skin irritation testing: the current status. ECVAM skin irritation task force report 1. Altern. Lab. Anim. 26 (1998) 195-211
11. Bradlaw J., Gupta K., Green S., Hill R., and Wilcox N. Practical application of non-whole animal alternatives: summary IRAG workshop on eye irritation. Food Chem. Toxicol. 35 (1997) 175-178
12. Brantom P.G., Bruner L.H., Chamberlain M., De Silva O., Dupuis J., Earl L.K., Lovell D.P., Pape W.J.W., and Utley M. A summary report of the COLIPA international validation study on alternatives to the Draize rabbit eye irritation test. Toxicol. In Vitro 11 (1997) 141-179
13. Bruner L.H., Miller K.R., Owicki J.C., Parce J.W., and Muir V.C. Testing ocular irritancy in vitro with the silicon microphysiometer. Toxicol. In Vitro 5 (1991) 277-284
14. Cater K.C., and Harbell J.W. Prediction of eye irritation potential of surfactant-based rinse-off personal care formulations by the bovine corneal opacity and permeability (BCOP) assay. Cutan. Ocul. Toxicol. 25 (2006) 217-233
15. Cater K., and Harbell J. Comparison of in vitro eye irritation potential by bovine corneal opacity and permeability (BCOP) assay to erythema scores in human eye sting test of surfactant-based formulations. Cutan. Ocul. Toxicol. 27 (2008) 77-85
16. Cooper K.J., Earl L.K., Harbell J., and Raabe H. Prediction of ocular irritancy of prototype shampoo formulations by the isolated rabbit eye (IRE) test and bovine corneal opacity and permeability (BCOP) assay. Toxicol. In Vitro 15 (2001) 95-103
17. Cotovio, J., Grandidier, M-H., LeLièvre, D. Bremond, C., Flamard, N., Loisel-Joubert, S., Van Der Lee, A., Capallere, C., Meunier, J-R., Leclaire, J., 2007. The use of the reconstructed human corneal model (HCE) to assess in vitro eye irritancy of chemicals. AATEX 14, 343-350 (special issue).
18. Cotovio, J., LeLièvre, D Grandidier,, M-H., Loisel-Joubert, S., Van Der Lee, A., Amsellem, C., Capallere, C., Maloug,, S., Chiron, M-L., Ovigne, J-M., Meunier, J-R., Leclaire, J., 2008. Optimized 1h/16h SkinEthic human corneal epithelial (HCE) protocol to predict ocular irritancy: application to a large set of 435 industrial chemicals. Poster Presentation. ESTIV Congress. October 2008.
19. Cottin M., and Zanvit A. Fluorescein leakage test: a useful tool in ocular safety assessment. Toxicol. In Vitro 11 (1997) 399-405
20. Courtellemont P., Hebert P., Biesse J.P., Castelli D., Friteau L., Serrano J., and Robles C. Relevance and reliability of the PREDISAFE assay in the COLIPA eye irritation validation program (Phase 1): COLIPA eye irritation validation programme. Toxicol. In Vitro 13 (1999) 305-312
21. Doucet O., Lanvin M., Thillou C., Linossier C., Pupat C., Merlin B., and Zastrow L. Reconstituted human corneal epithelium: a new alternative to the Draize eye test for the assessment of the eye irritation potential of chemicals and cosmetic products. Toxicol. In Vitro 20 (2006) 499-512
22. ECVAM, 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. Available from: .
23. EPAA, 2008. Overcoming barriers to validation of non-animal partial replacement methods/integrated testing strategies, EPAA-ECVAM, 19-20 November 2008. Available from: .
24. 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. Eye irritation. ALTA 33 1 (2005) 47-81
25. EU, 2008. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No. 1907/2006. Official Journal of the European Union L 353/1-1354.
26. EU, 2004. Commission Directive 2004/73/EC of 29 April 2004 adapting 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 labelling of dangerous substances. Official Journal of the European Union L152, 1-316.
27. EU, 1976. Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. Official Journal of the European Union L262, 169-172 most recently amended in 2008-42-EC.
28. EU, 2003, EC - 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 L66, 11/03/2003, p. 26.
29. Gerner I., Liebsch M., and Spielmann H. Assessment of the eye irritating properties of chemicals by applying alternatives to the Draize rabbit eye test: the use of (Q)SARs and in vitro tests for the classification of eye irritation. Altern. Lab. Anim. 33 (2005) 215-237
30. Gettings S.D., Teal J.J., Bagley D.M., Demetrulias J.L., DiPasquale L.C., Hintze K.L., Rozen M.G., Weise S.L., Chudkowski M., Marenus K.D., Pape W.J.W., Roddy M., Schnetzinger R., Silber P.M., Glaza S.M., and Kurtz P.J. CTFA evaluation of alternatives program: an evaluation of in vitro alternatives to the Draize primary eye irritation test (phase I) hydro-alcoholic formulations; (part 2) Data and biological significance. In Vitro Toxicol. 4 (1991) 247-288
31. 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., Glaza S.M., Hintze K.L., Janus J., Kurtz P.J., Lordo R.A., Marenus K.D., Moral J., Muscatiello M., Pape W.J.W., Renskers K.J., Roddy M., and Rozen M.G. 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. 32 (1994) 943-976
32. Gettings S.D., Lordo R.A., Hintze K.L., Bagley D.M., Casterton P.L., Chudkowski M., Curren R.D., Demetrulias J.L., DiPasquale L.C., Earl L.K., Feder P.I., Galli C.L., Glaza S.M., Gordon V.C., Janus J., Kurtz P.J., Marenus K.D., Moral J., Pape W.J.W., Renskers K.J., Rheins L.A., Roddy M., Rozen M.G., Tedeschi J.P., and Zyracki J. 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 Chem. Toxicol. 34 (1996) 79-117
33. Grindon C., Combes R., Cronin M.T., Roberts D.W., and Garrod J.F. An integrated decision-tree testing strategy for eye irritation with respect to the requirements of the EU REACH legislation. ALTA 36 1 (2008) 81-92
34. Harbell J., Koontz S.W., Lewis R.W., Lovell D., and Acosta D. IRAG working group 4: cell cytotoxicity assays. Food Chem. Toxicol. 35 (1997) 79-126
35. Harbell J.W., Osborne R., Carr G.J., and Peterson A. Assessment of the cytosensor microphysiometer assay in the COLIPA in vitro eye irritation validation study. Toxicol. In Vitro 13 (1999) 313-323
36. ICCVAM, 2006. In vitro test methods for detecting ocular corrosives and severe irritants. test method evaluation report. November 2006. Available from: .
37. Jester J. 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. 25 (2006) 41-54
38. Jones P.A., Bracher M., Marenus K., and Kojima H. Performance of the neutral red uptake assay in the COLIPA international validation study on alternatives to the rabbit eye test. Toxicol. In Vitro. 32 (1999) 5-333
39. Jones P.A., Budynsky E., Cooper K.J., Decker D., Griffiths H.A., and Fentem J.H. Comparative evaluation of five in vitro tests for assessing the eye irritation potential of hair-care products. ALTA 29 (2001) 669-692
40. Kaluzny, Y., Argembeau-Thornton, L., Kandarova, H., Hayden, P., Klausner, M., 2008. Expanded utilization of the EpiOcular™ human corneal tissue model for ocular irritation testing. Poster presentation SOT, USA.
41. Kroes R., Renwick A.G., Cheeseman M., Kleiner J., Mangelsdorf I., Piersma A., Schilter B., Schlatter J., van Schothorst F., Vos J.G., and Würtzen G. Structure based thresholds of toxicological concern (TTC): guidance for application to substances present at low levels in the diet. Food Chem. Toxicol. 42 (2004) 65-83
42. Kroes R., Renwick A.G., Feron V., Galli C.L., Gibney M., Greim H., Guy R.H., Lhuguenot J.C., and van de Sandt J.J. Application of the threshold of toxicological concern (TTC) to the safety evaluation of cosmetic ingredients. Food Chem. Toxicol. 45 12 (2007) 2533-2562
43. Lagarto A., Vega R., Vega Y., Guerra I., and González R. Comparative study of red blood cell method in rat and calves blood as alternatives of Draize eye irritation test. Toxicol. In Vitro 20 (2006) 529-533
44. Maurer J.K., Parker R.D., and 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. Reg. Toxicol. Pharmacol. 36 (2002) 106-117
45. Mehling A., Kleber M., and Hensen H. Comparative studies on the ocular and dermal irritation potential of surfactants. Food Chem. Toxicol. 45 (2007) 747-758
46. OECD TG 405, 2002. OECD guidelines for the testing of chemicals test, no. 405: acute eye irritation/corrosion. OECD series on testing and assessment, number 14, 2002. Detailed review document on classification systems for eye irritation/corrosion in OECD member countries.
47. Ohno Y., Kaneko T., Kobayashi T., Inoue T., Kuroiwa Y., Yoshida T., Momma J., Hayashi M., Akiyama J., Atsumi T., Chiba K., Endo T., Fujii A., Kakishima H., Kojima H., Masdamoto K., Masuda M., Matsukawa S., Ohkoshi K., Okada J., Sakamoto K., Takano K., and Takanaka A. First phase validation of the in vitro eye irritation tests for cosmetic ingredients. In Vitro Toxicol. 7 (1994) 89-94
48. 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. Toxicol. Sci. 28 (1995) 139-153
49. Pape W.J.W., Pfannenbecker U., and Hoppe U. Validation of the red blood cell test system as in vitro assay for the rapid screening of irritation potential of surfactants. Mol. Toxicol. 1 (1987) 525-536
50. Pape W.J.W., and Hoppe U. Standardization of an in vitro red blood cell test for evaluating the acute cytotoxic potential of tensides. Arzneimittelforschung 40 (1990) 498-502
51. Pape W.J.W., and Hoppe U. In vitro methods for the assessment of primary local effects of topically applied preparations. Skin Pharmacol. 4 (1991) 205-212
52. Pape W.J.W., Pfannenbecker U., Argembeaux H., Bracher M., Esdaile D.J., Hagino S., Kasai Y., and Lewis R.W. COLIPA validation project on in vitro eye irritation tests for cosmetic ingredients and finished products (phase I): the red blood cell test for the estimation of acute eye irritation potentials. Present status. Toxicol. In Vitro 13 2 (1999) 343-354
53. Prinsen M.K. The chicken enucleated eye test (CEET): a practical (pre)screen for the assessment of eye irritation/corrosion potential of test materials. Food Chem. Toxicol. 34 (1996) 291-296
54. Spielmann H., Kalweit S., Liebsch M., Wirnsberger T., Gerner I., Bertram-Neis E., Krauser K., Kreiling R., Miltenburger G., Pape W., and Steiling W. Validation study of alternatives to the Draize eye irritation test in Germany: cytotoxicity testing and HET-CAM test with 136 industrial chemicals. Toxicol. In Vitro 7 (1993) 505-510
55. Spielmann H., Liebsch M., Kalweit S., Moldenhauer F., Wirnsberger T., Holzhutter H.-G., Schneider B., Glaser S., Gerner I., Pape W.J.W., Kreiling R., Krauser K., Miltenburger H.G., Steiling W., Luepke N.P., Muller N., Kreuzer H., Murmann P., Spengler J., Bertram-Neis E., Siegemund B., and 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. ALTA 24 (1996) 741-858
56. Spielmann H., Liebsch M., Moldenhauer F., Holzhütter H.-G., Bagley D.M., Lipman J.M., Pape W.J.W., Miltenburger H., De Silva O., Hofer H., and Steiling W. IRAG working group 2: CAM-based assays. Food Chem. Toxicol. 35 (1997) 39-66
57. Steiling W., Brachter M., Coutellemont P., and 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 13 (1999) 375-384
58. Takahashi Y., Koike M., Honda H., Ito Y., Sakaguchi H., Suzuki H., and Nishiyama N. Development of the short time exposure (STE) test: an in vitro eye irritation test using SIRC cells. Toxicol. In Vitro 22 (2008) 760-770
59. Tsakovska I., Saliner A.G., Netzeva T., Pavan M., and Worth A.P. Evaluation of SARs for the prediction of eye irritation/corrosion potential: structural inclusion rules in the BfR decision support system. SAR QSAR. Environ. Res. 18 3-4 (2007) 221-235
60. UN, 2003. Globally harmonised system of classification and labelling of chemicals (GHS). Part 3: health and environmental hazards, pp. 107-228. New York, NY, USA, and Geneva, Switzerland: United Nations Organisation.
61. Van Goethem F., Adriaens E., Alépée N., Straube F., De Wever B., Cappadoro M., Catoire S., Hansen E., Wolf A., and Vanparys P. Prevalidation of a new in vitro reconstituted human cornea model to assess the eye irritating potential of chemicals. Toxicol. In Vitro 20 (2006) 1-17
62. van Leeuwen C.J., Patlewicz G.Y., and Worth A.P. Intelligent testing strategies. In: van Leeuwen C.J., and Vermeire T.G. (Eds). Risk Assessment of Chemicals: An Introduction. second ed. (2007), springer, AA Dordrecht, The Netherlands (P.O. Box 17, 3300), ISBN 978-1-4020-6101-1(HB)
63. Worth A.P. The tiered approach to toxicity assessment based on the integrated use of alternative (non-animal) tests. In: Cronin M.T.D., and Livingstone D.J. (Eds). Predicting Chemical Toxicity and Fate (2004), CRC Press, Boca Raton, FL, USA 389-410
64. Worth A.P., and Cronin M.T.D. The use of pH measurements to predict the potential of chemicals to cause acute dermal and ocular toxicity. Toxicology 169 (2001) 119-131
65. Young J.R., How M.J., Walker A.P., and Worth W.M.H. Classification as corrosive or irritant to skin of preparations containing acidic or alkaline substances, without testing on animals, Toxicol. In Vitro 2 (1994) 19-26
66. Zanvit A., Meunier P.-A., Clothier R., Ward R., and Buiatti-Tcheng M. Ocular irritancy assessment of cosmetics formulations and ingredients: fluorescein leakage test. Toxicol. In Vitro 13 (1999) 385-391