Alternative Methods for Skin Irritation Testing: The Current Status. ECVAM Skin Irritation Task Force Report 1

ATLA Alternatives to Laboratory Animals

Volumn 26, Issue 2, 1998, Pages 195-211

  Botham, Philip A ^a   Earl, Lesley K ^b   Fentem, Julia H ^c   Roguet, Roland ^d   Van De Sandt, Johannes J M ^e  

^a ASTRAZENECA   (United Kingdom)

^b UNILEVER RESEARCH   (United Kingdom)

^c JOINT RESEARCH CENTRE   (Italy)

^d L ORÉAL RECHERCHE   (France)

^e TNO   (Netherlands)

Author keywords

Corrosion; Human; In vitro; Irritation; Keratinocytes; Skin

Indexed keywords

ANIMALIA;

EID: 2542595373     PISSN: 02611929     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (63)

1. Draize, J.H., Woodward, 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 and Experimental Therapeutics 82, 377-390.
2. Frazier, J.M. (1991). Alternatives to acute ocular and dermal toxicity tests in animals. In Dermatotoxicology, 4th edn (ed. F.N Marzulli & H I. Maibach), pp. 817-833. New York: Hemisphere Publishing.
3. Swanston, D.W., Black, J., Duffy, P A. & Pemberton, M.A. (1991). The current status of nonanimal alternative methods in skin and eye irritancy testing In Animals and Alternatives in Toxicology, Present Status and Future Prospects (ed. M. Balls, J. Bridges & J Southee), pp. 23-51 Basingstoke, UK: Macmillan Press
4. Gad, S.C (1993) Alternatives to in vivo studies in toxicology. In General and Applied Toxicology (ed. B Ballantyne, T. Marrs & P. Turner), pp. 179-206. London. Macmillan Press
5. Basketter, D.A. (1997). Skin irritation testing: what are the alternatives? Comments on Toxicology 6, 87-100.
6. Botham, P.A., Chamberlain, M., Barratt, M D., Curren, R D . Esdaile, D J., Gardiner, J R., Gordon, V C., Hildebrand, B . Lewis, R.W., Liebsch, M., Logemann, P , Osborne, R., Ponec, M , Régnier, J-F , Steiling, W , Walker, A.P & Balls, M (1995). A prevalidation study on in vitro skin corrosivity testing. The report and recommendations of ECVAM workshop 6. ATLA 23, 219-255.
7. Fentem, J.H , Archer, G E.B., Balls, M., Botham, P.A, Curren, R D., Earl, L.K , Esdaile, D.J., Holzhutter, H-G. & Liebsch, M. (1998). The ECVAM international validation study on in vitro tests for skin corrosivity. II. Results and evaluation by the Management Team Toxicology in Vitro, in press.
8. Chamberlain, M & Earl, L (1995) Use of cell cultures in irritancy testing In Alternative Methods in Toxicology and the Life Sciences, Vol. 11, The World Congress on Alternatives and Animal Use in the Life Sciences. Education, Research, Testing (ed A M Goldberg & L.F.M van Zutphenl, pp 59-67 New York Mary Ann Liebert
9. Lawrence, J.N (1997) Application of in vitro human skin models to dermal irritancy. a brief overview and future prospects Toxicology in Vitro 11, 305-312
10. Wilcox, D K. & Bruner, L.H (1990) In vitro alternatives for ocular safety testing an outline of assays and possible future developments. ATLA 18, 117-128
11. Basketter, D A , Whittle, E & Chamberlain, M (1994) Identification of irritation and corrosion hazards to skin, an alternative strategy to animal testing Food and Chemical Toxicology 32, 539-542.
12. Spielmann, H., Lovell, W W., Hölzle, E., Johnson, B.E., Maurer, T, Miranda, M.A., Pape, W J W., Sapora, O & Sladowski, D (1994). In vitro phototoxicity testing. The report and recommendations of ECVAM workshop 2. ATLA 22, 314-348.
13. Basketter, D.A., Scholes, E.W., Chamberlain, M. & Barratt, M D (1995). An alternative strategy to the use of guinea-pigs for the identification of skin sensitisation hazard Food and Chemical Toxicology 33, 1051-1056
14. Anon. (1992). OECD Guideline for the Testing of Chemicals, No. 404: Acute Dermal Irritation/Corrosion. 6 pp. Paris, France: OECD.
15. Anon (1996). Final Report of the OECD Workshop on Harmonization of Validation and Acceptance Criteria for Alternative Toxicological Test Methods 62 pp. Paris, France: OECD.
16. Anon (1997) Revised Step 2 Proposal for a Harmonized System for the Classification of Chemicals Which Cause Skin Irritation/Corrosion, Draft ENV/MC/CHEM/HCL (97)3, 12 pp. Paris, France: OECD.
17. Barratt, M.D. (1996). Quantitative structureactivity relationships (QSARs) for skin corrosivity of organic acids, bases and phenols: principal components and neural network analysis of extended datasets. Toxicology in Vitro 10, 85-94.
18. Barratt, M.D. (1996) Quantitative structureactivity relationships for skin irritation and corrosivity of neutral and electrophilic organic chemicals. Toxicology in Vitro 10, 247-256.
19. Barratt, M.D., Brantom, P G , Fentem, J.H , Gerner, I , Walker, A P & Worth A P. (1998). The ECVAM international validation study on in vitro tests for skin corrosivity. I Selection and distribution of the test chemicals. Toxicology in Vitro, in press
20. Krause, P, Fox, J & Judson, P. (1993/4). An argumentation-based approach to risk assessment IMA Journal of Mathematics Applied in Business and Industry 5, 249-263
21. Dearden, J C , Barratt, M.D , Benigni, R., Bristol. D W , Combes, R.D , Cronin, M.T.D., Judson, P N , Payne, M P , Richard, A.M., Tichy, M, Worth, A P. & Yourick, J J. (1997). The development and validation of expert systems for predicting toxicity The report and recommendations of an ECVAM/ECB workshop (ECVAM workshop 24). ATLA 25, 223-252
22. Payne, M.P & Morley, J (1997) Structure-activity rules for skin and eye irritation and corrosion (abstract) Human and Experimental Toxicology 16, 410
23. Worth, A P , Barratt, M D & Houston, J.B. (1998) The validation of computational prediction techniques ATLA 26, 241-247.
24. Young, J R , How, M J , Walker, A P & Worth, W M H (1988) Classification as corrosive or irritant to skin of preparations containing acidic or alkaline substances without testing on animals. Toxicology in Vitro 2, 19-26
25. Young, J R & How, M J (1994) Product classification as corrosive or irritant by measuring pH and acid/alkali reserve In Alternative Methods in Toxicology, Vol. 10, In Vitro Skin Toxicology Irritation, Phototoxicity, Sensitization (ed. A. Rougier, A M Goldberg & H.I. Maibach), pp 23-27. New York: Mary Ann Liebert.
26. Anon. (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 Labelling of Dangerous Substances. Official Journal of the European Communities L110A, 1-86
27. Ponec, M. (1992). In vitro cultured human skin cells as alternatives to animals for skin irritancy screening. International Journal of Cosmetic Science 14, 245-264
28. De Leo, V.A., Harber, L.C., Kong, B.M. & De Salva, S.J. (1987) Surfactant-induced alteration of arachidonic acid metabolism of mammalian cells in culture. Proceedings of the Society of Experimental Biology & Medicine 184, 477-482.
29. Osborne, R. & Perkins, M.A. (1991). In vitro skin irritation testing with human skin cell cultures. Toxicology in Vitro 5, 563-567.
30. Wilhelm, K P , Samblebe, M. & Siegers, C.P. (1994). Quantitative in vitro assessment of Nalkyl sulphate-induced cytotoxicity in human keratinocytes (HaCaT): comparison with in vivo human irritation tests. British Journal of Dermatology 130, 18-23.
31. Korting, H.C., Herzinger, T , Hartinger, A., Kerscher, M., Angerpointner, T. & Maibach, H.I. (1994). Discrimination of the irritancy potential of surfactants in vitro by two cytotoxicity assays using normal human keratinocytes, HaCaT cells and 3T3 mouse fibroblasts: correlation with in vivo data from a soap chamber assay. Journal of Dermatological Science 7, 119-129.
32. Dickson, F M., Lawrence, J.N. & Benford, D.J. (1994) Cytotoxicity of 12 chemicals of known human and animal skin irritation potential in human keratinocyte cultures. Toxicology in Vitro 8, 661-663.
33. Korting, H.C., Schindler, S , Hartinger, A., Kerscher, M., Angerpointner, T. & Maibach, H.I. (1994). MTT-assay and neutral red release (NRR)-assay: relative role in the prediction of the irritancy potential of surfactants. Life Sciences 55, 533-540.
34. Eun, H.C. (1995) In vitro skin irritancy: application of keratinocyte cell culture and its correlation with human patch test responses. Current Problems in Dermatology 55, 231-236.
35. Brosin, A, Wolf, W, Mattheus, A & Heise, H. (1997). Use of XTT assay to assess the cytotoxicity of different surfactants and metal salts in human keratinocytes (HaCaT). Acta Dermatologia Venereologia 77, 26-28.
36. van de Sandt, J J.M , van Schoonhoven, J., Maas, W.J M & Rutten, A.A.J.J L (1993). Skin organ culture as an alternative to in vivo dermatotoxicity testing ATLA 21, 443-449
37. van de Sandt, J J M & Rutten, A A.J.J.L. (1995). Differential effects of chemical irritants in rabbit and human skin organ cultures Toxicology in Vitro 9, 157-168
38. van de Sandt, J J.M., Bos, T.A & Rutten, A A J J L (1995) Epidermal cell proliferation and terminal differentiation in skin organ culture after topical exposure to sodium dodecyl sulfate. In Vitro Cellular and Developmental Biology 31, 761-766
39. van de Sandt, J.J M , Maas, W J M., Doornink, P.C & Rutten, A.A J.J.L (1995) Release of arachidonic and linoleic acid metabolites in skin organ cultures as characteristic of in vivo skin irritancy. Fundamental and Applied Toxicology 25, 20-28.
40. van de Sandt, J.J.M., Rutten, A.A.J.J.L. & Koëter, H.B.W.M. (1993). Cutaneous toxicity testing in organ culture, neutral red uptake and reduction of tetrazolium salt (MTT). Toxicology in Vitro 7, 81-86.
41. Pittermann, W., Jackwerth, B. & Schmitt, M. (1997). The isolated perfused bovine udder skin model: a new in vitro model for the assessment of skin penetration and irritation. In Vitro Toxicology 10, 17-21.
42. Bell, E., Ehrlich, H.P., Buttle, D.J. & Nakatsuji, T. (1981) Living tissue formed in vitro and accepted as skin-equivalent tissue of full thickness. Science 211, 1051-1054.
43. Rosdy, M. & Clauss, L.C. (1990). Complete human epidermal cell differentiation in chemical defined medium at the air-liquid interface on inert filter substrates Journal of Investigative Dermatology 95, 409-414
44. Tinois, E., Tilher, J., Gaucherand, M., Dumas, H., Tardy, M. & Thivolet, J. (1991). In vitro and post-transplantation differentiation of human keratinocytes grown on the human type IV collagen film of a bilayered dermal substitute. Experimental Cell Research 193, 310-319.
45. Roguet, R. & Schaefer, H (1997). Overview of in vitro cell culture technologies and pharmacotoxicological applications Toxicology in Vitro 11, 591-599.
46. Kubilus, J., Cannon, C , Neal, P., Sennot, H & Klausner, M. (1996). Response of the EpiDerm skin model to topically applied irritants In Vitro Toxicology 9, 157-166
47. Ponec, M. & Kempenaar, J (1995). Use of skin recombinants as an in vitro model for testing the irritation potential of cutaneous irritants Skin Pharmacology 8, 49-59.
48. Pruméras, M (1994). Skin and epidermal equivalents: a review. In Alternative Methods in Toxicology, Vol. 10, In Vitro Skin Toxicology' Irritation, Phototoxicity, Sensitization (ed A Rougier, A.M Goldberg & H I. Maibach), pp 97-105. New York: Mary Ann Liebert.
49. Roguet, R , Cohen, C. & Leclaire, J (1995) The use of a human reconstructed epidermis EPISKIN for the assessment of safety and efficacy of cosmetic products. In Vitro Toxicology 8, 427-429.
50. Roguet, R , Cohen, C , Dossou, K G & Rougier, A (1994) EPISKIN, a reconstituted human epidermis for assessing in vitro the irritancy of topically applied compounds Toxicology in Vitro 8, 283-291
51. Cannon, C L , Neal, P.J , Southee, J A , Kubilus, J & Klausner, M (1994) New epidermal model for dermal irritancy testing Toxicology in Vitro 8, 889-891.
52. Roguet, R. (1997). Cutaneous pharmacotoxicology in vitro In In Vitro Methods in Pharmaceutical Research (ed J.V Castell & M.J. Gómez-Lechón), pp. 241-264. London, UK: Academic Press.
53. Roguet, R., Regnier, M , Cohen, C , Dossou, K.G. & Rougier, A. (1994) The use of in vitro reconstituted skin in dermotoxicity testing. Toxicology in Vitro 8, 635-639.
54. Doucet, O., Robert, C & Zastrow, L. (1996). Use of a serum-free reconstituted epidermis as a skin pharmacological model. Toxicology in Vitro 10, 305-313.
55. Roguet, R., Cohen, C., Robles, C., Courtellemont, P., Tolle, M., Guillot, J P. & Pouradier Duteil, X. (1998). An interlaboratory study of the reproducibihty and relevance of EPISKIN, a reconstructed human epidermis, in the assessment of cosmetics irritancy. Toxicology in Vitro, in press.
56. Anon. (1995) Skin Irritation and Corrosion: Reference Chemicals Data Bank ECETOC Technical Report No. 66, 247 pp. Brussels, Belgium: European Centre for Ecotoxicology and Toxicology of Chemicals.
57. Bagley, D.M., Gardner, J.R , Holland, G , Lewis, R W., Régnier, J-F., Stringer, D.A. & Walker, A.P. (1996). Skin irritation: reference chemicals data bank Toxicology in Vitro 10, 1-6.
58. Basketter, D A., Chamberlain, M., Griffiths, H.A , Rowson, M., Whittle, E. & York, M. (1997). The classification of skin irritants by human patch test Food and Chemical Toxicology 35, 845-852
59. Griffiths, H A , Wilhelm, K-P , Robinson, M.K , Wang, X.M., McFadden, J , York, M. & Basketter, D.A. (1997). Interlaboratory evaluation of a human patch test for the identification of skin irritation potential/hazard Food and Chemical Toxicology 35, 255-260.
60. Basketter, D., Reynolds, F, Rowson, M., Talbot, C. & Whittle, E (1997) Visual assessment of human skin irritation, a sensitive and reproducible tool Contact Dermatitis 37, 218-220.
61. Anon. (1997). OECD Guideline for the Testing of Chemicals Proposal for a Draft New Guideline. Acute Dermal Irritation Study in Human Volunteers. ENV/MC/CHEM/TG(97)16, 7 pp Paris, France. OECD.
62. Fentem, J H. & Balls, M (1997) The ECVAM approach to validation In Developments in Animal and Veterinary Sciences, Vol. 27, Animal Alternatives, Welfare and Ethics. Proceedings of the 2nd World Congress on Alternatives and Animal Use in the Life Sciences, Utrecht. 20-24 October 1996 (ed L F M van Zutphen & M Balls), pp 1083-1089 Amsterdam: Elsevier.
63. Basketter, D A., Hall-Manning, T , Robinson, M.K , Whittle, E & York, M (1998) Determination of acute skin irritation potential in the human 4-hour patch test. Food and Chemical Toxicology, in press.