The use of human keratinocytes and human skin models for predicting skin irritation: The report and recommendations of ECVAM Workshop 38

ATLA Alternatives to Laboratory Animals

Volumn 27, Issue 5, 1999, Pages 723-743

  Van De Sandt, Johannes ^a,l   Roguet, Roland ^b   Cohen, Catherine ^b   Esdaile, David ^c   Ponec, Maria ^d   Corsini, Emanuela ^e   Barker, Carol ^f   Fusenig, Norbert ^g   Liebsch, Manfred ^h   Benford, Diane ⁱ   De Brugerolle De Franissinette, Anne ^j   Fartasch, Manigé ^k  

^a TNO   (Netherlands)

^b Ctrl Department of Products Safety   (France)

^c SANOFI   (France)

^d LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^e UNIVERSITY OF MILAN   (Italy)

^f UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^g GERMAN CANCER RESEARCH CENTER DKFZ   (Germany)

^h FEDERAL INSTITUTE FOR RISK ASSESSMENT   (Germany)

ⁱ UNIVERSITY OF SURREY   (United Kingdom)

^j NOVARTIS PHARMA AG   (Switzerland)

^k UNIVERSITY OF ERLANGEN NUREMBERG   (Germany)

^l JOINT RESEARCH CENTRE   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

IRRITANT AGENT;

ARTICLE; ERYTHEMA; EXPERIMENTAL MODEL; HUMAN; HUMAN CELL; KERATINOCYTE; PRIORITY JOURNAL; SKIN EDEMA; SKIN FUNCTION; SKIN IRRITATION; SKIN SENSITIVITY; STRATUM CORNEUM;

EID: 0032744822     PISSN: 02611929     EISSN: None     Source Type: Journal    
DOI: 10.1177/026119299902700504     Document Type: Article

References (97)

1. ECVAM (1994). ECVAM News & Views. ATLA 22, 7-11.
2. Wahlberg, J.E. (1996). Clinical overview of irritant dermatitis. In The Irritant Contact Dermatitis Syndrome (ed. P.G.M. van der Valk & H.I. Maibach), pp. 1-6. Boca Raton, FL, USA: CRC Press.
3. 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.
4. Basketter D.A., Reynolds F.S. & York M. (1999). Predictive testing in contact dermatitis: irritant dermatitis. Clinics in Dermatology 15, 637-644.
5. York, M., Griffiths, H.A., Whittle, E. & Basketter, D.A. (1996). Evaluation of a human patch test for the identification and classification of skin irritation potential. Contact Dermatitis 34, 204-212.
6. Botham, P.A., Earl, L.K., Fentem, J.H., Roguet, R. & van de Sandt, J.J.M. (1998). Alternative methods for skin irritation: the current status. ECVAM skin irritation task force report 1. ATLA 26, 195-211.
7. 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.
8. Botham, P.A., Chamberlain, M., Barratt, M.D., Curren, R.D., Esdaile, D.J., Gardner, 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.
9. Howes, D., Guy, R., Hadgraft, J., Heylings, J., Hoeck, U., Kemper, F., Maibach, H., Marty, J-P., Merk, H., Parra, J., Rekkas, D., Rondelli, I., Schaefer, H., Täuber, U. & Verbiese, N. (1996). Methods for assessing percutaneous absorption. The report and recommendations of ECVAM workshop 13. ATLA 24, 81-106.
10. Emmett, E.A. (1986). Toxic responses of the skin. In Casarett and Doull's Toxicology (ed. C.D. Klaassen, M.O. Amdur & J. Doull), pp. 412-431. New York, USA: Macmillan.
11. Wilkinson, J.D. & Rycroft, R.J.G (1992). Contact dermatitis. In Textbook of Dermatology (ed. R.H. Champion, J.L. Burton & F.J.G. Ebling), pp. 611-715. Oxford, UK: Blackwell Scientific Publications.
12. COLIPA (1995). Cosmetic Product Test Guidelines for the Assessment of Human Skin Compatibility, 22pp. Brussels, Belgium: COLIPA.
13. OECD (1992). Acute dermal irritation/corrosion. In OECD Guidelines for Testing of Chemicals. Guideline 404, 6pp. Paris, France: OECD.
14. European Community (1998). Non-clinical local tolerance testing of medicinal products. In The Rules Governing Medicinal Products in the European Union, Volume 3b, pp. 109-116. Luxembourg: European Community.
15. OECD (1998). Revised proposal for the harmonization of hazard classification based on irritation/corrosion, 12pp. Document no. ENV/MC/CHEM/HCL(98)4. Pans, France: OECD.
16. Fentem, J.H., Archer, G.E.B., Balls, M., Botham, P.A., Curren, R.D., Earl, L.K., Esdaile, D.J., Holzhütter, 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 12, 483-524.
17. ECETOC (1995). Skin Irritation and Corrosion: Reference Chemicals Data Bank. Technical Report No. 66, 247pp. Brussels, Belgium: European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC).
18. Davies, R.E., Harper, K.H. & Kynoch, S.R. (1972). Inter-species variation in dermal reactivity. Journal of the Society of Cosmetic Chemists 23, 371-381.
19. ECETOC (1993). Percutaneous Absorption. Monograph No. 20, 78pp. Brussels, Belgium: European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC).
20. Mortz, C.G., Andersen, K.E. & Halkier-Sorensen, L. (1997). The efficiency of different moisturizers on barrier recovery in hairless mice evaluated by non-invasive bioengineering methods: a model to select the potentially most effective product. Contact Dermatitis 36, 297-301.
21. Basketter, D.A., Griffiths, H.A., Wang, X.M., Wilhelm, K.P. & McFadden, J. (1996). Individual, ethnic and seasonal variability in irritant susceptibility of skin: the implications for a predictive human patch test. Contact Dermatitis 35, 208-213.
22. Judge, MR., Griffiths, H.A., Basketter, D.A., White, I.R., Rycroft, R.J. & McFadden, J.P. (1996). Variation in response of human skin to irritant challenge. Contact Dermatitis 34, 115-117.
23. Fartasch, M., Schnetz, E. & Diepgen, T.L. (1999). Characterization of detergent-induced barrier alterations: effect of barrier cream on irritation. Journal of Investigative Dermatology 3, 121-127.
24. Tupker, R.A., Willis, C., Berardesca, E., Lee, C.H., Fartasch, M., Agner, T. & Serup, J. (1997). Guidelines on sodium lauryl sulfate (SLS) exposure tests: a report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis 37, 53-69.
25. 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.
26. Frosch, P.J. & Kligman, A.M. (1979). The soap chamber test. Journal of the American Academy of Dermatology 1, 35-41.
27. Huener, A., Fartasch, M., Hornstein, O.P. & Diepgen, T.L. (1994). The irritant effect of different metalworking fluids. Contact Dermatitis 31, 220-225.
28. Frosch, P.J., Kurte, A. & Pilz, B. (1993). Efficacy of skin barrier creams. III. The repetitive irritation test (RIT) in humans. Contact Dermatitis 29, 113-118.
29. Frosch, P.J. & Kurte, A. (1994). Efficacy of skin barrier creams. IV. The repetitive irritation test (RIT) with a set of four standard irritants. Contact Dermatitis 31, 161-168.
30. Pirilä, V. (1975). Chamber test versus patch test for epicutaneous testing. Contact Dermatitis 1, 48-52.
31. Fartasch, M. (1995). Human barrier formation and reaction to irritation. Current Problems in Dermatology 23, 95-103.
32. Fartasch, M. (1997). Ultrastructure of the epidermal barrier after irritation. Microsurgical Research Techniques 37, 193-199.
33. Yang, L., Mao-Qiang, M., Taljebini, M., Elias, P.M. & Feingold, K.R. (1995). Topical stratum corneum lipids accelerate barrier repair after tape stripping, solvent treatment and some but not all types of detergent treatment. British Journal of Dermatology 133, 679-685.
34. Bettley, F.R. (1972). The irritant effect of detergents. Transactions of St John's Hospital Dermatology Society 58, 65-74.
35. Willis, C.M., Stephens, C.J.M. & Wilkinson, J.D. (1989). Epidermal damage induced by irritants in man: a light and electron microscopic study. Journal of Investigative Dermatology 93, 695-699.
36. Willis, C.M., Stephens, C.J.M. & Wilkinson, J.D. (1993). Differential patterns of epidermal leukocyte infiltration in patch test reactions to structurally unrelated chemical irritants. Journal of Investigative Dermatology 101, 364-370.
37. Fusenig, N.E., Boukamp, P., Breitkreutz, D., Hülsen, A., Petrusevska, S., Cerutti, P. & Stanbridge, E. (1990). In vitro transformation of human skin epithelial cells: role of ras oncogene in malignant progression. Toxicology in Vitro 4, 627-634.
38. Boukamp, P., Popp, S., Altmeyer, S., Holsen, A., Fasching, C., Cremer, T. & Fusenig, N.E. (1997). Sustained non-tumorigenic phenotype correlates with a largely stable chromosome content during long-term culture of the human keratinocyte line HaCaT. Genes, Chromosomes and Cancer 19, 201-214.
39. Baden, H.P., Kubilus, J., Kvedar, J.C., Steinberg, M.L. & Wolman, S.R. (1987). Isolation and characterization of a spontaneously arising long-lived line of human keratinocytes (NM1). In Vitro Cellular and Developmental Biology 23, 205-213.
40. Boukamp, P., Petrussevska, R.T., Breitkreutz, D., Hornung, J., Markham, A. & Fusenig, N.E. (1988). Normal keratinisation in a spontaneously immortalized aneuploid human keratinocyte cell line. Journal of Cell Biology 106, 761-771.
41. Rice, R.H., Steinmann, K.E., de Graffenried, L.A., Qhin, Q., Taylor, N. & Schlegel, N. (1993). Elevation of cell cycle control proteins during spontaneous immortalization of human keratinocytes. Molecular Biology 14, 185-194.
42. Breitkreutz, D., Boukamp, P., Ryle, C.M., Stark, H-J., Roop, D.R. & Fusenig, N.E. (1991). Epidermal morphogenesis and keratin expression in c-Ha-ras-transfected tumorigenic clones of the human HaCaT cell line. Cancer Research 51, 4402-4409.
43. Breitkreutz, D., Schoop, V.M., Mirancea, N., Baur, M., Stark, H-J. & Fusenig, N.E. (1998). Epidermal differentiation and basement membrane formation by HaCaT cells in surface transplants. European Journal of Cell Biology 75, 1-14.
44. Ryle, C.M., Breitkreutz, D., Stark, H-J., Leigh, I.M., Steinert, P.M., Roop, D. & Fusenig, N.E. (1989). Density-dependent modulation of synthesis of keratins 1 and 10 in the human keratinocyte line HaCaT in ras-transfected tumorigenic clones. Differentiation 40, 42-54.
45. 2+. Differentiation 54, 201-207.
46. Fusenig, N.E. (1994). Cell culture models: reliable tools in pharmacotoxicology. In Cell Culture in Pharmaceutical Research (ed. N.E. Fusenig & H. Graf), pp. 1-7. Berlin, Germany: Springer Verlag.
47. Barker, J.N.W.N., Mitra, R.S., Griffiths, C.E.M., Dixit, V.M. & Nickoloff, B.J. (1991). Keratinocytes as initiators of inflammation. Lancet 337, 211-214.
48. DeLeo, V.A., Carver, M.P., Hong, J., Fung, K., Kong, B. & DeSalva, S. (1996). Arachidonic acid release: an in vitro alternative for dermal irritancy testing. Food and Chemical Toxicology 34, 167-176.
49. Gueniche, A. & Ponec, M. (1993). Use of human skin cell cultures for the estimation of potential skin irritants. Toxicology in Vitro 1, 15-24.
50. Müller-Decker, K., Furstenberger, G. & Marks, F. (1994). Keratinocyte-derived pro-inflammatory key mediators and cell viability as in vitro parameters of irritancy: a possible alternative to the Draize skin irritation test. Toxicology and Applied Pharmacology 127, 99-108.
51. Rheinwald, J.G. & Green, H. (1975). Serial cultivation of strains of human epidermal keratinocytes: the formation of keratinizing colonies from single cells. Cell 6, 331-344.
52. Boyce, S.T. & Ham, G. (1985). Cultivation, frozen storage and clonal growth of normal human epidermal keratinocytes in serum-free media. Journal of Tissue Culture Methods 9, 83-93.
53. Lawrence, J.N., Starkey, S., Dickson, F.M. & Benford, D.J. (1996). Use of human and rat keratinocyte cultures to assess skin irritation potential. Toxicology in Vitro 10, 331-340.
54. Osborne, R. & Perkins, M.A. (1991). In vitro skin irritation testing with human skin cultures. Toxicology in Vitro 5, 563-567.
55. Rutten, A.A.J.J.L., Béquet-Passeleqo, B.G.A.G.G. & Koëter, H.B.W.M. (1990). Two-compartment model for rabbit skin organ culture. In Vitro 25, 353-360.
56. Parish, W.E. (1985). Relevance of in vitro tests to in vivo acute skin inflammation: potential in vitro applications of skin keratome slices, neutrophils, fibroblasts, mast cells and macrophages. Food and Chemical Toxicology 23, 275-285.
57. Parish, W.E. (1986). Evaluation of in vitro predictive tests for irritation and allergic sensitization. Food and Chemical Toxicology 24, 481-494.
58. Kao, J.K., Hall, J. & Holland, J.M. (1983). Quantification of cutaneous toxicity: an in vitro approach using skin organ culture. Toxicology and Applied Pharmacology 68, 206-217.
59. Galli, C.L. & Marinovich, M. (1990). In vitro markers of skin toxicity. In NATO ASI Series, Vol. 181, Skin Pharmacology and Toxicology. Recent Advances (ed. C.L. Galli, C.N. Hensby & M. Marinovich), pp. 165-179. New York, USA: Plenum Press.
60. Bartnik, F.G. & Pittermann, W.F. (1994). Skin organ culture for the study of skin irritancy. In Alternative Methods in Toxicology, Vol. 10, In Vitro Skin Toxicology (ed. A. Rougier, A.M. Goldberg & H.I. Maibach), pp. 171-181. New York, USA: Mary Ann Liebert.
61. Nakamura, M., Rikimaru, T., Yano, T., Moore, G., Pula, P.J., Schofield, B.H. & Dannenberg, A.M. (1990). Full-thickness human skin explants for testing the toxicity of topically applied chemicals. Journal of Investigative Dermatology 95, 325-332.
62. Monteriro-Riviere, N.A., Inman, A.Q., Qiao, G., Snider, T.H., Blank, J.A. & Hobson, D.W. (1997). Comparison of in vitro human skin equivalent models to normal human skin for dermatological research. Perspectives in Percutaneous Penetration 5, 65.
63. Ponec, M. (1991). Human epidermis reconstructed on de-epidermized dermis: expression of differentiation-specific markers and lipid composition. Toxicology in Vitro 5, 597-606.
64. Simonetti, O., Hoogstraate, A.J., Bilaik, W., Kempenaar, J.A., Schrijvers, A.H.G., Boddé, H.E. & Ponec, M. (1995). Visualization of diffusion pathways across the stratum corneum of native and in vitro reconstructed epidermis by confocal laser scanning microscopy. Archives of Dermatological Research 87, 465-473.
65. 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 characteristics of in vitro skin irritancy. Fundamental and Applied Toxicology 25, 20-28.
66. Cohen, C., Selvi-Bignon, C., Barbier, A., Rougier, A., Lacheretz, F. & Roguet, R. (1994). Measurement of proinflammatory mediator production by cultured keratinocytes: a predictive assessment of cutaneous irritation In Alternative Methods in Toxicology, Vol. 10, In Vitro Skin Toxicology (ed. A. Rougier, A.M. Goldberg & H.I. Maibach), pp. 83-96, New York, USA: Mary Ann Liebert.
67. Rosdy, M. & Clauss, L.C. (1990). Complete human epidermal cell differentiation in chemically defined medium at the air-liquid interface on inert filter substrates. Journal of Investigative Dermatology 95, 409-414.
68. Tinois, E., Tiollier, J., Gaucherand, M., Dumas, H., Tardy, M. & Thivolet, J. (1991). In vitro and post-transplantation differentiation of human keratinocytes grown on human type IV collagen film of a bilayered dermal substitute. Experimental Cell Research 193, 310-331.
69. Regnier, M., Asselineau D. & Lenoir, M.C. (1990). Human epidermis reconstructed on dermal substrates in vitro: an alternative to animals in skin pharmacology. Skin Pharmacology 3, 70-85.
70. Bell, E., Parenteau, N., Gay, R., Nolte, C., Kemp, P., Ekstein B. & Johnson, E. (1991). The living skin equivalent: its manufacture, its organotypic properties and its response to irritants. Toxicology in Vitro 5, 591-596.
71. Naughton, G.K., Jacob, L. & Naughton, B.A. (1989). A physiological model for in vitro toxicity studies. In Alternative Methods in Toxicology, Vol. 7, In Vitro Skin Toxicology (ed. A.M. Goldberg), pp. 335-343. New York, USA: Mary Ann Liebert.
72. Boyce, S., Michel., S., Reichert, U., Shroot, B. & Schmidt, R. (1990). Reconstructed skin from cultured human keratinocytes and fibroblasts on a collagen-glycosaminoglycan biopolymer substrate. Skin Pharmacology 2, 136-143.
73. Ponec, M. (1992). In vitro cultured human skin cells as alternatives to animals for skin irritancy screening. International Journal of Cosmetic Sciences 14, 245-264.
74. Ponec, M. (1996). In vitro models to predict skin irritation. In The Irritant Contact Dermatitis Syndrome (ed. P.G.M. van der Valk & H.I. Maibach), pp. 335-341. Boca Raton, FL, USA: CRC Press.
75. Ponec, M., Weerheim, A., Kempenaar, J., Mulder, A., Gooris, G.S., Bouwstra, J. & Mommaas, A.M. (1997). The formation of competent barrier lipids in reconstructed human epidermis requires the presence of vitamin C. Journal of Investigative Dermatology 109, 348-355.
76. ECETOC (1990). ECETOC Monograph 15: Skin Irritation, 77pp. Brussels, Belgium: European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC).
77. Tatnall, F.M., Leigh, I.M. & Gibson, J.R. (1990). Comparative study of antiseptic toxicity on basal keratinocytes, transformed human keratinocytes and fibroblasts. Skin Pharmacology 3, 157-163.
78. Petrali, J.P. & Oglesby-Megee, S. (1997). Toxicity of mustard gas skin lesions. Microscopical Research Techniques 37, 221-228.
79. Helman, R.G., Hall, J.W. & Kao, J.Y. (1986). Acute dermal toxicity: in vivo and in vitro comparisons in mice. Fundamental and Applied Toxicology 1, 94-100.
80. 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.
81. Ponec, M. & Kempenaar, J. (1995). Use of human skin recombinants as an in vitro model for testing the irritation potential of cutaneous irritants. Skin Pharmacology 8, 49-59.
82. Boelsma, E., Tanojo, H., Boddé, H.E. & Ponec, M. (1996). Assessment of the potential irritancy of oleic acid on human skin: evaluation in vitro and in vivo. Toxicology in Vitro 10, 729-742.
83. Boss, J.D. & Kapsenberg, M.L. (1993). The skin immune system: progress in cutaneous biology. Immunology Today 14, 75-78.
84. McKenzie, R.C. & Sauder, D.N. (1990). The role of keratinocyte cytokines in inflammation and immunity. Journal of Investigative Dermatology 95, Suppl, 105-107.
85. Williams, I.R. & Kupper, T.S. (1996). Immunity at the surface: homeostatic mechanisms of the skin immune system. Life Sciences 58, 1485-1507.
86. Kupper, T.S. (1990). Immune and inflammatory processes in cutaneous tissue: mechanisms and speculations. Journal of Clinical Investigation 86, 1783-1789.
87. Kupper, T.S. & Groves, R.W. (1995). The interleukin-1 axis and cutaneous inflammation. Journal of Investigative Dermatology 105, Suppl., 62-66.
88. Sauder, D.N. & Pastore, S. (1993). Cytokines in contact dermatitis. American Journal of Contact Dermatitis 4, 215-224.
89. Roguet, R., Cohen, C., Dossou, G. & Rougier, A. (1994). A reconstituted human epidermis for assessing in vitro the irritancy of topically applied compounds. Toxicology in Vitro 8, 283-291.
90. Luster, M.I., Wilmer, J.L., Germolec, D.R., Spalding, J., Yoshida, T., Gaido, K., Simeonova, P.P., Burleson, F.G. & Bruccoleri, A. (1995). Role of keratinocyte-derived cytokines in chemical toxicity. Toxicology Letters 82/83, 471-476.
91. Dykes, P.J., Edwards, M.J., O'Donovan, M.R., Merrett, V., Morgan, H.E. & Marks, R. (1991). In vitro reconstruction of human skin equivalents as potential indicators of cutaneous toxicity. Toxicology in Vitro 5, 1-8.
92. Rogiers, V., Balls, M., Basketter, D., Berardesca, E., Edwards, C., Eisner, P., Ennen, J., Lévêque, J.L., Lóden, M., Masson, P., Parra, J., Paye, M., Piérard, G., Rodrigues, L., Schaefer, H., Salter, D. & Zuang, V. (1999). The potential use of non-invasive methods in the assessment of cosmetic products. The report and recommendations of ECVAM workshop 36. ATLA 27, 515-537.
93. Osborne, S., Mayer, F.K., Spake, A., Rosdy, M., DeWever, B., Ettlin, R.A. & Cordier, A. (1999). Predictivity of an in vitro model for acute and chronic skin irritation (SkinEthic) applied to the testing of topical vehicles. Cell Biology and Toxicology 15, 121-135.
94. TM, a reconstructed human epidermis, in the assessment of cosmetics irritancy. Toxicology in Vitro 12, 295-304.
95. Fentem, J.H., Botham, P.A., Earl, L.K., Roguet, R. & van de Sandt, J.J.M. (1999). Prevalidation of in vitro tests for acute skin irritation. ATLA 27, Special Issue, 346A.
96. Gibbs, S., Vicanova, J., Bouwstra, J., Valstar, D., Kempenaar, J. & Ponec, M. (1997). Culture of reconstructed epidermis in a defined medium at 33°C shows a delayed epidermal maturation, prolonged lifespan and improved stratum corneum. Archives of Dermatological Research 289, 585-595.
97. Vicanova, J., Boelsma, E., Mommaas, A.M., Kempenaar, J.A., Forslind, B., Pallon, J., Egelrud, T., Koerten, H.K. & Ponec, M. (1998). Normalization of epidermal calcium distribution profile in reconstructed human epidermis is related to improvement of terminal differentiation and stratum corneum barrier formation. Journal of Investigative Dermatology 111, 97-106.