Use of skin equivalents for dermal absorption and toxicity

Dermal Absorption and Toxicity Assessment, Second Edition

Volumn , Issue , 2007, Pages 141-160

  Schäfer Korting, Monika ^a   Schreiber, Sylvia ^a  

^a FREIE UNIVERSITÄT BERLIN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85056943465     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (112)

1. OECD. Test Guideline 431: In Vitro Skin Corrosion: Human Skin Model Test. Adopted on 13th April 2004.
2. OECD. Guidance Document No 28 for the Conduct of Skin Absorption Studies. Adopted at 35th Joint Meeting August 2003.
3. OECD. Test Guideline 428: Skin Absorption: In Vitro Method. Adopted on 13th April 2004.
4. Diembeck W, Beck H, Benech-Kieffer F, et al. Test guidelines for in vitro assessment of dermal absorption and percutaneous penetration of cosmetic ingredients. European Cosmetic, Toiletry and Perfumery Association. Food Chem Toxicol 1999; 37(2-3):191-205.
5. Wagner H, Kostka KH, Lehr CM, et al. Drug distribution in human skin using two different in vitro test systems: comparison with in vivo data. Pharm Res 2000; 17(12):1475-81.
6. Jacobi U, Gautier J, Sterry W, et al. Gender-related differences in the physiology of the stratum corneum. Dermatology 2005; 211(4):312-7.
7. Dubertret L, Coulomb B. Reconstruction of human skin in culture. C R Seances Soc Biol Fil 1994; 188(3):235-44.
8. Rheinwald JG, Green H. Serial cultivation of strains of human epidermal keratinocytes:the formation of keratinizing colonies from single cells. Cell 1975; 6(3):331-43.
9. Gysler A, Lange K, Korting HC, et al. Prednicarbate biotransformation in human foreskin keratinocytes and fibroblasts. Pharm Res 1997; 14(6):793-7.
10. Lange K, Gysler A, Bader M, et al. Prednicarbate versus conventional topical glucocorticoids:pharmacodynamic characterization in vitro. Pharm Res 1997; 14(12):1744-9.
11. Fusenig NE, Boukamp P. Multiple stages and genetic alterations in immortalization, malignant transformation, and tumor progression of human skin keratinocytes. Mol Carcinog 1998; 23(3):144-58.
12. Zouboulis CC, Seltmann H, Neitzel H, et al. Establishment and characterization of an immortalized human sebaceous gland cell line (SZ95). J Invest Dermatol 1999; 113(6):1011-20.
13. Kitajima T, Ariizumi K, Bergstresser PR, et al. T cell-dependent loss of proliferative responsiveness to colony-stimulating factor-1 by a murine epidermal-derived dendritic cell line, XS52. J Immunol 1995; 155(11):5190-7.
14. Kitajima T, Ariizumi K, Mohamadazadeh M, et al. T cell-dependent secretion of IL-1 beta by a dendritic cell line (XS52) derived from murine epidermis. J Immunol 1995; 155(8):3794-800.
15. Radeke HH, von Wenckstern H, Stoidtner K, et al. Overlapping signaling pathways of sphingosine 1-phosphate and TGF-beta in the murine Langerhans cell line XS52. J Immunol 2005; 174(5):2778-86.
16. Gilchrest BA, Vrabel MA, Flynn E, et al. Selective cultivation of human melanocytes from newborn and adult epidermis. J Invest Dermatol 1984; 83(5):370-6.
17. Staiano-Coico L, Hefton JM, Amadeo C, et al. Growth of melanocytes in human epidermal cell cultures. J Trauma 1990; 30(8):1037-42 (discussion 1043).
18. Kippenberger S, Bernd A, Bereiter-Hahn J, et al. Transcription of melanogenesis enzymes in melanocytes: dependence upon culture conditions and co-cultivation with keratinocytes. Pigment Cell Res 1996; 9(4):179-84.
19. Marjukka Suhonen T, Pasonen-Seppanen S, Kirjavainen M, et al. Epidermal cell culture model derived from rat keratinocytes with permeability characteristics comparable to human cadaver skin. Eur J Pharm Sci 2003; 20(1):107-13.
20. Asselineau D, Bernhard B, Bailly C, et al. Epidermal morphogenesis and induction of the 67 kD keratin polypeptide by culture of human keratinocytes at the liquid-air interface. Exp Cell Res 1985; 159(2):536-9.
21. Bodde HE, Holman B, Spies F, et al. Freeze-fracture electron microscopy of in vitro reconstructed human epidermis. J Invest Dermatol 1990; 95(1):108-16.
22. Ponec M, Weerheim A, Kempenaar J, et al. Lipid composition of cultured human keratinocytes in relation to their differentiation. J Lipid Res 1988; 29(7):949-61.
23. Regnier M, Schweizer J, Michel S, et al. Expression of high molecular weight (67 K) keratin in human keratinocytes cultured on dead de-epidermized dermis. Exp Cell Res 1986; 165(1):63-72.
24. Freeman AE, Igel HJ, Herrman BJ, et al. Growth and characterization of human skin epithelial cell cultures. In Vitro 1976; 12(5):352-62.
25. Regnier M, Asselineau D, Lenoir MC. Human epidermis reconstructed on dermal substrates in vitro: an alternative to animals in skin pharmacology. Skin Pharmacol 1990; 3(2):70-85.
26. Bell E, Ivarsson B, Merrill C. Production of a tissue-like structure by contraction of collagen lattices by human fibroblasts of different proliferative potential in vitro. Proc Natl Acad Sci USA 1979; 76(3):1274-8.
27. Naughton G, Jacob L, Naughton B. A Physiological Skin Model for In Vitro Toxicity Studies. New York: Mary Ann Liebert, 1989.
28. Coulomb B, Lebreton C, Dubertret L. Influence of human dermal fibroblasts on epidermalization. J Invest Dermatol 1989; 92(1):122-5.
29. Mackenzie IC, Fusenig NE. Regeneration of organized epithelial structure. J Invest Dermatol 1983; 81(Suppl. 1):189s-94.
30. Bertaux B, Morliere P, Moreno G, et al. Growth of melanocytes in a skin equivalent model in vitro. Br J Dermatol 1988; 119(4):503-12.
31. Nakazawa K, Nakazawa H, Collombel C, et al. Keratinocyte extracellular matrixmediated regulation of normal human melanocyte functions. Pigment Cell Res 1995; 8(1):10-8.
32. Todd C, Hewitt SD, Kempenaar J, et al. Co-culture of human melanocytes and keratinocytes in a skin equivalent model: effect of ultraviolet radiation. Arch Dermatol Res 1993; 285(8):455-9.
33. Pellegrini G, Bondanza S, Guerra L, et al. Cultivation of human keratinocyte stem cells:current and future clinical applications. Med Biol Eng Comput 1998; 36(6):778-90.
34. Pianigiani E, Risulo M, Andreassi A, et al. Autologous epidermal cultures and narrow-band ultraviolet B in the surgical treatment of vitiligo. Dermatol Surg 2005; 31(2):155-9.
35. Andreassi L, Pianigiani E, Andreassi A, et al. A new model of epidermal culture for the surgical treatment of vitiligo. Int J Dermatol 1998; 37(8):595-8.
36. Ponec M, Weerheim A, Kempenaar J, et al. The formation of competent barrier lipids in reconstructed human epidermis requires the presence of vitamin C. J Invest Dermatol 1997; 109(3):348-55.
37. Gibbs S, Vicanova J, Bouwstra J, et al. Culture of reconstructed epidermis in a defined medium at 338C shows a delayed epidermal maturation, prolonged lifespan and improved stratum corneum. Arch Dermatol Res 1997; 289(10):585-95.
38. Ponec M, Gibbs S, Weerheim A, et al. Epidermal growth factor and temperature regulate keratinocyte differentiation. Arch Dermatol Res 1997; 289(6):317-26.
39. Kandarova H. Evaluation and Validation of Reconstructed Human Skin Models as Alternatives to Animal Tests in Regulatory Toxicology. Berlin: Free University of Berlin, 2006.
40. Hafner J, Kuhne A, Trueb RM. Successful grafting with EpiDex in pyoderma gangrenosum. Dermatology 2006; 212(3):258-9.
41. Tausche AK, Skaria M, Bohlen L, et al. An autologous epidermal equivalent tissueengineered from follicular outer root sheath keratinocytes is as effective as splitthickness skin autograft in recalcitrant vascular leg ulcers. Wound Repair Regen 2003; 11(4):248-52.
42. Hoffmann J, Heisler E, Karpinski S, et al. Epidermal-skin-test 1000 (EST-1000)-a new reconstructed epidermis for in vitro skin corrosivity testing. Toxicol In Vitro 2005; 19(7):925-9.
43. Limat A, Noser FK. Serial cultivation of single keratinocytes from the outer root sheath of human scalp hair follicles. J Invest Dermatol 1986; 87(4):485-8.
44. Limat A, Breitkreutz D, Hunziker T, et al. Restoration of the epidermal phenotype by follicular outer root sheath cells in recombinant culture with dermal fibroblasts. Exp Cell Res 1991; 194(2):218-27.
45. Boelsma E, Gibbs S, Faller C, et al. Characterization and comparison of reconstructed skin models: morphological and immunohistochemical evaluation. Acta Derm Venereol 2000; 80(2):82-8.
46. Marjukka Suhonen T, Pasonen-Seppanen S, Kirjavainen M, et al. Epidermal cell culture model derived from rat keratinocytes with permeability characteristics comparable to human cadaver skin. Eur J Pharm Sci 2003; 20(1):107-13.
47. Hoeller D, Huppertz B, Roos TC, et al. An improved and rapid method to construct skin equivalents from human hair follicles and fibroblasts. Exp Dermatol 2001; 10(4):264-71.
48. Augustin C, Collombel C, Damour O. Use of dermal equivalent and skin equivalent models for identifying phototoxic compounds in vitro. Photodermatol Photoimmunol Photomed 1997; 13(1-2):27-36.
49. Augustin C, Collombel C, Damour O. Measurements of the protective effect of topically applied sunscreens using in vitro three-dimensional dermal and skin equivalents. Photochem Photobiol 1997; 66(6):853-9.
50. Hoffmann C, Müller-Goymann CC. Use of artificial skin constructs in permeation studies of clindamycin phosphate. Pharmazie 2005; 60(5):350-3.
51. Rosdy M, Clauss LC. Terminal epidermal differentiation of human keratinocytes grown in chemically defined medium on inert filter substrates at the air-liquid interface. J Invest Dermatol 1990; 95(4):409-14.
52. Gibbs S, Boelsma E, Kempenaar J, et al. Temperature-sensitive regulation of epidermal morphogenesis and the expression of cornified envelope precursors by EGF and TGF alpha. Cell Tissue Res 1998; 292(1):107-14.
53. Ponec M. Reconstruction of human epidermis on de-epidermized dermis: expression of differentiation-specific protein markers and lipid composition. Toxicol In Vitro 1991; 5:597-606.
54. Tinois E, Tiollier J, Gaucherand M, et al. In vitro and post-transplantation differentiation of human keratinocytes grown on the human type IV collagen film of a bilayered dermal substitute. Exp Cell Res 1991; 193(2):310-9.
55. Ponec M, Boelsma E, Weerheim A, et al. Lipid and ultrastructural characterization of reconstructed skin models. Int J Pharm 2000; 203(1-2):211-25.
56. Bouwstra JA, Honeywell-Nguyen PL, Gooris GS, et al. Structure of the skin barrier and its modulation by vesicular formulations. Prog Lipid Res 2003; 42(1):1-36.
57. Pilgram GS, Vissers DC, van der Meulen H, et al. Aberrant lipid organization in stratum corneum of patients with atopic dermatitis and lamellar ichthyosis. J Invest Dermatol 2001; 117(3):710-7.
58. Gazel A, Ramphal P, Rosdy M, et al. Transcriptional profiling of epidermal keratinocytes:comparison of genes expressed in skin, cultured keratinocytes, and reconstituted epidermis, using large DNA microarrays. J Invest Dermatol 2003; 121(6):1459-68.
59. Faller C, Bracher M. Reconstructed skin kits: reproducibility of cutaneous irritancy testing. Skin Pharmacol Appl Skin Physiol 2002; 15(Suppl. 1):74-91.
60. Faller C, Bracher M, Dami N, et al. Predictive ability of reconstructed human epidermis equivalents for the assessment of skin irritation of cosmetics. Toxicol In Vitro 2002; 16(5):557-72.
61. Ponec M, Boelsma E, Weerheim A. Covalently bound lipids in reconstructed human epithelia. Acta Derm Venereol 2000; 80(2):89-93.
62. Ponec M, Boelsma E, Gibbs S, et al. Characterization of reconstructed skin models. Skin Pharmacol Appl Skin Physiol 2002; 15(Suppl. 1):4-17.
63. Kandarova H, Liebsch M, Spielmann H, et al. Assessment of the human epidermis model SkinEthic RHE for in vitro skin corrosion testing of chemicals according to new OECD TG 431. Toxicol In Vitro 2006; 20(5):547-59.
64. van de Sandt JJ, van Burgsteden JA, Cage S, et al. In vitro predictions of skin absorption of caffeine, testosterone, and benzoic acid: a multi-centre comparison study. Regul Toxicol Pharmacol 2004; 39(3):271-81.
65. OECD. Test Guideline 427: Skin Absorption: In Vivo Method. Adopted on 13th April 2004.
66. OECD. Test Guideline 402: Acute Dermal Toxicity. Updated Guideline, adopted on 24th February 1987.
67. van Ravenzwaay B, Leibold E. The significance of in vitro rat skin absorption studies to human risk assessment. Toxicol In Vitro 2004; 18(2):219-25.
68. Regnier M, Caron D, Reichert U, et al. Barrier function of human skin and human reconstructed epidermis. J Pharm Sci 1993; 82(4):404-7.
69. Schmook FP, Meingassner JG, Billich A. Comparison of human skin or epidermis models with human and animal skin in in-vitro percutaneous absorption. Int J Pharm 2001; 215(1-2):51-6.
70. Lotte C, Patouillet C, Zanini M, et al. Permeation and skin absorption: reproducibility of various industrial reconstructed human skin models. Skin Pharmacol Appl Skin Physiol 2002; 15(Suppl. 1):18-30.
71. Dreher F, Fouchard F, Patouillet C, et al. Comparison of cutaneous bioavailability of cosmetic preparations containing caffeine or alpha-tocopherol applied on human skin models or human skin ex vivo at finite doses. Skin Pharmacol Appl Skin Physiol 2002; 15(Suppl. 1):40-58.
72. Haberland A, Schreiber S, Maia CS, et al. The impact of skin viability on drug metabolism and permeation-BSA toxicity on primary keratinocytes. Toxicol In Vitro 2006; 20(3):347-54.
73. Netzlaff F, Kostka KH, Lehr CM, et al. TEWL measurements as a routine method for evaluating the integrity of epidermis sheets in static Franz type diffusion cells in vitro. Limitations shown by transport data testing. Eur J Pharm Biopharm 2005; 63:44-50.
74. Schafer-Korting M, Bock U, Gamer A, et al. Reconstructed human epidermis for skin absorption testing: results of the German prevalidation study. Altern Lab Anim 2006; 34(3):283-94.
75. Schreiber S, Mahmoud A, Vuia A, et al. Reconstructed epidermis versus human and animal skin in skin absorption studies. Toxicol In Vitro 2005; 19(6):813-22.
76. Netzlaff F, Schaefer UF, Lehr CM, et al. Comparison of bovine udder skin with human and porcine skin in percutaneous permeation experiments. ATLA 2006; 34:499-513.
77. Hartung T, Bremer S, Casati S, et al. A modular approach to the ECVAM principles on test validity. Altern Lab Anim 2004; 32(5):467-72.
78. Bos JD, Meinardi MM. The 500 Dalton rule for the skin penetration of chemical compounds and drugs. Exp Dermatol 2000; 9(3):165-9.
79. Haltner-Ukomadu E, Vuia A, Bock U, et al. Reconstructed human epidermis versus native skin for skin absorption testing-results of the German validation stud. In: CRSMeeting, 22nd-26th July. Vienna, 2006.
80. Jacobi U, Tassopoulos T, Surber C, et al. Cutaneous distribution and localization of dyes affected by vehicles all with different lipophilicity. Arch Dermatol Res 2006; 297(7):303-10.
81. Mahmoud A, Haberland A, Dürrfeld M, et al. Cutaneous estradiol permeation, penetration and metabolism in pig and man. Skin Pharmacol Physiol 2005; 18(1):27-35.
82. Cross SE, Anissimov YG, Magnusson BM, et al. Bovine-serum-albumin-containing receptor phase better predicts transdermal absorption parameters for lipophilic compounds. J Invest Dermatol 2003; 120(4):589-91.
83. Boelsma E, Anderson C, Karlsson AM, et al. Microdialysis technique as a method to study the percutaneous penetration of methyl nicotinate through excised human skin, reconstructed epidermis, and human skin in vivo. Pharm Res 2000; 17(2):141-7.
84. OECD. Test Guideline 404: Acute Dermal Irritation/Corrosion. Updated Guideline, adopted on 24th April 2002.
85. Fentem JH. Validation of in vitro tests for skin corrosivity. Altex 1999; 16(3):150-3.
86. Liebsch M, Traue D, Barrabas C, et al. The ECVAM prevalidation study on the use of EpiDerm for skin corrosivity testing. Altern Lab Anim 2000; 28:371-401.
87. OECD. Test Guideline 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER). Adopted on 13th April 2004.
88. Fentem JH, Botham PA. ECVAM’s activities in validating alternative tests for skin corrosion and irritation. Altern Lab Anim 2002; 30(Suppl. 2):61-7.
89. Zuang V. ECVAM’s research and validation activities in the fields of topical toxicity and human studies. Altern Lab Anim 2002; 30(Suppl. 2):119-23.
90. Kandarova H, Liebsch M, Genschow E, et al. Optimisation of the EpiDerm test protocol for the upcoming ECVAM validation study on in vitro skin irritation tests. Altex 2004; 21(3):107-14.
91. Kandarova H, Liebsch M, Gerner I, et al. The EpiDerm test protocol for the upcoming ECVAM validation study on in vitro skin irritation tests-an assessment of the performance of the optimised test. Altern Lab Anim 2005; 33(4):351-67.
92. Liebsch M, Spielmann H, Pape W, et al. UV-induced effects. Altern Lab Anim 2005; 33(Suppl. 1):131-46.
93. OECD. Test Guideline 432: In Vitro 3T3 NRU Phototoxicity Test. Adopted on 13th April 2004.
94. Spielmann H, Balls M, Dupuis J, et al. The international EU/COLIPA in vitro phototoxicity validation study: results of phase II (blind trial), part 1: the 3T3 NRU phototoxicity test. Toxicol In Vitro 1998; 12:305-27.
95. Spielmann H, Balls M, Dupuis J, et al. A study on UV filter chemicals from Annex VII of EU Directive 76/768/EEC in the 3T3 NRU phototoxicity test. ATLA 1998; 26:679-708.
96. Bernard FX, Barrault C, Deguercy A, et al. Development of a highly sensitive in vitro phototoxicity assay using the SkinEthic reconstructed human epidermis. Cell Biol Toxicol 2000; 16(6):391-400.
97. Harris IR, Siefken W, Beck-Oldach K, et al. Comparison of activities dependent on glutathione S-transferase and cytochrome P-450 IA1 in cultured keratinocytes and reconstructed epidermal models. Skin Pharmacol Appl Skin Physiol 2002; 15(Suppl. 1):59-67.
98. Harris IR, Siefken W, Beck-Oldach K, et al. NAD(P)H:quinone reductase activity in human epidermal keratinocytes and reconstructed epidermal models. Skin Pharmacol Appl Skin Physiol 2002; 15(Suppl. 1):68-73.
99. Pham MA, Magdalou J, Siest G, et al. Reconstituted epidermis: a novel model for the study of drug metabolism in human epidermis. J Invest Dermatol 1990; 94(6):749-52.
100. Slivka SR, Landeen LK, Zeigler F, et al. Characterization, barrier function, and drug metabolism of an in vitro skin model. J Invest Dermatol 1993; 100(1):40-6.
101. Münster U, Hammer S, Blume-Peytavi U, et al. Testosterone metabolism in human skin cells in vitro and its interaction with estradiol and dutasteride. Skin Pharmacol Appl Skin Physiol 2003; 16(6):356-66.
102. Kubota K, Ademola J, Maibach HI. Metabolism and degradation of betamethasone 17-valerate in homogenized living skin equivalent. Dermatology 1994; 188(1):13-7.
103. Gysler A, Kleuser B, Sippl W, et al. Skin penetration and metabolism of topical glucocorticoids in reconstructed epidermis and in excised human skin. Pharm Res 1999; 16(9):1386-91.
104. Santos Maia C, Mehnert W, Schaller M, et al. Drug targeting by solid lipid nanoparticles for dermal use. J Drug Target 2002; 10(6):489-95.
105. Munster U, Nakamura C, Haberland A, et al. RU 58841-myristate-prodrug development for topical treatment of acne and androgenetic alopecia. Pharmazie 2005; 60(1):8-12.
106. Stecova J, Mehnert W, Blaschke T, et al. Cyproterone acetate loading to lipid nanoparticles for topical acne treatment: particle characterisation and skin uptake. Pharm Res 2007; 24:991-1000.
107. Kizu J, Watanabe S, Yasuno N, et al. Development and clinical application of high performance liquid chromatography for the simultaneous determination of plasma levels of theophylline and its metabolites without interference from caffeine. Biomed Chromatogr 1999; 13(1):15-23.
108. Ha HR, Chen J, Freiburghaus AU, et al. Metabolism of theophylline by cDNAexpressed human cytochromes P-450. Br J Clin Pharmacol 1995; 39(3):321-6.
109. Ademola JI, Wester RC, Maibach HI. Cutaneous metabolism of theophylline by the human skin. J Invest Dermatol 1992; 98(3):310-4.
110. Bronaugh RL, Stewart RF, Storm JE. Extent of cutaneous metabolism during percutaneous absorption of xenobiotics. Toxicol Appl Pharmacol 1989; 99(3):534-43.
111. Zhao JF, Zhang YJ, Kubilus J, et al. Reconstituted 3-dimensional human skin as a novel in vitro model for studies of carcinogenesis. Biochem Biophys Res Commun 1999; 254(1):49-53.
112. Duval C, Schmidt R, Regnier M, et al. The use of reconstructed human skin to evaluate UV-induced modifications and sunscreen efficacy. Exp Dermatol 2003; 12(Suppl. 2):64-70.