In vitro approaches to the assessment of skin irritation and phototoxicity of topically applied materials

Dermatotoxicology, Eighth Edition

Volumn , Issue , 2012, Pages 284-295

  Eskes, Chantra ^a   Barroso, Joao ^b   Basketter, David ^c  

^a SeCAM   (Switzerland)

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

^c DABMEB CONSULTANCY LTD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84876578097     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (126)

1. Chew AL, Maibach HI. Irritant Dermatitis. Berlin: Springer, 2006.
2. Draize JH, Woodard G, Calvery HO. Methods for the study of imitation and toxicity of substances applied topically to the skin and mucous membranes. J Pharmacol Exp Ther 1944; 82: 377-90.
3. EU. Annex to Commission Directive 92/69/EEC of 31 July 1992 adapting to technical progress for the seventeenth 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. Off J Eur Commun 1992; L383A: 35.
4. EU. Council Directive of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations. Off J Eur Commun 1998; L18: 14.
5. Phillips L, Steinberg M, Maibach HI, Akers WA. A comparison of rabbit and human skin response to certain irritants. Toxicol Appl Pharmacol 1972; 21: 69-382.
6. Pierard GE, Goffin V, Hermanns-Le T, Arrese JE, Peirard-Franchimont C. Surfactant-induced dermatitis: comparison of corneosurfametry with predictive testing on human and reconstructed skin. J Am Acad Dermatol 1995; 333: 462-9.
7. Nixon GA, Tyson CA, Wertz WC. Interspecies comparisons of skin irritancy. Toxicol Appl Pharmacol 1975; 31: 481-90.
8. Robinson MK, Perkins MA, Basketter DA. Application of a four hour human patch test method for comparative and investigative assessment of skin irritation. Contact Dermatitis 1998; 38:194-202.
9. Basketter DA, Holland G, York M. Corrosive materials. In:Chew AL, Maibach HI, eds. Irritant Dermatitis. Berlin: Springer, 2006: 239-48.
10. Basketter DA, Whittle E, Griffiths HA, York M. The identification and classification of skin irritation hazard by human patch test. Food Chem Toxicol 1994; 32: 769-75.
11. Basketter DA, York M, McFadden JP, Robinson MK. Determination of skin irritation potential in the human 4-h patch test. Contact Dermatitis 2004; 51: 1-4.
12. Hannuksela A, Hannuksela M. Irritant effects of a detergent in wash and chamber tests. Contact Dermatitis 1995; 32: 163.
13. Hall-Manning TJ, Holland GH, Basketter DA, Barratt MD. Skin irritation potential of mixed surfactant systems in a human 4 hour covered patch test. Allergologie 1995; 18: 465.
14. Welss T, Basketter DA, Schroder KR. In vitro skin irritation: facts and future. State of the art review of mechanisms and models. Toxicol In Vitro 2004; 18: 231-43.
15. Botham PA. The validation of in vitro methods for skin irritation. Toxicol Lett 2004; 149: 387-90.
16. Zuang V, Alonso MA, Botham PA, et al. Subchapter 3.2.Skin Irritation. In: Eskes C, Zuang V, eds. Alternative (Non-Animal) Methods for Cosmetics Testing: Current Status and Future Prospects. ATLA 2005; 33-S1: 35-46.
17. Harvell J, Basson MM, Maibach HI. In vitro skin irritation assays:relevance to human skin. J Toxicol Clin Toxicol 1992; 30: 359-69.
18. DeLeo VA, Carver MP, Hong J, et al. Arachidonic acid release: an in vitro alternative for dermal irritancy testing. Food Chem Toxicol 1996; 34: 167-76.
19. Gajjar L, Benford DJ. Irritancy testing in cultured keratinocytes. Mol Toxicol 1987-1988; 1: 513-23.
20. Chamberlain M, Earl L. Use of cell cultures in irritancy testing. In:Rougier A, Goldberg AM, Maibach HI, eds. In Vitro Skin Toxicology. New York: Mary Ann Liebert, 1994: 59-69.
21. Cohen C, Selvi Bignon C, Barbier A. et al. Measurement of proinflammatory mediator production by cultured keratinocytes: a predictive assessment of cutaneous irritancy. In: Rougier A, Goldberg AM, Maibach HI, eds. In Vitro Skin Toxicology. New York: Mary Ann Liebert, 1994; 83-96
22. Roguet R, Cohen C, Rougier A. A reconstituted human epidermis to assess cutaneousirritation, photoirritation and photoprotection in vitro. In: Rougier A, Goldberg A, Maibach H, eds. Alternative methods in toxicology. In vitro skin toxicology-irritation, phototoxicity, sensitization. USA, New York: Mary Ann Liebert, 1994; 10: 141-9.
23. Cotovio J, Grandidier MH, Portes P, Roguet R, Rubinstenn G. The in vitro acute skin irritation of chemicals: optimisation of the EPISKIN prediction model within the framework of the ECVAM validation process. ATLA 2005; 33: 329-49.
24. 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. ATLA 2005; 33: 351-67.
25. Tornier C, Rosdy M, Maibach HI. In vitro skin irritation testing on reconstituted human epidermis: reproducibility for 50 chemicals tested with two protocols. Toxicol in Vitro 2006; 20: 401-16.
26. Botham PA, Chamberlain M, Barratt MD, et al. A prevalidation study on in vitro skin corrosivity testing. the report and recommendations of ECVAM workshop 6. ATLA 1995; 23: 219-55.
27. Barratt MD, Brantom PG, Fentem JH, et al. The ECVAM international validation study on in vitro tests for skin corrosivity1 selection and distribution of the test chemicals. Toxicol In Vitro 1998; 12:471-82.
28. Fentem JH, Archer GEB, Balls M, et al. The ECVAM international validation study on in vitro tests for skin corrosivity. 2. Results and evaluation by the management team. Toxicol In Vitro 1998; 12:483-524.
29. ESAC. Statement on the scientific validity of the rat skin transcutaneous electrical resistance (TER) test (an in vitro test for skin corrosivity). ATLA 1998; 26: 275-7.
30. ESAC. Statement on the scientific validity of the EPISKIN™ test (an in vitro test for skin corrosivity). ATLA 1998; 26: 277-80.
31. ESAC. Statement on the application of the Epiderm™ human skin model for skin corrosivity testing. ATLA 2000; 28: 365-6.
32. Liebsch M, Traue D, Barrabas C, et al. The ECVAM prevalidation study on the use of epiderm for skin corrosivity testing. ATLA 2000; 28: 371-401.
33. Liebsch M, Spielmann H, Pape W, et al. UV-induced effects in alternative (non-animal) methods for cosmetics testing: current status and future prospects. In: Eskes C, Zuang V, eds. ATLA 2010; 33(Suppl 1): 131-46.
34. 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: 547-59.
35. ESAC. Statement on the application of the SkinEthic™ human skin model for skin corrosivity testing. 2006. [Available at http://ecvam. jrc.ec.europa.eu under “Publications, " “ESAC statements”]
36. 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: 925-9.
37. ICCVAM (Interagency coordinating committee on the validation of alternative methods). Validation and Regulatory Acceptance of Toxicological Test Methods. NIH Publication No. 97-3981. NC, USA:National Institute of Environmental Health Sciences, Research Triangle Park, 1997. [Available from: http://iccvam.niehs.nih.gov/ docs/guidelines/validate.pdf]
38. ESAC. ESAC Statement on the scientific validity of an in vitro test method for skin corrosivity testing. 2009. [Available from: http:// ecvam.jrc.ec.europa.eu under “Publications, " “ESAC statements”]
39. EU. Annex I to Commission Directive 2000/33/EC adapting to technical progress for the 27th 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. Off J Eur Commun 2000a; L136: 91-7.
40. EU. Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Off J Eur Union 2008a; L142: 1-739.
41. OECD. OECD Guidelines for the Testing of Chemicals. In vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER). Paris, France: Organisation for Economic Cooperation and Development, 2004; 430: 12.
42. OECD. OECD Guidelines for the Testing of Chemicals. In vitro Skin Corrosion: Human Skin Model Test. Paris, France: Organisation for Economic Cooperation and Development, 2004; 431: 8.
43. OECD. OECD Guidelines for the Testing of Chemicals. In Vitro Membrane Barrier Test Method for Skin Corrosion. Paris, France:Organisation for Economic Cooperation and Development, 2006; 435: 15.
44. United Nations-Economic Commission for Europe (UN/ECE). Globally harmonised system of classification and labelling of chemicals (GHS). Updated Part 3 Health and Environmental Hazards - Serious eye damage/ eye irritation. New York, USA, and Geneva, Switzerland:United Nations, 2009; 3: 133-44. [Available from: http://www.unece. org/trans/danger/publi/ghs/ ghs_rev03/English/03e_part3.pdf]
45. EU. 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. Off J Eur Union 2008b; L353: 1-1355.
46. EU. Commission Directive 2001/59/EC of 6 August 2001 adapting to technical progress for the 28th 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. Off J Eur Commun 2001; L225: 1-333.
47. United Nations (UN). Part 2 Classification. In: Recommendations on the Transport of Dangerous Goods - Model Regulations, 20th revised edn. 2001. [Available from: http://www.unece.org/trans/ danger/publi/unrec/English/Part2.pdf]
48. OECD. OECD Guideline for Testing of Chemicals. Acute Dermal Irritation, Corrosion, revised version, as adopted on 24 April 2002, plus Annex and Supplement. Paris, France: Organisation for Economic Cooperation and Development, 2002; 404: 7.
49. Whittle E, Basketter DA. In vitro skin corrosivity test using human skin. Toxicol In Vitro 1994; 8: 861-3.
50. Mossman T. Rapid colorimetric assay for cellular growth and survival:application to proliferation and cytotoxicity assays. J Immunol methods 1983; 65: 55-63.
51. NIH. Corrositex®: An in Vitro Test Method for Assessing Dermal Corrosivity Potential of Chemicals. NC, USA: Research Triangle Park, NIH Publication 1999; 99-4495, 236. NIEHS.
52. OECD; Harmonised Integrated Classification System for Human Health and Environmental Hazards of Chemical Substances and Mixtures. OECD series on testing and assessment. Organisation for Economic Cooperation and Development. Paris: France, 2001; 249.
53. ESAC. Statement on the application of the CORROSITEX® assay for skin corrosivity testing. ATLA 2001; 29: 96-7.
54. ECHA. Guidance on the application of the CLP criteria. Guidance to regulation EC N. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures. 2009; 528. [Available from: http:// guidance.echa.europa.eu/docs/guidance_document/clp_en.pdf]
55. Botham PA, Earl LK, Fentem JH, et al. Alternative methods for skin irritation testing: the current status. ECVAM skin irritation task force report 1. ATLA 1998; 26: 195-211.
56. Van de Sandt J, Roguet R, Cohen C, et al. The use of human keratinocytes and human skin models for predicting skin irritation. the report and recommendations of ECVAM workshop 38. ATLA 1999; 27: 723-43.
57. Wakuri S, Tanaka N, Ono H. In vitro phototoxicity assay using culture cells. Proceedings of the 8th annual meeting of the JSAAE in Tokyo 1994; abstract p.19.AATE (Alternatives to animal testing and experimentation, 1995; 3: 67.
58. Fentem JH, Briggs D, Chesné C, et al. A prevalidation study on in vitro tests for acute skin irritation: results and evaluation by the management team. Toxicol In Vitro 2001; 15: 57-93.
59. Fentem JH, Botham PA. ECVAM’s activities in validating alternative tests for skin corrosion and irritation. ATLA 2002; 30(Suppl 2):61-7.
60. Zuang V, Balls M, Botham PA, et al. Follow-up to the ECVAM prevalidation study on in vitro tests for acute skin irritation. ECVAM skin irritation task force report 2. ATLA 2002; 30: 109-29.
61. Heylings JR, Diot S, Esdaile DJ, et al. A prevalidation study on the in vitro skin irritation function test(SIFT) for prediction of acute skin irritation in vivo: results and evaluation of ECVAM Phase III. Toxicol In Vitro 2003; 17: 123-38.
62. Portes P, Grandidier MH, Cohen C, Roguet R. Refinement of the EPISKIN™ protocol for the assessment of acute skin irritation of chemicals: follow-up to the ECVAM prevalidation study. Toxicol In Vitro 2002; 16: 765-70.
63. 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: 107-14.
64. Spielmann H, Hoffmann S, Liebsch M, et al. The ECVAM international validation study on in vitro tests for acute skin irritation:report on the validity of the EPISKIN and epiderm assays and on the skin integrity function test. ATLA 2007; 35: 559-601.
65. ESAC. Statement on the validity of in vitro tests for skin irritation. 2007. [Available from: http://ecvam.jrc.ec.europa.eu under “Publications”, “ESAC statements”]
66. ESAC. Statement on the Scientific Validity of In vitro tests for Skin Irritation testing (SkinEthic and modified EpiDerm). 2008. [Available from: http://ecvam.jrc.ec.europa.eu under “Publications”, “ESAC statements”]
67. ESAC. Statement on the Performance under UN GHS of three in vitro assays for Skin Irritation testing and the Adaptation of the Reference chemicals and defined accuracy values of the ECVAM Skin Irritation Performance Standards. 2009. [Available from: http:// ecvam.jrc.ec.europa.eu under “Publications”, “ESAC statements”]
68. EU. Annex III. Method B.46. In vitro Skin Irritation: Reconstructed Human Epidermis Model Test. 24-35. In: Commission Regulation (EC) No 761/2009 of 23 July 2009 amending for the purpose of its adaptation to technical progress, Regulation No. 440/2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Off J Eur Union 2009; L220: 1-94.
69. OECD. OECD Guidelines for the Testing of Chemicals. In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method. Paris, France: Organisation for Economic Cooperation and Development, 2010; 439: 18.
70. ECHA. Guidance on Information Requirements and Chemical Safety Assessment. 2008. [Available from: http://guidance.echa. europa.eu/docs/guidance_document/information_ requirements_ en.htm?time 1232447649]
71. Eskes C, Detappe V, Koeter H, et al. (submitted). Regulatory Assessment of In Vitro Skin Corrosion & Irritation Data within the European Framework: Workshop Recommendations.
72. ECHA. R.7.2. Skin- and eye irritation/corrosion and respiratory irritation. In: Guidance on information requirements and chemical safety assessment. Chapter R.7a: Endpoint Specific Guidance. 2008: 199-255. [Available from: http://guidance.echa.europa.eu/ docs/guidance_document/information_requirements_r7a_en. pdf?vers 20_08_08]
73. Robinson MK, Perkins MA. A strategy for skin irritation testing. Am J Contact Dermatitis 2002; 13: 21-9.
74. Cooper K, Marriott M, Peters L, Basketter D. Stinging and irritating substances: their identification and assessment. In: Lóden M, Maibach HI, eds. Dry Skin and Moisturisers, 2nd edn. Boca Raton: CRC Taylor and Francis, 2005: 501-14.
75. de Brugerolle de Fraissinette A, Picarles V, Chibout S, et al. Predictivity of an in vitro model for acute and chronic skin irritation (skinethic) applied to the testing of topical vehicles. Cell Biol Toxicol 1999; 15: 121-35.
76. Spiekstra SW, Dos Santos GG, Scheper RJ, Gibbs S. Potential method to determine irritant potency in vitro-comparison of two reconstructed epidermal culture models with different barrier competency. Toxicol In vitro 2009; 23: 349-55.
77. Lambert LA, Wamer WG, Kornhauser A. Animal models for phototoxicity testing (reprinted from dermatotoxicology, 1996). Toxicol Methods 1996; 6: 99-114.
78. Maurer T. Phototoxicity testing in vivo and in vitro. Food Chem Toxicol 1987; 25: 407-14.
79. Macfarlane M, Jones P, Goebel C, et al. A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics:skin irritation. Regul Toxicol Pharmacol 2009; 54: 188-96.
80. Spielmann H, Lovell WW, Hoelzle E, et al. In vitro phototoxicity testing. The report and recommendations of ECVAM workshop 2. ATLA 1994; 22: 314-48.
81. OECD. Ad hoc meeting on tests for effects on the skin: phototoxicity. Office. Paris: France, OECD Publications, 1991.
82. OECD. Acute Dermal Phototoxicity Screening Test; Draft Proposal for a New Guideline. Paris, France: OECD Publications Office, 1995.
83. Balls M, Blaauboer B, Brusick D, et al. Report and recommendations of the CAAT ERGATT workshop on the validation of toxicity test procedures. ATLA 1990; 18: 313-37.
84. Spielmann H, Muller L, Averbeck D, et al. The second ECVAM workshop on phototoxicity testing-The report and recommendations of ECVAM workshop 42. ATLA 2000; 28: 777-814.
85. Spielmann H, Balls M, Brand M, et al. EEC COLIPA project on in vitro phototoxicity testing - first results obtained with a BALB/C 3T3 cell phototoxicity assay. Toxicol In Vitro 1994; 8: 793-6.
86. 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.
87. Spielmann H, Balls M, Dupuis J, et al. A study on UV filter chemicals from annex-vii of european-union directive 76/768/EEC, in the in vitro 3T3 NRU phototoxicity test. ATLA 1998; 26: 679-708.
88. Clothier R, Willshaw A, Cox H, et al. The use of human keratinocytes in the EU/COLIPA international in vitro phototoxicity test validation study and the ECVAM/COLIPA study on UV filter chemicals. ATLA 1999; 27: 247-59.
89. Cohen C, Dossou KG, Rougier A, Roguet R. Episkin: an in vitro model for the evaluation of phototoxicity and sunscreen photoprotective properties. Toxicol In Vitro 1994; 8: 669-71.
90. EU. ANNEX II: B.41. In vitro 3T3 NRU Phototoxicity Test. Commission Directive 2000/33/EC of 25 April 2000, adapting to technical progress for the 27th 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. Off J Eur Commun 2000b; L136: 90-107.
91. Oliver GJA, Pemberton MA, Rhodes C. OECD Test Guideline 432In Vitro 3T3 NRU Phototoxicity Test. Paris: OECD, 1986.
92. An in vitro skin corrosivity test - modifications and validation. Food Chem Toxicol 2004; 24: 507-12.
93. Liebsch M, Botham P, Fentem J, et al. The ECVAM validation study of three in vitro methods for acute skin irritation-Interim report of the validation management team. Naunyn-Schmiedebergs Arch Pharmacol 2005; 371(Suppl 1): 518.
94. Corsini E, Sangha N, Feldman SR. Epidermal stratification reduces the effects of UVB (but not UVA) on keratinocyte cytokine production and cytotoxicity. Photodermatol Photoimmunol Photomed 1997; 13: 147.
95. Jones PA, Lovell WW, King AV, Earl LK. In vitro testing for phototoxic potential using the epidermtm 3-D reconstructed human skin model. Toxicol Methods 2001; 11: 1-19.
96. Jowsey I. Proactive surveillance of contact allergies: an important component of the risk management strategy for skin sensitizers. Contact Dermatitis 2007; 56: 305-10.
97. Edwards SM, Donnelly TA, Sayre RM, et al. Quantitative in vitro assessment of phototoxicity using a human skin model: skin2. Photodermatol Photoimmunol Photomed 1994; 10: 111-17.
98. Liebsch M, Döring B, Donnelly TA, et al. Application of the human dermal model skin2zk 1350 to phototoxicity and skin corrosivity testing. Toxicol In Vitro 1995; 9: 557-62.
99. Api AM. In vitro assessment of phototoxicity. In Vitro Toxicol 1997; 10: 339-50.
100. 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: 27-36.
101. Liebsch M, Barrabas C, Traue D, Spielmann H. Entwicklungeinesneuen in vitro Tests auf dermale Phototoxizitätmiteinem modell menschlicher epidermis, epiderm™. Alternativenzu Tierexperimenten (ALTEX) 1997; 14: 165-74.
102. Bernard FX, Barrault C, Deguery A, de Wever B, Rosdy M. Development of a highly sensitive phototoxicity assay using the reconstructed human epidermis skinethic. In: Clark D, Lisansky S, Macmillan R, eds. Alternatives to animal testing II: Proceedings of the second international scientific conference organised by the European cosmetic industry. Brussels, Belgium. Newbury, UK: CPL Press, 1999: 167-74.
103. Jones P, King A, Lovell W, Earl L. Phototoxicity testing using 3-D reconstructed human skin models. In: Clark D, Lisansky S, Macmillan R, eds. Alternatives to animal testing II: Proceedings of the second international scientific conference organised by the European cosmetic industry; Brussels: Newbury: Belgium: UK: CPL, Press, 1999: 138-41.
104. Medina J, Elsaesser C, Picarles V, et al. Assessment of the phototoxic potential of compounds and finished topical products using a human reconstructed epidermis. In vitr Mol Toxicol 2001; 14: 157-78.
105. Liebsch M, Traue D, Barrabas C, et al. Prevalidation of the epiderm phototoxicity. test. In: Clark D, Lisansky S, Macmillan R, eds. Alternatives to Animal Testing II: Proceedings of the second international scientific conference organised by the European cosmetic industry; Brussels: Belgium: UK: Newbury: CPL Press, 1999: 160-6.
106. Stephens TJ, Bergstresser PR. Fundamental concepts in photoimmunology and photoallergy. J Toxicol Cut Ocular Toxicol 1985; 4:193-218.
107. Barratt MD, Brown KR. Photochemical binding of photoallergens to human serum albumin: a simple in vitro method for screening potential photoallergens. Toxicol Lett 1985; 24: 1-6.
108. Pendlington RU, Barratt MD. Molecular basis of photocontact allergy. International J Cosmet Sci 1990; 12: 91-103.
109. Lovell WW. A scheme for in vitro screening of substances for photoallergenic potential. Toxicol In Vitro 1993; 7: 95-102.
110. Lovell WW, Jones PA. An evaluation of mechanistic in vitro tests for the discrimination of photoallergic and photoirritant potential. ATLA 2000; 28: 707-24.
111. Lynch AM, Wilcox P. Review of the performance of the 3T3 NRU in vitro phototoxicity assay in the pharmaceutical industry. Exp Toxicol Pathol 2011; 63: 209-14.
112. OECD. Environmental Health and Safety Publications, Series on Testing and Assessment No. 7" Guidance Document On Direct Phototransformation Of Chemicals In Water. Paris: Environment Directorate, OECD, 1997.
113. Benavides T, Martinez V, Mitjans M, et al. Assessment of the potential irritation and photoirritation of novel amino acid-based surfactants by in vitro methods as alternative to the animal tests. Toxicology 2004; 201: 87-93.
114. Nam C, An SS, Lee E, et al. An in vitro phototoxicity assay battery (photohaemolysis and 3T3 NRU PT test) to assess phototoxic potential of fragrances. ATLA 2004; 32: 693-7.
115. Dijoux N, Guingand Y, Bourgeois C, et al. Assessment of the phototoxic hazard of some essential oils using modified 3T3 neutral red uptake assay. Toxicol In Vitro 2006; 20: 480-9.
116. Ponec M, Wauben-Penris PJJ, Burger A, Kempenaar J, Bodde HE. Nitroglycerin and sucrose permeability as quality markers for reconstructed human epidermis. Skin Pharmacol 1990; 3: 126-35.
117. Regnier M, Caron D, Reichert U, Schaefer H. Reconstructed human epidermis: A model to study in vitro the barrier function of the skin. Skin Pharmacol 1992; 5: 49-56.
118. Michel M, Germain L, Belanger PM, Auger FA. Functional evaluation of anchored skin equivalent cultured in vitro: Percutaneous absorption studies and lipid analysis. Pharmacol Res 1995; 12:455-8.
119. Doucet O, Garcia N, astrow L. Skin culture model: a possible alternative to the use of excised human skin for assessing in vitro percutaneous absorption. Toxicol In Vitro 1998; 12: 273-83.
120. Doucet O, Garcia O, Zastrow L. Potential of skin culture models for assessing in vitro percutaneous absorption. In: Clark D, Lisansky S, Macmillan R, eds. Alternatives to Animal Testing II. Proceedings of the second international scientific conference organised by the European cosmetics industry. UK: Newbury: CPL Press, 1999: 246-9.
121. Jones PA, King AV, Earl LK, Lawrence RS. An assessment of the phototoxic hazard of a personal product ingredient using in vitro assays. Toxicol In Vitro 2003; 17: 471-80.
122. Ceridono M, Siviglia E, Bauer D, et al. (submitted). The 3T3 Neutral Red Uptake Phototoxicity Test: Practical Experience and Implications for Phototoxicity Testing-The Report of an ECVAM-EFPIA workshop.
123. Henry B, Foti C, Alsante K. Can light absorption and photostability data be used to assess the photosafety risks in patients for a new drug molecule? J Photochem Photobiol B 2009; 96: 57-62.
124. Onoue S, Tsuda Y. Analytical studies on the prediction of photosensitive/ phototoxic potential of pharmaceutical substances. Pharm Res 2006; 23: 156-64.
125. Onoue S, Kawamura K, Igarashi N, et al. Reactive oxygen species assay-based assessment of drug-induced phototoxicity: classification criteria and application to drug candidates. J Pharm Biomed Anal 2008; 47: 967-72.
126. Pape WJW, Maurer T, Pfannenbecker U, Steiling W. The red blood cell phototoxicity test (photohaemolysis and haemoglobin oxidation):EU/COLIPA validation programme on phototoxicity (Phase II). ATLA 2001; 29: 145-62