Alternative methods for eye and skin irritation tests: An overview

Journal of Pharmaceutical Sciences

Volumn 97, Issue 1, 2008, Pages 46-59

  Vinardell, M P ^a   Mitjans, M ^a  

^a UNIVERSITY OF BARCELONA   (Spain)

Author keywords

Cell culture; in vitro models; in vitro in vivo correlations (IVIVC); Skin; Toxicity; Toxicology

Indexed keywords

COSMETIC; HEMOGLOBIN;

CELL CULTURE; CHICK; CHORIOALLANTOIS; CORNEA OPACITY; CORNEA PERMEABILITY; COST EFFECTIVENESS ANALYSIS; COW; DENATURATION; DRUG SAFETY; ELECTRIC RESISTANCE; ENUCLEATION; EPIDERMIS CELL; ERYTHROCYTE; EYE IRRITATION; GUINEA PIG; HUMAN; IN VITRO STUDY; KERATINOCYTE; LABORATORY TEST; MOUSE; NONHUMAN; PHOTOTOXICITY; RABBIT; RAT; REVIEW; RISK ASSESSMENT; SCORING SYSTEM; SKIN IRRITATION; TOXICITY TESTING;

EID: 38349175746     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21088     Document Type: Article

References (103)

1. Green K. 1992. A brief history of ocular toxicology. Lens Eye Toxic Res 9:153-159.
2. Draize JH, Woodward G, Calvery HO. 1944. Method for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J Pharmacol Exp Ther 82:377-390.
3. Fitzhugh OG, Woodard G, Braun HA. 1946. The toxicities of compounds related to 2,3-dimercaptopropanol (BAL) with a note on their relative therapeutic efficiency. J Pharmacol Exp Ther 87:23-27.
4. Kay JH, Calandra JC. 1962. Interpretation of eye irritation tests. J Soc Cosmet Chem 13:281-289.
5. Draize JH, Kelly EA. 1952. Toxicity to the eye mucosa of certain cosmetic preparation containing surface-active agents. Proc Sci Sec Toilet Good Assoc 17:1-4.
6. York M, Steiling W. 1998. A critical review of the assessment of eye irritation potential using the Draize rabbit eye test. J Appl Toxicol 18:233-240.
7. Griffith JF, Nixon GA, Bruce RD, Reeer PJ, Bannan EA. 1980. Dose-response studies with chemical irritants in the albino rabbis eye as a basis for selecting optimum testing conditions for predicting hazard to the humane eye. Toxicol Appl Pharmacol 55:501-513.
8. Freeberg FE, Nixon GA, Reer PJ, Weaver JE, Bruce RD, Griffith JF, Sanders LW III. 1986. Human and rabbit eye responses to chemical insult. Fundam Appl Toxicol 7:626-634.
9. Bosshard E. 1985. Review on skim and mucous-membrane irritation tests and their application. Food Chem Toxicol 23:149-153.
10. Cormier EM, Parker RD, Henson C, Cruse LW, Merritt AK, Bruce RD, Osborne R. 1996. Determination of the intra- and interlaboratory reproducibility of the low volume eye test and its statistical relationship to the Draize eye test. Regul Toxicol Pharmacol 23:156-161.
11. Gettings SD, Lordo RA, Feder PL, Hintze KL. 1998. A comparison of low volume, Draize and in vitro eye irritation test data. III. Surfactant-based formulations. Food Chem Toxicol 36:209-231.
12. Freeberg FE, Griffith JF, Bruce ED, Bay PHS. 1984. Correlation of animal test methods with human experiences for house-hold products. J Toxicol Cut Ocular Toxicol 3:53-64.
13. Calvin G. 1992. New approaches to the assessment of eye and skin irritation. Toxicol Lett 64:157-164.
14. Sekizawa J, Yasuhara K, Suyama Y, Yamanaka S, Tobe M, Nishimura M. 1994. A simple method for screening assessment of skin and eye irritation. J Toxicol Sci 19:25-35.
15. Bruner LH, Carr GJ, Curren RD, Chamberlain M. 1998. Validation of alternative methods for toxicity testing. Environ Health Perspect 106:477-484.
16. Balls M, Blaauboer BJ, Fentem JH, Bruner L, Combes RD, Ekwall B, Fielder RJ, Guillouzo A, Lewis RW, Lovell DP, Reinhardt CA, Repetto G, Sladowski D, Spielman H, Zucco F. 1995. Practical aspects of the validation of toxicity test procedures. The reports and recommendations of ECVVAM. ATLA 23:129-147.
17. Koeter HB, Visser R. 2000. Work in OECD on chemical safety: Approaches for human risk assessment. Ind Health 38:109-119.
18. Worth AP, Balls M. 2002. Alternative (non animal) methods for chemicals testing: Current status and future prospects. A report prepared by ECVAM and ECVAM working group on chemicals. ATLA 30:1-15.
19. Balls M, Botham PA, Bruner LH, Spielmann H. 1995. The EC/HO international validation study on alternatives to the Draize eye irritation test. Toxicol In Vitro 9:871-929.
20. Spielmann H, Liebsch M, Kaweilt S, Moldenhauer F, Wirnsberger T, Holzhutter HG, Schneider B, Glaser S, Gerner I, Pape WJW, Kreiling R, Krauser K, Miltenburger HG, Steiling W, Luepke NP, Müller N, Kreuzer H, Mürmann P, Spengler J, Bertram-Neis E, Siegemund B, Wiebel FJ. 1996. Results of a validation study in Germany on two in vitro alternatives to the Draize eye irritation test, the HET-CAM test and the 3T·NRU cytotoxicity test. Altern Lab Anim 24:741-858.
21. Brantom PG, Bruner LH, Chamberlain M, De Silva O, Dupuis J, Earl LK, et al. 1997. A summary report of the COLIPA international validations study on alternatives to the Draize rabbit eye irritation test. Toxicol In Vitro 11:141-179.
22. Ohno Y, Kaneto T, Inoue T, Morikawa Y, Yoshida T, Fujii A, et al. 1999. Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. Overview of the validation study and Draize scores for the evaluation of the tests. Toxicology 13:73-98.
23. Moldehauer F. 2003. Using in vitro prediction models instead of the rabbit eye irritation test to classify and label new chemicals: A post hoc data analysis of the international EC/HO validation study. Altern Lab Anim 31:31-46.
24. Taniguchi Y, Suzuki K, Nakajima K, Najakima M, Miwa Y, Yamada Y, Satoh M, Takeyoshi M, Akie Y, Moriyasu M, et al. 1994. Inter-laboratory validation study of the Skin2 Dermal Model ZK1100 and MTT cytotoxicity assay kits. J Toxicol Sci 19:37-44.
25. Fentem JH, Botham PA. 2002. ECVAM's activities in validating alternative tests for skin corrosion and irritation. Altern Lab Anim 30:61-67.
26. Wilcox DK, Bruner LH. 1990. Applications of the neutral red cytotoxicity assay to in vitro toxicology. Altern Lab Anim 18:129-144.
27. Pape WJ, Pfannenbeckker U, Hoppe U. 1987. Validation of the red blood cell test system as in vitro assay for the rapid screening of irritation potential of surfactants. Mol Toxicol 1:525-536.
28. Pape WJ, Hoppe U. 1990. Standardization of an in vitro red blood cell test for evaluating the acute cytotoxic potential of tensides. Arzneimittelforschung 40:498-502.
29. Pape WJ, Hoppe U. 1991. In vitro methods for the assessment of primary local effects of topically applied preparations. Skin Pharmacol 4:205-212.
30. Pape WJW, Pfannenbeckker U, Argembeaux H, Bracher M, Esdaile DJ, Hagino S, Kasai Y, Lewis RW. 1999. 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 acuete eye irritation potentials. Present status. Toxicol In Vitro 13:343-354.
31. Okamoto Y, Ohkoshi K, Itagaki H, Tsuda T, Kakishima H, Ogawa T, et al. 1999. Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (3) Evaluation of the haemolysis test. Toxicol In Vitro 13:115-124.
32. Mitjans M, Martínez V, Clapés P, Pérez L, Infante MR, Vinardell MP. 2003. Low potential ocular irritation of arginine-based gemini surfactants and their mixtures with nonionic and zwitterionic surfactants. Pharm Res 20:1697-1701.
33. Miyazawa K, Ogawa M, Mitsui T. 1984. The physicochemical properties and protein denaturation potential of surfactant mixtures. Int J Cosmet Sci 6:33-46.
34. Hayashi T, Itagaki H, Fukuda T, Tamura U, Kato S. 1993. Quantitative evaluation for the prediction of eye irritation using haemoglobin. Alt Anim Test Exper AATEX 2:25-31.
35. Vinardell MP, Gonzalez S, Infante MR. 1999. Adaptation of hemoglobin denatruation for assessment of ocular irritation of surfactants and manufactured products. J Toxicol-Cut Ocular Toxicol 18:375-384.
36. Hatao M, Murakami N, Sakamoto K, Ohnuma M, Matsushige C, Kakishima H, et al. 1999. Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (4) Haemoglobin denaturation test. Toxicol In Vitro 13:125-137.
37. Hayashi T, Itagaki H, Fukuda T, Tamura U, Kato S. 1994. Multivariate factorial analysis of data obtained for predicting eye irritancy. Toxicol In Vitro 8:215-220.
38. Luepke NP. 1985. Hen's egg chorioallantoic membrane test for irritation potential. Food Chem Toxicol 23:287-291.
39. Luepke NP, Kemper FH. 1986. The HET-Cam test: An alternative to the Draize eye test. Food Chem Toxicol 24:495-496.
40. Gilleron L, Coecke S, Sysmans M, Hansen E, Oproy S, van Marzin D, et al. 1996. Evaluation of a modified HET-CAM assay as a screening test for eye irritancy. Toxicol In Vitro 10:431-446.
41. Macián M, Seguer J, Infante MR, Selve C, Vinardell MP. 1996. Preliminary studies of the toxic effects of non-ionic surfactants derived from lysine. Toxicology 106:1-9.
42. Debbasch C, Ebenhahn C, Dami N, Pericoi M, Van den Berghe C, Cottin M, Nohynek GJ. 2005. Eye irritation of low-irritant cosmetic formulations: Correlation of in vitro results with clinical data and product composition. Food Chem Toxicol 43:155-165.
43. Budai P, Varnagy L, Fejes S, Somlyay IM, Linczmayer K, Pongracz A. 2004. Irritative effects of some pesticides and a technical component on tissue structure of the chorioallantoic membrane. Commun Agric Appl Biol Sci 69:807-809.
44. Vinardell MP, Rimbau V, Mitjans M. 2004. Potential eye irritation of some "biodegradable" liquid scintillation cocktails determined in vitro. Food Chem Toxicol 42:1287-1290.
45. Vinardell MP, Mitjans M. 2006. The chorioallantoic membrane test as a model to predict the potential human eye irritation induced by commonly used laboratory solvents. Toxicol In Vitro 20:1066-1070.
46. Ai R, Dahl JE, Morisbak E, Polyzois GL. 2005. Irritation and cytotoxic potential of denture adhesives. Gerondol 22:177-183.
47. Gettings SD, Lordo RA, Hintze KL, Bagley DM, Casterton PL, Chudkowski M, et al. 1996. 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 34:79-117.
48. Djabari Z, Bauza E, Dal Farra C, Domloge N. 2002. The HET-CAM test combined with histological studies for better evaluation of active ingredient innocuity. Int J Tissue React 24:117-121.
49. Hagino S, Itagaki H, Kato S, Kobayashi T, Tanaka M. 1991. Quantitative evaluation to predict the eye irritancy of chemicals: Modification of chorioallantoic membrane test by using trypan blue. Toxicol In Vitro 5:301-304.
50. Hagino S, Itagaki H, Kato S, Kobayashi T. 1993. Further evaluation of the quantitative chorioallantoic membrane test using trypan blue stain to predict the eye irritancy of chemicals. Toxicol In Vitro 7:35-39.
51. Ohno Y, Kaneko T, Inoue T, Morikawa T, Yoshida A, Fujii A, et al. 1997. Interlaboratory validation of alternative methods to the eye irritation test for the safety evaluation of cosmetic ingredients: An overview of the plan and the results. In: van Zutphen LFM, Balls M, editors. Animal alternatives, welfare and ethics. Amsterdam: Elsevier. pp 1155-1158.
52. Vinardell MP, García L. 2000. The quantitive chlorioallantoic membrane test using trypan blue stain to predict the eye irritancy of liquid scintillation cocktails. Toxicol In Vitro 14:551-555.
53. Gautheron P, Dukic M, Alix D, Sina JF. 1992. Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam Appl Toxicol 18:442-149.
54. Gautheron P, Giroux J, Cottin M, Audegond L, Morula A, Mayordomo-Blanco L, Tortajada A, Haynes G, Vericat JA. 1994. Interlaboratory assessment of the bovine corneal opacity and permeability (BCOP) assay. Toxicol In vitro 8:381-392.
55. Prinsen MK, Koeter HB. 1993. Justification of the enucleated eye test with eyes of slaughterhouse animals as an alternative to the Draize eye irritation test with rabbits. Food Chem Toxicol 31:69-76.
56. Gamberlain M, Gad SC, Gautheron P, Prinsen MK. 1997. IRAG working group 1. Organotypic models for the assessment/prediction of ocular irritation. Interagency Regulatory Alternatives Group. Food Chem Toxicol 35:23-37.
57. Yang W, Acosta D. 1994. Cytotoxicity potential of surfactant mixtures evaluated by primary cultures of rabbit corneal epithelial cells. Toxicol Lett 70:309-318.
58. Mertens S, Bednarz J, Engelmann K. 2002. Evidence of toxic side effects of perfluorohexyloctane after vitreoretinal surgery as well as in previously established in vitro models with ocular cell types. Graefes Arch Clin Exp Ophthalmol 240:989-995.
59. Parnigotto PP, Bassani V, Montesi F, Conconi MT. 1998. Bovine corneal stroma and epithelium reconstructed in vitro: Characterisation and response to surfactants. Eye 12:304-310.
60. Cottin M, Zanvit A. 1997. Fluorescein leakage test: A useful tool in ocular safety assessment. Toxicol In Vitro 11:399-405.
61. Shaw AJ, Clothier RH, Balls M. 1990. Loss of trans-epithelial impermeability of a confluent monolayer of Madin-Darby Canine Kidney (MDCK) cells as a determinant of ocular irritancy potential. Altern Lab Anim 18:145-151.
62. Clothier RH, Starzec G, Stipho S, Kwong YC. 1999. Assessment of initial damage and recovery following exposure of MDCK cells to an irritant. Toxicol In Vitro 13:713-717.
63. Bruner LH, Parker RD. 1990. Evaluation of six in vitro alternatives for ocular irritancy testing. Toxicologist 10:258.
64. Harbell JW, Osborne R, Carr GJ, Peterson A. 1999. Assessment of the cytosensor microphysiometer assay in the CCOLIPA in vitro eye irritation validation study. Toxicol In Vitro 13:313-323.
65. Gerner I, Liebsch M, Spielmann H. 2005. Assessment of the eye irritating properties of chemicals by applying alternatives to the Draize rabbit eye test: The use of QSARs and in vitro tests for the classification of eye irritation. Altern Lab Anim 33:215-237.
66. Kruszewski FH, Hearn LH, Smith KT, Teal JJ, Gordon VC, Dickens MS. 1992. Application of the EYTEX™ system to the evaluation of cosmetic products and their ingredients. Altern Lab Anim 20:146-163.
67. Régnier JF, Imbert C, Boutonnet JC. 1994. Evaluation of the EYTEX® system as a screening method for the ocular irritancy of chemical products. Altern Lab Anim 22:32-51.
68. Blazka M, Harbell JW, Klausener M, Merrill JC, Kubilus J, Kloss C, Bagley DM. 2003. Evaluating the ocular irritation potential of 54 test articles using the EpiOcular human tissue construct model (OCL-200). Toxicologist 48:336.
69. Jones PA, Budnsky E, Cooper KJ, Decker D, Griffiths HA, Fentem JA, 2001. Comparative evaluation of five in vitro tests for assessing the eye irritation potential of hair-care products. Altern Lab Anim 29:669-692.
70. Robinson MK, Osborne R, Perkins MA. 2000. Iin vitro and human testing strategies for skin irritation. Ann NY Acad Sci 919:192-204.
71. Osborne R, Perkins MA. 1991. In vitro skin irritation. Testing with human skin cultures. Toxicol In Vitro 5:563-567.
72. Sanchez L, Mitjans M, Martínez MR, Vinardell MP. 2006. Potential irritation of lysine derivative surfactants by hemolysis and HaCaT cell viability. Toxicol Lett 161:53-60.
73. Gueniche A, Ponec M. 1993. Use of human skin cell cultures for the estimation of potential skin irritants. Toxicol In Vitro 7:15-24.
74. Corsini E, Bruccoletri A, Marinovich M, Galli CL. 1996. Endogenous interleukin-1 alpha associated with skin irritation induced by tributylin. Toxicol Appl Pharmacol 138:268-274.
75. Martínez V, Corsini E, Mitjans M, Pinazo A, Vinardell MP. 2006. Evaluation of eye and skin irritation of arginine-derivative surfactants using different in vitro endpoints as alternatives to the in vivo assays. Toxicol Lett 164:259-267.
76. Roguet R. 1999. Use of skin cell cultures for in vitro assessment of corrosion and cutaneous irritancy. Cell Biol Toxicol 15:63-75.
77. Hockley K, Baxter D. 1986. Use of the 3T3 cell-neutral red uptake assay for irritants as an alternative to the rabbit (Draize) test. Food Chem Toxicol 24:473-475.
78. Jirova D, Kejlova K, Brabec M, Bendova H, Kolarova H. 2003. The benefits of the 3T3 NRU test in the safety assessment of cosmetics: Long-term experience from pre-marketing testing in the Czech Republic. Toxicol In Vitro 17:791-796.
79. Benavides T, Martínez V, Mitjans M, Infante MR, Moran C, Clapes P, Clothier R, Vinardell MP. 2004. Assessment of the potential irritation and photoirritation of novel amino acid-based surfactants by in vitro methods as alternative to the animal tests. Toxicology 201:87-93.
80. Nagasawa M, Hayashi H, Nakayoshi T. 2002. In vitro evaluation of skin sensitivity of povidone-iodine and other antiseptics using a three-dimensional human skin model. Dermatology 204:109-113.
81. Sandra C, Balls M, Bowe G, Davis J, Gstrauthaler G, Hartung T, et al. 2005. Guidance on good cell culture practice. A report of the second ECVAM task force on good cell culture practice. Altern Lab Anim 33:261-287.
82. Bason MM, Harbell J, Realica B, Gordon V, Maibach HI. 1992. Comparison of in vitro and human in vivo dermal irritancy data for four primary irritants. Toxicol In Vitro 6:383-387.
83. Netzlaff F, Lehr CM, Wertz PW, Schaefer UF. 2005. SkinEthic and EpiDerm: An evaluation of morphology and their suitability for testing phototoxicity, irritancy, corrosivity, and substance transport. Eur J Pharm Biopharm 60:167-178.
84. Stobbe JL, Drake KD, Maier KJ. 2003. Comparison of in vivo (Draize method) and in vitro (Corrositex assay) dermal corrosion values for selected industrial chemicals. Int J Toxicol 22:99-107.
85. Kaufmann T, Remmele M, Holzhutter HG. 2000. The ECVAM prevalidation study on the use of EpiDermTM for skin corrosivity testing. Altern Lab Anim 28:371-101.
86. Faller C, Bracher M. 2002. Reconstructed skin kits: Reproducibility of cutaneous irritancy testing. Skin Pharmacol Appl Skin Physiol 15:74-91.
87. Kandarova H, Liebch M, Genschow E, Gerner I, Traue D, Slawik B, Spielmann H. 2004: Optimisation of the EpiDerm test protocol for the upcoming ECVAM validation study on in vitro skin irritation tests. ALTEX 21:107-114.
88. Kandarova H, Liebch M, Spielmann H, Genschow E, Schmidt E, Traue D, et al. 2006. 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 20:547-559.
89. Portes P, Grandidier MH, Cohen C, Roguet R. 2002. Refinement of the Episkin protocol for the assessment of acute skin irritation of chemicals: Follow-up to the ECVAM prevalidation study. Toxicol In Vitro 16:765-770.
90. Cotovio J, Grandidier MH, Portes P, Roguet R, Rubinstenn G. 2005. The in vitro skin irritation of chemicals: Optimisation of the EPISKIN prediction model within the framework of the ECVAM validation process. Altern Lab Anim 33:329-349.
91. Hoffmann S, Hartung T. 2006. Designing validation studies more efficiently according to the modular approach: Retrospective analysis of the EPISKIN test for skin corrosion. Altern Lab Anim 34:177-191.
92. Demetrulias J, Donnelly T, Morhenn V, Jessee B, Hainsworth S, Casterton P, et al. 1998. Skin2 - an in vitro human skin model: The correlation between in vivo and in vitro testing of surfactants. Exp Dermatol 7:18-26.
93. Oliver GJA, Pemberton MA, Rhodes C. 1986. An in vitro skin corrosivity test - modifications and validation. Food Chem Toxicol 24:507-512.
94. Lewis RW, Basketter DA. 1995. Transcutaneous electrical resistance: Application in predicting skin corrosives. Curr Probl Dermatol 23:243-255.
95. Pape WJW, Maurer T, Pfannenbecker U, Steiling W. 2001. The red blood cell phototoxicity test (photohaemolysis and haemoglobin oxidation): EU/COLIPA validation programme on phototoxicity (phase II). Altern Lab Anim 29:145-162.
96. Spielmann H, Liebsch M, Doring B, Moldenhauer F. 1994. First results of an EC/COLIPA validation project of in vitro phototoxicity testing methods. ALTEX 11:22-31.
97. Peters B, Holzhutter HG. 2002. In vitro phototoxicity testing: Development and validation of a new concentration response analysis software and biostatistical analyses related to the use of various prediction models. ATLA Altern Lab Anim 30:415-432.
98. Benavides T, Martínez V, Mitjans M, Infante MR, Moran C, Clapes P, Clothier R, Vinardell MP. 2004. Assessment of primary eye and skin irritants by in vitro cytotoxicity and phototoxicity models: An in vitro approach of new arginine-based surfactant-induced irritation. Toxicology 197:229-237.
99. Spielmann H, Balls M, Dupuis J, Pape WJW, Pechovitch G, De Silva O, et al. 1998. The international EU/COLIPA in vitro phototoxicity validation study: Results of phase II (blind trial), part I: The 4T3 NRU phototoxicity tests. Toxicol In Vitro 12:305-327.
100. Duffy PA, Bennett A, Roberts M, Flint OP. 1987. Prediction of phototoxic potential using human A431 cells and mouse 3T3 cells. Mol Toxicol 1:579-587.
101. Duffy PA. 1995. Cell culture phototoxicity test. Methods Mol Biol 43:219-226.
102. Clothier RH, Willshaw A, Cox H, Garle M, Bowler H, Combes R. 1999. 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. Altern Lab Anim 27:247-259.
103. Augustin C, Collombel C, Damour O. 1997. Use of dermal equivalent and skin equivalent models for identifying phototoxic compounds in vitro. Photodermatol Photoimmunol Photomed 13:27-36.