In vitro methods for the prediction of ocular and dermal toxicity

Handbook of Toxicology, Second Edition

Volumn , Issue , 2001, Pages 826-857

  Harbell, John W ^a   Curren, Rodger D ^a  

^a Institute for In Vitro Sciences Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84941257177     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (69)

1. Curren, R. D., Southee, J. A., Spielmann, H., Liebsch, M., Fentem, J. H., and Balls, M., The role of prevalidation in the development, validation, and acceptance of alternative methods, ATLA, 23, 211-217, 1995.
2. Bruner, L. H., Carr, G. J., Chamberlain, M., and Curren, R. D., Validation of alternative methods for toxicity testing, Toxicol. In Vitro, 10, 479-501, 1996.
3. Bruner, L. H., Carr, G., Chamberlain, M., and Curren, R., No prediction model, no validation study, ATLA, 24, 139-142, 1996.
4. Cooper-Hannan, R., Harbell, J. W., Coecke, S., Balls, M., Bowe, G., Cervinka, M., Clothier, R., Hermann, F., Klahm, L. K., de Lange, J., Liebsch, M., and Vanparys, P., The principles of good laboratory practice: application to in vitro toxicology studies, ATLA, 27(4), 539-577, 1999.
5. Anonymous, ECVAM News and Views, ATLA, 22, 7-11, 1994.
6. Anonymous, Validation and Regulatory Acceptance of Toxicological Test Methods, National Institute of Health Publication 97-3981, Interagency Coordinating Committee on the Validation of Alternative Methods, National Institute of Environmental Health Sciences, Research Triangle Park, NC, 1997.
7. Ahmad, A. E., Aronson J., and Jacobs, S., Induction of oxidative stress and TNF-alpha secretion by dichloroacetonitrile, a water disinfectant by-product, as possible mediators of apoptosis or necrosis in a murine macrophase cell line (RAW), Toxicol. In Vitro, 14(3), 199-210, 2000.
8. Nieminen, A. L., Gores, G. J., Bond, J. M., Imberti, R., Herman, B., and Lemasters, J. J., A novel cytotoxicity screening assay using a multiwell fluorescence scanner, Toxicol. Appl. Pharmacol., 115(2), 145-155, 1992.
9. Rhoads, L. S., Cook, J. R., Patrone L. M., and van Buskirk R. G., A human epidermal model can be assayed employing a multiple fluorescent endpoint assay and the Cytofluor 2300, J. Toxicol. Cutaneous Ocular Toxicol., 12(2), 87-108, 1993.
10. Magoffin, D. A., Kushell, D. L., and Schlesinger, R. J., The chromium-51 release cytotoxicity test: comparison to the agar overlay and cell-growth inhibition tests, in Cell-Culture Test Methods, ASTM STP 810, Brown, S. A., Ed., American Society for Testing and Materials, Philadelphia, 1983, 94-101.
11. Bockman, C. S., Griffith, M., and Watsky, M. A., Properties of whole-cell ionic currents in cultured human corneal epithelial cells, Invest. Ophthalmol. Vision Sci., 39(7), 1143-1151, 1998.
12. Buckman, S. Y., Gresham, A., Hale, P., Hruza, G., Anast, J., Masferrer, J., and Pentland, A. P., COX- 2 expression is induced by UVB exposure in human skin: implications for the development of skin cancer, Carcinogenesis, 19(5), 723-729, 1998.
13. McConnell, H. M., Owicki, J. C., Parce, J. W., Miller, D. L., Baxter, G. T., Wada, H. G., and Pitchford, S., The Cytosensor microphysiometer: biological applications of silicon technology, Science, 257, 1906-1912, 1992.
14. Harbell, J. W., Osborne, R., Carr, G. J., and Peterson, A., Assessment of the Cytosensor microphysiometer in the COLIPA in vitro eye irritation validation study, Toxicol. In Vitro, 13, 313-323, 1999.
15. Masters, B. A., Palmoski, M. J., Flint, O. P., Gregg, R. E., Wang-Iverson, D., and Durham, S. K., In vitro myotoxicity of the 3-hydroxy-3-methylgluaryl coenzyme A reductase inhibitors, Parvastatin, Lovastatin, and Simvastatin, using neonatal rat skeletal myocytes, Toxicol. Appl. Pharmacol., 131, 163-174, 1995.
16. Mosmann, T., Rapid colorimetric assay for cellular growth and survival: application to proliferation and cytotoxicity assays, J. Immunol. Methods, 65, 55-63, 1983.
17. Weislow, O. S., Kiser, R., Fine, D. L., Bader, J., Shoemaker, R. H., and Boyd, M. R., New solubleformazan assay for HIV-1 cytopathic effects: application to high-flux screening of synthetic and natural products for AIDS-antiviral activity, J. Natl. Cancer Inst., 81(8), 577-586, 1989.
18. Filman, D. J., Brawn R. J., and Dandliker, W. B., Intracellular supravital stain delocalization as an assay for antibody-dependent complement-mediated cell damage, J. Immunol. Methods, 6(3), 189-207, 1975.
19. Barstad, R., Cortesi, J., and Janus, J., Use of Clonetics’ neutral red bioassay to optimize components of serum-free medium for normal human anchorage-dependent cells, In Vitro Cell. Dev. Biol., 27(3), 160, 1991.
20. Jiang, T., Grant, R. L., and Acosta, D., A digitized fluorescence imaging study of intracellular free calcium, mitochondrial integrity and cytotoxicity in rat renal cells exposed to ionomycin, a calcium ionophore, Toxicology, 85(1), 41-65, 1993.
21. North-Root, H., Yackovich, F., Demetrulias, J., Gacula, M., Jr., and Heinze, J. E., Evaluation of an in vitro cell toxicity test using rabbit corneal cells to predict the eye irritation potential of surfactants, in Safety Evaluation and Regulation of Chemicals, Homburger, F., Ed., Karger, Basel, Switzerland, 1983, 259-269.
22. Pham, X. T. and Huff, J. W., Cytotoxicity evaluation of multipurpose contact lens solutions using an in vitro test battery, CLAO J., 25(1), 28-35, 1999.
23. Livingston, R. B., Titus, G. A., and Heilbrun, L. K., In vitro effects on DNA synthesis as a predictor of biological effect from chemotherapy, Cancer Res., 40, 2209-2212, 1980.
24. Harbell, J. W., Wallace, K. A., Curren, R. D., Naughton, G. K., and Triglia, D., A comparison of four measures of toxicity applied to human dermal fibroblasts grown in three dimensional culture on nylon mesh (Skin2 Dermal Model), in Alternative Methods Toxicol., Goldberg, A. M., Ed., Mary Ann Liebert, New York, 8, 301-309, 1991.
25. Lewis, R. W., McCall, J. C., and Botham, P. A., A comparison of two cytotoxicity tests for predicting the ocular irritancy of surfactants, Toxicol. In Vitro, 7, 155-158, 1993.
26. Berridge, M. V., Tan, A. S., McCoy, K. D., and Wang, R., The biochemical and cellular basis of cell proliferation assays that use tetrazolium salts, Boehringer Mannheim Biochem., 4, 14-23, 1996.
27. Marshall, N. J., Goodwin, C. J., and Holt, S. J., A critical review of the use of microculture tetrazolium assays to measure cell growth and function, Growth Regul., 5, 69-84, 1995.
28. Borenfreund, E. and Puerner, J. A., Toxicity determined in vitro by morphological alterations and neutral red absorption, Toxicol. Lett., 24, 119-124, 1985.
29. Reader, S. J., Blackwell, V., O’Hara, R., Clothier, R. H., Griffin, G., and Balls, M., A vital dye release method for assessing the short term cytotoxic effects of chemicals and formulations, ATLA, 17, 28-37, 1989.
30. Harbell, J. W., Koontz, S. W., Lewis, R. W., Lovel, D., and Acosta, D., IRAG working Group 4: cell cytotoxicity assays, Food Chem. Toxicol., 35, 79-126, 1997.
31. Harbell, J. W., Southee, J. A., and Curren, R. C., The path to regulatory acceptance of in vitro methods is paved with the strictest standards, in Animal Alternatives, Welfare and Ethics, van Zutphen, L. F. M. and Balls, M., Eds., Elsevier Science, Amsterdam, 1997, 1177-1181.
32. Centers for Disease Control, Biosafety in Microbiological and Biomedical Laboratories, 3rd ed., U. S. Government Printing Office, Washington, D. C., 1993.
33. Gautheron, P., Dukic, M., Alix, D., and Sina, J. F., Bovine corneal opacity and permeability test: an in vitro assay of ocular irritancy, Fundam. Appl. Toxicol., 18, 442-449, 1992.
34. Sina, J. F., Galer, D. M., Sussman, R. G., Gautherone, P. D., Sargent, E. V., Leong, B., Shah, P. V., Curren, R. D., and Miller, K., A collaborative evaluation of seven alternatives to the Draize eye irritation test using pharmaceutical intermediates, Fundam. Appl. Toxicol., 26, 20-31, 1995.
35. Bagley, D. M., Waters, D., and Kong, B. M., Development of a 10-day chorioallantoic membrane vascular assay as an alternative to the Draize rabbit eye irritation test, Food Chem. Toxicol., 33(12), 1155-1160, 1994.
36. Bagley, D. M., Cervin, D., and Harbell, J. W., Assessment of the chorioallantoic membrane vascular assay (CAMVA) in the COLIPA in vitro eye irritation validation study, Toxicol. In Vitro, 13, 285-293, 1999.
37. Chamberlain, M., Gad, S. C., Gautherone P., and Prinsen, M. K., Organotypic models for the assessment/prediction of ocular irritation, Food Chem. Toxicol., 35, 23-37, 1997.
38. Tchao, R., Trans-epithelial permeability of fluorescein in vitro as an assay to determine eye irritants, in Alternative Methods in Toxicology, Vol. 6, Goldberg, A. M., Ed., Mary Ann Liebert, New York, 1988, 271-283.
39. Shaw, A. J., Clothier, R. H., and Balls, M., Loss of trans-epithelial impermeability of a confluent monolayer of Madin-Darby canine kidney (MDCK) cells as a determinant of ocular irritancy potential, ATLA, 18, 145-151, 1990.
40. Kruszewski, F. H., Walker, T. L., Ward, S. L., and Dipasquale, L. C., Progress in the use of human ocular tissues for in vitro alternative methods, Comments Toxicol., 5, 203-224, 1995.
41. Luepke, N. P. and Kemper F. H., HET-CAM: an alternative to the Draize eye test, Food Chem. Toxicol., 24, 495-496, 1986.
42. Balls, M., Botham, P. A., Bruner, L. H., and Spielmann, H., The EC/HO international validation study on alternatives to the Draize eye irritation test, Toxicol. In Vitro, 9, 871-929, 1995.
43. Kristen, U. and Kappler, R., The pollen tube growth test, in In Vitro Testing Protocols. Methods in Molecular Biology, Vol. 43, O’Hare, S. and Atterwill, C. K., Humana Press, Totowa, NJ, 1995, 189-198.
44. Pape, W. J. W., Pfannenbecker, U., and Hoppe, U., Validation of the red blood cell test system as an in vitro assay for the rapid screening of irritation potential of surfactants, Mol. Toxicol., 1, 525-536, 1987.
45. Osborne, R., Perkins, M. A., and Roberts, D. A., Development and intralaboratory evaluation of an in vitro human cell-based test to aid ocular irritancy assessments, Fundam. Appl. Toxicol., 28, 139-153, 1995.
46. Stern, M., Klausner, M., Alvarado, R., Renskers, K., and Dickens, M., Evaluation of the EpiOcular™ tissue model as an alternative to the Draize eye irritation test, Toxicol. In Vitro, 12, 455-461, 1998.
47. Blazka, M. E., Harbell, J. W., Klauzner, M., Raabe, H., Kubilus, J., Hsia, F., Minerath, B., Kotler, M., and Bagley, D. M., Colgate-Palmolive’s program to validate the EpiOcular™ human tissue construct model, Toxicologist, 54(1), 188, 2000.
48. Brantom, P. G., Bruner, L. H., Chamberlain, M., De Silva, O., Dupuis, J., Earl, L. K., Lovell, D. P., Pape, W. J. W., Uttley, M., Bagley, D. M., Baker, F. W., Bracher, M., Courtellemont, P., Declercq, L., Freeman, S., Steiling, W., Walker, A. P., Carr, G. J., Dami, N., Thomas, G., Harbell, J., Jones, P. A., Pfannenbecker, U., Southee, J. A., Tcheng, M., Argembeaux, H., Castelli, D., Clothier, R., Esdaile, D. J., Itigaki, H., Jung, K., Kasai, Y., Kojima, H., Kristen, U., Larnicol, M., Lewis, R. W., Marenus, K., Moreno, O., Peterson, A., Rasmussen, E. S., Robles, C., and Stern, M., A summary report of the COLIPA international validation study on alternatives to the Draize Rabbit Eye Irritation Test, Toxicol. In Vitro, 11, 141-179, 1997.
49. Shopsis, C. and Eng, B., In vitro ocular irritancy prediction: assays in serum-free medium correlate better with in vitro data, in Alternative Methods in Toxicology, Vol. 6, Goldberg, A. M., Ed., Mary Ann Liebert, New York, 1988, 253.
50. Gettings, S. D., Lordo, R. A., Hintze, K. L., Bagley, D. M., Casterton, P. L., Chudkowski, M., Curren, R. D., Demetrulias, J. L., DiPasquale, L. C., Earl, L. K., Feder, P. I., Galli, C. L., Glaza, S. M., Gordon, V. C., Janus, J., Kuntz, P. J., Marenus, K. D., Moral, J., Pape, W. J. W., Renskers, K. J., Rheins, L. A., Roddy, M. T., Rozen, M. G., Tedeschi, J. P., and Zyracki, J., 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, 1996.
51. Harbell, J. W. and Curren, R. D., The bovine corneal opacity and permeability assay: observations on assay performance, In Vitro Mol. Toxicol., 11, 337-341, 1998.
52. Harbell, J., Raabe, H., Dobson, T., Evans, M., and Curren, R., Histopathology associated with opacity and permeability changes in bovine corneas in vitro, ATLA, 27, 347, 1999.
53. Curren, R. D., Evans, M. G., Raabe, H. A., Ruppalt, R. R., and Harbell, J. W., An histological analysis of damage to bovine corneas in vitro by selected ocular toxicants, Toxicologist, 54(1), 188, 2000.
54. Wilmer, J. L., Burleson, F. G., Kayama, F., Kanno, J., and Luster, M. I., Cytokine induction in human epidermal keratinocytes exposed to contact irritants and its relation to chemical-induced inflammation in mouse skin, J. Invest. Dermatol., 102, 915-922, 1994.
55. Spielmann, H., Balls, M., Dupuis, J., Pape, W. J., Pechovitch, G., de Silva, O., Holzhütter, H. G., Clothier, R., Desolle, P., Gerberick, F., Liebsch, M., Potthast, J. M., Csato, M., Sladowski, D., Steiling, W., and Brantom, P., 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, 12, 305-327, 1998.
56. Holzhütter, H. G., A general measure of the in vitro phototoxicity derived from pairs of dose response curves and its use for predicting in vitro phototoxicity of chemicals, ATLA, 25, 445-462, 1997.
57. Spielmann, H., Balls, M., Dupuis, J., Pape, W. J., de Silva, O., Holzhütter, H. G., Gerberick, F., Liebsch, M., Lovell, W. W., and Pfannenbecker, U., A study on UV filter chemicals from Annex VII of European Union Directive 76/768/EEC, in the In Vitro 3T3 Phototoxicity Test, ATLA, 26, 679-708, 1998.
58. Zerler, B., Roemer, E., Raabe, H, Reeves, A., and Harbell, J. W., Evaluation of the phototoxic potential of chemically modified tetracyclines using the 3T3 Neutral Red Assay, ATLA, 27, 107, 1999.
59. Bronaugh, R. L. and Collier, S. W., In vitro methods for measuring skin permeation, in Skin Permeation Fundamentals and Applications, Zatz, J. L., Ed., Allured Publishing Corporation, Wheaton, IL, 1993, 93-111.
60. Heylings, J. R., Clowes, H. M., Trebilcock, K. L., and Hughes, L., Prediction of skin irritation potential using the skin integrity function test (SIFT), Kosmetica Speciale Dermatologia, May 2001.
61. van de Sandt, J., Roguet, R., Cohen, C., Esdaile, D., Ponec, M., Corsini, E., Barker, C., Fusenig, N., Liebsch, M., Benford, D., de Brugerolle de Fraissinette, A., and Fartasch, M., The use of human keratinocytes and human skin models for predicting skin irritation. The report and recommendations of ECVAM workshop 38, ATLA, 27, 723-743, 1999.
62. Koschier, F. J., Roth, R. N., Wallace, K. A., Curren, R. D., and Harbell, J. W., A comparison of three dimensional human skin models to evaluate the dermal irritation of selected petroleum products, In Vitro Toxicol., 10(4), 391-406, 1997.
63. Liebsch, M., Traue, D., Barrabas, C., Spielmann, H., Uphill, P., Wilkins, S., McPherson, J. P., Wiemann, C., Kaufmann, T., Remmele, M., and Holzhütter, H-G., The ECVAM prevalidation study on the use of EpiDerm for skin corrosivity testing, ATLA, 28, 371-401, 2000.
64. Roguet, R., Cohen, C., Robles, C., Courtellemont, P., Tolle, M., Guillot, J. P., and Pouradier Duteil, X., An interlaboratory study of the reproducibility and relevance of Episkin™, a reconstructed human epidermis, in the assessment of cosmetics irritancy, Toxicol. In Vitro, 12, 295-304, 1998.
65. Osborne, S., Mayer, F. K., Spake, A., Rosdy, M., De Wever, B., Ettlin, R. A., and Cordier, A., Predictivity of an in vitro model for acute and chronic skin irritation (SkinEthic) applied to the testing of topical vehicles, Cell Biol. Toxicol., 15, 121-135, 1999.
66. Medina, J., de Brugerolle de Fraissinette, A., Chibout, S. D., Kolopp, M., Kammermann, R., Burtin, P., Ebelin, M. E., and Cordier A., Use of human skin equivalent Apligraf for in vitro assessment of cumulative skin irritation potential of topical products, Toxicol. Appl. Pharmacol., 164, 38-45, 2000.
67. Fentem, J. H., Briggs, D., Chesné, C., Elliott, G. R., Harbell, J. W., Heylings, J. R., Portes, P., Roguet, R., Van De Sandt, J. J. M., and Botham, P. A., A prevalidation study on in vitro tests for acute skin irritation: results and evaluation by the management team, Toxicol. In Vitro, 15, 57-93, 2001.
68. Anonymous, Corrostitex: An In vitro Test Method for Assessing Dermal Corrosivity Potential of Chemicals, National Institute of Health Publication 99-4495, Interagency Coordinating Committee on the Validation of Alternative Methods, National Institute of Environmental Health Sciences, Research Triangle Park, NC, 1999.
69. Fentem, J. H., Archer, G. E. B., Balls, M., Botham, P. A., Curren, R. D., Earl, L. K., Esdaile, D. J., Holzhütter, H. -G., and Liebsch, M., The ECVAM international validation study on in vitro tests for skin corrosivity. 2. Results and evaluation by the management team, Toxicol. In Vitro, 12, 483-524, 1998.