Testes in vitro como alternativa aos testes in vivo de Draize
pdf

Palavras-chave

teste de Draize
irritação ocular
irritação cutânea
citotoxicidade
testes in vitro

Como Citar

1.
Cruz Áurea S, Barbosa ML, Pinto T de JA. Testes in vitro como alternativa aos testes in vivo de Draize . Rev Inst Adolfo Lutz [Internet]. 30º de junho de 2004 [citado 4º de dezembro de 2024];63(1):1-9. Disponível em: https://periodicos.saude.sp.gov.br/RIAL/article/view/34734

Resumo

Os procedimentos descritos por Draize deram origem aos testes de irritação ocular e cutânea adotados internacionalmente para avaliar produtos e substâncias. Entretanto, eles são criticados por motivos éticos, devido à crueldade com os animais, mesmo após diferentes modificações terem sido propostas nos protocolos originais. Metodologias alternativas têm sido estudadas para avaliar a toxicidade de produtos usados em seres humanos. Entre as mais citadas encontram-se as que utilizam organismos inferiores, células vivas de mamíferos, sistemas organotípicos e substratos inertes, além de bancos de dados informatizados e programas que avaliam a toxicidade pela determinação de relação estrutura-atividade. Os métodos utilizando células vivas têm sido muito utilizados para predizer com segurança a irritação, contribuindo para a redução do número de animais utilizados nos testes in vivo. Até o momento, não existem métodos validados para substituir os ensaios de irritação ocular e cutânea, mas somente para avaliar substâncias corrosivas.

 

https://doi.org/10.53393/rial.2004.63.34734
pdf

Referências

1. American Society for Testing and Materials. Standard test method for agar diffusion cell culture screening for cytotoxicity: designation: F 895-84. Philadelphia: ASTM, 1995, p.276-9.

2. Azevedo, J.C. Avaliação de metodologia alternativa in vitro ao teste de irritação ocular de Draize. São Paulo, 1998. 145p. (Dissertação de Mestrado - Faculdade de Ciências Farmacêuticas USP).

3. Babich, H.; Babich, J.P. Sodium lauryl sulfate and triclosan: in vitro cytotoxicity studies with gingival cells. Toxicol. Lett., 91: 189-96, 1997.

4. Babich, H.; Borenfreund, E. Cytotoxic and morphological effects of phenylpropanolamine, caffeine, nicotine, and some of their metabolites studied in vitro. Toxicol. In Vitro, 6 (6): 493-502, 1992.

5. Bagley, D.M. et al. Eye irritation: reference chemicals data bank. Toxicol. In Vitro, 6: 487-91, 1992b.

6. Bagley, D.M. et al. An evaluation of five potential alternatives in vitro to the rabbit eye irritation test in vivo. Toxicol. In Vitro, 6 (4): 275-84, 1992a.

7. Bagley, D.M. et al. Skin irritation: reference chemicals data bank. Toxicol. In Vitro, 10:1-6, 1996.

8. Balls, M. Scientific validation: a crucial and unavoidable prerequisite to the acceptability of new tests and testing strategies. ATLA, Altern. Lab. Anim., 23: 474-9, 1995.

9. Balls, M. et al. The EC/HO international validation study on alternatives to the Draize eye irritation test. Toxicol. In Vitro, 9 (6): 871-929, 1995.

10.Balls, M.; Fentem, J.H. The validation and acceptance of alternatives to animal testing. Toxicol. In Vitro, 13: 837-46, 1999.

11. Barratt, M.D. QSARS for the eye irritation potential of neutral organic chemicals. Toxicol. In Vitro, 11: 1-8, 1991.

12. Barratt, M.D. et al. The ECVAM international validation study on in vitro tests for skin corrosivity. 1. Selection and distribution of the test chemicals. Toxicol. In Vitro, 12: 471-82, 1998.

13. Barrela, C., Roque, J.; Silva, T. Métodos alternativos à experimentação animal na indústria de cosméticos. [http:// www.fmv.utl.pt/democ/sft/ sem0001/G23.html]. 16 janeiro 2002.

14. Borenfreund, E.; Babich, H.; Martin-Alguacil, N. Comparisons of two in vitro cytotoxicity assays- the neutral red (NR) and tetrazolium MTT tests. Toxicol. In Vitro, 2 (1): 1-6, 1988.

15. Borenfreund, E.; Puerner, J.A. A simple quantitative procedure using monolayer cultures for cytotoxicity assays (HTD/NR-90). J. Tissue Cult. Methods, 9 (1): 7-9, 1984.

16. Borenfreund, E.; Puerner, J.A. Toxicity determined in vitro by morphological alterations and neutral red absorption. Toxicol. Lett., 24: 119-24, 1985.

17. Botham, P. et al. Cell function-based assays. Food Chem. Toxicol., 35: 67-77, 1997.

18. Bradlaw, J.A.; Wilcox, N.L. Workshop on eye irritation testing: Practical applications of non-whole animal alternatives. Food Chem. Toxicol., 35: 1-11, 1997.

19. Brantom, P.G. et al. A summary report of the COLIPA international validation study on alternatives to the Draize rabbit eye irritation test. Toxicol. In Vitro, 11: 141-79, 1997.

20. Bruner, L.H. et al. Validation of alternative methods for toxicity testing. Toxicol. In Vitro, 10: 479-501, 1996.

21. Cade, P. Avaliação da ação antiirritante, comparação entre métodos in vivo e in vitro. Cosmet. Toiletries, Ed. Port., 2: 13-7, 1990.

22. Chamberlain, M. et al. Organotypic models for the assessment/prediction of ocular irritation. Food Chem. Toxicol., 35: 23-37, 1997.

23. Chamberlain, M.; Parish, W.E. Hazard and risk based on in vitro test data. Toxicol. In Vitro, 4 (4/5): 694-7, 1990.

24. Chiba, K. et al. Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients (9): evaluation of cytotoxicity test on Hela cells. Toxicol. In Vitro, 13: 189-98, 1999.

25. Chiba, K., Kawakami, K., Tohyama, K. Simultaneous evaluation of cell viability by neutral red, MTT and crystal violet staining assays of the same cells. Toxicol. In Vitro, 12: 251-8, 1998.

26. Ciapetti, G. et al. Application of a combination of neutral red and amido black staining for rapid, reliable cytotoxicity testing of biomaterials. Biomaterials, 17 (13): 1259-64, 1996.

27. Clothier, R. et al. Assessment of initial damage and recovery following exposure of MDCK cells to an irritant. Toxicol. In Vitro, 13: 713-7, 1999.

28. Combrier, E., Castelli, D. The agarose overlay method as a screening approach for ocular irritancy: application to cosmetic products. ATLA, Altern. Lab. Anim., 20 (3): 438-44, 1992.

29. Cooper, K.J. et al. Prediction of ocular irritancy of prototype shampoo formulations by the isolated rabbit eye (IRE) test, and bovine corneal opacity and permeability (BCOP) assay. Toxicol. In Vitro, 15: 95-103, 2001.

30. Courtellemont, P. et al. Relevance and reliability of the PREDISAFE assay in the COLIPA eye irritation validation program (phase 1). Toxicol. In Vitro, 13: 305-12, 1999.

31. Cronin, M.T.D.; Basketter, D.A., York, M. A quantitative structureactivity relationship (QSAR) investigation of a Draize eye irritation database. Toxicol. In Vitro, 8 (1): 21-8, 1994.

32. Curren, R.D. et al. Other assays. Food Chem. Toxicol., 35: 127-58, 1997.

33. De Angelis, I. et al. In vitro toxicity of some cosmetic ingredients. Food Chem. Toxicol., 24 (6/7): 477-9, 1986.

34. Dickson, F.M., Lawrence, J.N.; Benford, D.J. Surfactant-induced cytotoxicity in cultures of human keratinocytes and a commercially available cell line (3T3). Toxicol. In Vitro, 7 (4): 381-4, 1993.

35. Draize, J.H.; Woodard, G.; Calvery, H.O. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. Exp. Ther., 82: 377-90, 1944.

36. Earl, L.K. et al. Comparison of five potential methods for assessing ocular irritation in vitro. Toxicol. In Vitro, 9 (3): 245-50, 1995.

37. Eisenbrand, G. et al. Methods of in vitro toxicology. Food Chem. Toxicol., 40: 193-236, 2002.

38. FDA.U.S. Food and Drug Administration. Animal testing. [http://vm.cfsan.fda.gov/~dms/cos-205html]. 8 março 2001.

39. Fentem, J.H. 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, 12: 483-524, 1998.

40. Fentem, J.H. et al. 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.

41. Gautheron, P. et al. Interlaboratory assessment of the bovine corneal opacity and permeability (BCOP) assay. Toxicol. In Vitro, 8 (3): 381-92, 1994.

42. Gettings, S.D. et al. The CTFA evaluation of alternatives program: an evaluation of in vitro alternatives to the Draize primary eye irritation test. (Phase II) oil/water emultions. Food Chem. Toxicol., 32 (10): 943-76, 1994.

43. Gettings, S.D. et al. Comparison of low-volume, Draize and in vitro eye irritation test data. I. Hydroalcoholic formulations. Food Chem. Toxicol., 34: 737-49, 1996b

44. Gettings, S.D. et al. The CFTA 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 (1): 79-117, 1996a.

45. Gettings, S.D. et al. A comparison of low volume, Draize and in vitro eye irritation test data. II. Oil/water emulsions. Food Chem. Toxicol., 36: 47-59, 1998.

46. Gordon, V.C. The scientific basis of the EYTEX system. ATLA, Altern. Lab. Anim., 20: 537-48, 1992.

47. Guess, W.L. et al. Agar diffusion method for toxicity screening of plastics on cultured cell monolayers. J. Pharm. Sci., 54: 1545-7, 1965.

48. Harbell, J.W. et al. Cell cytotoxicity assays. Food Chem. Toxicol., 35: 79-126, 1997.

49. Hockley, K.; Baxter, D. Use of the 3T3 cell-neutral red uptake assay for irritants as an alternative to the rabbit (Draize) test. Food Chem. Toxicol., 24 (6/7): 473-5, 1986.

50. Husoy, T.; Syversen, T.; Jenssen, J. Comparisons of four in vitro cytotoxicity tests: the MTT assay, NR assay, uridine incorporation and protein measurements. Toxicol. In Vitro, 7 (2): 149-54, 1993.

51. International Organization for Standartization. ISO 10.993-5: Biological evaluation of medical devices. Part 5. Test for cytotoxicity: in vitro methods. Geneva: ISO, 1992. 7p.

52. Itagaki, H. et al. An in vitro alternative to the Draize eye-irritation test: evaluation of the crystal violet staining method. Toxicol. In Vitro, 5 (2): 139-43, 1991.

53. Jester, J.V. et al. Extent of initial corneal injury as a basis for alternative eye irritation tests. Toxicol. In Vitro, 15: 115-30, 2001.

54. Kay, J.H.; Calandra, J.C. Interpretation of eye irritation tests. J. Soc. Cosmet. Chem., 13: 281-9, 1962.

55. Kojima, H. et al. Evaluation of seven alternative assays on the main ingredients in cosmetics as predictors of Draize eye irritation scores. Toxicology in Vitro, 9 (3): 333-40, 1995.

56. Lawrence, J.N. Application of in vitro human skin models to dermal irritancy: a brief overview and future prospects. Toxicol. In Vitro, 11: 305-12, 1997.

57. LEE, J.K. et al. In vitro cytotoxicity tests on cultured human skin fibroblasts to predict skin irritation potential of surfactants. Toxicol. In Vitro, 14: 345-9, 2000.

58. Lewis, R.W.; Mccall, J.C.; Botham, P.A. A comparison of two cytotoxicity tests for predicting the ocular irritancy of surfactants. Toxicol. In Vitro, 7 (2): 155-8, 1993.

59. Lordo, R.A.; Feder, P.I.; Gettings, S.D. Comparing and evaluating alternative (in vitro) tests on their ability to predict the Draize maximum average score. Toxicol. In Vitro, 13: 45-72, 1999.

60. Louekari, K. In vitro toxicology and the test guidelines. ATLA, Altern. Lab. Anim., 24: 435-8, 1996.

61. Lovell, D.P. Principal component analysis of tissue scores from substances used in the COLIPA eye irritation validation study. Toxicol. In Vitro, 13: 491-503, 1999.

62. Majmudar, G., Smith, M. Técnicas de screening in vitro em dermatologia. Cosmet. Toiletries, Ed. Port., 10: 44-9, 1998.

63. Mosmann, T. Rapid colorimetric assay for cellular growth and survival: application to proliferation and cytotoxicity assays. J. Immunol. Methods, 65: 55-63, 1983.

64. Noser, F. Cultura de células a serviço da cosmetologia. Cosmet. Toiletries, Ed. Port., 3: 46-7, 1991.

65. O’Brien, K.A.F. et al. An in vitro study of the eye irritation potential of new shampoo formulations. Toxicol. In Vitro, 8 (2): 257-61, 1994.

66. Ohno, Y. et al. Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (1) overview of the validation study and Draize scores for the evaluation of the tests. Toxicol. In Vitro, 13: 73-98, 1999.

67. Okumura, H. et al. Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (10) evaluation of cytotoxicity test on CHL cells. Toxicol. In Vitro, 13: 199-208, 1999.

68. Olivier, P. et al. Effect of high polyol concentrations on the neutral red absorption assay and tetrazolium- MTT test of rat hepatocytes in primary culture. Toxicol. In Vitro, 9 (2): 133-8, 1995.

69. Pinto, T.J.A.; Azevedo, J.C.; Cruz, A.S. Comparative study of epithelial and fibroblastic cell lines as an alternative cytotoxicity test to the Draize method. J. AOAC Int., 83 (3): 665-8, 2000.

70. Pinto, T.J.A.; Kaneko, T.M.; Ohara, M.T. Controle biológico de qualidade de produtos farmacêuticos, correlatos e cosméticos. São Paulo: Atheneu, 2000. 309p.

71. Riddell, R.J.; Clothier, R.H.; Balls, M. An evaluation of three in vitro cytotoxicity assays. Food Chem. Toxicol., 24 (6/7): 469-71, 1986.

72. Robinson, M.K. et al. Non-animal testing strategies for assessment of the skin corrosion and skin irritation potential of ingredients and finished products. Food Chem. Toxicol., 40: 573-92, 2002.

73. Robinson, M.K.; Osborne, R.; Perkins, M.A. Strategies for the assessment of acute skin irritation potential. J. Pharmacol. Toxicol. Methods, 42: 1-9, 1999.

74. Roggeband, R. et al. Eye irritation responses in rabbit and man after single applications of equal volumes of undiluted model liquid detergent products. Food Chem. Toxicol., 38: 727-34, 2000.

75. Roguet, R. et al. 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.

76. Roguet, R.; Schaefer, H. Overview of in vitro cell culture technologies and pharmaco-toxicological applications. Toxicol. In Vitro, 11: 591-9, 1997.

77. Rosenbluth, S.A. et al. Tissue culture method for screening toxicity of plastic materials to be used in medical practice. J. Pharm. Sci., 54: 156-9, 1965.

78. Rougier, A. et al. The use of in vitro methods in the ocular irritation assessment of cosmetic products. Toxicol. In Vitro, 8 (4): 893-905, 1994.

79. Rutten, A.A.J.J.L., Van de Sandt, J.J.M. In vitro dermal toxicology using skin organ cultures. Toxicol. In Vitro, 8 (4): 703-5, 1994.

80. Saotome, K.; Morita, H.; Umeda, M. Cytotoxicity test with simplified crystal violet staining method using microtitre plates and its application to injection drugs. Toxicol. In Vitro, 3 (4): 317-21, 1989.

81. Sasaki, T. et al. Detergent cytotoxicity simplified assay of cytolysis by measuring LDH activity. Toxicol. In Vitro, 6 (5): 451-7, 1992.

82. Seabaugh, V.M. et al. Use of ophthalmic topical anesthetics. Food Chem. Toxicol., 31: 95-8, 1993.

83. Southee, J.A. et al. The performance of the tissue equivalent assay using the skin ZK 1200 model in the COLIPA international validation study on alternatives to the Draize eye irritation test. Toxicol. In Vitro, 13: 355-73, 1999.

84. Spielmann, H.; Liebsch, M. Lessons learned from validation of in vitro toxicity test: from failure to acceptance into regulatory practice. Toxicol. In Vitro, 15: 585-90, 2001.

85. Spielmann, H. et al. CAM-based assays. Food Chem. Toxicol., 35: 39-66, 1997.

86. Springer, J.A. et al. Number of animals for sequential testing. Food Chem. Toxicol., 31: 105-9, 1993.

87. Tani, N. et al. Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (8): evaluation of cytotoxicity tests on SIRC cells. Toxicol. In Vitro, 13: 175-87, 1999.

88. Tsutsui, T. et al. Quantitative comparison of cytotoxicity of dental antiseptics to normal human oral keratinocytes in vitro. Toxicol. In Vitro, 8 (6): 1253-8, 1994.

89. Uchiyama, T. et al. Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients (7): evaluation of cytotoxicity test by CornePack. Toxicol. In Vitro, 13: 163-73, 1999.

90. United States Pharmacopeia. 22.ed. Rockville: United States Pharmacopeial Convention, 1990. p.1495-7.

91. United States Pharmacopeia. 23.ed. Rockville: United States Pharmacopeial Convention, 1995. p.1697-9.

92. United States Pharmacopeia. 24.ed. Rockville: United States Pharmacopeial Convention, 1999. p.1831-2.

93. United States Pharmacopeia. 25.ed. Rockville: United States Pharmacopeial Convention, 2002. p.1893-5.

94. United States Pharmacopeia. 26.ed. Rockville: United States Pharmacopeial Convention, 2003. p.2026-8.

95. Van de Sandt, J.J.M.; Rutten, A.A.J.J.L. Differential effects of chemical irritants in rabbit and human skin organ cultures. Toxicol. In Vitro, 9 (2): 157-68, 1995.

96. Van de Sandt, J.J.M.; Rutten, A.A.J.J.L.; Koeter, H.B.W.M. Cutaneous toxicity testing in organ culture: neutral red uptake and reduction of tetrazolium salt (MTT). Toxicol. In Vitro, 7 (1): 81-6, 1993.

97. Van Zutphen, L.F.M.; Van der Valk, J.B.F. Developments on the implementation of the three Rs in research and education. Toxicol. In Vitro, 15: 591-5, 2001.

98. Vian, L. et al. Comparison of three in vitro cytotoxicity assays for estimating surfactant ocular irritation. Toxicol. In Vitro, 9 (2): 185-90, 1995.

99. Wilhelmus, K.R. The Draize eye test: therapeutic reviews. Surv. Ophthalmol., 45 (6): 493-515, 2001.

Creative Commons License
Este trabalho está licenciado sob uma licença Creative Commons Attribution 4.0 International License.

Copyright (c) 2004 Áurea Silveira Cruz, Maria Luisa Barbosa, Terezinha de Jesus Andreoli Pinto

Downloads

Não há dados estatísticos.