Cosmetic safety: Proposal for the replacement of in vivo (Draize) by in vitro test

Open Toxicology Journal

Volumn 3, Issue , 2009, Pages 1-7

  Pinto, T J A ^a   Ikeda, T I ^b   Miyamaru, L L ^b   Santa, M C ^b   Santos, Bárbara R P ^b   Cruz, A S ^b  

^a UNIVERSITY OF SÃO PAULO   (Brazil)

^b INSTITUTO ADOLFO LUTZ   (Brazil)

Author keywords

[No Author keywords available]

Indexed keywords

COSMETIC; SOAP; SUNSCREEN;

AGAR DIFFUSION; ANIMAL CELL; ANIMAL EXPERIMENT; ARTICLE; CHILD; CONTROLLED STUDY; DISEASE SEVERITY; ERYTHEMA; EVALUATION; EXPERIMENTAL RABBIT; EYE IRRITATION; HUMAN; HUMAN CELL; IMMUNOREACTIVITY; NONHUMAN; PRIORITY JOURNAL; RISK ASSESSMENT; SKIN ABRASION; SKIN EDEMA; SKIN IRRITATION;

ANIMALIA; ORYCTOLAGUS CUNICULUS;

EID: 77953378868     PISSN: None     EISSN: 18743404     Source Type: Journal    
DOI: 10.2174/1874340400903010001     Document Type: Article

References (23)

1. Draize JH, Woodard G, Calvery HO. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J Pharmacol Exp Ther 1944; 82: 377-390
2. Guess WL, Rosenbluth SA, Schmidt B, Autian J. Agar diffusion method for toxicity screening of plastics on cultured cell monolayers. J Pharm Sci 1965; 54: 1545-1547
3. th ed. Rockville: United States Pharmacopeial Convention 2008; (1): 102-103
4. Springer JA, Chambers WA, Green S, et al. Number of animals for sequential testing. Food Chem Toxicol Oxford 1993; 31: 105-109
5. International Organization For Standartization. ISO 10.993-5: Biological evaluation of medical devices. Part 5. Test for cytotoxicity: in vitro methods. Geneva: ISO, 1999. p.12.
6. Barrela C, Roque J, Silva T. Métodos alternativos à experimentação animal na indústria de cosméticos. [Updated 2002 Jan 16] Available from: http://www.fmv.utl.pt/democ/sft/ sem0001/G23. html.
7. Lee JK, Kim DB, Kim JI, Kim PY. In vitro cytotoxicity tests on cultured human skin fibroblasts to predict skin irritation potential of surfactants. Toxicol In Vitro 2000; 14: 345-349
8. Watanabe M, Watanabe K, Suzuki K, et al. Use of primary rabbit cornea cells to replace the Draize rabbit eye irritancy test. Toxicol In Vitro 1989; 3(4): 329-334 (Pubitemid 20019738)
9. Rougier A, Cottin M, Silva O, Catroux P, Roguet R, Dossou KG. The use of in vitro methods in the ocular irritation assessment of cosmetic products. Toxicol In Vitro 1994; 8(4): 893-905.
10. Wilhelmus KR. The Draize eye test: therapeutic reviews. Surv Ophthalmol Brookline 2001; 45(6): 493-515.
11. Pinto TJA, Azevedo JC, Cruz AS. Comparative study of epithelial and fibroblastic cell lines as an alternative cytotoxicity test to the Draize method. J AOAC Int Gaithersburg 2000; 83(3): 665-668
12. Cornelis M, Dupont C, Wepierre J. Prediction of eye irritancy potential of surfactants by cytotoxicity tests in vitro on cultures of human skin fibroblasts and keratinocytes. Toxicol In Vitro 1992; 6(2): 119-128
13. Earl LK, Jones PA, Dixit MB, O'Brien KAF. Comparison of five potential methods for assessing ocular irritation in vitro. Toxicol In Vitro 1995; 9(3): 245-250
14. Harbell JW, Koontz SW, Lewis RW, Lovell D, Acosta D. Cell cytotoxicity assays. Food Chem Toxicol 1997; 35: 79-126.
15. O'Brien KAF, Basketter DA, Jones P, Dixit M. An in vitro study of the eye irritation potential of new shampoo formulations. Toxicol In Vitro 1994; 8(2): 257-261
16. Combrier E, Castelli D. The agarose overlay method as a screening approach for ocular irritancy: application to cosmetic products. Altern Lab Anim 1992; 20(3): 438-444
17. O'Brien KAF, Jones PA, Rockley J. Evaluation of an agarose overlay assay to determine the eye irritation potential of detergent-based products. Toxicol In Vitro 1990; 4: 311-313 (Pubitemid 20364907)
18. Wallin RF, Hume RD, Jackson EM. The agarose diffusion method for ocular irritancy screening: cosmetic products, part I. J Toxicol Cutan Ocul Toxicol 1987; 6(4): 239-250
19. Gettings SD, Lordo RA, Hintze KL, 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 1996; 34(1): 79-117.
20. Courtellemont P, Hebert P, Biesse JP, et al. Relevance and reliability of the PREDISAFE assay in the COLIPA eye irritation validation program (phase 1). Toxicol In Vitro 1999; 13: 305-312 (Pubitemid 29288617)
21. Draelos ZD. Special considerations in eye cosmetics. Clin Dermatol 2001; 19: 424-430
22. Wolf R, Wolf D, Tuzun B, Tuzun Y. Contact dermatitis to cosmetics. Clin Dermatol Philadelphia 2001; 19: 502-515
23. Ohno Y, Kaneko T, Inoue T, 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 1999; 13: 73-98.