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The Draize Eye Irritancy Test1 Nedim C. Buyukmihci, V.M.D.2 in the Draize Eye Irritancy Test, Any Compound Which Might Intention

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The Draize Eye Irritancy Test1 Nedim C. Buyukmihci, V.M.D.2 in the Draize Eye Irritancy Test, Any Compound Which Might Intention The Draize Eye Irritancy Test1 Nedim C. Buyukmihci, V.M.D.2 Summary This paper discusses the harmful and fatal use of non-human animals, particularly rabbits, in the Draize eye irritancy test. It argues and demonstrates that such use is not scientifically valid if the results are applied to human beings. Moreover, not only can this test result in extreme suffering (and death at the end) for non-human beings, dependence on this has the potential for harm to people. Alternatives to such use are discussed in the context of being more defensible ethically and scientifically. Keywords: alternative, animal welfare, compassion, Draize eye irritancy test, Draize skin irritancy test, ethics, kindness, morality, non-human animal, ocular irritancy test, rabbit, scientific method, species differences, toxicity testing In the Draize eye irritancy test, any compound which might intentionally or accidentally gain access to the eye is tested by being placed onto the eyes of conscious, restrained rabbits. The animals are observed over a period of several days to see if there is an adverse reaction to the substance. There may be no reaction or there may be irritation ranging from minor to severe. In the worst situation, the cornea may ulcerate and perforate. Because the cornea is one of the most sensitive tissues in the body, rich in nerve endings, irritation or ulceration produces considerable pain. The rabbits usually are restrained in stocks which hold the animals by the neck and prevent them from rubbing their eyes. Therefore, they cannot in any way mitigate the discomfort or pain produced by the material placed in their eyes. As an ophthalmologist and scientist, it is my professional opinion that the Draize test (19) has little, if any, relevance to human safety. It is fraught with technical and biological problems which make extrapolation of results to the human situation not only tenuous, but also dangerous. The rabbit is the primary animal used in the Draize eye test (11). The rabbit’s eye and reaction to topical irritants often is considerably different from that of a human being’s (11, 14, 23, 28, 38, 41). A compound found to be safe in the rabbit may actually cause great harm to a human being. On the other hand, a compound found to be toxic to the rabbit may actually cause no problems for a person while providing great benefits. From a practical standpoint, therefore, the tremendous suffering that some of the animals go through in these tests is absolutely unnecessary. Their misery in no way guarantees the safety of human beings. Similar criticism can be made against the Draize skin test (11, 20, 41, 45). There are numerous alternative methods to obtain data to predict whether a particular material will be safe for human use. These include those for ocular irritancy (2, 3, 4, 10, 12, 13, 17, 18, 22, 23, 24, 27, 29, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 42, 43, 44) and for the Draize skin test (5, 6, 7, 8, 9, 16, 25, 26, 30). These methods are more reliable and more humane than the Draize test. In some cases the methods only represent a refinement in the test or a reduction in the numbers of animals used. In other cases, however, there is evidence that a total replacement, using a number of in vitro tests, is possible. It often is stated that a proposed alternative to the Draize test must first be ‘validated.’ This means that the proposed alternative must be reasonably close in predicting what would be the result using the standard Draize test. There are at least two systematic errors with this approach. One, as mentioned, is that the data indicate the Draize test is not a reliable indicator of human reactivity. Another is that, to my knowledge, there has been no validation of the Draize test itself. It has been accepted as the standard with no rigorous attempt at verifying its reliability. Therefore, 1 The intent of this brief review is to demonstrate that reliance on rabbits or other animals unnecessary, as well as immoral, to ensure a product is safe for human use. Although some of the references may be considered 'dated', they are still valid in developing and supporting the arguments made. Additional strong moral arguments against subjecting non-consenting beings to harm and death is the subject of another manuscript (15). 2 Emeritus Professor of Veterinary Medicine, University of California and Emeritus Diplomate, American College of Veterinary Ophthalmologists; contact: [email protected]; Copyright © 2017 Nedim C. Buyukmihci. The Draize eye irritancy test Page 2 of 6 N.C. Buyukmihci although it is true that new methods of determining irritancy should be ‘validated,’ the standard should be against known reactions to various categories of substances by the human eye. Tradition alone appears to be the major momentum behind the continued reliance on such an archaic and unreliable method as the Draize test. There are no regulations which require the use of this test for determining the safety of material which may be used by human beings (1). The data derived from testing on other animals may not even be admissible in court when a person brings action against a company due to injury from a particular product (21). References3: 1. Anonymous. 1982. "CPSC: Exclusive use of Draize test not required." Lab Animal 11:19.i 2. Anonymous. 1989. "Beyond the Draize test." 10 pp. Physicians Committee for Responsible Medicine.ii 3. Anonymous. 1989. "EYTEX: An analysis." The Alternatives Report 1(2):1,3-5.iii 4. Anonymous. 1989. "SDA alternatives program." The Alternatives Report 1(2):7-8.iv 5. Anonymous. 1989. "Testskin: An analysis." The Alternatives Report 1:1-6.v 6. Anonymous. 2007. "Corrositex." InVitro International. Accessed 27 October 2016. http://www.invitrointl.com/products/corrosit.php 7. Anonymous. 2016. "EpiDerm™." MatTek Corporation. Accessed 27 October 2016. https://www.mattek.com/products/epiderm/ 8. Anonymous. 2016. "EpiSkin." SkinEthic. Accessed 27 October 2016. http://www.episkin.com/EPISKIN.asp 9. Babich, Harvey and Borenfreund, Ellen. 1989. "Development of an alternative to the Draize rabbit skin test." International Foundation for Ethical Research Newsletter 3(2):1-2.vi 10. Borenfreund, Ellen and Borrero, Olina. 1984. " In vitro cytotoxicity assays. Potential alternatives to the Draize ocular allergy test." Cell Biology and Toxicology 1(1):55-65.vii 11. Bosshard, E. 1985. "Review on skin and mucous-membrane irritation tests and their application." Food and Chemical Toxicology 23(2):149-154.viii 12. Boue-Grabot, M.; Halaviat, B. and Pinon, J. Francois. 1992. "A simple method for cytotoxicity studies of non-hydrosoluble substances. Possible application as an alternative to the Draize test for cosmetics and toiletries." Alternatives to Laboratory Animals 20(2):307-312.ix 13. Boue-Grabot, Marc; Halaviat, Brigitte and Pinon, Jean-François. 1992. "Cytotoxicity of non- hydrosoluble substances towards human skin fibroblasts cultured on microporous membrane: A model for the study of ocular irritancy potential." Alternatives to Laboratory Animals 20(3):445-450. 14. Buehler, Edwin V. 1974. "Testing to predict potential ocular hazards of household chemicals." In Toxicology Annual 1974, Winek, C.J. and Shanor, S.P. (eds), 53-69. New York, NY: Marcel Dekker, Inc. 15. Buyukmihci, Nedim C. 2016. "Serious Moral Concern Is Not Species-limited." 8 pp. Accessed 20 November 2016. http://escholarship.org/uc/item/6604b7qj 16. Cook, Jeffery R.; Gabriels, Joseph; Patrone, Laura M.; Rhoads, Laura, S. and Van Buskirk, Robert G. 1992. "A human epidermal model that can be used in an automated multiple endpoint assay." Alternatives to Laboratory Animals 20(2):313-323.x 17. Courtellemont, Pascal; Hebert, Patrice and Redziniak, Gérard. 1992. "Evaluation of the EYTEX [TM] system as a screening method for ocular tolerance: Application to raw materials and finished products." Alternatives to Laboratory Animals 20(3):466-470.xi 18. Douglas, William H.J. 1982. "New methodology." Alternative Methods in Toxicology 1(1).xii 19. Draize, John H.; Woodard, Geoffrey and Calvery, Herbert O. 1944. "Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes." The Journal of Pharmacology and Experimental Therapeutics 82(3):377-390. 20. Gfeller, W.; Kobel, W. and Seifert, G. 1985. "Overview of animal test methods for skin irritation." Food and Chemical Toxicology 23(2):165-168.xiii 21. Gleeson, John Gerald. 1987. "Exclusion of animal data as evidence of chemically-induced disease." For the Defense 25-29. 22. Gordon, Virginia C. 1992. "The scientific basis of the EYTEXTM system." Alternatives to Laboratory 3 In this paper, I have cited only a few references to document various points because the literature on this subject is substantial. The Draize eye irritancy test Page 3 of 6 N.C. Buyukmihci Animals 20(4):537-548. 23. Griffith, John F. 1987. "The low volume eye irritation test: A more predictive and more humane approach to eye irritancy evaluation." Soap/Cosmetics/Chemical Specialties 32-36,58-60.xiv 24. Hadley, M.A. 1989. "Cell culture alternatives to the Draize test." Physicians Committee for Responsible Medicine.xv 25. Hareyan, Armine. 2008. "Newly approved ocular safety methods reduce animal testing." Huliq News. Accessed 27 October 2016. http://www.huliq.com/62615/newly-approved-ocular-safety-methods- reduce-animal-testing 26. Isseroff, Roslyn Rivkah. 1989. "An in vitro alternative to skin irritancy testing." International Foundation for Ethical Research Newsletter 3(2):2,4.xvi 27. Klopman, Gilles; Ptchelintsev, Dmitri; Frierson, Manton; Pennisi, Stephen; Renskers, Kevin and Dickens, Michael. 1993. "Multiple computer automated structure evaluation methodology as an alternative to in vivo eye irritation testing." Alternatives to Laboratory Animals 21(1):14-27.xvii 28. Kraushar, M.F.
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