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Draize test : ウィキペディア英語版
Draize test

The Draize Test is an acute toxicity test devised in 1944 by Food and Drug Administration (FDA) toxicologists John H. Draize and Jacob M. Spines. Initially used for testing cosmetics, the procedure involves applying 0.5mL or 0.5g of a test substance to the eye or skin of a restrained, conscious animal, and then leaving it for set amount of time before rinsing it out and recording its effects.〔〔(as a source for "conscious and restrained." )〕 The animals are observed for up to 14 days for signs of erythema and edema in the skin test, and redness, swelling, discharge, ulceration, hemorrhaging, cloudiness, or blindness in the tested eye. The test subject is commonly an albino rabbit, though other species are used too, including dogs.〔Carbone 2004, p. 24, with an image, fig 2.1, of two restrained rabbits and one dog undergoing Draize testing, citing ''The Journal of Pharmacology and Experimental Therapeutics''.〕 The animals are euthanized after testing if the test renders irreversible damage to the eye or skin. Animals may be re-used for testing purposes if the product tested causes no permanent damage. Animals are typically reused after a "wash out" period during which all traces of the tested product are allowed to disperse from the test site.〔(Animals in Product Testing ), National Anti-Vivisection Society, retrieved 29 June 2009.〕
The tests are controversial. They are viewed as cruel as well as unscientific by critics because of the differences between rabbit and human eyes, and the subjective nature of the visual evaluations. The FDA supports the test, stating that "to date, no single test, or battery of tests, has been accepted by the scientific community as a replacement () ... the Draize test" 〔"(Validation of In Vitro Methods: Regulatory Issues )", Animal Welfare Information Center Newsletter, Summer 1994, Vol. 5, no. 2〕 Because of its controversial nature, the use of the Draize test in the U.S. and Europe has declined in recent years and is sometimes modified so that anaesthetics are administered and lower doses of the test substances used.〔(Alternatives to Animal Testing Web Site ), retrieved 29 June 2009.〕 Chemicals already shown to have adverse effects ''in vitro'' are not currently used in a Draize test,〔(Eye irritation caused by chemicals ), 3R Research Foundation, retrieved 29 June 2009.〕 thereby reducing the number and severity of tests that are carried out.
== Background ==
John Henry Draize (1900–1992) obtained a BSc in chemistry then a PhD in pharmacology, studying hyperthyroidism. He then joined the University of Wyoming and investigated plants poisonous to cattle, other livestock, and people. The U.S. Army recruited Draize in 1935 to investigate the effects of mustard gas and other chemical agents.
In 1938, after a number of reports of coal tar in mascara leading to blindness, the U.S. Congress passed the Federal Food, Drug, and Cosmetic Act, placing cosmetics under regulatory control. The following year Draize joined the FDA, and was soon promoted to head of the Dermal and Ocular Toxicity Branch where he was charged with developing methods for testing the side effects of cosmetic products. This work culminated in a report by Draize, his laboratory assistant, Geoffrey Woodard, and division chief, Herbert Calvery, describing how to assess acute, intermediate, and chronic exposure to cosmetics by applying compounds to the skin, penis, and eyes of rabbits.
Following this report, the techniques were used by the FDA to evaluate the safety of substances such as insecticides and sunscreens and later adopted to screen many other compounds. By Draize's retirement in 1963, and despite never having personally attached his name to any technique, irritancy procedures were commonly known as "the Draize test" To distinguish the target organ, the tests are now often referred to as "the Draize eye test" and "the Draize skin test".

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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