Draize test

Draize test
PurposeTest cosmetics (allergic/toxic reaction)

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 0.5 mL or 0.5 g of a test substance to the eye or skin of a restrained, conscious animal, and then leaving it for a set amount of time before rinsing it out and recording its effects.[1][2] 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.[3] 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.[4]

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 [for] ... the Draize test".[5] 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.[6] Chemicals already shown to have adverse effects in vitro are not currently used in a Draize test,[7] thereby reducing the number and severity of tests that are carried out.

  1. ^ Cite error: The named reference RDS was invoked but never defined (see the help page).
  2. ^ Carbone, Larry (17 June 2004). What Animals Want: Expertise and Advocacy in Laboratory Animal Welfare Policy. New York: Oxford University Press. p. 63. ISBN 978-0-19-516196-0.[Used as a source for "conscious and restrained."]
  3. ^ 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.
  4. ^ Animals in Product Testing Archived May 16, 2006, at the Wayback Machine, National Anti-Vivisection Society, retrieved 29 June 2009.
  5. ^ "Validation of In Vitro Methods: Regulatory Issues Archived February 21, 2006, at the Wayback Machine", Animal Welfare Information Center Newsletter, Summer 1994, Vol. 5, no. 2
  6. ^ Alternatives to Animal Testing Web Site Archived February 9, 2006, at the Wayback Machine, retrieved 29 June 2009.
  7. ^ Eye irritation caused by chemicals, 3R Research Foundation, retrieved 29 June 2009.