[8] 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.
[9] 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.
[11] A 2004 study by the U.S. Scientific Advisory Committee on Alternative Toxicological Methods analyzed the modern Draize skin test.
They found that tests would:[12] According to the American National Anti-Vivisection Society, solutions of products are applied directly into the animals' eyes, which can cause "intense burning, itching and pain".
"[14] Kirk Wilhelmus, professor in the Department of Ophthalmology at Baylor College of Medicine, conducted a comprehensive review of the Draize eye test in 2001.
Wilhelmus concluded "The Draize eye test ... has assuredly prevented harm" to humans, but predicts it will be "supplanted as in vitro and clinical alternatives emerge for assessing irritancy of the ocular surface".
Before 2009 the Organisation for Economic Co-operation and Development (OECD) had not validated any alternative methods for testing eye or skin irritation potential.
[20][21] A 1995 study funded by the European Commission and British Home Office evaluated these among nine potential replacements, including the hens' egg chorioallantoic membrane (HET-CAM) assay and an epithelial model cultivated from human corneal cells,[18][22] in comparison with Draize test data.
If a rabbit shows signs of "severe pain" or distress it must be immediately killed, the study terminated and the compound may not be tested on other animals.