Editing Draize test (section)

== Alternatives ==
Industry and regulatory bodies responsible for public health are actively assessing animal-free tests to reduce the requirement for Draize testing. Before 2009 the [[Organisation for Economic Co-operation and Development]] (OECD) had not validated any alternative methods for testing eye or skin irritation potential.<ref>OECD, 1987. Eye irritation testing. OECD guidelines for testing of chemicals. Test guideline 405, Paris.</ref><ref>OECD, 1992. Acute skin irritation and corrosive testing. OECD guidelines for testing of chemicals. Test guideline 404, Paris.</ref><ref>Rodger D. Curren and John W. Harbell, "[http://www.iivs.org/documents/49.pdf Ocular Safety: A Silent (In Vitro) Success Story] {{webarchive |url=https://web.archive.org/web/20071018043132/http://www.iivs.org/documents/49.pdf |date=October 18, 2007 }}", ATLA 30, Supplement 2, 69-74, 2002</ref><ref name=Indans>{{cite journal |author=Indans I |title=The use and interpretation of in vitro data in regulatory toxicology: cosmetics, toiletries and household products |journal=Toxicol. Lett. |volume=127 |issue=1–3 |pages=177–82 |date=February 2002 |pmid=12052656 |doi= 10.1016/S0378-4274(01)00498-2}}</ref> However, since 2000 OECD had validated alternative tests for corrosivity, meaning acids, bases and other corrosive substances are no longer required to be Draize tested on animals.<ref name=Indans/> The alternative tests include a human skin equivalent model and the transepicutaneous resistance test (TER).<ref name=Indans/> In addition, the use of human corneal cell line (HCE-T cells) is also another good alternative method to test eye irritation on potential chemicals.<ref>{{Cite journal|title = A new cell-based method for assessing the eye irritation potential of chemicals: alternative to the Draize test|last = Cho|first = Sun|date = May 15, 2012|journal = Toxicology Letters|doi = 10.1016/j.toxlet.2012.05.004|pmid =22595615|volume=212|issue = 2|pages=198–204}}</ref>

In September 2009 the OECD validated two alternatives to the Draize eye test: the bovine cornea opacity test (BCOP) and isolated chicken eye test (ICE).<ref>{{cite web|url=http://tsar.jrc.ec.europa.eu/index.php?endpoint=2&method=1 |title=TSAR (Tracking System for Alternative test methods Review Validation and Approval in the Context of EU Regulations on Chemicals) |publisher=Tsar.jrc.ec.europa.eu |access-date=2012-08-13}}</ref><ref>{{cite web|url=http://tsar.jrc.ec.europa.eu/index.php?endpoint=2&method=2 |title=TSAR (Tracking System for Alternative test methods Review Validation and Approval in the Context of EU Regulations on Chemicals) |publisher=Tsar.jrc.ec.europa.eu |access-date=2012-08-13}}</ref> 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,<ref name=Indans/><ref>{{cite journal  |vauthors=Doucet O, Lanvin M, Thillou C, etal |title=Reconstituted human corneal epithelium: a new alternative to the Draize eye test for the assessment of the eye irritation potential of chemicals and cosmetic products |journal=Toxicol in Vitro |volume=20 |issue=4 |pages=499–512 |date=June 2006 |pmid=16243479 |doi=10.1016/j.tiv.2005.09.005 |bibcode=2006ToxVi..20..499D }}</ref> in comparison with Draize test data.<ref>{{cite journal |title=Toxicology in Vitro : The EC/HO international validation study on alternatives to the draize eye irritation test |doi=10.1016/0887-2333(95)00092-5 |pmid = 20650169|volume=9 |issue=6 |journal=Toxicology in Vitro |pages=871–929|year=1995 |last1=Balls |first1=M. |last2=Botham |first2=P.A. |last3=Bruner |first3=L.H. |last4=Spielmann |first4=H. }}</ref> The study found that none of the alternative tests, taken alone, proved to be a reliable replacement for the animal test.<ref name=Indans/>

Positive results from some of these tests have been accepted by regulatory bodies, such as the British [[Health and Safety Executive]] and US [[Department of Health and Human Services]], without testing on live animals, but negative results (no irritation) required further ''in vivo'' testing.<ref name=Indans/> Regulatory bodies have therefore begun to adopt a tiered testing strategy for skin and eye irritation, using alternatives to reduce Draize testing of substances with the most severe effects.<ref name=Indans/><ref>{{cite web |url=http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox.htm |title=NICEATM-ICCVAM - In Vitro Ocular Test Methods - Overview |url-status=dead |archive-url=https://web.archive.org/web/20120224201649/http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox.htm |archive-date=2012-02-24 }}</ref>