OECD Test No. 431 In vitro skin corrosion Human skin model test.pdf

OECD/OCDE 431 Adopted : 13 April 2004 1/8


 

  

         1. Skin corrosion refers to the production of irreversible tissue damage in the skin following the application of a test material [as defined by the Globally Harmonised System for the Classification and Labelling of Chemical Substances and Mixtures (GHS)] (1). This Test Guideline does not require the use of live animals or animal tissue for the assessment of skin corrosivity. 2. The assessment of skin corrosivity has typically involved the use of laboratory animals (2). Concern for the pain and suffering involved with this procedure has been addressed in the 2002 revision of Guideline 404 and the supplement to guideline 404 that allows for the determination of skin corrosion by using alternative,
methods, avoiding pain and suffering of animals. 3. The principal obstacle to completely replacing
testing for skin corrosion in Guideline 404 has been the lack of formal, independent, validation of
  tests. A first step towards defining alternative tests that could be used for skin corrosivity testing for regulatory purposes was the conduct of prevalidation studies (3). Following this, a formal validation study of
 methods for assessing skin corrosion (4)(5) was conducted (6)(7)(8). The outcome of these studies and other published literature (9) led to the recommendation that the following tests could be used for the assessment of
  skin corrosivity (10)(11)(12)(13): the human skin model test (this Guideline) and the transcutaneous electrical resistance test (see Test Guideline 430).   4. Definitions used are provided in the Annex.   5. Validation studies have reported that tests employing human skin models (3)(4)(5)(9) are able to reliably discriminate between known skin corrosives and non-corros