Long abstract

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Skin irritation refers to the production of reversible damage to the skin following the application of a test chemical for up to 4 hours [as defined by the United Nations (UN) Globally Harmonized System of Classification and Labelling of Chemicals (GHS)](1). This Test Guideline provides an in vitro procedure that allows the hazard identification of irritant chemicals (substances and mixtures) in accordance with GHS Category 2 (1)(2), as well as non-classified chemicals, i.e. GHS No-Category, for member countries or regions that do not adopt the optional Category 3 (mild irritants). Depending on regulatory requirements and the classification system in use, the test method can allow determining the skin irritancy of chemicals as a replacement for in vivo skin irritation testing, as a screening test, or within a tiered testing strategy in a weight of evidence approach (3).