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3.2.1.: Definitions and general considerations

3.2.1.1.

Skin corrosion means the production of irreversible damage to the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to 4 hours. Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology shall be considered to evaluate questionable lesions.

Skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

3.2.1.2.

In a tiered approach, emphasis shall be placed upon existing human data, followed by existing animal data, followed by in vitro data and then other sources of information. Classification results directly when the data satisfy the criteria. In some cases, classification of a substance or a mixture is made on the basis of the weight of evidence within a tier. In a total weight of evidence approach all available information bearing on the determination of skin corrosion/irritation is considered together, including the results of appropriate validated in vitro tests, relevant animal data, and human data such as epidemiological and clinical studies and well-documented case reports and observations (see Annex I, Part 1, Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5).