OECD 404: Acute Dermal Irritation/Corrosion

The Acute Dermal Irritation/Corrosion test is used to assess the localized toxic effects, irritation or corrosion resulting from a topical exposure of the skin to a substance. The test involves applying the test substance to the skin of laboratory animals and observing the resulting skin reactions. The study design follows the current OECD Test Guideline 404 entitled “Acute Dermal Irritation/Corrosion” and is typically performed on rabbits and in accordance with Good Laboratory Practice regulations.  This test is part of the Acute Toxicity Six-Pack tests.

How the OECD 404 Acute Dermal Irritation/Corrosion Test is Performed

If in vivo testing is required as a result of evidence from previous in vitro testing, the initial OECD 404 test itself is initially performed on a single test subject.  This test subject will have up to three test patches applied to a small area (approximately 6 cm²).  The test patches are kept on the test subject for varying time periods of up to 4-hours in length.  In the event a corrosive effect is observed after any of the exposures, the test is immediately terminated. If a corrosive effect is not seen, the following process occurs:

  • The test subject is observed for 14-days to verify the result and ensure that no irritation or corrosion occurs during the observation period; and
  • Per the OECD 404 test guidance, two additional test subjects will have the test article applied for a four-hour exposure period to verify this result.

Typically 10 grams of test article are required. This test is performed in compliance with Good Laboratory Practice Regulations.

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