The OECD 405 Test Guideline is used for identifying and evaluating test substances with the potential to cause acute eye irritation or corrosion. At a high level the test involves an initial test on a single test subject using an ophthalmic dosing procedure with a potential confirmatory test on subsequent test subjects. The study design follows the current OECD Test Guideline entitled “Test No. 405: Acute Eye 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 405 Acute Eye Irritation / Corrosion Test is Performed

Within the guidance, if in vivo testing is deemed to be required, the test substance is applied in a single dose to one of the eyes of a single test subject. The untreated eye would be utilized as a control. The eye is examined at pre-specified intervals to assess the degree of irritation or corrosion.  Scoring systems are used to quantify the ocular responses, such as corneal opacity, iritis, conjunctival redness and chemosis.  The test guideline provides recommendations on the use of topical anesthetics, systemic analgesics, and endpoints that minimize distress.

Pending the results of the dosing on the initial test subject, if serious irritation or corrosion are not observed the result may be confirmed with two additional test subjects.  The test subjects are evaluated for no more than 21 days.

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