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OptiSafe Test Method

OptiSafe is an in vitro test method in which a test substance is applied to a semipermeable membrane. Damage to macromolecules in the membrane is measured to assess the test substance’s potential to cause eye irritation.

NICEATM coordinated a validation study of the OptiSafe test method to demonstrate the accuracy and reliability of the method among the test method developer’s laboratory and two naïve laboratories (Choksi et al. 2020). Members of the ICCVAM Ocular and Dermal Irritation Workgroup comprised the validation management team for the study, and the study received support from an NIEHS Small Business Innovation Research grant. The study demonstrated that the OptiSafe method is useful for identifying non-surfactant substances that do not require classification for ocular irritancy and thus can reduce the use of animals for this type of testing. OECD is currently considering revising its Test Guideline 496 for in vitro test methods for eye irritation to include the OptiSafe method.