Safeguarding End-Users: A Comprehensive Guide to OECD TG 405 Eye Irritation Test
For medical devices and specialty chemicals, whether a product causes harm to the most sensitive human organ—the eye—is a critical focal point for regulatory bodies like TFDA, FDA, and EMA. OECD TG 405 (Acute Eye Irritation/Corrosion) is the globally recognized standard for assessing these risks.
What is OECD TG 405?
OECD TG 405 evaluates the acute effects of a substance applied to the eye. It distinguishes between:
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Eye Corrosion: Irreversible tissue damage (e.g., corneal perforation, persistent opacity) that does not recover within 21 days.
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Eye Irritation: Reversible changes (e.g., conjunctival redness, iritis, corneal cloudiness) that fully resolve within 21 days.
Why is TG 405 Essential for Your Product? -
Critical Risk Assessment: Essential for sprays, ophthalmic devices, or chemicals that might accidentally splash into the eye.
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ISO 10993 Alignment: A core part of "Irritation Testing" within the biocompatibility framework for medical devices.
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Global Market Passport: Reports generated under OECD GLP compliance streamline global registration by minimizing the need for redundant studies.
Technical Advantage: The Tiered Approach
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To prioritize animal welfare and data accuracy, our lab follows the OECD-recommended strategy:
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In-vitro Pre-screening: Utilizing validated methods like OECD TG 437 (BCOP) or TG 438 (ICE) to identify corrosives before considering in-vivo steps.
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Clinical Scoring: Using precise systems to evaluate the Cornea, Iris, and Conjunctiva, tracking both the severity of lesions and the timeline of recovery.
- Test species : Albino New Zealand rabbit
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The objective of this study is evaluation of the eye irritation/corrosion caused by test substance in rabbits. The rabbits will be exposed to the test substance by eye application and observed for at most 21 days. The changes of ocular reactions will be graded and recorded in accordance with the guideline of OECD TG-405.
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