TEST METHODOECD 492

In-vitro eye irritation testing for biocides, chemicals and cosmetics
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Eye irritation testing is performed using the EpiOcular model, which utilizes Reconstructed Human Cornea-Like Epithelium (RhCE). This method follows OECD 492, an internationally recognized guideline for assessing the eye irritation potential of biocides, chemicals, and cosmetics—without the need for animal testing.
The diagram below provides a summary of the test method according to OECD 492.
OECD 439
TESTING CRITERIA AND CUSTOMER PROCESS
Step 1: Is your product a chemical or medical device?

OECD 492 is specifically designed for hazard identification of eye irritant chemicals, biocides, and cosmetics.

If your product is a medical device, eye irritation testing may still be required, but there is no dedicated ISO 10993 standard for in vitro eye irritation testing. Thus, this method may be used to screen for the eye irritation potential of medical devices, depending on the specific regulation.

Step 2: What is the exposure time and condition?

The test substance is applied directly onto the Reconstructed Human Cornea-Like Epithelium (RhCE) for

  • Liquid samples: 30 minutes at 37°C
  • Solid samples: 6 hours at 37°C
Step 3: What is the passing criteria?

If cell viability after post-exposure incubation is ≤ 60%, the tested product is classified as Irritant

If cell viability after post-exposure incubation is > 60%, the tested product is classified as Non-Irritant.

*Irritant products may require further testing for classification of hazard depending on specific regulations.

Step 4: How does this relate to EU and GHS Hazard Classification?

If the product is classified as Non-Irritant, it is not assigned a GHS category.

If the product is classified as Irritant, further testing may be required to differentiate between GHS Category 1 (Serious Eye Damage) and GHS Category 2 (Eye Irritation).

For irritant products, the GHS hazard classification can be further predicted using a modified protocol or the EPA Eye Irritation Hazard classification with the MTT ET50 Assay.

Step 5: Place an order and send your sample to us

Fill in the test request form and place an order via email at info@tecolab-global.com. We will advise on the quantity of sample required for testing.

You can deliver the sample to us via courier or utilize our sample delivery service. We will monitor the delivery status and inform you when we receive the sample.

Step 6: Track the status of your request

Once we have received your sample, we will provide a tracking number to you. You can easily track the status of your request here.

Step 7: Download your password-protected test report

Download your readily available test report online with just a single click using the link and password provided via email notification. We will receive a notification once you have downloaded the test report.

For safety purposes, the uploaded test report will self-destruct after 7 days.

**Disclaimer: NO ANIMAL TESTING. TECOLAB is committed to ethical and cruelty-free testing practices. We do not conduct any form of testing on animals and all our biocompatibility tests are performed on in-vitro models.