TEST METHODEye Irritation Categorization Test

Using MTT ET-50 Protocol to categorize eye irritation of biocides, chemicals and cosmetics via in-vitro models
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The Neat Protocol MTT ET50 Assay is an advanced in vitro method for assessing eye irritation potential without the need for animal testing. This assay utilizes the EpiOcular model, a Reconstructed Human Cornea-Like Epithelium (RhCE), to evaluate ocular irritation based on exposure time and cell viability reduction to 50% (ET50 values). The ET50 value (in minutes or hours) determines the eye irritation potential and can also be used for EPA hazard classification.

The diagram below provides a summary of the test method.

MTT ET-50
TESTING CRITERIA AND CUSTOMER PROCESS
Step 1: Is your product a chemical or medical device?

The Neat Protocol MTT ET50 Assay is designed for the hazard identification of 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: Is the product expected to cause eye irritation?

If you do not expect your product to cause eye irritation, you may opt for OECD 492 to confirm that your product is non-irritating.

If your product might cause eye irritation, this assay can evaluate ocular irritation potential based on ET50 values. The ET50 value can help determine the severity of eye irritation and classify the product using EPA hazard classification.

Step 3: What is the exposure time and condition?

Standard Method Exposure Times: 3 min, 30 min, and 60 min

EPA Hazard Classification Exposure Times: 2 min, 15 min, 45 min, and 90 min

Step 4: What is the passing criteria?

Based on the standard method:

ET50 (min)
IRRITANCY CLASSIFICATION
>60
No or minimal irritation
30-60
Mild irritation
3-29.99
Moderate irritation
<3
Severe/extreme irritation

Based on EPA classification:

ET50 (min)
EPA IRRITANCY CATEGORY
IRRITANCY CLASSIFICATION
<4
EPA Category I
Causes irreversible eye damage
>4-<70
EPA Category III
Causes moderate eye irritation
>70
EPA Category IV
No irritation or minimal effects
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.