OECD Test Guideline 437: Bovine Corneal Opacity and Permeability (BCOP) Test
Purpose of BCOP test
The primary purpose of the BCOP test is to evaluate the hazard of chemicals inducing eye damage through changes observed in both the opacity and the permeability of the bovine cornea, which is a part of the eye that plays a crucial role in focusing vision.
Eye irritation test - BCOP assay
- To determine the eye irritation of a test substance, it is applied to the cornea of a cow.
- The opacity (cloudiness) and permeability of the cornea are then measured.
- These measurements are used to calculate the OcularIrritation Index (IVIS), which is indicative of the test substance’s eye irritation potential.
- Based on the opacity and permeability measurements obtained from the corneal exposure test, the ocular irritation index (IVIS) is calculated.
This index serves as a quantitative measure to evaluate the eye irritation potential of the test substance.
Test Process
Step 01
Preparation
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- Obtain fresh bovine eyes from slaughterhouses to ensure that the corneas are similar in physiologic condition to those in live animals.
- Isolate the corneas carefully to keep them intact and mount them in a special holder that exposes only the corneal surface.
Step 02
Treatment Application
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- Apply the test substance to the corneal surface. Depending on the guideline and specific test requirements, this can involve solid, liquid, or semi-solid substances.
- Expose the cornea to the test substance for a specified duration, typically around 10 minutes for liquids and possibly longer for solids.
Step 03
Assessment of Opacity
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- Measure the initial corneal opacity using an opacitometer before the application of the test substance.
- After exposure, wash the substance off and measure the post-treatment corneal opacity.
- Determine the increase in opacity caused by the test substance.
Step 04
Permeability Measurement
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- Introduce a fluorescein dye solution into the anterior chamber of the cornea post-treatment.
- After a specified incubation period, measure the amount of dye that has permeated to the posterior side of the cornea using a spectrophotometer.
- This permeability is indicative of damage to the corneal epithelium.
Step 05
Data Analysis
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- Calculate the In Vitro Irritancy Score (IVIS) based on changes in both opacity and permeability.
- Compare the IVIS against standard criteria to classify the eye irritation potential of the test substance.
Step 06
Classification
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- Substances are categorized based on their IVIS as either not classified, irritating, or corrosive to the eye.
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Frequently Asked Questions
What is the BCOP assay (OECD TG 437)?
The BCOP assay is an OECD-validated in vitro test that evaluates the potential of substances to cause serious eye damage by measuring corneal opacity and permeability in bovine corneas.
What regulatory purpose does OECD TG 437 serve?
OECD TG 437 is used to identify GHS Eye Damage Category 1 substances and is widely accepted for regulatory safety assessment and hazard classification.
Which products can be tested?
This assay is suitable for industrial chemicals, cosmetic ingredients and formulations, agrochemicals, and pharmaceutical compounds, including both liquids and solids.
Is the BCOP assay animal-free?
Yes. The method uses bovine corneas sourced as by-products from the food industry and does not involve live animal testing, supporting 3Rs and alternative testing strategies.
How are results reported?
Results are reported as an In Vitro Irritancy Score (IVIS) with clear interpretation based on OECD TG 437 decision criteria to support regulatory submissions.