Ocular Corrosion and Irritation Test Service
Overview Services Applications FAQs
The main goal of scientific research in toxicology is to protect humans from the possible adverse effects of contact with various substances. The contact can be accidental or intentional, such as certain drugs. One of the possible effects of exposure and accidental exposure to new live biotherapeutic drugs is eye corrosion/irritation. Therefore, finding an appropriate method to assess the possibility of eye corrosion/irritation is essential to ensure the personal safety of substances for new drug use. As a leader with extensive experience in live biotherapeutic product development, Creative Biolabs provides animal and non-animal eye irritation/corrosion tests to customers worldwide.
Overview
An integral part of the safety assessment of many types of live biotherapeutic products is to assess the potential for eye injury. Eye irritation and corrosion are the most commonly used evaluation indicators.
-
Ocular corrosion refers to eye tissue damage or severe physical deterioration of vision after using the test substance on the anterior surface of the eye, which is not completely reversible within 21 days after use.
-
Ocular irritation refers to the changes in the eye after the test substance is applied to the anterior surface of the eye, which is completely reversible within 21 days after use.
Our Ocular Corrosion and Irritation Test Services
The ocular surface is a complex system composed of corneal and conjunctival epithelial cells, underlying stroma, and related cells. Its complexity makes it difficult to develop alternative tests with a physiological and mechanical basis that can eliminate animal needs. In addition to the Draize rabbit eye test, we have also carried out a lot of research to find a safer test method to replace the eyes of animals. Among them, the application of tissue culture technology, cell, and molecular biology, and cell analysis technology can bring us closer to our goal, that is, no animals are needed in eye corrosion and irritation tests.
Ocular Corrosion Testing Service
-
Bovine corneal opacity permeability (BCOP) test
-
Isolates rabbit eye test.
-
Fluorescein leakage.
-
Hen's egg test-Chorioallantoic membrane (HET-CAM).
Ocular Irritation Testing Service
-
Red blood cells (RBCs) test.
-
Haemoglobin denaturation test.
-
Short-time exposure (STE) in vitro test.
-
Isolated cornea opacity and permeablity test.
Testing Standards
-
16 CFR Part 1500.42
-
ISO 10993.10-2010
-
Other similar standards.
Samples
-
Drugs
-
Cosmetics
-
Chemicals
-
Others
Turnaround Time
From 4-6 weeks.
Deliverables
Upon completion of the testing services, a final report will be issued.
Applications
-
Learn about product details.
-
Improve product quality.
-
Import and export of products.
-
Product quality control.
-
Publish scientific research.
Frequently Asked Questions
Why ocular corrosion and irritation tests are necessary?
The ocular corrosion and irritation test is essential for assessing the potential health hazards of exposure to chemicals, including liquids, solids, and aerosols, when they come into contact with the eye. Here's why it's necessary:
-
Safety Evaluation: The test provides critical information about the substance's impact on the eye.
-
Product Development: For chemical characterization, industrial hygiene, and product safety standards, understanding ocular irritation potential is crucial. It guides product development and ensures safety.
-
Regulatory Compliance: The test aligns with regulatory requirements. It determines whether a substance requires classification for eye damage or irritation. It's a valuable step in safety assessment.
What are the in vitro models of ocular corrosion and irritation tests?
In vitro models play a crucial role in assessing ocular irritation potential without relying on animal testing. Here are some widely recognized methods:
-
SkinEthic RhCE Test (OECD 492B): This method uses reconstructed human epidermis (RhCE) to mimic the corneal epithelium.
-
EpiOcular Eye Irritation Test (OECD 492): Another RhCE-based test, EpiOcular identifies chemicals that don't require classification.
-
Bovine Corneal Opacity and Permeability Assay (BCOP) (OECD 437): BCOP assesses eye irritation potential using living corneal tissue obtained from abattoirs
-
Isolated Chicken Eye Test (ICE) (OECD 438): ICE is an alternative method that evaluates ocular irritation potential.
In addition to ocular corrosion/irritation testing, Creative Biolabs continues to provide comprehensive toxicology research services for new live biotherapeutic product research. If you are interested in our services, please contact us for more information.
For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.
Related Services
