Eye Irritation
Strategies for Eye Irritation Testing
Determination of ocular irritation potential is a key toxicological endpoint required to support chemical and raw material characterization and industrial hygiene, to guide product development, and to achieve final product safety standards. IIVS possesses extensive experience with numerous test methods and testing strategies for commercial, industrial and regulatory applications. From standard regulatory hazard assessments to providing information on the degree of ocular irritation, to discriminating among extremely mild eye area products, IIVS’ Study Directors take the time to understand your specific goals and apply the most relevant, cost-effective strategies to achieve them.
Assessing Eye Sting-NociOcular Assay
Many personal care and cosmetic products accidentally contact the eye, which is very sensitive to numerous compounds that would otherwise be benign when applied to the skin. Due to the pain and stinging that is perceived, it is important for manufacturers of these products to be aware of the potential pain perceived should eye contact occur. (more…)
Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification (OECD 492B)
This test method is the first single non-animal eye irritation test method which can be used to distinguish between GHS Category 1, Category 2, and non-categorized substances and mixtures. Until recently, resolving GHS Category 2 Ocular Irritants had relied on a Weight-of-Evidence approach as the use of no single in vitro assay had been able to distinguish between Category 1, Category 2 and non-categorized test materials.With the approval of the OECD 492B test guideline, the determination of these classifications is now possible. (more…)
Eye Irritation Test using Reconstructed Human Corneal Epithelium (RhCE) Models (EIT, OECD 492)
The Eye Irritation Test (EIT) is an OECD-approved in vitro non-animal test method for identifying chemicals and mixtures that may be irritating to the corneal epithelium. The test method utilizes an in vitro reconstructed human corneal epithelium (RhCE) model (EpiOcular™, MatTek Corp. or HCE, SkinEthic™), in an acute exposure assay to support international regulatory labeling requirements, according to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). (more…)
Eye Irritation Time-to-Toxicity Test using Reconstructed Human Corneal Epithelium (RhCE) Models
The ocular irritation potential of formulations, products, ingredients, and chemicals can be evaluated using in vitro reconstructed human corneal epithelium (RhCE) models, such as the EpiOcular™ (MatTek Corp.) and SkinEthic HCE (EPISKIN) organotypic 3-D tissue constructs. Whether evaluating ultra-mild cosmetics and personal care products, or rank ordering the irritation potential of candidate formulations and ingredients, we can provide custom Ocular Screening protocols to best meet your testing goals. (more…)
Bovine Corneal Opacity and Permeability (BCOP, OECD 437) with Optional Histology
The BCOP (Bovine Corneal Opacity and Permeability) assay is an in vitro eye irritation test method developed by Gautheron et al. (1992), which uses living bovine corneal tissue, obtained as a by-product from abattoirs, to evaluate the potential ocular irritancy of a test article. Types of injury caused by exposure to the test article are quantitatively measured by changes in opacity and permeability to fluorescein. (more…)
Short Time Exposure (STE, OECD 491)
The Short Time Exposure (STE) assay, developed by Kao Corporation (Japan), is an in vitro assay used to assess acute eye irritation potential as an alternative to the traditional in vivo Draize test. The test method evaluates the cytotoxicity induced by a series of test chemical dilutions in a monolayer of rabbit corneal fibroblasts (Statens Seruminstitut Rabbit Cornea – SIRC) after a single five-minute exposure. (more…)
Ocular Irritection (OECD 496)
The Ocular Irritection Assay is an in chemico eye irritation assay that detects, ranks, and predicts the corneal irritation potential of a test material. The assay assesses changes to the reagent solution (containing proteins, glycoproteins, lipids), which mimics the denaturation and disruption that occurs in corneal proteins in vivo. (more…)
Assessing Corneal Recovery
Corneal recovery is a key property of ocular irritation classification schemes used in the regulatory arena. However, no current validated non-animal ocular irritation test methods or prediction tools are able to predict corneal recovery in a manner consistent with the animal tests historically employed. Whereas some efforts have been made to demonstrate recovery with in vitro or ex vivo corneal models, the current state of these technologies do not support demonstration of recovery of the corneal stromal elements, which are key to discriminate between moderate and severe irritants. (more…)