Short Time Exposure (STE, OECD 491)

August 24, 2016
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. Two prediction models were initially developed for the STE assay — one categorizes the test material as...

Assessing Eye Sting-NociOcular Assay

August 24, 2016
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. Due to the subjective nature of the unpleasant perception, animal models are inconclusive and may even be prohibited due regulations.  Fortunately, IIVS has developed a...

Eye Irritation Test using Reconstructed Human Corneal Epithelium (RhCE) Models (EIT, OECD 492)

August 24, 2016
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). The Eye Irritation Test can be used to support...

Bovine Corneal Opacity and Permeability (BCOP, OECD 437) with Optional Histology

August 24, 2016
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. The BCOP assay allows for the investigation of the mechanism of the damage caused. Corneal opacity...

Eye Irritation Time-to-Toxicity Test using Reconstructed Human Corneal Epithelium (RhCE) Models

August 24, 2016
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. The Ocular Screening protocols use a time-to-toxicity procedure to determine the test material...

Cosmetics & Personal Care

August 24, 2016
European legislation and US research activities towards ‘21st century toxicology’ are setting the standards for animal-free toxicological assessments and the cosmetics industry has been the first to feel the effects. As per EU Regulation 1223/2009, animal testing of cosmetic ingredients and finished products is currently banned in the EU, as is the marketing of finished cosmetic products and the ingredients contained therein which were tested on animals for cosmetic safety assessment purposes. These bans hold irrespective of the availability of validated...

Pigmentation & Melanogenesis

August 23, 2016
The efficacy of ingredients or final formulations in modulating human skin pigmentation can be assessed in vitro by analysis of melanin production in reconstructed tissue models of various phototypes. In addition, this testing platform is suitable for investigation of the dermal irritation potential of test materials after repeated exposures using a tissue viability endpoint. The evaluation of the potential impact on melanin production of raw ingredients or finished products intended for the modulation of skin pigmentation can be assessed using pigmented...

Webinar: Regulatory Initiatives for New Approaches to Traditional Toxicity Testing

July 1, 2016
This one-hour webinar features presentations by Dr. Jennifer McLain, Deputy Director, Office of Pesticide Programs, Antimicrobial Division and IIVS CEO Dr. Rodger Curren. Dr. McLain discusses the EPA OPP's plans to reduce the use of animal testing in acute toxicity testing and provides suggestions on how stakeholders and EPA can cooperate to advance animal reduction goals. Dr. Curren then talks about IIVS' activities in developing the current non-animal strategy for eye irritation, and recent investigations into in vitro methods to...