Archive

Direct Peptide Reactivity Assay (DPRA, OECD 442C)

August 24, 2016
The DPRA  (OECD 442C) is an in chemico assay that  models the first key event in the skin sensitization Adverse Outcome Pathway (AOP) - skin, protein reactivity. Compounds implicated in causing Allergic Contact Dermatitis (ACD) are generally electrophilic in nature. This assay identifies dermal sensitizers based on their reactivity with synthetic peptides containing the nucleophilic amino acid residues lysine and cysteine. Using LC/UV, conjugation of the test material with the peptides can be analyzed. Trained by the developers of this assay (Procter & Gamble), IIVS...

Skin Irritation Test (SIT, OECD 439)

August 24, 2016
Skin Irritation Test (SIT) in a Reconstructed Human Epidermis (RhE) Model Skin Irritation in the regulatory hazard classification and labeling context is defined as the production of reversible damage to skin following a defined chemical exposure. The Skin Irritation Test (SIT) is an in vitro, non-animal test designed to identify those chemicals and mixtures capable of inducing moderate skin irritation (UN GHS Category 2 Skin Irritants1), and to discriminate UN GHS Category 2 Skin Irritants from UN GHS 3 Mild Skin...

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...

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...

Corrositex (OECD 435)

August 23, 2016
The Corrositex® assay is a standardized and quantitative in vitro test developed as a replacement for the dermal corrosivity rabbit test. The Corrositex kit, manufactured by In Vitro International (IVI), uses a proprietary biobarrier membrane to model the skin for evaluating the potential dermal corrosivity of a test material. A test material is evaluated based on its penetration through the biobarrier membrane into a Chemical Detection System (CDS). The time required for the test material to break through the biobarrier and into the CDS is...

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...