Archive
Webinar: How GLPs Enhance the Quality of Regulated and Non-Regulated Toxicology
October 18, 2016This one-hour webinar, led by IIVS Director of Quality and Compliance, introduces some of the concepts of Good Laboratory Practices (GLPs) designed to promote study and data integrity within an in vitro toxicology framework. Applying these concepts within your own laboratory should aid in production of robust, repeatable studies. View Slides...
Human Cell Line Activation Test (h-CLAT, OECD 442E)
August 24, 2016The human Cell Line Activation Test (h-CLAT) is a cell-based assay that identifies skin sensitizers by examining changes in the expression of cell surface markers (CD54 and CD86) implicated in dendritic cell activation, the third key event of the skin sensitization AOP. Following exposure of the THP-1 human monocyte cell line to the test substance, expression levels of CD54 and CD86 are quantified by flow cytometry and compared to controls. The method has been reviewed by the European Union Reference Laboratory for...
Direct Peptide Reactivity Assay (DPRA, OECD 442C)
August 24, 2016The 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...
Dermal Irritation Time to Toxicity
August 24, 2016Product development/product stewardship scientists and formulators typically find it desirable to compare or rank order the skin irritation potential of candidate formulations, or to monitor the impact of changes in formulations or ingredients on skin tolerance. Foremost, industry researchers need timely, accurate, cost-effective test results to help them get safer products to the marketplace. The Dermal Irritation Screening assay using a Time-to-Toxicity (ET50) protocol coupled with IIVS’ expertise in the methods help researchers meet their testing goals. The assay is designed...
Skin Irritation Test (SIT, OECD 439)
August 24, 2016Skin 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...
Eye Irritation Test using Reconstructed Human Corneal Epithelium (RhCE) Models (EIT, OECD 492)
August 24, 2016The 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, 2016The 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...
Corrositex (OECD 435)
August 23, 2016The 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...
Occupational Safety & Industrial Hygiene
July 28, 2016Employers are required to inform workers of the hazards of the chemicals or products that they are using. Many in vitro assays are suited to accomplish this goal. As Hazard Communication is now aligned with the Globally Harmonized System (GHS), assays that are approved for assigning GHS hazard categories can provide a method for properly labelling chemicals and preparing safety data sheets. Skin Corrosion assays (Reconstructed Human Epidermis (OECD TG 431) and Membrane Barrier Test (OECD TG 435)) can be used...