Archive
Regarding the References for Reference Chemicals of Alternative Methods
March 18, 2019The selection of reference and proficiency chemicals is an important component of method validation and proficiency evaluations. Reference chemicals are a set of test substances used by a method developer to evaluate there liability and relevance of a new method, in comparison to reference data (usually to a validated reference method). Proficiency chemicals, as defined in OECD Guidance Document on Good In Vitro Method Practices, are defined post validation as a subset of the reference chemicals, or other chemicals with...
Tiered In Vitro Testing Strategy For Assessing The Ocular and Dermal Irritation/Corrosion Potential of Pharmaceutical Compounds
July 23, 2018Read our latest publication with Bristol-Myers Squibb regarding a tiered testing strategy for occupational hazards of pharmaceutical intermediates now published in the Cutaneous and Ocular Toxicology Journal. Irritation reactions are a frequently reported occupational illness. The potential adverse effects of pharmaceutical compounds (PCs) on employees' eyes and skin can now be assessed using validated in vitro methods. Our overall aim is to reduce animal testing by replacing the historically utilized in vivo test methods with validated in vitro test methods which accurately determine the ocular...
In Vitro Assessment of Skin Irritation Potential of Surfactant-based Formulations by Using a 3-D Skin Reconstructed Tissue Model and Cytokine Response
January 24, 2017The personal care industry is focused on developing safe, more efficacious, and increasingly milder products, that are routinely undergoing preclinical and clinical testing before becoming available for consumer use on skin. In vitro systems based on skin reconstructed equivalents are now established for the preclinical assessment of product irritation potential and as alternative testing methods to the classic Draize rabbit skin irritation test. We have used the 3-D EpiDerm™ model system to evaluate tissue viability and primary cytokine interleukin-1α release...
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...
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...
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...
Pharmaceutical
August 16, 2016Pharmaceutical companies can use in vitro testing for assessing worker safety. Pharmaceutical intermediates should be evaluated to determine the primary hazards associated with them so that those involved in the manufacturing process can take necessary precautions to avoid hazardous exposures. Pharmaceutical compounds can vary widely in their physical forms, such as powders, liquids, and creams. Many in vitro assays such as those using 3-dimensional tissue constructs, and the Bovine Corneal Opacity and Permeability (BCOP) Assay, are suitable for testing different test...
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...
Agro/Petrochemical
July 28, 2016Agricultural chemicals consist of multiple product types including fertilizers, pesticides, and herbicides. As a result, these chemicals can cover a wide range in the irritation spectrum, from materials that are classified as mild irritants to those that are designated as corrosive. Classification is needed for registration through organizations such as the US EPA, REACH, or Brazil ANVISA. Multiple in vitro assays have OECD test guidelines that can be used to provide GHS hazard classifications that may meet necessary testing requirements. Ocular...