Archive
Modernization of EPA “6-Pack” of Acute Toxicity Tests Continues
July 27, 2018The US Environmental Protection Agency (US EPA) continues to drive significant efforts in the United States to modernize the battery of acute toxicity tests classically known as the “6-pack.” Learn More....
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...
Addressing the Assignment of US EPA Hazard Categories for Dermal Safety by a Revised Prediction Model of the Validated In Vitro Skin Irritation Test (OECD TG 439)
March 30, 2017One of the current goals of the United States Environmental Protection Agency Office of Pesticide Programs (US EPA OPP) is to replace by non-animal testing methods as many of the endpoints of the battery of acute toxicity tests known as the “6-pack” as possible. One of the “6-pack” tests is the Draize rabbit test for dermal irritation. We investigated whether the validated in vitro Skin Irritation Test (SIT, OECD TG 439) can be used to determine US EPA OPP dermal...
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...
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...
Specialty Chemical
August 24, 2016Specialty chemicals are chemical products identified on the basis of their performance or function, rather than their composition. They can be single-chemical entities or formulations and cover a wide range of product categories such as consumer products, cosmetics, food additives, manufacturing, etc. As a result, testing for these chemicals can include a wide range in the irritation spectrum, from materials that are classified as mild irritants to those that are designated as corrosive. The testing needs also cover a wide range...
Cosmetics & Personal Care
August 24, 2016European 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...
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...