Archive
European Partnership Supports IIVS Training of Chinese Scientists in Non-animal Tests
May 9, 2019Gaithersburg, MD – May 8, 2019 – The Institute for In Vitro Sciences, Inc. (IIVS) has received a grant from the European Partnership for Alternative Approaches to Animal Testing (EPAA) to support its annual training of Chinese scientists in non-animal testing methods. As part of the agreement, two scientists from BASF SE, a member of EPAA, will join IIVS to provide hands-on training in China for four non-animal approaches for skin sensitization. This training follows the recent announcement by China’s...
China’s Acceptance of Certain Non-Animal Testing Methods for the Regulation of Cosmetics
April 3, 2019Gaithersburg, MD – April 3, 2019 – The Institute for In Vitro Sciences (IIVS) applauds China’s National Medical Products Administration (NMPA) for their acceptance of certain non-animal (alternative) test methods for the regulation of cosmetics. In a notice issued on March 22, the NMPA drafted acceptance of nine test methods including: Direct Peptide Reaction Assay (DPRA) for Skin Sensitization (OECD TG 442C) Short Time Exposure Assay (STE) for eye irritation (OECD TG 491) These new regulations will go into effect January...
China’s NMPA Approves Two New In Vitro Methods For Regulating Cosmetics
March 22, 2019We are pleased to share that today China’s National Medical Products Association (NMPA) has approved new methods for the regulations of cosmetics. Among these are two in vitro methods: DPRA for skin sensitization and the Short Time Exposure (STE) assay for eye irritation. IIVS’ International Outreach Program introduced these methods during its training program with NMPA and we will continue to support their implementation in key laboratories....
Strategies for Eye Irritation Testing
September 17, 2018Determination of ocular irritation potential is a key toxicological endpoint required to support chemical and raw material characterization and industrial hygiene, to guide product development, and to achieve final product safety standards. IIVS possesses extensive experience with numerous test methods and testing strategies for commercial, industrial and regulatory applications. From standard regulatory hazard assessments to providing information on the degree of ocular irritation, to discriminating among extremely mild eye area products, IIVS’ Study Directors take the time to understand your...
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...
Ocular Irritection (OECD 496)
August 24, 2016The Ocular Irritection Assay is an in chemico eye irritation assay that detects, ranks, and predicts the corneal irritation potential of a test material. The assay assesses changes to the reagent solution (containing proteins, glycoproteins, lipids), which mimics the denaturation and disruption that occurs in corneal proteins in vivo.The test article is applied to a membrane disc that controls the delivery to the reagent solution. The changes in the protein structure are measured by optical density readings in the reagent...
Short Time Exposure (STE, OECD 491)
August 24, 2016The 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...
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...
Eye Irritation Time-to-Toxicity Test using Reconstructed Human Corneal Epithelium (RhCE) Models
August 24, 2016The 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...