Archive

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...

Next Generation Tobacco Products

August 24, 2016
IIVS has a long-standing history of working with various industries to help establish or utilize in vitro models for the prediction of risk and the assessment of products under development. With the Food and Drug Administration extending its authority to all tobacco products (including e-cigarettes, cigars, and hookah) the tobacco industry is faced with the task of assessing product safety for product development and regulatory submission. Further, the manufacture of tobacco products may entail risk to workers that come in...

Household & Cleaning Products

August 24, 2016
The majority of the products manufactured or sold by the Household and Cleaning Products industry are subject to the requirements of the Federal Hazardous Substances Act (FHSA) which mandates that the product have appropriate safety labeling. The FHSA does not specifically require animal testing be conducted to determine if a hazard is present, but historically many companies have used animal testing for this purpose – and have continued to do so because of lack of familiarity with newer, non-animal  methods. IIVS...

Cosmetics & Personal Care

August 24, 2016
European 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...

Pharmaceutical

August 16, 2016
Pharmaceutical 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, 2016
Employers 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, 2016
Agricultural 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...

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...