Documents & Resources

International Harmonization and Cooperation in the Validation of Alternative Methods

September 27, 2016

The development and validation of scientific alternatives to animal testing is important not only from an ethical perspective (implementation of 3Rs), but also to improve safety assessment decision making with the use of mechanistic information of higher relevance to humans. To be effective in these efforts, it is however imperative that validation centres, industry, regulatory bodies, academia and other interested parties ensure a strong international cooperation, cross-sector collaboration and intense communication in the design, execution, and peer review of validation studies. Read chapter.

Implementation of New Test Methods into Practical Testing

September 27, 2016

New toxicology test methods, especially those using in vitro methods, are continually being developed. Some are used by industry for screening purposes; others are eventually validated for regulatory use. However, for a new test method to be firmly adopted by industry it must be readily available, generally through an in-house industry laboratory, an academic laboratory, or a contract research organization. Read chapter.  

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 ...

Bridging the Gap Between Regulatory Acceptance and Industry Use of Non-animal Methods

June 2, 2016

Clippinger, AJ, Hill, E, Curren, R, Bishop, P. Alternatives to Animal Experimentation (ALTEX)

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Evaluation of the Validated In Vitro Skin Irritation Test (OECD TG 439) for the Assignment of EPA Hazard Categories

April 1, 2016

Progress within the in vitro toxicology field has made available testing platforms based on reconstructed tissue models that are validated to address the skin corrosion and irritation endpoints. While the validated in vitro assays can be used for the hazard identification of chemicals irritant to skin in accordance with the United Nations (UN) Globally Harmonized System (GHS) for Classification and Labeling of Chemicals, they were not calibrated to address the classification system used by the United States Environmental Protection Agency (US EPA).