In cases where promising in vitro techniques require additional development or validation in order to gain regulatory acceptance, PISC members assist in providing funding. To date, PISC members have contributed more than €1,600,000 ($1,800,000) toward improving and implementing nonanimal research methods. Projects funded in part by PISC members include the advancement of QSAR models to estimate chemical carcinogenicity and toxicity and other nonanimal models to test chemicals for acute toxicity, skin sensitisation and irritation, and endocrine activity.
“PETA has been at the technical forefront of the animal protection community in its campaign to replace animal methods with in vitro methods in regulatory toxicity testing. Importantly, they have backed up their activities with real dollars to support the development of nonanimal methods.”
Dr. Rodger Curren
Institute for In Vitro Sciences
PISC is coordinating financial support provided by PETA Foundation UK and PETA Germany, the largest European members of PISC, for the validation process for a new nonanimal method to assess skin sensitisation. The current test using mice or guinea pigs uses tens of thousands of animals in the EU each year and can be estimated to use hundreds of thousands worldwide. It is used extensively in the evaluation of cosmetics and toiletries ingredients as these are applied to the skin. This is the first time any animal rights organisation has supported the validation process for an alternative method in this way.
The CeeTox assay to assess dermal sensitisation can be used to significantly reduce or completely replace the need for animal testing. This nonanimal assay replaces two dermal sensitisation methods that cause a great deal of suffering to the guinea pigs or mice who are used. The results obtained with the CeeTox assay also provide additional information, such as potency. This project has been very successful and is now entering the third, and final, stage of the validation process.
Skin Corrosion and Skin Irritation
PISC members PETA Foundation UK and PETA US, in consultation with PISC, have funded the development and optimisation of methods to strengthen nonanimal dermal corrosion and irritation testing used for the transportation of chemicals and hazardous materials. PETA Foundation UK provided funding towards the final validation of Epiderm, which resulted in its acceptance as an OECD test guideline. PETA US is providing funds for a skin corrosion method that is being additionally validated to segregate corrosive chemicals into hazard classes, a distinction that is significant under the Classification, Labeling and Packaging of Substances and Mixtures (CLP) regulation. PISC and its members continue to work on international harmonisation with this two-level hazard classification, which could dramatically reduce the number of rabbits used to satisfy transportation regulations in the EU, US and elsewhere.
“MatTek is extremely gratified to be recognized by PETA and appreciates PETA’s support in its quest to produce new and improved in vitro test methods that reduce or eliminate animal testing.”
Dr. Mitch Klausner
Vice President of Scientific Affairs
Computer Models and QSARs
PISC members, in some instances in association with PISC, have funded the development of computer models to characterise chemical properties and reduce animal testing. In 2009, members funded a successful international review of a method to predict endocrine activity of chemicals, and in 2010 and 2012 members funded a series of workshops to create computer models to predict cancer-causing activity. Computer models developed with PISC-member support, including the endocrine model, have been incorporated into a publicly available predictive tool managed by the OECD. The OECD “QSAR Toolbox” is now widely used to fulfil data requirements for regulatory programmes around the globe. As part of the International Council on Animal Protection in OECD Programmes (ICAPO), PISC partnered with computational toxicology experts to train U.S. Environmental Protection Agency regulators on use of the OECD Toolbox.
PISC member PETA US funded the 2nd McKim Workshop on Reducing Data Redundancy in Cancer Assessment, which was hosted by the International QSAR Foundation and held on 8-10 May 2012 in Baltimore, Maryland. Participants reviewed recent developments in QSAR screening methods for grouping chemicals based on their potential to cause cancer through epigenetic pathways and evaluated the combined use of structural domains and in vitro data to reduce the need for the rodent carcinogen assay. In particular, Romualdo Benigni, of the Istituto Superiore di Sanità in Rome, Italy, described his PETA US-funded research demonstrating that a tiered approach including the Ames bacterial test, newly identified structural alerts and an in vitro cell transformation assay correctly detects 90 to 95 percent of carcinogens tested.
“The science PETA is sponsoring is critical to the elimination of animal use. PETA puts its money where its mouth is and has steadfastly supported better use of science to reduce reliance on animal testing.”
Dr. Gilman Veith
Chair of the Board
International QSAR Foundation