In cases where promising in vitro or in silico techniques require additional development or validation in order to gain regulatory acceptance, the PETA International Science Consortium and its members assist in providing funding. To date, Consortium members have contributed more than €1,800,000 ($2,000,000) towards improving and implementing nonanimal research methods. Projects funded in part by Consortium members include the advancement of quantitative structure-activity relationship (QSAR) models to estimate chemical carcinogenicity and toxicity, and other nonanimal models to test substances for acute and subchronic toxicity, skin sensitisation and irritation, and endocrine activity, a few of which are described below.
“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
The Consortium is funding a project to develop a nonanimal approach to assess the effects of nanomaterials on the lungs. As part of this project, the Consortium awarded $200,000 to three international laboratories for the development of a nonanimal system to predict pulmonary fibrosis in humans following exposure to nanomaterials.
The increasing use of nanomaterials in consumer products means a greater likelihood of human exposure, and inhalation of nanomaterials has been linked to possible lung effects in humans. Therefore, regulatory agencies such as the US Environmental Protection Agency require that they undergo testing.
The ultimate goal of this project is to develop an animal-free testing strategy using in vitro and in silico tests to reduce and replace the use of animals in the assessment of inhalation toxicity of nanomaterials and other substances.
The Consortium coordinated financial support provided by PETA Foundation UK and PETA Germany for the validation of a 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 is estimated to use hundreds of thousands worldwide. This was the first time an animal rights organisation had supported the validation process for an alternative method in this way.
The SenCeeTox® skin sensitisation assay replaces two dermal sensitisation tests that cause the guinea pigs or mice used in the tests a great deal of suffering. The results obtained with the SenCeeTox® assay also provide additional information, such as potency.
Skin Corrosion and Skin Irritation
Consortium members PETA Foundation UK and PETA US 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 EpiDermTM, which resulted in its acceptance as an OECD test guideline. PETA US also provided funds for a skin corrosion method that was validated to segregate corrosive chemicals into hazard classes, a distinction that is significant under the regulation on the classification, labelling and packaging of substances and mixtures (CLP). The Consortium 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
The Consortium and its members have funded the development of computer models to characterise chemical properties and decrease animal testing. In 2009, members funded a successful international review of a method to predict endocrine activity of chemicals; in 2010 and 2012, members funded a series of workshops to create computer models to predict cancer-causing activity. Computer models developed with the support of Consortium members, including the endocrine model, have been incorporated into a publicly available predictive tool managed by the OECD called the OECD QSAR Toolbox, which 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), the Consortium partnered with computational toxicology experts to train US Environmental Protection Agency regulators in the use of the OECD QSAR Toolbox.
Consortium 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 in Baltimore, Maryland, in May 2012. 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 use of the rodent carcinogen assay. Of particular note, 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 per cent 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
Workshops and Webinars
The Consortium has sponsored various workshops, including one focused on the development of nonanimal methods to examine the subchronic inhalation toxicity of nanomaterials and another on alternative methods for the identification of acute systemic toxicity. In addition, the Consortium has sponsored webinars focused on the use of alternative approaches to meet REACH requirements (here) and to test for acute inhalation toxicity (here).
Contests and Awards
The Consortium holds contests and provides awards such as those listed below to promote the development of alternative test methods.
• Contest for best proposals on uses of in vitro tissue models to reduce animal testing
• Award for adverse outcome pathway development
• Award for the development of a nonanimal system to assess the inhalation toxicity of nanomaterials