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July 14, 2010

Q&A About the AXLR8 Project

AXLR8

Q: What is AXLR8?

A: AXLR8 (=accelerate) is a European Union-funded initiative being coordinated by Humane Society International and scientists from the Free University of Berlin and the Flemish Institute for Technological Research. AXLR8 is designed to speed up the transition toward a "21st century" cell- and computer-based approach in chemical and drug safety testing. AXLR8 was launched in January 2010 as part of growing international efforts to modernize the science of safety testing by moving away from decades-old animal toxicity tests. If successful, 21st century toxicology could mean the end of animal testing as it exists today, sparing more than a million animals from suffering and death each year worldwide.

Q: Why change the way we do safety testing?

A: Toxicity data are needed in order to evaluate chemicals used in everything from cosmetics and household cleaners to pharmaceuticals, food additives, and pesticides. But the current testing approach is dominated by tests on animals such as rodents, rabbits and dogs, which are decades old, time-consuming, costly and of questionable relevance to human beings under real-world exposure conditions. They also cause suffering to millions of animals globally.

Such unreliable and lengthy test regimes are failing to meet the demands of new chemicals regulations, which require better and faster data. However, dramatic advances in molecular and cellular biology have made available a wide range of new research tools that can more accurately study the effects of chemicals on cells, tissues and organisms in a rapid and cost-efficient manner. If initiatives like AXLR8 are successful, in the not-so-distant future most toxicity testing could be carried out using a combination of computer modeling and human cell tests, using super-fast testing robots capable of working nearly 1,500 times faster than a human technician.

Q: Will a transition to 21st century toxicity benefit consumers?

A: Yes. It’s in all our interests to improve the credibility of safety testing techniques because regulators rely on safety data as a vital part of their assessment and evaluation of a chemical’s safety for human use and environmental release. Time-consuming and costly animal tests can significantly delay proper regulation, and if the results they produce are of questionable relevance to humans, there are also concerns about how effective regulation can be in properly protecting consumers. For example, to evaluate the cancer-causing potential of a single chemical in a conventional rodent test takes up to five years, 800 animals and 3 million Euros ($3,700,000). For the same price and without any use of animals, as many as 350 chemicals could be tested in less than one week in 200 different cell or gene tests using a robot-automated high throughput approach.

Q: How does 21st century toxicity testing work?

A: Instead of observing signs of severe sickness or death in chemically overdosed animals, the new approach is based on studying how chemicals interact with cellular “pathways” in the human body at environmentally relevant doses. Because the key to understanding adverse toxic effects lies at the cellular level, this mechanistic approach involves looking at the human body system according to its various cell types (brain, skin, lung, liver, etc). Each of these cell types is then individually tested in cell culture for different types of toxic response. In order to reconstruct the whole body scenario again, highly sophisticated computer-based approaches, called “systems biology” and “pharmacokinetic models,” are used. These relate toxicity data at the cellular level to expected real-world conditions for a living, breathing human being.

Q: What will AXLR8 do?

A: Across the European Union, there are many different research groups developing new 3Rs (replacement, reduction and refinement) test methods and strategies as modern alternative approaches to safety testing on animals. AXLR8 will act as a focal point for dialogue and collaboration among these EU, national and international 3Rs research projects, monitoring their progress through a series of annual scientific workshops and thereby in order to identify knowledge gaps and recommend strategic priorities for future research. Annual progress reports will be prepared and disseminated along with a recommended R&D roadmap to help the European Commission determine future EU research priorities. Stakeholder engagement will be vital, in particular regulators, to ensure that authorities are kept informed of progress at the R&D level and that regulatory considerations are understood and fed back to the scientists developing 3Rs/21st century approaches to safety assessment.

Q: Is the United States engaged in 21st century toxicity activity?

A: Absolutely, in fact much of the momentum behind the aim of a global transition to more modern and humane approaches in toxicity testing began in the United States. In 2007, the United States National Research Council published the influential report “Toxicity Testing in the 21st Century: a Vision and a Strategy,” calling for an overhaul of safety testing. As a result, U.S. regulatory and research agencies joined forces under the banner of the “Tox21” initiative to advance the scientific understanding of cellular mechanisms by which chemical toxicity occurs, and to develop more predictive methods for safety testing. In 2009, experts from six continents representing industry, academia, in vitro sciences and animal welfare, endorsed a global resolution endorsing the NRC vision.

Q: What is HSI doing to promote 21st century toxicity internationally?

A: In addition to co-running AXLR8, Humane Society International and its affiliates have enlisted some of the globe’s largest consumer product, chemical and pharmaceutical companies to help bring about a revolution in toxicology. Participants include Dow, DuPont, Exxon-Mobil, Johnson & Johnson, Procter & Gamble and Unilever. Mapping the cellular pathways of the human body and developing targeted research programs, is an ambitious “big biology” project that could take upwards of 10 years. It will require international collaboration and substantial investment, which is why HSI is working on both sides of the Atlantic to bring together international experts comprising academia, industry, government and regulators.

Q: Where can I find out more about AXLR8?

A: Visit AXLR8.eu.

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