AXLR8, a European Commission-funded initiative, has been launched as part of an effort to revolutionise chemical and drug-safety testing with cell- and computer-based methods.
According to experts, the successful transition to '21st century toxicology' could mean the end of animal testing as it exists today, sparing at least a million animals from suffering and death each year in the EU alone.
AXLR8 is a collaboration between the Humane Society (HSI) and academic scientists, and technical experts from Germany and Belgium.
The initiative, which has been awarded a EUR0.5m (GBP0.4m) grant from the European Commission under the 7th Framework Programme for Research and Technology Development, will help to monitor and support European research to modernise the science of safety testing, and strengthen international coordination in this area.
The vision is said to be a future in which most toxicity testing is carried out using a combination of computer modelling and human-cell tests, which can already be performed using high-throughput testing robots capable of working nearly 1,500 times faster than a human technician.
Troy Seidle, director of research and toxicology for HSI, said: 'Exposing relatively short-lived animals to unrealistic doses of chemicals in sterile laboratory conditions is a primitive approach to assessing chemical effects on humans in real-life conditions.
'If utilised to their full potential, cell- and computer-based methods could transform toxicity testing, making it quicker, cheaper and more applicable to real-life human exposure scenarios.
He added: 'As well as having enormous benefits for human health and environmental protection, this transition towards 21st century toxicity could significantly reduce and ultimately replace testing on animals.' In 2007 the US National Research Council published the report 'Toxicity testing in the 21st century: a vision and a strategy', calling for just such an overhaul of safety testing.
As a result, US regulatory and research agencies joined forces under 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.
Toxicity data are needed to evaluate chemicals used in everything from cosmetics and household cleaners to pharmaceuticals, food additives and pesticides.
However, scientists and legislators across the EU and US are coming to recognise that conventional tests, in which animals such as rodents, rabbits and dogs are given unrealistically large doses of chemicals, are too costly, time consuming and of uncertain relevance to human health effects to meet the demands for better and faster data - as part of new chemicals regulation such as REACH.
A recent report by the US Food and Drug Administration estimates that new drug candidates have only an eight per cent chance of reaching the market, in large part because animal studies so often 'fail to predict the specific safety problem that ultimately halts development'.
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 EUR3m (GBP2.6m).
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.
This mechanistic approach involves a virtual dissection of the human body into its various cell types and then tests each of these cell types individually for different types of toxic response.
Computerised biology and pharmacokinetic models are then used to recreate the whole body scenario and relate conditions at the cellular level to expected real-world conditions for a living, breathing human being.
HSI and its affiliates are said to be spearheading initiatives in the EU and US to achieve this transition away from observing gross pathological effects in chemically overdosed animals to one based on studying how chemicals interact with cellular pathways in the human body at environmentally relevant exposure levels.
Dow, Dupont, Johnson and Johnson, Procter and Gamble, and Unilever have joined forces with HSI and its affiliates to add corporate support to help bring about the evolution in toxicology.
In the EU, the HSI-envisioned AXLR8 initiative will bring together leading scientists to advise the European Commission regarding future research needs and priorities to transition towards 21st century toxicology.
