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The Concept explained

IntroductionChemical safety and animal testing became connected in the 50ies and 60ies of last century. At that time more and more chemicals were used in a large range of applications and products. This was followed by the identification of an increasing number of chemical pollutants in our environment and food. At the same time new technology e.g. auto-analysers changed clinical medicine. It allowed testing large numbers of blood and urine samples for an increasing range of compounds. This very same technology could now be applied in laboratory animals. Screening of large numbers of animals for a wide range of biological variables at a reasonable cost had become possible. This linked safety assessment and animal testing.SafetySociety expects the air they breathe, the food they eat, the water they drink and the products they use to be safe. Unfortunately, today’s reality is that chemical safety of air, water, food, medicines, cosmetics, products for personal hygiene, cleaning agents, fertilisers and any other products can only be guaranteed when animal testing has been involved. Notwithstanding the development of additional test batteries and improved test strategies aiming at reducing and refining animal testing no alternative for testing in animals for safety reasons has been found yet!Current practice applies large safety factors to animal data when assessing safe levels for man, animals and the environment. This approach has proven to be reasonably effective in protecting health. Animal Testing.Since the late 50ies of the last century much time and energy has been invested in animal welfare. It was based on the principle of the 3Rs; refining, reducing and replacing developed by Russell and Burch in 1959. Animal testing is being carried out for a variety of very different reasons. A distinction can been made between animal testing for safety reasons i.e. health protection and animal testing for other reasons such as science, research & development of medicines and pesticides and for quality control in vaccine production.About 10% of all animal testing is carried out to generate data for safety assessment amounting to about one million animals per annum in the European Union and other European countries such as Switzerland. It is expected that a similar percentage applies to the rest of the world but there are no reliable absolute numbers available. ASAT –Assuring Safety without Animal Testing- is different from the many existing research efforts in the area of chemical safety because it focuses on risk assessment and public health protection. Its perspective is to make testing of chemicals in animals redundant. ASAT takes advantage of rapid advances in science and technology. Current toxicological approach to safety involves extrapolating animal data to man. ASAT does not require extrapolating from animal data. It is reverse engineering our current approach. It replaces today’s paradigm by assessing what health risks have to be managed for a specific chemical (or chemicals) and its application. A thorough understanding of the biological mechanisms, networks and processes in man responsible for the health risks of concern (e.g. hepatitis, skin irritation, asthma, squamous cell carcinoma of the bladder) will allow for the definition of relevant indicators, biomarkers, for the risks to be scrutinised. This is where Biological Science, Clinical Medicine including Drug Research and Experimental Toxicology are lining up and co-operate.These very same biological processes will be included in experimental models. Exposure of these models to the chemicals under scrutiny and their metabolites will allow measuring these indicators and thus generating data that will enable the assessment of the specific relevant risks.ObjectiveThe objective is that this approach will allow safety decision that are based on human health risks using data derived experimental models that based on a thorough understanding of human biology. The ASAT Initiative takes into account and is building on numerous research programmes aiming at improvement of tests and procedures within the EU at national and Commission level as well as in Northern America, Japan and other countries.The Concept was first published in 2004 in the Scientific Journal Alternatives to Laboratory Animals in an article The Feasibility of Replacing Animal Testing for Assessing Consumer Safety: A Suggested Future Direction. ATLA 32, 617–623, 2004

The Concept Explained

Assuring Safetywithout Animal Testing

ASAT logic is irresistible

ASAT is science based

ASAT is comprehensive

ASAT is global

Benefit to experimental animals

Benefit to environmental protection

Benefit to public health