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Die Chemikalienindustrie könnte bald Zugang zu schnelleren und kostengünstigeren Mitteln für die Überprüfung der toxischen Wirkung von Chemikalien haben. Die US-amerikanischen Nationalen Gesundheitsinstitute (NIH) und die US-Umweltschutzagentur (EPA) kooperieren, um Fortschritte in den Bereichen Computertechnologie, Genomforschung und Zellbiologie zu nutzen. Es soll eine neue Hochgeschwindigkeitsmethode entwickelt werden, mit der Chemikalien in vitro getestet werden können.
The new method would "allow for the testing of thousands to hundreds of thousands of chemicals a day to determine their possible toxic effect," said Francis S. Collins, director of the US National Human Genome Research Institute (NHGRI
), speaking at the annual meeting of the American Association for the Advancement of Science (AAAS
) on 15 February 2008.
The aim of the collaborative agreement
between the US government agencies, announced
on 14 February, is to shift chemical toxicity testing from animal screening to a cell-based, in-vitro system, while also exploring the possibility of using more primitive animal species, such as fish and worms, in safety testing. Ultimately, the data is expected to provide new risk assessors for the protection of human health and the environment.
Studying toxicology in-vitro consists of exposing different human cell lines - epidermal or in the brainl, for example - to a chemical in order to see how the cells react to it depending on the quantities used and the time of exposure.
The EU's chemicals regulation REACH, in force since June 2007, requires producers and importers of chemicals to register all such substances within the European chemicals agency and to prove that they are safe. Based on the safety data, the EU agency will then either authorise or reject the applications for market authorisation. The regulation was strongly objected to by the chemicals industry, which argued that the economic burden of the imposed safety testing was unacceptable.
Current safety testing of chemicals relies mainly on animal tests, which are slow and very expensive. In addition, the public has become increasingly "uncomfortable with the use of large numbers of animals, particularly in the kinds of painful tests which establishing toxicology sometimes requires," said Christopher Austin, director of the National Chemical Genomics Center (NCGC
).
Another reason behind the initiative, according to NHGRI, is "the realisation that the presence or lack of toxicity in an animal does not necessarily correspond to toxicity in a human". The new trans-agency collaboration is therefore expected to generate data that is more relevant to humans. The budget for the co-operation has not yet been set.
The advantages of this type of automated testing could be considerable to the chemical industry, which in general bears the cost of its products' toxicology studies. Furthermore, it could reduce the time between the actual invention of a chemical and its introduction to the market.
The new testing approaches of this "hoped-for paradigm shift in toxicity testing" will, however, also require validation - a process which is expected to take several years.