Cyprotex is providing PK prediction capability to the EU-funded OSIRIS (Optimized Strategies for Risk Assessment of Chemicals based on Intelligent Testing) consortium.
What is REACH?
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the new European Law on Chemicals that entered into force on June 1st 2007. Its aim is to improve the protection of human health and the environment by requiring demonstration of the safe manufacture of chemicals and their safe use throughout the supply chain. All new and existing chemicals which are produced or imported into the EU above one tonne per year will require hazard and risk evaluation – a potentially massive undertaking. Whilst REACH is based on the precautionary principle, it includes the aim of reducing traditional testing methods where possible.
What is OSIRIS?
OSIRIS is a project funded by EU FP6 (6th Framework Programme) that will address this issue by developing integrated testing strategies which are fit for REACH that will enable non-testing information to be used for regulatory decision making. Its aim is to significantly increase the use of non-testing information and thus to minimise the need for testing. This will both reduce the cost and address the ethical issues associated with large-scale toxicity testing.
Cyprotex’s Role in OSIRIS
Cyprotex is leading the OSIRIS work package on ADME & Toxicokinetics (TK), working closely with Dutch partners RIVM and TNO Quality of Life. The role of the work package is to link exposure scenarios of the European populace and industry workers to chemicals – for example via drinking water, food, inhalation or dermal contact (external exposure) – with the concentrations and dynamics of the chemicals in blood and tissues (internal exposure), via knowledge of the ADME/TK properties of the chemicals. By this means we can try to identify chemicals for which the internal exposures – for realistic exposure scenarios – are low compared to their measured toxicities. Traditional toxicity tests would not significantly add to our understanding of the risks posed by these chemicals, thus tests could be waived. The REACH legislation makes very limited provision for the use of TK information in the waiving of tests. In the ADME & TK work package Cyprotex will be striving to increase the use of TK information to ease the testing burden, by pioneering novel approaches to predict internal exposure and by using this information to identify tests that could consequently be waived.
For further information:
Dr Simon Thomas, Head of Scientific Computing
Tel: +44 1625 505 100