Chemical substance in vitro/in silico screening system to predict human- and ecotoxicological effects (ChemScreen)

Background

Registration Evaluation Authorisation of Chemicals (REACH) The current system of risk assessment of chemicals is complex, very resource-intensive and has been working extremely slowly.  In 1981, of the 100,106 chemicals on the market, only 1% was tested on hazardous properties, a situation which has not changed substantially since then (see EU White Paper: Strategy for a future Chemicals Policy, 2001). Because of this a major regulatory endeavor has been initiated, the REACH legislation aiming to greatly speed up this process. However, when traditional animal tests are used progress of REACH will be seriously hampered by:
Ethics: resistance to the excessive use of animals.
Costs: particular those linked to labor intensive animal testing
Capacity: lack of capacity to carry out these tests.
Speed: the use of the same traditional methods will not allow major advances in speed of the process to be made.

These obstacles necessitate the serious consideration of alternative, non-animal (in silico and in vitro) testing strategies.

Priority areas for reduction and replacement of animal testing

Reproductive toxicity testing alone will be the major consumer of animals (more than 60% of all).  Therefore, it  is the prime area within REACH in which alternative methods can lead to a vast reduction of animal experimentation. ChemScreen will focus on alternative methods to test for reproductive toxicity.

 To complete the screening system  the current program will concentrate on the following tasks:  

• Establish in silico  prescreening and toxicity prediction methods prioritizing in vitro  toxicity testing (WP1, leading partner; DTU)
• Establish a database and an in silico prescreen to identify potential reproductive toxicants (WP2, FhG)
• Establishment  of sensitive parameters and a medium throughput ‘minimal essential’ in vitro assay panel (WP3, RIVM)
• Establish a high throughput mechanistic pathway screen, ReproScreen HTP, for reproductive toxicants (WP4, EKUT)
• Integrative methods to predict in vivo reprotoxicity allowing informed decisions on prioritization for eventual further testing (WP5, TNO)
• Integration into one user-friendly tool (WP6, P&GEN)