The implementation of alternative in vitro methods for the replacement of animal testing under the REACH legislation: State of the Art.
The European REACH (Registration, Evaluation and Authorisation of Chemicals) legislation endorses every chemical that is produced and/or sold in the EC has to be evaluated for environmental health and safety to an extent dependent on tonnage level and degree of concern based on existing data.
Any REACH compliant substance should preferentially be tested using non-animal methods, however before they can be implemented, these "in vitro" methods must be scientifically validated and approved by regulatory authorities.
A number of alternative methods has now been accepted as "valid" test that can be used under REACH. However a majority of toxicological endpoints are still under development.
This session aims at providing a state-of-the-art update on new promising alternative methods, on validated alternative test methods as well as on test strategies that are sufficiently well developed so they allow pre-screening of test compounds that require REACH documentation.
Both regulators as well as industrial scientists are invited to share their experiences.
Plenary lecture:
"Sustainable development and alternatives for animal testing"
Bjorn Hansen, DG Environment
| Theme 1: New promising methods for the replacement and reduction of animal tests |
While the implementation of several alternative methods has become reality, the majority of toxicological endpoints still require animal testing as scientific relevant methods are still lacking.
Especially the evaluation of more complex hazard reactions including neurotoxicology, teratogeinicity, genotoxocity, sensitization, chronic toxicity, amongst others, are currently required by industry and regulators.
This session will provide an update on the progress of development, industrial assessment and implementation of new promising methods.
Invited lecture:
"The new toxicology – In vitro approaches to hazard assessment and safety evaluation"
Alan M. Goldberg, CAAT, USA
Topics:
- Recent methods developments for chronic toxicity and repeat dose testing;
- Systemic toxicity models;
- New technologies and methods for safety testing;
- Cancer models in vitro.
|
| Theme 2: Validated models and test methods |
In recent years, industry, in close collaboration with regulatory agencies across the globe, have made tremendous progress in the validation of alternative methods.
This session will address the toxicological endpoints for which methods and models have been successfully validated and for which new and more refined approaches are needed.
Invited lecture:
"Validation of alternative methods: realisations, needs and state of the art concerning the process of validation"
Joachim Kreysa, ECVAM
Topics:
- Progress in the validation of methods for sensitization;
- ‘Me-too’ methods in topical toxicity testing.
|
| Theme 3: New concepts of test strategies for hazard and risk assessment |
Toxicological testing shifts from a descriptive science to technology based on advanced molecular and computational knowledge and insight in complex cellular networks and biological pathways which lead to adverse health effects if disturbed.
In vitro models and in vitro testing methods are promising tools to unravel these toxicological pathways and are powerful screening tools for toxicity. Actual progress and the potentials and limits for interpretation of these tests in the context of hazard and risk assessment will be covered.
The session will highlight the possibilities and pitfalls of these modern approaches and will give guidance on how to proceed.
Invited lecture:
"The Development and Application of Genomic Tools for Hazard Identification and Risk Assessment"
Russel S. Thomas (Hamner Institutes for Health Sciences)
Topics:
- Receptor based assays;
- Pathway approaches in risk assessment;
- 21st century toxicity testing.
Scientific Advisory Board
Name |
Members of the Advisory Board |
Theme 1: New promising methods for the replacement and reduction of animal tests
|
- Philippe Vanparys
- Alan Goldberg
|
Theme 2: Validated models and test methods
|
- Bart De Wever
- Joachim Kreysa
|
Theme 3: New concepts for integrated test strategies for hazard and risk assessment
|
- Greet Schoeters
- Russel Thomas
|
|
|
