Repeated Dose Toxicity testing: Report from an EPAA Partners' Forum
This report describes the main findings and conclusions of The European Partnership for Alternative Approaches to Animal Testing (EPAA) Partners' Forum on the topic of repeated dose toxicity (RDT) testing, held on 19 November 2018 in Brussels, Belgium. The EPAA Partners' Forum aimed to identify synergies between industrial sectors and stakeholders along with opportunities to progress these in existing research and testing frameworks. The EPAA Partners’ Forum brought together 36 participants from industry and the European Commission (EC), along with invited representatives from regulatory agencies and researchers from a large EU-funded project.
The EPAA Partners’ Forum concluded that whilst there are currently no valid or validated non-animal alternatives that replace RDT tests directly, there is increasing use of alternatives in decision making e.g. for exposure-driven risk assessment in the cosmetics industry. Further, despite it being highly unlikely that a direct and complete one-to-one replacement of RDT testing will be possible, dependent on context, (non-validated) alternatives and different approaches are being increasingly applied to assist in safety decision making e.g. in the cosmetics industry. The lack of validated alternatives is due to the complexity of the RDT endpoint and the wealth of information that it provides on organ level and many other effects as well as the nature of the current validation paradigm. The information provided from the current RDT tests is, at present, essential in many industry sectors to assure human safety.
Among the main initiatives and projects relating to the development and increased acceptance of non-animal approaches for repeated dose toxicity testing (RDT) discussed at the EPAA Partners’ Forum we highlight the ones where MN-AM technology (ChemTunes•ToxGPS®) plays a crucial role:
The development of a chemoinformatics platform (CE-ToxGPS). the CE-ToxGPS platform develops further the COSMOS database and is intended to extend the role of the system from data storage to data integration with active workflows and inclusion of predictive capabilities to help risk assessors;
Many learnings on the extraction, curation and storage of data from legacy RDT study reports were made in the EU IMI eTOX Project. The sharing of data would be greatly assisted by the digitalisation of data and use of an appropriate electronic format – there is a clear opportunity to harmonise data storage to facilitate sharing at various levels e.g. between industry and the appropriate regulatory agency as well as with other scientists. As the data matrices become more complex with different types of data, so will the associated databases. The EU IMI eTransafe Project is attempting to create such a translational database to support human safety assessment.
If you want to learn more about CE-ToxGPS, the COSMOS database, the eTOX Project and the eTransafe Project feel free to get in touch with us at firstname.lastname@example.org.
The link to the full report is PDF