The Recommendations up for comment include; The Direct Peptide Reactivity Assay (DPRA) and the Cell Transformation Assay (CTA).
The first has been developed to contribute to the assessment of chemicals and their potential to cause skin sensitisation and the second, based on the Bhas 42 cell line, is aimed at predicting the potential of chemicals to cause cancer.
According to the EU, the methods are not considered to be standalone tests for these health effects but are envisaged to be used within integrated approaches for safety assessment.
A Recommendation also suggests possible follow-up activities in view of addressing knowledge gaps and broadening a method's applicability, for more information on this consultation, please see here.
Committed to the progress of alternative assays
Prior to this public commenting phase, EURL ECVAM consulted with its advisory body for Preliminary Assessment of Regulatory Relevance (PARERE), the EURL ECVAM Stakeholder Forum (ESTAF) and its international validation partner organisations within the International Cooperation on Alternative Test Methods (ICATM).
The body is part of the European Commission, directly providing scientific support to the Commission and Member States in making such regulation a reality. Most importantly this makes it independent of vested interests.
ECVAM launched back in 1991, has long been involved in alternative approaches to animal testing, particularly in the validation of methods which reduce, refine or replace the use of animals for safety testing.
EURL recently received a Good Laboratory Practice (GLP) accreditation from the Economic Co-operation and Development (OECD) for its work in developing alternative methods and approaches.
The OECD, an intergovernmental organisation representing 29 industrialised countries in North America, Europe and the Pacific, offers the GLP award to labratories meeting its guidelines of uniformity, consistency, reliability, reproducibility, quality, and integrity of non-clinical safety tests for chemicals from physio-chemical properties to kinetic and dynamic toxicity.