Current test systems have largely been optimised to provide information that supports a better understanding of a substance's (human or environmental) effects. Understanding biomonitoring information, however, requires not only an understanding of effects, but also an understanding of the relationship between adverse (or pre-clinical or other observations) and their variation over time etc. REACH anticipates that data will be acquired in a tiered manner that is determined by manufactured (or imported) tonnage and which links to existing (OECD validated and invariably in vivo) test methods. Many of these methods can provide information that assists in the interpretation of biomonitoring findings. But it is not their primary intention.
This project therefore examines the extent to which a tiered framework for biomonitoring data interpretation might be developed that aligns with and complements that indicated under REACH. More specifically, the work would address the extent to which this might be successfully executed using available in silico or in vitro methods.
The aim of this research program would be to develop an approach to predict potential chemical metabolites to compliment the computational tools and to reliably interpret biomonitoring information. It is envisaged the research would allow a "sensitivity assessment" to be made of available information (e.g. via preliminary grouping or categorization) in order that it can be assessed and the value of undertaking additional (in vitro) testing, to help better characterize the nature of metabolism, evaluated. The research would include:
- characterization of a tiered approach for data collection, accounting for likely REACH expectations i.e. accounting for Annexes V to IX.
- identification of likely data gaps, with recommendations for how such gaps should be filled using available in vitro or in silico techniques
- where methods do not exist or are considered to be inadequate, for research to be identified and undertaken to establish the basis for reliable (validated) methods in the area.
It is anticipated the framework will be verified against a representative range of case examples. It is expected that the findings will developed into a peer reviewed publication, following presentation at a suitable scientific conference. Short interim reports on progress are required at 3 to 6-monthly intervals. The proposal does not extend to the development of any new methods that may be considered absent. However, it would be expected that where significant gaps/ deficiencies are identified, then these would be characterized in sufficient detail to enable follow-up research to be initiated if appropriate.