Cefic-lri Programme | European Chemical Industry Council

LRI-HBM2: Computational tools for the derivation of biomonitoring guidance values

Background

The historical process whereby occupational guidance values (e.g. inhalation and biomonitoring) have been developed has relied heavily on the availability of (mostly in vivo) test data. While a reasonable degree of confidence might, as a consequence, be invested in the data quality underpinning resultant guidance values, the process has resulted in a comparatively limited range of guidance values being developed. This is particularly so in the case of biomonitoring guidance values, where a more extensive understanding of data (covering effects, dose and kinetics) is required before any value can be established.
Concurrent with the collection of biomonitoring data and the need to interpret it, society has also required that processes for health protection are reliable, efficient and respect animal welfare. The consequence of this is a desire to incorporate non-animal information acquisition systems into the process wherever sensible. The aim of this activity is therefore to identify, evaluate and recommend a suite of simple computational tools that enable (different forms of) biomonitoring data to be reliably interpreted from a minimal or tiered data approach.

Objectives

Identify, evaluate and recommend a suite of simple tools that enable biomonitoring data to be reliably interpreted. By definition, the tools required to be fit for purpose i.e. the extent to which their complexity/sophistication would be a function of their intended use and inherent reliability. Other considerations the research would need to consider include:

  • the broader acceptability of the approach at the international level
  • the desirability of executing the research in partnership with key knowledge groups in academia and regulatory community
  • to build off relevant research in the area already supported by CEFIC LRI e.g. the PBPK modelling suite
  • the need to include well described case studies to emphasize the relevance and validity of the proposed approach
  • the development of supporting guidelines that address where existing QSARs e.g. for the prediction of relevant physico-chemical and physiological properties, can be applied.

Scope

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 tools that may either be considered missing or in need of improvement. However, it would be expected that where significant gaps/deficiencies are identified, then these are characterised in sufficient detail to enable follow-up research to be initiated if appropriate.

Timing: Start end of 2007, duration 18-30 months

Cost: Budget in the order of €200,000-400,000

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