Pesticide metabolites for residue definition
EFSA Guidance on the establishment of the residue definition for dietary risk assessment provides directions for determining the metabolites that require hazard identification and characterisation using scientific tools and methods ((Q)SAR), read-across, threshold of toxicological concern (TTC)) and available data in combination, and for developing an appropriate testing strategy for these compounds.
The procedure of derivation of the residue definition for dietary risk assessment is a screening exercise, where the relevance of all metabolites, individually or in groups, is thoroughly assessed in a stepwise approach. For every single metabolite, this screening generates an inventory of toxicities.
The genotoxicity assessment is recommended to be assisted by application of (Q)SAR and read-across of metabolites. The assessment of general toxicity is proposing the combined use of the TTC approach, elements of grouping and read-across, besides testing.
We can support you in the safety assessment of pesticide metabolites with a range of solutions and services:
- Strategy definition for the hazard assessment of pesticide metabolites
- Analysis of existing information on the pesticide/active ingredient (a.i.) and related metabolites
- Identification of relevant endpoints
- Analysis of the structural similarity between the target metabolite and a.i.
- Definition of the workflow to characterise the safety profile of individual metabolites making the best use of non-testing methodologies
- Database search and expert review of experimental toxicological data
- TTC assessment
- (Q)SAR predictions for genotoxicity and other relevant endpoints
- Read-across predictions
- Grouping of chemicals
Evaluation of the applicability of existing (Q)SAR models for predicting the genotoxicity of pesticides:
The report evaluates the applicability of existing in silico models for predicting the genotoxicity of pesticides and their metabolites, including analysis of the impact on genotoxicity of the metabolic structural changes.
Co-author: Mojca Fuart Gatnik