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A framework to facilitate consistent characterization of read across uncertainty
Karen Blackburn1, Sharon B Stuard1
1Central Product Safety Department, The Procter & Gamble Company, Mason Business Center, 8700 Mason Montgomery Road, Cincinnati, OH 45040, United States.
Regulatory Toxicology and Pharmacology : RTP
|January 25, 2014
Summary
This study introduces a systematic framework and questionnaire to characterize uncertainty in structure-activity relationship (SAR) read-across assessments. This approach aims to standardize toxicological evaluations and improve consistency among risk assessors.
Area of Science:
- Toxicology and Chemical Risk Assessment
- Computational Chemistry and Cheminformatics
Background:
- Structure-activity relationship (SAR) based read-across is widely used to fill toxicological data gaps.
- Existing methods lack a systematic framework for characterizing the uncertainty introduced by read-across.
- Previous work established analogue evaluation processes for SAR assessments.
Purpose of the Study:
- To present a systematic framework for identifying and describing potential uncertainties in read-across assessments.
- To introduce a questionnaire to aid risk assessors in documenting the consideration of these uncertainties.
- To enhance the standardization and transparency of SAR-based read-across evaluations.
Main Methods:
- Development of a framework evaluating uncertainty based on analogue data suitability, critical effect severity, and concordance of effects and potency.
- Creation of a questionnaire for risk assessors to document uncertainty considerations.
- Application of the framework to guide the characterization of uncertainty in read-across.
Main Results:
- The proposed framework systematically describes potential areas of additional uncertainty in read-across.
- The questionnaire facilitates consistent documentation of uncertainty considerations by risk assessors.
- The approach provides a transparent method for assigning uncertainty levels to SAR-based read-across.
Conclusions:
- The developed framework and questionnaire represent a significant step towards standardizing the read-across process.
- This methodology enhances transparency and consistency in assigning uncertainty to read-across assessments.
- The tool supports more reliable toxicological data gap filling and risk assessment.
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