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A proposed framework for assessing risk from less-than-lifetime exposures to carcinogens
Susan P Felter1, Rory B Conolly, Joel P Bercu
1The Procter & Gamble Company, Cincinnati, Ohio, USA.
Critical Reviews in Toxicology
|May 20, 2011
Summary
A new framework standardizes cancer risk assessment for intermittent or short-term human exposures. This approach addresses data gaps and inconsistencies in evaluating potential carcinogens with less-than-lifetime exposure.
Area of Science:
- Toxicology
- Risk Assessment
- Environmental Health
Background:
- Established quantitative methods exist for lifetime cancer risk estimation.
- Methodologies for less-than-lifetime exposures are varied, leading to assessment inconsistencies.
- A unified framework for evaluating cancer risk from non-lifetime exposures was lacking.
Purpose of the Study:
- To develop a common framework for cancer risk assessment of less-than-lifetime exposures.
- To provide decision trees and guidance based on mode of action and dose-response.
- To address inconsistencies in risk assessment practices for intermittent or short-term exposures.
Main Methods:
- A multisector workshop convened by the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute.
- Review of available literature, methodologies, and statistical approaches for dose rate and duration.
- Consideration of rodent and epidemiological studies, including scenarios with limited bioassay data.
Main Results:
- A proposed decision tree framework for cancer risk assessment of less-than-lifetime exposures.
- Guidance incorporating mode of action and dose-response relationships.
- Inclusion of approaches for situations with data gaps, using structural alerts or genotoxicity.
Conclusions:
- The proposed framework offers a standardized approach to cancer risk assessment for less-than-lifetime exposures.
- This framework aims to improve consistency and reliability in evaluating potential carcinogens.
- Further steps are suggested to refine and implement the proposed assessment methodology.
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