Table 1.
Exposure | Toxicology/toxicokinetics | Epidemiology | Analytical methodology/biomarker of exposure | Risk assessment/risk management |
---|---|---|---|---|
Source(s) identified? | Are there sufficient data including longer duration studies? | Are reasonable cause–effect inferences supported?* | Were standard reference materials used in the biological matrix of interest? | Are there sufficient and relevant toxicology data |
Pathway(s)/route(s) understood? | Do routes used in toxicology studies compare to anticipated human exposure? | Has an adverse health effect been observed in humans? | Have specificity and sensitivity of methods been described? | Known relationship between biomarker of exposure and human health effect? |
Human exposure relationship to existing toxicology data | Are toxicokinetic data in animals available? | Has the pathogenesis of the health effect been described? | Is biomarker of exposure valid for intended use?† | Applicable toxicokinetic data? |
Exposure–dose relationship understood? | Is/are the critical effect(s) known? | Is there a health effect in the exposed population | Does sampling strategy consider potential sources of error? | If applicable – evidence that remediation efforts are working? |
Temporality/duration understood‡ | Is the mode/mechanism of action understood? | Have toxicokinetic and/or toxicodynamic genetic polymorphisms been described which may impact risk? | Does sampling strategy consider stability of biomarker of exposure? | |
Did sampling strategy incorporate toxicokinetics? |
*Are the Bradford-Hill criteria fulfilled?
†Does the biomarker of exposure accurately reflect the intended use?
‡Temporality refers to the relationship of when exposure occurred relative to when the sample was collected. Duration refers to how long the exposure occurred relative to when the sample was collected.