Table 1.
Assessment Elements (AE) used in Testing proposal Evaluation (TPE) submissions and decisions. See Supplemental Table 2 for a detailed explanation of each AE.
Assessment Elements Based on Toxicodynamic and Other Considerations | Assessment Elements Based on Toxicokinetic Considerations | ||
---|---|---|---|
AE.1 | Structure/Physicochemical Properties | AE.9 | Formation of Common (Identical) Compounds |
AE.2 | Common Biological Targets with Common Metabolites | AE.10 | Exposure of Biological Targets to Common Compounds |
AE.3 | Common Biological Targets without Common Metabolites (Qualitative) | AE.11 | Extent of the Bioavailability of the Parent Compound |
AE.4 | Common Biological Targets without Common Metabolites (Quantitative) | AE.12 | Formation and Impact of Non-common Compounds/Exposure to Other Compounds than those Linked to the Prediction |
AE.5 | Environmental Degradation to Non-common Compounds | AE.13 | Metabolites of Source and Target have been Identified |
AE.6 | Environmental Bioaccumulation of Potential Non-common Compounds | AE.14 | Potential Presence of Uncharacterized Metabolites or Impurities |
AE.7 | Common Environmental Degradation Pathways | Other Assessment Elements | |
AE.8 | Toxicodynamic Similarity based on the Data from a Bridging (OECD Test Guideline) Study | AE.15 | Characterization of Constituents (for Multi-Constituent or UVCB Substances) |
AE.16 | Toxicodynamic Similarity based on the Data from a Bridging (Not a Guideline) Study | ||
AE.17 | Lack of Observed Adverse Effects |