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[Preprint]. 2024 Aug 30:2024.08.29.610278. [Version 1] doi: 10.1101/2024.08.29.610278

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