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RR-04: Biological Activity of Bisphenol a (BPA) Structural Analogues

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RR-04: Biological Activity of Bisphenol a (BPA) Structural Analogues NTP RESEARCH REPORT ON BIOLOGICAL ACTIVITY OF BISPHENOL A (BPA) STRUCTURAL ANALOGUES AND FUNCTIONAL ALTERNATIVES NTP RR 4 OCTOBER 2017 NTP Research Report on Biological Activity of Bisphenol A (BPA) Structural Analogues and Functional Alternatives Research Report 4 October 2017 National Toxicology Program Public Health Service U.S. Department of Health and Human Services ISSN: 2473-4756 Research Triangle Park, North Carolina, USA Biological Activity of Bisphenol A (BPA) Structural Analogues and Functional Alternatives Table of Contents Tables ............................................................................................................................................. iii Figures............................................................................................................................................ iii About This Report.......................................................................................................................... iv Peer Review ................................................................................................................................... vi Protocol Review ............................................................................................................................. vi Publication Details ........................................................................................................................ vii Acknowledgments......................................................................................................................... vii Abstract ........................................................................................................................................ viii Introduction ......................................................................................................................................1 Background .................................................................................................................................1 Objectives ....................................................................................................................................2 Methods............................................................................................................................................4 Systematic Review Methods .......................................................................................................4 Formulate the Study Question .....................................................................................................4 Search For and Select Studies for Inclusion ...............................................................................5 Literature Search Strategy....................................................................................................5 Searching Other Resources ..................................................................................................5 Study Selection Criteria ..............................................................................................................5 Extract Data from Studies ....................................................................................................6 Assess Internal Validity (“Risk of Bias”) of Individual Human and Animal Studies ........................................................................................................................6 Structural and Biological Similarity Analysis.............................................................................7 Structural Similarity Analysis ..............................................................................................7 HTS Data .............................................................................................................................7 Biological Similarity Analysis Based on HTS Data ............................................................7 Integrated Chemical and Biological Similarity....................................................................8 Results ..............................................................................................................................................9 Literature Search Results ............................................................................................................9 Survey of Evidence ...................................................................................................................10 Human Evidence ................................................................................................................10 Animal Evidence ................................................................................................................10 In Vitro Evidence ...............................................................................................................13 Health Outcomes and Mechanistic Findings.............................................................................13 Repeated Dose Effects .......................................................................................................13 Reproductive and Developmental Effects .........................................................................13 Estrogenic and Anti-estrogenic Activity ............................................................................16 Androgenic and Anti-androgenic Activity.........................................................................21 Thyroid and Anti-thyroid Activity .....................................................................................21 Other Receptor Activity .....................................................................................................22 Acute Toxicity and DNA Damage .....................................................................................22 ii Biological Activity of Bisphenol A (BPA) Structural Analogues and Functional Alternatives Other Endpoints .................................................................................................................23 Structural and Biological Similarity Analysis...........................................................................23 Structural Similarity Analysis ............................................................................................23 Biological Similarity Analysis Based on HTS Data ..........................................................24 Integrated Chemical and Biological Similarity..................................................................28 Discussion ......................................................................................................................................30 Data Gaps and Research Needs.................................................................................................30 Limitations of the Review .........................................................................................................31 Summary ........................................................................................................................................32 References ......................................................................................................................................33 Appendix A. Supplemental Materials ......................................................................................... A-1 Tables Table 1. BPA Analogues Included in Systematic Review ...............................................................1 Table 2. PECO (Populations, Exposures, Comparators Outcomes) Statement ...............................4 Table 3. Inventory of Published Literature by Chemical and Evidence Stream ............................10 Table 4. Summary of Animal Evidence .........................................................................................12 Table 5. Summary of In Vitro Evidence ........................................................................................14 Table 6. Summary of Most Sensitive Endpoints in Subchronic Studies .......................................15 Table 7. Summary of In Vitro Estrogen Endpoints .......................................................................17 Figures Figure 1. Study Flow Diagram.........................................................................................................9 Figure 2. Estrogenic Activity .........................................................................................................20 Figure 3. Structural Similarity of BPA Analogues to BPA and E2 ................................................24 Figure 4. Biological Similarity Analyses in Tox21 .......................................................................26 Figure 5. Biological Similarity of BPA Analogues to E2 and BPA in Context of the Entire Tox21 Library ................................................................................................................28 Figure 6. Integrated Structural and Biological Similarity of the BPA Analogues to E2 and BPA ................................................................................................................................29 This report has been reformatted to meet new NTP publishing requirements; its content has not changed. iii Biological Activity of Bisphenol A (BPA) Structural Analogues and Functional Alternatives About This Report Authors Katherine E. Pelch1, Jessica A. Wignall3, Alexandra E. Goldstone3, Pam K. Ross3, Robyn B. Blain3, Andrew J. Shapiro1, Stephanie D. Holmgren2, Jui-Hua Hsieh1, Daniel Svoboda4, Scott S. Auerbach1, Frederick M. Parham1, Scott A. Masten1, Kristina A. Thayer5
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