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Bisphenol a Alternatives in Thermal Paper Bisphenol A Alternatives in Thermal Paper Chapter 4 Hazard Evaluation of Bisphenol A (BPA) and Alternatives FINAL REPORT August 2015 [Supercedes version dated January 2014] U.S. Environmental Protection Agency Table of Contents 4. Hazard Evaluation of Bisphenol A (BPA) and Alternatives .......................................... 4-1 4.1 Toxicological and Environmental Endpoints ............................................................... 4-1 4.1.1 Definitions of Each Endpoint Evaluated Against Criteria ........................... 4-1 4.1.2 Criteria ......................................................................................................... 4-4 4.1.3 Endpoints Characterized but Not Evaluated ................................................ 4-7 4.2 Data Sources and Assessment Methodology ............................................................... 4-8 4.2.1 Identifying and Reviewing Measured Data ................................................. 4-8 4.2.2 Hierarchy of Data Adequacy ..................................................................... 4-10 4.2.3 Assessment of Oligomeric Mixtures .......................................................... 4-11 4.3 Importance of Physical and Chemical Properties, Environmental Transport, and Biodegradation ................................................................................................................... 4-11 4.4 Evaluating Human Health Endpoints ......................................................................... 4-18 4.4.1 Endpoints Characterized and Evaluated Against Criteria Based on Measured Data…… ................................................................................................................... 4-18 4.4.2 SAR – Application of SAR and Expert Judgment to Endpoint Criteria .... 4-19 4.5 Evaluating Environmental Endpoints ........................................................................ 4-20 4.5.1 Ecotoxicity ................................................................................................. 4-20 4.5.2 Bioaccumulation ........................................................................................ 4-21 4.5.3 Environmental Persistence ......................................................................... 4-22 4.6 Endocrine Activity ..................................................................................................... 4-25 4.7 Hazard Summary Table ............................................................................................. 4-28 4.8 Hazard Profiles........................................................................................................... 4-31 Bisphenol A ............................................................................................................... 4-31 Bisphenol F................................................................................................................ 4-81 Bisphenol C ............................................................................................................. 4-114 MBHA ..................................................................................................................... 4-141 BisOPP-A ................................................................................................................ 4-163 Bisphenol AP ........................................................................................................... 4-185 Substituted Phenolic Compound #1 ........................................................................ 4-209 Substituted Phenolic Compound #2 ........................................................................ 4-229 PHBB....................................................................................................................... 4-254 Bisphenol S.............................................................................................................. 4-277 2,4-BPS.................................................................................................................... 4-302 TGSA....................................................................................................................... 4-316 BPS-MAE ................................................................................................................ 4-334 BPS-MPE ................................................................................................................ 4-348 D-8 ........................................................................................................................... 4-364 D-90 ......................................................................................................................... 4-380 DD-70 ...................................................................................................................... 4-394 Pergafast 201 ........................................................................................................... 4-405 BTUM ..................................................................................................................... 4-422 UU ........................................................................................................................... 4-433 i List of Acronyms and Abbreviations AIM Analog Identification Methodology ACR Acute to Chronic Ratio ADME Absorption, Distribution, Metabolism, and Excretion AIST Advanced Industrial Science and Technology ASTM American Society for Testing and Materials BAF Bioaccumulation Factor BCF Bioconcentration Factor BMD Benchmark Dose BMDL Benchmark Dose Lower-confidence Limit BPA Bisphenol A BPS Bisphenol S BOD Biochemical Oxygen Demand CASRN Chemical Abstracts Service Registry Number CDC Centers for Disease Control and Prevention CHO Chinese Hamster Ovary Cells ChV Chronic Value CPSC Consumer Product Safety Commission CVL Crystal Violet Lactone DfE Design for the Environment DOC Dissolved Organic Carbon dpi Dots per inch EC50 Half Maximal Effective Concentration ECHA European Chemicals Agency ECOSAR Ecological Structure Activity Relationships EDSP Endocrine Disruptor Screening Program EEC European Economic Community Eh Redox potential EKG Electrocardiogram EPA U.S. Environmental Protection Agency EPCRA Emergency Planning and Community Right-to-Know Act EPI Estimations Program Interface ERMA Environmental Risk Management Authority EU European Union EWG Environmental Working Group FDA U.S. Food and Drug Administration GHS Globally Harmonized System of Classification and Labeling of Chemicals GLP Good Laboratory Practice HGPRT Hypoxanthine-Guanine Phosphoribosyl-Transferase HIPAA Health Insurance Portability and Accountability Act of 1996 HPLC High Performance Liquid Chromatography HPV High Production Volume HSDB Hazardous Substances Data Bank IARC International Agency for Research on Cancer IR Infrared ii IRIS Integrated Risk Information System IUCLID International Uniform Chemical Information Database Koc Soil adsorption coefficient Kow Octanol/water partition coefficient LC50 Median Lethal Concentration LCA Life-cycle Assessment LD50 Median Lethal Dose LD Lactation Day LFL Lower Limit of Flammability LOAEL Lowest Observed Adverse Effect Level LOEC Lowest Observed Effective Concentration MDI Mean Daily Intake MF Molecular Formula MITI Japanese Ministry of International Trade and Industry MW Molecular Weight MSDS Material Safety Data Sheet NAICS North American Industry Classification System NES No Effects at Saturation NGO Non-Governmental Organization NHANES National Health and Nutrition Examination Survey NICNAS National Industrial Chemicals Notification and Assessment Scheme NIOSH National Institute for Occupational Safety and Health NIR Near Infrared NOAEL No Observed Adverse Effect Level NOEC No Observed Effect Concentration NOEL No Observed Effect Level NTP National Toxicology Program OECD Organisation for Economic Cooperation and Development OPPT Office of Pollution Prevention and Toxics P2 Pollution Prevention PBB Poly-Brominated Biphenyls PBDE Polybrominated Diphenyl Ether PBT Profiler Persistent, Bioaccumulative, and Toxic (PBT) Chemical Profiler PMN Premanufacture Notice PNEC Predicted No Effect Concentration POS Point-of-sale ppb parts per billion ppm parts per million PVC Polyvinyl Chloride REACH Registration, Evaluation, Authorisation and Restriction of Chemical substances RoHS Restriction of Hazardous Substances SAR Structure Activity Relationship SCAS Semi-Continuous Activated Sludge SF Sustainable Futures SMILES Simplified Molecular-Input Line-Entry System SPARC Sparc Performs Automated Reasoning in Chemistry iii TDI Total Daily Intake TOC Total Organic Carbon TRI Toxics Release Inventory TSCA Toxic Substances Control Act QSAR Quantitative Structure Activity Relationships UFL Upper Limit of Flammability USGS U.S. Geological Survey WHO World Health Organization WWTP Wastewater Treatment Plant iv 4. Hazard Evaluation of Bisphenol A (BPA) and Alternatives This chapter summarizes the toxicological and environmental hazards of bisphenol A (BPA) and each of the 19 alternative chemicals that were identified as potential functional substitutes for BPA. Evaluations of chemical formulations may also require the consideration of associated substances (e.g., starting materials, byproducts, and impurities) if their presence is specifically required to allow that alternative to fully function in the assigned role. In general, associated substances were assumed to remain unchanged in this assessment, but may need to be considered in the selection of an alternative. Otherwise, pure substances were analyzed
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