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Pfoa) Or Perfluorooctane Sulfonate (Pfos National Toxicology Program NTP U.S. Department of Health and Human Services NTP Monograph Immunotoxicity Associated with Exposure to Perfluorooctanoic Acid or Perfluorooctane Sulfonate September 2016 NTP MONOGRAPH ON IMMUNOTOXICITY ASSOCIATED WITH EXPOSURE TO PERFLUOROOCTANOIC ACID (PFOA) OR PERFLUOROOCTANE SULFONATE (PFOS) September, 2016 Office of Health Assessment and Translation Division of the National Toxicology Program National Institute of Environmental Health Sciences National Institutes of Health U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Systematic Review of Immunotoxicity Associated with Exposure to PFOA or PFOS TABLE OF CONTENTS Table of Contents ...............................................................................................................................II List of Table and Figures ................................................................................................................... IV Abstract ............................................................................................................................................. 1 Peer Review Of The Draft NTP Monograph ......................................................................................... 2 Peer-Review Panel .............................................................................................................................. 2 Introduction ...................................................................................................................................... 3 Objective and Specific Aims ................................................................................................................ 4 Objective ............................................................................................................................................. 4 Specific Aims ....................................................................................................................................... 4 Methods ............................................................................................................................................ 5 Problem Formulation and Protocol Development .............................................................................. 5 PECO Statements ................................................................................................................................ 5 Literature Search ................................................................................................................................. 6 Databases Searched ................................................................................................................................. 7 Searching Other Resources ...................................................................................................................... 7 Unpublished Data ..................................................................................................................................... 7 Study Selection .................................................................................................................................... 7 Evidence Selection Criteria ....................................................................................................................... 7 Screening Process ..................................................................................................................................... 7 Data Extraction .................................................................................................................................... 8 Extraction Process and Data Warehousing .............................................................................................. 8 Quality Assessment of Individual Studies ........................................................................................... 8 Organizing and Rating Confidence in Bodies of Evidence ................................................................. 10 Health Outcome and Endpoint Grouping by Three Main Categories of Immune Response ................. 10 Considerations for Pursuing a Narrative or Quantitative Evidence Synthesis .................................. 11 Confidence Rating: Assessment of Body of Evidence ............................................................................ 11 Preparation of Level of Evidence Conclusions .................................................................................. 12 Integrate Evidence to Develop Hazard Identification Conclusions ................................................... 13 Consideration of Human and Animal Data ............................................................................................. 13 Consideration of Mechanistic Data ........................................................................................................ 14 Results and Evidence Synthesis ........................................................................................................ 16 Literature Search Results .................................................................................................................. 16 Health Effects Results ....................................................................................................................... 16 Main Findings PFOA ............................................................................................................................... 17 Main Findings PFOS ................................................................................................................................ 19 Risk of Bias Considerations..................................................................................................................... 21 PFOA Immune Evidence .................................................................................................................... 22 Immunosuppression: Antibody Response .............................................................................................. 22 Immunosuppression: Disease Resistance/Infectious Disease Outcomes .............................................. 36 Immunosuppression: Natural Killer (NK) Cell Activity ............................................................................ 42 Hypersensitivity-related Effects and Outcomes ..................................................................................... 43 Autoimmunity-related Effects and Outcomes ....................................................................................... 56 PFOS Immune Evidence .................................................................................................................... 61 II Systematic Review of Immunotoxicity Associated with Exposure to PFOA or PFOS Immunosuppression: Antibody Response .............................................................................................. 61 Immunosuppression: Disease Resistance/Infectious Disease Outcomes .............................................. 66 Immunosuppression: Natural Killer (NK) Cell Activity ............................................................................ 72 Hypersensitivity-related Effects and Outcomes ..................................................................................... 75 Autoimmunity-related Effects and Outcomes ....................................................................................... 80 Discussion ........................................................................................................................................ 81 Limitations of the Evidence Base ...................................................................................................... 83 Limitations of the Systematic Review ............................................................................................... 85 Conclusion ....................................................................................................................................... 86 References ....................................................................................................................................... 87 Data Figures ..................................................................................................................................... 96 Immunosuppression-related Effects and Outcomes ........................................................................ 96 Antibody Response ................................................................................................................................ 96 Disease Resistance/Infectious Disease Outcomes ............................................................................... 106 Natural Killer (NK) Cell Activity ............................................................................................................. 111 Hypersensitivity-related Effects and Outcomes ............................................................................. 113 Hypersensitivity Data ........................................................................................................................... 113 Autoimmunity-related Effects and Outcomes ................................................................................ 117 Autoimmunity Data .............................................................................................................................. 117 About This Review ......................................................................................................................... 119 Sources of Support .........................................................................................................................
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