SERA TR-056-10-03b Chlorophacinone Human Health and Ecological Risk Assessment Final Report Submitted to: Dr. Harold Thistle USDA Forest Service Forest Health Technology Enterprise Team 180 Canfield St. Morgantown, WV 26505 Email: [email protected] USDA Forest Service Contract: AG-3187-C-12-0009 USDA Forest Order Number: AG-3187-D-14-0144 SERA Internal Task No. 56-10 Submitted by: Patrick R. Durkin Syracuse Environmental Research Associates, Inc. 8125 Solomon Seal Manlius, New York 13104 E-Mail: [email protected] Home Page: www.sera-inc.com July 31, 2015 Table of Contents LIST OF TABLES ......................................................................................................................... vi LIST OF FIGURES ....................................................................................................................... vi LIST OF APPENDICES ................................................................................................................ vi Note on 508 Compliance ............................................................................................................... vi ACRONYMS, ABBREVIATIONS, AND SYMBOLS ............................................................... vii COMMON UNIT CONVERSIONS AND ABBREVIATIONS .................................................... x CONVERSION OF SCIENTIFIC NOTATION ........................................................................... xi EXECUTIVE SUMMARY .......................................................................................................... xii 1. INTRODUCTION ...................................................................................................................... 1 1.1. Chemical Specific Information ............................................................................................ 1 1.2. General Information ............................................................................................................. 2 2. PROGRAM DESCRIPTION ...................................................................................................... 4 2.1. Overview .............................................................................................................................. 4 2.2. Chemical Description and Commercial Formulations ......................................................... 4 2.3. Application Methods ............................................................................................................ 6 2.4. Mixing and Application Rates ............................................................................................. 7 2.5. Use Statistics ........................................................................................................................ 8 3. HUMAN HEALTH .................................................................................................................. 10 3.1. HAZARD IDENTIFICATION ........................................................................................ 10 3.1.1. Overview ..................................................................................................................... 10 3.1.2. Mechanism of Action .................................................................................................. 11 3.1.3. Pharmacokinetics and Metabolism ............................................................................. 11 3.1.3.1. Metabolism .......................................................................................................... 11 3.1.3.2. Absorption............................................................................................................ 12 3.1.3.2.1. Oral Absorption ............................................................................................ 12 3.1.3.2.2. First-Order Dermal Absorption..................................................................... 12 3.1.3.2.3. Zero-Order Dermal Absorption .................................................................... 13 3.1.3.3. Excretion .............................................................................................................. 13 3.1.4. Acute Oral Toxicity .................................................................................................... 15 3.1.4.1. Experimental Mammals ....................................................................................... 15 3.1.4.1.1. Gavage Dosing .............................................................................................. 15 3.1.4.1.2. Dietary Exposures ......................................................................................... 16 3.1.4.2. Data on Humans ................................................................................................... 18 3.1.4.2.1. Poisonings ..................................................................................................... 18 3.1.4.2.2. Experimental ................................................................................................. 19 3.1.5. Subchronic or Chronic Systemic Toxic Effects .......................................................... 19 ii 3.1.6. Effects on Nervous System ......................................................................................... 20 3.1.7. Effects on Immune System ......................................................................................... 20 3.1.8. Effects on Endocrine System ...................................................................................... 21 3.1.9. Reproductive and Developmental Effects .................................................................. 21 3.1.9.1. Developmental Studies ........................................................................................ 21 3.1.9.2. Reproduction Studies ........................................................................................... 22 3.1.10. Carcinogenicity and Mutagenicity ............................................................................ 22 3.1.11. Irritation and Sensitization (Effects on the Skin and Eyes) ...................................... 22 3.1.12. Systemic Toxic Effects from Dermal Exposure ....................................................... 23 3.1.13. Inhalation Exposure .................................................................................................. 24 3.1.14. Adjuvants and Other Ingredients .............................................................................. 24 3.1.15. Impurities and Metabolites ....................................................................................... 24 3.1.15.1. Metabolites ......................................................................................................... 24 3.1.15.2. Impurities ........................................................................................................... 24 3.1.16. Toxicological Interactions ........................................................................................ 25 3.2. EXPOSURE ASSESSMENT .......................................................................................... 26 3.2.1. Overview ..................................................................................................................... 26 3.2.2. Workers ....................................................................................................................... 26 3.2.2.1. General Exposures ............................................................................................... 26 3.2.2.2. Accidental Exposures........................................................................................... 27 3.2.2.2.1. Standard Accidental Exposure Scenarios ..................................................... 27 3.2.2.2.2. Poor Worker Hygiene ................................................................................... 28 3.2.3. General Public ........................................................................................................... 28 3.2.3.1. General Considerations ........................................................................................ 28 3.2.3.2. Consumption of Bait by a Child .......................................................................... 29 3.2.3.3. Dermal Exposure from Contaminated Vegetation ............................................... 29 3.2.3.4. Contaminated Water ............................................................................................ 29 3.2.3.4.1. Accidental Spill ............................................................................................. 29 3.2.3.4.2. Accidental Direct Spray/drift for a Pond or Stream ...................................... 30 3.2.3.4.3. GLEAMS Modeling...................................................................................... 30 3.2.3.4.4. Other Modeling Efforts ................................................................................. 31 3.2.3.4.5. Monitoring Data ............................................................................................ 31 3.2.3.4.6. Concentrations in Water Used for Risk Assessment .................................... 31 3.2.3.5. Oral Exposure from Contaminated Fish .............................................................. 32 3.2.3.6. Dermal Exposure from Swimming in Contaminated Water ................................ 33 3.2.3.7. Oral Exposure from Contaminated Vegetation.................................................... 33 3.3. DOSE-RESPONSE ASSESSMENT ................................................................................. 34 iii 3.3.1. Overview