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TOXICOLOGICAL REVIEW of FORMALDEHYDE (CAS No DRAFT - DO NOT CITE OR QUOTE EPA/635/R-10/002A www.epa.gov/iris TOXICOLOGICAL REVIEW OF FORMALDEHYDE - INHALATION ASSESSMENT (CAS No. 50-00-0) In Support of Summary Information on the Integrated Risk Information System (IRIS) VOLUME II of IV Hazard Characterization June 2, 2010 NOTICE This document is an External Review draft. This information is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency determination or policy. It is being circulated for review of its technical accuracy and science policy implications. U.S. Environmental Protection Agency Washington, DC 1 1 DISCLAIMER 2 3 This document is a preliminary draft for review purposes only. This information is 4 distributed solely for the purpose of pre-dissemination peer review under applicable information 5 quality guidelines. It has not been formally disseminated by EPA. It does not represent and 6 should not be construed to represent any Agency determination or policy. Mention of trade 7 names or commercial products does not constitute endorsement or recommendation for use. 8 This document is a draft for review purposes only and does not constitute Agency policy. II-ii DRAFT—DO NOT CITE OR QUOTE CONTENTS IN BRIEF VOLUME I: INTRODUCTION, BACKGROUND, AND TOXICOKINETICS Chapter 1: Introduction Chapter 2: Background Chapter 3: Toxicokinetics VOLUME II: HAZARD CHARACTERIZATION Chapter 4: Hazard Characterization VOLUME III: QUANTITATIVE ASSESSMENT, MAJOR CONCLUSIONS IN THE CHARACTERIZATION OF HAZARD AND DOSE RESPONSE, AND REFERENCES Chapter 5: Quantitative Assessment: Inhalation Exposure Chapter 6: Major Conclusions in the Characterization of Hazard and Dose-Response References VOLUME IV: APPENDICES Appendix A: Summary of External Peer Review and Public Comments and Dispositions Appendix B: Simulations of Interindividual and Adult-to-Child Variability in Reactive Gas Uptake in a Small Sample of People (Garcia et al., 2009) Appendix C: Lifetable Analysis Appendix D: Model Structure & Calibration in Conolly et al. (2003, 2004) Appendix E: Evaluation of BBDR Modeling of Nasal Cancer in the F344 Rat: Conolly et al. (2003) and Alternative Implementations Appendix F: Sensitivity Analysis of BBDR Model for Formaldehyde Induced Respiratory Cancer in Humans Appendix G: Evaluation of the Cancer Dose-Response Modeling of Genomic Data for Formaldehyde Risk Assessment Appendix H: Expert Panel Consultation on Quantitative Evaluation of Animal Toxicology Data for Analyzing Cancer Risk Due to Inhaled Formaldehyde This document is a draft for review purposes only and does not constitute Agency policy. II-iii DRAFT—DO NOT CITE OR QUOTE CONTENTS—TOXICOLOGICAL REVIEW OF FORMALDEHYDE (CAS No. 50-00-0) VOLUME II LIST OF TABLES ................................................................................................................... II-viii LIST OF FIGURES .................................................................................................................. II-xv 4. HAZARD CHARACTERIZATION ...................................................................................... 4-1 4.1. HUMAN STUDIES ...................................................................................................... 4-1 4.1.1. Noncancer Health Effects ................................................................................. 4-1 4.1.1.1. Sensory Irritation (Eye, Nose, Throat Irritation) ................................. 4-1 4.1.1.2. Pulmonary Function .......................................................................... 4-11 4.1.1.3. Asthma ............................................................................................... 4-50 4.1.1.4. Respiratory Tract Pathology .............................................................. 4-65 4.1.1.5. Immunologic Effects ......................................................................... 4-69 4.1.1.6. Neurological/Behavioral ................................................................... 4-82 4.1.1.7. Developmental and Reproductive Toxicity ....................................... 4-85 4.1.1.8. Oral Exposure Effects on the Gastrointestinal Tract ......................... 4-96 4.1.1.9. Summary: Noncarcinogenic Hazard in Humans ............................... 4-96 4.1.2. Cancer Health Effects ..................................................................................... 4-97 4.1.2.1. Respiratory Tract Cancer ................................................................... 4-98 4.1.2.2. Nonrespiratory Tract Cancer ........................................................... 4-134 4.1.2.3. Summary: Carcinogenic Hazard in Humans ................................... 4-188 4.2. ANIMAL STUDIES ................................................................................................. 4-191 4.2.1. Reflex Bradypnea.......................................................................................... 4-192 4.2.1.1. Tolerance ......................................................................................... 4-195 4.2.1.2. Cross-Species Differences in Inhaled Dose .................................... 4-195 4.2.1.3. Cross-Tolerance ............................................................................... 4-198 4.2.1.4. Formaldehyde Binding and Activation of Trigeminal Nerve Afferent Activity ............................................................................. 4-199 4.2.2. Respiratory Tract Pathology ......................................................................... 4-201 4.2.2.1. Mucociliary Clearance .................................................................... 4-202 4.2.2.2. Cell Proliferation ............................................................................. 4-209 4.2.2.3. Short-Term Studies .......................................................................... 4-226 4.2.2.4. Subchronic Studies .......................................................................... 4-241 4.2.2.5. Chronic Inhalation Bioassays .......................................................... 4-261 4.2.2.6. Summary of Respiratory Pathology and Carcinogenic Potential .... 4-287 4.2.3. Gastrointestinal Tract Pathology................................................................... 4-292 4.2.3.1. Short-Term and Subchronic Ingestion Studies ................................ 4-292 4.2.3.2. Chronic Ingestion Studies ............................................................... 4-295 4.2.3.3. Summary of Gastrointestinal Effects and Evaluation of Carcinogenic Potential .................................................................... 4-301 4.2.4. Immune Function .......................................................................................... 4-301 4.2.5. Hypersensitivity and Atopic Reactions ......................................................... 4-310 This document is a draft for review purposes only and does not constitute Agency policy. II-iv DRAFT—DO NOT CITE OR QUOTE CONTENTS (continued) 4.2.5.1. Inhalation Studies in Experimental Animals ................................... 4-312 4.2.5.2. Dermal Sensitization ....................................................................... 4-332 4.2.5.3. Summary of Sensitization Studies ................................................... 4-334 4.2.6. Neurological and Neurobehavioral Function ................................................ 4-339 4.2.6.1. Inhalation Exposure ......................................................................... 4-339 4.2.6.2. Oral Exposure .................................................................................. 4-368 4.2.6.3. Summary ......................................................................................... 4-370 4.2.6.4. Other Considerations ....................................................................... 4-370 4.2.7. Reproductive and Developmental Toxicity .................................................. 4-371 4.2.7.1. Inhalation Studies Addressing Developmental and Reproductive Toxicity ..................................................................... 4-371 4.2.7.2. Oral Exposure Studies Addressing Developmental and Reproductive Toxicity ..................................................................... 4-388 4.2.7.3. Intraperitoneal Studies Addressing Developmental and Reproductive Toxicity ..................................................................... 4-391 4.2.7.4. Dermal Exposure Studies Addressing Developmental and Reproductive Toxicity ..................................................................... 4-393 4.2.7.5. Summary of Reproductive and Developmental Effects .................. 4-394 4.3. GENOTOXICITY ..................................................................................................... 4-407 4.3.1. Formaldehyde-DNA Reactions ..................................................................... 4-407 4.3.1.1. DNA-Protein Cross-Links (DPXs) .................................................. 4-410 4.3.1.2. DNA Adducts .................................................................................. 4-416 4.3.1.3. DNA-DNA Cross-Links (DDXs) .................................................... 4-419 4.3.1.4. Single Strand Breaks ....................................................................... 4-419 4.3.1.5. Other Genetic Effects of Formaldehyde in Mammalian Cells ........ 4-421 4.3.2. In Vitro Clastogenicity .................................................................................
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