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Figure 3-7. Exposure-Response Array of Female Reproductive Effects, Maternal Weight and Toxicity, Following Oral Exposure to DIBP

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Figure 3-7. Exposure-Response Array of Female Reproductive Effects, Maternal Weight and Toxicity, Following Oral Exposure to DIBP EPA/635/R-14/333 Preliminary Materials www.epa.gov/iris Preliminary Materials for the Integrated Risk Information System (IRIS) Toxicological Review of Diisobutyl Phthalate (DIBP) (CASRN No. 84-69-5) September 2014 NOTICE This document is comprised of preliminary materials. This information is distributed solely for the purpose of pre-dissemination 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. National Center for Environmental Assessment Office of Research and Development U.S. Environmental Protection Agency Washington, DC Preliminary Materials for the IRIS Toxicological Review of Diisobutyl Phthalate DISCLAIMER This document is comprised of preliminary materials for review purposes only. This information is distributed solely for the purpose of pre-dissemination 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. Mention of trade names or commercial products does not constitute endorsement or recommendation for use. This document is a draft for review purposes only and does not constitute Agency policy. ii DRAFT—DO NOT CITE OR QUOTE Preliminary Materials for the IRIS Toxicological Review of Diisobutyl Phthalate CONTENTS PREFACE ...................................................................................................................................................... viii 1. INTRODUCTION ................................................................................................................................... 1-1 1.1. DIBP IN THE ENVIRONMENT ......................................................................................................... 1-1 1.1.1. Production and Use ........................................................................................................... 1-1 1.1.2. Environmental Fate ........................................................................................................... 1-2 1.1.3. Human Exposure Pathways ............................................................................................... 1-2 1.2. SCOPE OF THE ASSESSMENT ......................................................................................................... 1-3 2. METHODS FOR IDENTIFYING AND SELECTING STUDIES ...................................................................... 2-1 2.1. DRAFT LITERATURE SEARCH AND SCREENING STRATEGY ............................................................ 2-1 2.2. SELECTION OF CRITICAL STUDIES IN EARLY STAGES OF DRAFT DEVELOPMENT ........................ 2-14 2.2.1. General Approach ............................................................................................................ 2-14 2.2.2. Exclusion of Studies ......................................................................................................... 2-15 2.3. STUDY CHARACTERISTICS THAT WILL BE CONSIDERED IN THE FUTURE EVALUATION AND SYNTHESIS OF THE CRITICAL EPIDEMIOLOGICAL STUDIES FOR DIBP ......................................... 2-16 2.3.1. Study Population ............................................................................................................. 2-16 2.3.2. Exposure Considerations ................................................................................................. 2-17 2.3.3. Primary Outcome Measures ............................................................................................ 2-20 2.3.4. Confounding .................................................................................................................... 2-26 2.3.5. Data Analysis ................................................................................................................... 2-27 2.4. STUDY CHARACTERISTICS THAT WILL BE CONSIDERED IN THE FUTURE EVALUATION AND SYNTHESIS OF THE CRITICAL EXPERIMENTAL STUDIES FOR DIBP ............................................... 2-30 3. PRELIMINARY EVIDENCE TABLES AND EXPOSURE-RESPONSE ARRAYS ............................................... 3-1 3.1. DATA EXTRACTION FOR EPIDEMIOLOGICAL AND EXPERIMENTAL STUDIES: PREPARATION OF PRELIMINARY EVIDENCE TABLES ..................................................................... 3-1 3.2. EPIDEMIOLOGICAL STUDIES.......................................................................................................... 3-2 3.2.1. Sexual Differentiation Measures ....................................................................................... 3-2 3.2.2. Male Reproductive Effects in Humans .............................................................................. 3-4 3.2.3. Male Pubertal Development in Humans ........................................................................... 3-7 3.2.4. Female Pubertal Development in Humans ....................................................................... 3-9 3.2.5. Female Reproductive Effects in Humans ......................................................................... 3-12 3.2.6. Pregnancy Outcomes in Humans .................................................................................... 3-15 This document is a draft for review purposes only and does not constitute Agency policy. iii DRAFT—DO NOT CITE OR QUOTE Preliminary Materials for the IRIS Toxicological Review of Diisobutyl Phthalate 3.2.7. Immune Effects in Humans ............................................................................................. 3-18 3.2.8. Neurodevelopmental Effects in Humans ........................................................................ 3-25 3.2.9. Thyroid Hormone Effects in Humans .............................................................................. 3-30 3.2.10. Obesity and Metabolic Effects in Humans ...................................................................... 3-31 3.3. EXPERIMENTAL STUDIES ............................................................................................................. 3-44 3.3.1. Developmental Effects .................................................................................................... 3-44 3.3.2. Male Reproductive Effects .............................................................................................. 3-62 3.3.3. Female Reproductive Effects ........................................................................................... 3-73 3.3.4. Liver Effects ..................................................................................................................... 3-79 3.3.5. Kidney Effects .................................................................................................................. 3-83 3.3.6. Hematopoietic Effects ..................................................................................................... 3-87 3.3.7. Other Effects .................................................................................................................... 3-90 3.4. PRELIMINARY MECHANISTIC INFORMATION FOR DIBP ............................................................. 3-94 4. REFERENCES ........................................................................................................................................ 4-1 This document is a draft for review purposes only and does not constitute Agency policy. iv DRAFT—DO NOT CITE OR QUOTE Preliminary Materials for the IRIS Toxicological Review of Diisobutyl Phthalate TABLES Table 2-1. Database search strategy for DIBP ........................................................................................... 2-2 Table 2-2. Summary of additional search strategies for DIBP .................................................................. 2-3 Table 2-3. Inclusion criteria used to identify animal studies of health-related endpoints, supporting data, or secondary literature ......................................................................... 2-8 Table 2-4. Summary of search terms: targeted epidemiology search ...................................................... 2-9 Table 2-5. Inclusion criteria used to identify epidemiology studies of health-related endpoints .......... 2-11 Table 2-6. Summary of additional search strategies for epidemiology studies of phthalate exposure in relation to health-related endpoints ......................................................... 2-12 Table 2-7. Primary source epidemiological studies examining health effects of DIBP ........................... 2-12 Table 2-8. General and outcome-specific considerations for DIBP study evaluation ............................. 2-28 Table 2-9. Questions and relevant experimental information for the evaluation of experimental animal studies ................................................................................................................ 2-31 Table 3-1. Evidence pertaining to DIBP and sexual differentiation effects in humans ............................. 3-2 Table 3-2. Evidence pertaining to DIBP and semen parameters or infertility in adult men or couples ............................................................................................................................. 3-4 Table 3-3. Evidence pertaining to DIBP and reproductive hormones in adult men ................................. 3-6 Table 3-4. Evidence pertaining to DIBP and the timing of male puberty
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