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Toxicity Review for Diisononyl Phthalate (DINP)

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Toxicity Review for Diisononyl Phthalate (DINP) risk is performed to evaluate whether the chemical may be considered a “hazardous substance” under the FHSA. Purpose and Scope of the Report The primary purpose of the attached report is to complete the first two steps in the risk assessment process, that is, the hazard identification and dose response assessment. In addition, the report briefly summarizes published information relating to exposure, as well as published exposure and risk assessments. The sections on exposure and risk assessment are included to provide additional context for the reader, and as background for future risk assessments. However, quantitative exposure and risk assessments are beyond the scope of this report. Cumulative risks from exposure to multiple phthalates are also not included in this report, although they are briefly discussed. The information in this report will be provided to the Chronic Hazard Advisory Panel on Phthalates. This panel will convene in 2010 to assess the potential health effects of cumulative exposure to phthalates from all sources, including children’s articles and cosmetics. -2- Contents Summary ..............................................................................................................................v Abbreviations .................................................................................................................... vii 1. Introduction ...........................................................................................................1 2. Chemistry and Use ................................................................................................4 3. Acute Toxicity, Skin and Eye Irritation ................................................................7 4. Toxicokinetics .......................................................................................................9 5. Systemic Health Effects ......................................................................................14 Liver ....................................................................................................................14 Kidney .................................................................................................................26 Hematology .........................................................................................................27 Endocrine System ...............................................................................................27 Immune System ..................................................................................................32 Summary of Systemic Effects .............................................................................35 6. Reproductive and Developmental Effects ..........................................................37 Reproductive Effects ...........................................................................................37 Developmental Effects ........................................................................................40 7. Genotoxicity ........................................................................................................57 8. Carcinogenicity ...................................................................................................58 Liver ...............................................................................................................59 Kidney ............................................................................................................81 Mononuclear Cell Leukemia ..........................................................................82 Other sites .......................................................................................................82 Summary of Carcinogenicity ..........................................................................83 9. Dose Response ....................................................................................................85 Liver ....................................................................................................................85 Kidney .................................................................................................................86 Reproductive Toxicity ........................................................................................87 Developmental Toxicity......................................................................................87 i 10. Exposure .............................................................................................................90 Production and Use ........................................................................................90 DINP Levels in the Environment, Food, and Products ..................................90 DINP Migration from PVC Products .............................................................98 Scenario-Based Exposure Assessments .......................................................100 Biomonitoring Studies ..................................................................................107 Summary of Exposure ..................................................................................114 11. Discussion .........................................................................................................115 Multiple Forms of DINP ..............................................................................115 Availability of Toxicity Data and Data Gaps ...............................................115 PPARα ..........................................................................................................116 Toxic Effects of DINP ..................................................................................118 Exposure and Risk ........................................................................................122 12. References .........................................................................................................123 Tables 1-1. Dialkyl ortho-phthalates (o-DAP’s) banned by the Consumer Product Safety Improvement Act of 2008 (CPSIA) ........................................................3 2-1. Comparison of different forms of diisononyl phthalate (DINP) ........................4 2-2. Percent composition of diisononyl phthalate .....................................................5 2-2. Physico-chemical properties of DINP ...............................................................5 4-1. Levels of major DINP metabolites identified in rat urine ................................11 4-2. Median levels (ng/mL) of major DINP metabolites in human urine ...............12 5-1. Increased liver weight following DINP exposure ............................................16 5-2. Incidence of selected liver lesions in Fischer rats exposed to DINP for two years—all deaths (Lington et al. 1997) .....................................19 5-3. Incidence of selected liver lesions in Fischer rats exposed to DINP for two years—all deaths (Moore 1998a) ..............................................20 5-4. Incidence of selected liver lesions in Sprague-Dawley rats exposed to DINP-A for two years—all deaths (Bio/dynamics 1986) ................................21 5-5. Incidence of spongiosis hepatis in male rats at terminal sacrifice— pooled data when 4 slides are viewed ..............................................................25 5-6. Kidney effects following DINP exposure ........................................................28 5-7. Endocrine effects of DINP and MINP exposure in males ...............................32 5-8. Summary of non-cancer systemic effects in 2-year feeding studies ................36 ii 6-1. Estimated doses (mg/kg-d) in the two-generation study with DINP-1 ............39 6-2. Estimated doses (mg/kg-d) in the one-generation study with DINP-1 ............39 6-3. Reproductive Studies of DINP in Animals ......................................................41 6-4. Ability of phthalate diesters to induce testicular effects in male rats ..............43 6-5. Developmental Studies of DINP in Animals—Prenatal Exposure ..................45 6-6. Developmental Studies of DINP in Animals—Perinatal Exposure .................49 8-1. Lifetime dietary studies of DINP .....................................................................58 8-2. Incidence of hepatocellular neoplasia in a 2-year dietary study of DINP-1 in Fischer 344 rats (Lington et al., 1997) ...........................................60 8-3. Incidence of hepatocellular neoplasia in a 2-year dietary study of DINP-1 in Fischer 344 rats (Moore, 1998a) ....................................................60 8-4. Incidence of hepatocellular neoplasia in a 2-year dietary study of DINP-A in Sprague-Dawley rats ....................................................................61 8-5. Incidence of hepatocellular neoplasia in a 2-year dietary study of DINP-1 in B6C3F1 (Moore, 1998b) ................................................................62 8-6. Mechanistic data relating to DINP-induced hepatocellular tumorigenesis ......67 8-7. Palmitoyl-CoA oxidase activity in B6C3F1 mice following DINP exposure for 4 weeks .............................................................................70 8-8. Liver tumor incidence in mice feed DEHP for up to two years .......................78 8-9. Incidence of renal tubular carcinoma in male Fischer 344 rats in a 2-year dietary study of DINP-1 (Moore 1998a) ...........................................81 8-10. Incidence of mononuclear cell leukemia in a 2-year dietary study of DINP-1 in Fischer 344 (Lington et al., 1997) ..................................................82
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