Document jg19dr7wyX8mkQp23GnKKO57p

fj&EPA #t i' - United States Environmental Protection Agency Office of Health and Environmental Assessment Washington DC 20460 EPA-600/8-84-006A April 1984 External Review Draft Research and Development Health Assessment Review Document for Draft 1,2-Dichloroethane (Do Not Cite or Quote) (Ethylene Dichloride) Part 2 of 2 NOTICE This document is a preliminary draft. It has not been formally released by EPA and should not at this stage be construed to represent Agency policy. It is being circulated for comment on its technical accuracy and policy implications. SL 067564 (Do Not Cite or Quote) E PA-600/8-84-006A April 1984 External Review Draft Health Assessment Document for 1,2,- Dichioroethane (Ethylene Dichloride) Part 2 of 2 NOTICE This document is a preliminary draft. It has not been formally released by the U.S. Environmental Protection Agency and should not at this stage be construed to represent Agency policy. It is being circulated for comment on its technical accuracy and policy implications. U.S ENVIRONMENTAL PROTECTION AGENCY Office of Research and Development Office of Health and Environmental Assessment Environmental Criteria and Assessment Office Research Triangle Park, North Carolina 27711 SL 067565 DISCLAIMER This report is an external draft for review purposes only and does not constitute Agency Policy. Mention of trade names or commercial products does not constitute endorsement or recommendation for use. ii SL 067566 PREFACE The Office of Health and Environmental Assessment has prepared this health assessment to serve as a "source document" for EPA use. The health assessment document was originally developed for use by the Office of Air Quality Planning and Standards to support decision-making regarding possible regulation of ethylene dichloride as a hazardous air pollutant. However, the scope of this document has since been expanded to address multimedia aspects. In the development of the assessment document, the scientific literature has been inventoried, key studies have been evaluated and sumraary/conclusions have been prepared so that the chemical's toxicity and related characteristics are qualitatively identified. Observed effect levels and other measures of dose-response relationships are discussed, where appropriate, so that the nature of the adverse health responses are placed in perspective with observed environmental levels. m SL 067567 The EPA's Office of Health and Environmental Assessment (OHEA) is responsible for the preparation of this health assessment document. The OHEA Environmental Criteria and Assessment Office (ECAO-RTP) had overall responsibility for coordination and direction of the document (Dr. Robert M. Bruce, Project Manager). The chapters addressing physical and chemical properties, sampling and analysis and toxic effects were either rewritten or revised by Syracuse Research Corporation. The pharmacokinetics chapter was written by Dr. I.W.F. Davidson of the Bowman Gray School of Medicine, Wake Forest University. The air quality chapters addressing sources, emissions and ambient concentrations were originally written by Syracuse Research Corporation and revised by Radian Corporation under a contract with the Office of Air Quality < Planning and Standards. The principal authors of the chapters prepared by Syracuse Research Corporation are: Stephen Bosch Life and Environmental Sciences Division Syracuse Research Corporation Syracuse, New York 13210-4080 D. Anthony Gray, Ph.D. Life and Environmental Sciences Division Syracuse Research Corporation Syracuse, New York 13210-4080 Joseph Santodonato, Ph.D., C.I.H. Life and Environmental Sciences Division Syracuse Research Corporation Syracuse, New York 13210-4080 The OHEA Carcinogen Assessment Group (CAG) was responsible for preparation of the sections on carcinogenicity. Participating members of the CAG are listed below (principal authors of present carcinogenicity materials are designated by an asterisk (). iv SL 067568 Roy Albert, M.D. (Chairman) Elizabeth L. Anderson, Ph.D. Larry D. Anderson, Ph.D. Steven Bayard, Ph.D. David L. Bayliss, M.S. Chao W. Chen, Ph.D.* Margaret M.L. Chu, Ph.D. Herman J. Gibb, M.S., M.P.H. Bernard H. Haberman, D.V.M., M.S. Charalingayya B. Hiremath, Ph.D.* Robert McGaughy, Ph.D. Dharm V. Singh, D.V.M., Ph.D. Todd W. Thorslund, Sc.D. The OHEA Reproductive Effects Assessment Group (REAG) was responsible for the preparation of sections on mutagenicity, teratogenicity and reproductive effects. Participating members of REAG are listed below (principal authors of present sections are indicated by an asterisk (*). The Environmental Mutagen Information Center (EMIC), in Oak Ridge, TN, identified literature bearing on the i mutagenicity of EDC. John R. Fowle III, Ph.D.* Ernest R. Jackson, M.S. Casey Jason, M.D., Medical Officer David Jacobson-Kram, Ph.D. K.S. Lavappa, Ph.D. Sheila L. Rosenthal, Ph.D. Carol N. Sakai, Ph.D.* Carmella Tellone, B.S. Vicki L. Vaughan-Dellarco, Ph.D. Peter E. Voytek, Ph.D. (Director) The following individuals provided peer review of this draft and/or earlier drafts of this document: U.S. Environmental Protection Agency Karen Blanchard Office of Air, Noise and Radiation Office of Air Quality Planning and Standards Research Triangle Park, NC Robert M. Bruce, Ph.D. Office of Health and Environmental Assessment Environmental Criteria and Assessment Office Research Triangle Park, NC v SL 067569 Larry T. Cuppitt, Ph.D. Office of Research and Development Environmental Sciences Research Laboratory Research Triangle Park, NC James W. Falco, Ph.D. Office of Health and Environmental Assessment Exposure Assessment Group Washington, DC Lester D. Grant, Ph.D. Office of Health and Environmental Assessment Environmental Criteria and Assessment Office Research Triangle Park, NC Thomas G. McLaughlin, Ph.D. Office of Health and Environmental Assessme-" Exposure Assessment Group Washington, DC David Patrick Office of Air, Noise and Radiation Office of Air Quality Planning and Standards Research Triangle Park, NC David J. Reisman Office of Health and Environmental Assessment Environmental Criteria and Assessment Office Cincinnati, OH Jerry F. Stara, D.V.M. Office of Health and Environmental Assessment Environmental Criteria and Assessment Office Cincinnati, OH Consultants, reviewers and contributing authors: Joseph F. Borzelleca, Ph.D. Virginia Commonwealth University Richmond, VA Mildred Christian, Ph.D. Argus Research Laboratories, Inc. Perkasia, PA Herbert H. Cornish, Ph.D. The University of Michigan Ypsilanti, MI I.W.F. Davidson, Ph.D. Bowman Gray School of Medicine Wake Forest University Winston Salem, NC SL 067570 vi ri Larry Fishbein, Ph.D. National Center for Toxicological Research Jefferson, AR Mark M. Greenberg Office of Health and Environmental Assessment Environmental Criteria and Assessment Office Research Triangle Park, NC Derek Hodgson, Ph.D. University of North Carolina Chapel Hill, NC George R. Hoffman, Ph.D. Holy Cross College Worcester, MA Rudolph J. Jaeger, Ph.D. Consultant Toxicologist 7 Bolgert Place Westwood, NJ Marshall Johnson, Ph.D. Thomas Jefferson Medical College Philadelphia, PA Bruce Kleinstein, Ph.D. 1500 Locust Street, Suite 350^4 Philadelphia, PA John L. Laseter, Ph.D. Environmental Affairs, Inc. New Orleans, LA Edmond J. LaVoie, Ph.D. American Health Foundation Valhalla, NY Marvin S. Legator, Ph.D. University of Texas Medical Branch Galveston, TX P.D. Lotilaker, Ph.D. Fels Research Institute Temple University Medical Center Philadelphia, PA Jean C. Parker, Ph.D. Office of Waste Programs Enforcement U.S. Environmental Protection Agency Washington, DC vii SL 067571 Bernard Schwetz, Ph.D. National Institute of Environmental Health Sciences Research Triangle Park, NC Sam Shibko, Ph.D. Health and Human Services Division of Toxicology Washington, DC Charles M. Sparacino, Ph.D. Research Triangle Institute Research Triangle Park, NC Danial S. Straus, Ph.D. University of California Riverside, CA Darrell D. Sumner, Ph.D. CIBA GEIGY Corporation High Point, NC Robert Tardiff, Ph.D. 1423 Trapline Court Vienna, VA Norman M. Trieff, Ph.D. University of Texas Medical Branch Department of Pathology, UTMB Galveston, TX Benjamin Van Duuren, Ph.D. New York University Medical Center 550 First Avenue New York, NY Jim Withey, Ph.D. Department of National Health and Welfare Tunney's Pasture Ottawa, Ontario CANADA K1A 01Z SL 067572 viii TABLE OF CONTENTS Page LIST OF TABLES............................................................................................................................ xi LIST OF FIGURES.......................................................................................................................... xvi 1. SUMMARY AND CONCLUSIONS............................................................................................... 1-1 2. INTRODUCTION....................................................................................................................... 2-1 3. PHYSICAL AND CHEMICAL PROPERTIES........................................................................... 3-1 3.1 NAME.............................................................................................................................. 3.2 CAS REGISTRY, RTECS, AND STORET NUMBERS................................................ 3.3 DESCRIPTION.............................................................................................................. 3.4 STRUCTURE................................................................................................................... 3.5 PHYSICAL PROPERTIES OF PURE ETHYLENEDICHLORIDE................................. 3-1 3-1 3-1 3-1 3-1 4. SAMPLING AND ANALYSIS OF ETHYLENE DICHLORIDE................................................. 4-1 t 4.1 SAMPLING..................................................................................................................... 4.2 ANALYSIS..................................................................................................................... 4-1 4-1 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 4.2.6 Ethylene Dichloride in Air.......................................................... Ethylene Dichloride in Water........................................................ Ethylene Dichloride in SolidSamples........................................ Ethylene Dichloride in Blood........................................................ Ethylene Dichloride in Urine..................................................... Ethylene Dichloride in Tissue..................................................... 4-1 4-2 4-3 4-3 4-3 4-4 5. SOURCES IN THE ENVIRONMENT........................................................................................ 5-1 5.1 PRODUCTION PROCESSES........................................................................................... 5.2 ETHYLENE DICHLORIDE PRODUCERS....................................................................... 5-3 ETHYLENE DICHLORIDE PRODUCTIONAND TRENDS.............................................. 5.4 ETHYLENE DICHLORIDE USES.................................................................................. 5.5 SOURCES OF EMISSIONS............................................................................................ 5-1 5-2 5-2 5-5 5-9 5.5.1 5.5.2 5.5.3 Production and Related Facilities............................................. Dispersive Uses.................................................................................... Conclusions............................................................................................. 5-12 5-13 5--14 6. FATE AND TRANSPORT IN THE ENVIRONMENT............................................................... 6-1 6.1 ATMOSPHERE................................................................................................................. 6.2 AQUATIC MEDIA.......................................................................................................... 6.3 SOIL.............................................................................................................................. 6.4 SUMMARY....................................................................................................................... 6-1 6-7 6-8 6-9 ix SL 067573 TABLE OF CONTENTS (cont.) Page 7. ENVIRONMENTAL LEVELS AND EXPOSURE......................................................................... 7-1 7.1 ENVIRONMENTAL LEVELS........................................................................................... 7-1 7.1.1 7.1.2 7.1.3 Atmospheric Levels.............................................................................. Ground and Surface Water Levels................................................. Soil and Sediment Levels.......................................................... 7-1 7-9 7-1 ^ 7.2 ENVIRONMENTAL EXPOSURE...................................................................................... 7-14 7.2.1 7.2.2 7.2.3 Exposure from Air........................ Exposure from Water........................................................................... Exposure from Food...................... 7-18 7-20 7-20 7.3 CONCLUSIONS............................................................................................................... 7-20 8. ECOLOGICAL EFFECTS.......................................................................................................... 8-1 9. BIOLOGICAL EFFECTS IN MAN AND EXPERIMENTALANIMALS...................................... 9-1 9.1 PHARMACOKINETICS.................................................................................................... 9-1 9.1.1 9.1.2 9.1.3 9.1.4 Absorption and Distribution.............................................................. Excretion...................................................................................................... Metabolism................................................................................. Summary and Conclusions....................................................................... 9-1 9-18 9-32 9-55 9.2 ACUTE, SUBCHRONIC AND CHRONIC TOXICITY................................................... 9-57 9.2.1 9.2.2 9.2.3 Effects in Humans.................................................................................... Effects in Animals.................................................................................. Summary of Acute, Subchronic and Chronic Toxicity.............. 9-57 9-85 9-115 9.3 REPRODUCTIVE AND TERATOGENIC EFFECTS........................................................ 9-122 9.3.1 Summary........................................................................................ 9-129 9.4 MUTAGENICITY............................................................................................................. 9-131 9.5 CARCINOGENICITY...................................................................................................... 9-166 9.5.1 9.5.2 9.5.3 9.5.4 9.5.5 Animal Studies........................................................................................... Epidemiologic Studies........................................................................... Quantitative Estimates......................................................................... Summary........................................................................................................... Conclusions.................................................................................................. 9-166 9-205 9-206 9-233 9-234 10. REFERENCES .......................................................................................................................... 10-1 Appendix A Appendix B Appendix C SL 67574 x I1 LIST OF TABLES Table 5-1 Major Manufacturers of Ethylene Dichloride.............................................. 5-2 U.S. Production and Sales of Ethylene Dichloride................................. 5-3 Ethylene Dichloride Uses...................................................................................... 5-4 Consumption of Ethylene Dichloride in 1979 and 197*1.......................... 5-5 Uses of Ethylene Dichloride for Intermediate Purposes...................... 5- 6 Estimated Environmental Releases of Ethylene Dichloride in 1979............................................................................................. 6- 1 Rate Constants for a Few Chlorinated Ethanes at Room Temperature................................................................................................. 7- 1 Ambient Atmospheric Levels of Ethylene Dichloride.............................. 7-2 Ambient Concentrations of Ethylene Dichloride in Urban Areas............................................................................................................. 7-3 Reported Occurrence of Ethylene Dichloride in Groundwater System........................................................................................................................ 7-4 Reported Occurrence of Ethylene Dichloride in Surface Water Systems........................................................................................................ 7-5 State Data on Ethylene Dichloride in Groundwater................................. 7-6 Estimated Respiratory Intake of Ethylene Dichloride by Adults and Infants............................................................................................. 7-7 Maximum Concentration Level in the Vicinity of Various Emission Sources.................................................................................................. 7-8 Total Estimated Population (in Thousands) Exposed to Ethylene Dichloride in Drinking Water at the Indicated Concentration Ranges......................................................................................... 7-9 Estimated Drinking Water Intake of Ethylene Dichloride by Adults and Infants...................................................................................... 9-1 Physical Properties of Ethylene Dichloride and Other Chloroethanes........................................................................................... 9-2 Partition Coefficients for Ethylene Dichloride..................................... page 5-3 5-4 5-6 5-7 5-8 5-11 6-3 7-2 I 7-8 7-15 7-16 7-17 7-19 7-21 7-22 7-23 9-3 9-4 xi SL 067575 LIST OF TABLES (cont.) Table 9-3 Fate of ^C-EDC in Rats 48 Hours After Oral (150 mg/kg) or Inhalation (150 ppm, 6-hr) Exposure................................................... Page 9-6 9-4 Peak Blood and Tissue Levels After Single Oral Dosage of EDC in Male Rats............................................................................................. 9-* 9-5 The Absorption Rate Constants (k ) and Area Under Curve (AUC) for Rats After Single Orll with Doses of EDC in Oil and in Water as Vehicle and After Intravenous Administration........................................................................................................ 9-9 9-6 EDC Tissue Levels After 50 ppm Inhalatory Exposure.............................. 9-14 9-7 EDC Tissue Levels After 250 ppm Inhalatory Exposure............................ 9-15 9-8 Blood Tissue Levels of EDC in Male Rats 2 Hours After Single Oral Doses in Corn Oil....................................................................... 9-17 9-9 Percent Distribution of Radioactivity^gxcreted (48-hr) by Mice Receiving 1,2-Dichloroethane- C................................................ 1 9-20 9-10 Pharmacokinetic Parameters of EDC Administered as Single Bolus Intravenous Injections in Saline to Sprague-Dawley Male Rats. Parameters Calculated from a 2-Compartment Open Model................................................................................................................. 9-24 9-11 Pharmacokinetic Parameters of EDC Administered as Single Oral Doses in Corn Oil and Water to Sprague-Dawley Male Rats. Parameters Calculated from a 2-Compartment Open Model............................................................................................................................ 9-26 9-12 Pharmacokinetic Parameters of EDC Following Termination of Steady State Inhalation (5-hr Exposure) of 50 and 250 ppm to Male Sprague-Dawley Rats........................................................................... 9-29 9-13 Pharmacokinetic Parameters of EDC Following Termination of Steady State Inhalation Conditions; 6-Hr Exposure, 150 ppm to Male Osborne-Mendel Rats. Parameters Calculated from a 2-Compartment Model............................................................................................. 9-30 9-14 9-15 Identified Metabolites of Ethylene Dichloride and Ethylene Bromide.................................................................................................... Percent Distribution of Radioactivity Excreted (48-hr) as . Urinary Metabolites by Hjl^ce Receiving 1,2-Dichloroethane-14C or 2-Chloroacetic Acid- C......................................................................... 9-34 9-37 SL 067576 xii LIST OF TABLES (cont.) Table 9-16 Total Macromolecular Binding and DNA Binding in Selected Tissue of Rats After Exposure to TMC-EDC by Oral or Inhalation Routes............................................................................................. 9-17 Effect of Dietary Disulfiram Upon the Content of Liver Nuclei Isolated 24 or 48 Hours After Administration of a Single Oral Dose of 15 mg/mg [U- ^C]EDB................................. 9-18 Effects Associated with Acute Lethal Oral Doses of Ethylene Dichloride in Humans.................................................................. 9-19 Effects of Acute Oral Ingestion of 1,2-Dichloroethane (Survey Results)............................................................................................... 9-20 Effect of Ethylene Dichloride Exposure on Eye Sensitivity to Light...................................................................................... 9-21 Morbidity and Lost Workdays of Aircraft Industry Gluers Exposed to Ethylene Dichloride................................................................ 9-22 Concentrations of Ethylene Dichloride in Oil Refinery Mineral Oil Purification Process Air................................................... 9-23 9-24 Effects Observed in Polish Oil Refinery Workers............................... Effects of Acute Exposure to Ethylene Dichloride............................. 9-25 Effect of Ethylene Dichloride on the Cornea........................................ 9-26 Effect of Subchronic Exposure to Ethylene Dichloride.................... 9-27 Summary of Mutagenicity Testing of EDC: Gene Mutations in Rantfiria.......................................................................................................... 9-28 Summary of Mutagenicity Testing of EDC: Higher Plants................ 9-29 Summary of Mutagenicity Testing of EDC: Gene Mutation Teats in Inserts............................................................................................... 9-30 Summary of Mutagenicity Testing of EDC: Mammalian Cells In f!n 1 hnrp............................................................................................... .. 9-31 Summary of Mutagenicity Testing of EDC: Chromosomal Ahprrahi nns ........................ .. . . . ........................................ .. 9-32 Summary of Mutagenicity Testing of EDC: PolA Assay...................... 9-33 Summary of Mutagenicity Testing of EDC: DNA Binding Studies................................................................................................................... Page 9-52 9-54 9-58 9-65 9-72 9-78 9-80 9-81 9-87 9-95 9-102 9-132 9-145 9-147 9-153 9-155 9-160 9-163 xiii SL 067577 LIST OF TABLES Table 9-34 Page Design Summary for 1,2-Dichloroethane (EDC) Gavage Experiment in Osborne-Mendel Rats................................................................ 9-163 9-35 Terminal Survival of Osborne-Mendel Rats Treated With l ,2-Dichloroethane (EDC)................................................................................ 9-172 9-36 Squamous Cell Carcinomas of the Forestomach in OsborneMendel Rats Treated With 1 ,2-Dichloroethane (EDC)............................. 9-173 9-37 Hemangiosarcomas in Osborne-Mendel Rats Treated With 1 ,2-Dichloroethane (EDC)................................................................................ 9-179 9-38 Adenocarcinomas of the Mammary Gland in Female OsborneMendel Rats Treated With 1,2-Dichloroethane (EDC)...................... . 9-175 9-39 Design Summary for 1 ,2-Dichloroethane (EDC) Gavage Experiment in B6C3F1 Mice.............................................................................. 9-177 9-40 Terminal Survival of B6C3F1 Mice Treated With 1,2-Dichloroethane (EDC)................................................................................ 9-1781 9-41 Hepatocellular Carcinomas in B6C3F1 Mice Treated With 1,2-Dichloroethane (EDC)................................................................................ 9--181 9-42 Alveolar/Bronchiolar Adenomas in B6C3F1 Mice Treated With 1 ,2-Dichloroethane (EDC)..................................................................... 9-182 9-43 Squamous Cell Carcinomas of the Forestomach in B6C3F1 Mice Treated With 1,2-Dichloroethane (EDC)................................................. 9-183 9-44 Adenocarcinomas of the Mammary Gland in Female B6C3E1 Mice Treated With 1,2-Dichloroethane (EDC)................................................. 9-184 9-45 Endometrial Polyp or Endometrial Stromal Sarcomas in Female B6C3F1 Mice Treated With 1,2-Dichloroethane (EDC)......................... 9-184 9-46 Characterization of 1,2-Dichloroethane (EDC) Inhalation Experiment in Sprague-Dawley Rats........................................................... 9-185 9-47 Design Summary for 1,2-Dichloroethane (EDC) Experiment in Sprague-Dawley Rats..................................................... *............................ 9-186 9-48 Survival of Sprague-Dawley Rats Exposed to EDC at 52 and 104 Weeks................................................................................................................. 9-188 9-49 Tumor Incidence in Sprague-Dawley Rats Exposed to EDC..................... 9-189 9-50 Mammary Tumors in Sprague-Dawley Rats Exposed to EDC....................... 9-193 SL 067578 xiv Table 9-51 9-52 9-53 9-54 9-55 9-56 9-57 9-58 9-59 LIST OF TABLES Design Summary for 1,2-Dichloroethane (EDC) Experiment in Swiss Mice........................................................................................... Survival of Swiss Mice Exposed to EDC at 52 and 78 Weeks. Tumor Incidence in Swiss Mice Exposed to EDC........................... Pulmonary Tumor Response in Strain A/st Mice Injected with EDC.................................................................................. Mouse Skin Bioassay of 1,2-Dichloroethane and Chloroacetaldehyde................................................................................ Incidence Rates of Hemangiosarcomas in the Circulatory Systems of Male Osborne-Mendel Rats.......................................... Incidence Rates of Hepatocellular Carcinomas in Male B6C3F1 Mice............................................................................................... Upper-Bound Estimate of Risk At 1 Mg/kg/day............................. Relative Carcinogenic Potencies Among 53 Chemicals Evaluated by the ^atjcinogen Assessment Croup as Suspect Human Carcinogens ' ' ....................................................................... Page 9-196 9-197 9-193 9-202 9-204 9-220 9-220 9-223 9-230 xv SL 6757Q LIST OF FIGURES Figure Page 9-1 EDC levels after single oral administration in rats............................ 9-7 9-2 Top: Blood levels of EDC observed during and following a 6-hour inhalation exposure to 150 ppm EDC. Bottom: Semilogarithmic plot of EDC blood levels vs. time after exposure termination............................................................................................... 9-12 9-3 Blood levels of EDC in rats after i.v. administration........................ 9-23 9-4 Levels of EDC in rats after inhalatory exposure to 50 ppm (top) and 250 ppm (bottom). Levels were measured at termination of 5-hour exposure period..................................................... 9-27 9-5 Microsomal oxidative metabolism of 1,2-dihaloethanes.......................... 9-39 9-6 Further metabolism of 2-chloroacetaldehyde and 1-chloroso2-chloroethane from microsomal oxidation............................................... 9-41 9-7 Cytosolic metabolism of ethylene dichloride.............................................. 9-44 9-8 Growth curves for male and female Osborne-Mendel rats administered 1,2-dichloroethane (EDC) by gavage................................ 9-170 9-9 Survival comparisons for male and female Osborne-Mendel rats administered 1,2-dichloroethane (EDC) by gavage............................... 9-171 9-10 Growth curves for male and female B6C3F1 mice administered 1,2-dichloroethane (EDC) by gavage............................................................... 9-179 9-11 Survival comparisons for male and female B6C3F1 mice administered 1,2-Dichloroethane (EDC) by gavage.............................. 9--180 9-12 Point and upper-bound estimates of four dose-response models over low-dose region on basis of hemangiosarcomas in rats; dose with surface correction............................................................................ 9-224 9-13 Point and upper-bound estimates of four dose-response models over low-dose region on the basis of liver carcinomas in mice; dose with surface correction............................................................ 9-225 9-14 Histogram representing the frequency distribution of the potency indices of 53 suspect carcinogens evaluated by the Carcinogen Assessment Group..................................................................... 9-229 SI 067580 xvi 10. 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Toxicological studies of compounds investigated for use as inhibitors of biological processes. II. Toxicity of ethylene chlorohydrin. Arch. Inc. Hyg. Occup. Med. 2: 591-597. 1 0-1 SL 067581 Araoore, J.E. and D. Venstrom. 1966. Sensory analysis of odor qualities in term of the stereochemical theory. J. Food. Science. 31 : 118, Anders, M.W. and J.C. Livesey. 1980. Metabolism of 1,2-dihaloethanes, in "Banbury Report No. 5, Ethylene Dichloride: A Potential Health Risk?", B. Ames, P. Infante and R. Reitz, eds., Cold Spring Harbor Laboratory, p. 331-343. Andriukin, A.A. 1979. Toxic effects of dichloroethane on the cardiovascular system. Klin. Med. 57: 43-47 (Rus.) (Summarized in Chem. Abstr. 79: 2088, 197). Anonymous. 1946. Ethylene Dichloride, in Annual Report of the Chief Inspector of Factories for the Year 1945. London, His Majesty's Stationery Office, p. 77. (Summarized in NIOSH, 1976). Appleby, A. 1976. Atmospheric Freons and Halogenated Compounds. EPA-600/3-76108, Office of Research and Development, U.S. Environmental Protection Agency. Archer, W.L. 1979. 1,2-Dichloroethane. In: Kirk-Othmer Encyclopedia of Chemical Technology, Third Edition., Grayson, M. and Eckroth, D,, eds. John Wiley and Sons, Inc., NY8, Vol. 5, p. 724-727. Archer, W.L. 1979. Other Chloroethanes. In: Kirk-Othmer Encyclopedia of Chemical Technology, Third Edition, Grayson, M. and Eckroth, D., eds. John Wiley and Sons, Inc., NY. Vol. 5, p. 722-742. SL 067582 1 0-2 > Armitage, P. and R. Doll. 19 54. The age distribution of cancer and a multistage theory of carcinogenesis. Br. J. Cancer. 8: 1-12. Auerbach Associates. 1978. Miscellaneous and Small Volume Consumption of Ethylene Dichloride. Unpublished report prepared for the U.S. Environmental Protection Agency under contract number EPA-68-01-3899 and Auerbach Associates, Inc., number AAI-2431-104-TN-1, Philadelphia, PA, p. 7. Baader, E.W. 1950. Multiple poisonings from a floor cleaner because of failure to observe safety laws. Arch. Hyg. Bakteriol. 132: 219-226. (Ger.) (Summarized in NIOSH, 1976). l Banerjee, S. and B.L. Van Duuren. 1978. Interaction of activated carcinogenic intermediates of ethylene dihalides with protein and DNA in mice and rat tissue in vitro. Proc. Amer. Assoc. Cancer Res. 19: 67. Banerjee, S. and B.L. Van Duuren. 1979a. Binding of carcinogenic halogenate hydrocarbons to cellular macromolecules. J. Natl. Cancer Inst. 63: 707* Banerjee, S., B.L. Van Duuren and S.A. Kline. 1979b. Interaction of potential metabolites of the carcinogen ethylene dibromide with protein and DNA in vitro. Biochem. Biophys. Res. Comm. 90: 1214-1220. Banerjee, S., B.L. Van Duuren and F.I. Oruambo. 1980. Microsome-mediated covalent binding of i,2-dichloroethane to lung microsomal protein and salmon sperm DNA. Cancer Res. 40: 21 70-21 73- 10-3 SL 067583 Bang, Y.H. and H.S. Telford. 1966. 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Delo. 7: 134-139. Siegel, I.M. 1947. Ethylene dichloride. JAMA. (Lett). 133= 577. Simmon, V.F. 1980. Review of nonbacterial tests of the genotoxic activity of ethylene dichloride. In: Banbury Report 5. Ethylene dichloride: A potential health risk? B.N. Ames, P. Infante and R, Reitz, eds. Cold Spring Harbor Laboratory Press. Cold Spring Harbor, NY. p, 97-103. Singh, H.B. 1977. Atmospheric halocarbons. 1977. Evidence of favor of reduced average hydroxyl radical concentrations in the troposphere. Geophy. Res. Lett. 4(3): 101-104. SL 067622 10-42 Singh, H.B. 19 78. Letter to the editor. Atmos. Environ. 12: 18 09 Singh, H.B., L. Salas, D. Lillian, R.R. Arnts and A. Appleby. 1977. Generation of accurate halocarbon primary standards with permeation tubes. Environ. Sci. Technol. 11 (5): 511-513. Singh, H.B., L.J. Salas, H. Shigeishi, A.J. Smith, E. Schibner and L.A. Cavanagh. 1979. Atmospheric distributions, sources and sinks of selected halocarbons, hydrocarbons, SFg and N02< Grant No. 8038020. EPA-600/3-79-107. Singh, H.B., L.J. Salas, A. Smith and H. Shigeishi. 1980. Atmospheric measure ments of selected toxic organic chemicals - interim report 1979. Grant No. 805990. EPA-600/3-80-072. Singh, H.B., L.J. Salas, A. Smith and P. Shigeshi, 1980. Atmospheric measure ments of selected toxic organic chemicals: Halogenated alkanes, chlorinated aromatics, aromatic hydrocarbons and secondary organics. Prepared by SRI Inter national for Environmental Sciences Research Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, NC. Interim report. SRI Project 7774. Singh, H.B., L.J. Salas, A.J. Smith and H. Shigeishi. 1981. Measurements of some potentially hazardous organic chemicals in urban environments. Atmos. Environ. 15(4): 601-612. 10-43 SL 067623 Singh, H.B., L.J. Salas and R.E. Stiles. 1982. 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Lethal poisoning from dichloroethane (ethylene chloride). Pharmazie. 3: 398-400. (Ger.) (Summarized in NIOSH, 1976). Whitney, W. 1961. Fumigation hazards as related to the physical, chemical, and biological properties of fumigants. Pest. Control. 29(7): 16-21, Whittemore, A. 1978. Quantitative theories of carcinogenesis. In: Advances in cancer research. Vol. 27. Academic Press, New York, NY. p. 55-58. Whittemore, A. and B. Keller. 1978. Quantitative theory of carcinogenesis. Society for Industrial and Applied Mathematics Review. 20: 1-30. Williams, R.T. 1959. Detoxication mechanisms. London, p. 55. Wilson, J.T., C.G. Enfield, W.J. Dunlap, R.L. Cosby, D.A. Foster and L.B. Baskin. 1981. Transport and fate of sel-_,ted organic pollutants in a sandy soil. J. Environ. Qual. 10(4): 501-506. Wirtschafter, Z.T. and E.D. Schwartz. 1939* poisoning. J. Ind. Hyg. Toxicol. 21: 126--131. Acute ethylene dichloride SL 067634 10-54 Withey, J.R. and B.T. Collins. 1980. Chlorinated aliphatic hydrocarbons used in teh food industry: The comparative pharmacokinetics of methylene chloride, i,2dichloroethane, chloroform and trichloroethylene after i.v. administration in the rat. J. Environ. Pathol. Toxicol. 3: 313-332. Withey, J.R., B.T. Collins and P.G. Collins. 1982. Effect of vehicle on the pharmacokinetics and uptake of four halogenated '.ydrocarbons from the gastro intestinal tract of the rat. Pre-print paper submitted to J. Appl. Toxicol. December, 1982. Woodward, G., S. Lange, K. Nelson and H. Calvery. 1981. The acute oral toxicity of acetic, chloroacetic, dichloroacetic and trichloroacetic acids. J. Ind. Hyg. Toxicol. 23: 78-82. Yasoda, S.K. and E. Dan Loughran. 1977. Air sampling methods for S-tetrachloroethane and other related chlorinated hydrocarbons. J. Chromat. 137-283-292. Yllner, S. 1971a. Metabolism of chloroacetate-1- 14 C in the mouse. Pharmacol. Toxicol. 30: 69-80/ Acta. Yllner, S. 1971b. Metabolism of 1 ,2-dichloroethane-1**C in the mouse. Acta. Pharmacol. Toxicol. 30: 257-265. Yllner, S. n.d. Chlorinated aliphatic hydrocarbons used in the foods industry. The comparative pharmacokinetics of methylene chloride, 1,2-dichloroethane, chloroform, and trichloroethylene after I.V. administration in the rat. J. Environ. Pathol. Toxicol. 3: (in press). 10-55 SL 067635 APPENDIX A COMPARISON AMONG DIFFERENT EXTRAPOLATION MODELS Four models used for low-dose extrapolation, assuming the independent background, are: Multistage: P(d) = 1 - exp [-(q^d + ... + q^d^)] where are non-negative parameters; Probit: P(d) = A + Bln(d) / F(x) dx " CO where f(.) is the standard normal probability density function; Weibull: P(d) * 1 - exp [-bd^] where b and k are non-negative parameters; and One-hit: P(d) = 1 - exp [--bd] where b is a non-negative parameter. The maximum likelihood estimates (MLE) of the parameters in the multi stage and one-hit models are calculated by means of the program GLOBAL82, which was developed by Howe and Crump (1982). The MLE estimates of the parameters in the probit and Weibull models are calculated by means of the program RISK81, which was developed by Kovar and Krewski (1981). Table A-l presents the MLE of parameters in each of the four models that are applicable to a data set. A-l SL 067636 TABLE A-l. MAXIMUM LIKELIHOOD ESTIMATES OF THE PARAMETERS FOR EACH OF THE FOUR EXTRAPOLATION MODELS BASED ON DIFFERENT DATA BASES Data base Hemangiosarcomas in male rats, dose with surface corre ctIon Hemangiosarcomas in male rats, dose without surface correction He pa to ce 1 lu la r ca rc i nomas in male mice, dose with surface correction Heptocellular carcinomas in male mice, dose without surface corrections Multistage qj = 3.65 X ID'2 q2 = 0 qi = 7 -l q2 = 0 .O'3 -Q NJ * II q, = 1.03 X IQ'2 X 10-3 *>1 8.18 x q2 9.25 xX Probi t A = -1.43 B = 0.34 A = -1.99 B = 0.34 A = -2.75 B = 0.86 A = -4.92 B = 0.86 Weibul1 b = 9.08 X 10 2 k = 0.52 b = 3.84 X 10"2 k = 0.52 b = 8.07 X IQ"3 k = 1.49 b = 1.84 x 10-4 k = 1.49 One-hit b = 3.65 X 10~2 b = 7.03 X 10-3 b = 2.32 X 10-2 b = 3.04 x 10 3 APPENDIX B RISK CALCULATION BASED ON TIME-TO-EVENT DATA Because of the high mortality rate of rats in the high-dose group of the NCI (1978) gavage study, it is more appropriate to use time-to-event data (Table B-l) to calculate the potency of EDC. The probability of cancer by time t at dose d is given by: P(d,t) = 1 - exp [--f(t) x g(d)] where g(d) is a polynomial in dose d, and f(t) is a function of time t. The maximum likelihood estimate of the parameters and the asymptotic properties of the incremental risk estimate were investigated by Daffer et al. (1980). Their approach to estimating the parameters resembles Cox's regression-lifetable approach (Cox 1972), in which the time function f(t) need not be specified. Using the data in Table B-l, the lifetime cancer risk is estimated to be q* = 6.9 x 10-2 mg/kg/day 1 This value is the 95% upper bound of the risk calculated at t = 90 weeks. Since the model fits the data very well up to 90 weeks but poorly beyond 90 weeks (overestimates), P(d, 90) is used to approximate the lifetime risk. This seems reasonable because the median lifespan for control animals is also less than 90 weeks (approximately 70% of the control animals died before 90 weeks). B-l SL 067638 TABLE B-l. TIME-TO-DEATH IN WEEKS FROM HEMANGIOSARCOMAS IN MALE OSBORNE-MENDEL RATS FED EDO BY GAVAGE Control (vehicle and untreated): 28, 37 , 50, 50, 53, 53, 53, 54, 57, 57, 57, 57, 57, 61 , 61, 69, 71, 76, 78, 80, 80, 83, 85, 86, 87, 89, 90, 101, 101, 104, 106, 106, 106, 106, 106, 108, 110, 110, 110, 110. Low-dose group: 30, 34, 36, 51, 52, 52, 55, 55, 59, 61, 63, 65, 69, 73(H), 74(H), 75, 75, 76, 77, 77, 77(H), 77, 80, 81, 82, 82, 82, 84, 87(H), 89(H), 89, 89, 89, 90, 92, 92, 93(H), 95(H), 96, 97, 98, 99, 99, 102(H), 103, 103, 104, 104, 109(H), 110. High-dose group: 3, 8, 9, 9, 10, 10, 10, 10, 10, 11, 15, 15, 16, 20, 22, 33, 33, 33, 34, 37, 41, 48, 51, 52, 54, 57, 58, 59, 60, 61(H), 62, 63, 63, 68(H), 68(H), 71, 72, 73, 74, 74(H), 74, 74, 76(H), 76, 78(H), 83(H), 84, 89, 101. aH indicates death from hemangiosarcoma. B-2 SL 067639 APPENDIX C .CINOGENIC POTENCIES BY GAVAGE AND INHALATION ROUTES calculating the potency of EDB by gavage are presented in "rom the high-dose group are not used because the dose -dose group was drastically modified during the experi;line-weighted dose almost identical to that of the lowe life-table approach (Kaplan and Meier 1958), the at week 49 (the end of the study) is 0.37 with the 95% dence limit at 0.46. Thus, the upper-bound estimate of nit model, P * 1 - exp (-bd), is: -In (1 --P) ] /d -In (l-0.46]/5.01 .12 mg/kg/day. otency, adjusting for the less-than-lifetime study, is 2 x (90/49)3 = 0.74 mg/kg/day a lifespan that is also used in the EDC calculation when re used. Is approximately 10 times more potent than EDC (i.e., C-l SL 067640 The data used for calculating the potency of EDB by inhalation are presented in Table C-2. The carcinogenic potency of EDB by inhalation is calculated on the basis of nasal cavity tumors in male rats from the NCI inhalation study on EDB (NCI 1979), using the linearized multistage model. The potency of EDB by inhalation is 6.77 x 10"V (ug/m^). SL 067641 C-2 TABLE C-l. T1ME-TO-DEATH IN WEEKS FROM HEMANGIOSARCOMAS IN MALE OSBORNE-MENDEL RATS FED EDB BY GAVAGE (NCI 1978) Low-dose group (38 mg/kg/day)a 31(H)b, 42, 43, 48, 48, 49, 49, 32, 34(H), 34(H), 35, 36, 37, 38(H), 39, 39, 40, 41, 43, 43, 43, 43, 43, 44, 44, 44, 46, 46, 47, 47, 48(H), 48, 48, 49(H), 49(H), 49(H), 49(H), 49(H), 49(H), 49, 49, 49, 49, 49, 49, 49, 49, 49, 49, 49. aThe animals were fed EDB 5 days per week for 47 weeks (out of 49 weeks observa tion period). The human equivalent dose is (38 mg/kg/day) x (5/7) x (47/49) x (0.5/70)1/-* * 5.01 mg/kg/day. ^H indicates that the animals died from hemangiosarcomas. It is assumed that all animals observed with tumors at week 49 died from the tumors. This assumption seems reasonable, since the time from exposure to tumor death was very short. TABLE C-2. INCIDENCE OF NASAL CAVITY TUMORS IN MALE FISCHER 344 RATS ADMINISTERED EDB BY INHALATION (NCI 1979) Human equivalent dose (ug/m3)a Animal dose (ppm) Response 0 1.39 x 104 5.57 x 104 0 0/50 (0%) 10 39/50 (78%) 40 41/50 (82%) aHuman equivalent dose * d x (5/7) x (6/24) = 0.178 x d. The dose is converted to the unit of ug/ra3 by using 1 ppm - 7.83 x 103 ug/m3. C-3 SL 067642