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1,2-Dichloroethane (Do Not
Cite or Quote)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.
-------
(Do Not
Cite or Quote)
EPA-600/8-84-006A
April 1984
External Review Draft
Health Assessment Document
for 1,2,- Dichloroethane
(Ethylene Dichloride)
Part 2 of 2
This document isa 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
NOTICE
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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
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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 summary/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.
iii
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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 132104080
D. Anthony Gray, Ph.D.
Life and Environmental Sciences Division
Syracuse Research Corporation
Syracuse, New York 13210-^080
Joseph Santodonato, Ph.D., C.I.H.
Life and Environmental Sciences Division
Syracuse Research Corporation
Syracuse, New York 13210^080
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
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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
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
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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 Assessment
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. Corni3h, 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
vi
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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^
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
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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
viii
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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 3-1
3.2 CAS REGISTRY, RTECS, AND STORET NUMBERS 3-1
3.3 DESCRIPTION 3-1
3.4 STRUCTURE 3-1
3.5 PHYSICAL PROPERTIES OF PURE ETHYLENE DICHLORIDE 3-1
SAMPLING AND ANALYSIS OF ETHYLENE DICHLORIDE 1-1
4.1 SAMPLING 4-1
4.2 ANALYSIS . 4-1
4.2.1 Ethylene Dichloride in Air 4-1
4.2.2 Ethylene Dichloride in Water 4-2
4.2.3 Ethylene Dichloride in Solid Samples 4-3
4.2.4 Ethylene Dichloride in Blood 4-3
4.2.5 Ethylene Dichloride in Urine 4-3
4.2.6 Ethylene Dichloride in Tissue 4-4
5. SOURCES IN THE ENVIRONMENT 5-1
5.1 PRODUCTION PROCESSES 5-1
5.2 ETHYLENE DICHLORIDE PRODUCERS 5-2
5.3 ETHYLENE DICHLORIDE PRODUCTION AND TRENDS 5-2
5.4 ETHYLENE DICHLORIDE USES 5-5
5.5 SOURCES OF EMISSIONS 5-9
5.5.1 Production and Related Facilities 5-12
5.5.2 Dispersive Uses 5-13
5.5.3 Conclusions 5-14
6. FATE AND TRANSPORT IN THE ENVIRONMENT 6-1
6.1 ATMOSPHERE 6-1
6.2 AQUATIC MEDIA 6-7
6.3 SOIL 6-8
6.4 SUMMARY 6-9
ix
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TABLE OF CONTENTS (cont.)
Page
7. ENVIRONMENTAL LEVELS AND EXPOSURE 7-1
7.1 ENVIRONMENTAL LEVELS 7-1
7.1.1 Atmospheric Levels 7-1
7.1.2 Ground and Surface Water Levels 7-9
7.1.3 Soil and Sediment Levels 7-14
7.2 ENVIRONMENTAL EXPOSURE 7-14
7.2.1 Exposure from Air 7-18
7.2.2 Exposure from Water 7-20
7.2.3 Exposure from Food 7-20
7.3 CONCLUSIONS 7-20
8. ECOLOGICAL EFFECTS 8-1
9. BIOLOGICAL EFFECTS IN MAN AND EXPERIMENTAL ANIMALS 9-1
9.1 PHARMACOKINETICS 9-1
9.1.1 Absorption and Distribution 9-1
9.1.2 Excretion 9-18
9.1.3 Metabolism 9-32
9.1.4 Summary and Conclusions 9-55
9.2 ACUTE, SUBCHRONIC AND CHRONIC TOXICITY 9-57
9.2.1 Effects in Humans 9-57
9.2.2 Effects in Animals 9-86
9.2.3 Summary of Acute, Subchronic and Chronic Toxicity 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 Animal Studies 9-166
9.5.2 Epidemiologic Studies 9-205
9.5.3 Quantitative Estimates 9-206
9.5.4 Summary 9-233
9.5.5 Conclusions 9-234
10. REFERENCES 10-1
Appendix A
Appendix B
Appendix C
x
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LIST OF TABLES
Table Page
5-1 Major Manufacturers of Ethylene Dichloride 5-3
5-2 U.S. Production and Sales of Ethylene Dichloride.. 5-4
5-3 Ethylene Dichloride Uses 5-6
5-4 Comsumption of Ethylene Dichloride in 1979 and 197^4 5-7
5-5 Uses of Ethylene Dichloride for Intermediate Purposes 5-8
5-6 Estimated Environmental Releases of Ethylene
Dichloride in 1979 5-11
6-1 Rate Constants for a Few Chlorinated Ethanes at
Room Temperature 6-3
7-1 Ambient Atmospheric Levels of Ethylene Dichloride 7-2
7-2 Ambient Concentrations of Ethylene Dichloride in
Urban Areas 7-8
7-3 Reported Occurrence of Ethylene Dichloride in Groundwater
System 7-15
7-4 Reported Occurrence of Ethylene Dichloride in Surface
Water Systems 7-16
7-5 . State Data on Ethylene Dichloride in Groundwater 7-17
7-6 Estimated Respiratory Intake of Ethylene Dichloride by
Adults and Infants 7-19
7-7 Maximum Concentration Level in the Vicinity of Various
Emission Sources 7-21
7-8 Total Estimated Population (in Thousands) Exposed to
Ethylene Dichloride in Drinking Water at the Indicated
Concentration Ranges 7-22
7-9 Estimated Drinking Water Intake of Ethylene Dichloride
by Adults and Infants 7-23
9-1 Physical Properties of Ethylene Dichloride and
Other Chloroethanes 9-3
9-2 Partition Coefficients for Ethylene Dichloride 9-4
xi
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LIST OF TABLES (cont.)
Table Page
9-3 Fate of 1l
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LIST OF TABLES (cont.)
Table Page
9-16 Total Macromolecular Binding and DNA Binding in Selected
Tissue of Rats After Exposure to C-EDC by Oral or
Inhalation Routes. 9-52
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 9-54
9-18 Effects Associated with Acute Lethal Oral Doses of
Ethylene Dichloride in Humans 9-58
9-19 Effects of Acute Oral Ingestion of 1f2-Dichloroethane
(Survey Results) . 9-65
9-20 Effect of Ethylene Dichloride Exposure on Eye
Sensitivity to Light 9-72
9-21 Morbidity and Lost Workdays of Aircraft Industry Gluers
Exposed to Ethylene Dichloride 9-78
9-22 Concentrations of Ethylene Dichloride in Oil Refinery
Mineral Oil Purification Process Air 9-80
9-23 Effects Observed in Polish Oil Refinery Workers 9-81
9-24 Effects of Acute Exposure to Ethylene Dichloride 9-87
9-25 Effect of Ethylene Dichloride on the Cornea 9-95
9-26 Effect of Subchronic Exposure to Ethylene Dichloride 9-102
9-27 Summary of Mutagenicity Testing of EDC: Gene Mutations
in Bacteria 9-132
9-28 Summary of Mutagenicity Testing of EDC: Higher Plants 9-145
9-29 Summary of Mutagenicity Testing of EDC: Gene Mutation
Tests in Insects 9-147
9-30 Summary of Mutagenicity Testing of EDC: Mammalian Cells
in Culture 9-153
9-31 Summary of Mutagenicity Testing of EDC: Chromosomal
Aberrations Tests 9-155
9-32 Summary of Mutagenicity Testing of EDC: PolA Assay 9-160
9-33 Summary of Mutagenicity Testing of EDC: DNA Binding
Studies 9-163
xiii
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LIST OF TABLES
Table Page
9-3^ Design Summary for 1,2-Dichloroethane (EDC) Gavage
Experiment in Osborne-Mendel Rats . 9-168
9-35 Terminal Survival of Osborne-Mendel Rats Treated With
1,2-Dichloroethane (EDC) 9-172
9-36 Squamous Cell Carcinomas of the Forestomach in Osborne-
Mendel Rats Treated With 1,2-Dichloroethane (EDC) 9-173
9-37 Hemangiosarcomas in Osborne-Mendel Rats Treated With
1,2-Dichloroethane (EDC) 9-174
9-38 Adenocarcinomas of the Mammary Gland in Female Osborne-
Mendel 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) 9-178
9-41 Hepatocellular Carcinomas in B6C3F1 Mice Treated With
1,2-Dichloroethane (EDC) 9181
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 B6C3F1 Mice
Treated With 1,2-Dichloroethane (EDC) 9-184
9-15 Endometrial Polyp or Endometrial Stromal Sarcomas in Female
B6C3F1 Mice Treated With 1,2-Dichloroethane (EDC) 9-184
9-^6 Characterization of 1,2-Dichloroethane (EDC) Inhalation
Experiment in Sprague-Dawley Rats. 9-185
9-47 Design Summary for t,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
xiv
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LIST OF TABLES
Table Page
9-51 Design Summary for 1,2-Dichloroethane (EDC) Experiment
in Swiss Mice 9-196
9-52 Survival of Swiss Mice Exposed to EDC at 52 and 78 Weeks...... 9-197
9-53 Tumor Incidence in Swiss Mice Exposed to EDC 9-198
9-5^ Pulmonary Tumor Response in Strain A/st Mice
Injected with EDC 9-202
9-55 Mouse Skin Bioassay of 1,2-Dichloroethane and
Chloroacetaldehyde.. . 9-20M
9-56 Incidence Rates of Hemangiosarcomas in the Circulatory
Systems of Male Osborne-Mendel Rats.. 9-220
9-57 Incidence Rates of Hepatocellular Carcinomas in Male
B6C3F1 Mice 9-220
9-58 Upper-Bound Estimate of Risk At 1 Mg/kg/day 9-223
9-59 Relative Carcinogenic Potencies Among 53 Chemicals
Evaluated by the Carcinogen Assessment Group as Suspect
Human Carcinogens ' ' 9-230
xv
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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: Semi-
logarithmic 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-^ 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-chloroso-
2-chloroethane from microsomal oxidation 9-^1
9-7 Cytosolic metabolism of ethylene dichloride 9-^
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 9-22^
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-TJ Histogram representing the frequency distribution of the
potency indices of 53 suspect carcinogens evaluated by
the Carcinogen Assessment Group 9-229
xvi
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Ambrose, A. 1950. Toxicological studies of compounds investigated for use as
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Borisova, M.K. 1957. Experimental data for determination of the maximum allow-
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10-55
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APPENDIX A
COMPARISON AMONG DIFFERENT EXTRAPOLATION MODELS
Four models used for low-dose extrapolation, assuming the independent
background, are:
Multistage: P(d) = 1 - exp [(qid + ... + qkdk)]
where are non-negative parameters;
Probit: A + Bln(d)
P(d) = ; F(x) dx
00
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
-------
TABLE A-l. MAXIMUM LIKELIHOOD ESTIMATES OF THE PARAMETERS FOR EACH OF THE FOUR
EXTRAPOLATION MODELS BASED ON DIFFERENT DATA BASES
Data base
Multistage
Probit
Weibull
One-hi t
Hemangiosarcoraas in male
rats, dose with surface
correction
Hemangiosarcoraas in male
rats, dose without
surface correction
Hepatocellular carcinomas
in male mice, dose with
surface correction
Heptocellular carcinomas in
male mice, dose without
surface corrections
q^ = 3.65 x
q2 = 0
10
-2
qj = 7.03 x.
q2 = °
10
-3
q2
qi
q2
= 1.03 X
= 1.47 x
= 8.18
= 9.25
10
10
-2
-3
10
10
-4
-6
A = -1.43
B = 0.34
A = -1.99
B = 0.34
A = -2.75
B = 0.86
A = -4.92
B = 0.86
b = 9.08 x 10 2
k = 0.52
b = 3.84 x 10
k = 0.52
-2
b = 8.07 x 10
k = 1.49
-3
b = 1.84 x 10
k = 1.49
-4
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-life-
table 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
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
-------
TABLE B-l. TIME-TO-DEATH IN WEEKS FROM HEMANGIOSARCOMAS
IN MALE OSBORNE-MENDEL RATS FED EDC 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, 10.6, 106, 106, 106, 106, 108, 110, 110, 1 10, 110.
Low-dose group:
30, 34, 36, 51, 52, 52, 55, 55, 59, 61, 63, 65, 69, 73(H)a,
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
-------
APPENDIX C
CALCULATION OF EDB CARCINOGENIC POTENCIES BY GAVAGE AND INHALATION ROUTES
The data used for calculating the potency of EDB by gavage are presented in
Table C-l. The data from the high-dose group are not used because the dose
pattern from the high-dose group was drastically modified during the experi-
ment, resulting in a time-weighted dose almost identical to that of the low-
dose group. Using the life-table approach (Kaplan and Meier 1958), the
probability of cancer at week 49 (the end of the study) is 0.37 with the 95%
one-sided upper-confidence limit at 0.46. Thus, the upper-bound estimate of
the slope in the one-hit model, P = 1 - exp (-bd), is:
b = [-In (l-P)]/d
= l-ln (1-0.46J/5.01
= 0.12 mg/kg/day.
The lifetime cancer potency, adjusting for the less-than-lifetime study, is
B = 0.12 x (90/49)3 = 0.74 mg/kg/day
where 90 weeks is the lifespan that is also used in the EDC calculation when
time-to-event data are used.
Therefore, EDB is approximately 10 times more potent than EDC (i.e.,
0.74/0.069).
C-l
-------
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 10-5/(ug/m3).
C-2
-------
TABLE C-l. TIME-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, 32, 34(H), 34(H), 35, 36, 37, 38(H), 39, 39, 40, 41,
42, 43, 43, 43, 43, 43, 43, 44, 44, 44, 46, 46, 47, 47, 48(H),
48, 48, 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, 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)i/3 = 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 Animal dose
dose (ug/m^)a (ppm) Response
0 0 0/50 (0%)
1.39 x 104 10 39/50 (78%)
5.57 x 10^ 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/m^ by using 1 ppm = 7.83 x 10^ ug/m^.
C-3
------- |