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Table 1 (continued): Reference Hayes et al. 1989 USA Steenland et al. 1990 USA Study Design, Population, and Exposures Case-control Pooled Analysis Truck Drivers < 10 yrs employed > 10 yrs employed Heavy Equipment < 10 yrs employed > 10 yrs employed Bus Drivers < 10 yrs employed Case-control Occupation data: 1) Teamster records data Long-haul driver Short-haul driver 2) Next -of-kin data Truck driver, diesel Truck driver, gasoline Truck driver, both Duration employment after 1959*: 1) Teamster records data Long-haul driver 1-11 years 12-17 years >18 years 2) Next -of-kin data Diesel truck driver 1-24 years 25-34 years >35 years Epidemiological Studies of Exposure to Diesel Exhaust and Lung Cancer Studies Among Truck Drivers Cases or deaths 161 112 7 10 23 162 228 213 48 72 56 Effect Measure OR 1.0 1.5 1.5 2.1 1.1 OR 1.27 1.31 1.42 1.22 1.25 1.08 1.41 1.55 1.27 1.26 1.89 Confidence Interval a or P-Value 0.8-1.3 1.1-2.0 0.4-5.3 0.6-7.1 0.6-2.1 0.83-1.93 0.81-2.11 0.89-2.26 0.79-1.88 0.81-1.95 0.68-1.70 0.90-2.21 0.97-2.47 0.70-2.27 0.74-2.16 1.04-3.42 Comments The study is a pooled analysis of three case-control studies conducted between 1976 and 1983 in Florida, New Jersey, and Louisiana. Total eligible cases = 2,291 and controls = 2,570. All occupational data were recoded from original interviews. No specific in<strong>format</strong>ion regarding diesel exposure or engine type. ORs were adjusted for birth cohort(
Table 1 (continued): Reference Burns and Swanson 1991 USA Swanson et al. 1993 USA Study Design, Population, and Exposures Case-control Drivers (white) All drivers (race adj.) Railroad workers Case-control Occupation and duration: 1) White males Heavy truck drivers 0 years 1-9 years 10-19 years 20+ years Light truck drivers 0 years 1-9 years 10+ years Railroad workers 0 years 1-9 years 10+ years 2) Black males Heavy truck drivers 0 years 1-9 years 10-19 years 20+ years Railroad workers 0 years Epidemiological Studies of Exposure to Diesel Exhaust and Lung Cancer Studies Among Truck Drivers Cases or deaths 187 238 14 88 78 38 121 88 46 36 73 27 40 12 27 16 16 15 Effect Measure OR 2.40 1.88 1.27 OR 1.0 1.4 1.6 2.5 1.0 1.7 2.1 1.0 1.2 2.4 1.0 2.7 1.9 2.1 1.0 Confidence Interval a or P-Value 1.65-3.48 1.37-2.58 0.45-3.53 Reference 0.8-2.4* 0.8-3.5* 1.1-4.4* Reference 0.9-3.3 0.9-4.6 Reference 0.5-2.7 1.1-5.1 Reference 0.8-9.2 0.5-7.2 0.5-9.2 Reference Comments Occupational and smoking histories were obtained by telephone interview for 5,935 incident lung cancer cases and 3,956 incident colon and rectal cancer controls diagnosed between 1984 and 1987 and reported to the Detroit cancer registry. The smoking- and raceadjusted OR for all drivers (238 cases, 86 controls) was 1.88 (95% C.I. = 1.37-2.58), while drivers of “heavy trucks” (166 cases, 48 controls), maintained a higher risk even after adjustment for smoking, OR = 2.31 (95% C.I. = 1.56-3.42). Mechanics also had a significantly elevated OR for lung cancer (OR = 1.72, 95% C.I. = 1.15-2.59). The types of the vehicle engines were not specified. Results were adjusted for smoking. See Swanson et al. 1993. Cases and controls were from OCISS (see Burns and Swanson, 1991 for description of subjects). Incident lung cancer cases among black and white males, aged 40 to 84, from 1984 through 1987 are included in this report. Controls were colon and rectal cancer cases. In<strong>format</strong>ion on occupation, smoking, medical history were obtained by telephone interview. Results were adjusted for age at diagnosis, race and smoking. *Test for trend p ≤ 0.05. a 95% Confidence intervals unless noted. N.S.= Not significant. No confidence intervals or p-values reported in original study. DE = Diesel Exhaust. OR = Odds Ratio, RR = Relative Risk, SIR = Standardized Incidence Ratio, SMR = Standardized Mortality Ratio 440
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Air Toxics Hot Spots Program Risk A
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Prepared by: John D. Budroe, Ph.D.
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This document is one of five docume
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TABLE OF CONTENTS PREFACE i INTRODU
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N-Nitrosodimethylamine 401 N-Nitros
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Hot Spots Unit Risk and Cancer Pote
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Additional ATES and PETS documents
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data. If several data sets (dose an
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US EPA Calculation of Carcinogenic
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exposure to a concentration of 1 µ
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incidences for each of the dose lev
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computes the surface area of a sphe
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Comparison of Hot Spots Cancer Unit
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Gold, L., de Veciana, M., Backman,
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Animal Studies Rats Woutersen et al
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ased on sufficient evidence of carc
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ACETAMIDE CAS No: 60-35-5 I. PHYSIC
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Methodology Expedited Proposition 6
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cancer mortality. However, US EPA (
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Table 2. Lung adenoma incidence in
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Table 3 (continued). Acrylamide-ind
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Robinson M, Bull RJ, Knutsen GL, Sh
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Also, a trend was observed correlat
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eported. Cause-specific expected de
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Bio/Dynamics Inc. conducted a study
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examination. Interim sacrifices wer
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Table 8. Tumor incidence in male an
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Gaffey WR and Strauss ME. 1981. A m
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(technical grade; 98% pure) by gava
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International Agency for Research o
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still alive in the low-dose control
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ANILINE CAS No: 62-53-3 I. PHYSICAL
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fibrosarcomas, stromal sarcomas, ca
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ARSENIC (INORGANIC) CAS No: 7440-38
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elationship between arsenic exposur
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al. (1988) did not induce lung tumo
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A risk assessment was also conducte
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Chen C, Chuang Y, You S, Lin T and
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Schrauzer G, White D, McGinness J,
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Table 1: Summary of epidemiologic s
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had at least one animal demonstrati
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mesothelioma, recommended lifetime
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National Institute for Occupational
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BENZENE CAS No: 71-43-2 I. PHYSICAL
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Animal Studies Available experiment
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Table 3: Summary of NTP bioassay re
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Table 4: Summary of benzene low-dos
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Maltoni C, Conti B and Cotti G. 198
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a benign tumor of the kidney. No ba
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al. (1968) found no tumors in lifet
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following relationship, where C(t 1
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Miakawa M. and Yoshida O. 1975. Pro
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human population and that BPDE-DNA
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demonstrated the tumor initiating a
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Table 4: Bronchoalveolar tumors fro
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Table 5: IARC groupings of PAHs, mi
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Table 6 (continued): IARC Group 3 P
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Potency Equivalency Factors (PEF) f
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This was rounded to a PEF of 0.1. 1
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experiment (Takayama et al., 1985)
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Deutsch-Wenzel RP, Brune H, Grimmer
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Krewski D, Thorslund T and Withey J
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U.S. Environmental Protection Agenc
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Sorahan et al. (1983) studied cance
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Lijinsky W. 1986. Chronic bioassay
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the drinking water (Schroeder and M
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Table II. Effective dose, upper-bou
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BIS(2-CHLOROETHYL)ETHER CAS No: 111
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IV. DERIVATION OF CANCER POTENCY Ba
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BIS(CHLOROMETHYL)ETHER CAS No: 542-
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Table 1. Bis(chloromethyl)ether-ind
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Drew RT, Laskin S, Kuschner M and N
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ates for the 1968 U.S. male populat
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Table 1: Incidence of primary tumor
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National Institute of Occupational
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was less than 0.05 when controlling
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up period. The final cohort include
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If the cadmium-exposed workers incl
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on personnel records (20%); (3) eva
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were exposed to a continuous (23.5
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procedure (NLIN), the parameters we
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International Agency for Research o
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Two reports were published on cance
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Mendel rats, respectively), and sub
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Eschenbrenner A and Miller E. 1946.
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III. CARCINOGENIC EFFECTS Human Stu
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cancers, were less than expected. T
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and no cases of cancer (although cl
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There was a statistically significa
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NTP (1982a) also conducted an carci
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Several pathologists have independe
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hepatocellular adenoma/carcinoma tu
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carcinogenic potency may decline in
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Cochrane W, Singh J and Miles W. 19
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North Atlantic Treaty Organization,
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CHLORINATED PARAFFINS (average chai
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ased on dose-response data for beni
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chloroform in drinking water with k
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Overall, the present epidemiologica
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female dogs received toothpaste bas
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Calculated q 1 * values from the ab
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Hogan MD, Chi Py, Hoel DG and Mitch
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Table 1. Study design summary for N
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V. REFERENCES California Environmen
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toluidine. Followup of this subcoho
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feeding studies on by NCI (1979) us
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CHROMIUM (HEXAVALENT) CAS No: 18540
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expected rate may be inflated becau
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Oral Borneff et al. (1968) exposed
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CREOSOTE (COAL TAR-DERIVED) CAS No:
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from an inhalation exposure study (
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Table 1. Study design summary for N
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Table 1. Experimental design for ca
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Hazardous Substance Data Bank (HSDB
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Table 1: Tumor induction in Fischer
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Hazardous Substance Data Bank (HSDB
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Table 1. Experimental design of 2,4
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Additional analysis of these data b
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Jackson RJ, Greene CJ, Thomas JT, M
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Table 1. Tumor incidence in rats ex
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Girard R, Tolot F, Martin P and Bou
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exposed more than 16 years before t
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interpretation of dose extrapolatio
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1, 1-DICHLOROETHANE CAS No: 75-34-3
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Table 1b. Study design for carcinog
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National Cancer Institute (NCI) 197
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mice, hepatocellular carcinoma inci
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V. REFERENCES California Department
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DAB/day by gavage for the life of t
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2,4-DINITROTOLUENE CAS No: 121-14-2
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Ellis et al.(1979) (also reported b
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Final Statement of Reasons for OAL,
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to the small sample size and short
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In an inhalation study, Torkelson e
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V. REFERENCES American Conference o
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EPICHLOROHYDRIN CAS No: 106-89-8 I.
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espiratory tumors were noted in the
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Table 4. Epichlorohydrin-induced fo
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Konishi Y, Kawabata A, Denda A, Ike
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exposed to arsenicals for 20 months
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espectively (all statistically sign
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ETHYLENE DICHLORIDE CAS No: 107-06-
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Several factors have been suggested
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myelogenous leukemias (4 and 8 year
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statistically significant. CDHS not
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combined with the incidence in the
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incidence of primary brain tumors.
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Table 6 (continued): Organ/Sex Mali
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An Upper 95% Confidence Limit (UCL)
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ETHYLENE THIOUREA (ETU) CAS No: 96-
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male and female rats. Tumor inciden
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FORMALDEHYDE CAS No: 50-00-0 I. PHY
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presented an extension of a previou
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Methodology In developing a spectru
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Casanova M, Morgan KT, Steinhagen W
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Tobe M, Kaneko T, Uchida Y, Kamata
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Table 1. Hexachlorobenzene-induced
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50 pups (F 1 ) of each sex were ran
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Ertürk E, Lambrecht RW, Peters HA,
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Table 1. Liver hepatoma incidence i
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1988). An airborne unit risk factor
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HYDRAZINE CAS No: 302-01-2 I. PHYSI
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Methodology Inhalation A linearized
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LEAD AND LEAD COMPOUNDS (INORGANIC)
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and other occupational carcinogens
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y inhalation is similar for rats an
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Goyer RA. 1992. Nephrotoxicity and
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LINDANE (g-Hexachlorocyclohexane) C
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Using these relationships, a human
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METHYL TERT-BUTYL ETHER (MTBE) CAS
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Tumor incidences according to the r
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kidney changes indicative of chroni
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Interspecies scaling for oral doses
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Table 4 (continued): Dose Response
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Experimental Pathology Laboratories
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Animal Studies Male and female HaM/
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Gold L, Sawyer C, Magaw R, Backman
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Using the statistical tests (one-ta
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Table 1: Methylene chloride-induced
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Significant treatment-related incre
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National Toxicology Program (NTP) 1
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noted; however, the study duration
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Crump KS, Howe RB, Van Landingham C
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Table 1. Michler’s ketone-induced
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NICKEL AND NICKEL COMPOUNDS CAS No:
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the high exposure group was 14.0. A
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male and 121 female rats, was expos
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2.1 - 2.6 × 10 -4 (µg/m 3 ) -1 .
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The increased incidence of bladder
Page 397 and 398: A linearized multistage procedure w
Page 399 and 400: N-NITROSO-N-METHYLETHYLAMINE CAS No
Page 401 and 402: Hazardous Substance Data Bank (HSDB
Page 403 and 404: propylamine in drinking water at 0.
Page 405 and 406: N-NITROSODIETHYLAMINE CAS No: 55-18
Page 407 and 408: Table 2. Treatment groups, concentr
Page 409 and 410: California Department of Health Ser
Page 411 and 412: animals and the second generation t
Page 413 and 414: ationale for selection of the OEHHA
Page 415 and 416: A unit risk value based upon air co
Page 417 and 418: N-NITROSODIPHENYLAMINE CAS No: 86-3
Page 419 and 420: Methodology Dosage estimates of NDP
Page 421 and 422: Crump KS, Howe RB. 1984. The multis
Page 423 and 424: Table 1. P-Nitrosodiphenylamine-ind
Page 425 and 426: N-NITROSOMORPHOLINE CAS No: 59-89-2
Page 427 and 428: IV. DERIVATION OF CANCER POTENCY Ba
Page 429 and 430: N-NITROSOPIPERIDINE CAS No: 100-75-
Page 431 and 432: Table 3. N-Nitrosopiperidine-induce
Page 433 and 434: Crump KS, Howe RB, Van Landingham C
Page 435 and 436: testicular tumors were noted in the
Page 437 and 438: PARTICULATE MATTER FROM DIESEL-FUEL
Page 439 and 440: etired railroad workers who had had
Page 441 and 442: employment (χ 2 test for trend: p
Page 443 and 444: elevated smoking-adjusted risk esti
Page 445 and 446: Table 1 (continued): Reference Miln
Page 447: Table 1 (continued): Reference Damb
Page 451 and 452: Table 1 (continued): Reference Raff
Page 453 and 454: Table 1 (continued): Epidemiologica
Page 455 and 456: Table 1 (continued): Epidemiologica
Page 457 and 458: Table 1 (continued): Reference Wegm
Page 459 and 460: Animal Studies Section 6.1 (Animal
Page 461 and 462: The variability, or heterogeneity,
Page 463 and 464: estimate for those studies for whic
Page 465 and 466: Figure 1: Estimates of Relative Ris
Page 467 and 468: q 1 * = Excess relative risk × CA
Page 469 and 470: Table 3: Number of Workers in the E
Page 471 and 472: u nexposed workers at zero concentr
Page 473 and 474: for each µg/m 3 of diesel exhaust
Page 475 and 476: Table 4: Values from Unit Risk for
Page 477 and 478: their findings that a reasonable es
Page 479 and 480: Garshick E, Schenker M, Woskie S an
Page 481 and 482: Lewis T, Green, FH MW, Burg J and L
Page 483 and 484: Rothman K. 1986. Modern epidemiolog
Page 485 and 486: PENTACHLOROPHENOL CAS No: 87-86-5 I
Page 487 and 488: The default lifespan for mice is 10
Page 489 and 490: documented. An excess risk from ski
Page 491 and 492: B6C3F 1 mice and F344/N rats were e
Page 493 and 494: This model, rather than a time depe
Page 495 and 496: POLYCHLORINATED BIPHENYLS (PCBs) CA
Page 497 and 498: several benign adenomatous lesions
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Ito et al. (1973) exposed groups of
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could not be characterized by chlor
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exposure (all pathways and mixtures
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National Toxicology Program 1993. T
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Table 1. Potassium bromate-induced
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1,3-PROPANE SULTONE CAS No: 1120-71
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PROPYLENE OXIDE CAS No: 75-56-9 I.
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oxide. In the NTP carcinogenicity s
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1,1,2,2-TETRACHLOROETHANE CAS No: 7
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assumed a body weight of 70 kg and
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total); an untreated control group
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TOLUENE DIISOCYANATE CAS No: 26471-
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Animal Studies The National Toxicol
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Mortillaro PT and Schiavon M. 1982.
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male or female rats. Increases in h
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TRICHLOROETHYLENE CAS No: 79-01-6 I
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A mortality analysis of a cohort of
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elative to that of the controls whi
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applied or metabolized. The range o
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Katz RM and Jowett D. 1981. Female
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10,000 ppm 2,4,6-trichlorophenol in
Page 543 and 544:
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Bionetics Research Laboratories. 19
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control; females: 6/10 exposed, 0/1
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over controls (p < 0.04). Other tum
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was increased (100/314 exposed vs.
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Table 3. Cancer potency estimates f
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Crouch E. 1983. Uncertainties in in
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VINYL CHLORIDE CAS No: 75-01-4 I. P
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Table 1 (continued): A Summary of E
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al., 1983). Histopathology of all o
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Table 3: Tumor incidences in 100 pp
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experiment, animals were exposed to
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Experiment BT1 Most previous risk a
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No statistical analyses of mortalit
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Table 11 gives unit risk estimates
Page 573 and 574:
Bertazzi PA, Villa A, Foa V, Saia B
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Nicholson WJ, Hammond EC, Seidman H
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immunotoxicity, reproductive toxici
Page 579 and 580:
scheme. TEFs for two major noncance
Page 581 and 582:
NATO/CCMS (1988a) Pilot Study on In
Page 583 and 584:
Table 2 Toxicity Equivalency Factor
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Table 4 A Comparison of CTEF- and I
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Office of Environmental Health Haza
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Group 4: The agent is probably not
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TECHNICAL SUPPORT DOCUMENT FOR DESC
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US EPA IRIS Inhalation Unit Risk an
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TECHNICAL SUPPORT DOCUMENT FOR DESC
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as appropriate, and revise IRIS fil
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Chemical Exposure Route Study Type
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Methyl tert-butyl ether p. 5: Added
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