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International Agency for Research on Cancer (IARC). 1982. Chemicals, industrial processes, and industries associated with cancer in humans. IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals to Man. Vol. Suppl. 4. IARC, Lyon, France, pp. 1-29. Johnson R, Kugler M and Brown S. 1981. Soft tissue sarcomas and chlorinated phenols. Lancet 2:40. Kociba R, Keyes D, Beyer J, Carreon R, Wade C, Dittenber D, Kalnins R, Frauson L, Park C, Barnard S, Hummel R and Humiston C. 1978. Results of a two-year chronic toxicity and oncogenicity study of 2,3,7,8-tetrachlorodibenzo-p-dioxin in rats. Toxicol Appl Pharmacol 46:279-303. May G. 1973. Chloracne from the accidental production of tetrachlorodibenzodioxin. Br J Ind Med 30:276-283. May G. 1982. Tetrachlorodibenzodioxin: a survey of subjects ten years after exposure. Br J Ind Med 39:128-135. Milham S. 1982. Herbicides, occupation, and cancer. Lancet 1:1464-1465. Moses M and Selikoff I. 1981. Soft tissue sarcomas, phenoxy herbicides, and chlorinated phenols. Lancet 1:1370. National Institute for Occupational Safety and Health (NIOSH) 1994. NIOSH Pocket Guide to Chemical Hazards. Washington, DC. National Toxicology Program (NTP) 1980. Bioassay of 1,2,3,6,7,8- and 1,2,3,7,8,9- hexachlorodibenzo-p-dioxin for possible carcinogenicity (dermal study). DHHS Publ. No. (NIH) 80- 1758. Carcinogenesis Testing Program, National Cancer Institute, Bethesda, MD, and National Toxicology Program, Research Triangle Park, NC. National Toxicology Program (NTP) 1980. Bioassay of 1,2,3,6,7,8-and 1,2,3,7,8,9- hexachlorodibenzo-p-dioxin (gavage) for possible carcinogenicity. DHHS Publ. No. (NIH) 80-1754. Carcinogenesis Testing Program, National Cancer Institute, Bethesda, MD, and National Toxicology Program, Research Triangle Park, NC. National Toxicology Program (NTP) 1982. Bioassay of 2,3,7,8-tetrachlorodibenzo-p-dioxin for possible carcinogenicity (dermal). DHHS Publ No. (NIH) 80-1757. Carcinogenesis Testing Program, National Cancer Institute, Bethesda, MD, and National Toxicology Program, Research Triangle Park, NC. National Toxicology Program (NTP) 1982. Bioassay of 2,3,7,8-tetrachlorodibenzo-p-dioxin for possible carcinogenicity (gavage study). DHHS Publ No. (NIH) 82-1765. Carcinogenesis Testing Program, National Cancer Institute, Bethesda, MD, and National Toxicology Program, Research Triangle Park, NC. 185
North Atlantic Treaty Organization, Committee on the Challenges of Modern Society NATO CCMS 1988. Pilot Study on International Information Exchange on Dioxins and Related Compounds. Report 176. North Atlantic Treaty Organization, Committee on the Challenges of Modern Society NATO CCMS 1988. Pilot Study on International Information Exchange on Dioxins and Related Compounds. Report 178. Olsen J and Jensen O. 1984. Nasal cancer and chlorophenols. Lancet 2:47-48. Ott M, Holder B and Olson R. 1980. A mortality analysis of employees engaged in the manufacture of 2,4,5-trichlorophenoxyacetic acid. J Occup Med 22:47-52. Rappe C, Nygren M and Buser H. 1982. Occupational exposure to polychlorinated dioxins and dibenzofurans. In: Chlorinated Dioxins and Related Compounds: Impact on the Environment. Hutzinger O, Frei R, Merian E and Pocchiari F, eds. Pergamon Press, Oxford, pp. 495-515. Riihimaki V, Asp S, Pukkala E and Hernberg S. 1983. Mortality and cancer morbidity among chlorinated phenoxyacid applicators in Finland. Chemosphere 12:779-784. Royal Commisission on the Use and Effect of Chemical Agents on Australian Personnel in Vietnam 1985. Final Report. Australian Government Publishing Service, Canberra, Australia. 8; XV12-13, XV23. Sarma P and Jacobs J. 1982. Thoracic soft tissue sarcoma in Vietnam veterans exposed to Agent Orange. N Engl J Med 306:1109. Schuler R. 1983. Review of selected neoplastic and nonneoplastic liver lesions in rats given hexachlorodibenzo-p-dioxins. B Haberman. U.S. Environmental Protection Agency, Washington, DC. Smith A, Pearce N, Fisher D, Giles H, Teague C and Howard J. 1984. Soft tissue sarcoma and exposure to phenoxyherbicides and chlorophenols in New Zealand. J Natl Cancer Inst 73:1111-1117 . Squire R. 1983. An assessment of the experimental evidence for potential carcinogenicity of hexachlorodibenzo-p-dioxins. TA Robinson. Vulcan Chemicals, Birmingham, AL. Thiess A, Frentzel-Beyme R and Link R. 1982. Mortality study of persons exposed to dioxin in a trichlorophenol-process accident that occurred in the BASF AG on November 17, 1953. Am J Ind Med 3:179-189. Toth K, Somfai-Relle S, Sugar J and Bence J. 1979. Carcinogenicity testing of herbicide 2,4,5- trichlorophenoxyethanol containing dioxin and of pure dioxin in Swiss mice. Nature 278:548-549. 186
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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
Page 143 and 144: BIS(CHLOROMETHYL)ETHER CAS No: 542-
Page 145 and 146: Table 1. Bis(chloromethyl)ether-ind
Page 147 and 148: Drew RT, Laskin S, Kuschner M and N
Page 149 and 150: ates for the 1968 U.S. male populat
Page 151 and 152: Table 1: Incidence of primary tumor
Page 153 and 154: IV. DERIVATION OF CANCER POTENCY Ba
Page 155 and 156: National Institute of Occupational
Page 157 and 158: was less than 0.05 when controlling
Page 159 and 160: up period. The final cohort include
Page 161 and 162: If the cadmium-exposed workers incl
Page 163 and 164: on personnel records (20%); (3) eva
Page 165 and 166: were exposed to a continuous (23.5
Page 167 and 168: procedure (NLIN), the parameters we
Page 169 and 170: International Agency for Research o
Page 171 and 172: Two reports were published on cance
Page 173 and 174: Mendel rats, respectively), and sub
Page 175 and 176: Eschenbrenner A and Miller E. 1946.
Page 177 and 178: III. CARCINOGENIC EFFECTS Human Stu
Page 179 and 180: cancers, were less than expected. T
Page 181 and 182: and no cases of cancer (although cl
Page 183 and 184: There was a statistically significa
Page 185 and 186: NTP (1982a) also conducted an carci
Page 187 and 188: Several pathologists have independe
Page 189 and 190: hepatocellular adenoma/carcinoma tu
Page 191 and 192: carcinogenic potency may decline in
Page 193: Cochrane W, Singh J and Miles W. 19
Page 197 and 198: CHLORINATED PARAFFINS (average chai
Page 199 and 200: ased on dose-response data for beni
Page 201 and 202: chloroform in drinking water with k
Page 203 and 204: Overall, the present epidemiologica
Page 205 and 206: female dogs received toothpaste bas
Page 207 and 208: Calculated q 1 * values from the ab
Page 209 and 210: Hogan MD, Chi Py, Hoel DG and Mitch
Page 211 and 212: Table 1. Study design summary for N
Page 213 and 214: V. REFERENCES California Environmen
Page 215 and 216: toluidine. Followup of this subcoho
Page 217 and 218: feeding studies on by NCI (1979) us
Page 219 and 220: CHROMIUM (HEXAVALENT) CAS No: 18540
Page 221 and 222: expected rate may be inflated becau
Page 223 and 224: Oral Borneff et al. (1968) exposed
Page 225 and 226: CREOSOTE (COAL TAR-DERIVED) CAS No:
Page 227 and 228: from an inhalation exposure study (
Page 229 and 230: U.S. Environmental Protection Agenc
Page 231 and 232: Table 1. Study design summary for N
Page 233 and 234: Methodology Expedited Proposition 6
Page 235 and 236: Table 1. Experimental design for ca
Page 237 and 238: Hazardous Substance Data Bank (HSDB
Page 239 and 240: Table 1: Tumor induction in Fischer
Page 241 and 242: Hazardous Substance Data Bank (HSDB
Page 243 and 244: Table 1. Experimental design of 2,4
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Methodology Expedited Proposition 6
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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
Page 325 and 326:
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/
Page 369 and 370:
Gold L, Sawyer C, Magaw R, Backman
Page 371 and 372:
Using the statistical tests (one-ta
Page 373 and 374:
Table 1: Methylene chloride-induced
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Significant treatment-related incre
Page 377 and 378:
National Toxicology Program (NTP) 1
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noted; however, the study duration
Page 381 and 382:
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 .
Page 393 and 394:
Page 395 and 396:
The increased incidence of bladder
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A linearized multistage procedure w
Page 399 and 400:
N-NITROSO-N-METHYLETHYLAMINE CAS No
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Hazardous Substance Data Bank (HSDB
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propylamine in drinking water at 0.
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N-NITROSODIETHYLAMINE CAS No: 55-18
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Table 2. Treatment groups, concentr
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California Department of Health Ser
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animals and the second generation t
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ationale for selection of the OEHHA
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A unit risk value based upon air co
Page 417 and 418:
N-NITROSODIPHENYLAMINE CAS No: 86-3
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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
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N-NITROSOMORPHOLINE CAS No: 59-89-2
Page 427 and 428:
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
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testicular tumors were noted in the
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PARTICULATE MATTER FROM DIESEL-FUEL
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etired railroad workers who had had
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employment (χ 2 test for trend: p
Page 443 and 444:
elevated smoking-adjusted risk esti
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Table 1 (continued): Reference Miln
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Table 1 (continued): Reference Damb
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Table 1 (continued): Reference Burn
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
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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
Page 499 and 500:
Ito et al. (1973) exposed groups of
Page 501 and 502:
could not be characterized by chlor
Page 503 and 504:
exposure (all pathways and mixtures
Page 505 and 506:
National Toxicology Program 1993. T
Page 507 and 508:
Table 1. Potassium bromate-induced
Page 509 and 510:
1,3-PROPANE SULTONE CAS No: 1120-71
Page 511 and 512:
Page 513 and 514:
PROPYLENE OXIDE CAS No: 75-56-9 I.
Page 515 and 516:
oxide. In the NTP carcinogenicity s
Page 517 and 518:
1,1,2,2-TETRACHLOROETHANE CAS No: 7
Page 519 and 520:
assumed a body weight of 70 kg and
Page 521 and 522:
total); an untreated control group
Page 523 and 524:
TOLUENE DIISOCYANATE CAS No: 26471-
Page 525 and 526:
Animal Studies The National Toxicol
Page 527 and 528:
Mortillaro PT and Schiavon M. 1982.
Page 529 and 530:
male or female rats. Increases in h
Page 531 and 532:
TRICHLOROETHYLENE CAS No: 79-01-6 I
Page 533 and 534:
A mortality analysis of a cohort of
Page 535 and 536:
elative to that of the controls whi
Page 537 and 538:
applied or metabolized. The range o
Page 539 and 540:
Katz RM and Jowett D. 1981. Female
Page 541 and 542:
10,000 ppm 2,4,6-trichlorophenol in
Page 543 and 544:
Page 545 and 546:
Bionetics Research Laboratories. 19
Page 547 and 548:
control; females: 6/10 exposed, 0/1
Page 549 and 550:
over controls (p < 0.04). Other tum
Page 551 and 552:
was increased (100/314 exposed vs.
Page 553 and 554:
Table 3. Cancer potency estimates f
Page 555 and 556:
Crouch E. 1983. Uncertainties in in
Page 557 and 558:
VINYL CHLORIDE CAS No: 75-01-4 I. P
Page 559 and 560:
Table 1 (continued): A Summary of E
Page 561 and 562:
al., 1983). Histopathology of all o
Page 563 and 564:
Table 3: Tumor incidences in 100 pp
Page 565 and 566:
experiment, animals were exposed to
Page 567 and 568:
Experiment BT1 Most previous risk a
Page 569 and 570:
No statistical analyses of mortalit
Page 571 and 572:
Table 11 gives unit risk estimates
Page 573 and 574:
Bertazzi PA, Villa A, Foa V, Saia B
Page 575 and 576:
Nicholson WJ, Hammond EC, Seidman H
Page 577 and 578:
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
Page 585 and 586:
Table 4 A Comparison of CTEF- and I
Page 587 and 588:
Office of Environmental Health Haza
Page 589 and 590:
Group 4: The agent is probably not
Page 591 and 592:
TECHNICAL SUPPORT DOCUMENT FOR DESC
Page 593 and 594:
US EPA IRIS Inhalation Unit Risk an
Page 595 and 596:
TECHNICAL SUPPORT DOCUMENT FOR DESC
Page 597 and 598:
as appropriate, and revise IRIS fil
Page 599 and 600:
Chemical Exposure Route Study Type
Page 601 and 602:
Page 603 and 604:
Page 605 and 606:
Methyl tert-butyl ether p. 5: Added
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