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exposure level of 1.0 ppm, the prediction of 95% upper confidence limits on respiratory tract cancer was 32 × 10 -3 for the three-stage tissue-dose model with generic contact scaling factor. Thus, the upper range of human cancer risk predictions from the rat bioassay data (Kerns et al., 1983) was consistent with the occupational exposure cancer risk data. V. REFERENCES Acheson ED, Barnes HR, Gardner MJ, Osmond C, Pannett B and Taylor CP. 1984a. Formaldehyde in the British chemical industry. Lancet 1:611-616. Acheson ED, Barnes HR, Gardner MJ, Osmond C, Pannett B and Taylor CP. 1984b. Formaldehyde process workers and lung cancer. Lancet 1:1066-1067. Albert RE, Sellakumar AR, Laskin S, Kuschner M, Nelson N and Snyder DA. 1982. Gaseous formaldehyde and hydrogen chloride induction of nasal cancer in the rat. JNCI 68:597-603. Berke JH. 1987. Cytologic examination of the nasal mucosa in formaldehyde-exposed workers. J Occup Med 29:681-684. Bertazzi PA, Pesatori AC, Radice L, Zocchetti C and Vai T. 1986. Exposure to formaldehyde and cancer mortality in a cohort of workers producing resins. Scand J Work Environ Health 12:461-468. Bertazzi PA, Pesatori A, Guercilena S, Consonni D and Zocchetti C. 1989. Cancer risks among workers producing formaldehyde-based resins: extension of follow-up. Med Lav 80:112-122. Blair A, Stewart P, O' Berg M, Gaffey W, Walrath J, Ward J, Bales R, Kaplan S and Cubit D. 1986. Mortality among industrial workers exposed to formaldehyde. JNCI 76:1071-1084. Blair A, Stewart PA, Hoover RN and Fraumeni RF. 1987. Cancers of the nasopharynx and oropharynx and formaldehyde exposure. JNCI 78:191-192. Blair A, Stewart PA and Hoover RN. 1990a. Mortality from lung cancer among workers employed in formaldehyde industries. Am J Ind Med 17:683-699. Boysen M, Zadig E, Digernes V, Abeler V and Reith A. 1990. Nasal mucosa in workers exposed to formaldehyde: a pilot study. Br J Ind Med 47:116-121. California Department of Health Sciences (CDHS) 1985. Guidelines for Chemical Carcinogen Risk Assessments and Their Scientific Rationale. Casanova M, Deyo DF and Heck HD. 1989. Covalent binding of inhaled formaldehyde to DNA in the nasal mucosa of Fischer 344 rats: analysis of formaldehyde and DNA by high-performance liquid chromatography and provisional pharmacokinetic interpretation. Fund Appl Toxicol 12:397-419. 315
Casanova M, Morgan KT, Steinhagen WH, Everitt JI, Popp A and Heck HD. 1991. Covalent binding of inhaled formaldehyde to DNA in the respiratory tract of rhesus monkeys: pharmacokinetics, rat to monkey interspecies scaling, and extrapolation to man. Fund Appl Toxicol 17:409-428. Collins JJ, Caporossi JJ and Utidjian HMD. 1988. Formaldehyde exposure and nasopharyngeal cancer: reexamination of the National Cancer Institute study and an update of one plant. JNCI 80:376-377. Edling C, Hellquist H and Odkvist L. 1988. Occupational exposure to formaldehyde and histopathological changes in the nasal mucosa. Br J Ind Med 45:761-765. Feron VJ, Til HP and Woutersen RA. 1990. Letter to the Editor. Toxicol Ind Health 6:637-639. Gerin M, Siemiatycki J, Nadon L, Dewar R and Krewski D. 1989. Cancer risks due to occupational exposure to formaldehyde: results of a multi-site case-control study in Montreal. Int J Cancer 44:53- 58. Hayes RB, Raatgever JW, de Bruyn A and Gerin M. 1986. Cancer of the nasal cavity and paranasal sinuses and formaldehyde exposure. Int J Cancer 37:487-492. Holmstrom M, Wilhelmsson B, Hellquist H and Rosen G. 1989a. Histological changes in the nasal mucosa in persons occupationally exposed to formaldehyde alone and in combination with wood dust. Acta Otolarynogol (Stockh) 107:102-129. Homma Y, Nowels K and Oyasu R. 1986. Effects of formalin-induced injuries on urinary bladder carcinogenesis. Cancer Lett 32:117-123. International Agency for Research on Cancer (IARC). 1987. In: Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes 1 to 42. Suppl 7. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. World Health Organization, Lyon, France, pp. 211-215. Iversen OH. 1988. Formaldehyde and skin tumorigenesis in SENCAR mice. Environ Int 14:23-27. Kerns WD, Pavkov KL, Donofrio DJ, Gralla EJ and Swenberg JA. 1983. Carcinogenicity of formaldehyde in rats and mice after long-term inhalation exposure. Cancer Res 43:4382-4392. Linos A, Blair A, Cantor KP, Burmeister L, VanLier S, Gibson RW, Schuman L and Everett G. 1990. Leukemia and non-Hodgkin's lymphoma among embalmers and funeral directors. JNCI 82:66. Malker HSR, McLaughlin JK, Weiner JA, Silverman DT, Blot WJ, Ericsson JLE and Fraumeni JF Jr. 1990. Occupational risk factors for nasopharyngeal cancer in Sweden. Br J Ind Med 47:213-214. Muller P, Raabe G and Schumann D. 1978. Leukoplakia induced by repeated deposition of formalin in rabbit oral mucosa. Exp Path 16:36-42. Hazardous Substance Data Bank (HSDB) (Internet version) 1998. National Library of Medicine, Bethesda MD. 316
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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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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
Page 273 and 274: 2,4-DINITROTOLUENE CAS No: 121-14-2
Page 275 and 276: Ellis et al.(1979) (also reported b
Page 277 and 278: Final Statement of Reasons for OAL,
Page 279 and 280: to the small sample size and short
Page 281 and 282: In an inhalation study, Torkelson e
Page 283 and 284: V. REFERENCES American Conference o
Page 285 and 286: EPICHLOROHYDRIN CAS No: 106-89-8 I.
Page 287 and 288: espiratory tumors were noted in the
Page 289 and 290: Table 4. Epichlorohydrin-induced fo
Page 291 and 292: Konishi Y, Kawabata A, Denda A, Ike
Page 293 and 294: exposed to arsenicals for 20 months
Page 295 and 296: espectively (all statistically sign
Page 297 and 298: ETHYLENE DICHLORIDE CAS No: 107-06-
Page 299 and 300: Several factors have been suggested
Page 301 and 302: U.S. Environmental Protection Agenc
Page 303 and 304: myelogenous leukemias (4 and 8 year
Page 305 and 306: statistically significant. CDHS not
Page 307 and 308: combined with the incidence in the
Page 309 and 310: incidence of primary brain tumors.
Page 311 and 312: Table 6 (continued): Organ/Sex Mali
Page 313 and 314: An Upper 95% Confidence Limit (UCL)
Page 315 and 316: ETHYLENE THIOUREA (ETU) CAS No: 96-
Page 317 and 318: male and female rats. Tumor inciden
Page 319 and 320: FORMALDEHYDE CAS No: 50-00-0 I. PHY
Page 321 and 322: presented an extension of a previou
Page 323: Methodology In developing a spectru
Page 327 and 328: Tobe M, Kaneko T, Uchida Y, Kamata
Page 329 and 330: Table 1. Hexachlorobenzene-induced
Page 331 and 332: 50 pups (F 1 ) of each sex were ran
Page 333 and 334: Ertürk E, Lambrecht RW, Peters HA,
Page 335 and 336: Table 1. Liver hepatoma incidence i
Page 337 and 338: 1988). An airborne unit risk factor
Page 339 and 340: HYDRAZINE CAS No: 302-01-2 I. PHYSI
Page 341 and 342: Methodology Inhalation A linearized
Page 343 and 344: LEAD AND LEAD COMPOUNDS (INORGANIC)
Page 345 and 346: and other occupational carcinogens
Page 347 and 348: y inhalation is similar for rats an
Page 349 and 350: Goyer RA. 1992. Nephrotoxicity and
Page 351 and 352: LINDANE (g-Hexachlorocyclohexane) C
Page 353 and 354: Using these relationships, a human
Page 355 and 356: METHYL TERT-BUTYL ETHER (MTBE) CAS
Page 357 and 358: Tumor incidences according to the r
Page 359 and 360: kidney changes indicative of chroni
Page 361 and 362: Interspecies scaling for oral doses
Page 363 and 364: Table 4 (continued): Dose Response
Page 365 and 366: Experimental Pathology Laboratories
Page 367 and 368: 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
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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
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A linearized multistage procedure w
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N-NITROSO-N-METHYLETHYLAMINE CAS No
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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
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N-NITROSODIPHENYLAMINE CAS No: 86-3
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Methodology Dosage estimates of NDP
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Crump KS, Howe RB. 1984. The multis
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Table 1. P-Nitrosodiphenylamine-ind
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N-NITROSOMORPHOLINE CAS No: 59-89-2
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Page 429 and 430:
N-NITROSOPIPERIDINE CAS No: 100-75-
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Table 3. N-Nitrosopiperidine-induce
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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
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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
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Table 1 (continued): Reference Raff
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Table 1 (continued): Epidemiologica
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Table 1 (continued): Epidemiologica
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Table 1 (continued): Reference Wegm
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Animal Studies Section 6.1 (Animal
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The variability, or heterogeneity,
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estimate for those studies for whic
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Figure 1: Estimates of Relative Ris
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q 1 * = Excess relative risk × CA
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Table 3: Number of Workers in the E
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u nexposed workers at zero concentr
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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
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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
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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.
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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
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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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