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International Agency for Research on Cancer (IARC) 1978. N-Nitrosomorpholine. In: IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals to Man, Volume 17. IARC, Lyon, France, pp. 263-280. Ketkar MB, Holste J, Preussmann R and Althoff J. 1983. Carcinogenic effect of nitrosomorpholine administered in the drinking water to Syrian golden hamsters. Cancer Lett 17:333-338. Lijinsky W, Taylor HW and Keffer LK. 1976. Reduction of rat liver carcinogenicity of 4- nitrosomorpholine by Â-deuterium substitution. J Natl Cancer Inst 57:1311-1313. Müller, H-A. 1964. Morphologische untersuchungen zur wirkung von N-nitrosomorpholin auf die lunge der maus. Z Krebsforsch 66:303-309. 419
N-NITROSOPIPERIDINE CAS No: 100-75-4 I. PHYSICAL AND CHEMICAL PROPERTIES (From HSDB, 1994) Molecular weight 114.15 Boiling point 217 °C (@ 721 mmHg) Melting point not available Vapor pressure not available Air concentration conversion 1 ppm = 4.7 mg/m 3 II. HEALTH ASSESSMENT VALUES Unit Risk Factor: 2.7 E-3 (µg/m 3 ) -1 Slope Factor: 9.4 E+0 (mg/kg-day) -1 [Rat liver tumors (Eisenbrand et al., 1980), contained in Gold et al. (1987) database, expedited Proposition 65 methodology (Cal/EPA, 1992), with cross-route extrapolation.] III. CARCINOGENIC EFFECTS Human Studies No studies on the potential carcinogenic effects of N-nitrosopiperidine in humans are known to exist. Animal Studies Takayama (1969) fed 33 male ICR mice diets containing 50 mg/kg N-nitrosopiperidine for a period of 12 months; a 30 animal untreated control group was included. An increased incidence of forestomach (squamous cell carcinoma), liver and lung (adenomas) tumors were observed in treated animals when compared to controls. Tumor incidence data is listed in Table 1. Table 1. N-nitrosopiperidine-induced tumor incidence in male ICR mice (Takayama, 1969) Dose group Average dose 1 Tumor type Tumor incidence 2 (mg/kg-day) controls 0 forestomach 0/30 liver 0/30 lung 2/30 treated 6 forestomach 18/33 liver 6/33 lung 10/33 1. Doses as reported by Gold et al. (1984). 2. Tumor incidences as reported by Gold et al. (1984). 420
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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
Page 377 and 378: National Toxicology Program (NTP) 1
Page 379 and 380: noted; however, the study duration
Page 381 and 382: Crump KS, Howe RB, Van Landingham C
Page 383 and 384: Table 1. Michler’s ketone-induced
Page 385 and 386: NICKEL AND NICKEL COMPOUNDS CAS No:
Page 387 and 388: the high exposure group was 14.0. A
Page 389 and 390: male and 121 female rats, was expos
Page 391 and 392: 2.1 - 2.6 × 10 -4 (µg/m 3 ) -1 .
Page 393 and 394: U.S. Environmental Protection Agenc
Page 395 and 396: 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: IV. DERIVATION OF CANCER POTENCY Ba
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 and 448: Table 1 (continued): Reference Damb
Page 449 and 450: 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
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
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Lewis T, Green, FH MW, Burg J and L
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Rothman K. 1986. Modern epidemiolog
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PENTACHLOROPHENOL CAS No: 87-86-5 I
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The default lifespan for mice is 10
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documented. An excess risk from ski
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B6C3F 1 mice and F344/N rats were e
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This model, rather than a time depe
Page 495 and 496:
POLYCHLORINATED BIPHENYLS (PCBs) CA
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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
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.
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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
Page 523 and 524:
TOLUENE DIISOCYANATE CAS No: 26471-
Page 525 and 526:
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
Page 531 and 532:
TRICHLOROETHYLENE CAS No: 79-01-6 I
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A mortality analysis of a cohort of
Page 535 and 536:
elative to that of the controls whi
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applied or metabolized. The range o
Page 539 and 540:
Katz RM and Jowett D. 1981. Female
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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
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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
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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
Page 601 and 602:
Page 603 and 604:
Page 605 and 606:
Methyl tert-butyl ether p. 5: Added
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