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Group E: Evidence of Noncarcinogenicity for Humans This group is used for agents that show no evidence for carcinogenicity in at least two adequate animal tests in different species or in both adequate epidemiologic and animal studies. The designation of an agent as being Group E is based on the available evidence and should not be interpreted as a definitive conclusion that the agent will not be a carcinogen under any circumstances. REFERENCES International Agency for Research on Cancer (IARC) 1987. Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes 1 to 42 In: IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals to Man, Supplement 7. IARC, Lyon, France, pp. 31-32. U.S. Environmental Protection Agency (US EPA) 1986. Guidelines for Carcinogen Risk Assessment, Federal Register 45 FR 79318. 581
TECHNICAL SUPPORT DOCUMENT FOR DESCRIBING AVAILABLE CANCER POTENCY FACTORS APPENDIX D Asbestos Quantity Conversion Factors The unit risk factor for asbestos is listed in this document in units of 100 PCM fibers/m 3 [1.9 E-4 (100 PCM fibers/m 3 ) -1 ] and in units of µg/m 3 [6.3 E-2 (µg/m 3 ) -1 ]. The value listed in the Toxic Air Contaminant (TAC) document for asbestos (CDHS, 1986) was 1.9 E-4 (100 PCM fibers/m 3 ) -1 . However, emitted asbestos quantities reported to the various Air Quality Districts under the requirements of the Air Toxics “Hot Spots” In<strong>format</strong>ion and Assessment Act of 1987 (Health and Safety Code (HSC) Section 44300 et seq. and as amended by Statutes 1992, Chapter 1162) are in units of pounds/year and maximum pounds/hour. Therefore, the original TAC unit risk value has been converted using a factor of 0.003 µg asbestos = 100 asbestos fibers which has been derived from in<strong>format</strong>ion published by US EPA (1985). The number of asbestos fibers associated with a given mass of asbestos can vary appreciably. Also, US EPA (1985) has stated that this conversion factor is the geometric mean of measured relationships between optical fiber counts and mass airborne chrysotile in several published studies, the range of the conversion factor between the different studies is large (0.0005 - 0.015 µg asbestos/100 asbestos fibers), and carries with it an appreciable uncertainty. Use of the unit risk factor listed in the asbestos TAC document [1.9 E-4 (100 PCM fibers/m 3 ) -1 ], wherever possible, will result in a more precise risk estimation. Additionally, the unit risk factor expressed in units of (µg/m 3 ) -1 may change if a conversion factor with less uncertainty is developed, or may be eliminated if asbestos quantity reporting requirements render use of a unit risk factor expressed in units of (µg/m 3 ) -1 unnecessary. REFERENCES California Department of Health Services (CDHS) 1986. Report to the Air Resources Board on Asbestos. Part B. Health Effects of Asbestos. Epidemiological Studies Section, Berkeley, CA. U.S. Environmental Protection Agency (US EPA) 1986. Airborne Asbestos Health Assessment Update. EPA/600/8-84/003F, Office of Health and Environmental Assessment, Washington, DC. 582
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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
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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
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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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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
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Table 4: Values from Unit Risk for
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their findings that a reasonable es
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Garshick E, Schenker M, Woskie S an
Page 481 and 482:
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
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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
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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
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: IV. DERIVATION OF CANCER POTENCY Ba
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: Group 4: The agent is probably not
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 605 and 606: Methyl tert-butyl ether p. 5: Added
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