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TECHNICAL SUPPORT DOCUMENT FOR DESCRIBING AVAILABLE CANCER POTENCY FACTORS APPENDIX F Hot Spots Cancer Unit Risk Values Which Differ from Corresponding US EPA IRIS Cancer Unit Risk Values Chemical Source Hot Spots Unit Risk IRIS Unit Risk HS/IRIS Ratio (µg/m 3 ) -1 (µg/m 3 ) -1 Acetaldehyde TAC 2.7 E-6 2.2 E-6 1.2 Acrylonitrile RCHAS-S 2.9 E-4 6.8 E-5 4.3 Arsenic (inorganic) (inhalation) TAC 3.3 E-3 4.3 E-3 0.8 Asbestos TAC 6.3 E-2 7.7 E-3 8.2 1.9 E-4 # 2.3 E-5 # Benzene TAC 2.9 E-5 8.3 E-6 3.5 Benzidine RCHAS-S 1.4 E-1 6.7 E-2 2.1 Bis(2-chloroethyl) ether RCHAS-S 7.1 E-4 3.3 E-4 2.2 Bis(chloromethyl)ether RCHAS-S 1.3 E-2 6.2 E-2 0.2 1,3-Butadiene TAC 1.7 E-4 2.8 E-4 0.6 Cadmium (and compounds) TAC 4.2 E-3 1.8 E-3 2.3 Carbon tetrachloride TAC 4.2 E-5 1.5 E-5 2.8 Chloroform TAC 5.3 E-6 2.3 E-5 0.2 Chromium (hexavalent) TAC 1.5 E-1 1.2 E-2 12.5 3,3'-Dichlorobenzidine RCHAS-S 3.4 E-4 1.3 E-4 2.6 1,4-Dioxane RCHAS-S 7.7 E-6 3.1 E-6 2.5 Epichlorohydrin RCHAS-S 2.3 E-5 1.2 E-6 19.2 Ethylene dibromide TAC 7.1 E-5 2.2 E-4 0.3 Ethylene dichloride TAC 2.1 E-5 2.6 E-5 0.8 Formaldehyde TAC 6.0 E-6 1.3 E-5 0.5 Hexachlorobenzene RCHAS-S 5.1 E-4 4.6 E-4 1.1 Hexachlorocyclohexanes (technical grade) RCHAS-S 1.1 E-3 5.1 E-4 2.2 Methylene chloride TAC 1.0 E-6 4.7 E-7 2.1 Nickel compounds TAC 2.6 E-4 2.4 E-4 1.1 N-Nitrosodi-n-butylamine RCHAS-S 1.1 E-1 1.6 E-3 68.8 N-Nitrosodiethylamine RCHAS-S 1.0 E-2 4.3 E-2 0.2 N-Nitrosodimethylamine RCHAS-S 4.6 E-3 1.4 E-2 0.3 N-Nitrosodiphenylamine RCHAS-S 2.6 E-6 1.4 E-6 1.9 Pentachlorophenol RCHAS-S 5.1 E-6 3.4 E-5 0.2 2,4,6-Trichlorophenol RCHAS-S 2.0 E-5 3.1 E-6 6.5 Footnotes #: [100 PCM fibers/m 3 ] -1 Source Key TAC RCHAS-S RCHAS-E Toxic Air Contaminant document, Office of Environmental Health Hazard Assessment (OEHHA) Standard Proposition 65 document, OEHHA Expedited Proposition 65 document, OEHHA Note: The TSD Unit Risk and Cancer Potency Factors Table includes 13 US EPA IRIS cancer unit risk values. 585
TECHNICAL SUPPORT DOCUMENT FOR DESCRIBING AVAILABLE CANCER POTENCY FACTORS APPENDIX G Procedures for Revisiting or Delisting Cancer Potency Factors by the Program of Origin Toxic Air Contaminant documents Submissions of new scientific information pertaining to Toxic Air Contaminant (TAC) risk assessments should be made to the Air Resources Board (ARB) at the following address: Air Resources Board Executive Officer P.O. Box 2815 Sacramento, CA 95812 The submission process, as approved by the ARB Scientific Review Panel (SRP) on December 12, 1989, is described below. Scientific Review Panel Process For Evaluation And Response To Submittals Of New Scientific Information As Evidence For Review Of Toxic Air Contaminant (TAC) Risk Assessments I. STATEMENT OF NEED It is anticipated that submittal of information pertaining to a toxic air contaminant (TAC) risk assessment could result in a request from the Chairperson of the ARB, for the SRP to provide a formal evaluation and recommendation. A procedure is needed for the SRP to process the submittal and evaluation of such information. The following elements have been identified by the SRP for inclusion in such a procedure: o o Screening submittals of new scientific evidence Performing SRP/OEHHA analysis of newly submitted scientific evidence to determine the need to review an original (TAC) risk assessment II. PROCESS A. Screening Submittals Of New Scientific Evidence To prevent a misuse of valuable SRP time and resources, the submittal of new scientific evidence should first be screened by the staff of the ARB and OEHHA to determine whether the material contains the necessary elements to warrant the SRP's attention. The screening criteria shall include the following: 586
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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
Page 479 and 480:
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
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Katz RM and Jowett D. 1981. Female
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10,000 ppm 2,4,6-trichlorophenol in
Page 543 and 544: 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 and 590: Group 4: The agent is probably not
Page 591 and 592: TECHNICAL SUPPORT DOCUMENT FOR DESC
Page 593: US EPA IRIS Inhalation Unit Risk an
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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