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seen to increase with both increased dose and a longer follow-up time. Table 1: A Summary of Epidemiologic Data for Occupationally Exposed Vinyl Chloride Workers Study Place Cohort Deaths (%) Tabershaw and Gaffey 1 (1974) U.S. 8,384 352 (4.7) Duck et al. U.K. 2,122 152 (1975) (7.2) Nicholson et al. U.S. 257 24 (1975) (9.3) Ott et al. 2 (1975) U.S. 594 79 (13.3) Byren et al. Sweden 771 58 (1976) (75) Waxweiler et al. U.S. 1,294 136 (1976) (10.5) Fox and Collier (1977) U.K. 7,717 409 (5.3) EEH (1975) 1 U.S. 10,173 707 (6.9) Buffler et al. Texas 464 28 (1979) (6.0) Bertazzi et al. Italy 4,777 62 (1979) (1.3) Masuda et al. Japan 304 26 (1979) (8.5) Weber et al. Germany 7,021 414 (1981) production (5.9) 4,007 360 processing (9) 4,910 417 unexposed (8.5) Cooper 1 (1981) U.S. 10,173 707 (6.9) Heldaas et al. Norway 454 50 (1984) (11) Theriault and Allard (1981) Canada 451 exposed 871 unexposed 59 (2.6) 233 (26.8) Exposure in SMR years All Liver Brain Lung Lymphoma Sites (LAS) > 1 110 94 3 155 4 112 106 10.2%>20 yrs (6) > 0 96 93 3 -- 103 -- (0) > 5 231 - -- -- -- (3) > 0 81 - -- 77 -- (0) > 0 -- 413 a 612 a 168 -- (2) > 5 149 a 1,155 b 329 a5 156 159 (f/u > 10 yrs) (11) > 5 189 b 1,606 b 498 a 194 a 176 (f/u > 15 yrs) - > 0 90.7 1,408 a 54.6 89.8 90.9 8% > 20 yrs (2) > 1 104 75 3 203 a 107 112 19.3%>20 yrs (5) > 0 138 - -- 208 a -- (0) > 0.5 97 800 a 125 81 133 (3) > 1 138 500 a -- 125 -- (0) > 0 112 1,523 b 162 -- 214 a - > 0 85 434 a 535 a -- 34 - n/a 83 401 a 184 -- 77 - > 1 104 75 3 203 a 107 112 (8) > 1 114 - -- 180 -- (1) Relative Risk > 5 1.48 6.25 a -- .36 -- (10) n/a 549
Table 1 (continued): A Summary of Epidemiologic Data for Occupationally Exposed Vinyl Chloride Workers LAS = angiosarcoma of the liver; f/u = follow-up 1 The studies of Cooper and EEH are reanalyses of the Tabershaw and Gaffey Cohort 2 SMR subjects also in the Tabershaw and Gaffey Cohort 3 SMR is for the “digestive system cancer”, not liver cancer 4 SMR is for “other and unspecified cancer”, 40% of which were brain cancer 5 SMR is for cancer of CNS, not brain a b p < 0.05 p < 0.01 The association between VC exposure and increased risk for other cancers is not as clear as that for liver cancer. Some evidence associates exposure to VC with increased mortality ratios for brain cancer, lung cancer, and lymphoma. Since these cancers appear more commonly in the general population than LAS and primary liver cancer, it becomes more difficult to show increased risk. Workers exposed to VC appear to be at greater risk for brain cancer than do non-exposed populations. Of the six studies that assessed the risk of brain cancer, five showed a positive trend for increased risk of this cancer type following exposure to VC, with four demonstrating statistical significance (p < 0.05). Cancer risk increased an average of four times above that expected in the general population in those studies that exhibited a significantly increased risk. Of the two studies not showing a significant increase in risk for brain cancer, statistical power in the Bertazzi and associates study was only about 35% (Bertazzi et al., 1979), while that of Fox and Collier (1977) was approximately 80% (Beaumont and Breslow, 1981). In the Fox and Collier study, the number of deaths overall was low and, most importantly, a large percentage of workers in the cohort was very recently employed in the VC industry and thus had a short follow-up time. These factors may partially explain why this study failed to detect an association between VC exposure and brain cancer. The evidence linking VC exposure with lung cancer remains inconclusive. Analyses of SMRs for cancer of the lung were performed in 12 studies. Of these, seven studies showed an increased risk for lung cancer, but only one was statistically significant at the 5% level (Buffler et al., 1979). This increased risk persisted after adjusting for personal smoking habits (for this particular cohort). However, this cohort was small and the study was unable to demonstrate an increased risk for any other cancer. The Waxweiler et al. (1976) cohort (which had a follow-up period greater than 15 years) also used a small group. An association between VC exposure and lymphoma has not been established. Five studies evaluated the risk of lymphoma development among workers occupationally exposed to VC. Four of the studies showed a positive trend for lymphoma among VC workers, but statistical significance was noted only by Weber et al. (1981). However, the statistical power in all of these studies was less than 80% to demonstrate a relative risk of two, and less than 40% to show a relative risk of 1.5.
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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
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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
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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
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: IV. DERIVATION OF CANCER POTENCY Ba
Page 513 and 514: PROPYLENE OXIDE CAS No: 75-56-9 I.
Page 515 and 516: oxide. In the NTP carcinogenicity s
Page 517 and 518: 1,1,2,2-TETRACHLOROETHANE CAS No: 7
Page 519 and 520: assumed a body weight of 70 kg and
Page 521 and 522: total); an untreated control group
Page 523 and 524: TOLUENE DIISOCYANATE CAS No: 26471-
Page 525 and 526: Animal Studies The National Toxicol
Page 527 and 528: Mortillaro PT and Schiavon M. 1982.
Page 529 and 530: male or female rats. Increases in h
Page 531 and 532: TRICHLOROETHYLENE CAS No: 79-01-6 I
Page 533 and 534: A mortality analysis of a cohort of
Page 535 and 536: elative to that of the controls whi
Page 537 and 538: applied or metabolized. The range o
Page 539 and 540: Katz RM and Jowett D. 1981. Female
Page 541 and 542: 10,000 ppm 2,4,6-trichlorophenol in
Page 543 and 544: 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: VINYL CHLORIDE CAS No: 75-01-4 I. P
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 605 and 606: Methyl tert-butyl ether p. 5: Added
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