- Page 1 and 2: Air Toxics Hot Spots Program Risk A
- Page 3: Prepared by: John D. Budroe, Ph.D.
- Page 7 and 8: TABLE OF CONTENTS PREFACE i INTRODU
- Page 9 and 10: N-Nitrosodimethylamine 401 N-Nitros
- Page 11 and 12: Hot Spots Unit Risk and Cancer Pote
- Page 13 and 14: Hot Spots Unit Risk and Cancer Pote
- Page 15 and 16: Hot Spots Unit Risk and Cancer Pote
- Page 17 and 18: Additional ATES and PETS documents
- Page 19 and 20: data. If several data sets (dose an
- Page 21 and 22: US EPA Calculation of Carcinogenic
- Page 23 and 24: exposure to a concentration of 1 µ
- Page 25 and 26: incidences for each of the dose lev
- Page 27 and 28: computes the surface area of a sphe
- Page 29 and 30: Comparison of Hot Spots Cancer Unit
- Page 31 and 32: Gold, L., de Veciana, M., Backman,
- Page 33 and 34: Animal Studies Rats Woutersen et al
- Page 35 and 36: ased on sufficient evidence of carc
- Page 37 and 38: ACETAMIDE CAS No: 60-35-5 I. PHYSIC
- Page 39 and 40: Methodology Expedited Proposition 6
- Page 41 and 42: cancer mortality. However, US EPA (
- Page 43 and 44: Table 2. Lung adenoma incidence in
- Page 45 and 46: Table 3 (continued). Acrylamide-ind
- Page 47 and 48: Robinson M, Bull RJ, Knutsen GL, Sh
- Page 49 and 50: Also, a trend was observed correlat
- Page 51 and 52: eported. Cause-specific expected de
- Page 53 and 54: 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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IV. DERIVATION OF CANCER POTENCY Ba
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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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U.S. Environmental Protection Agenc
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Table 1. Study design summary for N
- Page 233 and 234:
Methodology Expedited Proposition 6
- Page 235 and 236:
Table 1. Experimental design for ca
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Hazardous Substance Data Bank (HSDB
- Page 239 and 240:
Table 1: Tumor induction in Fischer
- Page 241 and 242:
Hazardous Substance Data Bank (HSDB
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Table 1. Experimental design of 2,4
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Methodology Expedited Proposition 6
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Additional analysis of these data b
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IV. DERIVATION OF CANCER POTENCY Ba
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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
- Page 301 and 302:
U.S. Environmental Protection Agenc
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myelogenous leukemias (4 and 8 year
- Page 305 and 306:
statistically significant. CDHS not
- Page 307 and 308:
combined with the incidence in the
- Page 309 and 310:
incidence of primary brain tumors.
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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
- Page 327 and 328:
Tobe M, Kaneko T, Uchida Y, Kamata
- Page 329 and 330:
Table 1. Hexachlorobenzene-induced
- Page 331 and 332:
50 pups (F 1 ) of each sex were ran
- Page 333 and 334:
Ertürk E, Lambrecht RW, Peters HA,
- Page 335 and 336:
Table 1. Liver hepatoma incidence i
- Page 337 and 338:
1988). An airborne unit risk factor
- Page 339 and 340:
HYDRAZINE CAS No: 302-01-2 I. PHYSI
- Page 341 and 342:
Methodology Inhalation A linearized
- Page 343 and 344:
LEAD AND LEAD COMPOUNDS (INORGANIC)
- Page 345 and 346:
and other occupational carcinogens
- Page 347 and 348:
y inhalation is similar for rats an
- Page 349 and 350:
Goyer RA. 1992. Nephrotoxicity and
- Page 351 and 352:
LINDANE (g-Hexachlorocyclohexane) C
- Page 353 and 354:
Using these relationships, a human
- Page 355 and 356:
METHYL TERT-BUTYL ETHER (MTBE) CAS
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Tumor incidences according to the r
- Page 359 and 360:
kidney changes indicative of chroni
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Interspecies scaling for oral doses
- Page 363 and 364:
Table 4 (continued): Dose Response
- Page 365 and 366:
Experimental Pathology Laboratories
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Animal Studies Male and female HaM/
- Page 369 and 370:
Gold L, Sawyer C, Magaw R, Backman
- Page 371 and 372:
Using the statistical tests (one-ta
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Table 1: Methylene chloride-induced
- Page 375 and 376:
Significant treatment-related incre
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National Toxicology Program (NTP) 1
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noted; however, the study duration
- Page 381 and 382:
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 .
- Page 393 and 394:
U.S. Environmental Protection Agenc
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The increased incidence of bladder
- Page 397 and 398:
A linearized multistage procedure w
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N-NITROSO-N-METHYLETHYLAMINE CAS No
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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
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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
- Page 415 and 416:
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
- Page 423 and 424:
Table 1. P-Nitrosodiphenylamine-ind
- Page 425 and 426:
N-NITROSOMORPHOLINE CAS No: 59-89-2
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IV. DERIVATION OF CANCER POTENCY Ba
- Page 429 and 430:
N-NITROSOPIPERIDINE CAS No: 100-75-
- Page 431 and 432:
Table 3. N-Nitrosopiperidine-induce
- Page 433 and 434:
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,
- Page 463 and 464:
estimate for those studies for whic
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Figure 1: Estimates of Relative Ris
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q 1 * = Excess relative risk × CA
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Table 3: Number of Workers in the E
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u nexposed workers at zero concentr
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for each µg/m 3 of diesel exhaust
- Page 475 and 476:
Table 4: Values from Unit Risk for
- Page 477 and 478:
their findings that a reasonable es
- Page 479 and 480:
Garshick E, Schenker M, Woskie S an
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Lewis T, Green, FH MW, Burg J and L
- Page 483 and 484:
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
- Page 489 and 490:
documented. An excess risk from ski
- Page 491 and 492:
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
- Page 501 and 502:
could not be characterized by chlor
- Page 503 and 504:
exposure (all pathways and mixtures
- Page 505 and 506:
National Toxicology Program 1993. T
- Page 507 and 508:
Table 1. Potassium bromate-induced
- Page 509 and 510:
1,3-PROPANE SULTONE CAS No: 1120-71
- Page 511 and 512:
IV. DERIVATION OF CANCER POTENCY Ba
- Page 513 and 514:
PROPYLENE OXIDE CAS No: 75-56-9 I.
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oxide. In the NTP carcinogenicity s
- Page 517 and 518:
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-
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Animal Studies The National Toxicol
- Page 527 and 528:
Mortillaro PT and Schiavon M. 1982.
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male or female rats. Increases in h
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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
- 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
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control; females: 6/10 exposed, 0/1
- Page 549 and 550:
over controls (p < 0.04). Other tum
- Page 551 and 552:
was increased (100/314 exposed vs.
- Page 553 and 554:
Table 3. Cancer potency estimates f
- Page 555 and 556:
Crouch E. 1983. Uncertainties in in
- Page 557 and 558:
VINYL CHLORIDE CAS No: 75-01-4 I. P
- Page 559 and 560:
Table 1 (continued): A Summary of E
- Page 561 and 562:
al., 1983). Histopathology of all o
- Page 563 and 564:
Table 3: Tumor incidences in 100 pp
- Page 565 and 566:
experiment, animals were exposed to
- Page 567 and 568:
Experiment BT1 Most previous risk a
- Page 569 and 570:
No statistical analyses of mortalit
- Page 571 and 572:
Table 11 gives unit risk estimates
- Page 573 and 574:
Bertazzi PA, Villa A, Foa V, Saia B
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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
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Office of Environmental Health Haza
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Group 4: The agent is probably not
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TECHNICAL SUPPORT DOCUMENT FOR DESC
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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
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Chemical Exposure Route Study Type
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Chemical Exposure Route Study Type
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Methyl tert-butyl ether p. 5: Added