Document evneNXY5wV8YZrLQBoJqoBBMG
/<y itjL DEPARTMENT OF HEALTH & HUMAN SERVICES
June 11, 1985
Public Health Service
National Institutes of Health National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, N.C. 27709
Mr. Gerald A. Emison Director Office of Air Quality Planning
and Standards U.S. Environmental Protection Agency Research Triangle Park, Ntp 27711
Dear Mr. Emison:
This Is In response to yodr letter of May 20 to Dr. Canter in which you requested Information on ^he NTP studies of perchloroethylene (tetrachloroethylene) and trichloroethylene.
ii
The draft technical report on the NTP inhalation toxicology and carcinogenesis studies of perchloroethylene in rats and mice is currently being revised. The TRTP itaff reviewed and evaluated the data on June 4, and these Interpretations are being placed into the draft Technical Report. In these studies rats wer exposed to 0, 200 and 400 ppm of the chemical, and mice were exposed to 0, 100 and 200 ppm. Increased Incidences of liver tumors were noted in male and female mice. The results of the rat portion of the study indicates an association with an increase in mononuclear cell leukemia. The draft Technical Report is scheduled for peer review by the Technical Reports Review Subcommittee of the NTP Board of Scientific Counselors on August 14 id Research Triangle Park, N.C. A copy of the draft report will be sent to you when it becomes available. Meanwhile, the appendix containing the statistical analyses is enclosed.
The NTP has also conducted toxicology and carcinogenesis studies of perchloroethylene (tetrachloroethylene) by the gavage route in four strains of rats and in the B6C3F1 mouse. The histopathology has been completed for these studies, which were performed at Gulf South Research Institute. The doses utilized were 0, 375, and 750 mg/kg body weight per day of perchloroethylene for the rats and 0, 25, 100 and 200 mg/kg body weight per day for the mice. Due to problems encountered in certain of the Gulf South studies, the Program has decided to perform audits of the data from all of the studies conducted by that laboratory for the NTP. No decision will be made on the reporting of he perchloroethylene gavage studies until we have a more comprehensive assessment of the quality of the data generated by Gulf South.
With respect to trichloroethylene, the NTP has completed toxicology and carcinogenesis studies of the chemical by the gavage route in F344 rats and B6C3F1 mice. The draft report of these studies was peer reviewed in September, 1982, and a fihal Technical Report is currently in preparation;
SL 035599
Page 2 - Mr. Gerald A. Emison
data audits have been completed recently, and this Information will be added to the Report beforje printing and distribution. When this report becomes available, a copy will be sent to you. The tumor analysis tables are enclosed.
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The NTP has also conducted toxicology and carcinogenesis studies of trichloroethylene in four* strains of rats by the gavage route at doses of 0, 500, and 1000 mg/kg body weight per day. The histopathology portion of these studies has been completed, as well as an audit of the data from the studies. Currently the draft Technical Report is being prepared. The peer review of this report has been scheduled tentatively for the fall of this year or the first of next year. For your use a set of analysis tables are enclosed.
Letters were not sent onjthe preliminary results from the perchloroethylene or the trichloroethylene studies as were sent to Dr. John Moore and Dr. Laurence Rosenstein of EPA on methylene chloride. The main reason for this is that the NTP sends out notifications on those studies in which the preliminary findings are(highly significant, both biologically and statistically. Since thd preliminary results from the perchloroethylene and trichloroethylene studies did not appear as unique as those from the methylene chloride studies, we did not consider an early notification in either Of these cases. For example, we do expect liver tumors in mice from these short chain aliphatic hydrocarbons, and did not consider these as being unusual enough to Send a notice of preliminary findings. This class of chemicals also seems to induce an effect on rat kidneys, albeit a low yet consistent increase Across studies.
I
Please let me know if I tan provide further information on perchloro ethylene and trichloroethylene, or on other chemicals of concern to your Program. You or one of your staff may wish to attend this open-to-thepublic Peer Review meeting. Contact Dr. L. Hart (FTS 629-3971) for more information.
Sincerely yours.
Enclosure cc: Dr. Rail Dr. Canter Dr. Mennear Dr. Rosenstein
I
Ernest E. McConnell, D.V.M. Acting Director, Toxicology
Research & Testing Program
SL 035600
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Office of Air Qjuality Planning and Standards Research Triangle Park, North Carolina 27711
2 0 MAY 1S85
Dr, Dorothy Canter Assistant to the Director National Toxicology Program National Institute of Health Bethesda, Maryland 20205
Dear Dr. Canter:
This Is to Inform you of!the status of the EPA regulatory program on the solvents perchloroethylent (tetrachloroethylene) and trichloroethylene and to request Information onjthe status of the NTP studies on these chemicals*
In response to a Congressional commitment, EPA Is In the late stages of regulatory decision making! on these solvents. At this time, the studies available to assess the carcinogenicity of these chemicals are few and controversial, with only one Otudy demonstrating a positive carcinogenic response in test animals as a! result.of exposure to perchloroethylene. More recent studies conducted! by NTP may therefore be very pertinent to our policy recommendations.
It Is our understanding (that a new study on perchloroethylene is nearing conpletlon, with peer! review ejected late this summer. We would apprec*iate a st atus repor*t- on, this*---# a- n_ dJ other. i____^ NTP studies_ j. _ii__ o_ n_ _pe_ _rc_ hloroethylene and trichloroethylene, with p relimlnary results If available, and a schedule of the review process. A letter similar to the one sent July 26, 1984 from you t-o----D- -r-.--L--a--u-r-e--n--c-e- R---o-s--e--n-s--t-e-ln on the preliminary results of the NTP study on methylene chloride would satisfy our Information needs. As we expect to review our recommendations with the Deputy Administrator In mid-June, we would appreciate receiving a response by June 7.
Thank you for your help iln providing us with the most current Information for consideration In regulatory decision making. Please call David Patrick at FTS 629-5645 If you have ajny questions.
Sincerely,
cc: Dr. McConnell (NTP) Dr. Mennear (NTP) Dr. Rosenstefn (TS-778)
*<Sef57dA. Emison Director
Office of Air Quality Planning and Standards
O'!'
Appendix e
j
ANALYSES OF PRIMARY TUMORS IN RATS AND MICE IN THE TWO-YEAR INHALATION STUDIES OF TETRACHLOROETHYLENE
SL 035602
E-l Tetrachloroethylene, NTP TR 311, Draft 5/85
TABLE El. 'ANALYSIS OF PRIMARY TUMbRS IN MALE RATS IN THE TWO-YEAR INHALATION STUDY 0|F TETRACHLOROETHYLENE
i Control
Skin*. Keratoacanthoma Overall Rsus (a > Adjusted Raus<b)
Terminal Rates ici Week of First Obaarvation
Lift Table Tests (d> Incidental Tumor Tests (d) Cochran-Armitage Trend Test (d> Fisher Exact Test id i
3/50*6%)
10.1% 1/2314%)
89 P-0.125N P--0.07 IN P-0.060N
Skin: Squamous Cod Papilloma or Carcinoma
Overall Rates ta >
I
Adjusted Raws (b)
1
Terminal Rates ic>
Week of First Observation
Life Table Teste idi
Incidental Tumor Testa idi
Cochran-Armitsfr Trend Test id)
Fisher Exact Test idi
i
Subcutaneous Tissue: Fibroma Overall Rates la) Adjusted Rates lb) Terminal Rates <o Week ofFirst Observation Life Table Testa id l Incidenul Tumor Tests id)
Cochran-Armitage Trend Test id) Fisher Exact Test id >
3/50 16* > 10.0% 1/23(4%) 95 P--0.112N P-0.081N P-0.060N
3/50(6%) 9.1% 0/23(0%) 98 P-0.260 P-0.423 P-0.412
Hematopoietic System: Mononuclear Cell Lei iktmia
Overall Rates <ai
28/50(56%)
Adjusted Rates(b)
64.6%
Terminal Rates id
9/23(39%)
Week ofFirst Observation
66
Life Tabic Tests id)
P-0.004
Incidenwl Tumor Tests id)
P-0.097
Cochran-Armiuge Trend Test id)
P-0034
Fisher Exact Test id*
Oral Cavity: Squamous Cell Papilloma or Carcinoma
Overall Ratesta> Adjusted Rates (bi
Terminal Raws (ci Week ofFirst Observation Life Table Tests (d) Incidental Tumor Tests (d) Cochran-Armitage Trend Test id) Fisher Exact Test (d >
1/50(2%) 2.7%
0/23 (0%) 97 P-0.133 P-0.241 P-0.202
Liver: Neoplastic Nodule Overall Rates (a) Adjusted Rates (b> Terminal Raws Id Week ofFirst Observation
Life Table Tests id) Incidental Tumor Tests id) Cochran-Armileft Trend Test (d> Fisher Exact Test Id)
4/50(8%) 17.4% 4/23(17%)
104
P-0.192 P-0.285 P- 0.553
200 ppm
1/50(2%) 5.0% 1/20(5%) 104 P-0.368N P-0.329N
P-0.309N
1/50(2%) 5.0% 1/20(5%) 104 P-0.362N P-0.367N
P-0.309N
<e> 1/50 (2%) 3.0% 0/20(0%) 98 P-0.358N P- 0.373 N
P-0.309N'
37/50(74%) 80.1% 11/20(55%) 53 P* 0.046 P- 0.023
P- 0.046
1/50(2%) 5.0% 1/20(5%) 104 P-0.732 P-0.723
P-0.753
7/50(14%) 30.6% 5/20 (25% 1 91 P-0.177 P-0.195
P-0.262
400 ppm
0/50(0%) 0.0% 0/12(0%)
P-0.231N P-0.1 UN
P-0.121N
0/50(0%) 0.0% 0/12(0%)
P-0.200N P-0.130N
P-0.121N
4/50(8%) 23.6% 2/12(17%) 99 P-0.301 P- 0.484
P-0.500
37/50(74%) 90.8% 9/12(75%) 68 P-0.004 P-0.104
P-0.046
3/50(6%) 10.8% 0/12(0%) 77 P* 0.232 P-0.428
P- 0.309
4/49(8%) 30.8% 3/12(25%) 103 P-0.267 P 0,330
P-0.631
-
Tetrachloroethylene, NTP TR 311, Draft 5/85 E*2
SL 035603
TABLE El ANALYSIS OF PRIMARY TUMORS IN MALE RATS IN THE TWO-YEAR INHALATION STUDY OF TETRACHLOROETHYLENE (Continued)
Control
S00 ppm
400 ppm
Liver: Neoplastic Nodule or Hepatocellular Carcinoma
Overall Rate*(a)
4/50(8%)
Adjusted Rates (b>
17.4%
Terminal Rate* (c>
4/23 < 17%)
Week ofFirst Observation
104
Life Table Tests (d>
P-0.117
Incidental Turoor Testa (d >
P- 0.201
Cochrsn-Armitafe Trend Test id >
P-0.422
Fisher Exact Test (di
Kidney: Tubular Cell Adenoma
Overall Rates (ai Adjusted Rates ib)
Terminal Rates (ci Week ofFirst Observation Life Table Testa <d> Incidental Tumor Tests id) Cochran-Armitaf* Trend Test (d> Fisher Exact Testid)
1/49 < 2%) 4.3% 1/2314%) 104
P--0.242 P 0.350 P-0.407
Kidney: Tubular Cell Adenoma or Adenocarcinommaa
Overall Rate* <a) Adjusted Rates (b i
1/49(2%) 4.3%
Terminal Rates (ci
1/23(4%)
Week ofFirst Observation
104
Life Table Tests (d) Incidental Tumor Tests (d>
P-0.054 P-0.107
Cochran-Armita|e Trend Test (d>
P-0-.138
Fisher Exact Test id)
Pituitary Gland: Adenoma
Overall Rates <a) Adjusted Rates ib: Terminal Rates let Week ofFirst Observation Life Table Tests id i Incidental Tumor Tests id) Cochran-Armitaf* Trend Test id) Fisher Exact Test id)
17/47(36%) 49.2% 7/23(30%) 90 P-0.185 P-0.484N P-0.429N
Pituitary Gland: Carcinoma
Overall Rates is) Adjusted Rates (bi
Terminal Rates (ci Week of First Observation Life Table Tests id) Incidental Tumor Tests Id) Cochran-Armitaf* Trend Test (d) Fisher Exact Test id)
3/47(6%) 9.6% 0/23(0%) 99 P-0.566N P-0.308N P-0.397N
Pituitary Gland: Adenoma or Carcinoma Overall Rates (a) Adjusted Rates (b) Terminal Rates tc) Week ofFirst Observation
Life Table Teats (d) Incidental Tumor Tests Id) Cochnn-Armitafe Trend Test Id) Fisher Exact Test (d)
20/47 (43%) 54.2% 7/23 (30%) 90
P-0.20': P-0.352N P-0.346N
7/50(14%) 30.6% 5/20(25%) 91 P-0.177 P-0.195
P-0.262
3/49(6%) 10.8% 1/20(5%) 91 P-0.259 P-0.296
P-0.309
(f) 3/49(6%) 10.8% 1/20(5%) 91 P-0.259 P-0.296
P- 0.309
12/47(26%) 50.9% 9/20145%) 98 P-0.357N P-Q.293N
P-0.1S6N
2/47(4%) 7.3% 1/20(5%) 86 P-0.575N P-0.514N
P-0.500N
14/47(30%) 56.5% 10/20(50%) 86 P-0.326N P-0.233N
P-0.I42N
5/49(10%) 32.3% 3/12(25%) 83 P-0.168 P-0.243
P-0.487
2/50(4%) 12.7% l/12(8%i 102 P-0.316 P-0.376
P- 0.508
4/50(8%) 22.4% 2/12(17%) 83 P- 0.070 P-0.114
P-0.187
16/48(33%) 48.9% 1/12(8%) 73 P- 0.238 P-0.335N
P-0.470N
2/48(4%) 7.4% 0/12(0%) 85 P-0.657N P-0.376N
P--0.490N
18/48(38%) 53.6% 1/12(8%) 73 P- 0.259 P-0.210N
P-0J85N
03560* st
E-3 Tetrachloroethylene, NTP TR 311, Draft 5/85
TABLE El. ANALYSIS OF PRIMARY TUMORS IN MALE RATS IN THE TWO-YEAR INHALATION STUDY OF TETRACHLOROETHYLENE (Continued)
1
Control
200 ppm
Adrenal Gland: Pheochroroocyloma
Overall Rate* ia) Adjusted Rata* <b> Terminal Rates ic)
Week of Firct Observation Life Table Testa (<1) Incidental Timor Tests (d > Cochran-Anmtaff Trend Test id > Fisher Exact Test id)
i
22/49(45%) 64.7% 12/23 (52%) 89 P-0.041 P-0.293 P-0,460
21/49(43%) 70.0% 12/20160%) 82 P-0.420 P-0.488
P-0.SOON
Adrenal Gland: Pheochromocytoma or Mslifi iant Pheochromocytoma
Overall Rates la)
22/49(45%)
21/49(43%)
Adjusted Rates lb)
$4.7%
70.0%
Terminal Rates ic)
12/23(52%)
12/20(60%)
Week ofFirst Observation
89 82
Life Table Tasts <d)
P- 0.025
P-0.420
Incidental Tumor Tests id)
P-0.212
P-0.488
Cochran-Armitaft Trend Test id >
P-0.380
Fisher Exact Test id)
P-0.500N
Thyroid Gland: C-Cell Adenoma
Overall Ratesia> Adjusted Rates(b) Terminal Rates to
Week ofFirst Observation Life Table Tests id) Incidental Tumor Tests Id) Cochran-Armitagt Trend Test id) Fisher Exact Test id 1
3/47(6%)
11.5% 2/23 (9%) 99 P-0.196 P-0.329 P-0.409
3/48(6%) 12.0% 1/20(5%) 99 P-0.599 P-0.614
P-0.65 IN
Thyroid Gland: C-Cell Carcinoma
Overall Rates is) Adjusted Rates<b> Terminal Rates ici
Week ofFirm Observation Life Table Tasts id) Incidental Tumor Testa id) Cochran-Armitaft Trend Test id) Fisher Exact Test td >
4/47(9%) 16.4%
3/23(13%) 103
P-0.236N P-0.139N
P-0.083N
Thyroid Gland: C-Cell Adenoma or Carcinoma
Overall Rates la >
7/47 (15%)
Adjusted Rates (b)
27.0%
Terminal Rates ic)
5/23(22%)
Week of First Observation
99
Life Table Tasts td)
P-0.516
Incidental Tumor Tests id)
P-0.373N
Cochran-Armitaft Trend Test Id)
P-0.242N
Fisher Exact Test <d>
Pancreatic Islets: Islet Ceil Adenoma Overall Rataela) Adjusted Rate* (b)
Terminal Rates to Week ofFirst Observation Life Table Teste (d) Incidental Tumor Tests id)
Cochran-Armitaft Trend Teft td) Fisher ExectTestid)
3/43 (7%) 13.6% 3/22(14%) 104
P-0475N P--0.297N P-0.200N
6/48(13%) 24.0% 3/20(15%) 98 P- 0.288 P- 0.300
P- 0.384
9/48(19%) 33.7% 4/20(20%) 98 P-0.289 P-0.300
P-0.410
2/46(4%) 8.2% 1/20 (5%) 99 P-0.546N P-0.542N
P-0.468N
400 ppm
23/49(47% 78.0% 7/12(58%) 77 P-0.049 P- 0.356
P--0.500
24/49(49% 82.4% 8/12(67%) 77 P 0.030 P 0.259
P-0.420
4/46(9%) 26.7% 2/12(17%) 102 P 0.225 P 0.357
P-0.468
0/46(0%) 0.0% 0/12(0%)
P-0.176N P-0.124N
P-0.061 N
4/46(9%) 26.7% 2/12(17%) 102 P-0.613 P-0.464N
P-0.274N
1/46(2%) 3.1% 0/12(0%) 95 P-0.496N P-0.438N
P-0.283N
Tetrachloroethylene,NTPTR311,Draft5/85 E-4
gL Q35605
TABLE El. 'ANALYSIS OF PRIMARY TL'MORS IN MALE RATS IN THE TWO-YEAR INHALATIONSTl'DY OF TETRACHLOROETHYLENE (Continued)
Control
200 ppm
400 ppm
Prtpuliil Gland: Adenoma Overall Rates (*' Adjusted Rates <b) Terminal Raiasici Weak ofFirat Observation Ufa Table Teats id) Incidamal Tumor Taau id) Cochran-Armitafr Trand Test id i Fisher Exact Teal id)
Preputial Gland: Carcinoma Overall Rataaia) Adjusted Ratea ib> Terminal Rataaici Weak ofFirat Observation Life Table Team id i Incidental Tumor Teats id> Cochran-Armitage Trend Teat id) Fisher Exact Teat id)
Preputial Gland: Adenoma or Carcinoma Overall Rates ia) Adjusted Rates lb i Terminal Rates ic) Week ofFirst Observation Life Table Teste id) Incidental Tamor Tests id > Cochrsn-Armitafe Trend Test id) Fisher Exact Test id)
Testis: Interstitial Cell Tumor Overall Rates is i Adjusted Rates ib) Terminal Rates id Week of First Observation Life Table Tests id) Incidental Tumor Tests id i Cochran-Armitaft Trend Test id) Fisher Exact Test id >
Brain: Glioma Overall Rates isi Adjusted Rates (b) Terminal Rates ici Week of First Observation Life Table Testa id i Incidental Tumor Tests id) Coehran-Armitage Trend Testid) Fisher Exact Testid)
All Silos: Mesothelioma Overall Rates ia) Adjusted Rates lb) Terminal Rates id Week ofFirst Observation Life Table Tests id) Incidental Tumor Tests id) Coehran-Armitage Trend Test id) Fisher Exact Test id)
l/50(2%> 4.3% 1/23(4%) 104 P-0.107 P-0.170 P-0.238
2/50(4%) 8.0% 1/23(4%) 103 P-0.205 P-0.318 P-0.406
3/50(6%) 12.2% 2/23 (8%) 103 P-0.047 P-0.112 P-0.195
35/50(70%) 91.4% 20/23(87%) 69 PcO.OOl P-0.012 P-0.095
1/50(2%) 4.3% 1/23(4%) 104 P-0.039 P-0.103 P-0.082
2/50(4%) 6.3% 1/23(4%) 69 P-0.254 P-0.422 P-0.399
3/50(6%) H.2% 1/20(5%) 87 P -0.255 P-0.285
P-0.309
2/50(4%) 10.0% 2/20(10%) 104 P-0.637 P-0.638
P-0.691
5/50(10%) 20.6% 3/20(15%) 87 P-0.277 P-0.299
P-0.357
39/49)80%) 97.5% 19/20(95%) 82 P 0.093 P- 0.047
P-0.193
0/50(0%) 0.0% 0/20(0%)
P-0.528N P-0.528N
P-0.500N
1/50(2%) 4.8% 0/20(0%) 103 P-0.548N P-0.461N
P-0.500N
3/50(6%) 19.8% 2/12(17%) 99 P-0.137 P-0.164
P-0.309
3/50(6%) 15.0% 1/12(8%) 86 P- 0.285 P-0.467
P-0.500
6/50(12%) 33.0% 3/12(25%) 86 P-0.063 P-0.139
P- 0.243
41/50(82%) 100.0% 12/12(100%: 68 P-0.001 P-0.024
P-0.121
4/50(8%) 17.3% 0/12(0%) 88 P- 0.083 P 0.207
P-0.181
3/50(6%) 15.3% 1/12(8%) 91 P* 0.342 P- 0.509
P* 0.500
SL 035606 E*5 Tetrechloroethylene, NTP TR 311, Draft 5/85
TABLE El. ANALYSIS OF PRIMARY TUmIoRS IN MALE RATS IN THE TWO-YEAR INHALATION STUDY OF TETRACHLOROETHYLENE (Continued)
() Number of tumor-bearing ammab/number of animal* examined at the site (b> Kaptan-Meier estimated tumor incidences at the end nf the study after adjusting for intercurrent mortality ic > Observed tumor incidence at terminal lull <d) Beneath the control incidence are the P values associated with the trend test. Benesth the dosed group incidence are the P values corresponding to pairwise comparisons between that dosed group and the controls. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as nonfatal. The Cochran-Armitage and Fisher's exact test compare directly the overall incidence rates A negative trend or lower incidence in a dosed groi^p is indicated by (N1. <e i A fibrosarcoma was also present in this animal. (fi A nephroblastoma and a lipoma were also observed in this group.
Tetrachloroethylene, NTP TR 311, Draft 5/85 E-6
TABLE El. ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS IN THE TWO-YEAR INHALATION STUDY OF TETRACHLOROETHYLENE
Control
200 ppm
400 ppm
Hematopoietic Brim: Mononuclear Coll Leukemia
Overall Rates (a)
Adjusted Rata*ib) Terminal Rates ici Week ofFirst Observation
Life Table Tests Id i Incidental Tumor Testa id) Cochran-Armitage Trend Teat id >
18/50(36%) 53.8%
8/23(39%) 84
P- 0.053 P-0.012 P-0.018
Fisher Exact Tost id)
30/50(60%) 71.4% 10/21 (48%) 60 P-0.023 P-0.013
P-0.014
Pituitary Gland: Adenoma Overall Rates la) Adjusted Rates lb i
Terminal Rates>c) Week of First Observation
Life Table Tests id) Incidental Tumor Tests id) Cochrsn-Armitage Trend Test id)
Fisher Exact Test id>
19/50(38%)
55.6% 9/23(39%) 59 P-0.471 P-0.479
P-0.459
21/48(44%) 63.7% 10/20(50%) 60 P-0.304 P-0.345
P-0.354
Pituitary Gland: Carcinoma Overall Rates (a) Adjusted Rates lb i Terminal Rates ici Week ofFirst Observation Life Table Tests id) Incidental Tumor Tests id) Cochran-Armitage Trend Test (d)
Fisher Exact Test Id)
4/50(8%) 13.9% 2/23 (9%) 87 P-0.422N P-0.458N P-0.417N
2/48<4%i 5.6% 0/20(0%) 90 P-0.376N P--0.357N
P-0.359N
Pituitary Gland: Adenoma or Carcinoma Overall Rates ta> Adjusted Rates (b)
Terminal Rates ic* Week ofFirst Observation
Life Table Tests id) Incidental Tumor Testa Id) Cochran-Armitage Trend Test id)
Fisher Exact Test idi
23/50(46%) 64.1% 11/23(48%) 59 P-0.529N P- 0.539 P- 0.540
23/48(48%) 65.8% 10/20(50%) 60 P-0.426 P-0.493
P-0.505
Overall Rates (si
Adjusted Rates lb) Terminal Rates ic) Week ofFirst Observation Life Table Tests id > Incidental Tumor Toots id) Cochran-Armitage Trend Test Id)
Fisher Exact Test (d)
U Pheochromocytoma
1/50(2%)
0/49(0%)
4.3%
0.0%
1/23(4%)
0/21 (0%)
104
P-0.176 P-0.171
P-0.518N P-0.518N
P-0.162
P-0.505N
Thyroid Gland: C-Cell Adenoma Overall Rates la) Adjusted Rates lb) Terminal Rates to Week of First Observation Life Table Tests Id) Incidental Tumor Tests (d) Cochran-Armitage Trend Test id) Fisher Exact Test Id >
3/46(7%) 9.3% 0/22(0%) 89 P-0.58') P-0.511 P- 0.595
1/48(2%) 4.8% 1/21(5%) 104 P-0.331N P-0J11N
P-0.292N
29/50(58%) 66.3% 10/24(42%) 76 P-0.053 P-0.014
P- 0.022
20/50(40%) 60.9% 12/24(50%) 76 P-0.514 P-0.513
P-0.500
3/50(6%) 10.5% 2/24(8%) 85 P-0.494N P -0.533 N
P-0.500N
23/50(46%) 68.2% 14/24(58%) 76 P-0.554N P-0.575
P-0.579
3/47(6%) 11.4% 2/23(9%) 95 P- 0.300 P- 0.292
P-0.285
3/46(7%) 9.8% 1/23(4%) 89 P-0.650 P-0.547
P-0.662
SL 0356 E*7 Tetrachloroethylene, NTP TR 311, Draft 5/85
I
TABLE 2. ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS IN THE TWO-YEAR INHALATION STUDY OF TETRACHLOROETHYLENE (Continued)
Control
200 ppm
400 ppm
Thyroid Gland: C-Call Carcinoma Overall Rates ia) Adjusted Rats* tbi Terminal Rates <ei Week ofFirst Observation
Life Table Testa id) Incidental Tumor Testa id)
Cochran-Armitage Trend Test id) Fisher Exact Test tdi
1/46(2%) 3.8% 0^210%) 103
P-0.596N P-0.560 P-0.602
Thyroid Gland: C-Celt Adenoma or Carcinom ,
Overall Rates <a) Adjusted Rates (b) Terminal Rates <ci Week ofFirst Observation Life Table Tests id) Incidental Tumor Tests id > Cochran-Armittge Trend Test id)
Fisher Exact Test id)
4/46(9%) 12.9% 0/22 (0%) 89 P-0.567
P-0.479 P-0.571
Mammary Gland: Fibroadenoma Overall Rates (a) Adjusted Rates ibi Terminal Rates id Week of Ftrst Observation Life Table Tests id) Incidental Tumor Tests id) Cochran-Artnitage Trend Test id) Fisher Exact Test id)
7/50(14%)
21.1%
3/23 (13%) 87
P-0.457N P-0 465N P-0.436N
Mammary' Gland: Adenoma or Fibroadenoma Overall Rates ia> Adjusted Rates <b>
Terminal Ratesic) Week ofFirst Observation
Life Table Tests <d) Incidental Tumor Testa id i Cochran-Armitage Trend Test id) Fisher Exact Test id)
7/50(14%) 21.1% 3/23113%) 87 P-0.541 P-0.528 P-0.563
Mammary Gland: Adenoma. Fibroadenoma or Adenocarcinoma
Overall Rates ia>
8/50(16%)
Adjusted Rates lb)
25.1%
Terminal Rates to
4/23 (17%)
Week ofFirst Observation
87
Life Table Tests id)
P-0.459K
Incidental Tumor Testa id)
P-0.453N*
Cochran-Armitage Trend Testld)
P-0.442N
Fisher Exact Test id)
Clitoral Gland: Adenoma Overall Rates (a) Adjusted Rates (bi
Terminal Rates(c) Week ofFirst Observation
Life Table Tests id> Incidental Tumor Tests (di
Cochran-Armitage Trend Test id) Fisher Exact Test id)
3/50(6%) 11.3% 2/23(9%) 98
P-0.392X P-0.395X
P-0.399N
4/48(8%) 15.1% 2/21 (10%) 96 P-0.168 P-0.173
P-0.194
5M8(10%> 19.6% 3/21(14%) 96 P- 0.464 P- 0.490
P-0.527
3/50(6%) 10.3% 1/21 (5%) 96 P-0.194N P-0.158N
P-0.159N
3/50(6%) 10.3% 1/21 (5%) 96 P-0.194N P-0.158N
P-0.159N
5/50(10%) 14.4% 1/21 (5%) 73 P-0.318N P-0.262N
P-0.277N
1/50(2%) 4.8% 1/21(5%) 104 P-0.335N P-0.330N
P-0.309N
1/46(2%) 4.3% 1/23(4%) 104 P-0.760N P-0.737
P-0.753
4/46(9%) 13.9% 2/23(9%) 89 P-0.632 P- 0.525
P-0.643
6/50(12%) 18.5% 2/24(8%) 77 P-0.517N P-0.532N
P-0.500N
7/50(14%) 20.8% 2/24(8%) 77 P- 0.590 P-0.575
P-0.613
7/50(14%) 20.8% 2/24(8%) 77 P-0.515N P- 0.536N
P-0.500N
2/50(4%) 8.3% 2/24(8%) 104 P- 0.493 N P-0.49SN
P-0.500N
Tetrachloroethyiene, NTP TR 311, Draft 5/85 E-8
SL 035609
TABLE El. ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS IN THE TWO-YEAR INHALATION STUDY OF TETRACHLOROETHYLENE (Continued >
Control
800 ppm
400 ppm
Clitoral Gland: Carcinoma Overall'Rates (a) Adjusted Rates (b) Terminal Rates id Week ofFirst Observation Life Table Tests (d) Incidental Tumor Teats tdi Cochran-Armitage Trend Test (d) Fisher Exact Test id)
2/50(4%) 6.4%
1/23(4%) 84
P-0.588 P-0.567 P-0.584
Clitoral Gland: Adenoma or Carcinoma Overall Rates is) Adjusted Rate*<b) Terminal Rates ic) Week ofFirst Observation
Life Table Tests (d) Incidental Tumor Tests id > Cochran-Armitage Trend Test (d> Fisher Exact Tasttd)
5/50(10%) 17.4% 3/23(13%) 84 P-0.427N P-0.447N
P-0.429N
Uterus: Endometrial Stromal Polyp Overall Rates (a) Adjusted Rates(b) Terminal Rates (c) Week ofFirst Observation Life Table Tests (d> Incidental Tumor Tests <d) Cochran-Armitage Trend Test id)'
Fisher Exact Testid)
5/49(10%) 16.6%
2/23 (9%) 96 P- 0.330 P 0.272
P-0.340
Utorus: Endometrial Stromal Polyp or Sarcoma
Overall Rates (a)
5/49(10%)
Adjusted Rates (b)
16.6%
Terminal Rates (c)
2/23 (9%)
Week ofFirst Observation
96
Life Table Team <d)
P-0.250
Incidental Tumor Tests (d)
P-0.194
Cochran-Armitage Trend Test (d)
P- 0.253
Fisher Exact Test <d)
3/50(6%) 9.3% 1/21(5%) 85 P-0.475 P-0.510
P-0.500
4/50 (8% 1 13.8% 2/21(10%) 85 P-0.541N P-0.512N
P-0.500N
7/49(14%) 23.1% 2/21(10%) 85 P-0.345 P-0.343
P- 0.380
9/49(18%) 29.1% 3/21 (14%) 85 P-0.177 P-0.170
P-0.194
2/50(4%) 8.3% 2/24(8%) 104 P-0.691N P-0.686
P-0.691
4/50(8%) 16.7% 4/24(17%) 104 P-0.492N P-0.505N
P-0.S00N
7/50(14%) 23.5% 4/24(17%) 88 P-0.382 P- 0.334
P-0.394
8/50(16%) 27.3% 5/24(21%) 88 P- 0.283 P-0.241
P-0.290
(a) Number oftumor-bearing animals/number of enimels examined at the tit* (b > Kaplan*Meier estimated tumor incidence* at the end of the study after adjusting for intereurrent mortality (e) Observed tumor incidence at terminal kill (d) Beneath the control incidence are the P value* associated with the trend test. Beneath the dosed group incidence are the P values corresponding to pairwise comparisons between that dosed group and the controls. The life table analysis regard* tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause ofdeath. The incidental tumor test regards these lesions as nonfataL The Cochran-Amutage and Fisher's exact teat compare directly the overall incidence rates. A negative trend or lower incidence in a dosed group is indicated by (N).
0^ SV
E-9 Tetrachloroethylene, NTP TR 311, Draft 5/85
TABLE E3. ANALYSIS OF PRIMARY Tl MORS IN MALE MICE IN THE TWO-YEAR INHALATION STVDY OF TETRACHLOROETHYLENE
Control
100 ppm
200 ppm
Lung: Alveolar/Broncbiolar Adenoma
Overall Ratas (a) Adjusted Rates ib) Terminal Rates ic> Week ofFirst Observation
Life Table Testa (d) Incidental Tumor Tests id) Cochran-Armitafe Trend Test (d) Fisher Exact Teat (d >
3/49(6%)
6.5% 3/46(7%)
104 P-0.446N P-0.378N P-0.256N
Lung: Alveolar/BroncMolar Carcinoma
Overall Rates (a) Adjusted Rates (b) Terminal Rates id Week ofFirst Observation Life Table Tests id) Incidental Tumor Tests (d) Cochran-Armitage Trend Teat id i Fisher Exact Test id t
4/49(8%) 8.7% 4/46(9%) 104 P-0.390 P-0.441
P-0.573N
Lung: Alveolar/Bronchiolar Adenoma or Can :inoma
Overall Rate*<a>
6/49(12%)
Adjusted Rates ib)
13.0%
Terminal Rates ic)
6/46(13%)
Week of First Observation
104
Life Table Tests id)
P-0.414
Incidental Tumor Tests <d)
P-0.502
Cochran-Armitage Trend Test id)
P 0.423 N
Fisher Exact Test id)
Hematopoietic System: Lymphoma, All Malignant
Overall Rates<a*
3/49(6%)
Adjusted Rates ib)
6.5%
Terminal Rates<c)
3/46(7%)
Week ofFirst Observation
104
Life Table Tests id)
P-0.378
incidental Tumor Tests id)
P-0.496N
Cochran-Armitage Trend Test id)
P-0.558N
Fisher Exact Test id)
Circulatory System: Hemangioma or Hemangioaarcoma
Overall Rates la 1
3/49(6%)
Adjusted Rates ib)
6.5%
Terminal Rates ic)
3/46(7%)
Week ofFirst Observation
104
Life Table Tests id)
P-0.576N
Incidental Tumor Tests Id)
P-0.517N
Cochran-Armitage Trend Test Id)
P-0.398N
Fisher Exact Test Id)
Liver Hepatocellular Adenoma
Overall Rates (a) Adjusted Rates (b) Terminal Rates ic) Week of First Observation
Life Table Tests idl Incidental Tumor Tests (d,e)
Cochran-Armitage Trend Test Id) Fisher Exact Test id)
11/49(22%) 23.9% 11/46(24%) 104 PbO.OOo P-0.009
P 0.073
5/49(10%) 18.3% 4/25(16%) 89 P-0.110 P-0.196
P 0.357
1/49(2%) 4.0% 1/25(4%) 104 P-0.401N P-0.401 N
P--0.181N
6/49(12%) 22.2% 5/25 (20%) 89 P-0.220 P-0.335
P--0-620
7/50(14%) 20.3% 2/25(8%) 55 P--0.043 P-0.406
P--0.167
2/50(4%) 7.7% 1/25(4%) 102 P-0.601 P-0.638N
P--0.491N
8/49(16%) 29.9% 7/25(28%) 89 P--0.345 P-0.463
P-0.305N
1/50(2%) 3.1% 1/32(3%) 104 P-0.442N P-0.442N
P-0.301N
4/50(8%) 12.0% 3/32(9%) 103 P* 0.440 P 0.522
P-0.63 IN
5/50(10%) 15.1% 4/32 (13%) 103 P-0.507 P- 0.578
P-0.486N
3/50(6%) 9.4% 3/32(9%) 104 P-0.487 P-0.487
P-0652N
2/50(4%) 6.2% 2/32 (6%) 104 P-0.662N P-0.662N
P-0.491N
18/50(36%) 52.4% 16/32 (50%) 73 P-0.006 P-0.013
P-0.104
Tetrachloroethylene, NTP TR 311, Draft 5/85 E-10
SL 3561i
TABLE E3. ANALYSIS Or PRIMARY TUMORS IN MALE MICE IN THE TWO-YEAR INHALATION STUDY OF TETRACHLOROETHYLENE (Continued)
Control
100 ppm
200 ppm
Liver; Hepatocellular Carcinoma
Overall RatMta) Adjusted Raiei (b) Terminal Rates id Week ofFirst Observation
Life Table Teals (d> incidental Tumor Testa idS) Cochran-Armitage Trend Test <d>
Fisher Exact Test (d)
7/49 (14*1 14.9%
6/46(13*) 98 P<0.001 P- 0.002 P<0.001
Liver: Hepatocellular Adenoma or Carcinoma
Overall Rates ta) Adjusted Rates tb i Terminal Rates <c) Week ofFirst Observation Life Table Tests id) Incidental Tumor Tests id,g) Cochran-Armitaf* Trend Test id > Fisher Exact Test id)
16/49(33*) 34.0* 15/46(33*) 98 P<0.001 P<0.001 P< 0.001
25/49 (51%) 58.3* 8/25(32*) 63 P<0.001 P-0.016
P< 0.001
31/49(63*) 73.0* 14/25(56*) 63 P<0.001 P-0.017
P-0.002
26/50(52*) 58.3* 14/32(44*1 60 P<0.001 P-0.001
P<0.001
40/50(80*) 86.8* 26/32(81*) 60 P<0.001 P< 0.001
P<0.001
la) Number oftumor-besrinf animala/number ofanimals examined at the site (bl Kaplan-Meier estimated tumor incidsncasat the end ofthe study after adjusting for intercurrent mortality ic) Observed tumor incidence at terminal kill Id) Beneath the control incidence are the P values associated with the trend test. Benestb the dosed group incidence are the P values corresponding to pairwise comparisons between that dosed group and the controls. The life table analysis regards tumors ui animals dying prior to terminal kill as being (directly or indirectly) the cause ofdeath. The incidental tumor test,
which regards these lesions as nonfatal, lacks sensitivity because the unusually good survival in the control group creates unsatisfactory comparisons in the early time intervals. The Cochran-Armitsg* and Fisher's exact test compare directly the
overall incidence rates. A negative trend or lower incidence ina dosed group is indicated by (N). is) P values determined with intervals ofweeks 0-52 and 53-103 and week 104: 0.000,0 438,0.014 <f) P values determined with intervals of weeks 0-52 and 53-103 and week 104: 0.003.0.021,0.001 Ig) P values determined with intervals ofweeks 0-52 and 53-103 and week 104. <0.001.0.020. <0.001
SL 035612 E-ll Tctrachloroethylene, NTP TR 311, Draft 5/85
TABLE E4. analysis of primary tutors IN female mice in the two-year inhalation STUDY QF TETRACHLOROETHYLENE
Control
100 ppm
300 ppm
Lung: Alveoiar/Bronchiolar Adenoma
Overall Rates is) Adjusted Rates <bi
Terminal Rat** (c> Week ofFirst Ob**rvstion
Lift Table Toils id) Incidental-Tumor T*su id) Cochran-Armitage Trend Tost tdi Fisbor Exact Ton (d)
4/48(8%) 11.1% 4/36(11%) 104 P*0^52N P*0.1I2N PaO.lOSN
Lung: Alveolar/Broncbiolar Adenoma or Car clnoma
Overall Rates (a) Adjusted Rates (bI
6/48(13%) 16.7%
Terminal Rates (cl
6/36(17%)
Week ofFirst Observation
104
Life Table Tests id) Incidental Tumor Tests id)
PaO.dllN P-05I6N
Cochran-Armitag* Trend Test id)
P-0.162N
Fisher Exact Test id)
Hematopoietic System: Lymphoma, All Malignant
Overall Rates (a)
8/49(16%)
Adjusted Rates(b)
19.4%
Terminal Rates (c)
4/36(11%)
Week ofFirst Observation
93
Life Table Test* id-)
Pa 0.193
Incidental Tumor Tests id >
P-0.418N
Coehran-Annitag* Trend Test id)
Pa0.53lN
Fisher Exact Test id)
Circulatory System: Hemangioearconta Overall Rates (a:
Adjusted Rates (b> Terminal Rates (ci Week ofFirst Observation
Life Table Tests <di Incidental Tumor Tests <d> Cochran-Armitage Trend Test (d I Fisher Exact Test id)
1/49(2%) 2.8% 1/36(3%) . 104
Pa0.576N P0.576N
Pa0.372N
Circulatory System: Hemangioma or Hemangiosarcoma
Overall Reus (a)
1/49 (2%)
Adjusted Rates (b)
2.8%
Terminal Rates <e>
1/36(3%)
Week of First Observation
104
Life Table Test* id)
! P 0.386
Incidental Tumor Tests <d)
Pa 0.386
Cochran-Armitage Trend Test (d)
P-0.603N
Fisher Exact Test id)
Liven Hepatocellular Adenossa Overall Rates la) Adjusted Rates (b)
Terminal Rates (c) Week of Fust Observation
Life Table Tost* id) Incidental Tumor Test* <d> Cochran-Armitage Trend Testld)
Fisher Exact Test (di
3/48(6%) 7.5% 1/36(3%) 96 Pa 0.479 Pa0-325N Pa0.401N
2/50(4%) 6.2% - 1/31(3%> 102 Pa0.403N PaOJ96N
P-0.319N
3/5016%) 9.3% 2m (6%) 102 P-0.317N P-0.311N
P-0.223N
13/50(26%i 35.2% 8/31 (26%) 34 PaO.104 PaO.159
. PaO.176
3/50(6%) 9.7% 3/31 (10%) 104 Pa 0.253 P - 0.253
P-0.316
3/50(6%) 9.7% 3/31(10%) 104 Pa0.253 Pa 0.253
PaO.316
6/50(12%) 18.7% 5/31(16%) 102 PaO.182 Pa0.193
P a 0.264
/
1/50(2%) 2.4% 0/19(0%) 85 Pa0.362X P-0.220N
P-0.168N
3/50(6%) 9.5% 1/19(5%) 67 Pa0.524K Pa0.339N
P0.223N
8/50(t6%> 29.4% 4/19(21%) 54 P-0.268 P-0.485N
P0.590N
0/5010%) 0.0% 0/19(0%)
P0.627N P-0.627N
P-0.495N
1/50(2%) 5.3% 1/19(5%) 104 P-0.613 P-0.613
Pa0.748N
2/50(4%) 6.1% 0/19(0%) 78 Pa0.641K P-0^13N
P0.481N
I Tetrachloroethylene, NTP TR 311, Draft 5/85 E-12
SL 0356X3
TABLE E4. ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE IN THE TWO-YEAR INHALATION STUDY OF TETRACHLOROETHYLENE (Continued)
Control
100 ppm
200 ppm
Liven Hepatocellular Carcinoma
Overall Rates (a> Adjusted Rates ib) Terminal Rates ici Week ofFirst Observation Life Table Tests id) Incidental Tumor Tests (dl Cochran-Armilage Trend Test(d) Fisher Exact Test (d)
1/48(2%)
2.8% 1/36(3%) 104 P<0.001 PcO.OOl PcO.OQl
Liver; Hepatocellular Adenoma or Carcinoma
Overall Rates iai Adjusted Rates (b >
Terminal Rates(c) Week ofFirst Observation Life Table Tests (d) Incidental Tumor Tastsid)
Cochran-Armitagt Trend Testtdi Fisher Exact Teat id)
4/48(8%) 10.1% 2/36 (6% i
96 P<0.001 P<0.001 P<0.001
Pituitary Gland: Carcinoma Overall Rates (a) Adjusted Rates (b> Terminal Rates <c) Week ofFirst Obssrvation Life Table Tests td >
Incidental Tumor Tests (d) Cochran*Armitage Trend Test (d i Fisher Exact Taat (d>
5/45(11%) 14.7%
5/34(15%) 104
P-0.549
P-0.544N P-0.316N
Pituitary Gland: Adanoma or Carcinoma Overall Rates is> Adjusted Rates <b> Terminal Rates ic) Week ofFirst Observation Life Table Tests id > Incidental Tumor Tests id > Cochran-Armitage Trend Test (dl Fisher Exact Test (d>
7/45(16%) 19.7%
6/34(18%) 97
P-0.480 P-0.387N
P-0J49N
Harderian Gland: Adanoma or Carcinoma (e)
Overall Rates ia> Adjusted Rates<bi Terminal Rates to Week of First Observation Life Table Testa id) Incidental Tumor Totts id) Cochran-Armttage Trend Test id) Fisher Exact Tast(d)
1/49(2%) 2.4%
0/3610%) 97 P-0.093 P-0.202 P-0.207
13/50(26%) 35.5% 8/31 (26%) 76 PC0.001 PcO.OOI
P<0.001
17/50 (34%) 46.7% 12/31 (39%) 76 P<0.001 P< 0.001
P-0.002
3/43(7%) 9.7% 3/31 (10%) 104 P-0.406N P-0.406N
P-0.383N
3/43(7%) 9.7% 3/31 (10%) 104 P- 0.200N P-0.193N
P-0.176N
1/50(2%) 3.2% 1/31 (3%) 104 P-0.726 P-0.726
P-0.747N
36/50(72%) 91.7% 16/19(84%) 67 P<0.001 P<0.001
P< 0.001
38/50(76%) 92.2% 16/19(84%) 67 PC0.001 P<0.001
P<0.001
3/42(7%i 15.4% 2/lT(l2%> 102 P-0.573 P-0.645N
P-0.396N
5/42(12%) 20.5% 2/17(12%) 88 P-0.473 P-0.462N
P-0.429N
3/50(6%) 14.3% 2/19(11%) 102 P-0.155 P-0.325
P-0.316
(a) Number oftumor-bearing animala/number ofanimals examined at the site <b> Kaplan-Meier estimated tumor incidences at the end ofthe study after adjusting for intercurrent mortality
(e) Observed tumor incidence at terminal kill (dl Beneath the control incidence are the P values associated with the trend test. Beneath the dosed group incidence are the P values corresponding to pairwise comparisons between that dosed group and the controls. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly > the eause ofdeath. The incidental tumor lest regards these lesions as nonfatal. The Cochran-Amuteg* and Fisher's exact test compare directly the overall incidence rates. A negative trend or tower incidence in a dosed group is indicated by (N i. (e> Includes adenoma. NOS, papillary adenoma, and papillary carcinoma
SL 035614 E-13 Tetrachloroethylene, NTPTR 311, Draft 5/85
Tetrachlorocthylene, NTP TR 311, Draft 5/85 E-14
SX, 035&3-5
TABU 4. ANALYSIS OF PBIMARY TUMOKS IN MALI BATS fig)
Untreated Control
Vehicle Control
Low Does
High Dose
Tumor Rues Overall fb) Abutted ft) Terminal fd)
Sutistical Tern ft) Life Table Incidental Tumor Te*t Cochran-Armiuge Trend Tcct Fisher Exact Test
3/30 (6%)
Skin or Subcutaneous Tine FBrwm Tumor Rates
Overall (b) Adjusted (e) Terminal (d) Sutistical Tesu ft) Life Table Incidental Tumor Test Cochran-Annitaie Trend Test Fisher Exact Test
3/30 (6%)
Lung: Alveolar/Rrooehioiar Cardaoa Tumor Rates
Overall fb) Adjusted (c) Terminal (d) Statistical Tests ft) Life Table Incidental Tumor Test Cochran-Armitage Trend Test Fisher Exact Test
1/49(2%)
Lung: Alveolar/Srooehioiar Adenoma or Carcinoma
Tumor Rates
Overall fb)
1/49 (2%)
Adjusted ft)
Terminal (d)
Sutistical Tesu ft)
Life Table
Incidenul Tumor Test
Cochran-Armiuge Trend Test
Fisher Exact Test
Hematopoietic System: Leukemia Tumor Rates
Overall (b) Adjusted fc) Terminal (d) Sutistical Tests ft) Life Table Incidenul Tumor Test Cochran-Armiuge Trend Test Fisher Exact Test
11/30(22%)
4/30(8%) 10.2% 2/33 (6%)
PeO.lOSN P*0.064N P*.027N
4/30(1%) 10.2% 2/33 (6%)
PeOJISN P-0.23SN P-0.IO4N
3/50 (6%) 7.6% 2/33 (6%)
P=046t P*0.583N P*0.415N
4/50(8%) 10.4% 3/35 (9%)
P*0.384N P0.439N P*0.259N
3/30 (10%) 13.6% 4/35 (11%)
P0.394N P0.255N P=0.094N
1/30 (2%) 3.0% 1/20 (3%)
PNL336N P-0JI6N
PeO.ISIN
1/30 (2%) 3.0% 1/20 (5%)
P0.356N P0.216N
P"0.I8IN
2/30 (4%) 9.3% 1/20 (3%)
P*0.656 F0.494N
FeO.SOON
2/30 (4%) 9.5% 1/20(5%)
F=0.570N P=0J68N
POJ39N
5/30 (10%) 17.9% 2/20(10%)
PNJ.336 P*0.548
Pe0.630
6/49 (0%) 0X1% 0/16(0%)
P-0J08N PeO.MlN
P"0.06IN
1/49(2%) 6.3% 1/16(6%)
P=0.475N P=0.373N
P=0.187N
2/49 (4%) 10.9% 1/16(6%)
P*0.568 P0.639N
P*0.5I0N
2/49 (4%) 10.9% 1/16(6%).
P=0.669 P=0.5I6N
P=0.349
1/49(2%) 5.9% 0/16 (0%)
P*0.368N P*0.309N
P*0.I07N
Trichloroethylene
34
TABLE 4. ANALYSIS OF PRIMARY TUMORS IN MALE RATS fa) (Continued)
Untreated Control
Vehicle Control
Low Dose
Hematopoietic System: leufceuila * Lymphoma
Tumor Rates
Overall fb)
12/50 (24%)
Adjusted (c)
Terminal (d)
Statistical Tests ft)
Life Table
Incidental Tumor Test
Cochran*Armitage Trend Test
Fisher Exact Test
Kidney: Tubular-Cell Adenocarcinoma Tumor Rates
Overall (b) Adjusted (c) Terminal (d) Statistical Tesu ft) Life Table Incidental Tumor Test Cochran*Aimitage Trend Test Fisher Exact Test
10/49 (0%)
Kidney: Tubular-Cell Adenoma or Adtpocardno--
Tumor Rates
Overall (b)
0/49(0%)
. Adjusted (c)
Terminal (d)
Statistical Tests ft)
Life Table
Incidental Tumor Test
Cochran*Armitage Trend Test
Fisher Exact Test
Pituitary: Chromophobe Adenoma Tumor Rates
Overall fb) Adjusted ft) Terminal (d) Statistical Tests ft) Life Table Incidental Tumor Test Cochran*Armitate Trend Test Fisher Exact Test
4/39 (10%) fit) '
,
Adrenal: All Pheoehromocytomas Tumor Rates
Overall fb) Adjusted fc) Terminal fd) Statistical Tests ft) Life Table Incidental Tumor Test Cochran-Armitage Trend Test Fisher Exact Test
18/45 (18%)
,
i
;
6/50(12%) 15.4% 4/35(11%)
P=0.287N P*0.I21N P=0.051N
0/48 (0%) 0.0% 0/33 (0%)
Ps0.009 P=0.009 P*0.038
0/48 (0%) 0.0% 0/33(0%)
P=0.0I9 PsO.030 P=0.084
7/42 (17%) fh) 21.2% 7/33(21%)
P=0.147N P=0.I25N P=0.150N
4/45 (9%) 13.3% 4/30(13%)
P=0.348N P*0.270N P*0.140N
5/50(10%) 17.9% 2/20(10%)
P=0.455 P0.5I2N
Pn0.5OON
0/49 (0%) 0.0% 0/20(0%)
(f) (f)
(f)
2/49 (4%) 5.6% 0/20(0%)
P=0.!94 P=0.327
PsO.253
2/35 (6%) fi) 8.2% 1/18(6%)
P=0.285N P=0.250N
P=O.I28N
3/42 (7%) 15.8% 3/19(16%)
P=0.571 P=0.571
P=0.539N
High Dose
1/49(2%) 5.9% 0/16 (0%)
P=0.270N P*0.I26N P=0.059N
3/49 (6%) 18.8% 3/16(19%)
P=0.028 PeO.028
P=0.125
3/49 (6%) 18.8% 3/16(19%)
Pe0.028 PsO.028
P0.I25
1/26(4%) 7.7% 1/13(8%)
P=0.258N P*0.258N
psO.IHN
1/44(2%) 3.2% 0/16(0%)
P=0.393N P=0.254N
P=0.187N
SL 035617
35
Trichloroethylene
TABLE 4. ANALYSIS OF PRIMARY TUMORS IN MALE RATS () (Continued)
Untreated Control
Vehicle Control
Low Dose
Thyroid: C-CeM Carcinoma Tumor Rates
Overall (b)
Adjusted fc) Terminal (d) Sutistical Tests (t) Life Table Incidental Tumor Test Cochran-Armitage Trend Test Fisher Exact Test
0/44 (0%)
Thyroid: C-CeH Adenoma or Carchtoma
Tumor Rates
Overall fbj
5,44(11??)
Adjusted ft)
Terminal (d)
Statistical Tests it)
Life Table
Incidental Tumor Test
Cochran-Armitage Trend Test
Fisher Exact Test
Preputial Gland: Adenoma Tumor Rates
Overall (hj Adjusted fc) Terminal (dj Statistical Tests (e) Life Table Incidental Tumor Test Cochran-Armitage Trend Test Fisher Exact Test
4 50 (8??)
Preputial Gland: Adenoma or Adenocarcinoma
Tumor Rates
Overall fb)
4/50 (89?)
Adjusted ft)
Terminal (d)
Statistical Tests ft)
Life Table
Incidental Tumor Test
Cochran-Armiuge Trend Test
Fisher Exact Test
Testis: Interstitial-Cell Tumor Tumor Rates
Overall (b) Adjusted fc) Terminal (d) Statistical Tests (t) Life Table Incidental Tumor Test Cochran-Armitage Trend Test Fishci Exact Test
44/47 (94%) P<0.00IN
2/44 (5%) 6.5% 2/31 (6%)
P=0.470N P=0.429N P*0.232N
4/44 (9%) 12.9% 4,31 (13%)
Ps0.224N P=0.197N P=0.061N
4 50 (8%) 11.4% 4 35 (11%)
P=0.253N P=0.253N P=0.084N
5/50(10%) 13.5% 4/35(11%)
P0.553 P*0.457N P=0.272N
47/49 (96%) 100.0% 35 ;3S (100%)
Pe0.004 P=0.252N
3/43 (7%) 15.9% 2,15(13%)
P*0.23l P*0.28l
peO.489
3 43 (7%) 15.9% 2 15(13%)
P=0.464 P=0.5I9
P=0.5I3N
0 50 (0%) 0.0% 0 20 (0%)
P=0.I54N P=0.I54N
P=0.059N
1/50(2%) 5.0% 1/20(5%)
P=0.254 P*0.2I1N
P*0.I02N
47/49 (96%) 100.0% 20/20(100%)
P<0.00l P=0.190
P=0.69l
High Dose
0/39(0%) 0.0% 0/14 (0%)
P=0.425N P=0.425N P*0.278N
0 39 (0%) 0.0% 0 14(0%)
P=0.202N P=0.202N
P=0.074N
1/49(2%) 6.2% 1/16(6%)
P*0.473N P=0.473N
P=0.187N
3/49(6%) 13.4% 1/16(6%)
PsO.536 P=0.541N
P=0.369N
32'46 (70%) 96.8% 14/15(93%)
P=0.008 P=0.594N
P=0.001N
Tnchlorotthylene
36
TABLE 4. ANALYSIS OF PRIMARY TUMORS IN MALE RATS {) (Continued)
Untreated Control
Vthick Control
Low Dose
High Dom
Peritoneum; Malignant Mesothelioma Tumor Rate*
Overall (b) Adjusted (c) Terminal (d) Statistical Tests (*) Life Table Incidental Tumor Test Cochraa-Anmiagt Trend Test Fisher Exact Test
Peritoneum: All MaaotheHomos Tumor Rates
Ovetall (b) Adjusted (e) Terminal (d) Sutistical Tests (t) Life Table Incidental Tumor Test Cochnn-Armitage Trend Test Fisher Exact Test
1/30(2%) 1/30(2%)
1/30(2%) 2.9% 1/33 (3%)
P=0.518 P=0.348N P*0.407N
1/30(2%) 2.9% 1/35(3%)
P=0.286 P*0.383 P*0.585
5/30(10%) 16.1% 0/20 (0%)
P=0.042 P*0.274
P0.I02
0/49 (0%) 0.0% 0/16(0%)
P=0.656N P*0.656N
P=0.505N
5/30(10%) 13.6% 0/20 (0%)
P=0.042 P=0.274
P*0.I02
1/49(2%) 6.3% 1/16 (6%)
P=0.578 P=0.578
P=0.747
(a) Dosed groups received doses of 500 or 1,000 mg; kg of trichloroethylene by gavage. (b) Number of tumor bearing animals, number of animals examined at the site. (c) Kaplan-Meier estimated lifetime tumor incidence after adjusting for intercurrent mortality. (d) Observed tumor incidence at terminal kill. (e) Beneath the control incidence artj the P values associated with the trend test. Beneath each dosed group
incidence is the P value corresponding to the pairwise comparison between that dosed group and the controls. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. Thf incidental tumor test regards these lesions as non-fatal. The CochranArmitage and Fisher's exact test compare directly the overall incidence rates. A negative trend or lower incidence is indicated by (N). (f) Not significant; no tumors were observed in dosed or control groups. (t) Two chromophobe carcinomas, one adenoma. NOS. and one carcinoma, NOS. were also observed. (h) One chromophobe carcinoma wai also observed. (i) One adenoma, NOS. was also observed.
37 SL 035619
Trichloroethylene
TABLE S. ANALYSIS OF PKIMAKY TUMORS IN FEMALE RATS ()
Untreated Control
Vehicle Control
Low Doer
Lmc; Ahcolii/lraMMAhr AtumomoerCareino-e
Tumor Rato
Overall (b)
0l*9<0%)
A4jtttudfe)
Terminal (d)
Statistical Test* (t)
Life Table
Incidental Tumor Tot
Cochran-Armiugc Trend Ten
Fisher Exact Test
HimtoeoMe System: Leukemia Tumor Rates
Overall (b)
Adjusted (c) Terminal (d) Statistical Tests (t)
Life Table Incidenul Tumor Tot Cochran-Armiuge Trend Tot Fisher Exact Test
10/49 (30%) ff)
Pituitary: Chromophobe Adenoma Tumor Rato
Overall (b)
Adjusted (e) Terminal (d) Statistical Tots (ti Life Table Incidenul Tumor Test Cochran-Armhage Trend Tot Fisher Exact Tot
18/43 (42%)
Pituitary: AD Adenomas or Cardn Tumor Rato
Overall (b) Adjusted (c) Terminal (d) Sutistical Tern (t) Life Table Incidenul Tumor Tot Cochran-Anniuge Trend Tot Fisher Exact Tot
19/43 (44%)
Adrenal: Cortical Adenoma Tumor Rato
Overall (b) Adjusted (e) Terminal (d) Sutistical Tou (t) Life Table Incidenul Tumor Tot Corhran-Armiuge Trend Tot Fisher Exact Tot
2/45 (4%) P=0.227
1/30 (2%) 2.7% 1/37 (3%)
P0.I51 P-0J26 P-0.302
1/49 (2%) 3.0% 1/33(3%)
P*0.?36 P0.736
P*).747
14/50(28%) 33.8% 10/37 (27%)
P=0.316N P>0.II0N P*0.12IN
4/50 (8%) 10.7% 2/33 (6%)
P=0.019N P=0.004N
P*0.009N
13/37 (35%) 37.5% 9/29 (31%)
P-0.131N P*0.036N ps0.022N
6/34(18%) 24.0% 5/23 (22%)
P*0.135N P0.075N
P*0.081N
13/37 (35%) 37.5% 9/29 (31%)
P=0.15IN P*0.038N P0.024N
8/34 (24%) 30.3% 6/23 (26%)
P=0.297N P=0.I88N
P=0.209N
1/46(2%) 3.095 1/33 (3%)
Pe0.l42 P0.142
P*0.5I6
2/48 (4%) 6.1% 2/33 (6%)
P=0.500 P*0.500
P0.3I7
High Dose
3ISO (6%) 7.5% 0/26(0%)
P=0.246 P*0.54l
P=0.309
9/50(18%) 29.1% 6/26(23%)
P0.446N P=0.182N
P*0.I7IN
6/41 (15%) 22.0% 3/22(14%)
P=0.191N P=0.040N
P=0.032N
6/41 (15%) 22.0% 3/22(14%)
P=0.I9!N P=0.040N
P=0.032N
3/47 (6%) 12.0% 3/25(12%)
P=0.2I0 Pe0.2l0
Trichloroethylene
38
SL 035620
TABLE i ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS (*) (Continued)
1-----------------------Untreated Control
Vehicle Control
Low . Dose
High Dose
Thyroid: C-Ce* Adenoma Tumor Rates
Overall (b) Adjusted (e) Terminal (d) Statistical Tests ft) Life Table Incidental Tnor Teat Cochian-Armitagt Trend Ten Fisher Exact Test
i
! Twvmw
'
!
i
i
Mammary Gland: Fibroadenoma
Tumor Rates Overall (b) Adjusted (c)
10/49 (20%) 1
Terminal (d)
Statistical Tests ft)
Life Table
Incidental Tumor Test
Cochran-Armitage Trend Test
;
Fisher Exact Test
,
Uterus: Endometrial Stromal Polyp i1
Tumor Rates
Overall (b) Adjusted (c) Terminal fd)
10/4S (22%) !
!
Statistical Tests ft)
Life Table
Incidental Tumor Test
Cochran-Armitage Trend Test
Fisher Exact Test
Uterus: Endometrial Stromal Polyp or Sartoma
Tumor Rates
Overall (b)
10/45 (22%)
Adjusted (c)
Terminal fd)
Statistical Tests ft)
Life Table
Incidental Tumor Test
Cochran-Armitage Trend Test
Fisher Exact Test
4/41 (10%) 10.9% 3/34(9%)
P*0.I68N P0.127N P=0.086N
9/50(18%) 22.9% 7/37 (19%)
P*0.307N P=0.169N P*0.1I4N
15/48(31%) 40.1% 13/35(37%)
P=0.074N PS0.035N P=O.OI9N
15/48 (31%) 40.1% 13/35 (37%)
P=O.I27N P=0.060N P*0.037N
1/45(2%) 3.3% 1/30(3%)
P0JI4N P=0.)68N
P-0.152N
12/50 (24%) 32.6% 9/33 (27%)
Pe0.240 P*0.353
P*0.312
8/48 (17%) 23.1% 7/33 (21%)
P0.098N P*0.069N
P=0.075N
8/48(17%) 23.1% 7/33 (21%)
P=0.098N P=0.069N
P*0.075N
1/44 (2%) 4.2% 1/24(4%)
P=0.290N P=0.2I0N
P=0.159N
4/50(8%) 14.5% 3/26(12%)
P*0.285N P=0.|77N
P=0.I17N
6/46(13%) 21.0% 4/25(16%)
P=0.120N P=0.056N
P=0.030N
7/46(15%) 23.5% 4/25(16%)
P=0.I93N P=0.086N
P*0.055N
(a) Doted groups received doses of 100 or 1,000 mg/kg of trichloroethylene by gavage. (b) Number of tumor bearing animals/number of animals examined at the site. (c) Kaplan-Meier estimated lifetime tumor incidence after adjusting for intercurrent mortality. (d) Observed tumor incidence at terminal kill. (e) Beneath the control incidence ate the P values associated with the trend test. Beneath each dosed group
incidence is the P value corresponding to the pairwise comparison between that dosed group and the controls. The life table analysis regards turnon in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. T|he incidental tumor test regards these lesions as non-fatal. The CochranArmitage and Fisher's exact test compare directly the overall incidence rates. A negative trend or lower incidence is indicated by (N). (f) One malignant lymphoma, histiocytic type, was also observed. (l) One C-cell carcinoma was also observed.
39 Trichloroethylene
SL 035621
FINAL ^
WIM0u:)t
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR MICE
CBDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL: CROUP IDS-'
C04546 TRICHLOROETHYLENE
M3-01VM
M3-01HM
M3-01VF
M3-01HF
SURVIVAL AT MINIMUM TERMINAL SACRIFICE(HEEK)
33/50
66X 105
16/50 32X
105
32/50 64X 104
23/50 46X
104
MALE
FEMALE
DOSE IN GM/KG
0.0
1.0
0.0 1.0
ALL TOPOGRAPHIES ALL TUMORS
TUMOR RATES OVERALL (a) ADJUSTED (b) TERMINAL (c.) FIRST INCIDENCE (HEEKS)
33/50 ( 00) 69.7X
19/33 ( 50) 61
45/50 ( 90) TOO.OX
16/16 (100) 57
21/40 ( 44)
SI. 4X 13/32 ( 41)
46
30/49 ( 70) 00.2X
10/23 ( 70) 65
STAtl$TiCH TESlS-tdi
LIFE TABLE INCIDENTAL TUMOR TEST COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P<9.001 P-0.014
PSiUHM
P<0.001 P-0.003
P<0.00
LUNG NOS ALL TUMORS
TUMOR RATES OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (HEEKS)
7/49 ( 14) 19.2X
5/33 ( 15)
73
6/50 ( 12) 30. OX
4/16 ( 25) 84
1/48 (
2.5X 0/32 (
88
2) 0)
4/48 ( 14.3X
2/22 ( 85
8) 9)
5TJTTsTpp"7E5T03i
INCIDENTAL TUMOR TEST COCHRAN-ARMITAGE TREND fISHEft EXACT IE5IS________
P=0.310 P^O.575
P=B.48SH_.
P=0.132 P=0.184
. P iOiiM.
LUNG NOS AL VEOL AR/BRONCHIOLAft ADENOMA
TOMQR RATES
.OVERALL (a) ADJUSTED (b>
TERMINAL (c> FIRST INCIDENCE (HEEKS)
4/49 ( 10.5X
2/33 ( 73
8) 6)
5/50 ( 10) 27. IX
4/16 ( 25) 84
0/48 ( 0)
o.ox
0/32 ( 0)
4/48 ( 8)
14. SX 2/22 ( 9)
85
INCIDENTAL TUMOR TEST COCHRAN-ARMITAGE TREND .FISHER EXACT TESTS
p=e.197 psO.375
Psfl.5.,U,
P-0.040 P-0.064
PAGE: VERSION: 11/13/ RUN DATE* 03/01/
<S in cn o tn
,x t HUO.
IfltERCURRCNT MORIALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR MICE
CUDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS:
M3-01VM
M3-01HM
M3-01VF
M3-01HF
HALE
DOSE IN GM/KG
0.0 1.0
LUNG NOS ALVEOLAR/BRONCHIOLAR CARCINOMA
TUMOR RATES OVERALL (a) ADJUSTED (b) TERMINAL Cc) FIRST INCIDENCE CHEEKS)
3/49 C 9. IX
3/33 ! 105
6) 9)
1/50 C 4.OX
0/16 C 94
2) 0)
STATISTICAL TESTS UJ
LIFE TABLE INCIDENTAL TUMOR TEST COCHRAH-ARMITAGE TREND FISHER EXACT TESTS
P=0.553N P-0.407N
P=0.30 IN
LUNG NOS ALVEOLAR/BRONCHIOLAR ADENOMA
ALVEOLAR/BRONCHIOLAR CARCINOMA
TUMOR RATES OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE CHEEKS)
STATISTICAL Tests cd) LIFE TABU
INCIDENTAL TUMOR TEST COCHRAH-ARMITAGE TREND FISHER EXACT TESTS
7/49 C 14) 19.2X
5/33 I 15) 73
6/50 C 12) 30. OX
4/16 C 25) 84
Ps0.310 Ps0.575
P=0.484N
HEMATOPOIETIC SYSTEM ALL TUMORS
TUMOR RATES OVERALL ia)
ADJUSTED Cb)
TERMINAL Cc> FIRST INCIDENCE CHEEKS)
13/50 C 26) 28.5X
3/33 C 9) 61
13/50 C 26) 45.7X
3/16 C 19) 77
wpttift1 Uili M
INCIDENTAL TUMOR TEST COCHRAH-ARMITAGE TREND FISHER EXACT TESTS________
P=0.226 P-8.176H
P=0.S90N
FEMALE
0.0 1.0
1/48 C 2.5X
0/32 C 88
2) 0)
0/48 C 0) O.OX
0/22 C 0)
P=0.505N P=0.500N
P=0.500N
1/48 ( 2.5X
0/32 C 88
2) 0)
4/48 C 14. SX
2/22 1 85
8) 9)
P=0. 132 P=0.184
P=0.181
8/48 C 17) 20.5X
3/32 C 9) 62
14/49 C 29) 39.3X
3/23 ! 13) 66
P-0.056 P-0.442
__P.ijLJ3____
PAGE' VERSION: 11/13/ RUN DATE* 03/01/
CO m
CoO
i-3 xn
IIIT ERCURRENT MORTAL ITY ADJUSTED TUMOR I NCI DEUCE ANALYSIS FOR MICE
ODDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
CQ4546 TRICHLOROETHYLENE
GROUP IDS:
M3-0IVM
M3-01HM
H3-01VF
M3-01HF
MALE
DOSE IN GM/KG
0.0
f .0
HEMATOPOIETIC SYSTEM ALL LYMPHOMAS
iumqr.bajes OVERALL (a) ADJUSTED <b) TERMINAL (c> FIRST INCIDENCE
CHEEKS)
11/50 ( 22) 25.2X
3/33 C 9) 66
13/50 C 26) 45.7X
3/16 C 19) 77
ftftUflLJMllid
INCIDENTAL TUMOR TEST COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
PM. 116 PM.398H
HEMATOPOIETIC SYSTEM MALIGNANT LYMPHOMA, NOS
TUMOR. BATES OVERALL Ca)
ADJUSTED (b) TERMINAL (c> FIRST INCIDENCE CHEEKS)
1/50 C 2. IX
0/33 C 66
2) 0)
3/50 C 11.9X
1/16 C 88
6) 6)
FEMALE 0.0 1.0_____________________________
7/40 ( 15) IS.OX
3/32 C 9) 79
13/49 ( 27) 38. OX
3/23 < 13)
85
PM. 047 PM.331
P=o.n4___________________________
2/48 C 5.9X
1/32 t 101
4) 3)
2/49 C
6.5X 0/23 C
90
4) 0)
PAGE: VERSION) 11/13/1 RUN DATE) 03/01/1
Sf (V VO *o *> o
to
Agraa* TK15
INCIDENTAL TUMOR TEST COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
HEMATOPOIETIC SYSTEM MALIG.LYMPHOMA, UNDIFFER-TYPE
TUMOR RAtfeS OVERALL Ca) ADJUSTED Cb)
TERMINAL Cc) FIRST INCIDENCE CHEEKS)
3/50 C 6.7X
0/33 C 73
6) 0)
HttW lt5li <di
INCIDENTAL TUMOR TEST COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
PM.217 PM. 476 e.u,a____
5/50 C 10) 17.4X
1/16 C 6) 77
PM. 258 PM. 590
P=0-357____
PM. 601 PM.559N
P=0.684N
1/48 C
2.2X 0/32 C
79
2) 0)
3/49 C 10. IX
0/23 C
90
6) 0)
PM .252 PM.476 .
P.rJLttt------------------------------------------------------------------------------- -------------------- -
I HIERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR MICE
CBDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS:
M3-01VM
M3-01HM
M3-01VF
M3-01HF
PAGE* VERSION) 11/13 RUN DATE* 03/01
MALE
FEMALE
DOSE IN GM/KG_______________ __________5LJL-____________ L_fi_____ __________ SUL.____________ LJ!______________________________________________________________________
HEMATOPOIETIC SYSTEM MAL16.LYMPHOMA, LYMPHOCYTIC TYPE
TUMOR RATES OVERALL (a) ADJUSTED (b)
TERMINAL (c) FIRST INCIDENCE (MEEKS)
2/50 ( 5. IX
0/33 ( 86
4) 0)
STATISTICAL, TESTS Id) LIFE TABLE INCIDENTAL TUMOR TEST
COCHRAN-ARHITAGE TREND
FISHER EXACT TESTS
HEMATOPOIETIC SYSTEM MALIG.LYMPHOMA, HISTIOCYTIC TYPE
2/50 (
It.IX 0/16 ( 102
4)j
I 0)
t
P=0.504 P=0.341H
1
t
P=0.6?1H 1
0/48 < 0) 0. OX
0/32 ( 0)
3/49 ( 9.6X
0/23 ( 96
6) 0)
P=0.096 P-0.324
P=0.125
in <s i) in
o
a
CO
TUMOR RATES OVERALL (a) ADJUSTED (b> TERMINAL (c) FIRST INCIDENCE (MEEKS)
STATISTICAL TESTS (d)
1 [ 1
LIFE TABU
|
INCIDENTAL TUMOR TEST |
COCHRAN-ARMITAGE TREND f
FISHER EXACT TESTS________ [_
2/50 ( 5. IX
1/33 ( 66
4) 3)
0/50 ( 0) O.OX
0/16 ( 0)
P-0.322N P0.29 IN
1/48 ( 2.8X
0/32 ( 99
2) 0)
3/49 ( 10.9X
2/23 ( 85
6) 9)
P-0.228 P=0.323
HEMATOPOIETIC SYSTEM MALIGNANT LYMPHOMA. MIXED TYPE
TUMOR RAUS OVERALL (a) ADJUSTED (b)
TERMINAL (c) FIRST INCIDENCE (MEEKS)
3/50 ( 8.8X
2/33 ( 103
6) 6)
3/50 ( 14.6X
1/16 ( 97
6) 6)
3/48 ( 9. IX
2/32 ( 103
6) 6)
2/49 ( 7.5X
1/23 ( 98
4) A)
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P=0.348 P=0.663N
P=0*1H
PE0.636N P-0.424N
P=0.490N
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR MICE
LAOS CONTRACT' 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS'.
K3-01VM
M3-01HM
M3-01VF
M3-01HF
MALE
DOSE IN GM/K6
0.0
1.0
HEMATOPOIETIC SYSTEM ALL LYMPHOMAS ALL LEUKEMIAS
TUMOR RATES OVERALL <*>
ADJUSTED lb) TERMINAL (c) FIRST INCIDENCE CHEEKS)
11/50 C 22) 25.22
3/33 C 9)
66
13/50 C 26) 45.72
3/16 1 19) 77
STATISTICAL ..TESTS till
LIFE TABLE INCIDENTAL TUMOR TEST COCHRAN-ARHITA6E TREND FISHER EXACT TESTS
P*0.116 P*0.390N
P?i.40B
LIVER NOS HEPATOCELLULAR ADENOMA
TUMQRJiftm
OVERALL!)
ADJUSTED Cb) TERMINAL (c>
(FIRST INCIDENCE CHEEKS)
15) 14/50 C 20) 53. 12
1) 4/16 C 30) 69
LFE TAOLE
INCIDENTAL TUMOR TEST
C0CHRAM-ARM1T AGE TREND
FISHER EXACI.TESTS____
LIVER NOS HEPATOCELLULAR CARCINOMA
pSMIpApS
overall
ADJUSTED (b) .TERMINAL Cc) FIRST INCIDENCE CHEEK*
0/40 C 17) 22.12
6/33 C 10)
75
Hf^iTHABi LE 14-1 HD
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND\
FISHER EXACT TESTS
V
P*0.002 P&0.040
31/50 C 62) 92.92
14/16 C 00) 57
P<0.001 P<0.001 p<o.oot
FEMALE 0.0_
1.0_________________________________
7/40 C 15) 10.02
3/32 C 9)
79
14/49 C 29) 39.32
3/23 C 13) 66
P=0.032 P=0.207
_Pf.iL.QZi________________________
4/40 C 0) 12.52
4/32 C 13) 105
16/49 C 33) 55.62
11/23 C 40) 05
P<0.001 P=0.0Q1
2/40 C 6.22
2/32 C 106
4) 6)
13/49 C 27) 43.92
0/23 C 35)
05
P<0.001 P-0.002
P=0.002
v
)
PAGE* VERSION: 11/13/ RUN DATE> 03/01/
vO
vfl O
N? ERCURRENT MORTALITr ADJUSTED TUMOR INCIDENCE ANALYSIS FOR MICE
BDS CONTRACT: 600244 PAPANICOLAOU
HFM1CAL:
C04546 TRICHLOROETHYLENE
ROUP IDS:
M3-01VH
M3-OIHM
M3-OIVF
M3-0IHF
PAGE: VERSION: 11/13/8
RUN DATE> 03/01/8
UNOp R&IES IVERALLti) vDJUSTED Cb) ERMINAL Cc> IRST INCIDENCE CHEEKS)
IBFIllfft ,tils""
INCIDENTAL TUMOR TEST :OCHRAN-ARMIT AGE TREND ISHER EXACT TESTS______
TARDERIAN GLAND ADENOMA, NOS
IUHOR RA OVERALL U) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE CHEEKS)
STATISTICAL TE*tS l dT LIFE TAOLE INCIDENTAL TUMOR TEST C0CHRAN-ARH1TAGE TREND FISHER EXACT TESTS______
0/18 ( 0) O.OX
0/12 f 0)
0/22 ( 0)
O.OX 0/5 I 0)
() ()
-U2-
3/27 C II) 13.IX
2/19 ( 11)
101
0/28 ( 0) O.OX
0/14 ( 0)
P=0. 183N P*0.08 IN
PS9,.I12H
0/50 C 0) O.OX
0/33 C 0)
2/50 < 5.5X
0/18 (
77
4) 0)
P=0.215 P*0.399
Pg9.237.-
0/48 < 0) O.OX
0/32 ( 0)
3/49 (
8.3X 0/23 C
90
8) 0)
PsO.114 P=0.171
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR fllCf__
CDDS CONTRACT: 6002AA PAPANICOLAOU
CHEMICAL:
C0ASA6 TRICHLOROETHYLENE
CROUP IDS:
M3-0IVM
M3-01HK
H3-0IVF
M3-01HF
HALE
FEMALE
PQSE 1H-CWW_______________ __________m___________ ___LJ_____ _________ SUi______________ LJL
a) Number of tumor-bearinq animals/number of animals examined at the site (percent). b) Kaplan-Meier estimated lifetime tumor incidence after adjustinq for intercurrent mortality. c) Observed tumor incidence at terminal kill. e) Beneath the dosed qroup Incidence are the P-values corresponding to pairwise __
comparisons between that dosed group and the controls. The life table analysis reqards tumors in animals dying prior to terminal kill as beinq (directly or indirectly) the cause of death. The incidental tumor test reqards these lesions as non-fatal. The Cochran-Armitaqe and Fisher's exact tests compare directly the overall incidence rates. A neqatfve trend is indicated by N. e) Differences not significant; no tumors observed in dosed group or control group.
PAGE: VERSION* 11/13/ RUN DATE* 03/01/
oo cs ^ 0 i_T w
I
FINAL *f
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS__
CUDS CONTRACT : 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS:
RB-OtUM
RB-Q1VM
RB-OILM
RB-01HM
RB-01UF
ki:::
RB-01VF
" ^ ijd5
PAGE:
I
VERSION: 11/13/841
RUN DATE: 02/2U/B5
RB-OILF
RB-OlHF
SURVIVAL AT MINIMUM
j
TERMINAL SACRIFICE(NEEK)
32/50 64% 104
28/50
52% 104
12/50 24%
104
MALE
8/50 12%
104
31/50 82%
104
30/50 80% 104
12/50 24%
_____ 145________
FEMALE
10/50 20%
104_________
DOSE IN CH/KO______________ L_
0.0_____________ SUL.____________SL5____ ________ 1.0
_________ SLxO_____________!L0_____________SU5_____________ LJ1_____
ALL TOPOGRAPHIES ALL TUMORS
TUMOR RATES OVERALL (a) ADJUSTED (b)
TERMINAL (c) FIRST INCIDENCE (MEEKS)
38/49 ( 78) 97.4%
31/32 C 97) 73
37/50 ( 74) 97.3%
25/28 ( 98) 42
23/50 ( 48) 100.0%
12/12 (100)
50
32/50 ( 84) 100.0% 8/8 (TOO)
32
46/50 ( 92) 97.9%
30/31 < 97) 55
47/50 ( 94) 97.9%
29/30 ( 97) 51
31/50 ( 62)
93.3% 10/12 ( 83)
66
22/48 ( 46)
94.9%
9/10 ( 90) 28
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
KIDNEY NOS ALL TUMORS
TNflOR RATES OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
aW' TM*-mi
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P<0.001 P=0.007 P0. 102N
P<0.001
P=0.002 P=0.178N
P-0.003 P=0.050 P=0.092 P=0.081
P<0.001 P<0.001
P=0.024 P=0.008
P=0.00 IN
P=0. 104N
--Jia jafiM___ --P=SM3.4M_
P=0.091 P-0.005N P<0.00 IN
P=0.097
P=0.002N P<0.00 IN
P=0.045 P=0.052 P=0.043N P-0.013N
P=0.00 IN P<Q.00 IN
P=0. 156 P=0.157 P=0.0 ION P=0.003N
P<Q. 00 IN _11L P.QJJ1
2/49 (
6.2% 2/32 ( 105
4) 6)
0/49 ( 0) 0.0%
0/26 ( 0)
1/50 ( 4.0%
0/12 (
57
2) 0)
1/47 ( 9. 1%
0/6 ( 87
2) 0)
Ps0.462 P=0.416N P=0.390H
P-0.181
P-0.331 P-0.322
P-0.698 P=0.387 P=0.593N P=0.6 12
P=0.492N Ps0.505_____
P=0.522 P=0.276 P=Q. 742N P=0.398
P=0.516N f = ____
1/49 ( 3.2%
1/31 ( 105
2) 3)
0/50 ( 0) 0.0%
0/30 ( 0)
2/48 ( 14. 1%
1/12 ( 100
4) 8)
3/44 ( 7) 22.6%
2/10 ( 20)
64
P=0.029 P=0.050 P-0. 189
P=0.008
P=0.0 15 P-0.064
P=0.2 16 P = 0.086 P = 0.340 P=0.156
P=0.492 -.FS2..23L.
P=0.059 P=0.019 P-0.109 P-0.046
P=0,269 -EUi.Oig___
O' IN in co
4 c/l
I
IHTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT 600244 PAPANICOLAOU
CHEMICAL
C04546 TRICHLOROETHYLENE
GROUP IDSi
RI-OIUM
RB-01VM
RB-OILM
RB-OtHN
MALE
B05E.IH Ctk'M______________ ........... .... ft.B.
PITUITARY CHROMOPHOBE ADENOMA
--______ U__________ --1.1.5----------______ LJ_____
IWQB RATES OVERALL U)
ADJUSTED (b)
TERMINAL <c> FIRST INCIDENCE (HEEKS)
1/SB ( 3.8X
1/24 (
185
5> 4)
2/21 ( 10)
16.8X 1/7 ( 14)
88
0/25 ( 0) O.OX
0/11 ( 0)
0/28 ( .0) O.OX
0/3 ( 0)
kmw tw*u>
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAOE TREND FISHER EXACT TESTS
ADRENAL CORTICAL ADENOMA
i (Tizr ;fl J\ l
ADJUSTED (b) TERMINAL tc) FIRST INCIDENCE IHEEKS)
PM.548N PM.548N PM.S12N
PM.194H
P-0. 138N PM.067H
P=0.67 IN PM.285N PM. 67 IN Ps0.410H
PM.590N P=8,g(?iH
PM.904N PM.482N PM.9Q4N PM.329N
PM.563N Pfff, I7M-
0/48 1 0) O.OX
0/31 C 0)
2/48 i 6.4X
1/26 ( 81
-4) 4)
D/43 ( 0) O.OX
0/11 ( 0)
0/43 1 0) O.OX
0/6 ( )
TKTS{d)
INCIDENTAL TUMOR TEST COCHRAN-ARMITAOE TREND FISHER EXACT TESTS
(> () (>
PM .266N
PM.2S8N PM.109N
<a> P=0.473N
(a) PM.47 IN
(a) PM.5I6N (a) PM. 46 ON
(a) (a) PM.276H____ P*B.2ZL
RB-OtUF
RB-01VF
PAGE:
2
VERSION: 11/13/84T
RUN DATE: 02/20/85
RB-01LF
RB-01HF
- OH______
FEMALE 0.8_____________ JL5______
1.1_____
22/42 ( 52) 64.4X
15/26 ( 58) 69
18/45 ( 40) 51.7X
11/26 ( 42) 78
8/38 ( 21) 36.3X
2/It ( 18)
73
6/42 ( 14) 39.2X
2/9 t 22)
68
P-0.17 IN PM.0D3N P<0.001N
PSQ.412N
PM.03611 PM.004N
PM.243N PM .482N PM.019N PM.097N
PM.257N P=0.506N P=0.013N
PM.079N
P-0.004N
P<0.00 IN
PM 052N____ P=0.0Q7H
4/47 t 9) 12. IX
3/31 ( 10) 89
5/49 ( 10) 15.9X
4/29 ( 14) 91
2/47 ( 13.4X
1/12 (
97
4) 8)
3/43 ( 7) IB.SX
1/10 ( 10)
66
P-0.244 PM.483 PM .46 ON
PM. 346
PM.551 PM. 333N
PM .6 16
PM.620N P-0.S62N PM.514H
P-0.310
PM. 394 PM .621 PM.649H
PM. 339H
P-0.550N
PE,236H____ P=q.413N
o
<n
CO *o o
Co
IHTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT1 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS>
RB-01UH
RB-01VM
RB-01LM
RB-01HM
RB-OIUF
RB-01VF
PAGE
3
VERSION; 11/I3/84T
RUN DATE: 02/20/85
RB-01LF
RB-OfHF
POSE IH-fiteKG___________
ADRENAL PHEOCHROHOCYTOMA
TUHQR RftJfcS OVERALL (a) ADJUSTED (b) TERMINAL <c) FIRST INCIDENCE CHEEKS)
MALE
FEMALE
- L.B____ _____ m_________JL5____ _____ LJ____ _______ fi_Jl_________ ILK__________!Lu5__________LJ!___
19/48 ( 40) 55.6X
16/31 C 52) 89
21/48 ( 44) 69. IX
17/26 ( 65) 79
12/43 ( 28) 84.SX
9/11 ( 82) 65
11/43 ( 26)
89.4X 5/6 ( 83)
57
30/47 ( 64)
74. SX
21/31 ( 68) 61
39/49 ( 80) 92.7X
26/29 ( 90)
68
15/47 < 32) 76.5X
8/12 ( 67) 68
9/43 (21) 67.OX
6/10 ( 60)
82
ittPttK? TKts
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P-0.001 P0.107 P*0.090N
ADRENAL PHEOCHROHOCYTOMA, MALIGNANT
P=0.014
P-O.095 P-0.Q40N
P-0.033 P=0.147 P=Q.048 P=0.119
P=0. 17 IN
P=0.002 P=0.021 P=0. 190 P=0. 127
P=0.116N P=0.055N
P=0.4 19N P=0.019N P<0.001H
Pg0.050N P<0.00 IN P<O.OQtl!
P=0.396 P=0.263N P=0.090N P-0.002N
P = 0.397H P-0.067N P-0.026N
p<o.oottt
P=0.00 2 N
P<0.00 111
-P<P.PPN____ P<0.001ll
TUMOR RMl OVERALL () ------ADJUSTED <b>
TERMINAL (c) FIRST INCIDENCE tHEEKS)
4/48 ( 8) 5/48 ( 10) ------16.2X
3/31 ( 10) 2/26 C 8) 91 85
1/43 ( 9. IX
1/11 ( 104
2) 9)
2/43 ( 21.4X
0/6 C 86
5) 0)
4/47 C 9) 12.9X
4/31 ( 13)
105
4/49 ( 8)
13.ax 472^T 147 104
0/47 ( 0) O.OX
0/12 ( 0)
1/43 ( 2 10.OX
1710 C 10
104
LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
Pg0.298 P-0.467N P*0.280N
Ps0.517
P=0.440N P=0. 165N
Pg0.589N
P-0.420N P=0.703N PM. 693
P=0.329 P-0.524
P=0.557N P=0.500N
PM.2I7N
P=0.393N
Pg0.129H____ P=P.266M
PsO.379N Ps0.379N P-0.093N
P=0.354N P=0.354N P=Q. 100N
P=0.238N
P=0.222N P-0.23811 P =0.22211
P=0.62 IN
P = 0.59311 P=0.62111 P=0.593H
P=0.05911
P=0.2 ION
-LrJL, 84 ____ P=tt.224H
o to to o CO
I
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT' 600244 PAPANICOLAOU
CHEMICAL'
C04546 TRICHLOROETHYLENE
GROUP IDS'
RD-OIUM
RI-01VM
RB-01LH
RB-01HM
RB-OtUF
RB-01VF
PAGE'
4
VERSION' 11/13/S4T
RUN DATE' 02/20/85
RB-OILF
RB-01HF
CflSE-IW gfl/KQ______________ _________ IL1_____
ALL ADRENAL SITES PHEOCHROMOCYTOMA
IJJHQR, RATES OVERALL ()
ADJUSTED (b)
TERMINAL (c)
FIRST INCIDENCE (MEEKS)
19/48 ( 40)
55.6X
16/31 ( 52)
89
KALE 0.0
tJ______
FEMALE !_____ _________ Ul_____ _______ _________________U______
21/48 ( 44)
69. IX
17/26 ( 65)
79
12/43 < 28)
84.8X
9/11 ( 82)
65
11/43 ( 26)
89.4X
5/6 ( S3)
57
38/47 ( 64)
74.SX
21/31 ( 68)
61
39/49 ( 80)
92.7X 26/29 (90)
68
15/47 ( 32)
76.5X
8/12 ( 67)
68
i.o
9/43 ( 21)
67.OX 6/10 < 60)
82
BMW ,t5is t"1
INCIDENTAL ftlMOR TEST COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
Pa0.00t P*8.107 P*0.090N
P-0.014
P0.095 P-0.040H
Ps0.033 Pa0.147 P=0.048 P=0.119
P=0. 17 IN P=0.08BN____
Pa0.002 Pa0.021 Pa0.190 P*0.127
P-0. 116N Pa0.055N
Pa0.419N Pa0.019N P<0.00 IN
Pa0.050N
P<0.001N P<0.00 IN
Pa0.396 P-0.263H P-0.09011 Pa0.0Q2N
PB0.397N P-0.067H P-0.026N P<0.00 IN
P=0.002N
P<0.00 IN
--P<JL.PQih___ P<0.00 111
ALL ADRENAL SITES PHEOCHROMOCYTOMA, MALIGNANT
BW
ADJUSTED (b) TERMINAL <c) FIRST INCIDENCE (HEEKS)
IPlIft1
ia>
INCIDENTAL TUMOR TEST
COCHRAN-ARM1TAGE TREND FISHER EXACT TESTS
4/48 ( 8) 12. IX
3/31 ( 10)
91
5/48 C 10) 16,2X
2/26 ( 8) 85
1/43 ( 9. IX
1/11 (
104
2) 9)
2/43 C 21.4X
0/6 ( 86
5) 0)
Ps0.298 P*0.467N P=0.280H
P=0.517
P=0.440N P-0.165N
P=0.589N P=0.420N Pa0.703N P=0.695
P=0.217N
___
Pa0.329 Pa0.524 Pa0.557N P=fl.500H
Pa0.393N Pa0.266H
4/47 C 9) 12.9X
4/31 ( 13) 105
4/49 ( 8)
13.ax 4/29 ( 14) 104
0/47 ( 8) O.OX
0/ 12 ( 0 )
1/43 ( 2) 10.OX
1/10 ( 10) 104
Pa0.379N P=0.379N P-0.093N
Pa0.354N
Ps0.354N Pa0. IOON
P-0.238N Pa0.222N P=0.23811 P=0.222N
P-0.059N
P=0.62 IN P=0.593M P=0.621N P=0.593N
P=0.2 ION
-P-at.AH
$
O os O'
er . 03
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT> 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS:
RB-01UM
RB-01VM
RB-OILN
RB-81HN
RB-01UF
RB-OIVF
PAGE *
5
VERSION: 11/13/84T
RUN DATE: 02/20/83
RB-OtLF
RB-01HF
SL 035633
DOSE IN GM/KO
0.0
ALL ADRENAL SITES PHEOCHROMOCYTOMA PHEOCHROMOCYTOMA, MALIGNANT
MALE
0.0 a
0.5
TUMOR RATES OVERALL (a) ADJUSTED (b) TERMINAL <c> FIRST INCIDENCE (MEEKS)
CTATI^TirAI TF<TC tM\ LIFE fABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
23/48 ( 48) 65.4X
19/31 ( 41) 89
25/48 ( 52) 75.IX
18/26 ( 69) 79
12/43 ( 28) 84.8X
9/11 ( 82)
65
Pa0.002 P=0.224 P-0.027N
P-0.035
P=0.239 P-0.010N
P-0. 105 P-0.353 P=0. 114 P=0.158
P=0.040N P=0.0I6N
THYROID C-CELL ADENOMA
TUMOR RATES OVERALL (a)
ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
8/41 ( 20) 25.OX
8/32 ( 25) 105
4/41 ( 10) 14. OX
3/25 ( 12)
55
5/41 ( 12)
41.7X 5/12 ( 42)
104
1.0
12/43 ( 28) 90.9X
5/6 ( S3) 57
P=0.002 P=0.037 P-0.309 Ps0.288
P=0.040N P=0.016N
1
2/40 ( 5) 40.OX
2/5 ( 40) 104
FEMALE 0.0 0.0 0.5
1.0
32/47 ( 68) 79.8X
23/31 (74) 61
40/49 ( 82) 95. IX
27/29 ( 93) 68
15/47 ( 32) 76.5X
8/12 ( 67) 68
9/43 ( 21) 67. OX
6/10 ( 60)
82
P=0.3I4H P-Q.Q07N P<0.00 IN
Ps0.036H P<0.00 IN P<0.00 IN
P=0.489 P-0.222N P=0.04811 P<0.00 IN
P<0.00 IN P<0.00 IN
P-0.3Q6N P=Q.C50N P30.012N P<0.00 IN
P<0.001tl P<0,00 IN _
12/48 ( 25)
37.3X 11/31 ( 35)
95
10/43 ( 23) 31.8X
9/30 ( 30) 92
5/46 ( 11)
45.5X 5/11 ( 45) 104
4/43 ( 9) 26. ZZ
2/10 ( 20) 57
tmw '"'5
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P=0.210 P-0.210 P-0.034N
P=0.129
P=0.172 P=0.292N
P=0.242
P=0.113 P=0.242
P=0. 153
P=0.437 P=0.385 P=0.437 P=0.513
P=0.273N
P=0.048N
P=0.SOO____ _ P=0.350N
P0.560N
P=0.444N ( t P=0.025N | I___________________
P-0.432
P=0.552N P=0.046N
Ps0.513 P=0.394 P=0.589
P=0.423
P=0.58 311 P=0.561
P=0.418N P=0.473N
P=0.065N
P=0.044H
Pgfl.JQlH____ P=g,P71H
1NTERCURREHT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS:
RB-01UM
RB-01VM
RI-01LH
RB-OtHM
RB-01UF
RB-01VF
PAGE:
6
VERSION: 11/I3/84T
RUN DATE: 02/20/S5
RB-01LF
KB-01HF
1 MALE
POSE IN GH/KQ____________ _______ SLJ2__________9,9-_____ .8, S______ _____Lit____ _______ ILJ_____
THYROID C-CELL CARCINOMA
FEMALE
__ Qj.t_______________________ LJ!____
TUMOR RATES OVERALL (a) ADJUSTED <b)
TERMINAL (c> FIRST INCIDENCE (HEEKS)
4/41 ( 10) 12.5X
4/32 ( 13)
105
1/41 C 4. OX
1/25 ( 105
2) 4)
0/41 ( 0) O.OX
0/12 ( 0)
1/40 I 12.5X
0/5 ( 100
3) 0)
1/48 ( 3.2X
1/31 ( 105
2) 3)
0/43 ( 0) O.OX
0/30 ( 0)
2/46 ( S.5X
0/11 C
79
4) 0)
1/43 ( 2) to.OX
1/10 ( 10)
104
atfaity mir*J
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
THYROID C-CELL ADENOMA C-CELL CARCINOMA
1MH0R.M-TE5 OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (HEEKS)
Pa0.547N P=0.463N Pa0.0S4N
P=0.36 1
P=0.574 P=0.664
P=0.246N P-0.646N
P=0.246N P=0.646N
Pa0.621
Pa0.431 P=0.716 P=8.660
P=0.058N
P-0. ISSN
,.._P=lb MPH____ _PfO,i_4?____
P=0.287 P=.391 P=0.587
Pa0.139 P=0,249 P=0.359
P=0.27 1 Pa0.129 P=B.435 Pa0.331
P=0.484
PB0.492 P=0.282 P=0.492 P=0.282
P=0,724 P30.500___
12/41 ( 29) 37.5X
12/32 ( 38)
105
5/41 ( 12) 17.9X
4/25 ( 16)
55
5/41 ( 12)
41.7X
5/12 ( 42) 104
3/40 ( 8) 47.5X
2/5 ( 40) 100
13/48 ( 27) 40.4X
12/31 ( 39) 95
10/43 ( 23) 31.8X
9/30 ( 30) 92
7/46 ( 15) 50. IX
5/11 ( 45) 79
5/43 ( 121 35.5X
3/10 ( 30)
57
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS _______________________________ 1
Pa0.277 P=0.329 P=0.006N
P=0.078
P=0.170 P=Q.308N
P=0.537
P=0. 178 P=0.537 P=0.228
.
P=0.353 P=0.206 P=0.437
P=0.424
P=0.05011
P=fl.0 1 IN
P = 0.63 IN____ P=0,370H .
P-0.400 P=0.56 IN P=0.037N
Pa0.219
P-0.403 P-0.096N
Pa0.282 Pa0. ISO P=0.427 P*0.249
F~0.124H Pa0.244N
P=0.542 Pa0.364 P=0.549N P-0.593
P=0.055H -fa! 12 ML.
SL 035634
t
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT) 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS:
RD-OtUM
Rl-OtVM
RB-01LM
RB-01HM
RB-OIUF
RB-01VF
PAGE:
7
VERSION: 1I/I3/84T
RUN DATE) 02/20/85
RB-01LF
RB-01HF
HALE
FEMALE
POSE IN GM/KG______________ _________ sm______ ______ lU__________ _JLJ______ ______ LJ_____ _________ __________
MAMMARY GLAND ALL TUMORS
0.8_____________ LlS______
T.8_____
TUMOR RATES OVERALL (a) ADJUSTED (b> TERMINAL (c> FIRST INCIDENCE (MEEKS)
0/49 ( 0) O.OX
8/S2 ( 8)
0/50 ( 0) 8. OX
8/26 ( 0)
0/58 ( 8) O.OX
0/12 ( 81
8/50 ( 0)
0. OX 0/6 ( 0)
8/50 ( 16)
22.2X 5/51 ( 16)
55
14/58 ( 28)
56.8X
8/38 ( 27) 78
2/50 ( 4) 16.7X
2/12 ( 17) 104
4/48 ( 24.2X
0/10 (
78
8) 0)
STATISTICAL TEST? id) LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
(a)
-- (a)
(a) -- (a>
(a) Ps0.477
-- ----- (a) -- -- - - - - - ----- -
(a)
(a) (a>
P30.355N
(a) (a) (a)
(a) <a>
P=0.127N
(a) (a)
Ca)____
(a)
pr -n CLOn
P=8.032N Ps8.003N
Ps0.52 IN pf -nU < Un7r AUMI1
P=0.170N P=0.009N
P=0.474 #=r429H
P=0.596N P=0.062N
P=0.046N
P-0.199N
PSB.80 IN____ Ps8 81
MAMMARY GLAND FIBROADENOMA
TUMOR RATES OVERALL (a) ADJUSTED (b)
TERMINAL <c> FIRST INCIDENCE (MEEKS)
0/49 ( 0) O.OX
0/52 ( 0)
0/50 ( 0)
O.OX 0/26 ( 0)
0/50 ( 0) o.ex
0/12 ( 0)
0/50 ( 0) 0. OX
0/6 ( 0)
7/50 ( 14)
19.ax 5/51 ( 16)
55
11/50 ( 22)
28.2X 5/30 ( 17)
78
2/50 ( 4) 16.7X
2/12 ( 17) 104
4/48 (. 8) 24.2X
0/10 ( 0)
78
HtTOM TtSl51JI
(a)
(a) (a)
(a) (a) (a)
INCIDENTAL TUMOR TEST
(a)
(a) (a)
(a) (a) (a)
COCHRAN-ARMITAGE TREND
(a)
(a)
FISHER EXACT TESTS
(a) (a)
to)_________ la)
Ps0.386 P=0.48 IN P=0.203N
PB0.4 18N
P=0.087N P-0.023N
Ps0.404N P-0. 159N
P*0.302N P=0.024N
P-0.405 P-0.601N
P-0.496N P-0. 120H
Px0.080N
P=0.286N
P-0,008N____ P=0.054N
SL 035635
t
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CODS CONTRACT) <00244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS-'
RB-01UM
R1-01VH
RB-01LM
RI-01HM
RB-01UF
RB-B1VF
PAGE)
B
VERSION) 11/13/841
RUN DATE) 02/20/85
RB-OtLF
RB-01HF
MALE
PCSE-llL-ffll/Kfi______________ _________ LJ______ ______ U__________ MAMMARY GLAND
ADENOCARCINOMA, NOS
0^_____
lUMQR.feATLS OVERALL () ADJUSTED (b)
TERMINAL (c) FIRST INCIDENCE (MEEKS)
0/49 ( 0) 0. OX
0/32 ( 0)
0/50 ( 0) 0. OX
0/26 ( 0)
0/50 ( 0)
0. OX 0/12 ( 0)
FEMALE . I.ff_____ _________ U______ _____ U_____________ L5______ ______ L_B_____
0/50 ( 0)
o.ox
0/6 ( 0)
1/50 (
3.OX 0/31 (
too
2) 0)
3/50 ( 6)
10. OX 3/30 ( 10)
104
0/50 ( 0) O.OX
0/12 ( 0)
0/48 ( 0) O.OX
0/10 ( 0)
(a)
INCIDENTAL TUMOR TEST
(a)
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
(a)
___
TESTIS NOS INTERSTITIAL-CELL TUMOR
TUMQR,RAILS
OVERAUU) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
16/46 ( 35)
46.9X 14/32 ( 44)
98
a r.\ i h LIFE TABLE
INCIDENTAL TUMOR TEST
P<0.001 P<0.001
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
PaQ.003
(a) (a) (a)
17/46 ( 37) 55.7X
13/26 ( 50) 79
P<O.OOI PCO.OOI P=0.005
(a) (a) (a) (a)
(a) . U>-
(a) (a) (a) (a)
1 (a) 1
--Lai_____ ____ !
21/48 < 44) 95. IX
11/12 ( 92) 50
31/48 < 65) 100.OX 6/6 (100) 32
P<0.001 PCO.OOI P<0.001 p<o.oot
P=0.249 P=0.323___
P<0.001 P<0.001 P<0.001 P<0.001
Pa0.003 Pa0.007
P-0.432N P=0.286N Px0.274N
Pa8.157N
P=0.157H P=0.039N
P*0.644N P*0.320H P-0.383N P-0.320N
P=0.7 1811
P=0.366N Pa0.602N P=0.366N
Pa0.500N
P-0.510N
E0.22H------ f=lL.122H ..
U1 V* o Iji u . o> .w
O'
i
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT* 600244 PAPANICOLAOU
CHEMICAL)
C04546 TRICHLOROETHYLENE
GROUP IDSt
RB-OIUM
RB-81VM
RI-S1LM
RB-Q1HM
RB-81UF
DOSE IN GM/KG
TESTICULAR SITES INTERSTITIAL-CELL TUMOR
B.O
MALE 0.0
0.5
1.0
0.0
ADJUSTED (b) TERMINAL <c) FIRST INCIDENCE (HEEKS)
16/46 ( 35) 46.9X
14/32 ( 44) 98
17/46 ( 37)
55.7X 13/26 ( 50)
79
21/48 ( 44). 31/48 ( 65)
95. IX
100.OX
11/12 ( 92) 6/6 (100)
50 32
StATlStlCAL TtSTS (d) like Table
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
------ PCO.OOI P<O.OOt P-0.003
P<O.OOI
P<0.001 P-0.005
P<0.001-------P<O.OOI P<0.001 P<0.001
P=0.249 P-0.323
P< 0.001 P<0.001 P<0.001 P<0.001
P=0.003 P=0.007
--
TESTICULAR SITES INTERSTITIAL-CELL TUMOR INTERSTITIAL-CELL TUMOR, MALIGNANT
k TJ;ji]; J.l
ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (HEEKS)
16/46 ( 35) 46.9X
14/32 ( 44) 98
17/46 ( 37) 55.7X
13/26 ( 50)
79
21/48 ( 44) 95. IX
11/12 ( 92) 50
32/48 ( 67) 100.OX 6/6 (100) 32
STATlSTICftL -TESTS (d) LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P<0.001 P<0.001 P*0.001
' PC0.001
P<0.001 P=0.003
P<0.001 PC0.001 P<0.001 P<0.001
P=0.249 P = P:123-------
P<0.001 P<0.001 P<0.001 P<0.001
P-0.002 P=000*____
-.
-
RB-OIVF
PAGE*
9
VERSION' I 1/13/84T
RUN DATE* 02/20/85
RI-OILF
RI-OtHF
FEMALE 0.0
0.5
1.0_____
... --------
-------------------
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CRDS CONTRACT> 600244 PAPANICOLAOU
CHEMICAL'
C04546 TRICHLOROETHYLENE
GROUP IDS:
RB-01UM
RB-01VN
RB-01LH
RB-01HM
DOSE IN GM/KG
UTERUS NOS ENDOMETRIAL STROMAL POLYP
0.0
MALE
0.0
0.5
1.0
OVERALL (a) ADJUSTED (b> TERMINAL <c> FIRST INCIDENCE (KEEKS)
IIHW 1E5'5 ,ri
INCIDENTAL TIMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
UTERUS NOS ENDOMETRIAL STROMAL POLYP ENDOMETRIAL STROMAL SARCOMA
TUHQB-BATES OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (KEEKS)
STATISTICAL TESTS til) LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
RI-01UF 0.0
RB-OtVF
PAGE:
10
VERSION: 11/13/041
RUN DATE: 02/20/05
RB-OlLF
RB-01HF
FEMALE 0.0
0.5
10
6/47 ( 13) 17.OX
3/30 ( 10)
79
3/50 ( 8.2X
1/30 ( SO
0) 3)
5/45 < II) 23.2X
2/12 ( 17)
00
2/44 ( 5) 20. OX
2/10 < 20) 104
P-0.552 P-0.2S9N P=0.12iN
P*0.244
P=0.533 P=0.489N
P-0.339 P=0.107 Pa0.574N P*0.350
Ps9.53 IN Ps0.299
P=0.027N P=0.409 Pr0.400N P=0.505
P=0. 150H psQ.561H
*
0/47 ( 13)
17.OX 3/30 ( 10)
79
3/50 (
B.2X 1/30 (
00
0) 3)
5/45 ( 11) 23.2X
2/12 ( 17)
00
2/44 ( 5:
20. OX
2/10 ( 20; 104
P=0,552 P=0.289N P-0.120N
P*0.244
Ps0.533 P*0.409N
P=0.339 P=0.107 P-0.574N P-0.380
P-0.53 IN P=0.299
P=0.627N P=0.409 P=0.46ON P=0.505
P=0. 150N -P=8,.?Q1H .
1 ytvjI L,, f-Vuro 0^
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS>
RB-01UM
RB-01VM
RB-B1LN
RB-01HM
RB-01UF
RB-01VF
PAGE:
11
VERSION: 11/13/84T
RUN DATE' 02/20/85
RB-OILF
RB-01HF
MALE
FEMALE
DOSE IN OH/KO______________ _________ Ut______ ______ !L_fi__________
ALL TOPOGRAPHIES MESOTHELIOMA, NOS MESOTHELIOMA, MALIGNANT
0.5
______ U_____
o-o______ ______ U_____________ 1*5-----------
1.0-
IHQ8 RATES OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
2/49 ( 5.5X
1/52 ( 73
4) 3)
P-0.040 P=0.299 P=0.415
2/50 ( 6 .OX
0/26 ( 79
4) 0)
2/50 ( 4)
16.7X
2/12 ( 17) 104
P=0.063
P=Q.244 P=0.406
P=0.307 P=0.356 P=0.544 P=0.090
P=0.68411 - P=0.691N____
3/50 (
24.5X 0/6 (
63
6) 0)
P=0.094 P=0.127 P=0.673 P-0.496
--
P=0.509 P=0.500
0/50 ( O.OX
0/31 (
(e) (e) (e)
0) 0)
0/50 ( 0) O.OX
0/30 < 0)
0/50 ( 0) O.OX
0/12 ( 0)
0/48 ( 0) 0. OX
0/10 ( 0)
(e) (e)
(e) (e> (e) (a) Ca)
(a) ta) ( a)
(e) (a) (e)
__ 1*1-----
__ to) -
a) Numbor of tumor-bear inq aniaali/nunbtr of animals examined at the site (percent). b) Kaplan-Meier estimated lifetime tumor incidence after adjusting for intercurrent mortality.
c) Observed tumor Incidence at terminal kill. d) Beneath the control incidence are the P-values associated with the trend test.
Beneath the dosed qroup incidence are the P-values corresponding to pairwise
compart sons between that dosed group and the controls. The life table analysis reqards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. The Cochran~Armitaqe and Fisher's exact tests compare directly
the verall incidence rates. A negative trend is indicated by M.
e) Differences not significant; no tumors observed in dosed group or control group.
SL 035639
II FI NAL ^
RECENEO,^0-
t
INTERCURREHT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT> 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS'
RI-01UM
RI-81VM
R1-01LH
RI-01HM
RI-DTUF
RI-DIVF
VERSION: U/13/84T
RUN DATE> 02/20/85
RI-OILF
RI-D1HF
SURVIVAL AT MINIMUM TERMINAL SACRIFICE!HEEK)
24/50 48X
104
21/50 42X
104
T5750 26 X
104
16/49 SSX
104
26/50 52X 104
23751 46X 104
21751 52X
104
25751 50X 104
HALE
FEMALE
BOSE IH.WKQ______________ _________ U___ _________U____________ m____--______ U_____ _________ u___
ALL TOPOGRAPHIES ALL TUMORS
0.0______ :______ U___ _________ *.P
TUMOR RATES
OVERALL () ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
43/50 ( 06) 100.OX
24/24 (100)
62
45/50 ( 90)
100.OX 21/21 (100)
50
32/50 ( 64) 97.OX
12/13 ( 92) 65
27/49 ( 55)
100.DX 16/16 (100)
66
45/50 ( 90) 97.OX
25/26 ( 96) 50
43/50 ( 06)
93.4X 20/23 ( 07)
40
35/50 ( 70) 94.6X
24/26 ( 92) 70
29/50 ( 50) 93.4X
23/25 ( 92)
15
MATI5TKAL TESTS (dl
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
HEMATOPOIETIC SYSTEM ALL TUMORS
TUMOR RAtES OVERALL (a) ADJUSTED (b) TERMINAL (c> FIRST INCIDENCE (HEEKS)
STATISTICAL tE$TS (dl
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P*0.523N P-Q.173N P<0.001N
P-0.27SN
P=0.035N P<0.00 IN
P=0.142 P=0.325 P=0.646 P=0.25SN
P-0.010N P=0.003H___
P-0.478N P-0.243N P=0.239H P-0.044N
P<0.00 IN P<0.00 IN
P=0.015N P*0.077N P<0.00IN
P=0.012N
P-0.155N P-0.001N
Ps0.092N P-0.07QN P-0.123N Ps0.230N
P-0.012N -Pr0.045H
P=0.024N P=0.023N P-0.121N P=0.195N
P<0.001H P=0.002N
3/50 ( 7.2X
0/24 < 66
6) 0)
1/50 (
3. OX
0/21 ( 88
2) 0)
1/50 (
6.2X 0/13 (
100
2) 0)
2/49 (
10.7X 1/16 (
87
4) 6)
P=0.586N P=0.528N P=0.407N
P=0.257
P=0.202 P=0.372
P=Q.458N P-0.668 P=0.3I2N P=0.692
P=0.666
P=0.361 P=0.620N
P=0.338
P=0.309N
P=0.5 ION
P=QJH____ P=<L422____
0/50 ( 0) o.ox
0/26 ( 0)
1/50 ( 2.2X
0/23 ( 65
2) 0)
2/50 ( 6.9X
1/26 ( 100
4) 4)
5/50 ( 10)
18.2X
3/25 ( 12) 02
F-0.01I P-0.003 P*0.016
P*0.046
P*0.019 P-0.060
Pa0.243 P=0.509 P=0.191 P=0.480
P=0.247
P-0.022 P20.078 P=0.012 P=0.059
P-0.028 -P=P.1P2____
SL 035640
II
IHTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CUDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS:
RI-01UH
RI-01VN
RI-01LM
RI-01HM
RI-OtUF
RI-OIVF
PAGE:
2
VERSION: 11/13/841
RUN DATE' 02/20/85
RI-01LF
RI-01HF
HALE
FEMALE
POSE IN CM/KG______________ _________ u___________ SUL.___________
HEMATOPOIETIC SYSTEM ALL LEUKEMIAS
_________ ________ _________ u___ __ ______ Li____________U___ _______ LJ___
TUMOR RATES OVERALL(a)
ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (NEEKS)
2/50 ( 5. IX
0/24 ( 70
4) 0)
1/50 ( 3.OX
0/21 ( 88
2) 0)
0/50 ( 0)
O.OX 0/13 ( 0)
0/49 C 9) O.OX
0/18 C 0)
0/50 C 0> O.OX
0/28 < 0)
1/SO (
2.2X 0/23 C
65
2) 0)
0/50 ( 0)
O.OX 0/26 ( 0)
5/50 ( 10) 18.2X
3/25 ( 12)
82
STATISTICAL TESTS (d)
INCIDENTAL TUMOR TEST COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P=0. 156N P-0. 106N P=0.097N
P-0.344N
P=0.323N P=0.272H
P=0.328H P=0.572N P=0.215N P=0.473H
P=0.24ftH P=0SOON
P-0.346N P-0.600N P=0.288H P=0.612N
P=0.252N P0 SOSN
P=0.004 P-0.002 Pc0.006
P=0.027
P-0.020 P-0.037
(a) P-0.S23N ta) P=0.469N
P=0.022
P-0.078 P=0.012 P=0.059
(a) P-0.028 Ps0< SOON____ P=Q.H2___
HEMATOPOIETIC SYSTEM LEUKEMIA, NOS
mflQS-BAIES OVERALL (a) ADJUSTED 1b) TERMINAL (c) FIRST INCIDENCE (HEEKS)
2/50 ( 5. IX
0/24 ( 70
4) 0)
0/50 1 0) 0. OX
0/21 ( 0)
0/50 ( 0) O.OX
0/13 ( 0)
0/49 ( 0) O.OX
0/16 1 0)
0/50 ( 9) O.OX
0/26 ( 0)
1/50 ( 2.2X
0/23 < 65
2) 0)
0/50 ( 0) O.OX
0/26 ( 0)
3/50 < 6: 12.OX
3/25 C 12: 104
ffliW-'TM5 M
INCIDENTAL TUMOR TEST COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P0.156N P*0.106N P*0.097N
1 a)
(a) ta)
P=0.328N la) P-0.21SN ()
P=0.346N (a) P=0.288H ta)
P=0.248N
P=0.252N
la)___________ ta)_________
P-0.034 P=0.034 P-0.937
P*0. 165
P=0.211 P=0. 176
() P-0.523N (a) P-0.469N
P=0.112 P=0.292 P=0.112 P=0.365
(a) P-0. 121 _EzILSHflH____ Ps0.30___
SL 035641
IMTERCURREHT MORTAL ITV ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP JOS'
RI-OIUM
RI-01VH
RI-01LM
RI-tIHM
RI-01UF
RI-D1VF
PACE)
5
VERSION: 1I/1S/04T
RUN DATE* 02/20/05
RI-B1LF
RI-01HF
MALE
FEMALE
DOSE IN GM/KO______________ _________ LI_____________LL___________ u___ ___ :_____ lj_____ _________ LJ___ _________LL____________ U
HEMATOPOIETIC SYSTEM ALL LYMPHOMAS ALL LEUKEMIAS
_________ 1.
TUHOtt BATES OVERALL (a) ADJUSTED (b) TERMINAL tc> FIRST INCIDENCE (HEEKS)
S/50 ( 7.2X
0/24 ( 64
6) 0)
1/50 ( 3. OX
0/21 ( SO
2) 0)
1/50 C 6.2X
0/13 (
100
2) 0)
2/49 f 10.7X
1/16 t 07
41 6)
0/50 ( 0) O.OX
0/26 ( 0>
1/50 1 2.2X
0/23 ( 65
2) 0)
2/50 (
6.9X 1/26 (
100
4) 4)
5/50 ( 10.2X
3/25 I 02
STATISTICAL tfeSTS Id)
INCIDENTAL TUMOR TEST COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
KIDNEY HOS ALL TUMORS
P=0.506N P-0.S20N P-0.407N
P=0.257
P=0.202 Ps0.372
P-0.450N P=0.660 P=0.312N
P=0.692
Ps0.666 P=0.361 Ps0.620N P-0.330
P=0.309N
P=0.5 ION
Pg0753N____ P=0.492____
P=0.011 Px0.003 P=0.016
PxO.046
P=0.019 P=0.060
Ps0.243 P=0.509 P-0.191 P=0.450
Px0.247 _pai jh
Px0.022 PsO.070 Px0.012 Px0.059
P=0.020 PgQ.102
ADJUSTED <b) TERMINAL (c> FIRST INCIDENCE CHEEKS)
aUMMtfIB,i
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
era
f o
W cn O'
>to
0/50 ( 0)
O.OX 0/24 ( 0)
0/50 ( 0) O.OX
0/21 < 0)
3/50 f 16.5X
1/13 ( 09
6) 0)
1/49 ( 6.2X
1/16 ( 104
2) 6)
P=0.251 Px0.239 P=0.372
Px0.260
P=0.259 Px0.372
P=0.054 P=0.050 P=0.096 P=0.104
P=0.121 P=0.121
P=0.419 P=0.446 Px0.4 19 Px0.446
P=0.495 P=0.495
.
0/50 1 0)
o.ox
0/26 ( 0)
1/49 ( 4.3X
1/23 ( 194
2) 4)
4/40 ( 13.6X
2/26 C 92
0) 0)
0/50 ( 0) O.OX
0/25 ( 1)
P=0.575 P=0.422 P=0.621
Px0.390N
P=0.570N P=0.304N
P=0.060 Px0.210 Px0.034 Px0.123
Px0.054 PSL 174
(a) P=0.403H (a) P-0.403N
(a) P=Q.4N
tl
SL 035643
INTERCURREHT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CUDS CONTRACT* 400244 PAPANICOLAOU
CHEMICAL*
C04546 TRICHLOROETHYLENE
GROUP IDS*
RI-01UM
RI-01VM
RI-OILM
RI-OIHM
RI-01UF
RI-01VF
PAGE*
4
VERSION* 11/13/84T
RUN DATE* 02/20/85
RI-SILF
RI-0INF
MALE
FEMALE
DOSE IN GM/KG______________ _________ 1*2___________ SLJL___________ 0.5
KIDNEY NOS TU8ULAR-CELL ADENOMA TUBULAR-CELL ADENOCARCINOMA
_________ 1*1_____ _________ 1*1___ _________1*1_____________ Li___ _________ 1*1_____
TUMOR RATES OVERALL (a) ADJUSTED (b> TERMINAL <c> FIRST INCIDENCE (HEEKS)
HAllMlW. IlSLl.idl LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
PITUITARY ADENOMA, NOS
0/50 ( 0) O.OX
0/24 t 0)
P=0.252 P-0.248 P=0.355
0/50 I 0) O.OX
0/21 ( 0)
Ps0.274 P=0.271 P=0.355
2/50 ( 12.6X
1/13 C 92
4) 8)
P=0.129 P=Q. 141 P=0. 186 P=0.201
P=0.247 P=0.247
1/49 C 2)1
6.2X
I
1/16 ( 6)1
L104
T
P=0.419 1
P=0.446 P=0.419
I 1
P-0.446 1
1
_LP=0.495
Ps0,4?S
!
0/50 t 01
o.ex
0/26 ( 01
Ps0.575 P=0.422 P=0.621
1/49 (
4.3X 1/23 ( 104
2) 4)
4/48 ( 13.6X
2/26 ( 92
8) 8)
P=8,390N
P=0.570N P=0.384H
P**0.060 P-0.210 P-0.034 P-0.123
P-0.054 _ P*B,. 171
0/50 ( 0) O.OX
0/25 ( 0)
(a) P-0.483N (a) P*0.483H
(a) P=0.495H
TUMOR RATES
OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (HEEKS)
15/46 ( 33) 54.6X
11/23 ( 48)
92
23/44 ( 52) 70.3X
12/21 ( 57) 50
6/41 ( 15) 32.6X
2/11 ( 18) 78
4/41 ( 10) 26.7X
4/15 ( 27) 104
42/49 ( 86)
97.7X 25/26 (96)
65
32/49 ( 65) 83.9X
17/23 ( 74) 80
26/47 ( 55) 76. OX
18/26 ( 69) 78
18/43 ( 42) 66.6X
16/25 ( 64)
87
STATIST!Cftl TESTS. _ld) LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P=0.044N P*0.040H P-0.005N
P<0.00 IN P<0.00 IN P<0.00 IN
P=0.336N P=Q.0J8H P=0.2 I5N P=0.005N
P=0.043N P<0.001N____
P=0.049N Pr0.002N P-Q.056N P<0.001H
P-0.009N P<0.00 IN
P<0.00 IN P<0.00 IN P<0.00 IN
P*0.005N P*0.144N P*0.016N
P-0.007N P**0.116H
P-0.806N P-0.441N
P<0.00 IN P=0.007N Ps0.002N P-0.216H
P=0.002N
P<0.00 IN
--P.El*2J5M -- P=Q,Q2H.-
It
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT* 600244 PAPANICOLAOU
CHEMICAL*
C04546 TRICHLOROETHYLENE
GROUP IDS*
RI-61UH
RI-81VM
RI-D1LM
RI-OIHM
RI-OIUF
RI-D1VF
PAGE*
5
VERSION* 11/13/041
RUN DATE* 02/20/85
RI-81LF
RI-D1HF
HALE
POSE IN CM/KG______________ _________ U______ _____ ILJt________ -JLS_____ ______ U_____
PITUITARY CHROMOPHOBE ADENOMA
IMHgft RATES OVERALL ta) ADJUSTED tb) TERMINAL (c> ' FIRST INCIDENCE CHEEKS)
STATISTICAL TESTS Cdl LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARHITAGE TREND FISHER EXACT TESTS
PITUITARY CARCINOMA, NOS
1/46 t
2. IX D/23 t
62
2) D>
0/44 ( 0> Q.OX
0/21 ( 0)
1/41 ( 3.4X
0/11 ( 71
2) 0)
0/41 ( 01
o.ox
0/15 1 0)
P*0432N P*0-299N P-0.358N
P-0.658
P=0.697N P=0.720
P=0.687 P=0.426 P=0.738N P=0.557
P=0.723 P=0.482_____
P-0.59SN (a) P30.473N ta)
P=0.529N t>_________
TUMOR RATES OVERALL ta)
ADJUSTED (b)
TERMINAL (c) FIRST INCIDENCE CHEEKS)
0/46 ( 0) 0. OX
0/23 C 0)
3/44 t ' 7 ) 14.3X
3/21 ( 14) 104
0/41 ( 0)
O.OX 0/11 ( 0>
0/41 t 0) O.OX
0/15 ( 0)
STATISTIC^ TEST? tdJ LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAH-ARMITAGE TREND FISHER EXACT TESTS
(a) (a) (a)
P*0.074N
P-0.074H P=0.042N
ta) P-0.252H
ta) P=0.252N
ta) P30.ISSN
fa) P30. 183N
ta) ta) P=0. 134H____ P=0. 154M ..J
FEMALE D.i____ ________ L!_____________u______ ______ u_____
0/49 ( 0) O.OX
0/26 ( 0)
3/49 ( 6.4X
0/23 I 48
6> 0>
0/47 ( 0) O.OX
0/26 < 0)
0/43 ( 0> O.OX
0/25 ( 0)
ta) ta) ta)
PM.062N
P=0.150N
P*0.197N
ta) ta) (a)
P=0.01SN
P30.058N
Ps0.853N
fa) Ps0.044N
ta) (a)
_..g.122H____ P=i.147H
0/49 t 0) O.OX
0/26 C 0)
0/49 t 0) O.OX
0/23 C 0)
0/47 ( 0) 0. OX
0/26 C 0)
0/43 f 0. OX
0/25 (
ta) ta) (a) fa) ta) ta)
(a) ta) (a) (a) ta) ta)
ta) (a) ta) ta)
. - -- -taL. .
W r
o
LO
II
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS:
RI-01UM
RI-01VM
RI-01LH
RI-OIHH
RI-01UF
RI-11VF
PAGE:
6
VERSION: 11/13/84T
RUN DATE: 02/20/85
RI-01LF
RI-01HF
MALE
PPSUH CM/KQ____________ ________ILJ__________9UI________
PITUITARY ADENOMA, NOS CARCINOMA, NOS
8.5
FEMALE
_____LJ____ ________LA__________LA___________LA__________LJ____
TUMOR RATES OVERALL (a) ADJUSTED (b) TERMINAL (c> FIRST INCIDENCE (MEEKS)
-- - STATISTICAL TESTS LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND CO FISHER EXACT TESTS t-*
ADRENAL CORTICAL ADENOMA
15/46 ( 33) 54.6X
11/23 ( 48) 92
26/44 ( 59) 80.2X
15/21 C 71) 50
--
P=0.044H P-0.040N P-Q.Q05N
PC0.00IH
P<0.00 tN P<0.00 IN
6/41 ( 15) 32.6X
2/11 ( 18) 78
P=0.336N P=0.013N P=0.215N P<0.00 IN
P=0.043N _.p.<g jqih____
4/41 ( It) 26.7X
4/15 ( 27) 104
P=0.049N P<0.00 IN P=0.056N P<0.00 IN
P=0.009N
42/49 ( 86) 97.7X
25/26 ( 96)
65
32/49 ( 65) 83.9X
17/23 ( 74) 80
26/47 ( 55) 76. OX
18/26 ( 69)
78
18/43 ( 42) 66.6X
16/25 ( 64)
87
P<0.00tM P<0.BO IN P<0.00 IN
P-0.005N
P=0. 144N P-0.016N
P=B.007N P-0.116N P=0.006N P=0.44 IN
P<0.001N
P=0.007N P=0.002N P-0.216N
P=0.002N
P<0.00 IN
P=Q215M____ P=0J2QH_
TUMOR RATES OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
6/49 ( 12)
23.5X 5/24 (21)
93
5/50 ( 10)
20. OX 3/21 ( 14)
83
3/49 ( 6)
20.4X
2/13 ( 15) 99
5/47 ( II) 29.4X
4/16 ( 25) 99
4/50 ( 8) 14.OX
3/26 ( 12) 94
6/48 ( 13) 22.4X
4/23 ( 17)
96
6/48 ( 13)
23. IX 6/26 ( 23) 104
5/50 ( 10) 20. OX
5/25 ( 20) 104
STgTI$TKAl TESTS (d>
INCIDENTAL TUMOR TEST COCHRAH-ARMITAGE TREND FISHER EXACT TESTS
P=0.408 P=0.382 P=0.458N
P=0.356
P=0.271 P=0.533
P=0.589N P=0.627N P=0.572N
P=0.633N
P=0.464
P=0.4 14 P=0.436 P=0.333
Ps0.243H
P=0.530N
P=0.369N____ Ps0.589
P=0.393 P=0.335 P=0.434
Ps0.40 IN
P-0.520N P*0.409N
P=0.361 P=0.550N P=0,338 P=0.604N
P=0.455 P=0.480N P=0.356
Ps0.599
P-G.344
P=0.500
P=0.<21H____ Ps0.47 IN
035645
II
IHTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
GROUP IDS:
C04546 TRICHLOROETHYLENE
RI-01UH
RI-01VM
RI-01LM
RI-01HM
RI-01UF
RI-01VF
PAGE:
7
VERSION: 11/13/84T
RUN DATE> 02/20x85
RI-01LF
RI-OIHF
DOSE IN GM/KG
ADRENAL PHEOCHROMOCYTOMA
mMPB.BAIS OVERALL (a) ADJUSTED (b> TERMINAL <c> FIRST INCIDENCE (MEEKS)
STATISTICAL tEST$ tti) LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARHITAGE TREND FISHER EXACT TESTS
ALL ADRENAL SITES PHEOCHROMOCYTOMA
TUMOR RATES OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
mw^11 wi
INCIDENTAL TUMOR TEST
COCHRAN-ARHITAGE TREND FISHER EXACT TESTS
MALE 0.0 0.0 0.5 1.0
FEMALE 0.0 0.0 0.5
1.0
15/49 ( 31) 59.7X
14/24 ( 58) 93
10/50 ( 20) 41.OX
7/21 ( 33) 97
5/49 ( 10) 33.9X
4/13 ( 31)
89
2/47 ( 4)
12.5X 2/16 ( 13) 104
P-0.003N P30.0B2N P<0.001H
P-0.059H
P-0.053N P30.012N
P=0.162N P=0.455N P-8.14BN P=0.46BN
P=0.011N P=0.140H___
P-B.004H P30.B49N P30.004H P=0.073N
P=0.001N Pc0.019N__
6/50 ( 12) 20.5X
4/26 ( 15)
94
9/48 ( 19) 33.2X
6/23 ( 26)
92
2/48 ( 7.7X
2/26 (
104
4) 8)
0/50 ( 0) O.OX
0/25 ( 0)
Ps0.009N P=0.018N P=0.008N
p<o.ooih
P-0.00IN P<0.00 IN
P30.137N P-0.019N P30.170H P-0.034N
P-0.148N P30.026H___
P30.02SH P30.003N P30.059H P30.009H
P=0.014N P=0.00 IN
16/49 ( 33) 63.7X
15/24 ( 63) 93
10/50 ( 20) 41.OX
7/21 ( 33) 97
P30.001N P30.001N P<0.00 IN
P30.03.9N
P=0.053N P=0.012N
5/49 ( 10)
33.9X 4/13 ( 31)
89
2/47 (
12.5X 2/16 ( 104
4)1
I 13)1
I
6/50 ( 12)
20. SX
4/26 ( IS) 94
P=0.115H P=0.455N P=0.098H P=0.460N
P=0.006N P=P.14DH____
P=0.002N
P30.049N P30.002N P30.073N
P<0.00 IN
P=MH?H
| I
| I..
P30.009N P30.018N P=0.008N
9/48 ( 19) 33.2X
6/23 ( 26) 92
P<8.00IN
P-O.OOIN P<0.00 IN
2/48 ( 7.7X
2/26 ( 104
4) 8)
P=B.137H P=0.019N P=0.170H P30.034H
P=0. 148N P=8.026M
0/50 ( 0) O.OX
0/25 ( 0)
P30.025N P=0.003N P30.059N P30.009N
P30.014N P3O.OB1H
gSfcO
ID l*
P O'
II
SL 035647
INIERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
GROUP IDS:
CQ4546 TRICHLOROETHYLENE
RI-01UM
RI-01VM
RI-01LM
RI-DIHtt
RX-01UF
RI-01VF
PAGE*
8
VERSION: 11/13/84T
RUN DATE: 02/20/85
RI-OtLF
RI-01HF
MALE
POSE. IH CrVKQ__________ _________ UP_____________!L_e_________ US__ _________ 1.
ALL ADRENAL SITES PHEOCHROMOCYTOMA PHEOCHROMOCYTOMA, MALIGNANT
FEMALE
-_______ Ul___ ______ UL_________US__ _______Ul___
TUMQB BATES OVERALL (a)
1 |
ADJUSTED <b>
TERMINAL <c>
1
FIRST INCIDENCE (HEEKS) |
1
STATIST1CALTESTS--idt I
LIFE TABLE
|
INCIDENTAL TUMOR TEST 1
I COCHRAH-ARMITAGE TREND j
_FI_SH_E_R_E_X_ACT TE_ST_S____L
16/49 t SSI 63.7X
15/24 < 63) 93
P=0.004N
P=0.064N
PC0.001N
THYROID C-CELL ADENOMA
10/59 ( 201 41. OX
7/21 ( 33) 97
6/49 ( 12) 41.3X
5/13 ( 38) 89
1 3/47 ( 6)1
18.7X
1
3/16 ( 19)
104 |
P=0.090N
P=0.119N P=0.033N
*
P-0.211N P-0.602N
P=0.184H P=0.6 ION
P-D.006N
P=0.104N P=0.007N P=0. 150N
I
| | j
P=0.014N
P=0.002N
_frO l22QN____ Ps0.046H 1
6/59 { 12) 20.5X
4/26 ( 15) 94
9/48 ( 19) 33.2X
6/23 1 26) 92
2/48 ( 7.7X
2/26 ( 104
4) 8)
0/50 ( 0) o.ex
0/25 ( 0)
PSB.009N P=0.018N P=0.008N
P<9.00 IN P-0.00 IN P<0.01IN
P=0.137N P-0.019N P=0.170N P-0.034N
P=0.025N
P-0.003H P=0.0S9N P-0.009N
P=0.148H
P=0.014H
P=Q.P26N___ PS0.001N
TUMOR. BATES OVERALL ta)
ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (HEEXS)
3/49 ( 6)
13.OX 3/23 ( 13) 104
7/46 C 15) 27. IX
4/21 ( 19) 78
0/44 ( 0) 0. OX
0/13 ( 0)
0/45 ( 0) O.OX
0/16 ( 0)
0/50 ( 0) O.OX
0/26 ( 0)
0/49 ( 0) O.OX
0/23 ( 0)
3/49 ( 6) 12.OX
3/25 ( 12) 104
1/50 (
4.OX 1/25 ( 104
2) 4)
STATISTICAL TESTS (d) tlFE TABLE
INCIDENTAL TUMOR TEST
COCHRAH-ARMITAGE TREND FISHER EXACT TESTS
P=0.074N P=0.074N P=0.044N
P=0.005N P=0.005N P=0.00 IN
P=0.255N P=0.04 IN P=0.235N P-0.035N
P=0.142N P=0.007N
P=0.189N P=0.030N P=0.189N P=0.030N
P-0. 138N P=0.007H
P-0.365 P*0.365 P=0.379
P-0.403
P^o.403 P*0.385
P=0.112 P=0.134 P=0.112 P=0. 134
P*0.117 Ps0.121_____
P=0.492 P=0.517 P=0.492 Ps0.517
P=0.500 P=0505
il
INTERCURRENT MORTALITY AOJUSTEO TUMOR INCIDENCE ANALYSIS FOR RATS
CUDS CONTRACT* 400244 PAPANICOLAOU
CHEMICAL:
C04544 TRICHLOROETHYLENE
GROUP IDS:
RI-OtUN
RI-OIVM
RI-01LM
RI-01HM
RI-OIUF
RI-01VF
PAGE*
9
VERSION: 11/13/84T
RUN DATE' 92/20/*5
RI-OILF
RI-01HF
MALE
DOSE IN CM/KO______________ ________HJ__________fij________
THYROID C-CELL ADENOMA C-CELL CARCINOMA
0,5______ _____LJ____ ________i.D
OVERALL*!#!
ADJUSTED (b) TERMINAL (c> FIRST INCIDENCE (HEEKS)
STATISTICAL TESTS (d! LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
PANCREATIC ISLETS ISLET-CELL ADENOMA
IDMOR RATES
OVERALL () ADJUSTED (b) TERMINAL (c> FIRST INCIDENCE (HEEKS)
STATISTICAL TESTS (d) LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
5/49 ( 6! 15.OX
5/23 ( 15)
104
0/44 ( 17) 31.4X
5/21 ( 24) 78
0/44 ( 0) O.OX
0/13 ( 0)
0/45 I 0)
o.ox
0/14 ( 0)
P=0.074N P-O.074H P=0.044N
P=0.003N
P=0.003N P<Q.001N
P=0.235N P=0.027H
P=0.235N P=0.023N
P=0. I89N P=0.0 ION P=0. 189N
P=0.0 ION
P=0. 142N
P-O.130N
-CliLJOitM___ Pg0.0Q3H
0/50 ( 0) O.OX
0/24 ( 0)
P-0.375 P*0.575 P=0.391
5/49 ( 10) 19.OX
4/24 ( 17) 101
5/50 ( 10) 22. OX
4/21 ( 19) 99
0/49 ( 0)
O.OX 0/13 ( 0)
1/40 ( 4.2X
1/14 ( 104
2) 4)
P=0. 103N P=0.105H P-0.038N
P=0.079N
P-0.094N P=0.040N
P=0.11 IN P=0.088N P=0.104N P=0.090N
P=Q. 020N P=0030N--
Ps8.223N P-O.18 IN P-0.232N P-0.210N
P=0.107N P=0. 112N
1/50 ( 3.4X
0/24 ( 103
2) 0)
P*8.422 Ps0.404 P=0.428
FEMALE
l___________1*5_____
l-i____
0/49 ( 0)
O.OX 0/23 ( 0!
4/49 C 0) 14. OX
4/25 ( 14! 104
1/50 ( 4.OX
1/25 I 104
2) 4)
P*0.418
P=0.418 P-0.390
P-O.054 P=0.071
P-0.054 P-0.071
P-0.492 P-0.517 Ps0.492 Ps8.517
P-O.054
P-0.500
..Pt*13>_____ PeQ.MA.
0/49 ( 0) O.OX
0/23 ( 0)
1/40 (
3.OX 1/24 ( 104
2) 4)
1/40 ( 4. OX
1/25 (
104
2) 41
P*0.347
P0.347 P*0.327
P=0.752 P=0.524 P=0.7 11 P=0.524
P=0.742
Pso.4
Ps0.744 Ps0.517 P-0.551 P=0.517
P=0.742
PiTt.W
CO
035648
II
SL 035649
INTERCURRENT MORTALITY ADJUSTED TUMOR IKCIDEHCE ANALYSIS FOR RATS
CODS CONTRACT* 600244 PAPANICOLAOU
CHEMICAL*
C04546 TRICHLOROETHYLENE
GROUP IDS*
RI-01UM
RI-01VN
RI-01LM
RI-01HM
MALE
BOSE IH
______________ _________ o.o
______ JLJ__________ 0.5_____________ LJ_____
PANCREATIC ISLETS
ISLET-CELL ADENOMA ISLET-CELL CARCINOMA
IW1QR RATES
OVERALL(a) ADJUSTED (b)
TERMINAL (c) FIRST INCIDENCE (MEEKS)
5/49 ( 10)
19.OX 4/24 ( 17) 101
5/50 ( 10)
22. OX 4/21 ( 19)
99
0/49 ( 0)
O.OX 0/13 ( 0)
1/48 (
6.2X
1/16 ( 104
2) 6)
STATISTICAL tESTS Id) LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
MAMMARY GLAND ALL TUMORS
P'O. 10SN P-0.105N
P=0.038N
P=0.079N
P-0.094N P-0.040N
P=0.111N P-0.088N P=0.104N P=0.098N
P-0.223H P-0. 18 IN P-0.232H P=0.2 ION
R=0.028N
P=0. 107N
Pr0030H____ P*0.112H
TUMPR. RAIES OVERALL (a)
ADJUSTED (b)
TERMINAL (c) FIRST INCIDENCE (MEEKS)
1/50 ( 4.2X
1/24 ( 104
2) 4)
1/50 ( 4.2X
0/21 ( 103
2) 0)
1/50 ( 5.3X
0/13 ( 92
2) 0)
1/49 ( 6.2X
1/16 (
104
2) 6)
SJgI3ITCAL TESTS Id)
INCIDENTAL TUMOR TEST COCHRAN-ARHITAGE TREND FISHER EXACT TESTS
P=0.507 P=0.511 Ps0.634
P=0.520
P=0.462 P-0.634
P=0.633 P=0.633 P=0.7 11
P=0.692
P=0.670 P-0.683 Ps0.670
P=0.609
P=0.753N
P=0.748
P=,Z5SH____ Ps0.748.
RI-01UF
RI-01VF
PAGE*
10
VERSION* 11/13/84T
RUN DATE* 02/20/05
RI-01LF
Rl-OIHF
o.o______
FEMALE >0_____________U______
1.0_____
1/50 (
3.4X
0/26 (
103
2) 0)
0/49 ( 0)
O.OX
0/23 ( 0)
2/48 (
7.7X
2/26 (
104
4) 8)
1/48 ( 4. OX
1/25 (
104
2)
4)
Ps0.604 P-0.483 P=0.609
P-0.380
P-0.380 P*0.355
P=0.492 P=0.265 P=0.448 P-0.265
P=0.484 P9.242
Psfl.744 P=0.517 P=0.551 PE0.517
P=0.742 P=e,495
17/50 ( 34) 44.9X
6/26 ( 23) 80
17/50 ( 34) 45.7X
5/23 ( 22) 48
12/50 ( 24) 38. IX
7/26 ( 27) 86
5/50 ( 10) 1S.2X
4/25 ( 16) 56
Ps0.013N P-0.113H P-0.003H
Ps8.008N
P*0.06 IN P=0.003N
P30.252N P=0. ISSN
P=0.51 IN P-0.440N
P**0.019N P=0.013N P=0. 162N
P=0.058N
P-0. 189N
P=0.804N
PfB.
____ P=0.004N
il
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT: 00244 PAPANICOLAOU
CHEMICAL:
GROUP IDS:
C04546 TRICHLOROETHYLENE
RI-B1UH
RI-01VH
RI-01LM
RI-OtHM
RI-01UF
RI-01VF
PAGE<
11
VERSION: 11/15/84T
RUN DATE> 02/20/85
RI-01LF
RI-01HF
HALE
POSE IN QfVKC______________ _________ 1LJ_____________!LJL___________ 8.5
MAMMARY GLAND ADENOMA, NOS
FEMALE _________ LJ_____ _________ LJ___ _________LI____________ L5___ _________ U_____
IM.HOR BATES OVERALL (a) ADJUSTED (b) TERMINAL (c> FIRST INCIDENCE (MEEKS)
STATISTICAL TESTS (d) LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
MAMMARY GLAND FIBROADENOMA
0/50 ( 0) O.OX
0/24 ( B)
PM.223 PM.223 PM. 266
O/SB ( 0) O.OX
0/21 ( 0>
0/50 ( 0) 0. lx
0/15 ( 0)
PM.241
P=0.241 PM.266
.
(a) (a) (a) (a)
(a) -Ul-
1/49 ( 6.2X
1/16 ( 104
2> 6)
P-0.419 PM .446 P=0.419 PM .446
PM.495 PM495
5/50 ( 8.2X
0/26 (
92
6) 0)
4/50 (
12.5X 1/25 <
72
8) 4)
4/50 ( 8) 14.4X
5/26 < 12) 100
0/50 ( 0) O.OX
0/25 ( 0)
P-0. 160H P=0.569N PM.11SN
PM .B69N
PM. 135N PM.06ON
PM .483
PM.612N PM. 345 PM.562
PM.185N
PM.090N P=0.500N P=0.132N
Ps0.500
PM. I22N
PM.643H____
JUHOB BATES OVERALL (a) ADJUSTED (b) TERMINAL (c> FIRST INCIDENCE (MEEKS)
1/50 ( 4.2X
1/24 ( 104
2) 4)
1/50 ( 4.2X
0/21 ( 103
2) 0)
0/50 ( 0) O.OX
0/13 ( 0)
0/49 ( 0) O.OX
0/16 ( 0)
13/50 ( 26) 38.2X
6/26 < 23) 80
10/50 ( 20) 33. IX
4/25 ( 17) 86
8/50 ( 16) 25.9X
4/26 ( 15) 86
4/50 ( 8) 14.3X
3/25 ( 12) 56
LIFE TABLE TE5TS
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P=Q.542H P-0.542H P=0.272H
P-0.342N
P-0.436N P-0.272N
P-0.622N P=0.622N P=0.622N P-0.662N
P=0.500H P=0.500H
P=0.58 IN PM. 58 IN P=0.58 IN P=0.718N
PM. 505N PM. 505N
P-0.028N PM. 145N PM.011N
PM. 072N
PM.356N PM.060N
PM.207N PM.353N PM.375N
PM. 56 3
PM. 039N PM.090N
PM. 194N PM.385N
PM. 163H
PM.016H
PM. 39BH____ -PfLP74M
SL 035650
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
CROUP IDS*
RI-01UH
RI-01VM
RI-01LH
RI-01HM
RI-01UF
RI-OIVF
PACE:
12
VERSION: 11/13/841
RUN DATE* 02/20/85
RI-01LF
RI-01HF
DOSE IN GH/KO______________ _________ .o
TESTIS NOS INTERSTITIAL-CELL TUMOR
HALE
FEMALE
______ U__________ ,,-l,i____ _______ LJU____ _________ U______ ______ LA____________ L3______ _____ LJ------
TUMOR RATES OVERALL (aI ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
STATISTICAL TESTS
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
30/50 ( 72) 97.2X
23/24 ( 94)
06
34/50 ( 68) 97. IX
20/21 ( 95) 73
30/50 ( 00) 96.7X
12/13 ( 92) 05
.242 P8.249 P-0.0S3N
--
P'O.279
Pa0.129 Pa8.07SN
Pa0.041 P=0.049 P=0.133 P=0.055
P=0.140N P*=0 207N
20/49 ( 53)
100.OX 10/10 (100)
00
Ps0.339 P=0.385 P-0.288 P=0.179
-- ----------------------
P=0.04 IN Ps0.094H
-------------------
TESTICULAR SITES INTERSTITIAL-CELL TUMOR
TS9S0
r*
TUMOR RATES OVERALL (a)
30/50 ( 72) 34/50 ( 08) 30/50 ( 00) 20/49 ( 53)
ADJUSTED (b)
97- ZX
97. IX
96.7X
too.OX
TERMINAL (c)
23/24 ( 90) 20/21 ( 95) 12/13 ( 92) 10/10 (100)
FIRST INCIDENCE (MEEKS)
00
73
05 00
HtftiiEP
ld>
INCIDENTAL TUMOR TEST
C0CHRAN-ARH1TAGE TREND FISHER EXACT TESTS
Pa0.242 Pa0.249 P=0.033H
P=0.279
P=0. 129 P=0.078N
P=0.041 P*0.049 P=0.I33 P>0.055
P=0.146N P=0.267H___
P=0.339 P=0.385 P-0.288 P=0.179
P=0.04 IN
i
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT' 600266 PAPANICOLAOU
CHEMICAL'
GROUP IDS'
C06566 TRICHLOROETHYLENE
RI-01UN
RI-01VH
RI-01LM
RI-01HM
POSE IN GH/RC______________ _________ Q.JI______
TESTICULAR SITES INTERSTITIAL-CELL TUMOR INTERSTITIAL-CELL TUMOR, MALIGNANT
MALE . 0
0.5
1.0
IIMBR..BAIES OVERALL fa) ADJUSTED (b) TERMINAL (c> FIRST INCIDENCE (HEEKSI
STATISTICAL TESTS Id) LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
36/SO ( 72) 97.2X
23/2A ( 96) 66
36/50 C 60) 97. IX
20/21 ( 95)
73
30/50 ( 60) 96.7X
12/13 ( 92)
65
26/69 ( 53) 100.OX
16/16 (100) 66
Ps0.262 P-0.269 P-0.033N
P=0.279
P=0. 129 P-0.078N
P=0.061 P-0.069 P=0. 133 P-0.055
P=0.166N
P*0.339 P*0.385 P=0.286 P*0.179
P-0.06 IN
UTERUS NOS ENDOMETRIAL STROMAL POLYP
TMQR BATES OVERALL fa) ADJUSTED (b) TERMINAL <c> FIRST INCIDENCE (MEEKS)
HHW ,t815 ""
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
RI-01UF 0.0
RI-01VF
PAGE'
13
VERSION' 11/13/861
RUN DATE' 02/20/85
RI-01LF
RI-01HF
FEMALE 0.0
0.5
1.0
/
1/50 (
3.OX 1/26 ( 106
2) 6)
3/69 ( 6) 13.OX
3/23 ( 13)
106
0/68 ( 0)
O.OX 0/26 ( 0)
0/69 ( 0) O.OX
0/25 ( 0)
P"0.275N P=0.275N P-0.273N
P0.030N
PC0.030N PS0.036N
P=0.SOON P-0.098N P-0.500N P*0.098N
P-0.510N Ps0.125H
P-0.508H P=0.105H P30.508N P-0.105N
P=0.505N - P*0.121H
cn
IT*
035652
ft
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CUDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS:
RI-01UM
RI-01VN
RI-01LM
RI-01HH
R1-01UF
RI-01VF
PAGE:
1*
VERSION: 11/13/84T
RUN DATE: 02/20/85
RI-01LF
RI-01HF
DOSE IN GH/KG
0.0
UTERUS NOS ENDOMETRIAL STROMAL POLYP
ENDOMETRIAL STROMAL SARCOMA
MALE 0.0
0.5
1.0
FEMALE 0.0 0.0 0.5
1.0
IUtlOBL BATES OVERALL (a) ADJUSTED (b) TERMINAL (c> FIRST INCIDENCE (MEEKS)
STATISTICAL TESTS (d) Life table
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
1/50 2) 3/49 ( 6 >
3.8X
13. OX
1 1/26 ( 4) 3/23 ( 13)
1 104
104
r
P=0.275N
j P=0.275N
| P-0.273H
P=0.030N
P=0.030H P=0.038N
a) Number of tumor-bearing animals/number of animals examined at the site (percent).
b) Kaplan-Meier estimated lifetime tumor incidence after adjusting for intercurrant mortality. c) Observed tumor incidence at terminal kill. d) Beneath the control incidence are the P-values associated with the trend test.
Beneath the dosed group incidence are the P-values corresponding to pairwise
comparisons between that dosed group and the controls. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test reqards these lesions as non-fatal. The Cochran-Armitaqe and Fisher's exact tests compare directly the overall incidence rates. A neqative trend is indicated by N.
e) Differences not significant! no tumors observed in dosed group or control group.
0/48 ( 0) O.OX
0/26 ( 0)
0/49 ( 0) O.OX
0/25 ( 0)
Pz0.500N P=Q.098N P=0.500N P-0.09SN
P=0.508N P=0.105N
P=0.508N P-0.105H
P=0.510N
P=0.505N
P=g,125H____ P=?i 12*W ..
SL 035653
FINAL ^
ficr
INTERCURREHT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
GROUP IDS'
C04546 TRICHLOROETHYLENE
RC-0 IUM
RC-OIVM
RC-OILM
RC-OIHM
SURVIVAL AT MINIMUM TERMINAL SACRIFICE(MEEK)
39/50
78X 104
38/50
19/50
76X
38X
_____ 1H4_____________ 104_______
11/50 22X
104
HALE
POSE IM gH'KQ______________ _________ Ul_____________00
ALL TOPOGRAPHIES ALL TUMORS
_________L5_____________ U_____
fruHOR RATES OVERALL la) ADJUSTED (b)
TERMINAL (c> FIRST INCIDENCE (MEEKS)
45/49 ( 92) 97.OX
38/39 ( 97) 70
44/50 ( 88) 100.OX
38/38 (100) 50
27/49 C 55)
100.OX
19/19 1100) 53
17/50 ( 34) 100.OX
11/11 (100)
75
SjAjlStlfAl, TESTS (d)
INCIDENTAL TUMOR TEST COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P30.030 P30.574 P<0.00 IN
P=0.040
P=0.285N P<0.00 IN
P30.086 P=0.109 P=0.622 P=0.469N
P<0.001H P<0.00 IN____
P30.054 P=0.063 P30.667 P=0.366N
P<0.001N P<0.00 IN
HEMATOPOIETIC SYSTEM ALL TUMORS
ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
HMW im> ,di
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
2/49 (
4.6X 0/39 (
81
4) 0)
3/50 ( 7.2X
1/38 ( SO
6) 3)
1/49 ( 5. OX
0/19 (
102
2) 0)
0/50 ( 0) O.OX
0/11 ( 0)
P=0.397N P=0.283N P=0.t39N
P=0.246N
P30. I05N P30.06 IN
P=0.720N P=0.528N P=0.614N P=0.257N
P=0.500N
P30.527N P=0.384N P=0.428N P30.423N
P=0.243N P=0. 122H
RC-0IUF
5775?
74X 184
RL:CU.P.
RC-01VF
PAGE'
1
VERSION: 11/13/84T
RUN DATE1 02/20/85
RC-0 UF
RC-01HF
35/56
26/56
7 OX 40X
_____ 104_______ _____ 104_______
19755
38 X 104
FEMALE
0.0___ _________9,S..
0.5 _________ i.o
34/49 ( 69) 75.5X
26/37 ( 70) 54
32/50 1 64) 74. OX
24/35 1 69) 51
21/50 ( 42) 76.9X
14/20 (70) 68
18/46 ( 39) 77.5X
14/19 ( 74) 28
P30.483 P=0.203M P=0.002N
P30.464
P=l.26SN P=0.009N
P30.386 P=0.369 P30.190N P0.193N
P=0.006N P=0.025H
P30.564 P30.558 P30.279H P=0.283H
P30.003N P=0.0*5N
3/49 ( 7.8X
2/37 ( 99
6) 5)
2/50 ( 5.7X
2/35 ( 106
4) 6)
2/50 ( 4) 10.OX
2/20 ( 10)
104
1/46 ( 5.3X
1/19 ( 104
2) 5)
P30.4S6N P=0.512N P=0.239N
P>0.592
PM. 592 PM.419N
PM.594 P=0.481 P30.528 P30.481
PM.49 IN P=0.69IN
P30.563N P=8.708N P=0.584H P=0.708N
P=0.333N PSP < 532N
W
03565A
if
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT: 680244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS>
RC-OtUH
RC-01VN
RC-01LM
RC-01HH
RC-81UF
RC-01VF
PAGE)
2
VERSION* 11/11/841
RUN DATE' 02/20/85
RC-01LF
RC-OIHF
DOSE IN OH/KO______________ ________P.P
HEMATOPOIETIC SYSTEM ALL LEUKEMIAS
MALE
_____Q-Jl__________JL5___________ 1.8 -... _______ 0.8
FEMALE
______ LJ___________Li____
<8____
tUMOR RATES OVERALL la) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (HEEKS) I
1 HrntfiiirTnr^nrn LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARNITAGE TREND FISHER EXACT TESTS
HEMATOPOIETIC SYSTEM ALL LYMPHOMAS ALL LEUKEMIAS
2/49 ( 4.6X
0/39 ( 81
4) 0)
3/50 ( 7.2X
1/38 (
SO
8) 3)
0/49 ( 0) O.OX
0/19 ( 0)
8/50 ( 0)1
O.OX 0/11 ( 0)
P-0.246H P-0. 152N P-0.094N
P-0.139N
P-0.093N P-0.038N
P=0.389N
P=0-239N P=0.217N P=0.121N
P-0.527N P-0.384N
P-0.428H P-0.423N
P-Q.247H
P-0.243N
PSQ.)25H____ Es8122H
I |
1 1
2/49 ( 5.IX
1/37 1
99
4) 3)
0/50 ( 0) O.OX
0/35 ( 0>
0/50 ( 0) O.OX
0/20 ( 0)
1/46 ( 5.3X
1/19 C 104
2) 5)
P-0.562N P-8.596N P-0.376H
P-0.191
P-0.193 P-0.257
P-0.386H (a) P=0.488N (a)
P-0.243H Ml__________
F-0.7Z6IT P-0.378 P-0.719 P-0.378
P-0.524N
JUMPR RATES OVERALL (a) ADJUSTED (b) TERMINAL Cc> FIRST INCIDENCE (HEEKS)
2/49 (
4.6X 0/39 (
81
4) 0)-
3/50 ( 7.2X
1/38 ( 80
6) 3)
1/49 ( 5.OX
0/19 ( 102
2) 0)
0/50 ( 0) O.OX
0/11 ( 0)
3/49 ( 7.8X
2/37 ( 99
61 5)
1/50 ( 2.9X
1/35 (
106
2) 3)
2/50 ( 4) 10. OX
2/20 ( 10) 104
1/46 (
5.3X 1/19 c 104
2) 5;
pTATI^TlCgL.TESTS (d)
INCIDENTAL TUMOR TEST COCHRAN-ARNITAGE TREND FISHER EXACT TESTS
P=0.397N P-0.283N P=0. 139N
P-0.246N
P=0.105N P-0.06 IN
P=0.720N P=Q. 528N P-0.614N
P-0.257N
P=8.527N
P=0.3S4N P-0.42SN P=0.423N
P=0.500H
P=0.243N
P=0-3<6H____ P=0.122N
P-0.486H P-0.512H P=0.239H
P-8.411 P-0.411 P-0.596
P-0.594 P-0.308 P-0.528 P-0.308
P-0.49 IN P=0-SOO_____
P-0.563N P-0.620 P-0.584N P-0.620
P-0.333N P-0.731___
SL 035655
I
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT' 600244 PAPANICOLAOU
CHEMICAL'
C04546 TRICHLOROETHYLENE
CROUP IDS'
RC-OIUM
RC-OIVM
RC-OILM
RC-OtHM
RC-OtUF
RC-OIVF
PAGE'
3
VERSION' 1I/I3/84T
RUN DATE' 02/20/85
RC-01LF
RC-01HF
MALE
FEMALE
DOSE IN GH/KC______________ _________ __________ ______ Q-J__________ ...1,3______ ______LI_____ _________ U______ ______ LI____________ M
______ LI_____
KIDNEY NOS ALL TUMORS
TUMOR. RfttSS OVERALL ta) ADJUSTED (b>
TERMINAL tc) FIRST INCIDENCE (MEEKS)
3/49 ( 7.2X
2/39 (
87
6) 5)
8/50 ( 8) O.OX
0/38 ( 8)
1/49 ( 4.2X
8/19 ( 91
2) 8)
1/49 ( 9. IX
1/11 <
184
2) 9)
1/49 ( 2.4X
8/37 (
98
2) 8)
2/48 ( 5. IX
1/34 ( 83
4) 3)
6/47 ( 13) 24. ax
3/28 ( 15)
68
2/43 ( 9.4X
1/19 (
84
5) 5)
iatuJ
INCIDENTAL TUMOR TEST COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
PM.61IN PM. 49 IN PM.202H
PM.122
PM. 112 P=0.J27
PM.557N PM. 403 PM.253N P-0.545
P=0.309N P=1L49S_____
P-0.686 PM .255 PM .720 PM.255
PM.309N P=8.495____
PM.148 PM. 368 PM. 353
PM .266
PM. 528 PM .522
PM.010 PM. 835 PM .853 PM .219
PM.849 PM. 127
PM. 280 PM. 466 PM. 576 PM .678
PM. 451 - MAM
KIDNEY NOS TRANSITIONAL-CELL PAPILLOMA TRANSITIONAL-CELL CARCINOMA
ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
MKPiem u>
INCIDENTAL TIMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
3/49 ( 7.2X
2/39 (
87
6) 5)
0/50 ( 8)
O.OX 0/38 ( 0)
0/49 ( 8) O.OX
0/19 ( 0)
1/49 ( 9. IX
1/11 ( 104
2) 9)
PM. 523N PM.456N PM. 176N
PM. 116
PM. 116 PM. 267
PM.265H () PM. 138N (a)
PM. 121N (a)
PM.686 PM. 255 PM.720 PM .255
PM. 309N
0/49 ( 0) O.OX
0/37 ( 8)
1/48 (
2.9X
1/34 ( 106
2) 3)
2/47 ( 8.5X
1/20 ( 87
4) 5)
1/43 ( S.3X
1/19 (
104
2) 5)
PM. 199 PM. 304 PM. 326
PM .416
PM .493 PM. 588
PM. 133 PM. 327 P-0.377 PM.495
PM. 237 -Tgi.aw
PM. 367 P-0.627 PM. 367 PM .627
PM .467 -PJUL724
cn v*
O'
I
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT1 600244 PAPANICOLAOU
CHEMICAL1
C04546 TRICHLOROETHYLENE
GROUP IDS1
RC-OIUM
RC-01VM
RC-OtLM
RC-01HM
RC-01UF
RC-01VF
PAGE1
A
VERSION1 II/13/84T
RUN DATE1 02/20/85
RC-01LF
RC-01HF
1
HALE
DOSE IN GH/KO____________ _J_________ !LJi______ ______ 1L0________
PITUITARY ADENOMA, NOS
9,5_______ _____ 1.9
_________ LI______
FEMALE
_____________u_______ ____ LJ____
lUPQR.RMES OVERALL (a) ADJUSTED (b) TERMINAL (c> FIRST INCIDENCE (HEEKS)
STAT1STTCAI TFSTS (HI LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
PITUITARY ADENOMA, NOS CARCINOMA, NOS
8/48 ( 17) 19.9X
6/38 ( 16)
101
6/39 1 15)
16.9X 5/34 < 15) 100
4/33 ( 12) 19.5X
3/19 ( 16)
91
3/29 ( 18) 28.7X
2/9 ( 22) 102
P-0.368 P=0.427 P=0.259N
P=0.257
P=0.478 P=0.329N
P=0.626N P=0.522
P=0.569N P=0.547N
P=0.4 12 P=0.315 P=0.463 P=0.607
P=0.408N
P=0.340N
-EfLMBU____ P=JMft2H--
24/47 ( 51) 59. SX
21/37 C 57) 74
18/42 ( 43) 51. IX
16/33 < 48) 96
7/36 ( 19) 33.7X
6/19 ( 32)
78
7/32 C 22) 36. ax
7/19 ( 37)
104
P=0.030N P-0.024N P-0.003N
P=0.135N P=0.122N P=0.025N
P-0.059N P=0.196N Ps0.842N P=0.165N
P=0.062H
P=0. 197N P=0.054N P-8.211N
P-B.003N
P=0.008H
pso.Q24h____ P-8.049N
IUMQR_8&TJS OVERALL (a) ADJUSTED Lb)
TERMINAL (c> FIRST INCIDENCE (HEEKS)
8/48 ( 17) 19.9X
6/38 ( 16)
101
6/39 ( 15)
16.9X 5/34 ( 15) 100
4/33 ( 12) 19.5X
3/19 ( 16) 91
3/29 ( 10)
28.7X 2/9 ( 22) 102
24/47 ( 51) 59.8X
21/37 (57)
74
18/42 ( 43)
51. IX 16/33 ( 48)
96
7/36 ( 19) 33.7X
6/19 ( 32) 70
8/32 ( 25) 40. OX
7/19 ( 37) 101
STATISTICAL TESTS (d) Life table
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P=0.368 P=0.427 P=0.259N
P=0.257
P=0.478 P=0.329N
P=0.626N P=0.522 P=0.569N P-0.547N
P=0.408N P-0.480N
P=0.4 12 P=0.315 P=8.463 P=8.607
P=0.340N P=0409N
P=0.06 IN P=0.054H P=0.006H
P=0.223N
P=0.217N P*0.049N
P=0.059H P=0.196N
P=0.042N P=0. 165H
P=0.12 IN
P=0.512N P=0.109N P=0.34 IN
P=0.003N
P=0.018N
PsQt B24H____ P=0.088H
SL 035657
li
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT * 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS>
RC-OIUM
RC-OIVM
RC-OILN
RC-01HM
DOSE IN CHSKG______________ _________ ftj______
ADRENAL CORTICAL ADENOMA
KALE o-Q__________ 1.5______
I.D_____
TUMOl^ RftlES OVERALL (a) ADJUSTED (b)
TERMINAL (c> FIRST INCIDENCE (MEEKS)
S/48 ( 17) 19.9X
7/39 ( 18) tot
6/48 ( 13)
15.SX 6/38 ( 16)
105
1/44 ( 5.6X
1/18 ( 104
2) 6)
0/45 ( 0) O.OX
0/11 ( 0)
awaifl1 "*iii
INCIDENTAL TUMOR TEST COCHRAK-ARHITAGE TREND FISHER EXACT TESTS
ADRENAL PHEOCHROMOCYTOHA
P=0.038N P-D.D37N P=0.DO(N
P=0.080N
P=0.080N P=0.006H
P=0.I52N
P=0.260N P=0.158N P=0.266N
P=0.127N P0.191N P=0.119N
P=0. 19 IN
P=0.02IN
P=0.^a4N
P-g.OZJM____ P=0.016H
ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
STATISTICAL TESTS (d) LIFE TABLE
INCIDENTAL TUMOR TEST
C0CHRAH-ARMITA6E TREND FISHER EXACT TESTS
4/48 ( 8 > 10.3X
4/39 ( 10) 107
8/48 ( 17) 21. IX
8/38 1 21)
105
0/44 ( 0) O.OX
0/18 ( 0)
0/45 1 0) O.OX
0/11 ( 0)
P=0. 104N P=0. I84N PaO.OIBN
P:0.O17N
P=0.0 17N P<0.001N
P=0.199N P=0.047N
P=0. I99N P=0.047N
P*0.318H P=0.1I7N
P=0.318H P=0. 1I7H
P=0.070N
P=0.067N
P*0.004H____ P*fl.004N
RC-01UF
RC-I1VF
PAGE:
5
VERSION: 1I/13/84T
RUN DATE> 02/20/85
RC-IILF
RC-OtMF
M_____
FEMALE l>_____________ L5______ ____ 1.1_____
1/49 ( 2.7X
1/37 (
106
2) 3)
2/48 (
5.7X 2/35 ( 106
4) 6)
1/44 ( 5.OX
1/20 ( 105
2) 5)
3/40 ( 8) 15.8X
3/19 ( 16) 104
P*0.067 P*0.067 P=0.152
P0.179
P=0.179 P=0.329
PaO.619 Ps0.692N P=0.6I9
P*8.692N
Ps0107 P*0.235 P=0. 107 P*0.235
P=0.725
P=0.236
Ps0S33N____ P-0.413
1/49 ( 2.7X
1/37 (
106
2) 3)
3/48 (
7.9X 2/35 (
S3
6) 6)
0/44 ( 0) O.OX
0/20 ( 0)
2/40 ( 5) 10.5X
2/19 ( 11) 104
Ps0.195 P=0.195 P*0.307
P`0.594 PM.582N PM.456K
P=0.623N P=0.227N Ps0.623H P*0.139N
P=0.527H PSD.13BN
P=0.275 P*0.599 P=0.275 P=0.650
P=0.423 -Crmaztj
SL 035658
INTERCURREHT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CADS CONTRACT 600244 PAPANICOLAOU
CHEMICAL >
C04546 TRICHLOROETHYLENE
CROUP IDS'
RC-OIUM
RC-OIVM
RC-01LH
RC-01HM
RC-01UF
RC-01VF
PAGE:
6
VERSION* 11/I3/84T
RUN DATE> 02/20/85
RC-OILF
RC-01HF
MALE
PQSE IH Cff/RS______________ _________ m_____ _______U__________ ALL ADRENAL SITES
PHEOCHROMOCYTOMA
0.5______ ______ 1x4_____ _________ 1x0______
TUMOR RATES OVERALL fa) ADJUSTED (b) TERMINAL (c> FIRST INCIDENCE (HEEKS)
STATISTICAL TESTS (d) LIFE TAOLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
4/48 ( 8) 10.3X
4/39 ( 10) 107
P-0. I04N
P=0.104N
P=0.018N
8/48 ( 17) 21. IX
8/38 (21) 105
P=0.017N
P=0.017N P<0.001H
0/44 ( 0) O.OX
0/18 ( 0 )
0/45 (
O.OX 0/11 (
0)1
I
0)1
P=0.199N P=0,047N P=0.199N
P=0.047N
-------------------- 1---
P-0.318K
P=0.117N P=0.318N P=0.117N
|
t f j
P=Q. 07ON
P=0.067N j
P=00D4N____ Ps0.004M 1
1/49 ( 2.7X
1/37 C 106
2) 3)
P=0.195 P=f.195 P=0.307
ALL ADRENAL SITES PHEOCHROMOCYTOMA PHEOCHROMOCYTOMA, MALIGNANT
TUMOR, RATES
OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (HEEKS)
4/48 ( 8) 10.3X
4/39 ( 10) 107
8/48 ( 17)
21. IX 8/38 ( 21) 105
0/44 ( 0) O.OX
0/18 ( 0)
0/45 ( 0) O.OX
0/11 ( 0)
1/49 (
2.7X 1/37 ( 106
2) 3)
HBW '"'5 ,ri
INCIDENTAL TUMOR TEST COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P=0.104N P=0. 104N P=0.018N
P=0.0 17H
P=0.0 17N P<0.00 IN
P=0.199N P=0.047N P=0.199N P=0.047N
P=0.318N
P=0. 117N P=0.318H P-0. 117H
P=0.070N
P-0.067N
P-0.004N____ P=0.P04H
P-0.190 P=0.278 P=0.316
FEMALE o.Q____________ 1x4______
I.o_____
3/48 ( 7.9X
2/35 < 83
6) 6)
0/44 ( 0) O.OX
0/20 ( 0)
2/40 ( 5)
10.5X 2/19 ( 11) 104
P*0.594
Ps0.582N P=0.456N
P=0.623N
P=0.227N P=0.623N P=0.139H
P=0.275 Ps0.599
P=fl.275 P-0.650
P=0.527H
P-0.423
.. ..Pf-ix-iaM____ Ps0.587N
3/48 ( 7.9X
2/35 ( 83
6) 6)
1/44 (
3.6X 0/20 (
85
2) 0)
2/40 ( 5) 10.5X
2/19 ( 11) 104
P=0.541
P=0.578H Pe0.472N
P-0.643 Ps0.492N P=0.623N
P-0.267N
P=0.275 P=0.599
P=0.275 P-0.650
Ps0.725
P=0.423
PsB.a2H____ Ps0587M
SL 035659
II
INTERCURREHT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS.
CIDS CONTRACT* 600244 PAPANICOLAOU
CHEMICAL'
C04546 TRICHLOROETHYLENE
GROUP IDS'
RC-01UM
RC-OIVN
RC-01LM
RC-OIHH
RC-OIUF
RC-OIVF
PAGE*
7
VERSION* 11/13/04T
RUN DATE* 02/20/05
RC-01LF
RC-OIHF
HALE
FEMALE
DOSE IN GH/KO______________ _________ LI______ _____U_________1.5___________ Lul_____ _______LJ__________LJ__________L5____
MAMMARY GLAND ALL TUMORS
TUMQB RAILS OVERALL (a) ADJUSTED (b)
TERMINAL tc> FIRST INCIDENCE (MEEKS)
0/49 ( 0) O.OX
0/39 ( 0)
0/50 ( 0) O.OX
0/30 ( 0)
0/49 ( 0) O.OX
0/19 ( 0)
0/50 ( 0) O.OX
0/11 I 0)
5/49 (
0. IX 3/37 (
104
4) 0)
3/50 ( 7.5X
1/35 ( 96
4) 3)
1/50 ( 4.2X
0/20 < 09
2) 0)
. -J-.Q____
1/46 ( 5.3X
1/19 ( 104
2) 5)
hhw165,8 "
INCIDENTAL TIMOR TEST
COCHRAN-ARHITAGE TREND FISHER EXACT TESTS
PROSTATE NOS ADENOMA, NOS
mono OVERALL (aS 1 ; ADJUSTED (b) ` TERMINAL (e* jj, FIRST INCIDENCE (MEEKS)
its
INCIDENTAL
TEST
COCHRAH-ARHlfKGE TREND FISHER EXACT TESTS ------------------. .life'--------
(> (a) (a)
(a) (a) (a)
() (a) (a)
(a) (a) (a)
(a) (a)
(a) (a)
_U1____
Ca)
0/40 ( 0) 0. ex
0/39 ( 0)
3/49 ( 7.9X
3/30 ( 105
6) 0)
0/45 ( 0) O.OX
0/19 ( 0)
0/43 ( 1 O.OX
0/ 11 ( 1
(a) (a) (a)
P=0. I53N
P=0.266H
P=0.403H
(a) (a> (a)
P=0.153N
Ps0.266N
P=0.403H
(a) P-Q.D46M (a) (a)
P=0.(30N____ Ps0. 147M
P*0.429N P*0.31IN P=0.2I6N
PS0.420N P-9.466N P=0.222N
Ps0.535N P-0.547N P-0.240N PM.545N
P=0.30 IN -P*Latt___
P=0.562N P*0.555H P-0.562N P=9.650H
P=0.333N PsL5^tM
I
INTERCURRENT MORTAL ITV ADJUSTED TUHOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT: 6002AA PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS:
RC-OIUM
RC-OIVM
RC-OILH
RC-OIHN
RC-OIUF
RC-OIVF
PAGE*
VERSION* 11/13/841
RUN DATE* 02/20/85
RC-OIIF
RC-OIHF
MALE
POSE IN /*ff__________ ______ m____ -------- ^----------
TESTIS NOS INTERSTITIAL-CELL TUMOR
P.5_________ U____ ________LI_____
FEMALE
D.O_________ U____
TUMOR RATES OVERALL (a) ADJUSTED (b) TERMINAL (c> FIRST INCIDENCE (HEEKS)
StATlSTICftL .TESTS"(31
LIFE TABLE-
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
38/47 (81) 90.4*
34/38 ( 89) 70
36/49 ( 73) 94.7*
36/38 ( 95) 104
23/49 ( 47) 95.8*
18/19 ( 95)
84
17/49 ( 35) 100.OX
11/11 (100)
75
P=0.003 P*0.079 P<0.00 IN
P<O.QOI
P=0.019 P<0.00 IN
P=0.119 P=0.024 P=0.507 Ps0.223
P<0.00 IN Ps0.007N___
P-0.006 P<0.001 P*0.235 Ps0.P74
P<0.01 IN
p<oflgtw
TESTICULAR SITES INTERSTITIAL-CELL TUMOR
TUMOR RATES OVERALL (a)
j
ADJUSTED (b)
TERMINAL (c)
FIRST INCIDENCE (NEEKS) j
titfma*1
38/47 ( 81) 90.4X
34/38 ( 89) 70
36/49 ( 73) 94.7X
36/38 ( 95) 104
23/49 ( 47)
95.8X 18/19 ( 95)
64
17/49 ( 35) 100.OX
11/11 (100)
75
P=0.003
P=0. 119
P=0.006
1
P<0.001
P=0.024
P<0.001
INCIDENTAL TUHOR TEST j
P=0.079
P=0.507
P=0.235
|
P-0.019
P=0.223
P=0.074
COCHRAN-ARMITAGE TREND 1
P<0.00 IN
P<0.00 IN
_FI_SH_E_R_E_X_ACT TE_ST_S____L
P<0.00 IN
P<0.00 IN
P=0.007N___ P<0.00 IN
l.
9^
O'
V-*
I
IHTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CUDS CONTRACT> 600299 PAPANICOLAOU
CHEMICAL)
C09596 TRICHLOROETHYLENE
GROUP IDS)
RC-01UM
RC-OtVM
RC-01LH
RC-01HN
WSJB CHf'KS____________ ________U___
TESTICULAR SITES INTERSTITIAL-CELL TUMOR INTERSTITIAL-CELL TUMOR, MALIGNANT
MALE 0.0________ __fl.Ji____ ______ LJI____
ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
SIM_______
LIFE TABLE
S id)
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
38/97 (SO 90.9X
39/IS ( 89) 70
P=0.103
P=0.079
P<0.001N
UTERUS NOS ENDOMETRIAL STROMAL POLYP
TUMOR feATES OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
36/99 ( 73)
99.7Sf 36/38 ( 95)
109
23/99 ( 97) 95.8X
18/19 ( 95)
89
P<0.001
p=e.oi9 P<0.00 IN
P=0.119 Ps0.029 P=0.507 P=0.223
P<0.00 IN P=0.007H
17/99 ( 35) 100.OX
11/11 (100) 75
P=0.006 P<0.001 Ps0.235 P=0.079
P<0.001N
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
| |
I 1
*
RC-OIUF
RC-I1VF
PAGE1
9
VERSION) 1I/13/S9T
RUN DATE) 02/20/85
RC-OILF
RC-01HF
FEMALE _____ _____ (J___________ 0.5
1.0
1/98 ( 2.7X
1/37 ( 106
2) 3)
9/99 ( 10.7X
3/35 ( 96
8) 9)
3/98 ( 6)
15.OX
3/20 ( 15) 109
2/90 ( 5)
10.5X 2/19 ( 11) 109
P-O.163 P=0.163 P=0.329
PSQ.580N P-0.596 P*0.398N
P=0.119 P=8.505 P=0.119 P-0.939
P-0.308 P=0.512N
P=0.275 Ps0.69 IN P=0.275 P-0.668
P=0.931 Pa0.990N
co
t-f
035662
II
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
C8DS CONTRACT1 600244 PAPANICOLAOU
CHEMICAL)
C04546 TRICHLOROETHYLENE
GROUP IDS)
RC-01UM
RC-OIVM
RC-OILH
RC-81HH
DOSE IN GM/KG
8.8
UTERUS NOS ENDOMETRIAL STROMAL POLYP ENDOMETRIAL STROMAL SARCOMA
MALE 8.8
8.5
1.8
RC-81UF
r
_ 8.8
RC-01VF
PAGE'
10
VERSION) 1l/t3/S4T
RUN DATE* 02/20/85
RC-01LF
RC-OIHF
FEMALE 8.8
8.5
1.8
ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (HEEKS)
fH,s "
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
i/48 ( 2.7X
1/37 ( 106
2) 3)
4/49 ( 18.7 X
3/35 ( 96
8) 9)
P=0.072 P=8.086 P=0.178
P=0.398
P-0.426 Px0.526N
a) Number of tumor-bearing animals/number of anfaalt aaaainad at tha liU (percent). b) Kaplan-Moior estimated lifetime tumor incidanco after adjusting for fntercurrant Mortality. c) Observed tueor incidence at tereinal till.
d) Beneath the control incidence are the P-values associated with the trend test.
Beneath the dosed group incidence are tha P-values corresponding to pairwise comparisons between that dosed group and the controls. The life table analysis regards tumors in animals dying prior to terminal kill as beinq (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Tha Cochran-Armitage and Fisher's exact tests compare directly
the verall incidence rates. A neqative trend is indicated by N.
e) Differences not significant; no tumors observed in dosed group or control group.
3/48 ( 6) 15.8X
3/28 ( 15) 184
3/40 ( 8) 13.SX
2/19 ( 11) 71
P*0. 119 P-8.505 P*8.119
P'0.434
P-0.119 Pfl.49 1 Px0. 168
P=8.594
P*8.308
P-0.242
PC0.S12N____ F=9.<13N
SL 035663
FINAL
Obboroe-rnerdel Ra-ts
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS__
CODS CONTRACT) 600244 PAPANICOLAOU
CHEMICAL: GROUP IDS:
C04546 TRICHLOROETHYLENE
R7-01UM
R7-01VM
R7-011K
R7-01HM
R7-01UF
R7-01VF
RECEIVEDpAR0 H 1985 ,
VERSION: II/13/84T
RUM DATE: 02/20/85
R7-0ILF
R7-01HF
SURVIVAL AT MINIMUM TERMINAL SACRIFICECHEEK)
21/50 42X (04
22/5 0 44X 104
i77e
34X
104
i575o
30X 104
19/50 38X
104
15755
11/50
40X 22X
_____ UU__________m_______
7/50 14X
104
MALE
FEMALE
DOSE IN OH/KG______________
o.o___
00 __________U____________LJi_____ ________JU__________ m____
0.5____
1.0
ALL TOPOGRAPHIES All TUMORS
THOR RATES
OVERALL () ADJUSTED (b)
TERMINAL (c) FIRST INCIDENCE CHEEKS)
39/50 ( 78) 94.9X
19/21 ( 90) 63
37/50 C 74) 94.7X
20/22 C 91) 70
35/50 ( 70)
97. OX
16/17 ( 94) 11
29/50 ( 58) 96.3X
14/15 ( 93) 21
44/50 f 88) 100.OX
19/19 (100) 48
40/50 ( 80) 97.5X
19/20 ( 95)
19
36/50 ( 72) 100.OX
11/11 (100)
35
37/50 ( 74) 100.OX 7/7 { 100) 45
ST*IIS-IlAl..IESIS..Id2
LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P=0.352 P-0.334N P=0.020N
P=0.249
P=0.399N P=0.055N
Pc0.323 P-0.224 P-0.490N P-0.601N
P=0.248N P-0.412N
P=0.394 Ps0.294 P=0.434N P=0.529N
P=0.027N P=0.070N
P-0.081 P*0.070N PS0.058N
P*0.015
Ps0.432N P-O.28 III
P=0.319 P=0.109
P=0.073M P-Q.440N
P-0.096 P=0.020
P0.087N P=0.48211
Ps0.040N
P-0.063H
PS0,?.42N . __
SURCUT TISSUE NOS FIIROMA
twwonEi OVERALL (J ADJUSTED (b> TERMINAL (c> FIRST INCIDENCE CHEEKS)
3/50 { 9.8X
0/21 ( 95
6) 0)
4/50 ( 8) 13.6X
1/22 ( -5) 86
3/50 ( 6) 14.Ox
2/17 ( 12)
78
0/50 ( 0) o.ox
0/15 ( 0)
0/50 ( 0) O.OX
0/19 ( 0)
0/50 ( 0) O.OX
0/20 ( 0)
2/50 C 8.5X
0/11 ( 70
4) 0)
1/50 ( 2.9X
0/7 ( 80
2) 0)
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P-0.200N P=0.18 IN P*0. 10 IN
P=0. 112N
P=0.095N P=0.049N
P=0.552 P=0.612N P=0.587 P=0.54711
P=0.66 IN PSQ.?0,6H --
P=0.218N P=0.129N P=0.278N P-0.130N
P-0. 122N P=fl,-059H-
P=0.320 P=0.433 P=0.360
P=0.314
Ps0.491 P30.360
P=0.195 P-0. 194 P=0.278 P-0.3bd
P=0.247 P8.P47
P-0.500 P-0.489 Ps0.58 1 P-0.682
P=0.500 P=Q500
r1
035664
INTERCURREHT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CUDS CONTRACT) 60024A PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS:
R7-01UM
R7-01VM
R7-01LN
R7-01HM
R7-01UF
R7-01VF
PACE*
2
VERSION: 11/I3/B4T
RUN DATE: 02/20/85
R7-01LF
R7-0IHF
DOSE IN GM/KG______________ _________ 08
SUSCUT TISSUE NOS FIBROMA FIBROSARCOMA
tUHQR RATES OVERALL (a) ADJUSTED (b)
TERMINAL (c) FIRST INCIDENCE (MEEKS)
3/50 ( 9.8SC
0/21 C 95
6) 0)
StATISTICAL TESTS (d) LIFE TABLE
Ps0.200H
INCIDENTAL TUMOR TEST
P=Q. 18 IN
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P=0. 10 IN
INTEGUMENTARY SYSTEM FIBROMA
tWIQB RATES OVERALL (a)
ADJUSTED (b) TERMINAL <c> FIRST INCIDENCE (MEEKS)
3/50 ( 9.8X
0/21 ( 95
6) 0)
MALE SLJ! --Li______
t.o_____ _________ Lit______
FEMALE 0.0_____________ Li______
1.0_____
A/50 ( 13.6X
1/22 ( 86
8) 5)
3/50 ( 6) 14.OX
2/17 ( 12) 78
0/50 ( 0)
O.OX 0/15 ( 0)
P=0. 112H
P=0.095N P=0. Q49N
P=0.552 P=0.6I2N P=0.587 P=0.547N
P-0.66 IN P=0.500H
P=0.218N P=0. 129N P=0.278N P-0. 130N
P=0. 122N Ps0Q59H
0/50 ( 0) O.OX
0/19 1 0)
0/50 ( 0) O.OX
0/20 ( 0)
2/50 ( 8.5X
0/11 (
70
4) 0)
1/50 ( 2.9X
0/7 ( 80
2) 0)
P-0.320 P=0.433 P-0.360
P=0.314 P=0.491 P=0.360
P=0.195 P=0.194 P=0.278 P=0.300
P=0.247 P=0.247
P=0.500 P=Q.489 P=0.58 1 P=0.682
P=0.500 P=0.500
4/50 ( 13.6JC
1/22 ( 86
8) 5)
4/50 ( 8) 19.BX
3/17 ( 18)
78
2/50 ( 11.6*/:
1/15 ( 97
4) 7)
0/50 ( 0) 0. OX
0/19 ( 0)
0/50 ( 0) 0. Ox
0/20 ( 0)
2/50 ( 8.5X
0/11 ( 70
4) G)
1/50 ( 2.9X
0/7 ( 80
2) 0)
SL 035665
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P=0.548 P=0.545 P=0.417N
P=0.468N
P=0.45 IN P=0.274N
P=0.381 P=0.519 P=0.408 P=0.582
P=0.500 P=0.643N
P=0.664 P=0.528N P=0.573 P=B.548N
P=0.500N P=0.339N
P=0.320 P=0.433 P=0.360
Ps0.314 P=0.491 P=0.360
P=0.195 P=0.194 P=0.278 P=0.300
P=0.247 P=0 7
P=0.500 P=0.489 P=0.58 1 P=0.682
P=0.500 P=0.500
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS*
R7-0IUM
R7-01VM
R7-01LM
... R7-01HM
R7-01UF
R7-01VF
PAGE:
3
VERSION: 1I/13/84T
PUN DATE' 02/20/85
R7-0UF
R7-01HF
DOSE IN CM/ICG______________ _________ !L-fi______
INTEGUMENTARY SYSTEM FIBROMA FIBROSARCOMA
miaOAiEs OVERALL (a) ADJUSTED (b)
TERMINAL (c> FIRST INCIDENCE (HEEKS)
3/50 ( 9.8X
0/2t ( 95
6) 0)
SIAII.SIICfti_LES.ia tdi LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P-0.548 P-0.545 P*0.4 17H
HEMATOPOIETIC SYSTEM ALL TUMORS
tumor Rates OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (HEEKS)
STATISTICAL .tESIS
LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
1/50 ( 4.3X
0/21 ( 103
2) 0)
P=0. 114 P=0.159 P=0. 176
MALE 0.0 --JL5______ ______ LJJ_____ _________ OJS______
4/50 (
13.6X t/22 ( 88
8) 5)
4/50 ( 8) 19.8X
3/17 ( 18)
78
2/50 ( I1.6X
1/15 C 97
4) 7)
P=0.468N
P=0.45 IN P=0.274N
P=0.381 P=0.519 P=0.408 P=0.582
P=0.500 P=0.643N
P=0.644 P=0.528N P=0.573 P=0.54N
P=0.50011 P=0.339H
0/50 ( 0) a. OX
0/19 ( 0)
P=0.320 P=0.433 P=0.360
2/50 ( 6.35C
0/22 ( 70
4) 0)
0/50 ( 0) 0.0X
0/17 C 0)
3/50 ( 9.5X
0/15 ( 34
6) 0)
P=0.284
P=0.439 P=0.390
P=0.54911 P=0.230N P=0.573H P-0.266N
P-0.500N P=0.248H
P=0. 197 P=0.358 P=0.269 P=0.545
P=0.309 P~0.500
3/50 ( 10.2SC
0/19 t 85
6) 0)
P=0.544H P=0.28711 P=0.41711
FEMALE O.D_____________BL5______ ____ L-fl_____
0/50 ( 0) O.OX
0/20 ( 0)
2/50 ( 8.5X
0/11 ( 70
4) 0)
1/50 ( 2.93C
0/7 C 80
2) 0)
P=0.314
P=0.49 1 P=fl.360
P=0.195 P=0.194 P'0.278 P=0.300
Ps0.247 P-0.247
P=0.500 P-0.489 P=0.581 P-0.682
P=0.500 P=Q.S0n
2/50 ( 5.4X
0/20 ( 19
4) 0)
4/50 ( 15.9X
1/11 (
41
8) 9)
2/50 ( 9.3X
0/7 ( 79
4) 0)
P=C.471
P=0.53611 P-0.588
P-0.401 P=0.268 P=0.587 P = 0.355
P=0.500 PJ0 339
P=0.590H P=0.622 P=0.27 ill P=0.584N
P=0.50(111 P = 0.69 til
tn
035667
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL: GROUP IDS:
C04546 TRICHLOROETHYLENE
R7-01UM
R7-01VM
R7-0ILH
R>-01HM
HALE
DOSE IN 6M/K0______________ _______JL4____ ____ ILJt_______ -P.5___ :___
HEMATOPOIETIC SYSTEM ALL LEUKEMIAS
-0_____
OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
SlftllSTKAL TESTS LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
HEMATOPOIETIC SYSTEM ALL LYMPHOMAS ALL LEUKEMIAS
TUMOR RATES . OVERALL (a) ADJUSTED (b) TERMINAL (c> FIRST INCIDENCE (MEEKS)
STATIST K^L..TESlS-id>
INCIDENTAL TUMOR TEST
in COCHRAN-ARMITAGE TREND
FISHER EXACT TESTS
1/50 ( 4.32
0/21 (
103
2) 0)
1/50 ( 2.32
0/22 ( 70
2) 0)
0/50 ( 0) O.OX
0/17 ( 0)
----
P-0.253
P=0.549fT
P-0.261
P=0.514N
P-0.226
P=0,573N
P-0.292
P=0.527N
P=0.360
P-0.360
P=0.50ON
____P=0.SOON____
2/50 ( 7.42
0/15 ( 61
4) 0)
P=0.353 P-0.365 P-0.318 P=0.405
P-0.500 P=OSOO____
1/50 ( 4.32
0/21 ( 103
2) 0)
P=0.253 P-0.226 P-0.360
2/50 (
6.32 0/22 (
70
4) 0)
P-0.500 P-0.528 P-0.622
0/50 ( 0) 0.02
0/17 ( 0)
P-0.549N P-0.280N P-0.573N P-0.266N
P-0.SOON P-0.248H
2/50 ( 7.42
0/15 ( 81
4) 0)
P-0.353 P-0.550 P-0.318 P-0.572
P-0.500 P-0.69 IN
R7-01UF
R7-01VF
PAGE:
4
VERSION: I1/13/84T
RUN DATE: 02/20/85
R7-01LF
R7-01HF
00______
FEMALE 0.0_____________JL-5_______
t.Q_____
2/50 (
6.52 0/19 (
85
4) 0)
0/50 ( 0) 0.02
0/20 ( 0)
P=0.296N P-0.146N P-0.202H
- - --------- --
P=0.528
P-0.596 P-0.640
-
3/50 ( 13.92
I/ll (
41
6) 9)
0/50 ( 1 0.02
0/7 ( 1
P-0.422 P-0.089' P-0.57 1 P-0.109
P-0.500 P*0.121_____
rrucoon ( a) P=0. 15 IN (a)
P=0.248N (e>-_____
3/50 ( 10.22
0/19 ( 85
6) 0)
2/50 (
5.42 0/20 (
19
4) 0)
4/50 ( 15.92
1/11 (
41
8) 9)
2/50 ( 9.32
0/7 ( 79
4) 0)
P-0.544N P-0.2S7N P-0.417N
P-0.471
P-0.S36N P-0.588
F-0.401 P-0.268 P-0.587 P-0.355
P-0.500 P-0.339
P-0.590H P-0.622 P-0.27 IN P-0.584N
P-0.50011 P-0.69 IN
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RAH.
CUDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL <
C04546 TRICHLOROETHYLENE
GROUP IDS:
R7-01UM
R7-0IVM
R7-0ILH
R7-01HM
MALE
POSE IN Offcf.Kfi__________.. ______ HJl____ ____ P P _______
FORESTOMACH SQUAMOUS CELL CARCINOMA
OJ_____
1-0____
TUMOR RATES OVERALL (a)
ADJUSTED <b> TERMINAL (c> FIRST INCIDENCE (HEEKS)
3/50 ( 8.2X
0/21 ( 87
6) 0)
3/50 ( 11.5X
2/22 C 88
6) 9)
2/50 ( 6.3X
0/17 ( 30
4) D)
D/58 ( 0) O.OX
0/15 < 0)
STATISTTCAt .TEStS id)
LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P=0.1S5N P-0.07IN P=0.082N
P=0.14SN
P-0.054N P-0.0S2N
P=0.588N P=0.583N P = 0.41611 PS0.375N
PB0.225N PB0.20 IN P=0.225H P=0.199N
P=0.500N
P=0. 12211
P=0.5Q0M____ P*0.122H
FORESTOMACH SQUAMOUS CELL PAPILLOMA SQUAMOUS CELL CARCINOMA
OVERAlPII)
ADJUSTED (b) TERMINAL (c> FIRST INCIDENCE (HEEKS)
3/50 ( 8.2X
0/21 ( 87
6) 0)
3/50 ( 11.5X
2/22 (
88
6) 9)
2/50 (
5.3X
0/17 ( 30
4) 0)
0/50 ( 0) O.OX
0/15 ( 0)
HB1MlL-tHU-idl
INCIDENTAL TUMOR TEST COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
P=0.155N P-0.07 IN P=0.082N
P-Q. 143N P=0.054N P=0.082N
P=0.583N P=0.583N P-0.416N P=0.375N
P-0.500N P-0.500N
P-0.225N P=0.20 IN PB0.225N P*0.199N
PB0. I22N P=0.122M
R7-01UF
0.0
R7-01VF
PAGE:
5
VERSION: 1 1/13/84T
RUN DATE: 02/20/85
R7-0ILF
R7-C1HF
FEMALE
_________ L5_____
J-JI_
0/50 ( > O.OX
0/19 ( 0)
0/48 ( 0) a. ox
0/20 ( 0)
0/50 r 0) 8.OX
0/11 ( 0)
0/49 ( 0) O.OX
0/7 ( 0)
(a) (a) (a)
C a) (a) (>
(a) (a) (a)
(a) (a) (a)
(a) (a)
(a) (a)
______ til______
_____
0/50 ( 0) O.OX
0/19 ( 0)
0/48 ( 0) O.OX
0/20 ( 0)
0/50 ( 0) O.OX
0/11 ( 0)
0/49 ( 0) O.OX
0/7 C 0)
(a) ia) (a)
(a) (a) ( )
(a) (a) (a)
(a) (a) (a)
(a) (a)
(a) (a)
_____ ________
Ca)_________
cn
t-1
035668
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS _
CBDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
CO*546 TRICHLOROETHYLENE
GROUP IDS:
R7-01UM
R7-01VM
R7-OILH
R7-01HM
R7-01UF
R7-01VF
PAGE:
6
VERSION: 11/13/84T
RUN DATE> 02/20/85
R7-01LF
R7-D1HF
DOSE IN GH/KG
B. 0
KIDNEY NOS ALL TUMORS
TUHPB 8AI.ES OVERALL (a)
ADJUSTED (b> TERMINAL (c> FIRST INCIDENCE (MEEKS)
0/50 ( 0)
O.OX 0/21 ( 0)
STATISTICAL TESfS (d) LIFE TABLE
------- PM. 06 t-------
INCIDENTAL TUMOR TEST
P-0.056
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
PM.146
KIDNEY NOS TUBULAR-CELL ADENOMA
TMHPB. RATES OVERALL (a)
ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
STATISTICAL LIFE TABLE
(ill
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
0/50 ( 0) O.OX
0/21 ( 0)
PM.259 PM. 244 PM. 406
MALE 0.0
O.S
1.0
1/50 ( 4.5X
1/22 ( 105
2) 5)
6/50 ( 12)
32.2X 5/17 ( 29)
90
3/50 ( 6) 17.3X
2/15 ( 13) 92
---------- PM .008
P=0. 124
PM. 026
P-0.007
P=0. 122
PM.026
P-0.274
PM.013.
PM.056
P*0.065
PM.179 PM. 067 PM. 179
1
PM. 121
- ___
0/50 ( 0)
O.OX 0/22 ( 0)
6/50 ( 12)
32.2X 5/17 ( 29)
98
1/50 ( 6.7X
1/15 ( 104
2) 7)
PM. 246
PM. 243 PM. 406
____
PM. 008 PM. 007 PM. 007 PM. 007
PM. 0 13 PM .013_____
PM. 433 PM. 424 PM. 433 PM .424
PM.500 psQ.SOO
FEMALE 0.0 0.0 os_____________ Lup
1/50 (
5.3X
1/19 ( 105
2) 5)
0/50 ( 0)
O.OX 0/20 ( 0)
PM. 509------PM.633N PM .634
PM .293
PM .310 PM. 327
1/50 ( 2. IX
0/11 ( 35
2) 0)
1/49 ( 6.7X
0/7 ( 101
2) 0)
PM. 696 PM.508 PM. 723H PM .469
PM.753N PM.soe_____
PM. 6 10 PM. 424 PM. 7 50 PM. 567
PM .740 PM. 495
1/50 ( 5.3X
1/19 ( 105
2) 5)
0/50 ( 0) O.OX
0/20 ( 0)
0/50 ( 0) O.OX
0/11 ( 0)
1/49 ( 6.7 X
0/7 ( 101
2) 0)
P-0.520 P-0.640 P-0.665
--
PM.609N
PM. 223
1a) PM.609N
PM.319
(a)
P-0.266
PM .500N
--__ Ltl_________
PM .6 10 P-0.424 PM.750 PM. 567
PM. 748 P'-LI*1? --
SL 035669
SL 035670
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT' <00244 PAPANICOLAOU
CHEMICAL '
C04546 TRICHLOROETHYLENE
GROUP IDS'
R7-01UM
R7-01VH
R7-0ILH
R7-01HM
DOSE IN GM/KG
0.0
KIDNEY NOS TUBULAR-CELL ADENOMA TUBULAR-CELL ADENOCARCINOMA
TUMOR RATES
OVERALL U) ADJUSTED (b)
TERMINAL <c> FIRST INCIDENCE (MEEKS1
0/50 ( 0> O.OX
0/21 ( 0)
STATISTICAL -TESTS .Id*
LIFE TABLE
P-0.132
INCIDENTAL TUMOR TEST
P-0.123
COCKRAN-ARHITAGE TREND FISHER EXACT TESTS
P-0.252
PITUITARY ADENOMA, NOS
TUMQB RATES
OVERALL (a) ADJUSTED <b> TERMINAL (c> FIRST INCIDENCE (HEEKS)
STATISTICAL tfeStS <d) LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
14/46 ( 351 55.4X
9/21 ( 43) 90
P=0.3B0N
P-0.421N
P=0.193N
HALE 0.0
0.5
1.0
0/50 ( 0) O.OX
0/22 C 0)
6/50 ( 12) 32.2X
5/17 ( 29) 98
2/50 (
10.9X 1/15 (
92
4) 7)
P-0.125
P=0.122 P=0.252
P-0.008 P=0.007 P-0.007 P-0.007
P=0.013 P=0.013
P-0. 160 P-0. 158 P-0. 163 P-0. 158
P-0.247 P=0.247
11/42 ( 26) 42.OX
0/22 ( 36) 84
7/45 ( 16) 35. OX
5/17 ( 29) 86
10/38 ( 26) 50.6X
6/15 ( 40) 81
P-0.277
P-0.287 P-0.542N
P-0.103N P-0.41911
P=0.074N P-0.334N
P=0.497N P-O.294 P-0.57 IN P=0.300
Ps0.030N
P-0.276N
P=0,169H____ P=0594____
R7-0IUF
0.0
R7-01VF
PAGE'
7
VERSION' I1/13/S4T
RUN DATE' 02/20/85
R7-0ILF
R7-8IHF
FEMALE 0.0
05
______ LJ_____
1/50 ( 5.3X
1/19 (
105
2) 5)
0/50 ( 0) O.OX
0/20 ( 0)
0/50 ( 0) O.OX
0/11 ( 0)
1/49 C 6.7X
0/7 (
101
2) 0)
P=0.520 P-0.640 P-0.665
P-0.223 P-0.319 P-0.266
P-0.609N (e) P-0.609N {>
P-0.50QN fa)
P-0.6 10 P-0.424 P-0.750 P-0.567
P-0.748
13/47 ( 28)
61.6X 11/19 ( 58)
100
13/46 ( 28) 54.8X
10/20 ( 50)
74
9/47 C 19) 57.9X
5/11 ( 45) 93
8/46 ( 17) 50.6X
2/7 C 29) 71
P-0.313 P=0.43 IN P=0.139N
P-0.302
P-0.47 IN P-0.127N
P-0.472 F-0.437
P-0.492N
P-0.562N
P-0.358
P-0.3/3 P-0.52611
P-0.485N
P-6.233H
P-0. 175N
-P-Q. 2 ISA____ .=P^-16
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS:
R7-01UM
R7-01VM
R7-01LM
R7-01HM
R7-QIUF
R7-01VF
PAGE:
*
VERSION: I1/13/84T
RUN DATE: 02/20/85
R7-01LF
R7-DIHF
BPSE-IJt WkKP
PITUITARY ADENOMA, NOS CARCINOMA, NOS
_________ S.lQ-- ....
MALE 0.0 ___________ JLu5_______ :_____ LJU_____
TUMOR RATES OVERALL (a) ADJUSTED (b) TERMINAL <c) FIRST INCIDENCE (HEEKS)
5TAp|T|CAL TESlS.tdl
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
17/46 t 37I 56.42
9/21 ( 43) 66
P=0.305N P=0.311N
P-0.138N
11/42 < 26I 42.02
8/22 ( 36) 84
---------- ------
P=0.277
P=0.287 P=0.542N
7/45 ( 16) 35. OX
5/17 C 29) 86
P=0.073N P=0.419N P=0.044H P-0.334N
P-0.01811 P=0. 16911
10/38 ( 26) 50.62
6/15 ( 40) 81
F-0.424N P=Q.294 P=0.44SN P=0.300
P=0.2 11N P=0594____
ADRENAL CORTICAL ADENOMA
TU1iOR_RfiIS OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (HEEKS)
STATISTICAL TE5I5 Uil
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
11/50 ( 22) 40.32
7/21 ( 33) 78
P=0.192
P=0.239
P*0.548
9/50 ( 18) 32.42
5/22 ( 23) 88
P=0.094
P=0.t09 P0.356
11/49 ( 22) 41.12
3/17 ( 18) 80
P=Q.376 P=D.215 P=0.49 1 P=0.327
11/50 ( 22)
54.42
j
7/15 ( 47)(
3* 1I
P=0.227 |
P=0.115 P=0.364
P=0. 160
1 |
P=0.574
P=0.595H (
P = 0,382_____ P=0.401 1
JLJL
FEMALE
HJl__________ 9.Ji___________ LJL
13/47 ( 28) 61.62
11/19 ( 58) too
P=0.313
P=0.43 IN
P=0.139N
14/46 ( 30) 56.92
10/20 ( 50) 74 --
P=0.387
P*0.353N P=0.084N
9/47 C 19) 57.92
5/11 C 45) 93
P=0.472 P=0.522 P=0.492M P=0.466N
P*0.233N P=0-154H
8/46 ( 1?) 50.62
2/7 C 29) 71
P=0.358 Ps0.459 P=0.526 II P-0.S64N
P = 0.I75H f=a.J.UA
13/49 ( 27) 54.82
9/19 C 47)
82
16/50 ( 32) 55.62
9/20 ( 45)
61
13/50 ( 26)
66.32 6/11 ( 55)
75
19/49 ( 39)
92.72 6/7 ( 86)
^5
P=O.OOI P=0.017 P=0. 114
P-0.008
p=o.too P*fl.272
P-0.180 P=0.365 P=0.303
P=0.484N
P=0.001 p-a.oit
P=0.030 P=0. 127
P = 0.56711
P = 0. 141
P=0.330N____ P-0-310------
SL 035671
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CODS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL >
C04546 TRICHLOROETHYLENE
GROUP IDS)
R7-01UH
R7-01VM
R7-01LH
. R7-81HH
R7-81UF
R7-01VF
PAGE:
9
VERSION: 11/13/B4T
RUN DATE: 02/20/85
R7-01LF
R7-0IHF
DOSE IN GM/KG ADRENAL
PHEOCHRONOCYTOHA
ADJUSTED (b) TERMINAL tc) FIRST INCIDENCE CHEEKS)
atPtiiti1 TKlt (,i)
INCIDENTAL TUMOR TEST COCHRAN-ARHITAGE TREND FISHER EXACT TESTS
ALL ADRENAL SITES PHEOCHROMOCYTOMA
SFRI
ADJUSTED (b> TERMINAL (c> FIRST INCIDENCE (HEEKS)
INCIDENTAL TUMOR TEST COCHRAN-ARHITAGE TREND FISHER EXACT TESTS
MALE | FEMALE
0.0 0.0 0.5 1.0
0.0 0.0 0.5 ______LJt_____
9/50 ( 18)
34.OX 6/21 ( 29)
87
13/50 ( 26)
42.9X 7/22 ( 32)
74
6/49 ( 12)
31.6X 5/17 ( 29)
84
3/50 ( 6)
18.7X 2/15 ( 13)
103
P=0. 154N P=0.150N P=0.046N
P-0.028N
P-0.023N P=0.004N
P=0.472N P=0. I54N P=0.389N P=0. 128N
P=0.303N P=0.068N
P-0.193N P-0.052N P=0.2D8N PM.043H
P=0.06IN P=0.007N
3/49 ( 11.2X
1/19 (
83
6) 5)
8/50 ( 16) 30.4X
4/20 ( 20) 84
4/50 ( 18.8X
1/11 ( 87
8) 9)
1/49 C 6.7X
0/7 ( 101
2) 0)
P*0.427N P=0.200N P=0.25 IN
PS0.080N
P = 0.00911 P=O.Q11N
P=0.387 P=0.394H
P=0.48 1 P=0. 17811
P=0.46SN P = 0.11ON
P=0.249N P=0.G20N
P=0.511
P=0.30911
.. p?g.i7?H____ PM,<.1?N
9/50 ( IS) 34.8X
6/21 ( 29) 87
13/50 ( 26) 42.9X
7/22 < 32) 74
6/49 ( 12)
31.6X 5/17 ( 29)
84
3/50 C 6)
18.7X 2/15 ( 13) 103
P=0. 154N P-0. 150N P=0.046N
P-0.028N
P=Q.023N P=0.004N
P=0.472N P=0. 154H
P=0.389N
P=0. 128N
P=0. 193H P=0.052N
P=0.208N P=0.043N
P=0.30311
P=0.06 IN
P=0.068N____; Ps0.007H
4/49 < 8)
16. IX
2/19 ( 11)
S3
8/50 ( 16)
30.4X 4/20 ( 20>
84
4/50 (
18. ax 1/11 ( 87
8) 9)
1/49 C 6.7X
0/7 < 101
2) 0)
Ps0.323N P-0.138N P-0.I45N
P*0.080N
PM. 00911 P=0.0I1N
P*0.498 F=0.394H PM.592 P=0. 178N
PM.631N PM.179N
P-0.372H P=0.118N P=0.190N P=0.020N
P=0.18 HI
P*P.P17H
9^0
to
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT1 600244 PAPANICOLAOU
CHEMICAL)
C04546 TRICHLOROETHYLENE
GROUP IDS*
R7-01UM
R7-01VH
R7-01LM
R7-01HM
R7-01UF
R7-0IVF
PAGE)
tO
VERSION) 11/13/84T
RUN DATE) 02/20/85
R7-01LF
R7-01HF
MALE
MS-HL.QM'KG______________ _________ 0.0
ALL ADRENAL SITES PHEOCHROMOCYTOMA PHEOCHROMOCYTOMA, MALIGNANT
______ HJ__________ _JL5_____L______ LJ_____ _________ LJt______
iuHqr_r&ik OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE
(HEEKS)
10/50 ( 20) 39. IX
7/21 ( 33) 87
13/50 ( 26) 42.9X
7/22 C 32) 74
6/49 ( 12) 31.6X
5/17 C 29) 84
3/50 ( 6) 18.7X
2/15 ( 13) 103
4/49 ( 8) 16. IX
2/19 ( It)
83
FEMALE - _____________ U----------
9/50 ( 18) 33. IX
4/20 { 20)
84
6/50 ( 12) 26.8X f/ll ( 9)
87
1.0_____
1/49 ( 6.7X
0/7 ( 101
2) 0)
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
THYROID C-CELL ADENOMA
P=0. 100N P=0. 096N P=0. 026N
P=0.028N
P=0.023N P=0.004N
P=0.373N P=0. 15411 P=0.296N
P-0.128N
P-0. 135N P=0.052N P*0.146H
P=0.043N
P=0.220N
P-0.036N
P=0.068N____ Pg0.007N
P=0.359N P0.127N P=0.168H
P=0.073N
P=0.004N P=0.008N
P=0.241 P-0.564N P-0.350 P*0.252N
Pa0.383 P0.288N
P=0.372N P-0.084N P=0.190N P=0.009N
P-0. 18 1H P=0.009N__
ADJUSTED (b)
l
TERMINAL (c)
1
FIRST INCIDENCE (HEEKS)
STATISTICAL TESTS Ml
LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAH-ARMITAGE TREND FISHER EXACT TESTS
4/48 ( 8) 19.OX
4/21 ( 19) 104
8/49 ( 16)
33.9X 7/22 ( 32)
93
4/48 ( 8)
21.4X 3/17 ( 18)
99
1/48 ( 6.7X
1/15 ( 104
2) 7)
P=0.262N P=0.270N P*0. 146N
P-0.038N
P-0.038N P=0.011N
P=0.525
P=0.3I2N
P=0.525 P=0.299N
P=0.287N P=Q.055N
P=0.287N P=0.057N
P=0.643N
P=0. 18 IN
P=0.188N____ P=0.017N
5/49 ( 10) 24.2X
4/19 ( 21) 97
15/49 ( 31)
60.8X 11/20 ( 55)
62
5/49 ( 10) 32.7X
2/11 ( 18)
93
1/49 ( 6.7X
0/7 ( 101
2) 0)
P=0.352N P=0.134N P=Q.090N
P-Q.006N
P<0.00IN P<0.00 IN
/*0.334 P0. 127H P*0.541 Ps0.0S3H
pn.6Joti
P=0.348(1 P=(l. 0 13M P=0. 194(1 P-0.003N
P=Q. 102N PO.0O1N
SL 035673
SL 03567A
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT: 600244 PAPANICOLAOU
CHEMICAL:
C04546 TRICHLOROETHYLENE
GROUP IDS:
R7-01UM
R7-01VM
R7-81LM
R7-0IHM
POSE IH GM/RP______________
THYROID C-CELl ADENOMA C-CELL CARCINOMA
tUMSR-RATES OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (HEEKS)
i H i 1 I|jl 1II II IM
INCIDENTAL TUMOR TEST COCHRAH-ARMITAGE TREND FISHER EXACT TESTS
I 1
1 1
PANCREATIC ISLETS ISLET-CELL AOENOMA
TUHQft.RATES OVERALL La) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (HEERS)
Mitt1ianai
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
..... 0,0______
MALE
-JM__ '
_JL5____ _______ Ul_____
4/48 ( 8) 19. OX
4/21 C 191 104
9/49 ( 181 36.3X
7/22 ( 32) 93
4/48 ( 8)
21.4X 3/17 ( 18 >
99
1/48 ( 6.7X
1/15 ( 104
2) 7)
P-0.262N P=0.270N P=0.146N
Ps0.022N
P=0.022H P-0.005N
P=0.525 P-0.224N
P-0.525 P-0.211N
P=0.287N P=0.03SN P=0.287N P*0.039N
P-0.643H
P=0.181N
P=0. 125N____ PS0P09N
1/50 ( 4.8X
1/21 ( 105
2) 5)
3/49 (
12.OX 1/22 C
98
6) 5)
2/50 ( 4) 11.8X
2/17 ( 12) 104
0/50 ( 0) O.OX
0/15 ( 0)
P=0.454N P-0.454N P=0.36ON
P=0.152N
P=0.155N P=0.079N
P=Q.425 P-0.602N P=0.425 P-0.590N
P=0.500 P=Q.49 IN
P=0.567N P=0.203N P=0.567N P=0.213N
P=0.500N P=0 118N
R7-01UF
R7-01VF
PAGE:
11
VERSION: 11/13/84T
RUN DATE: 02/20/8S
R7-01LF
R7-0IHF
FEMALE
o.o______ ______ U_____________L-5______ .
1JI
5/49 1 10) 24. 2X
4/19 < 21) 97
15/49 (31) 60.8X
11/20 ( 55) 62
5/49 ( 10) 32.7X
2/11 ( 18)
93
1/49 (
6.7X 0/7 (
101
2) 0)
P=0. 352N P*0. 134N P=0. 090N
P*0.006H
P<0.001N P<8.00 IN
P=0.334 P-0. 127H Ps0.541
Pb0.053N
P=0.348N
P=0.0 13H P-0. 194H
P-0.003N
P-0.63QN
P-0. 102N
p*odiin____ P<0.00IN
0/50 ( 0) O.OX
0/19 ( 0)
3/50 ( 6) 14. IX
2/20 ( 10)
101
1/48 ( 3.2X
0/11 (
87
2) 0)
0/49 ( 0) O.OX
0/7 ( 0)
P-0.715 P*fl.670N P=0.727
P-0.153N
P=0.078N P=0.06311
F = 0.507
P=0.456N P=0.519 P-0.365N
(a)
P=0.29411 () P=0.22 IN
P=0.490
(e>
. -Rf Q 324H____ --P=iL 125H
SL 035675
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT 600244 PAPANICOLAOU
CHEMICAL:
CQ4546 TRICHLOROETHYLENE
GROUP IDS<
R7-01UM
R7-01VN
R7-0IlM
R7-01HM
DOSE IN GM/KG
PANCREATIC ISLETS ISLET-CELL ADENOMA ISLET-CELL CARCINOMA
0.0
HALE 0.0
0.5
1.0
ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
STATtSTIGAI TFST5 frfl LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
MAMMARY GLAND . ALL TUMORS
TUMPR RATES
|
OVERALL (a)
1
ADJUSTED (b)
1
TERMINAL (c)
FIRST INCIDENCE (MEEKS) 1
5JAJISTI&SL ttsts (d)
INCIDENTAL TUMOR TEST COCHRAN-ARHITAGE TREND FISHER EXACT TESTS
1 [ 1
1/50 (
4.8X
1/21 ( 105 .
2) 5)
4/49 ( 16. IX
2/22 ( 98
8) 9)
2/50 ( 4)
11.8X 2/17 ( 12) 104
0/50 ( 0) O.OX
0/15 ( 0)
P*0.A5AN P=0.A5AN P-0.36ON
P=0.082H
P=0.083N P-0.035N
P=0.425 P=0.448N P=0.425 P=0.435N
P=0.500 P=0.329N
P-0.567H P=0.127N P=0.567N P-0. 133N
P=0.500H P=0.057N
2/50 ( 6.8X
0/21 ( 95
4) 0)
0/50 ( 0)
O.OX 0/22 ( 0)
0/50 ( 0) O.OX
0/17 ( 0)
1/50 ( 5.OX
0/15 (
96
2) 0)
P=0.490N P=0.576N P*0.360N
P=0.220
P=0.200 P=0.269
P=0.313N (a) P=0.320N (a)
P=0.656N P=0.426 P=0.722
Ps0.398
P=0.248N
P=0.500N
(e>_________ _ P=0.500____
R7-01UF 0.0
R7-01VF
PAGE:
12
VERSION: 11/13/84T
RUN DATE: 02/20/85
R7-01LF
R7-01HF
FEMALE 0.0
8.5_______
1.0
0/50 ( 0) O.OX
0/19 ( 0)
3/50 ( 6)
14. IX 2/20 ( 10) 101
1/48 (
3.2X
0/11 I 87
2) 0>
0/49 ( 0) O.OX
0/7 ( 0)
P=0.715 P-0.670N P=0.727
P=0.153N P=0.078N P=0.063N
P=0.507 Ps0.456N P=0.519 P-0.365N
() P = 0.29411 (a) P=0.22111
P=0.490
(a)
P=0.324H____ P=0.125N
17/50 ( 34) 50.OX
5/19 ( 26) 62
16/50 ( 32) 48.2X
6/20 ( 30) 33
9/50 ( 18) 48.6X
3/11 ( 27) 74
14/50 ( 28) 69.5X
3/7 ( 43) 60
P*0.312 P=0.257N Ps0.286N
Ps0.202
P=0.372N P=0.366N
P=0.254N P=0.352N P=0.066N P=0. 106H
P=0.055N P=0 033N
P=0.345 P=0.229 P=0.27 3N P=0.36711
P-O.JiiH P=0,4 14H
INTERCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
CBDS CONTRACT) 600244 PAPANICOLAOU
CHEMICAL)
CQ4546 TRICHLOROETHYLENE
GROUP IDS)
R7-0TUM
R7-0 1VM
R7-01LM
R7-01HM
R7-0IUF
R7-01VF
PAGE<
IJ
VERSION) 11/I3/84T
RUN DATE* 02/20/85
R7-0ILF
R7-0THF
BQS IH gtf/M?___________ _______ ILJt_____
MAMMARY GLAND FIBROADENOMA
MALE
FEMALE
00________ -JLv?_____ _____ 1*1____ _______ Lufi_____ _____ ILJ__________ IL.5_____
t.o____
overall*!*)
ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
STATISTICAL TESTS <d) LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARM1TAGE TREND FISHER EXACT TESTS
1/50 ( 3.SiC
0/21 ( 102
2) 0)
P=0.342N P-0.375H P-0.269N
UTERUS NOS ENDOMETRIAL STROMAL POLYP
IUM9R RATES
OVERALL (a) ADJUSTED (b) TERMINAL (c) FIRST INCIDENCE (MEEKS)
STATISTICAL TESTS ld>
LIFE TABLE
INCIDENTAL TUMOR TEST
COCHRAN-ARMITAGE TREND FISHER EXACT TESTS
'
0/50 ( 0) 0. ax
0/22 t 0)
0/50 ( 0) 0.0X
0/17 ( 0)
0/50 ( 0)
0.0X 0/15 ( 0)
P=0.573N
P=0.597H
(a) (a) (a)
P=0.573H
P=0.654N
(a) (a) (a)
(a)
P=0.500N
P=0.500N
1___________ <>_________
Y
17/50 ( 34) 50. OX
5/19 ( 26) 62
14/50 ( 28)
45. IX 6/20 ( 30)
33
7/50 ( 14) 39.4X
2/11 ( 18)
74
11/50 ( 22)
56. IX 2/7 ( 29)
80
P=0.452N P=0.076N P=0,097H
P30.335
P=0.289H P=0.27 IN
P-0.117N P=0.29!N P=0.02 IN P*0. 104N
P-0.017(1
P-0.523N P=0.350 P-0.095N P=0.33 Oil
P-O.133N P=0.323H
4/50 ( 8) 14.5X
2/19 ( 11) 54
6/49 ( 12) 19.SX
2/20 ( 10)
61
1/49 ( 4.3X
0/11 (
90
2) 0)
6/50 ( 12) 24.9X
0/7 ( 0) 79
P=0.161 P=0.330 P-0.283
P-0.365
P-0.37 911 Pa0.558H
P=0.287N F = 0. 122H P=0.269N P=0.039N
P=0. 188(1 P=0.056N
P=0.205 P-0.386 P=0.417 Pa0.414N
P=0.370 -R?JL4JJH
CO
9^ C 0
NTEflCURRENT MORTALITY ADJUSTED TUMOR INCIDENCE ANALYSIS FOR RATS
:BDS CONTRACT > 60024* PAPANICOLAOU
HEMICAL'
C04546 TRICHLOROETHYLENE
JROUP IDS'
R7-0IUM
R7-01VM
R7-01LM
R7-01HM
R7-01UF
R7-01VF
PAGE>
14
VERSION *
11/13/84T
RUN DATE: 02/20/85
R7-01LF
R7-01HF
SL 035677
MALE
FEMALE
_______ .
ITERUS NOS ADENOCARCINOMA, NOS
0-0________ 9.5
10 _______ SLJt_____ _____ m__________ JLJ_____ _____ LJI____
mqqath
IVERALL la) iDJUSTED (b> ERMINAL (c)
CHEEKS)
D/50 C D)
0.0X 0/19 ( 0)
1/49 C
5.OX 1/20 ( 105
2) 5)
5/49 C 10) 32.7X
3/11 ( 27) 87
2/50 ( 4)
19.3X 1/7 ( 14) 98
IFE TABLE
S <d)
TEST TREND TS
P=0.068 P=0.128 P*0.239
P30.119
Ps0.233 P=0.421
p-o .an P=0.030 P30.013 P=0.055.
P-0.027
P-0.113 P-0.226 P=0.192 P30.305
P=0.247 PfQ.SM____
ITERUS NOS
ENDOMETRIAL STROMAL POLYP ENDOMETRIAL STROMAL SARCOMA
UMOR RATES IVERALL (a) .DJUSTED (b)
ERMINAL (c> IRST INCIDENCE CHEEKS)
4/50 ( 8)
14.5X 2/19 ( 11)
54
6/49 ( 12) 19.8X
2/20 C 10) 61
1/49 C 4. 3X
0/11 C
90
2) 0)
6/50 C 12) 24. 9X
0/7 C 0) 79
HiE TABLE
3S
NCIDENTAL TUMOR TEST
:OCHRAN-ARMITAGE TREND ISHER EXACT TESTS
Pa9.161 P=0.330 P=0.283
P=0.365
P=0.379N P-0.558N
P-0.287N P=0.122N P=0.269N Ps0.039N
P=0.188N
P=0.205 P = 0.3S6 P=0.417 Ps0.414N
P=0.370 flUHKH
.) Number of -tumor'bearing animals/number of animals examined at the site Ipercent).
t) Kaplan-Meier estimated lifetime tumor incidence after adjusting for intercurrent mortality. :) Observed tumor incidence at terminal kill. I) Bendath the control incidence are the P-values associated with the trend test.
Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between that dosed group and the controls. The life table analysis
regards tumors in animals dying prior to terminal kill as beinq (directly or indirectly) the cause of death. The incidental tumor test reqards those lesions as non-fatal. The Cochran-Armitage and Fisher's exact tests compare directly
the overall incidence rates. A negative trend is indicated by H. >) Differences not significant; no tumors observed in dosed group or control group.