TDMS Study 96020-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) DATE: 03/03/04
EXPERIMENT: 96020 TEST: 01 TIME: 13:56:23
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96020
PATHOLOGIST: SELLS, DONALD CAS: TEFBINARYMIX
------------------------------------------------------------------------------------------------------------------------------------
53 WEEK SSAC FINAL #1
REASONS FOR REMOVAL: 25017 Scheduled Sacrifice
REMOVAL DATE RANGE: 091699 091799
TREATMENT GROUPS: INCLUDE 001 0 NG / 0 UG
INCLUDE 004 300 NG /100 UG
INCLUDE 005 300 NG /300 UG
INCLUDE 006 300 NG /3000 UG
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) DATE: 03/03/04
EXPERIMENT: 96020 TEST: 01 TIME: 13:56:23
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96020
PATHOLOGIST: SELLS, DONALD CAS: TEFBINARYMIX
Rats(SPRAGUE-DAWLEY)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) DATE: 03/03/04
EXPERIMENT: 96020 TEST: 01 TIME: 13:56:23
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96020
PATHOLOGIST: SELLS, DONALD CAS: TEFBINARYMIX
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TEF EVALUATION (BINARY MIXTURE; PCB 126
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
===============================================================
Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 1
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 300 NG / 300 NG / 300 NG / |
| | 0 UG 100 UG 300 UG 3000 UG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/13 (0%) 2/10 (20%) 3/13 (23%) 1/9 (11%) |
|POLY-3 RATE (b) | 0/0.64 2/2.39 3/3.49 1/1.39 |
|POLY-3 PERCENT (g) | 0.0% 83.6% 85.9% 71.8% |
|INT SACRIFICE 1 (c)| 0/13 (0%) 2/10 (20%) 3/13 (23.1%) 1/9 (11.1%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 366 (I) 366 (I) 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.674N P=0.179 P=0.114 P=0.427 |
|POLY 3 | P=0.511N P=0.047 * P=0.031 * P=0.125 |
|POLY 1.5 | P=0.542N P=0.065 P=0.042 * P=0.172 |
|POLY 6 | P=0.501N P=0.043 * P=0.029 * P=0.113 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.676N P=0.178 P=0.110 P=0.409 |
|ORDER RESTRICTED | P=0.101 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 300 NG / 300 NG / 300 NG / |
| | 0 UG 100 UG 300 UG 3000 UG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/13 (0%) 2/10 (20%) 3/13 (23%) 1/9 (11%) |
|POLY-3 RATE (b) | 0/0.64 2/2.39 3/3.49 1/1.39 |
|POLY-3 PERCENT (g) | 0.0% 83.6% 85.9% 71.8% |
|INT SACRIFICE 1 (c)| 0/13 (0%) 2/10 (20%) 3/13 (23.1%) 1/9 (11.1%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 366 (I) 366 (I) 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.674N P=0.179 P=0.114 P=0.427 |
|POLY 3 | P=0.511N P=0.047 * P=0.031 * P=0.125 |
|POLY 1.5 | P=0.542N P=0.065 P=0.042 * P=0.172 |
|POLY 6 | P=0.501N P=0.043 * P=0.029 * P=0.113 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.676N P=0.178 P=0.110 P=0.409 |
|ORDER RESTRICTED | P=0.101 (e) (e) (e) |
|=================================================================================================================================|
Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 2
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 300 NG / 300 NG / 300 NG / |
| | 0 UG 100 UG 300 UG 3000 UG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/13 (0%) 2/10 (20%) 4/13 (31%) 1/9 (11%) |
|POLY-3 RATE (b) | 0/0.64 2/2.39 4/4.44 1/1.39 |
|POLY-3 PERCENT (g) | 0.0% 83.6% 90.0% 71.8% |
|INT SACRIFICE 1 (c)| 0/13 (0%) 2/10 (20%) 4/13 (30.8%) 1/9 (11.1%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 366 (I) 366 (I) 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.610N P=0.179 P=0.055 P=0.427 |
|POLY 3 | P=0.452N P=0.047 * P=0.011 * P=0.125 |
|POLY 1.5 | P=0.483N P=0.065 P=0.016 * P=0.172 |
|POLY 6 | P=0.443N P=0.043 * P=0.011 * P=0.113 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.611N P=0.178 P=0.048 * P=0.409 |
|ORDER RESTRICTED | P=0.070 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 300 NG / 300 NG / 300 NG / |
| | 0 UG 100 UG 300 UG 3000 UG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/8 (25%) 0/10 (0%) 1/8 (13%) 0/9 (0%) |
|POLY-3 RATE (b) | 2/2.30 0/0.49 1/1.34 0/0.44 |
|POLY-3 PERCENT (g) | 87.1% 0.0% 74.4% 0.0% |
|INT SACRIFICE 1 (c)| 2/8 (25%) 0/10 (0%) 1/8 (12.5%) 0/9 (0%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) --- 366 (I) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.326N P=0.185N P=0.500N P=0.207N |
|POLY 3 | P=0.137N P=0.047N* P=0.314N P=0.057N |
|POLY 1.5 | P=0.166N P=0.066N P=0.348N P=0.078N |
|POLY 6 | P=0.133N P=0.043N* P=0.304N P=0.052N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.323N P=0.183N P=0.500N P=0.206N |
|ORDER RESTRICTED | P=0.170N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 3
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 300 NG / 300 NG / 300 NG / |
| | 0 UG 100 UG 300 UG 3000 UG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/8 (25%) 0/10 (0%) 1/8 (13%) 0/9 (0%) |
|POLY-3 RATE (b) | 2/2.30 0/0.49 1/1.34 0/0.44 |
|POLY-3 PERCENT (g) | 87.1% 0.0% 74.4% 0.0% |
|INT SACRIFICE 1 (c)| 2/8 (25%) 0/10 (0%) 1/8 (12.5%) 0/9 (0%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) --- 366 (I) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.326N P=0.185N P=0.500N P=0.207N |
|POLY 3 | P=0.137N P=0.047N* P=0.314N P=0.057N |
|POLY 1.5 | P=0.166N P=0.066N P=0.348N P=0.078N |
|POLY 6 | P=0.133N P=0.043N* P=0.304N P=0.052N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.323N P=0.183N P=0.500N P=0.206N |
|ORDER RESTRICTED | P=0.170N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 300 NG / 300 NG / 300 NG / |
| | 0 UG 100 UG 300 UG 3000 UG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/13 (15%) 2/10 (20%) 3/13 (23%) 1/9 (11%) |
|POLY-3 RATE (b) | 2/2.54 2/2.39 3/3.49 1/1.39 |
|POLY-3 PERCENT (g) | 78.7% 83.6% 85.9% 71.8% |
|INT SACRIFICE 1 (c)| 2/13 (15.4%) 2/10 (20%) 3/13 (23.1%) 1/9 (11.1%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.470N P=0.602 P=0.500 P=0.632N |
|POLY 3 | P=0.330N P=0.436 P=0.354 P=0.431N |
|POLY 1.5 | P=0.355N P=0.466 P=0.381 P=0.468N |
|POLY 6 | P=0.323N P=0.428 P=0.347 P=0.422N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.470N P=0.596 P=0.500 P=0.642N |
|ORDER RESTRICTED | P=0.506N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 4
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 300 NG / 300 NG / 300 NG / |
| | 0 UG 100 UG 300 UG 3000 UG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/13 (15%) 2/10 (20%) 4/13 (31%) 1/9 (11%) |
|POLY-3 RATE (b) | 2/2.54 2/2.39 4/4.44 1/1.39 |
|POLY-3 PERCENT (g) | 78.7% 83.6% 90.0% 71.8% |
|INT SACRIFICE 1 (c)| 2/13 (15.4%) 2/10 (20%) 4/13 (30.8%) 1/9 (11.1%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.420N P=0.602 P=0.324 P=0.632N |
|POLY 3 | P=0.290N P=0.436 P=0.211 P=0.431N |
|POLY 1.5 | P=0.314N P=0.466 P=0.231 P=0.468N |
|POLY 6 | P=0.284N P=0.428 P=0.205 P=0.422N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.419N P=0.596 P=0.322 P=0.642N |
|ORDER RESTRICTED | P=0.442N (e) (e) (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) 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 the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).