TDMS Study 96022-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 04/27/04
EXPERIMENT: 96022 TEST: 02 TIME: 14:17:54
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022
PATHOLOGIST: MISSING CAS: TEFPCBMIX
------------------------------------------------------------------------------------------------------------------------------------
CONTROL & STOP GRPS FINAL#1
REASONS FOR REMOVAL: 25018 Dosing Accident
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 NG / 0 UG
INCLUDE 007 4000 NG/500UG ST
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 04/27/04
EXPERIMENT: 96022 TEST: 02 TIME: 14:17:54
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022
PATHOLOGIST: MISSING CAS: TEFPCBMIX
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.
---------------
Adrenal Cortex
Adrenal Medulla
Brain
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pituitary Gland
Thymus
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 04/27/04
EXPERIMENT: 96022 TEST: 02 TIME: 14:17:54
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022
PATHOLOGIST: MISSING CAS: TEFPCBMIX
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TEF EVALUATION (PCB MIXTURE;PCB 126/P
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Benign
Islets, Pancreatic Carcinoma or Adenoma
Liver Cholangiocarcinoma
Hepatocellular Adenoma
Lung Cystic Keratinizing Epithelioma
Mammary Gland Adenoma
Carcinoma
Carcinoma or Adenoma
Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthom
a, Trichoepitheliom
Thyroid Gland: C-Cell Adenoma
Carcinoma
Carcinoma or Adenoma
Uterus Polyp Stromal
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 04/27/04 EXPERIMENT: 96022 TEST: 02 Page 1
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/41.89 0/20.06 |
|POLY-3 PERCENT (g) | 7.2% 0.0% |
|TERMINAL (d) | 3/27 (11%) 0/9 (0%) |
|FIRST INCIDENCE | 726 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.366N |
|POLY 3 | P=0.444N |
|POLY 1.5 | P=0.322N |
|POLY 6 | P=0.548N |
|LOGISTIC REGRESSION| (e) |
|COCH-ARM / FISHERS | P=0.136N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.25 0/21.06 |
|POLY-3 PERCENT (g) | 4.7% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 649 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.477N |
|POLY 3 | P=0.585N |
|POLY 1.5 | P=0.466N |
|POLY 6 | P=0.678N |
|LOGISTIC REGRESSION| P=0.396N |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 04/27/04 EXPERIMENT: 96022 TEST: 02 Page 2
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Liver |
| Cholangiocarcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 19/50 (38%) |
|POLY-3 RATE (b) | 0/41.89 19/25.21 |
|POLY-3 PERCENT (g) | 0.0% 75.4% |
|TERMINAL (d) | 0/27 (0%) 8/10 (80%) |
|FIRST INCIDENCE | --- 303 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** |
|POLY 3 | P<0.001 ** |
|POLY 1.5 | P<0.001 ** |
|POLY 6 | P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/41.89 1/21.82 |
|POLY-3 PERCENT (g) | 4.8% 4.6% |
|TERMINAL (d) | 2/27 (7%) 0/10 (0%) |
|FIRST INCIDENCE | 726 (T) 451 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.695 |
|POLY 3 | P=0.805N |
|POLY 1.5 | P=0.730N |
|POLY 6 | P=0.823 |
|LOGISTIC REGRESSION| P=0.662N |
|COCH-ARM / FISHERS | P=0.522N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 04/27/04 EXPERIMENT: 96022 TEST: 02 Page 3
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Lung |
| Cystic Keratinizing Epithelioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 12/50 (24%) |
|POLY-3 RATE (b) | 0/41.89 12/28.27 |
|POLY-3 PERCENT (g) | 0.0% 42.5% |
|TERMINAL (d) | 0/27 (0%) 3/10 (30%) |
|FIRST INCIDENCE | --- 240 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** |
|POLY 3 | P<0.001 ** |
|POLY 1.5 | P<0.001 ** |
|POLY 6 | P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.41 0/21.06 |
|POLY-3 PERCENT (g) | 4.7% 0.0% |
|TERMINAL (d) | 1/27 (4%) 0/10 (0%) |
|FIRST INCIDENCE | 567 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.442N |
|POLY 3 | P=0.587N |
|POLY 1.5 | P=0.468N |
|POLY 6 | P=0.680N |
|LOGISTIC REGRESSION| P=0.344N |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 04/27/04 EXPERIMENT: 96022 TEST: 02 Page 4
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 5/53 (9%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/42.77 1/22.03 |
|POLY-3 PERCENT (g) | 11.7% 4.5% |
|TERMINAL (d) | 4/27 (15%) 0/10 (0%) |
|FIRST INCIDENCE | 362 209 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.347N |
|POLY 3 | P=0.420N |
|POLY 1.5 | P=0.306N |
|POLY 6 | P=0.510N |
|LOGISTIC REGRESSION| P=0.103N |
|COCH-ARM / FISHERS | P=0.116N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 6/53 (11%) 1/50 (2%) |
|POLY-3 RATE (b) | 6/43.29 1/22.03 |
|POLY-3 PERCENT (g) | 13.9% 4.5% |
|TERMINAL (d) | 4/27 (15%) 0/10 (0%) |
|FIRST INCIDENCE | 362 209 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.264N |
|POLY 3 | P=0.334N |
|POLY 1.5 | P=0.223N |
|POLY 6 | P=0.429N |
|LOGISTIC REGRESSION| P=0.053N |
|COCH-ARM / FISHERS | P=0.066N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 04/27/04 EXPERIMENT: 96022 TEST: 02 Page 5
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 42/53 (79%) 12/50 (24%) |
|POLY-3 RATE (b) | 42/51.89 12/23.73 |
|POLY-3 PERCENT (g) | 81.0% 50.6% |
|TERMINAL (d) | 19/27 (70%) 5/10 (50%) |
|FIRST INCIDENCE | 275 504 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.134N |
|POLY 3 | P=0.015N* |
|POLY 1.5 | P<0.001N** |
|POLY 6 | P=0.108N |
|LOGISTIC REGRESSION| P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 42/53 (79%) 12/50 (24%) |
|POLY-3 RATE (b) | 42/51.89 12/23.73 |
|POLY-3 PERCENT (g) | 81.0% 50.6% |
|TERMINAL (d) | 19/27 (70%) 5/10 (50%) |
|FIRST INCIDENCE | 275 504 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.134N |
|POLY 3 | P=0.015N* |
|POLY 1.5 | P<0.001N** |
|POLY 6 | P=0.108N |
|LOGISTIC REGRESSION| P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 04/27/04 EXPERIMENT: 96022 TEST: 02 Page 6
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 42/53 (79%) 13/50 (26%) |
|POLY-3 RATE (b) | 42/51.89 13/24.70 |
|POLY-3 PERCENT (g) | 81.0% 52.6% |
|TERMINAL (d) | 19/27 (70%) 5/10 (50%) |
|FIRST INCIDENCE | 275 209 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.182N |
|POLY 3 | P=0.019N* |
|POLY 1.5 | P<0.001N** |
|POLY 6 | P=0.121N |
|LOGISTIC REGRESSION| P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 30/53 (57%) 0/50 (0%) |
|POLY-3 RATE (b) | 30/44.61 0/21.06 |
|POLY-3 PERCENT (g) | 67.3% 0.0% |
|TERMINAL (d) | 21/27 (78%) 0/10 (0%) |
|FIRST INCIDENCE | 582 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** |
|POLY 3 | P<0.001N** |
|POLY 1.5 | P<0.001N** |
|POLY 6 | P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 04/27/04 EXPERIMENT: 96022 TEST: 02 Page 7
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.89 0/21.06 |
|POLY-3 PERCENT (g) | 4.8% 0.0% |
|TERMINAL (d) | 2/27 (7%) 0/10 (0%) |
|FIRST INCIDENCE | 726 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.474N |
|POLY 3 | P=0.579N |
|POLY 1.5 | P=0.464N |
|POLY 6 | P=0.667N |
|LOGISTIC REGRESSION| (e) |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 9/53 (17%) 4/49 (8%) |
|POLY-3 RATE (b) | 9/43.64 4/20.78 |
|POLY-3 PERCENT (g) | 20.6% 19.3% |
|TERMINAL (d) | 4/27 (15%) 3/9 (33%) |
|FIRST INCIDENCE | 548 474 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.523 |
|POLY 3 | P=0.653N |
|POLY 1.5 | P=0.481N |
|POLY 6 | P=0.673 |
|LOGISTIC REGRESSION| P=0.526N |
|COCH-ARM / FISHERS | P=0.150N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 04/27/04 EXPERIMENT: 96022 TEST: 02 Page 8
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 0/49 (0%) |
|POLY-3 RATE (b) | 4/42.04 0/20.06 |
|POLY-3 PERCENT (g) | 9.5% 0.0% |
|TERMINAL (d) | 3/27 (11%) 0/9 (0%) |
|FIRST INCIDENCE | 688 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.266N |
|POLY 3 | P=0.330N |
|POLY 1.5 | P=0.219N |
|POLY 6 | P=0.434N |
|LOGISTIC REGRESSION| P=0.252N |
|COCH-ARM / FISHERS | P=0.069N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 13/53 (25%) 4/49 (8%) |
|POLY-3 RATE (b) | 13/43.79 4/20.78 |
|POLY-3 PERCENT (g) | 29.7% 19.3% |
|TERMINAL (d) | 7/27 (26%) 3/9 (33%) |
|FIRST INCIDENCE | 548 474 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.471N |
|POLY 3 | P=0.367N |
|POLY 1.5 | P=0.198N |
|POLY 6 | P=0.523N |
|LOGISTIC REGRESSION| P=0.275N |
|COCH-ARM / FISHERS | P=0.024N* |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 04/27/04 EXPERIMENT: 96022 TEST: 02 Page 9
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 11/53 (21%) 8/50 (16%) |
|POLY-3 RATE (b) | 11/44.47 8/23.60 |
|POLY-3 PERCENT (g) | 24.7% 33.9% |
|TERMINAL (d) | 4/27 (15%) 2/10 (20%) |
|FIRST INCIDENCE | 534 541 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.163 |
|POLY 3 | P=0.368 |
|POLY 1.5 | P=0.490 |
|POLY 6 | P=0.311 |
|LOGISTIC REGRESSION| P=0.424 |
|COCH-ARM / FISHERS | P=0.357N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 53/53 (100%) 28/50 (56%) |
|POLY-3 RATE (b) | 53/53.00 28/33.22 |
|POLY-3 PERCENT (g) | 100.0% 84.3% |
|TERMINAL (d) | 27/27 (100%) 9/10 (90%) |
|FIRST INCIDENCE | 275 240 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.149 |
|POLY 3 | P=0.002N** |
|POLY 1.5 | P<0.001N** |
|POLY 6 | P=0.024N* |
|LOGISTIC REGRESSION| P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 04/27/04 EXPERIMENT: 96022 TEST: 02 Page 10
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 16/53 (30%) 20/50 (40%) |
|POLY-3 RATE (b) | 16/44.14 20/26.19 |
|POLY-3 PERCENT (g) | 36.3% 76.4% |
|TERMINAL (d) | 10/27 (37%) 8/10 (80%) |
|FIRST INCIDENCE | 362 209 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** |
|POLY 3 | P<0.001 ** |
|POLY 1.5 | P=0.008 ** |
|POLY 6 | P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** |
|COCH-ARM / FISHERS | P=0.201 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 4000 NG/ |
| | 0 UG 500UG ST |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 53/53 (100%) 36/50 (72%) |
|POLY-3 RATE (b) | 53/53.00 36/36.82 |
|POLY-3 PERCENT (g) | 100.0% 97.8% |
|TERMINAL (d) | 27/27 (100%) 10/10 (100%) |
|FIRST INCIDENCE | 275 209 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.005 ** |
|POLY 3 | P=0.793N |
|POLY 1.5 | P=0.003N** |
|POLY 6 | P=1.000N |
|LOGISTIC REGRESSION| P=0.166N |
|COCH-ARM / FISHERS | P<0.001N** |
|ORDER RESTRICTED | (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).