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: 06/10/04
EXPERIMENT: 96022 TEST: 02 TIME: 09:49:11
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022
PATHOLOGIST: MISSING CAS: TEFPCBMIX
Rats(SD)
-----------------------------
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
Clitoral/Preputial Gland
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pancreas
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: 06/10/04
EXPERIMENT: 96022 TEST: 02 TIME: 09:49:11
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
----- ----------
Liver Cholangiocarcinoma
Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Cystic Keratinizing Epithelioma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
Uterus Polyp Stromal
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 1
Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 4000 NG/ 4000 NG/ |
| | 500UG ST 500 UG |
|=================================================================================================================================|
| |
|Liver |
| Cholangiocarcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 19/50 (38%) 12/65 (18%) |
|POLY-3 RATE (b) | 19/25.19 12/17.30 |
|POLY-3 PERCENT (g) | 75.4% 69.4% |
|TERMINAL (d) | 8/10 (80%) 0/0 (0%) |
|FIRST INCIDENCE | 303 294 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** |
|POLY 3 | P=0.516N |
|POLY 1.5 | P=0.091N |
|POLY 6 | P=0.551 |
|LOGISTIC REGRESSION| P=0.102 |
|COCH-ARM / FISHERS | P=0.017N* |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 4000 NG/ 4000 NG/ |
| | 500UG ST 500 UG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 5/65 (8%) |
|POLY-3 RATE (b) | 1/21.77 5/13.16 |
|POLY-3 PERCENT (g) | 4.6% 38.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 451 245 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.025 * |
|POLY 3 | P=0.038 * |
|POLY 1.5 | P=0.072 |
|POLY 6 | P=0.027 * |
|LOGISTIC REGRESSION| P=0.156 |
|COCH-ARM / FISHERS | P=0.176 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 2
Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 4000 NG/ 4000 NG/ |
| | 500UG ST 500 UG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 5/65 (8%) |
|POLY-3 RATE (b) | 1/21.77 5/13.16 |
|POLY-3 PERCENT (g) | 4.6% 38.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 451 245 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.025 * |
|POLY 3 | P=0.038 * |
|POLY 1.5 | P=0.072 |
|POLY 6 | P=0.027 * |
|LOGISTIC REGRESSION| P=0.156 |
|COCH-ARM / FISHERS | P=0.176 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 4000 NG/ 4000 NG/ |
| | 500UG ST 500 UG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 5/65 (8%) |
|POLY-3 RATE (b) | 1/21.77 5/13.16 |
|POLY-3 PERCENT (g) | 4.6% 38.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 451 245 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.025 * |
|POLY 3 | P=0.038 * |
|POLY 1.5 | P=0.072 |
|POLY 6 | P=0.027 * |
|LOGISTIC REGRESSION| P=0.156 |
|COCH-ARM / FISHERS | P=0.176 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 3
Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 4000 NG/ 4000 NG/ |
| | 500UG ST 500 UG |
|=================================================================================================================================|
| |
|Lung |
| Cystic Keratinizing Epithelioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 12/50 (24%) 41/66 (62%) |
|POLY-3 RATE (b) | 12/28.23 41/42.27 |
|POLY-3 PERCENT (g) | 42.5% 97.0% |
|TERMINAL (d) | 3/10 (30%) 0/0 (0%) |
|FIRST INCIDENCE | 240 260 |
|-------------------| |
|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 | 4000 NG/ 4000 NG/ |
| | 500UG ST 500 UG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 12/50 (24%) 6/66 (9%) |
|POLY-3 RATE (b) | 12/23.70 6/14.33 |
|POLY-3 PERCENT (g) | 50.6% 41.9% |
|TERMINAL (d) | 5/10 (50%) 0/0 (0%) |
|FIRST INCIDENCE | 504 222 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.032 * |
|POLY 3 | P=0.491N |
|POLY 1.5 | P=0.124N |
|POLY 6 | P=0.607 |
|LOGISTIC REGRESSION| P=0.611N |
|COCH-ARM / FISHERS | P=0.027N* |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 4
Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 4000 NG/ 4000 NG/ |
| | 500UG ST 500 UG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 12/50 (24%) 6/66 (9%) |
|POLY-3 RATE (b) | 12/23.70 6/14.33 |
|POLY-3 PERCENT (g) | 50.6% 41.9% |
|TERMINAL (d) | 5/10 (50%) 0/0 (0%) |
|FIRST INCIDENCE | 504 222 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.032 * |
|POLY 3 | P=0.491N |
|POLY 1.5 | P=0.124N |
|POLY 6 | P=0.607 |
|LOGISTIC REGRESSION| P=0.611N |
|COCH-ARM / FISHERS | P=0.027N* |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 4000 NG/ 4000 NG/ |
| | 500UG ST 500 UG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 13/50 (26%) 6/66 (9%) |
|POLY-3 RATE (b) | 13/24.67 6/14.33 |
|POLY-3 PERCENT (g) | 52.7% 41.9% |
|TERMINAL (d) | 5/10 (50%) 0/0 (0%) |
|FIRST INCIDENCE | 209 222 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.089 |
|POLY 3 | P=0.445N |
|POLY 1.5 | P=0.091N |
|POLY 6 | P=0.652 |
|LOGISTIC REGRESSION| P=0.364N |
|COCH-ARM / FISHERS | P=0.015N* |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 5
Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 4000 NG/ 4000 NG/ |
| | 500UG ST 500 UG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/49 (8%) 1/66 (2%) |
|POLY-3 RATE (b) | 4/20.74 1/9.62 |
|POLY-3 PERCENT (g) | 19.3% 10.4% |
|TERMINAL (d) | 3/9 (33%) 0/0 (0%) |
|FIRST INCIDENCE | 474 636 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.383 |
|POLY 3 | P=0.640N |
|POLY 1.5 | P=0.264N |
|POLY 6 | P=0.978 |
|LOGISTIC REGRESSION| P=0.658 |
|COCH-ARM / FISHERS | P=0.104N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 4000 NG/ 4000 NG/ |
| | 500UG ST 500 UG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/49 (8%) 1/66 (2%) |
|POLY-3 RATE (b) | 4/20.74 1/9.62 |
|POLY-3 PERCENT (g) | 19.3% 10.4% |
|TERMINAL (d) | 3/9 (33%) 0/0 (0%) |
|FIRST INCIDENCE | 474 636 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.383 |
|POLY 3 | P=0.640N |
|POLY 1.5 | P=0.264N |
|POLY 6 | P=0.978 |
|LOGISTIC REGRESSION| P=0.658 |
|COCH-ARM / FISHERS | P=0.104N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 6
Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 4000 NG/ 4000 NG/ |
| | 500UG ST 500 UG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 8/50 (16%) 3/66 (5%) |
|POLY-3 RATE (b) | 8/23.57 3/11.72 |
|POLY-3 PERCENT (g) | 33.9% 25.6% |
|TERMINAL (d) | 2/10 (20%) 0/0 (0%) |
|FIRST INCIDENCE | 541 300 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.199 |
|POLY 3 | P=0.571N |
|POLY 1.5 | P=0.172N |
|POLY 6 | P=0.775 |
|LOGISTIC REGRESSION| P=0.459N |
|COCH-ARM / FISHERS | P=0.039N* |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 4000 NG/ 4000 NG/ |
| | 500UG ST 500 UG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 28/50 (56%) 45/66 (68%) |
|POLY-3 RATE (b) | 28/33.21 45/45.91 |
|POLY-3 PERCENT (g) | 84.3% 98.0% |
|TERMINAL (d) | 9/10 (90%) 0/0 (0%) |
|FIRST INCIDENCE | 240 222 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** |
|POLY 3 | P=0.006 ** |
|POLY 1.5 | P=0.011 * |
|POLY 6 | P=0.013 * |
|LOGISTIC REGRESSION| P<0.001 ** |
|COCH-ARM / FISHERS | P=0.125 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 7
Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 4000 NG/ 4000 NG/ |
| | 500UG ST 500 UG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 20/50 (40%) 14/66 (21%) |
|POLY-3 RATE (b) | 20/26.17 14/18.90 |
|POLY-3 PERCENT (g) | 76.4% 74.1% |
|TERMINAL (d) | 8/10 (80%) 0/0 (0%) |
|FIRST INCIDENCE | 209 294 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** |
|POLY 3 | P=0.635N |
|POLY 1.5 | P=0.141N |
|POLY 6 | P=0.442 |
|LOGISTIC REGRESSION| P=0.158 |
|COCH-ARM / FISHERS | P=0.023N* |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 4000 NG/ 4000 NG/ |
| | 500UG ST 500 UG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 36/50 (72%) 45/66 (68%) |
|POLY-3 RATE (b) | 36/36.81 45/45.91 |
|POLY-3 PERCENT (g) | 97.8% 98.0% |
|TERMINAL (d) | 10/10 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 209 222 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** |
|POLY 3 | P=0.961 |
|POLY 1.5 | P=0.690N |
|POLY 6 | P=1.000 |
|LOGISTIC REGRESSION| P=0.353 |
|COCH-ARM / FISHERS | P=0.407N |
|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).