TDMS Study 96007-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) DATE: 10/01/03
EXPERIMENT: 96007 TEST: 01 TIME: 12:15:21
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-75411 ROUTE: GAVAGE NTP C#: 96007D
PATHOLOGIST: MISSING CAS: 57465-28-8
------------------------------------------------------------------------------------------------------------------------------------
FINAL #3/CONTROL VS. GRPS. 3,4 & 5
REASONS FOR REMOVAL: 25022 Accidently Killed
25018 Dosing Accident
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 NG/KG
INCLUDE 003 30 NG/KG
INCLUDE 004 100 NG/KG
INCLUDE 005 175 NG/KG
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) DATE: 10/01/03
EXPERIMENT: 96007 TEST: 01 TIME: 12:15:21
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-75411 ROUTE: GAVAGE NTP C#: 96007D
PATHOLOGIST: MISSING CAS: 57465-28-8
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
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) DATE: 10/01/03
EXPERIMENT: 96007 TEST: 01 TIME: 12:15:21
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-75411 ROUTE: GAVAGE NTP C#: 96007D
PATHOLOGIST: MISSING CAS: 57465-28-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TOXIC EQUIVALENCY FACTOR EVALUATION (
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Brain Astrocytoma Malignant
Oligodendroglioma, Glioma, or Astrocytoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Uterus Sarcoma Stromal
All Organs Benign Tumors
Malignant and Benign Tumors
===============================================================
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 1
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/52 (15%) 3/55 (5%) 4/53 (8%) 2/53 (4%) |
|POLY-3 RATE (b) | 8/33.26 3/38.95 4/40.27 2/37.58 |
|POLY-3 PERCENT (g) | 24.1% 7.7% 9.9% 5.3% |
|TERMINAL (d) | 3/15 (20%) 2/25 (8%) 2/26 (8%) 1/22 (5%) |
|FIRST INCIDENCE | 531 607 586 660 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.032N* P=0.028N* P=0.050N P=0.020N* |
|POLY 3 | P=0.045N* P=0.052N P=0.093N P=0.025N* |
|POLY 1.5 | P=0.045N* P=0.064N P=0.115N P=0.028N* |
|POLY 6 | P=0.050N P=0.039N* P=0.072N P=0.022N* |
|LOGISTIC REGRESSION| P=0.038N* P=0.052N P=0.097N P=0.025N* |
|COCH-ARM / FISHERS | P=0.059N P=0.084N P=0.170N P=0.043N* |
|ORDER RESTRICTED | P=0.010N* (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/52 (15%) 3/55 (5%) 5/53 (9%) 3/53 (6%) |
|POLY-3 RATE (b) | 8/33.26 3/38.95 5/40.34 3/38.25 |
|POLY-3 PERCENT (g) | 24.1% 7.7% 12.4% 7.8% |
|TERMINAL (d) | 3/15 (20%) 2/25 (8%) 2/26 (8%) 1/22 (5%) |
|FIRST INCIDENCE | 531 607 586 500 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.091N P=0.028N* P=0.086N P=0.048N* |
|POLY 3 | P=0.115N P=0.052N P=0.158N P=0.055N |
|POLY 1.5 | P=0.117N P=0.064N P=0.191N P=0.064N |
|POLY 6 | P=0.122N P=0.039N* P=0.126N P=0.050N |
|LOGISTIC REGRESSION| P=0.108N P=0.052N P=0.158N P=0.064N |
|COCH-ARM / FISHERS | P=0.146N P=0.084N P=0.265N P=0.095N |
|ORDER RESTRICTED | P=0.029N* (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 2
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Brain |
| Astrocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/55 (0%) 0/53 (0%) 0/53 (0%) |
|POLY-3 RATE (b) | 2/31.82 0/38.53 0/39.60 0/37.32 |
|POLY-3 PERCENT (g) | 6.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/15 (7%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 600 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.091N P=0.165N P=0.156N P=0.183N |
|POLY 3 | P=0.125N P=0.196N P=0.191N P=0.202N |
|POLY 1.5 | P=0.119N P=0.209N P=0.206N P=0.211N |
|POLY 6 | P=0.138N P=0.179N P=0.176N P=0.196N |
|LOGISTIC REGRESSION| P=0.101N P=0.197N P=0.194N P=0.202N |
|COCH-ARM / FISHERS | P=0.115N P=0.238N P=0.248N P=0.248N |
|ORDER RESTRICTED | P=0.019N* (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 0/55 (0%) 0/53 (0%) 0/53 (0%) |
|POLY-3 RATE (b) | 3/32.80 0/38.53 0/39.60 0/37.32 |
|POLY-3 PERCENT (g) | 9.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/15 (7%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 201 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.041N* P=0.082N P=0.079N P=0.093N |
|POLY 3 | P=0.053N P=0.091N P=0.088N P=0.096N |
|POLY 1.5 | P=0.050N P=0.100N P=0.098N P=0.101N |
|POLY 6 | P=0.060N P=0.079N P=0.077N P=0.091N |
|LOGISTIC REGRESSION| P=0.065N P=0.128N P=0.156N P=0.155N |
|COCH-ARM / FISHERS | P=0.051N P=0.115N P=0.121N P=0.121N |
|ORDER RESTRICTED | P=0.005N** (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 3
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Heart |
| Schwannoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 1/54 (2%) 2/53 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/31.37 1/37.81 2/40.29 0/37.32 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 5.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/24 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- 652 602 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.601N P=0.578 P=0.312 (e) |
|POLY 3 | P=0.579N P=0.537 P=0.296 (e) |
|POLY 1.5 | P=0.591N P=0.523 P=0.275 (e) |
|POLY 6 | P=0.577N P=0.558 P=0.325 (e) |
|LOGISTIC REGRESSION| P=0.616N P=0.526 P=0.253 (e) |
|COCH-ARM / FISHERS | P=0.624 P=0.509 P=0.252 (e) |
|ORDER RESTRICTED | P=0.352N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Leiomyosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/55 (0%) 2/53 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/31.38 0/38.53 2/39.60 0/37.32 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 5.1% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 2/26 (8%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 727 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.505 (e) P=0.365 (e) |
|POLY 3 | P=0.499 (e) P=0.292 (e) |
|POLY 1.5 | P=0.495 (e) P=0.272 (e) |
|POLY 6 | P=0.493 (e) P=0.317 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.365 (e) |
|COCH-ARM / FISHERS | P=0.454 (e) P=0.248 (e) |
|ORDER RESTRICTED | P=0.294 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 4
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Leiomyosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/55 (0%) 2/53 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/31.38 0/38.53 2/39.60 0/37.32 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 5.1% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 2/26 (8%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 727 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.505 (e) P=0.365 (e) |
|POLY 3 | P=0.499 (e) P=0.292 (e) |
|POLY 1.5 | P=0.495 (e) P=0.272 (e) |
|POLY 6 | P=0.493 (e) P=0.317 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.365 (e) |
|COCH-ARM / FISHERS | P=0.454 (e) P=0.248 (e) |
|ORDER RESTRICTED | P=0.294 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 2/54 (4%) 0/53 (0%) 1/53 (2%) |
|POLY-3 RATE (b) | 0/31.36 2/38.32 0/39.60 1/37.32 |
|POLY-3 PERCENT (g) | 0.0% 5.2% 0.0% 2.7% |
|TERMINAL (d) | 0/15 (0%) 1/25 (4%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | --- 652 --- 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.599N P=0.343 (e) P=0.576 |
|POLY 3 | P=0.589N P=0.283 (e) P=0.535 |
|POLY 1.5 | P=0.610N P=0.265 (e) P=0.526 |
|POLY 6 | P=0.568N P=0.312 (e) P=0.543 |
|LOGISTIC REGRESSION| P=0.617N P=0.292 (e) P=0.576 |
|COCH-ARM / FISHERS | P=0.608 P=0.257 (e) P=0.505 |
|ORDER RESTRICTED | P=0.360 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 5
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 2/54 (4%) 1/53 (2%) 1/53 (2%) |
|POLY-3 RATE (b) | 0/31.36 2/38.32 1/40.08 1/37.32 |
|POLY-3 PERCENT (g) | 0.0% 5.2% 2.5% 2.7% |
|TERMINAL (d) | 0/15 (0%) 1/25 (4%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | --- 652 586 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.581 P=0.343 P=0.551 P=0.576 |
|POLY 3 | P=0.594 P=0.283 P=0.548 P=0.535 |
|POLY 1.5 | P=0.575 P=0.265 P=0.532 P=0.526 |
|POLY 6 | P=0.616 P=0.312 P=0.568 P=0.543 |
|LOGISTIC REGRESSION| P=0.557 P=0.292 P=0.494 P=0.576 |
|COCH-ARM / FISHERS | P=0.524 P=0.257 P=0.505 P=0.505 |
|ORDER RESTRICTED | P=0.318 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Nephroblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/55 (4%) 1/53 (2%) 1/53 (2%) |
|POLY-3 RATE (b) | 1/32.37 2/40.46 1/40.57 1/38.09 |
|POLY-3 PERCENT (g) | 3.1% 4.9% 2.5% 2.6% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 176 223 236 448 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.456N P=0.525 P=0.749N P=0.741N |
|POLY 3 | P=0.433N P=0.577 P=0.708N P=0.724N |
|POLY 1.5 | P=0.446N P=0.551 P=0.727N P=0.735N |
|POLY 6 | P=0.429N P=0.611 P=0.685N P=0.713N |
|LOGISTIC REGRESSION| P=0.368 P=0.422 P=0.497 P=0.581 |
|COCH-ARM / FISHERS | P=0.482N P=0.514 P=0.752N P=0.752N |
|ORDER RESTRICTED | P=0.567N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 6
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/55 (4%) 1/53 (2%) 0/53 (0%) |
|POLY-3 RATE (b) | 1/31.38 2/38.81 1/40.03 0/37.32 |
|POLY-3 PERCENT (g) | 3.2% 5.2% 2.5% 0.0% |
|TERMINAL (d) | 1/15 (7%) 1/25 (4%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 727 (T) 652 602 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.167N P=0.661 P=0.664N P=0.424N |
|POLY 3 | P=0.175N P=0.574 P=0.704N P=0.465N |
|POLY 1.5 | P=0.185N P=0.548 P=0.725N P=0.475N |
|POLY 6 | P=0.171N P=0.610 P=0.677N P=0.457N |
|LOGISTIC REGRESSION| P=0.184N P=0.616 P=0.723N (e) |
|COCH-ARM / FISHERS | P=0.214N P=0.514 P=0.752N P=0.500N |
|ORDER RESTRICTED | P=0.237N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/55 (4%) 1/53 (2%) 1/53 (2%) |
|POLY-3 RATE (b) | 1/31.38 2/38.81 1/40.03 1/37.32 |
|POLY-3 PERCENT (g) | 3.2% 5.2% 2.5% 2.7% |
|TERMINAL (d) | 1/15 (7%) 1/25 (4%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 727 (T) 652 602 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.411N P=0.661 P=0.664N P=0.675N |
|POLY 3 | P=0.427N P=0.574 P=0.704N P=0.722N |
|POLY 1.5 | P=0.441N P=0.548 P=0.725N P=0.732N |
|POLY 6 | P=0.423N P=0.610 P=0.677N P=0.711N |
|LOGISTIC REGRESSION| P=0.435N P=0.616 P=0.723N P=0.675N |
|COCH-ARM / FISHERS | P=0.482N P=0.514 P=0.752N P=0.752N |
|ORDER RESTRICTED | P=0.559N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 7
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/55 (4%) 1/53 (2%) 1/53 (2%) |
|POLY-3 RATE (b) | 1/31.38 2/38.81 1/40.03 1/37.32 |
|POLY-3 PERCENT (g) | 3.2% 5.2% 2.5% 2.7% |
|TERMINAL (d) | 1/15 (7%) 1/25 (4%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 727 (T) 652 602 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.411N P=0.661 P=0.664N P=0.675N |
|POLY 3 | P=0.427N P=0.574 P=0.704N P=0.722N |
|POLY 1.5 | P=0.441N P=0.548 P=0.725N P=0.732N |
|POLY 6 | P=0.423N P=0.610 P=0.677N P=0.711N |
|LOGISTIC REGRESSION| P=0.435N P=0.616 P=0.723N P=0.675N |
|COCH-ARM / FISHERS | P=0.482N P=0.514 P=0.752N P=0.752N |
|ORDER RESTRICTED | P=0.559N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/55 (0%) 2/53 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 2/31.38 0/38.53 2/40.21 0/37.32 |
|POLY-3 PERCENT (g) | 6.4% 0.0% 5.0% 0.0% |
|TERMINAL (d) | 2/15 (13%) 0/25 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 727 (T) --- 533 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.250N P=0.134N P=0.523N P=0.157N |
|POLY 3 | P=0.304N P=0.193N P=0.602N P=0.200N |
|POLY 1.5 | P=0.297N P=0.208N P=0.636N P=0.210N |
|POLY 6 | P=0.327N P=0.174N P=0.560N P=0.190N |
|LOGISTIC REGRESSION| P=0.274N (e) P=0.608N (e) |
|COCH-ARM / FISHERS | P=0.311N P=0.238N P=0.691N P=0.248N |
|ORDER RESTRICTED | P=0.091N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 8
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 6/53 (11%) 7/55 (13%) 9/53 (17%) 5/53 (9%) |
|POLY-3 RATE (b) | 6/32.44 7/39.35 9/40.77 5/38.47 |
|POLY-3 PERCENT (g) | 18.5% 17.8% 22.1% 13.0% |
|TERMINAL (d) | 3/15 (20%) 3/25 (12%) 6/26 (23%) 3/22 (14%) |
|FIRST INCIDENCE | 400 580 533 496 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.302N P=0.397N P=0.557N P=0.299N |
|POLY 3 | P=0.348N P=0.591N P=0.466 P=0.379N |
|POLY 1.5 | P=0.371N P=0.598 P=0.399 P=0.413N |
|POLY 6 | P=0.346N P=0.514N P=0.551 P=0.347N |
|LOGISTIC REGRESSION| P=0.362N P=0.569N P=0.474 P=0.397N |
|COCH-ARM / FISHERS | P=0.470N P=0.529 P=0.289 P=0.500N |
|ORDER RESTRICTED | P=0.387N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 7/53 (13%) 7/55 (13%) 10/53 (19%) 5/53 (9%) |
|POLY-3 RATE (b) | 7/32.44 7/39.35 10/40.77 5/38.47 |
|POLY-3 PERCENT (g) | 21.6% 17.8% 24.5% 13.0% |
|TERMINAL (d) | 4/15 (27%) 3/25 (12%) 7/26 (27%) 3/22 (14%) |
|FIRST INCIDENCE | 400 580 533 496 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.243N P=0.270N P=0.496N P=0.191N |
|POLY 3 | P=0.291N P=0.459N P=0.493 P=0.259N |
|POLY 1.5 | P=0.313N P=0.514N P=0.419 P=0.292N |
|POLY 6 | P=0.292N P=0.376N P=0.586 P=0.228N |
|LOGISTIC REGRESSION| P=0.298N P=0.426N P=0.522 P=0.271N |
|COCH-ARM / FISHERS | P=0.411N P=0.583N P=0.299 P=0.380N |
|ORDER RESTRICTED | P=0.297N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 9
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 39/53 (74%) 31/55 (56%) 35/53 (66%) 38/53 (72%) |
|POLY-3 RATE (b) | 39/45.19 31/45.30 35/47.68 38/47.78 |
|POLY-3 PERCENT (g) | 86.3% 68.4% 73.4% 79.5% |
|TERMINAL (d) | 11/15 (73%) 18/25 (72%) 18/26 (69%) 16/22 (73%) |
|FIRST INCIDENCE | 309 356 188 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.272N P=0.003N** P=0.010N* P=0.095N |
|POLY 3 | P=0.474N P=0.029N* P=0.085N P=0.263N |
|POLY 1.5 | P=0.496N P=0.027N* P=0.095N P=0.274N |
|POLY 6 | P=0.523N P=0.033N* P=0.101N P=0.318N |
|LOGISTIC REGRESSION| P=0.512 P=0.015N* P=0.127N P=0.283N |
|COCH-ARM / FISHERS | P=0.333 P=0.047N* P=0.263N P=0.500N |
|ORDER RESTRICTED | P=0.099N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 40/53 (75%) 31/55 (56%) 36/53 (68%) 38/53 (72%) |
|POLY-3 RATE (b) | 40/45.19 31/45.30 36/48.29 38/47.78 |
|POLY-3 PERCENT (g) | 88.5% 68.4% 74.6% 79.5% |
|TERMINAL (d) | 12/15 (80%) 18/25 (72%) 18/26 (69%) 16/22 (73%) |
|FIRST INCIDENCE | 309 356 188 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.243N P=0.002N** P=0.009N** P=0.070N |
|POLY 3 | P=0.400N P=0.013N* P=0.058N P=0.165N |
|POLY 1.5 | P=0.431N P=0.013N* P=0.074N P=0.182N |
|POLY 6 | P=0.439N P=0.014N* P=0.062N P=0.203N |
|LOGISTIC REGRESSION| P=0.506N P=0.008N** P=0.118N P=0.194N |
|COCH-ARM / FISHERS | P=0.373 P=0.029N* P=0.259N P=0.413N |
|ORDER RESTRICTED | P=0.057N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 10
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 42/53 (79%) 36/55 (65%) 38/53 (72%) 39/53 (74%) |
|POLY-3 RATE (b) | 42/46.17 36/46.12 38/48.57 39/48.24 |
|POLY-3 PERCENT (g) | 91.0% 78.1% 78.2% 80.8% |
|TERMINAL (d) | 12/15 (80%) 19/25 (76%) 19/26 (73%) 16/22 (73%) |
|FIRST INCIDENCE | 309 356 188 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.138N P=0.005N** P=0.007N** P=0.054N |
|POLY 3 | P=0.192N P=0.064N P=0.064N P=0.114N |
|POLY 1.5 | P=0.212N P=0.056N P=0.073N P=0.122N |
|POLY 6 | P=0.231N P=0.072N P=0.075N P=0.149N |
|LOGISTIC REGRESSION| P=0.274N P=0.023N* P=0.104N P=0.134N |
|COCH-ARM / FISHERS | P=0.492N P=0.083N P=0.249N P=0.324N |
|ORDER RESTRICTED | P=0.083N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 15/51 (29%) 18/54 (33%) 20/53 (38%) 16/53 (30%) |
|POLY-3 RATE (b) | 15/32.57 18/41.27 20/43.98 16/40.27 |
|POLY-3 PERCENT (g) | 46.1% 43.6% 45.5% 39.7% |
|TERMINAL (d) | 9/15 (60%) 8/25 (32%) 10/26 (39%) 8/22 (36%) |
|FIRST INCIDENCE | 603 434 328 487 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.344N P=0.271N P=0.362N P=0.280N |
|POLY 3 | P=0.352N P=0.511N P=0.574N P=0.377N |
|POLY 1.5 | P=0.391N P=0.561 P=0.473 P=0.447N |
|POLY 6 | P=0.358N P=0.356N P=0.424N P=0.313N |
|LOGISTIC REGRESSION| P=0.405N P=0.566N P=0.483 P=0.397N |
|COCH-ARM / FISHERS | P=0.494 P=0.412 P=0.245 P=0.551 |
|ORDER RESTRICTED | P=0.470N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 11
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 15/51 (29%) 18/54 (33%) 20/53 (38%) 17/53 (32%) |
|POLY-3 RATE (b) | 15/32.57 18/41.27 20/43.98 17/40.27 |
|POLY-3 PERCENT (g) | 46.1% 43.6% 45.5% 42.2% |
|TERMINAL (d) | 9/15 (60%) 8/25 (32%) 10/26 (39%) 9/22 (41%) |
|FIRST INCIDENCE | 603 434 328 487 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.417N P=0.271N P=0.362N P=0.340N |
|POLY 3 | P=0.443N P=0.511N P=0.574N P=0.463N |
|POLY 1.5 | P=0.480N P=0.561 P=0.473 P=0.532N |
|POLY 6 | P=0.453N P=0.356N P=0.424N P=0.398N |
|LOGISTIC REGRESSION| P=0.489N P=0.566N P=0.483 P=0.478N |
|COCH-ARM / FISHERS | P=0.410 P=0.412 P=0.245 P=0.468 |
|ORDER RESTRICTED | P=0.585N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/51 (2%) 2/54 (4%) 1/53 (2%) 0/53 (0%) |
|POLY-3 RATE (b) | 1/31.44 2/37.71 1/40.51 0/37.32 |
|POLY-3 PERCENT (g) | 3.2% 5.3% 2.5% 0.0% |
|TERMINAL (d) | 0/15 (0%) 2/25 (8%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 554 727 (T) 328 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.171N P=0.635 P=0.727N P=0.463N |
|POLY 3 | P=0.174N P=0.563 P=0.702N P=0.466N |
|POLY 1.5 | P=0.181N P=0.545 P=0.719N P=0.472N |
|POLY 6 | P=0.172N P=0.591 P=0.682N P=0.462N |
|LOGISTIC REGRESSION| P=0.217N P=0.566 P=0.690 P=0.515N |
|COCH-ARM / FISHERS | P=0.206N P=0.522 P=0.743N P=0.490N |
|ORDER RESTRICTED | P=0.230N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 12
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 15/52 (29%) 15/55 (27%) 15/52 (29%) 13/51 (25%) |
|POLY-3 RATE (b) | 15/33.48 15/41.22 15/42.66 13/39.21 |
|POLY-3 PERCENT (g) | 44.8% 36.4% 35.2% 33.2% |
|TERMINAL (d) | 8/15 (53%) 8/25 (32%) 7/26 (27%) 8/22 (36%) |
|FIRST INCIDENCE | 519 524 541 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.172N P=0.138N P=0.122N P=0.124N |
|POLY 3 | P=0.224N P=0.304N P=0.265N P=0.211N |
|POLY 1.5 | P=0.260N P=0.397N P=0.377N P=0.273N |
|POLY 6 | P=0.222N P=0.196N P=0.160N P=0.168N |
|LOGISTIC REGRESSION| P=0.257N P=0.307N P=0.295N P=0.240N |
|COCH-ARM / FISHERS | P=0.414N P=0.513N P=0.586N P=0.436N |
|ORDER RESTRICTED | P=0.249N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 1/55 (2%) 2/52 (4%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/31.37 1/38.53 2/39.64 0/36.51 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 5.1% 0.0% |
|TERMINAL (d) | 0/15 (0%) 1/25 (4%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- 727 (T) 709 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.583N P=0.602 P=0.368 (e) |
|POLY 3 | P=0.586N P=0.541 P=0.292 (e) |
|POLY 1.5 | P=0.602N P=0.527 P=0.272 (e) |
|POLY 6 | P=0.576N P=0.561 P=0.318 (e) |
|LOGISTIC REGRESSION| P=0.599N P=0.602 P=0.341 (e) |
|COCH-ARM / FISHERS | P=0.612 P=0.514 P=0.248 (e) |
|ORDER RESTRICTED | P=0.356N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 13
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 15/52 (29%) 16/55 (29%) 17/52 (33%) 13/51 (25%) |
|POLY-3 RATE (b) | 15/33.48 16/41.22 17/42.73 13/39.21 |
|POLY-3 PERCENT (g) | 44.8% 38.8% 39.8% 33.2% |
|TERMINAL (d) | 8/15 (53%) 9/25 (36%) 8/26 (31%) 8/22 (36%) |
|FIRST INCIDENCE | 519 524 541 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.168N P=0.176N P=0.200N P=0.124N |
|POLY 3 | P=0.214N P=0.385N P=0.417N P=0.211N |
|POLY 1.5 | P=0.253N P=0.482N P=0.543N P=0.273N |
|POLY 6 | P=0.211N P=0.261N P=0.278N P=0.168N |
|LOGISTIC REGRESSION| P=0.250N P=0.378N P=0.436N P=0.240N |
|COCH-ARM / FISHERS | P=0.419N P=0.574 P=0.416 P=0.436N |
|ORDER RESTRICTED | P=0.252N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 3/55 (5%) 1/53 (2%) 1/53 (2%) |
|POLY-3 RATE (b) | 0/31.38 3/38.64 1/39.86 1/37.32 |
|POLY-3 PERCENT (g) | 0.0% 7.8% 2.5% 2.7% |
|TERMINAL (d) | 0/15 (0%) 2/25 (8%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | --- 700 659 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.497N P=0.228 P=0.568 P=0.576 |
|POLY 3 | P=0.475N P=0.159 P=0.547 P=0.534 |
|POLY 1.5 | P=0.502N P=0.144 P=0.531 P=0.525 |
|POLY 6 | P=0.451N P=0.183 P=0.567 P=0.543 |
|LOGISTIC REGRESSION| P=0.512N P=0.206 P=0.535 P=0.576 |
|COCH-ARM / FISHERS | P=0.562N P=0.129 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.274 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 14
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 4/53 (8%) 5/55 (9%) 7/53 (13%) 3/53 (6%) |
|POLY-3 RATE (b) | 4/31.79 5/39.02 7/40.14 3/37.58 |
|POLY-3 PERCENT (g) | 12.6% 12.8% 17.4% 8.0% |
|TERMINAL (d) | 2/15 (13%) 2/25 (8%) 4/26 (15%) 2/22 (9%) |
|FIRST INCIDENCE | 660 630 652 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.326N P=0.479N P=0.591 P=0.328N |
|POLY 3 | P=0.363N P=0.628 P=0.407 P=0.408N |
|POLY 1.5 | P=0.379N P=0.584 P=0.353 P=0.432N |
|POLY 6 | P=0.369N P=0.591N P=0.474 P=0.387N |
|LOGISTIC REGRESSION| P=0.355N P=0.585N P=0.497 P=0.369N |
|COCH-ARM / FISHERS | P=0.460N P=0.524 P=0.263 P=0.500N |
|ORDER RESTRICTED | P=0.350N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/55 (0%) 0/53 (0%) 2/53 (4%) |
|POLY-3 RATE (b) | 0/31.38 0/38.53 0/39.60 2/37.58 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.3% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | --- --- --- 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.055 (e) (e) P=0.322 |
|POLY 3 | P=0.049 * (e) (e) P=0.279 |
|POLY 1.5 | P=0.048 * (e) (e) P=0.267 |
|POLY 6 | P=0.049 * (e) (e) P=0.291 |
|LOGISTIC REGRESSION| P=0.049 * (e) (e) P=0.285 |
|COCH-ARM / FISHERS | P=0.045 * (e) (e) P=0.248 |
|ORDER RESTRICTED | P=0.047 * (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 15
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 4/53 (8%) 5/55 (9%) 7/53 (13%) 5/53 (9%) |
|POLY-3 RATE (b) | 4/31.79 5/39.02 7/40.14 5/37.84 |
|POLY-3 PERCENT (g) | 12.6% 12.8% 17.4% 13.2% |
|TERMINAL (d) | 2/15 (13%) 2/25 (8%) 4/26 (15%) 3/22 (14%) |
|FIRST INCIDENCE | 660 630 652 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.518 P=0.479N P=0.591 P=0.571N |
|POLY 3 | P=0.476 P=0.628 P=0.407 P=0.610 |
|POLY 1.5 | P=0.458 P=0.584 P=0.353 P=0.580 |
|POLY 6 | P=0.476 P=0.591N P=0.474 P=0.638 |
|LOGISTIC REGRESSION| P=0.476 P=0.585N P=0.497 P=0.636N |
|COCH-ARM / FISHERS | P=0.373 P=0.524 P=0.263 P=0.500 |
|ORDER RESTRICTED | P=0.584 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/55 (0%) 0/53 (0%) 1/53 (2%) |
|POLY-3 RATE (b) | 2/31.60 0/38.53 0/39.60 1/37.32 |
|POLY-3 PERCENT (g) | 6.3% 0.0% 0.0% 2.7% |
|TERMINAL (d) | 1/15 (7%) 0/25 (0%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 671 --- --- 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.399N P=0.139N P=0.138N P=0.390N |
|POLY 3 | P=0.465N P=0.195N P=0.190N P=0.442N |
|POLY 1.5 | P=0.455N P=0.208N P=0.206N P=0.457N |
|POLY 6 | P=0.486N P=0.177N P=0.174N P=0.429N |
|LOGISTIC REGRESSION| P=0.407N P=0.168N P=0.164N P=0.409N |
|COCH-ARM / FISHERS | P=0.449N P=0.238N P=0.248N P=0.500N |
|ORDER RESTRICTED | P=0.093N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 16
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/55 (4%) 0/53 (0%) 2/53 (4%) |
|POLY-3 RATE (b) | 0/31.38 2/40.04 0/39.60 2/37.84 |
|POLY-3 PERCENT (g) | 0.0% 5.0% 0.0% 5.3% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- 82 --- 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.347 P=0.265 (e) P=0.316 |
|POLY 3 | P=0.368 P=0.294 (e) P=0.280 |
|POLY 1.5 | P=0.348 P=0.275 (e) P=0.268 |
|POLY 6 | P=0.392 P=0.324 (e) P=0.295 |
|LOGISTIC REGRESSION| P=0.219 P=0.195 (e) P=0.269 |
|COCH-ARM / FISHERS | P=0.302 P=0.257 (e) P=0.248 |
|ORDER RESTRICTED | P=0.150 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 45/53 (85%) 45/55 (82%) 48/53 (91%) 45/53 (85%) |
|POLY-3 RATE (b) | 45/45.97 45/47.51 48/51.17 45/48.55 |
|POLY-3 PERCENT (g) | 97.9% 94.7% 93.8% 92.7% |
|TERMINAL (d) | 15/15 (100%) 24/25 (96%) 23/26 (89%) 21/22 (96%) |
|FIRST INCIDENCE | 309 356 188 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.156N P=0.016N* P=0.032N* P=0.068N |
|POLY 3 | P=0.162N P=0.377N P=0.296N P=0.180N |
|POLY 1.5 | P=0.220N P=0.381N P=0.480N P=0.234N |
|POLY 6 | P=0.239N P=0.336N P=0.201N P=0.260N |
|LOGISTIC REGRESSION| P=0.211N P=0.158N P=0.613N P=0.117N |
|COCH-ARM / FISHERS | P=0.373 P=0.432N P=0.278 P=0.607N |
|ORDER RESTRICTED | P=0.156N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 17
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 13/53 (25%) 19/55 (35%) 18/53 (34%) 15/53 (28%) |
|POLY-3 RATE (b) | 13/35.14 19/45.38 18/44.03 15/40.97 |
|POLY-3 PERCENT (g) | 37.0% 41.9% 40.9% 36.6% |
|TERMINAL (d) | 5/15 (33%) 6/25 (24%) 8/26 (31%) 8/22 (36%) |
|FIRST INCIDENCE | 176 82 236 448 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.352N P=0.555 P=0.483N P=0.425N |
|POLY 3 | P=0.442N P=0.414 P=0.451 P=0.583N |
|POLY 1.5 | P=0.481N P=0.312 P=0.343 P=0.543 |
|POLY 6 | P=0.429N P=0.561 P=0.592 P=0.520N |
|LOGISTIC REGRESSION| P=0.478 P=0.162 P=0.244 P=0.500 |
|COCH-ARM / FISHERS | P=0.474 P=0.177 P=0.197 P=0.413 |
|ORDER RESTRICTED | P=0.592N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 49/53 (92%) 51/55 (93%) 51/53 (96%) 47/53 (89%) |
|POLY-3 RATE (b) | 49/49.21 51/52.35 51/52.14 47/49.77 |
|POLY-3 PERCENT (g) | 99.6% 97.4% 97.8% 94.4% |
|TERMINAL (d) | 15/15 (100%) 24/25 (96%) 25/26 (96%) 21/22 (96%) |
|FIRST INCIDENCE | 176 82 188 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.073N P=0.036N* P=0.021N* P=0.043N* |
|POLY 3 | P=0.081N P=0.466N P=0.543N P=0.125N |
|POLY 1.5 | P=0.092N P=0.452N P=0.654N P=0.134N |
|POLY 6 | P=0.160N P=0.507N P=0.515N P=0.229N |
|LOGISTIC REGRESSION| P=0.089N P=0.547N P=0.661 P=0.066N |
|COCH-ARM / FISHERS | P=0.323N P=0.621 P=0.339 P=0.371N |
|ORDER RESTRICTED | P=0.047N* (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).