TDMS Study 96007-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) DATE: 09/30/03
EXPERIMENT: 96007 TEST: 03 TIME: 08:52:44
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007G
PATHOLOGIST: SELLS, DONALD CAS: 1746-01-6
------------------------------------------------------------------------------------------------------------------------------------
FINAL # 3 RATS CONTROL VS TREATED
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/KG
INCLUDE 002 3 NG/KG
INCLUDE 003 10 NG/KG
INCLUDE 004 22 NG/KG
INCLUDE 005 46 NG/KG
INCLUDE 006 100 NG/KG
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) DATE: 09/30/03
EXPERIMENT: 96007 TEST: 03 TIME: 08:52:44
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007G
PATHOLOGIST: SELLS, DONALD CAS: 1746-01-6
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
Spleen
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) DATE: 09/30/03
EXPERIMENT: 96007 TEST: 03 TIME: 08:52:44
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007G
PATHOLOGIST: SELLS, DONALD CAS: 1746-01-6
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TOXIC EQUIVALENCY FACTOR EVALUATION
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Liver Cholangiocarcinoma
Hepatocellular Adenoma
Hepatocholangioma
Lung Cystic Keratinizing Epithelioma
Mammary Gland Carcinoma
Carcinoma or Adenoma
Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)
Squamous Cell Carcinoma
Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
Oral Mucosa Squamous Cell Carcinoma
Pancreas Carcinoma
Carcinoma or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Pituitary Gland: Pars Intermedia Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
Uterus Polyp Stromal
Squamous Cell Carcinoma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 1
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 0/54 (0%) 2/53 (4%) 2/53 (4%) 1/53 (2%) 1/53 (2%) |
|POLY-3 RATE (b) | 1/39.55 0/34.61 2/38.75 2/34.53 1/39.00 1/42.90 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 5.2% 5.8% 2.6% 2.3% |
|TERMINAL (d) | 1/25 (4%) 0/21 (0%) 2/23 (9%) 1/19 (5%) 1/22 (5%) 0/21 (0%) |
|FIRST INCIDENCE | 731 (T) --- 731 (T) 626 731 (T) 648 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.609N P=0.535N P=0.471 P=0.403 P=0.734 P=0.744 |
|POLY 3 | P=0.549N P=0.527N P=0.493 P=0.453 P=0.758 P=0.743N |
|POLY 1.5 | P=0.567N P=0.514N P=0.490 P=0.472 P=0.759 P=0.745N |
|POLY 6 | P=0.542N P=0.539N P=0.494 P=0.430 P=0.755 P=0.747N |
|LOGISTIC REGRESSION| P=0.560N (e) P=0.471 P=0.433 P=0.734 P=0.749N |
|COCH-ARM / FISHERS | P=0.614N P=0.495N P=0.500 P=0.500 P=0.752N P=0.752N |
|ORDER RESTRICTED | P=0.450 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 2/54 (4%) 2/53 (4%) 3/53 (6%) 3/53 (6%) 3/53 (6%) |
|POLY-3 RATE (b) | 3/39.55 2/34.61 2/38.75 3/34.16 3/39.09 3/43.18 |
|POLY-3 PERCENT (g) | 7.6% 5.8% 5.2% 8.8% 7.7% 7.0% |
|TERMINAL (d) | 3/25 (12%) 2/21 (10%) 2/23 (9%) 3/19 (16%) 2/22 (9%) 0/21 (0%) |
|FIRST INCIDENCE | 731 (T) 731 (T) 731 (T) 731 (T) 708 642 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.414 P=0.581N P=0.539N P=0.532 P=0.604 P=0.606 |
|POLY 3 | P=0.542 P=0.561N P=0.509N P=0.594 P=0.658 P=0.622N |
|POLY 1.5 | P=0.516 P=0.533N P=0.512N P=0.623 P=0.660 P=0.629N |
|POLY 6 | P=0.550 P=0.590N P=0.508N P=0.557 P=0.653 P=0.628N |
|LOGISTIC REGRESSION| P=0.492 P=0.581N P=0.539N P=0.532 P=0.618 P=0.642N |
|COCH-ARM / FISHERS | P=0.436 P=0.491N P=0.500N P=0.661N P=0.661N P=0.661N |
|ORDER RESTRICTED | P=0.688 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 2
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 2/54 (4%) 2/53 (4%) 3/53 (6%) 3/53 (6%) 3/53 (6%) |
|POLY-3 RATE (b) | 3/39.55 2/34.61 2/38.75 3/34.16 3/39.09 3/43.18 |
|POLY-3 PERCENT (g) | 7.6% 5.8% 5.2% 8.8% 7.7% 7.0% |
|TERMINAL (d) | 3/25 (12%) 2/21 (10%) 2/23 (9%) 3/19 (16%) 2/22 (9%) 0/21 (0%) |
|FIRST INCIDENCE | 731 (T) 731 (T) 731 (T) 731 (T) 708 642 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.414 P=0.581N P=0.539N P=0.532 P=0.604 P=0.606 |
|POLY 3 | P=0.542 P=0.561N P=0.509N P=0.594 P=0.658 P=0.622N |
|POLY 1.5 | P=0.516 P=0.533N P=0.512N P=0.623 P=0.660 P=0.629N |
|POLY 6 | P=0.550 P=0.590N P=0.508N P=0.557 P=0.653 P=0.628N |
|LOGISTIC REGRESSION| P=0.492 P=0.581N P=0.539N P=0.532 P=0.618 P=0.642N |
|COCH-ARM / FISHERS | P=0.436 P=0.491N P=0.500N P=0.661N P=0.661N P=0.661N |
|ORDER RESTRICTED | P=0.688 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/51 (2%) 0/54 (0%) 2/53 (4%) 0/53 (0%) 0/52 (0%) 0/52 (0%) |
|POLY-3 RATE (b) | 1/38.86 0/34.61 2/38.75 0/34.16 0/38.45 0/41.64 |
|POLY-3 PERCENT (g) | 2.6% 0.0% 5.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/21 (0%) 2/23 (9%) 0/19 (0%) 0/22 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 731 (T) --- 731 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.248N P=0.535N P=0.471 P=0.555N P=0.525N P=0.535N |
|POLY 3 | P=0.205N P=0.523N P=0.499 P=0.526N P=0.502N P=0.486N |
|POLY 1.5 | P=0.218N P=0.509N P=0.499 P=0.512N P=0.500N P=0.486N |
|POLY 6 | P=0.196N P=0.537N P=0.497 P=0.542N P=0.506N P=0.493N |
|LOGISTIC REGRESSION| P=0.248N (e) P=0.471 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.236N P=0.486N P=0.515 P=0.490N P=0.495N P=0.495N |
|ORDER RESTRICTED | P=0.245N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 3
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/51 (4%) 0/54 (0%) 2/53 (4%) 0/53 (0%) 0/52 (0%) 0/52 (0%) |
|POLY-3 RATE (b) | 2/39.17 0/34.61 2/38.75 0/34.16 0/38.45 0/41.64 |
|POLY-3 PERCENT (g) | 5.1% 0.0% 5.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/21 (0%) 2/23 (9%) 0/19 (0%) 0/22 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 645 --- 731 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.149N P=0.302N P=0.662 P=0.318N P=0.260N P=0.265N |
|POLY 3 | P=0.115N P=0.265N P=0.691 P=0.268N P=0.241N P=0.223N |
|POLY 1.5 | P=0.126N P=0.248N P=0.692 P=0.252N P=0.238N P=0.223N |
|POLY 6 | P=0.107N P=0.285N P=0.687 P=0.291N P=0.246N P=0.232N |
|LOGISTIC REGRESSION| P=0.133N P=0.263N P=0.693 P=0.267N P=0.239N P=0.224N |
|COCH-ARM / FISHERS | P=0.144N P=0.234N P=0.676N P=0.238N P=0.243N P=0.243N |
|ORDER RESTRICTED | P=0.053N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Nephroblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/54 (4%) 1/53 (2%) 0/53 (0%) 0/53 (0%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/39.55 2/36.54 1/39.71 0/34.16 0/39.00 0/42.60 |
|POLY-3 PERCENT (g) | 0.0% 5.5% 2.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) 0/23 (0%) 0/19 (0%) 0/22 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- 200 240 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.212N P=0.248 P=0.492 (e) (e) (e) |
|POLY 3 | P=0.218N P=0.219 P=0.501 (e) (e) (e) |
|POLY 1.5 | P=0.215N P=0.230 P=0.498 (e) (e) (e) |
|POLY 6 | P=0.224N P=0.208 P=0.502 (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.374N P=0.189 P=0.663 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.215N P=0.252 P=0.500 (e) (e) (e) |
|ORDER RESTRICTED | P=0.243N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 4
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Cholangiocarcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/54 (0%) 0/53 (0%) 1/53 (2%) 4/53 (8%) 25/53 (47%) |
|POLY-3 RATE (b) | 0/39.55 0/34.61 0/38.75 1/34.63 4/39.00 25/45.58 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.9% 10.3% 54.9% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) 0/23 (0%) 0/19 (0%) 4/22 (18%) 13/21 (62%) |
|FIRST INCIDENCE | --- --- --- 592 731 (T) 610 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.462 P=0.046 * P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.474 P=0.057 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.484 P=0.059 P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.461 P=0.055 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.508 P=0.046 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.500 P=0.059 P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 1/53 (2%) 13/53 (25%) |
|POLY-3 RATE (b) | 0/39.55 0/34.61 0/38.75 0/34.16 1/39.04 13/43.52 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 2.6% 29.9% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) 0/23 (0%) 0/19 (0%) 0/22 (0%) 7/21 (33%) |
|FIRST INCIDENCE | --- --- --- --- 720 642 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.476 P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.497 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.499 P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.494 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.487 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.500 P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 5
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocholangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 2/53 (4%) |
|POLY-3 RATE (b) | 0/39.55 0/34.61 0/38.75 0/34.16 0/39.00 2/42.93 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 4.7% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) 0/23 (0%) 0/19 (0%) 0/22 (0%) 1/21 (5%) |
|FIRST INCIDENCE | --- --- --- --- --- 638 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.015 * (e) (e) (e) (e) P=0.229 |
|POLY 3 | P=0.012 * (e) (e) (e) (e) P=0.256 |
|POLY 1.5 | P=0.012 * (e) (e) (e) (e) P=0.253 |
|POLY 6 | P=0.012 * (e) (e) (e) (e) P=0.251 |
|LOGISTIC REGRESSION| P=0.015 * (e) (e) (e) (e) P=0.251 |
|COCH-ARM / FISHERS | P=0.011 * (e) (e) (e) (e) P=0.248 |
|ORDER RESTRICTED | P=0.011 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Lung |
| Cystic Keratinizing Epithelioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/52 (0%) 0/53 (0%) 9/52 (17%) |
|POLY-3 RATE (b) | 0/39.55 0/34.61 0/38.75 0/33.71 0/39.00 9/42.72 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 21.1% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) 0/23 (0%) 0/19 (0%) 0/22 (0%) 4/21 (19%) |
|FIRST INCIDENCE | --- --- --- --- --- 610 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.002 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.002 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.002 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.002 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) (e) P=0.003 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 6
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/54 (0%) 1/53 (2%) 0/53 (0%) 0/53 (0%) 1/53 (2%) |
|POLY-3 RATE (b) | 2/39.90 0/34.61 1/38.75 0/34.16 0/39.00 1/42.60 |
|POLY-3 PERCENT (g) | 5.0% 0.0% 2.6% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 1/25 (4%) 0/21 (0%) 1/23 (4%) 0/19 (0%) 0/22 (0%) 1/21 (5%) |
|FIRST INCIDENCE | 631 --- 731 (T) --- --- 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.591N P=0.305N P=0.532N P=0.317N P=0.260N P=0.535N |
|POLY 3 | P=0.555N P=0.270N P=0.510N P=0.273N P=0.242N P=0.477N |
|POLY 1.5 | P=0.570N P=0.254N P=0.511N P=0.258N P=0.240N P=0.479N |
|POLY 6 | P=0.541N P=0.288N P=0.512N P=0.293N P=0.247N P=0.488N |
|LOGISTIC REGRESSION| P=0.555N P=0.263N P=0.507N P=0.267N P=0.240N P=0.479N |
|COCH-ARM / FISHERS | P=0.595N P=0.243N P=0.500N P=0.248N P=0.248N P=0.500N |
|ORDER RESTRICTED | P=0.110N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 4/53 (8%) 8/54 (15%) 4/53 (8%) 2/53 (4%) 2/53 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 4/40.42 8/37.03 4/39.08 2/35.28 2/39.22 0/42.60 |
|POLY-3 PERCENT (g) | 9.9% 21.6% 10.2% 5.7% 5.1% 0.0% |
|TERMINAL (d) | 2/25 (8%) 4/21 (19%) 1/23 (4%) 0/19 (0%) 1/22 (5%) 0/21 (0%) |
|FIRST INCIDENCE | 469 241 659 338 673 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.008N** P=0.127 P=0.616 P=0.439N P=0.377N P=0.077N |
|POLY 3 | P=0.004N** P=0.132 P=0.626 P=0.401N P=0.350N P=0.053N |
|POLY 1.5 | P=0.004N** P=0.155 P=0.624 P=0.374N P=0.345N P=0.054N |
|POLY 6 | P=0.004N** P=0.109 P=0.627 P=0.436N P=0.360N P=0.057N |
|LOGISTIC REGRESSION| P=0.006N** P=0.184 P=0.633 P=0.327N P=0.340N P=0.060N |
|COCH-ARM / FISHERS | P=0.006N** P=0.189 P=0.642N P=0.339N P=0.339N P=0.059N |
|ORDER RESTRICTED | P=0.005N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 7
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 6/53 (11%) 8/54 (15%) 5/53 (9%) 2/53 (4%) 2/53 (4%) 1/53 (2%) |
|POLY-3 RATE (b) | 6/40.77 8/37.03 5/39.08 2/35.28 2/39.22 1/42.60 |
|POLY-3 PERCENT (g) | 14.7% 21.6% 12.8% 5.7% 5.1% 2.4% |
|TERMINAL (d) | 3/25 (12%) 4/21 (19%) 2/23 (9%) 0/19 (0%) 1/22 (5%) 1/21 (5%) |
|FIRST INCIDENCE | 469 241 659 338 673 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011N* P=0.278 P=0.538N P=0.232N P=0.168N P=0.077N |
|POLY 3 | P=0.005N** P=0.310 P=0.530N P=0.182N P=0.143N P=0.048N* |
|POLY 1.5 | P=0.006N** P=0.350 P=0.528N P=0.160N P=0.139N P=0.048N* |
|POLY 6 | P=0.005N** P=0.266 P=0.536N P=0.214N P=0.151N P=0.053N |
|LOGISTIC REGRESSION| P=0.007N** P=0.385 P=0.515N P=0.137N P=0.137N P=0.051N |
|COCH-ARM / FISHERS | P=0.009N** P=0.402 P=0.500N P=0.135N P=0.135N P=0.056N |
|ORDER RESTRICTED | P=0.009N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 33/53 (62%) 40/54 (74%) 34/53 (64%) 29/53 (55%) 36/53 (68%) 24/53 (45%) |
|POLY-3 RATE (b) | 33/46.50 40/48.95 34/45.82 29/41.25 36/48.31 24/47.04 |
|POLY-3 PERCENT (g) | 71.0% 81.7% 74.2% 70.3% 74.5% 51.0% |
|TERMINAL (d) | 16/25 (64%) 16/21 (76%) 16/23 (70%) 12/19 (63%) 15/22 (68%) 12/21 (57%) |
|FIRST INCIDENCE | 185 241 236 453 141 396 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.021N* P=0.048 * P=0.404 P=0.338 P=0.256 P=0.174N |
|POLY 3 | P<0.001N** P=0.147 P=0.452 P=0.570N P=0.435 P=0.031N* |
|POLY 1.5 | P<0.001N** P=0.129 P=0.418 P=0.468N P=0.401 P=0.033N* |
|POLY 6 | P=0.002N** P=0.183 P=0.498 P=0.559 P=0.453 P=0.041N* |
|LOGISTIC REGRESSION| P=0.002N** P=0.104 P=0.445 P=0.424N P=0.337 P=0.043N* |
|COCH-ARM / FISHERS | P=0.009N** P=0.135 P=0.500 P=0.277N P=0.342 P=0.059N |
|ORDER RESTRICTED | P=0.002N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 8
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 35/53 (66%) 40/54 (74%) 35/53 (66%) 29/53 (55%) 36/53 (68%) 24/53 (45%) |
|POLY-3 RATE (b) | 35/46.86 40/48.95 35/45.82 29/41.25 36/48.31 24/47.04 |
|POLY-3 PERCENT (g) | 74.7% 81.7% 76.4% 70.3% 74.5% 51.0% |
|TERMINAL (d) | 17/25 (68%) 16/21 (76%) 17/23 (74%) 12/19 (63%) 15/22 (68%) 12/21 (57%) |
|FIRST INCIDENCE | 185 241 236 453 141 396 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.013N* P=0.079 P=0.454 P=0.435 P=0.352 P=0.109N |
|POLY 3 | P<0.001N** P=0.269 P=0.522 P=0.407N P=0.589N P=0.010N* |
|POLY 1.5 | P<0.001N** P=0.244 P=0.493 P=0.308N P=0.572 P=0.011N* |
|POLY 6 | P<0.001N** P=0.311 P=0.554 P=0.500N P=0.591N P=0.015N* |
|LOGISTIC REGRESSION| P<0.001N** P=0.192 P=0.523 P=0.275N P=0.495 P=0.016N* |
|COCH-ARM / FISHERS | P=0.004N** P=0.243 P=0.581N P=0.160N P=0.500 P=0.025N* |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 35/53 (66%) 43/54 (80%) 37/53 (70%) 31/53 (58%) 37/53 (70%) 24/53 (45%) |
|POLY-3 RATE (b) | 35/46.86 43/49.90 37/46.14 31/42.36 37/48.53 24/47.04 |
|POLY-3 PERCENT (g) | 74.7% 86.2% 80.2% 73.2% 76.2% 51.0% |
|TERMINAL (d) | 17/25 (68%) 17/21 (81%) 17/23 (74%) 12/19 (63%) 15/22 (68%) 12/21 (57%) |
|FIRST INCIDENCE | 185 241 236 338 141 396 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.007N** P=0.034 * P=0.344 P=0.318 P=0.303 P=0.109N |
|POLY 3 | P<0.001N** P=0.107 P=0.343 P=0.533N P=0.526 P=0.010N* |
|POLY 1.5 | P<0.001N** P=0.089 P=0.314 P=0.441N P=0.488 P=0.011N* |
|POLY 6 | P<0.001N** P=0.135 P=0.389 P=0.606 P=0.546 P=0.015N* |
|LOGISTIC REGRESSION| P<0.001N** P=0.062 P=0.349 P=0.411N P=0.412 P=0.016N* |
|COCH-ARM / FISHERS | P<0.001N** P=0.086 P=0.418 P=0.274N P=0.418 P=0.025N* |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 9
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/54 (4%) 1/53 (2%) 0/53 (0%) 4/53 (8%) 10/53 (19%) |
|POLY-3 RATE (b) | 1/40.42 2/34.91 1/39.25 0/34.16 4/39.40 10/45.45 |
|POLY-3 PERCENT (g) | 2.5% 5.7% 2.6% 0.0% 10.2% 22.0% |
|TERMINAL (d) | 0/25 (0%) 1/21 (5%) 0/23 (0%) 0/19 (0%) 1/22 (5%) 2/21 (10%) |
|FIRST INCIDENCE | 366 647 578 --- 659 546 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.444 P=0.757N P=0.496N P=0.166 P=0.009 ** |
|POLY 3 | P<0.001 ** P=0.449 P=0.755 P=0.533N P=0.169 P=0.007 ** |
|POLY 1.5 | P<0.001 ** P=0.471 P=0.753 P=0.520N P=0.173 P=0.006 ** |
|POLY 6 | P<0.001 ** P=0.428 P=0.756 P=0.549N P=0.165 P=0.007 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.527 P=0.725N P=0.436N P=0.180 P=0.002 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.507 P=0.752N P=0.500N P=0.181 P=0.004 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/54 (4%) 1/53 (2%) 0/53 (0%) 4/53 (8%) 10/53 (19%) |
|POLY-3 RATE (b) | 1/40.42 2/34.91 1/39.25 0/34.16 4/39.40 10/45.45 |
|POLY-3 PERCENT (g) | 2.5% 5.7% 2.6% 0.0% 10.2% 22.0% |
|TERMINAL (d) | 0/25 (0%) 1/21 (5%) 0/23 (0%) 0/19 (0%) 1/22 (5%) 2/21 (10%) |
|FIRST INCIDENCE | 366 647 578 --- 659 546 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.444 P=0.757N P=0.496N P=0.166 P=0.009 ** |
|POLY 3 | P<0.001 ** P=0.449 P=0.755 P=0.533N P=0.169 P=0.007 ** |
|POLY 1.5 | P<0.001 ** P=0.471 P=0.753 P=0.520N P=0.173 P=0.006 ** |
|POLY 6 | P<0.001 ** P=0.428 P=0.756 P=0.549N P=0.165 P=0.007 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.527 P=0.725N P=0.436N P=0.180 P=0.002 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.507 P=0.752N P=0.500N P=0.181 P=0.004 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 10
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/54 (4%) 1/53 (2%) 0/53 (0%) 4/53 (8%) 10/53 (19%) |
|POLY-3 RATE (b) | 1/40.42 2/34.91 1/39.25 0/34.16 4/39.40 10/45.45 |
|POLY-3 PERCENT (g) | 2.5% 5.7% 2.6% 0.0% 10.2% 22.0% |
|TERMINAL (d) | 0/25 (0%) 1/21 (5%) 0/23 (0%) 0/19 (0%) 1/22 (5%) 2/21 (10%) |
|FIRST INCIDENCE | 366 647 578 --- 659 546 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.444 P=0.757N P=0.496N P=0.166 P=0.009 ** |
|POLY 3 | P<0.001 ** P=0.449 P=0.755 P=0.533N P=0.169 P=0.007 ** |
|POLY 1.5 | P<0.001 ** P=0.471 P=0.753 P=0.520N P=0.173 P=0.006 ** |
|POLY 6 | P<0.001 ** P=0.428 P=0.756 P=0.549N P=0.165 P=0.007 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.527 P=0.725N P=0.436N P=0.180 P=0.002 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.507 P=0.752N P=0.500N P=0.181 P=0.004 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Pancreas |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 0/54 (0%) 0/52 (0%) 0/53 (0%) 0/52 (0%) 2/51 (4%) |
|POLY-3 RATE (b) | 0/38.86 0/34.61 0/38.64 0/34.16 0/38.45 2/41.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 4.9% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) 0/23 (0%) 0/19 (0%) 0/22 (0%) 1/21 (5%) |
|FIRST INCIDENCE | --- --- --- --- --- 641 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.014 * (e) (e) (e) (e) P=0.223 |
|POLY 3 | P=0.011 * (e) (e) (e) (e) P=0.250 |
|POLY 1.5 | P=0.011 * (e) (e) (e) (e) P=0.249 |
|POLY 6 | P=0.011 * (e) (e) (e) (e) P=0.244 |
|LOGISTIC REGRESSION| P=0.014 * (e) (e) (e) (e) P=0.247 |
|COCH-ARM / FISHERS | P=0.010 * (e) (e) (e) (e) P=0.248 |
|ORDER RESTRICTED | P=0.011 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 11
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Pancreas |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 0/54 (0%) 0/52 (0%) 0/53 (0%) 0/52 (0%) 3/51 (6%) |
|POLY-3 RATE (b) | 0/38.86 0/34.61 0/38.64 0/34.16 0/38.45 3/41.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 7.3% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) 0/23 (0%) 0/19 (0%) 0/22 (0%) 2/21 (10%) |
|FIRST INCIDENCE | --- --- --- --- --- 641 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.104 |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.129 |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.128 |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.123 |
|LOGISTIC REGRESSION| P=0.002 ** (e) (e) (e) (e) P=0.125 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.121 |
|ORDER RESTRICTED | P=0.002 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 25/53 (47%) 20/54 (37%) 26/52 (50%) 15/53 (28%) 20/53 (38%) 11/52 (21%) |
|POLY-3 RATE (b) | 25/42.82 20/36.20 26/40.49 15/36.38 20/42.25 11/44.01 |
|POLY-3 PERCENT (g) | 58.4% 55.3% 64.2% 41.2% 47.3% 25.0% |
|TERMINAL (d) | 15/25 (60%) 16/21 (76%) 15/23 (65%) 9/19 (47%) 10/22 (46%) 4/21 (19%) |
|FIRST INCIDENCE | 474 604 550 545 444 604 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004N** P=0.542N P=0.397 P=0.253N P=0.356N P=0.016N* |
|POLY 3 | P<0.001N** P=0.478N P=0.369 P=0.087N P=0.202N P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.334N P=0.372 P=0.056N P=0.203N P<0.001N** |
|POLY 6 | P<0.001N** P=0.545 P=0.363 P=0.146N P=0.212N P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.503N P=0.420 P=0.102N P=0.216N P<0.001N** |
|COCH-ARM / FISHERS | P=0.003N** P=0.193N P=0.462 P=0.035N* P=0.216N P=0.004N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 12
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/54 (0%) 0/52 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) |
|POLY-3 RATE (b) | 2/39.60 0/34.61 0/38.01 0/34.16 0/39.00 0/42.44 |
|POLY-3 PERCENT (g) | 5.1% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/21 (0%) 0/23 (0%) 0/19 (0%) 0/22 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 717 --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.259N P=0.277N P=0.245N P=0.311N P=0.272N P=0.268N |
|POLY 3 | P=0.226N P=0.268N P=0.246N P=0.271N P=0.240N P=0.222N |
|POLY 1.5 | P=0.235N P=0.253N P=0.248N P=0.257N P=0.239N P=0.225N |
|POLY 6 | P=0.216N P=0.284N P=0.244N P=0.290N P=0.244N P=0.226N |
|LOGISTIC REGRESSION| P=0.243N P=0.286N P=0.242N P=0.303N P=0.254N P=0.246N |
|COCH-ARM / FISHERS | P=0.250N P=0.243N P=0.252N P=0.248N P=0.248N P=0.252N |
|ORDER RESTRICTED | P=0.007N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 1/53 (2%) 0/54 (0%) 2/53 (4%) 0/53 (0%) 0/53 (0%) 1/53 (2%) |
|POLY-3 RATE (b) | 1/40.13 0/34.61 2/39.56 0/34.16 0/39.00 1/42.65 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 5.1% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) 0/23 (0%) 0/19 (0%) 0/22 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 548 --- 578 --- --- 717 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.605N P=0.505N P=0.509 P=0.515N P=0.490N P=0.747N |
|POLY 3 | P=0.612N P=0.529N P=0.495 P=0.532N P=0.506N P=0.747N |
|POLY 1.5 | P=0.628N P=0.516N P=0.491 P=0.519N P=0.503N P=0.748N |
|POLY 6 | P=0.601N P=0.544N P=0.499 P=0.548N P=0.511N P=0.755N |
|LOGISTIC REGRESSION| P=0.653 P=0.475N P=0.511 P=0.479N P=0.497N P=0.753 |
|COCH-ARM / FISHERS | P=0.650N P=0.495N P=0.500 P=0.500N P=0.500N P=0.752N |
|ORDER RESTRICTED | P=0.480N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 13
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 1/53 (2%) 0/54 (0%) 3/53 (6%) 1/53 (2%) 0/53 (0%) 1/53 (2%) |
|POLY-3 RATE (b) | 1/40.13 0/34.61 3/39.97 1/34.16 0/39.00 1/42.65 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 7.5% 2.9% 0.0% 2.3% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) 0/23 (0%) 1/19 (5%) 0/22 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 548 --- 578 731 (T) --- 717 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.451N P=0.505N P=0.313 P=0.721 P=0.490N P=0.747N |
|POLY 3 | P=0.439N P=0.529N P=0.303 P=0.724 P=0.506N P=0.747N |
|POLY 1.5 | P=0.458N P=0.516N P=0.298 P=0.740 P=0.503N P=0.748N |
|POLY 6 | P=0.430N P=0.544N P=0.309 P=0.704 P=0.511N P=0.755N |
|LOGISTIC REGRESSION| P=0.482N P=0.475N P=0.314 P=0.755 P=0.497N P=0.753 |
|COCH-ARM / FISHERS | P=0.493N P=0.495N P=0.309 P=0.752N P=0.500N P=0.752N |
|ORDER RESTRICTED | P=0.459N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Skin |
| Schwannoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 1/53 (2%) 0/54 (0%) 0/53 (0%) 2/53 (4%) 0/53 (0%) 1/53 (2%) |
|POLY-3 RATE (b) | 1/39.67 0/34.61 0/38.75 2/35.78 0/39.00 1/43.05 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 0.0% 5.6% 0.0% 2.3% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) 0/23 (0%) 0/19 (0%) 0/22 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 701 --- --- 380 --- 599 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.559 P=0.539N P=0.500N P=0.459 P=0.515N P=0.747N |
|POLY 3 | P=0.576 P=0.527N P=0.505N P=0.464 P=0.503N P=0.743N |
|POLY 1.5 | P=0.563 P=0.515N P=0.506N P=0.479 P=0.502N P=0.745N |
|POLY 6 | P=0.577 P=0.541N P=0.505N P=0.443 P=0.507N P=0.748N |
|LOGISTIC REGRESSION| P=0.441 P=0.536N P=0.504N P=0.552 P=0.505N P=0.763 |
|COCH-ARM / FISHERS | P=0.519 P=0.495N P=0.500N P=0.500 P=0.500N P=0.752N |
|ORDER RESTRICTED | P=0.501 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 14
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 1/53 (2%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 2/53 (4%) 1/53 (2%) |
|POLY-3 RATE (b) | 1/39.86 0/34.61 0/38.75 0/34.16 2/39.21 1/42.60 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 0.0% 0.0% 5.1% 2.4% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) 0/23 (0%) 0/19 (0%) 0/22 (0%) 1/21 (5%) |
|FIRST INCIDENCE | 646 --- --- --- 701 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.274 P=0.570N P=0.523N P=0.586N P=0.472 P=0.738 |
|POLY 3 | P=0.326 P=0.528N P=0.506N P=0.531N P=0.494 P=0.746N |
|POLY 1.5 | P=0.310 P=0.515N P=0.506N P=0.518N P=0.497 P=0.747N |
|POLY 6 | P=0.328 P=0.542N P=0.506N P=0.547N P=0.488 P=0.754N |
|LOGISTIC REGRESSION| P=0.299 P=0.508N P=0.502N P=0.511N P=0.495 P=0.749N |
|COCH-ARM / FISHERS | P=0.259 P=0.495N P=0.500N P=0.500N P=0.500 P=0.752N |
|ORDER RESTRICTED | P=0.249 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 20/52 (38%) 15/54 (28%) 17/53 (32%) 16/51 (31%) 13/53 (25%) 11/52 (21%) |
|POLY-3 RATE (b) | 20/42.85 15/37.10 17/39.42 16/37.06 13/41.12 11/43.05 |
|POLY-3 PERCENT (g) | 46.7% 40.4% 43.1% 43.2% 31.6% 25.6% |
|TERMINAL (d) | 10/25 (40%) 10/21 (48%) 13/23 (57%) 8/19 (42%) 8/22 (36%) 6/21 (29%) |
|FIRST INCIDENCE | 474 462 626 338 486 638 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.048N* P=0.422N P=0.430N P=0.551 P=0.180N P=0.091N |
|POLY 3 | P=0.010N* P=0.366N P=0.459N P=0.464N P=0.111N P=0.030N* |
|POLY 1.5 | P=0.015N* P=0.268N P=0.413N P=0.382N P=0.099N P=0.028N* |
|POLY 6 | P=0.010N* P=0.499N P=0.533N P=0.579N P=0.139N P=0.043N* |
|LOGISTIC REGRESSION| P=0.014N* P=0.286N P=0.338N P=0.385N P=0.093N P=0.028N* |
|COCH-ARM / FISHERS | P=0.047N* P=0.168N P=0.316N P=0.292N P=0.092N P=0.043N* |
|ORDER RESTRICTED | P=0.021N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 15
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 1/54 (2%) 0/53 (0%) 0/51 (0%) 2/53 (4%) 0/52 (0%) |
|POLY-3 RATE (b) | 1/38.90 1/35.04 0/38.75 0/33.58 2/39.00 0/41.66 |
|POLY-3 PERCENT (g) | 2.6% 2.9% 0.0% 0.0% 5.1% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/21 (0%) 0/23 (0%) 0/19 (0%) 2/22 (9%) 0/21 (0%) |
|FIRST INCIDENCE | 731 (T) 604 --- --- 731 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.506N P=0.712 P=0.517N P=0.555N P=0.455 P=0.535N |
|POLY 3 | P=0.468N P=0.738 P=0.501N P=0.529N P=0.501 P=0.486N |
|POLY 1.5 | P=0.475N P=0.750 P=0.502N P=0.519N P=0.504 P=0.487N |
|POLY 6 | P=0.472N P=0.724 P=0.501N P=0.543N P=0.493 P=0.492N |
|LOGISTIC REGRESSION| P=0.474N P=0.749 (e) (e) P=0.455 (e) |
|COCH-ARM / FISHERS | P=0.511N P=0.743N P=0.495N P=0.505N P=0.507 P=0.500N |
|ORDER RESTRICTED | P=0.306N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 21/52 (40%) 15/54 (28%) 17/53 (32%) 16/51 (31%) 14/53 (26%) 11/52 (21%) |
|POLY-3 RATE (b) | 21/42.85 15/37.10 17/39.42 16/37.06 14/41.12 11/43.05 |
|POLY-3 PERCENT (g) | 49.0% 40.4% 43.1% 43.2% 34.0% 25.6% |
|TERMINAL (d) | 11/25 (44%) 10/21 (48%) 13/23 (57%) 8/19 (42%) 9/22 (41%) 6/21 (29%) |
|FIRST INCIDENCE | 474 462 626 338 486 638 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.044N* P=0.354N P=0.358N P=0.534N P=0.188N P=0.066N |
|POLY 3 | P=0.008N** P=0.288N P=0.374N P=0.380N P=0.115N P=0.017N* |
|POLY 1.5 | P=0.013N* P=0.202N P=0.333N P=0.304N P=0.101N P=0.016N* |
|POLY 6 | P=0.008N** P=0.415N P=0.446N P=0.495N P=0.145N P=0.025N* |
|LOGISTIC REGRESSION| P=0.012N* P=0.225N P=0.264N P=0.316N P=0.095N P=0.016N* |
|COCH-ARM / FISHERS | P=0.043N* P=0.122N P=0.247N P=0.227N P=0.095N P=0.027N* |
|ORDER RESTRICTED | P=0.011N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 16
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/54 (4%) 0/53 (0%) 1/53 (2%) 2/53 (4%) 1/53 (2%) |
|POLY-3 RATE (b) | 0/39.55 2/34.61 0/38.75 1/34.16 2/39.00 1/42.66 |
|POLY-3 PERCENT (g) | 0.0% 5.8% 0.0% 2.9% 5.1% 2.3% |
|TERMINAL (d) | 0/25 (0%) 2/21 (10%) 0/23 (0%) 1/19 (5%) 2/22 (9%) 0/21 (0%) |
|FIRST INCIDENCE | --- 731 (T) --- 731 (T) 731 (T) 716 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.421 P=0.200 (e) P=0.445 P=0.210 P=0.492 |
|POLY 3 | P=0.489 P=0.208 (e) P=0.471 P=0.233 P=0.515 |
|POLY 1.5 | P=0.485 P=0.221 (e) P=0.483 P=0.235 P=0.513 |
|POLY 6 | P=0.476 P=0.195 (e) P=0.456 P=0.229 P=0.511 |
|LOGISTIC REGRESSION| P=0.443 P=0.200 (e) P=0.445 P=0.210 P=0.501 |
|COCH-ARM / FISHERS | P=0.441 P=0.252 (e) P=0.500 P=0.248 P=0.500 |
|ORDER RESTRICTED | P=0.246 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 11/53 (21%) 7/54 (13%) 4/53 (8%) 11/53 (21%) 10/53 (19%) 8/53 (15%) |
|POLY-3 RATE (b) | 11/40.11 7/35.74 4/39.04 11/36.29 10/40.43 8/44.05 |
|POLY-3 PERCENT (g) | 27.4% 19.6% 10.3% 30.3% 24.7% 18.2% |
|TERMINAL (d) | 8/25 (32%) 5/21 (24%) 2/23 (9%) 6/19 (32%) 5/22 (23%) 3/21 (14%) |
|FIRST INCIDENCE | 645 526 659 557 590 598 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.531 P=0.361N P=0.064N P=0.314 P=0.589 P=0.400N |
|POLY 3 | P=0.404N P=0.296N P=0.045N* P=0.490 P=0.492N P=0.223N |
|POLY 1.5 | P=0.452N P=0.257N P=0.048N* P=0.531 P=0.496N P=0.240N |
|POLY 6 | P=0.386N P=0.342N P=0.043N* P=0.445 P=0.491N P=0.225N |
|LOGISTIC REGRESSION| P=0.439N P=0.359N P=0.045N* P=0.395 P=0.527N P=0.253N |
|COCH-ARM / FISHERS | P=0.497 P=0.207N P=0.046N* P=0.594N P=0.500N P=0.307N |
|ORDER RESTRICTED | P=0.245N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 17
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 5/53 (9%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/39.55 0/34.61 0/38.75 0/34.16 5/40.55 0/42.60 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 12.3% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) 0/23 (0%) 0/19 (0%) 0/22 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- --- --- --- 589 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.300 (e) (e) (e) P=0.035 * (e) |
|POLY 3 | P=0.337 (e) (e) (e) P=0.032 * (e) |
|POLY 1.5 | P=0.318 (e) (e) (e) P=0.031 * (e) |
|POLY 6 | P=0.328 (e) (e) (e) P=0.033 * (e) |
|LOGISTIC REGRESSION| P=0.259 (e) (e) (e) P=0.033 * (e) |
|COCH-ARM / FISHERS | P=0.247 (e) (e) (e) P=0.028 * (e) |
|ORDER RESTRICTED | P=0.033 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 2/53 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/39.55 0/34.61 0/38.75 0/34.16 2/39.00 0/42.60 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 5.1% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) 0/23 (0%) 0/19 (0%) 2/22 (9%) 0/21 (0%) |
|FIRST INCIDENCE | --- --- --- --- 731 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.446 (e) (e) (e) P=0.210 (e) |
|POLY 3 | P=0.544 (e) (e) (e) P=0.233 (e) |
|POLY 1.5 | P=0.527 (e) (e) (e) P=0.235 (e) |
|POLY 6 | P=0.542 (e) (e) (e) P=0.229 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.210 (e) |
|COCH-ARM / FISHERS | P=0.461 (e) (e) (e) P=0.248 (e) |
|ORDER RESTRICTED | P=0.183 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 18
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 1/54 (2%) 1/53 (2%) 0/53 (0%) 1/53 (2%) 2/53 (4%) |
|POLY-3 RATE (b) | 0/39.55 1/35.31 1/39.12 0/34.16 1/39.64 2/42.60 |
|POLY-3 PERCENT (g) | 0.0% 2.8% 2.6% 0.0% 2.5% 4.7% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) 0/23 (0%) 0/19 (0%) 0/22 (0%) 2/21 (10%) |
|FIRST INCIDENCE | --- 490 626 --- 518 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.170 P=0.491 P=0.484 (e) P=0.505 P=0.200 |
|POLY 3 | P=0.172 P=0.477 P=0.498 (e) P=0.500 P=0.254 |
|POLY 1.5 | P=0.166 P=0.488 P=0.496 (e) P=0.500 P=0.252 |
|POLY 6 | P=0.169 P=0.467 P=0.500 (e) P=0.499 P=0.247 |
|LOGISTIC REGRESSION| P=0.138 P=0.536 P=0.500 (e) P=0.504 P=0.200 |
|COCH-ARM / FISHERS | P=0.145 P=0.505 P=0.500 (e) P=0.500 P=0.248 |
|ORDER RESTRICTED | P=0.107 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 45/53 (85%) 49/54 (91%) 45/53 (85%) 40/53 (75%) 46/53 (87%) 42/53 (79%) |
|POLY-3 RATE (b) | 45/48.82 49/50.46 45/47.09 40/44.36 46/49.52 42/49.59 |
|POLY-3 PERCENT (g) | 92.2% 97.1% 95.6% 90.2% 92.9% 84.7% |
|TERMINAL (d) | 23/25 (92%) 21/21 (100%) 22/23 (96%) 17/19 (90%) 21/22 (96%) 18/21 (86%) |
|FIRST INCIDENCE | 185 241 236 338 141 396 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.198N P=0.069 P=0.432 P=0.268 P=0.312 P=0.555 |
|POLY 3 | P=0.010N* P=0.232 P=0.383 P=0.511N P=0.610 P=0.173N |
|POLY 1.5 | P=0.017N* P=0.211 P=0.368 P=0.349N P=0.575 P=0.182N |
|POLY 6 | P=0.019N* P=0.301 P=0.440 P=0.657N P=0.619 P=0.217N |
|LOGISTIC REGRESSION| P=0.007N** P=0.129 P=0.451 P=0.309N P=0.487 P=0.125N |
|COCH-ARM / FISHERS | P=0.178N P=0.266 P=0.607N P=0.165N P=0.500 P=0.307N |
|ORDER RESTRICTED | P=0.018N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 19
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 13/53 (25%) 19/54 (35%) 13/53 (25%) 11/53 (21%) 24/53 (45%) 34/53 (64%) |
|POLY-3 RATE (b) | 13/43.94 19/41.93 13/42.97 11/38.84 24/42.50 34/48.63 |
|POLY-3 PERCENT (g) | 29.6% 45.3% 30.3% 28.3% 56.5% 69.9% |
|TERMINAL (d) | 4/25 (16%) 7/21 (33%) 3/23 (13%) 3/19 (16%) 12/22 (55%) 14/21 (67%) |
|FIRST INCIDENCE | 169 200 240 338 518 546 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.090 P=0.533 P=0.549 P=0.022 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.093 P=0.566 P=0.547N P=0.008 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.121 P=0.554 P=0.493N P=0.010 * P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.067 P=0.579 P=0.581 P=0.006 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.211 P=0.572N P=0.355N P=0.019 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.160 P=0.589N P=0.408N P=0.020 * P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 |
| | NG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 47/53 (89%) 54/54 (100%) 48/53 (91%) 44/53 (83%) 50/53 (94%) 50/53 (94%) |
|POLY-3 RATE (b) | 47/50.68 54/54.00 48/49.12 44/46.61 50/51.10 50/51.78 |
|POLY-3 PERCENT (g) | 92.7% 100.0% 97.7% 94.4% 97.9% 96.6% |
|TERMINAL (d) | 23/25 (92%) 21/21 (100%) 22/23 (96%) 18/19 (95%) 21/22 (96%) 20/21 (95%) |
|FIRST INCIDENCE | 169 200 236 338 141 396 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.436N P=0.037 * P=0.376 P=0.184 P=0.233 P=0.256 |
|POLY 3 | P=0.560 P=0.046 * P=0.223 P=0.535 P=0.205 P=0.317 |
|POLY 1.5 | P=0.526 P=0.027 * P=0.191 P=0.650 P=0.168 P=0.286 |
|POLY 6 | P=0.571 P=0.088 P=0.314 P=0.464 P=0.298 P=0.360 |
|LOGISTIC REGRESSION| P=0.387N P=0.014 * P=0.358 P=0.423N P=0.230 P=0.346 |
|COCH-ARM / FISHERS | P=0.342 P=0.013 * P=0.500 P=0.289N P=0.244 P=0.244 |
|ORDER RESTRICTED | P=0.109 (e) (e) (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).