TDMS Study 96007-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) DATE: 10/22/03
EXPERIMENT: 96007 TEST: 03 TIME: 16:15:51
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
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) DATE: 10/22/03
EXPERIMENT: 96007 TEST: 03 TIME: 16:15:51
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
----- ----------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Heart Schwannoma Malignant
Liver Cholangiocarcinoma
Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma or Cholangiocarcinoma
Hepatocholangioma
Lung Cystic Keratinizing Epithelioma
Mammary Gland 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
Skin Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
Uterus Carcinoma
Polyp Stromal
Squamous Cell Carcinoma
All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 10/22/03 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 | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/43.18 1/38.27 |
|POLY-3 PERCENT (g) | 7.0% 2.6% |
|TERMINAL (d) | 0/21 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 642 702 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.305N |
|POLY 3 | P=0.361N |
|POLY 1.5 | P=0.355N |
|POLY 6 | P=0.358N |
|LOGISTIC REGRESSION| P=0.341N |
|COCH-ARM / FISHERS | P=0.331N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/43.18 2/38.27 |
|POLY-3 PERCENT (g) | 7.0% 5.2% |
|TERMINAL (d) | 0/21 (0%) 1/21 (5%) |
|FIRST INCIDENCE | 642 702 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.497N |
|POLY 3 | P=0.567N |
|POLY 1.5 | P=0.559N |
|POLY 6 | P=0.564N |
|LOGISTIC REGRESSION| P=0.547N |
|COCH-ARM / FISHERS | P=0.528N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/22/03 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 | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Heart |
| Schwannoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/41.64 3/38.98 |
|POLY-3 PERCENT (g) | 0.0% 7.7% |
|TERMINAL (d) | 0/21 (0%) 1/21 (5%) |
|FIRST INCIDENCE | --- 484 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.121 |
|POLY 3 | P=0.110 |
|POLY 1.5 | P=0.110 |
|POLY 6 | P=0.112 |
|LOGISTIC REGRESSION| P=0.120 |
|COCH-ARM / FISHERS | P=0.114 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Cholangiocarcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 25/53 (47%) 2/50 (4%) |
|POLY-3 RATE (b) | 25/45.58 2/38.16 |
|POLY-3 PERCENT (g) | 54.9% 5.2% |
|TERMINAL (d) | 13/21 (62%) 1/21 (5%) |
|FIRST INCIDENCE | 610 729 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** |
|POLY 3 | P<0.001N** |
|POLY 1.5 | P<0.001N** |
|POLY 6 | P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/22/03 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 | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 13/53 (25%) 2/50 (4%) |
|POLY-3 RATE (b) | 13/43.52 2/38.29 |
|POLY-3 PERCENT (g) | 29.9% 5.2% |
|TERMINAL (d) | 7/21 (33%) 0/21 (0%) |
|FIRST INCIDENCE | 642 702 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003N** |
|POLY 3 | P=0.004N** |
|POLY 1.5 | P=0.004N** |
|POLY 6 | P=0.003N** |
|LOGISTIC REGRESSION| P=0.003N** |
|COCH-ARM / FISHERS | P=0.003N** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma or |
| Cholangiocarcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 29/53 (55%) 4/50 (8%) |
|POLY-3 RATE (b) | 29/46.02 4/38.30 |
|POLY-3 PERCENT (g) | 63.0% 10.4% |
|TERMINAL (d) | 14/21 (67%) 1/21 (5%) |
|FIRST INCIDENCE | 610 702 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** |
|POLY 3 | P<0.001N** |
|POLY 1.5 | P<0.001N** |
|POLY 6 | P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/22/03 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 | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Hepatocholangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.93 0/38.16 |
|POLY-3 PERCENT (g) | 4.7% 0.0% |
|TERMINAL (d) | 1/21 (5%) 0/21 (0%) |
|FIRST INCIDENCE | 638 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.257N |
|POLY 3 | P=0.279N |
|POLY 1.5 | P=0.274N |
|POLY 6 | P=0.275N |
|LOGISTIC REGRESSION| P=0.259N |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Lung |
| Cystic Keratinizing Epithelioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 9/52 (17%) 0/50 (0%) |
|POLY-3 RATE (b) | 9/42.72 0/38.16 |
|POLY-3 PERCENT (g) | 21.1% 0.0% |
|TERMINAL (d) | 4/21 (19%) 0/21 (0%) |
|FIRST INCIDENCE | 610 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004N** |
|POLY 3 | P=0.003N** |
|POLY 1.5 | P=0.003N** |
|POLY 6 | P=0.003N** |
|LOGISTIC REGRESSION| P=0.003N** |
|COCH-ARM / FISHERS | P=0.002N** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/22/03 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 | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 24/53 (45%) 32/50 (64%) |
|POLY-3 RATE (b) | 24/47.04 32/44.58 |
|POLY-3 PERCENT (g) | 51.0% 71.8% |
|TERMINAL (d) | 12/21 (57%) 13/21 (62%) |
|FIRST INCIDENCE | 396 345 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.105 |
|POLY 3 | P=0.027 * |
|POLY 1.5 | P=0.028 * |
|POLY 6 | P=0.035 * |
|LOGISTIC REGRESSION| P=0.034 * |
|COCH-ARM / FISHERS | P=0.044 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 24/53 (45%) 32/50 (64%) |
|POLY-3 RATE (b) | 24/47.04 32/44.58 |
|POLY-3 PERCENT (g) | 51.0% 71.8% |
|TERMINAL (d) | 12/21 (57%) 13/21 (62%) |
|FIRST INCIDENCE | 396 345 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.105 |
|POLY 3 | P=0.027 * |
|POLY 1.5 | P=0.028 * |
|POLY 6 | P=0.035 * |
|LOGISTIC REGRESSION| P=0.034 * |
|COCH-ARM / FISHERS | P=0.044 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/22/03 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 | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 24/53 (45%) 33/50 (66%) |
|POLY-3 RATE (b) | 24/47.04 33/45.18 |
|POLY-3 PERCENT (g) | 51.0% 73.0% |
|TERMINAL (d) | 12/21 (57%) 13/21 (62%) |
|FIRST INCIDENCE | 396 345 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.080 |
|POLY 3 | P=0.019 * |
|POLY 1.5 | P=0.018 * |
|POLY 6 | P=0.027 * |
|LOGISTIC REGRESSION| P=0.022 * |
|COCH-ARM / FISHERS | P=0.027 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 10/53 (19%) 5/50 (10%) |
|POLY-3 RATE (b) | 10/45.45 5/40.28 |
|POLY-3 PERCENT (g) | 22.0% 12.4% |
|TERMINAL (d) | 2/21 (10%) 0/21 (0%) |
|FIRST INCIDENCE | 546 520 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.202N |
|POLY 3 | P=0.193N |
|POLY 1.5 | P=0.186N |
|POLY 6 | P=0.189N |
|LOGISTIC REGRESSION| P=0.115N |
|COCH-ARM / FISHERS | P=0.160N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/22/03 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 | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 10/53 (19%) 5/50 (10%) |
|POLY-3 RATE (b) | 10/45.45 5/40.28 |
|POLY-3 PERCENT (g) | 22.0% 12.4% |
|TERMINAL (d) | 2/21 (10%) 0/21 (0%) |
|FIRST INCIDENCE | 546 520 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.202N |
|POLY 3 | P=0.193N |
|POLY 1.5 | P=0.186N |
|POLY 6 | P=0.189N |
|LOGISTIC REGRESSION| P=0.115N |
|COCH-ARM / FISHERS | P=0.160N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 10/53 (19%) 5/50 (10%) |
|POLY-3 RATE (b) | 10/45.45 5/40.28 |
|POLY-3 PERCENT (g) | 22.0% 12.4% |
|TERMINAL (d) | 2/21 (10%) 0/21 (0%) |
|FIRST INCIDENCE | 546 520 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.202N |
|POLY 3 | P=0.193N |
|POLY 1.5 | P=0.186N |
|POLY 6 | P=0.189N |
|LOGISTIC REGRESSION| P=0.115N |
|COCH-ARM / FISHERS | P=0.160N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/22/03 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 | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Pancreas |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/51 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 2/41.18 1/37.76 |
|POLY-3 PERCENT (g) | 4.9% 2.7% |
|TERMINAL (d) | 1/21 (5%) 1/21 (5%) |
|FIRST INCIDENCE | 641 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.513N |
|POLY 3 | P=0.541N |
|POLY 1.5 | P=0.538N |
|POLY 6 | P=0.534N |
|LOGISTIC REGRESSION| P=0.522N |
|COCH-ARM / FISHERS | P=0.515N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Pancreas |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/51 (6%) 1/49 (2%) |
|POLY-3 RATE (b) | 3/41.18 1/37.76 |
|POLY-3 PERCENT (g) | 7.3% 2.7% |
|TERMINAL (d) | 2/21 (10%) 1/21 (5%) |
|FIRST INCIDENCE | 641 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.315N |
|POLY 3 | P=0.345N |
|POLY 1.5 | P=0.342N |
|POLY 6 | P=0.337N |
|LOGISTIC REGRESSION| P=0.320N |
|COCH-ARM / FISHERS | P=0.324N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/22/03 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 | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 11/52 (21%) 19/50 (38%) |
|POLY-3 RATE (b) | 11/44.01 19/39.99 |
|POLY-3 PERCENT (g) | 25.0% 47.5% |
|TERMINAL (d) | 4/21 (19%) 9/21 (43%) |
|FIRST INCIDENCE | 604 584 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.081 |
|POLY 3 | P=0.023 * |
|POLY 1.5 | P=0.028 * |
|POLY 6 | P=0.023 * |
|LOGISTIC REGRESSION| P=0.027 * |
|COCH-ARM / FISHERS | P=0.049 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/42.65 2/39.00 |
|POLY-3 PERCENT (g) | 2.3% 5.1% |
|TERMINAL (d) | 0/21 (0%) 1/21 (5%) |
|FIRST INCIDENCE | 717 394 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.493 |
|POLY 3 | P=0.479 |
|POLY 1.5 | P=0.480 |
|POLY 6 | P=0.484 |
|LOGISTIC REGRESSION| P=0.533 |
|COCH-ARM / FISHERS | P=0.478 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/22/03 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 | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 11/52 (21%) 13/49 (27%) |
|POLY-3 RATE (b) | 11/43.05 13/38.54 |
|POLY-3 PERCENT (g) | 25.6% 33.7% |
|TERMINAL (d) | 6/21 (29%) 7/21 (33%) |
|FIRST INCIDENCE | 638 584 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.401 |
|POLY 3 | P=0.288 |
|POLY 1.5 | P=0.300 |
|POLY 6 | P=0.295 |
|LOGISTIC REGRESSION| P=0.307 |
|COCH-ARM / FISHERS | P=0.344 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 11/52 (21%) 14/49 (29%) |
|POLY-3 RATE (b) | 11/43.05 14/38.54 |
|POLY-3 PERCENT (g) | 25.6% 36.3% |
|TERMINAL (d) | 6/21 (29%) 8/21 (38%) |
|FIRST INCIDENCE | 638 584 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.319 |
|POLY 3 | P=0.208 |
|POLY 1.5 | P=0.221 |
|POLY 6 | P=0.211 |
|LOGISTIC REGRESSION| P=0.228 |
|COCH-ARM / FISHERS | P=0.264 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/22/03 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 | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Uterus |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/42.66 2/38.16 |
|POLY-3 PERCENT (g) | 2.3% 5.2% |
|TERMINAL (d) | 0/21 (0%) 2/21 (10%) |
|FIRST INCIDENCE | 716 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.500 |
|POLY 3 | P=0.475 |
|POLY 1.5 | P=0.477 |
|POLY 6 | P=0.477 |
|LOGISTIC REGRESSION| P=0.501 |
|COCH-ARM / FISHERS | P=0.478 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 8/53 (15%) 4/50 (8%) |
|POLY-3 RATE (b) | 8/44.05 4/38.16 |
|POLY-3 PERCENT (g) | 18.2% 10.5% |
|TERMINAL (d) | 3/21 (14%) 3/21 (14%) |
|FIRST INCIDENCE | 598 729 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.206N |
|POLY 3 | P=0.259N |
|POLY 1.5 | P=0.245N |
|POLY 6 | P=0.266N |
|LOGISTIC REGRESSION| P=0.229N |
|COCH-ARM / FISHERS | P=0.209N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/22/03 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 | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|Uterus |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/42.60 2/38.16 |
|POLY-3 PERCENT (g) | 0.0% 5.2% |
|TERMINAL (d) | 0/21 (0%) 2/21 (10%) |
|FIRST INCIDENCE | --- 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.237 |
|POLY 3 | P=0.225 |
|POLY 1.5 | P=0.226 |
|POLY 6 | P=0.226 |
|LOGISTIC REGRESSION| P=0.237 |
|COCH-ARM / FISHERS | P=0.233 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/42.60 1/39.05 |
|POLY-3 PERCENT (g) | 4.7% 2.6% |
|TERMINAL (d) | 2/21 (10%) 0/21 (0%) |
|FIRST INCIDENCE | 731 (T) 345 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.509N |
|POLY 3 | P=0.541N |
|POLY 1.5 | P=0.540N |
|POLY 6 | P=0.531N |
|LOGISTIC REGRESSION| P=0.451N |
|COCH-ARM / FISHERS | P=0.522N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/22/03 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 | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 42/53 (79%) 41/50 (82%) |
|POLY-3 RATE (b) | 42/49.59 41/45.87 |
|POLY-3 PERCENT (g) | 84.7% 89.4% |
|TERMINAL (d) | 18/21 (86%) 18/21 (86%) |
|FIRST INCIDENCE | 396 345 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.526 |
|POLY 3 | P=0.343 |
|POLY 1.5 | P=0.356 |
|POLY 6 | P=0.388 |
|LOGISTIC REGRESSION| P=0.274 |
|COCH-ARM / FISHERS | P=0.459 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 34/53 (64%) 19/50 (38%) |
|POLY-3 RATE (b) | 34/48.63 19/42.85 |
|POLY-3 PERCENT (g) | 69.9% 44.3% |
|TERMINAL (d) | 14/21 (67%) 9/21 (43%) |
|FIRST INCIDENCE | 546 345 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.023N* |
|POLY 3 | P=0.008N** |
|POLY 1.5 | P=0.007N** |
|POLY 6 | P=0.010N* |
|LOGISTIC REGRESSION| P=0.008N** |
|COCH-ARM / FISHERS | P=0.007N** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/22/03 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 | 100 100 NG/ |
| | NG/KG KG/STOP |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 50/53 (94%) 46/50 (92%) |
|POLY-3 RATE (b) | 50/51.78 46/48.66 |
|POLY-3 PERCENT (g) | 96.6% 94.5% |
|TERMINAL (d) | 20/21 (95%) 19/21 (91%) |
|FIRST INCIDENCE | 396 345 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.458N |
|POLY 3 | P=0.501N |
|POLY 1.5 | P=0.526N |
|POLY 6 | P=0.464N |
|LOGISTIC REGRESSION| P=0.613N |
|COCH-ARM / FISHERS | P=0.467N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).