TDMS Study 96007-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE) DATE: 09/29/03
EXPERIMENT: 96007 TEST: 04 TIME: 12:03:35
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007B
PATHOLOGIST: SELLS, DONALD CAS: TEFDIOXINMIX
------------------------------------------------------------------------------------------------------------------------------------
FINAL#4/RATS
REASONS FOR REMOVAL: 25018 Dosing Accident
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE) DATE: 09/29/03
EXPERIMENT: 96007 TEST: 04 TIME: 12:03:35
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007B
PATHOLOGIST: SELLS, DONALD CAS: TEFDIOXINMIX
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
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Salivary Glands
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE) DATE: 09/29/03
EXPERIMENT: 96007 TEST: 04 TIME: 12:03:35
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007B
PATHOLOGIST: SELLS, DONALD CAS: TEFDIOXINMIX
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Liver Cholangiocarcinoma
Hepatocellular Adenoma
Lung Cystic Keratinizing Epithelioma
Mammary Gland Carcinoma
Carcinoma or Adenoma
Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 1
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/52 (10%) 4/53 (8%) 4/53 (8%) 4/53 (8%) 1/51 (2%) |
|POLY-3 RATE (b) | 5/35.98 4/41.21 4/42.32 4/39.85 1/32.48 |
|POLY-3 PERCENT (g) | 13.9% 9.7% 9.5% 10.0% 3.1% |
|TERMINAL (d) | 3/16 (19%) 1/23 (4%) 1/24 (4%) 2/23 (9%) 0/8 (0%) |
|FIRST INCIDENCE | 693 456 456 669 674 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.207N P=0.345N P=0.305N P=0.333N P=0.263N |
|POLY 3 | P=0.128N P=0.414N P=0.398N P=0.435N P=0.122N |
|POLY 1.5 | P=0.107N P=0.441N P=0.437N P=0.454N P=0.112N |
|POLY 6 | P=0.161N P=0.383N P=0.356N P=0.411N P=0.143N |
|LOGISTIC REGRESSION| P=0.109N P=0.435N P=0.414N P=0.403N P=0.180N |
|COCH-ARM / FISHERS | P=0.089N P=0.488N P=0.488N P=0.488N P=0.107N |
|ORDER RESTRICTED | P=0.118N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Heart |
| Schwannoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/53 (0%) 0/53 (0%) 1/52 (2%) 3/53 (6%) |
|POLY-3 RATE (b) | 2/36.88 0/39.99 0/41.29 1/40.10 3/34.73 |
|POLY-3 PERCENT (g) | 5.4% 0.0% 0.0% 2.5% 8.6% |
|TERMINAL (d) | 1/16 (6%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 526 --- --- 465 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.080 P=0.189N P=0.180N P=0.441N P=0.434 |
|POLY 3 | P=0.090 P=0.219N P=0.212N P=0.471N P=0.472 |
|POLY 1.5 | P=0.098 P=0.225N P=0.223N P=0.483N P=0.486 |
|POLY 6 | P=0.081 P=0.212N P=0.201N P=0.458N P=0.446 |
|LOGISTIC REGRESSION| P=0.166 P=0.237N P=0.237N P=0.546N P=0.553 |
|COCH-ARM / FISHERS | P=0.111 P=0.248N P=0.248N P=0.507N P=0.500 |
|ORDER RESTRICTED | P=0.077 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 2
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 1/53 (2%) 1/53 (2%) 1/53 (2%) 0/51 (0%) |
|POLY-3 RATE (b) | 2/36.05 1/39.99 1/41.29 1/39.44 0/32.27 |
|POLY-3 PERCENT (g) | 5.6% 2.5% 2.4% 2.5% 0.0% |
|TERMINAL (d) | 1/16 (6%) 1/23 (4%) 1/24 (4%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | 655 729 (T) 729 (T) 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.270N P=0.402N P=0.383N P=0.395N P=0.348N |
|POLY 3 | P=0.207N P=0.464N P=0.453N P=0.469N P=0.261N |
|POLY 1.5 | P=0.195N P=0.473N P=0.470N P=0.477N P=0.249N |
|POLY 6 | P=0.222N P=0.454N P=0.435N P=0.460N P=0.284N |
|LOGISTIC REGRESSION| P=0.231N P=0.445N P=0.427N P=0.452N P=0.280N |
|COCH-ARM / FISHERS | P=0.182N P=0.493N P=0.493N P=0.493N P=0.252N |
|ORDER RESTRICTED | P=0.143N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Liver |
| Cholangiocarcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/53 (0%) 2/53 (4%) 7/53 (13%) 9/51 (18%) |
|POLY-3 RATE (b) | 0/36.25 0/39.99 2/41.51 7/40.30 9/34.61 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 17.4% 26.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 1/24 (4%) 5/23 (22%) 1/8 (13%) |
|FIRST INCIDENCE | --- --- 669 521 548 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.321 P=0.025 * P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.268 P=0.011 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.254 P=0.009 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.285 P=0.012 * P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.276 P=0.013 * P=0.002 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.248 P=0.006 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 3
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 1/53 (2%) 1/53 (2%) 1/53 (2%) 11/51 (22%) |
|POLY-3 RATE (b) | 0/36.25 1/39.99 1/41.29 1/39.44 11/35.45 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 2.4% 2.5% 31.0% |
|TERMINAL (d) | 0/16 (0%) 1/23 (4%) 1/24 (4%) 1/23 (4%) 2/8 (25%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.572 P=0.581 P=0.572 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.520 P=0.526 P=0.517 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.513 P=0.514 P=0.511 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.528 P=0.539 P=0.524 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.572 P=0.581 P=0.572 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.500 P=0.500 P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Lung |
| Cystic Keratinizing Epithelioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/53 (0%) 2/53 (4%) 20/53 (38%) |
|POLY-3 RATE (b) | 0/36.25 0/39.99 0/41.29 2/39.57 20/36.59 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.1% 54.7% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 1/23 (4%) 5/8 (63%) |
|FIRST INCIDENCE | --- --- --- 697 542 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.300 P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.256 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.249 P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.266 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.271 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.248 P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 4
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 6/53 (11%) 6/53 (11%) 3/53 (6%) 5/53 (9%) 1/53 (2%) |
|POLY-3 RATE (b) | 6/38.75 6/42.31 3/41.42 5/41.78 1/32.91 |
|POLY-3 PERCENT (g) | 15.5% 14.2% 7.2% 12.0% 3.0% |
|TERMINAL (d) | 2/16 (13%) 3/23 (13%) 1/24 (4%) 2/23 (9%) 0/8 (0%) |
|FIRST INCIDENCE | 218 227 702 276 548 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.111N P=0.481N P=0.137N P=0.388N P=0.120N |
|POLY 3 | P=0.081N P=0.559N P=0.207N P=0.446N P=0.084N |
|POLY 1.5 | P=0.065N P=0.579N P=0.225N P=0.465N P=0.072N |
|POLY 6 | P=0.105N P=0.535N P=0.187N P=0.426N P=0.105N |
|LOGISTIC REGRESSION| P=0.033N* P=0.535 P=0.254N P=0.584N P=0.049N* |
|COCH-ARM / FISHERS | P=0.046N* P=0.620N P=0.244N P=0.500N P=0.056N |
|ORDER RESTRICTED | P=0.080N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 6/53 (11%) 7/53 (13%) 3/53 (6%) 5/53 (9%) 1/53 (2%) |
|POLY-3 RATE (b) | 6/38.75 7/42.36 3/41.42 5/41.78 1/32.91 |
|POLY-3 PERCENT (g) | 15.5% 16.5% 7.2% 12.0% 3.0% |
|TERMINAL (d) | 2/16 (13%) 3/23 (13%) 1/24 (4%) 2/23 (9%) 0/8 (0%) |
|FIRST INCIDENCE | 218 227 702 276 548 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.092N P=0.579N P=0.137N P=0.388N P=0.120N |
|POLY 3 | P=0.062N P=0.570 P=0.207N P=0.446N P=0.084N |
|POLY 1.5 | P=0.050N P=0.546 P=0.225N P=0.465N P=0.072N |
|POLY 6 | P=0.082N P=0.597 P=0.187N P=0.426N P=0.105N |
|LOGISTIC REGRESSION| P=0.026N* P=0.423 P=0.254N P=0.584N P=0.049N* |
|COCH-ARM / FISHERS | P=0.035N* P=0.500 P=0.244N P=0.500N P=0.056N |
|ORDER RESTRICTED | P=0.072N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 5
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 34/53 (64%) 27/53 (51%) 35/53 (66%) 28/53 (53%) 18/53 (34%) |
|POLY-3 RATE (b) | 34/45.66 27/47.68 35/48.71 28/45.80 18/36.95 |
|POLY-3 PERCENT (g) | 74.5% 56.6% 71.9% 61.1% 48.7% |
|TERMINAL (d) | 11/16 (69%) 8/23 (35%) 16/24 (67%) 10/23 (44%) 6/8 (75%) |
|FIRST INCIDENCE | 176 362 263 333 409 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.258N P=0.041N* P=0.145N P=0.047N* P=0.183N |
|POLY 3 | P=0.024N* P=0.047N* P=0.477N P=0.115N P=0.008N** |
|POLY 1.5 | P=0.006N** P=0.067N P=0.565N P=0.129N P=0.003N** |
|POLY 6 | P=0.089N P=0.033N* P=0.400N P=0.100N P=0.031N* |
|LOGISTIC REGRESSION| P=0.002N** P=0.107N P=0.561 P=0.126N P=0.003N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.119N P=0.500 P=0.162N P=0.002N** |
|ORDER RESTRICTED | P=0.011N* (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 34/53 (64%) 28/53 (53%) 35/53 (66%) 28/53 (53%) 18/53 (34%) |
|POLY-3 RATE (b) | 34/45.66 28/47.72 35/48.71 28/45.80 18/36.95 |
|POLY-3 PERCENT (g) | 74.5% 58.7% 71.9% 61.1% 48.7% |
|TERMINAL (d) | 11/16 (69%) 8/23 (35%) 16/24 (67%) 10/23 (44%) 6/8 (75%) |
|FIRST INCIDENCE | 176 362 263 333 409 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.241N P=0.055N P=0.145N P=0.047N* P=0.183N |
|POLY 3 | P=0.018N* P=0.072N P=0.477N P=0.115N P=0.008N** |
|POLY 1.5 | P=0.005N** P=0.098N P=0.565N P=0.129N P=0.003N** |
|POLY 6 | P=0.074N P=0.051N P=0.400N P=0.100N P=0.031N* |
|LOGISTIC REGRESSION| P=0.002N** P=0.143N P=0.561 P=0.126N P=0.003N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.162N P=0.500 P=0.162N P=0.002N** |
|ORDER RESTRICTED | P=0.011N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 6
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 37/53 (70%) 33/53 (62%) 36/53 (68%) 31/53 (58%) 19/53 (36%) |
|POLY-3 RATE (b) | 37/48.01 33/50.04 36/48.82 31/48.14 19/37.52 |
|POLY-3 PERCENT (g) | 77.1% 65.9% 73.7% 64.4% 50.6% |
|TERMINAL (d) | 11/16 (69%) 10/23 (44%) 16/24 (67%) 10/23 (44%) 6/8 (75%) |
|FIRST INCIDENCE | 176 227 263 276 409 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.156N P=0.093N P=0.092N P=0.055N P=0.123N |
|POLY 3 | P=0.008N** P=0.151N P=0.441N P=0.116N P=0.005N** |
|POLY 1.5 | P<0.001N** P=0.188N P=0.490N P=0.128N P=0.002N** |
|POLY 6 | P=0.042N* P=0.118N P=0.394N P=0.104N P=0.026N* |
|LOGISTIC REGRESSION| P<0.001N** P=0.316N P=0.475N P=0.168N P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.269N P=0.500N P=0.156N P<0.001N** |
|ORDER RESTRICTED | P=0.007N** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/53 (2%) 1/53 (2%) 0/53 (0%) 0/53 (0%) 2/53 (4%) |
|POLY-3 RATE (b) | 1/36.48 1/40.53 0/41.29 0/39.44 2/33.59 |
|POLY-3 PERCENT (g) | 2.7% 2.5% 0.0% 0.0% 6.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 668 563 --- --- 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.232 P=0.730N P=0.454N P=0.443N P=0.450 |
|POLY 3 | P=0.261 P=0.737N P=0.475N P=0.484N P=0.471 |
|POLY 1.5 | P=0.270 P=0.746N P=0.486N P=0.490N P=0.484 |
|POLY 6 | P=0.251 P=0.727N P=0.464N P=0.478N P=0.449 |
|LOGISTIC REGRESSION| P=0.318 P=0.758 P=0.485N P=0.488N P=0.516 |
|COCH-ARM / FISHERS | P=0.283 P=0.752N P=0.500N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.155 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 7
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/53 (2%) 1/53 (2%) 0/53 (0%) 0/53 (0%) 2/53 (4%) |
|POLY-3 RATE (b) | 1/36.48 1/40.53 0/41.29 0/39.44 2/33.59 |
|POLY-3 PERCENT (g) | 2.7% 2.5% 0.0% 0.0% 6.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 668 563 --- --- 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.232 P=0.730N P=0.454N P=0.443N P=0.450 |
|POLY 3 | P=0.261 P=0.737N P=0.475N P=0.484N P=0.471 |
|POLY 1.5 | P=0.270 P=0.746N P=0.486N P=0.490N P=0.484 |
|POLY 6 | P=0.251 P=0.727N P=0.464N P=0.478N P=0.449 |
|LOGISTIC REGRESSION| P=0.318 P=0.758 P=0.485N P=0.488N P=0.516 |
|COCH-ARM / FISHERS | P=0.283 P=0.752N P=0.500N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.155 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/53 (2%) 1/53 (2%) 0/53 (0%) 0/53 (0%) 2/53 (4%) |
|POLY-3 RATE (b) | 1/36.48 1/40.53 0/41.29 0/39.44 2/33.59 |
|POLY-3 PERCENT (g) | 2.7% 2.5% 0.0% 0.0% 6.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 668 563 --- --- 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.232 P=0.730N P=0.454N P=0.443N P=0.450 |
|POLY 3 | P=0.261 P=0.737N P=0.475N P=0.484N P=0.471 |
|POLY 1.5 | P=0.270 P=0.746N P=0.486N P=0.490N P=0.484 |
|POLY 6 | P=0.251 P=0.727N P=0.464N P=0.478N P=0.449 |
|LOGISTIC REGRESSION| P=0.318 P=0.758 P=0.485N P=0.488N P=0.516 |
|COCH-ARM / FISHERS | P=0.283 P=0.752N P=0.500N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.155 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 8
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Ovary |
| Granulosa Cell Tumor: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 0/52 (0%) 2/53 (4%) 1/53 (2%) 1/51 (2%) |
|POLY-3 RATE (b) | 0/35.78 0/39.75 2/41.67 1/39.44 1/32.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 2.5% 3.1% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 1/24 (4%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- 621 729 (T) 682 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.229 (e) P=0.297 P=0.572 P=0.443 |
|POLY 3 | P=0.327 (e) P=0.272 P=0.519 P=0.481 |
|POLY 1.5 | P=0.354 (e) P=0.258 P=0.514 P=0.490 |
|POLY 6 | P=0.289 (e) P=0.288 P=0.526 P=0.465 |
|LOGISTIC REGRESSION| P=0.322 (e) P=0.260 P=0.572 P=0.468 |
|COCH-ARM / FISHERS | P=0.379 (e) P=0.252 P=0.505 P=0.495 |
|ORDER RESTRICTED | P=0.291 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 0/53 (0%) 2/53 (4%) 0/53 (0%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/35.78 0/39.99 2/41.29 0/39.44 0/32.27 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 0.0% 0.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 2/24 (8%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.656N (e) P=0.330 (e) (e) |
|POLY 3 | P=0.506N (e) P=0.270 (e) (e) |
|POLY 1.5 | P=0.504N (e) P=0.257 (e) (e) |
|POLY 6 | P=0.509N (e) P=0.284 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.330 (e) (e) |
|COCH-ARM / FISHERS | P=0.504N (e) P=0.252 (e) (e) |
|ORDER RESTRICTED | P=0.432 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 9
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Pancreas |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 1/53 (2%) 0/53 (0%) 2/53 (4%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/35.78 1/39.99 0/41.29 2/39.44 0/32.27 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 0.0% 5.1% 0.0% |
|TERMINAL (d) | 0/16 (0%) 1/23 (4%) 0/24 (0%) 2/23 (9%) 0/8 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.573 P=0.572 (e) P=0.320 (e) |
|POLY 3 | P=0.623 P=0.522 (e) P=0.259 (e) |
|POLY 1.5 | P=0.662 P=0.516 (e) P=0.253 (e) |
|POLY 6 | P=0.560 P=0.529 (e) P=0.266 (e) |
|LOGISTIC REGRESSION| (e) P=0.572 (e) P=0.320 (e) |
|COCH-ARM / FISHERS | P=0.648N P=0.505 (e) P=0.252 (e) |
|ORDER RESTRICTED | P=0.333 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Pancreas |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 1/53 (2%) 2/53 (4%) 2/53 (4%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/35.78 1/39.99 2/41.29 2/39.44 0/32.27 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 4.8% 5.1% 0.0% |
|TERMINAL (d) | 0/16 (0%) 1/23 (4%) 2/24 (8%) 2/23 (9%) 0/8 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.633 P=0.572 P=0.330 P=0.320 (e) |
|POLY 3 | P=0.533N P=0.522 P=0.270 P=0.259 (e) |
|POLY 1.5 | P=0.506N P=0.516 P=0.257 P=0.253 (e) |
|POLY 6 | P=0.574N P=0.529 P=0.284 P=0.266 (e) |
|LOGISTIC REGRESSION| (e) P=0.572 P=0.330 P=0.320 (e) |
|COCH-ARM / FISHERS | P=0.483N P=0.505 P=0.252 P=0.252 (e) |
|ORDER RESTRICTED | P=0.338 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 10
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 28/53 (53%) 29/53 (55%) 22/53 (42%) 20/53 (38%) 10/53 (19%) |
|POLY-3 RATE (b) | 28/41.67 29/46.41 22/43.67 20/41.29 10/33.29 |
|POLY-3 PERCENT (g) | 67.2% 62.5% 50.4% 48.4% 30.0% |
|TERMINAL (d) | 11/16 (69%) 11/23 (48%) 12/24 (50%) 15/23 (65%) 4/8 (50%) |
|FIRST INCIDENCE | 416 416 592 490 633 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.026N* P=0.239N P=0.018N* P=0.008N** P=0.048N* |
|POLY 3 | P<0.001N** P=0.401N P=0.075N P=0.052N P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.500N P=0.108N P=0.057N P<0.001N** |
|POLY 6 | P=0.003N** P=0.288N P=0.052N P=0.056N P=0.002N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.523N P=0.052N P=0.029N* P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.500 P=0.165N P=0.086N P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 28/53 (53%) 29/53 (55%) 23/53 (43%) 20/53 (38%) 10/53 (19%) |
|POLY-3 RATE (b) | 28/41.67 29/46.41 23/43.77 20/41.29 10/33.29 |
|POLY-3 PERCENT (g) | 67.2% 62.5% 52.5% 48.4% 30.0% |
|TERMINAL (d) | 11/16 (69%) 11/23 (48%) 12/24 (50%) 15/23 (65%) 4/8 (50%) |
|FIRST INCIDENCE | 416 416 592 490 633 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.025N* P=0.239N P=0.026N* P=0.008N** P=0.048N* |
|POLY 3 | P<0.001N** P=0.401N P=0.110N P=0.052N P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.500N P=0.151N P=0.057N P<0.001N** |
|POLY 6 | P=0.003N** P=0.288N P=0.078N P=0.056N P=0.002N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.523N P=0.075N P=0.029N* P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.500 P=0.218N P=0.086N P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 11
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/53 (4%) 2/53 (4%) 3/53 (6%) 0/53 (0%) |
|POLY-3 RATE (b) | 1/36.39 2/40.22 2/42.04 3/40.39 0/32.33 |
|POLY-3 PERCENT (g) | 2.8% 5.0% 4.8% 7.4% 0.0% |
|TERMINAL (d) | 0/16 (0%) 1/23 (4%) 1/24 (4%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | 693 668 456 542 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.422N P=0.588 P=0.595 P=0.371 P=0.605N |
|POLY 3 | P=0.363N P=0.535 P=0.550 P=0.343 P=0.524N |
|POLY 1.5 | P=0.330N P=0.522 P=0.529 P=0.328 P=0.513N |
|POLY 6 | P=0.412N P=0.550 P=0.574 P=0.361 P=0.541N |
|LOGISTIC REGRESSION| P=0.300N P=0.546 P=0.498 P=0.315 P=0.543N |
|COCH-ARM / FISHERS | P=0.287N P=0.500 P=0.500 P=0.309 P=0.500N |
|ORDER RESTRICTED | P=0.280N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/53 (4%) 2/53 (4%) 2/53 (4%) 4/53 (8%) 0/53 (0%) |
|POLY-3 RATE (b) | 2/36.63 2/40.22 2/42.04 4/40.58 0/32.33 |
|POLY-3 PERCENT (g) | 5.5% 5.0% 4.8% 9.9% 0.0% |
|TERMINAL (d) | 0/16 (0%) 1/23 (4%) 1/24 (4%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | 666 668 456 542 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.362N P=0.607N P=0.595N P=0.427 P=0.327N |
|POLY 3 | P=0.320N P=0.661N P=0.644N P=0.384 P=0.265N |
|POLY 1.5 | P=0.281N P=0.672N P=0.666N P=0.366 P=0.252N |
|POLY 6 | P=0.379N P=0.648N P=0.621N P=0.407 P=0.288N |
|LOGISTIC REGRESSION| P=0.249N P=0.655N P=0.693N P=0.356 P=0.271N |
|COCH-ARM / FISHERS | P=0.232N P=0.691N P=0.691N P=0.339 P=0.248N |
|ORDER RESTRICTED | P=0.226N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 12
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 17/53 (32%) 10/53 (19%) 18/51 (35%) 9/52 (17%) 5/51 (10%) |
|POLY-3 RATE (b) | 17/38.32 10/40.85 18/42.15 9/40.48 5/34.12 |
|POLY-3 PERCENT (g) | 44.4% 24.5% 42.7% 22.2% 14.7% |
|TERMINAL (d) | 7/16 (44%) 6/23 (26%) 10/24 (42%) 6/23 (26%) 0/8 (0%) |
|FIRST INCIDENCE | 568 627 617 548 542 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.070N P=0.020N* P=0.241N P=0.012N* P=0.067N |
|POLY 3 | P=0.005N** P=0.045N* P=0.531N P=0.027N* P=0.004N** |
|POLY 1.5 | P=0.004N** P=0.057N P=0.557 P=0.036N* P=0.004N** |
|POLY 6 | P=0.009N** P=0.037N* P=0.433N P=0.021N* P=0.006N** |
|LOGISTIC REGRESSION| P=0.009N** P=0.032N* P=0.443N P=0.023N* P=0.009N** |
|COCH-ARM / FISHERS | P=0.004N** P=0.090N P=0.444 P=0.063N P=0.005N** |
|ORDER RESTRICTED | P=0.005N** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/53 (0%) 0/51 (0%) 1/52 (2%) 1/51 (2%) |
|POLY-3 RATE (b) | 2/36.76 0/39.99 0/40.30 1/39.36 1/32.48 |
|POLY-3 PERCENT (g) | 5.4% 0.0% 0.0% 2.5% 3.1% |
|TERMINAL (d) | 1/16 (6%) 0/23 (0%) 0/24 (0%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | 575 --- --- 729 (T) 674 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.521 P=0.195N P=0.181N P=0.408N P=0.606N |
|POLY 3 | P=0.563 P=0.218N P=0.217N P=0.476N P=0.543N |
|POLY 1.5 | P=0.589 P=0.225N P=0.229N P=0.486N P=0.526N |
|POLY 6 | P=0.528 P=0.211N P=0.203N P=0.466N P=0.572N |
|LOGISTIC REGRESSION| P=0.596 P=0.228N P=0.235N P=0.475N P=0.537N |
|COCH-ARM / FISHERS | P=0.621 P=0.248N P=0.257N P=0.507N P=0.515N |
|ORDER RESTRICTED | P=0.216N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 13
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 18/53 (34%) 10/53 (19%) 18/51 (35%) 10/52 (19%) 6/51 (12%) |
|POLY-3 RATE (b) | 18/38.83 10/40.85 18/42.15 10/40.48 6/34.33 |
|POLY-3 PERCENT (g) | 46.4% 24.5% 42.7% 24.7% 17.5% |
|TERMINAL (d) | 7/16 (44%) 6/23 (26%) 10/24 (42%) 7/23 (30%) 0/8 (0%) |
|FIRST INCIDENCE | 568 627 617 548 542 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.115N P=0.013N* P=0.186N P=0.012N* P=0.081N |
|POLY 3 | P=0.011N* P=0.029N* P=0.457N P=0.031N* P=0.006N** |
|POLY 1.5 | P=0.008N** P=0.037N* P=0.540N P=0.040N* P=0.005N** |
|POLY 6 | P=0.018N* P=0.025N* P=0.370N P=0.026N* P=0.009N** |
|LOGISTIC REGRESSION| P=0.017N* P=0.021N* P=0.377N P=0.026N* P=0.011N* |
|COCH-ARM / FISHERS | P=0.007N** P=0.061N P=0.525 P=0.068N P=0.006N** |
|ORDER RESTRICTED | P=0.006N** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/53 (0%) 2/51 (4%) 0/52 (0%) 1/51 (2%) |
|POLY-3 RATE (b) | 0/36.25 0/39.99 2/40.56 0/39.36 1/32.43 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.9% 0.0% 3.1% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 1/24 (4%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- 659 --- 689 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.298 (e) P=0.317 (e) P=0.424 |
|POLY 3 | P=0.399 (e) P=0.263 (e) P=0.478 |
|POLY 1.5 | P=0.413 (e) P=0.247 (e) P=0.487 |
|POLY 6 | P=0.376 (e) P=0.283 (e) P=0.463 |
|LOGISTIC REGRESSION| P=0.375 (e) P=0.265 (e) P=0.460 |
|COCH-ARM / FISHERS | P=0.425 (e) P=0.238 (e) P=0.490 |
|ORDER RESTRICTED | P=0.284 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 14
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Uterus |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/53 (2%) 1/53 (2%) 2/53 (4%) 2/53 (4%) 1/53 (2%) |
|POLY-3 RATE (b) | 1/36.52 1/39.99 2/41.29 2/40.11 1/32.88 |
|POLY-3 PERCENT (g) | 2.7% 2.5% 4.8% 5.0% 3.0% |
|TERMINAL (d) | 0/16 (0%) 1/23 (4%) 2/24 (8%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | 658 729 (T) 729 (T) 505 562 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.465 P=0.702N P=0.621 P=0.577 P=0.726 |
|POLY 3 | P=0.549 P=0.741N P=0.543 P=0.533 P=0.738 |
|POLY 1.5 | P=0.582 P=0.748N P=0.524 P=0.521 P=0.748 |
|POLY 6 | P=0.501 P=0.733N P=0.563 P=0.547 P=0.720 |
|LOGISTIC REGRESSION| P=0.596 P=0.736N P=0.572 P=0.501 P=0.761 |
|COCH-ARM / FISHERS | P=0.601N P=0.752N P=0.500 P=0.500 P=0.752N |
|ORDER RESTRICTED | P=0.608 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Uterus |
| Leiomyoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/53 (0%) 2/53 (4%) 0/53 (0%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/36.25 0/39.99 2/41.55 0/39.44 0/32.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 0.0% 0.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 1/24 (4%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- 659 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.607N (e) P=0.317 (e) (e) |
|POLY 3 | P=0.503N (e) P=0.268 (e) (e) |
|POLY 1.5 | P=0.502N (e) P=0.254 (e) (e) |
|POLY 6 | P=0.504N (e) P=0.286 (e) (e) |
|LOGISTIC REGRESSION| P=0.547N (e) P=0.271 (e) (e) |
|COCH-ARM / FISHERS | P=0.499N (e) P=0.248 (e) (e) |
|ORDER RESTRICTED | P=0.431 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 15
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 4/53 (8%) 1/53 (2%) 3/53 (6%) 3/53 (6%) 2/53 (4%) |
|POLY-3 RATE (b) | 4/36.88 1/39.99 3/41.39 3/39.57 2/33.09 |
|POLY-3 PERCENT (g) | 10.9% 2.5% 7.3% 7.6% 6.0% |
|TERMINAL (d) | 1/16 (6%) 1/23 (4%) 2/24 (8%) 2/23 (9%) 0/8 (0%) |
|FIRST INCIDENCE | 627 729 (T) 702 697 562 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.492 P=0.114N P=0.333N P=0.363N P=0.489N |
|POLY 3 | P=0.512N P=0.153N P=0.437N P=0.461N P=0.387N |
|POLY 1.5 | P=0.480N P=0.161N P=0.464N P=0.474N P=0.364N |
|POLY 6 | P=0.552N P=0.145N P=0.408N P=0.447N P=0.424N |
|LOGISTIC REGRESSION| P=0.551N P=0.142N P=0.398N P=0.433N P=0.388N |
|COCH-ARM / FISHERS | P=0.431N P=0.181N P=0.500N P=0.500N P=0.339N |
|ORDER RESTRICTED | P=0.373N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Uterus |
| Schwannoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/53 (2%) 0/53 (0%) 1/53 (2%) 2/53 (4%) 1/53 (2%) |
|POLY-3 RATE (b) | 1/36.84 0/39.99 1/41.70 2/40.01 1/33.16 |
|POLY-3 PERCENT (g) | 2.7% 0.0% 2.4% 5.0% 3.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 540 --- 609 619 409 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.385 P=0.472N P=0.725N P=0.535 P=0.753 |
|POLY 3 | P=0.372 P=0.484N P=0.733N P=0.529 P=0.738 |
|POLY 1.5 | P=0.407 P=0.489N P=0.745N P=0.518 P=0.749 |
|POLY 6 | P=0.323 P=0.477N P=0.718N P=0.543 P=0.719 |
|LOGISTIC REGRESSION| P=0.490 P=0.533N P=0.751 P=0.493 P=0.733N |
|COCH-ARM / FISHERS | P=0.455 P=0.500N P=0.752N P=0.500 P=0.752N |
|ORDER RESTRICTED | P=0.423 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 16
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/53 (2%) 0/53 (0%) 1/53 (2%) 2/53 (4%) |
|POLY-3 RATE (b) | 2/36.91 1/39.99 0/41.29 1/39.84 2/33.40 |
|POLY-3 PERCENT (g) | 5.4% 2.5% 0.0% 2.5% 6.0% |
|TERMINAL (d) | 1/16 (6%) 1/23 (4%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 508 729 (T) --- 616 387 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.312 P=0.406N P=0.183N P=0.438N P=0.615 |
|POLY 3 | P=0.379 P=0.472N P=0.213N P=0.473N P=0.659 |
|POLY 1.5 | P=0.399 P=0.481N P=0.223N P=0.483N P=0.675 |
|POLY 6 | P=0.354 P=0.461N P=0.201N P=0.461N P=0.632 |
|LOGISTIC REGRESSION| P=0.444 P=0.484N P=0.240N P=0.505N P=0.684N |
|COCH-ARM / FISHERS | P=0.429 P=0.500N P=0.248N P=0.500N P=0.691N |
|ORDER RESTRICTED | P=0.372 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 45/53 (85%) 43/53 (81%) 46/53 (87%) 43/53 (81%) 39/53 (74%) |
|POLY-3 RATE (b) | 45/48.33 43/49.69 46/50.24 43/47.21 39/43.27 |
|POLY-3 PERCENT (g) | 93.1% 86.5% 91.6% 91.1% 90.1% |
|TERMINAL (d) | 14/16 (88%) 18/23 (78%) 22/24 (92%) 21/23 (91%) 8/8 (100%) |
|FIRST INCIDENCE | 176 362 263 333 409 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.037 * P=0.082N P=0.080N P=0.066N P=0.184 |
|POLY 3 | P=0.550N P=0.211N P=0.539N P=0.506N P=0.433N |
|POLY 1.5 | P=0.289N P=0.267N P=0.645N P=0.445N P=0.256N |
|POLY 6 | P=0.317 P=0.182N P=0.473N P=0.580N P=0.718N |
|LOGISTIC REGRESSION| P=0.174N P=0.268N P=0.610 P=0.230N P=0.167N |
|COCH-ARM / FISHERS | P=0.064N P=0.398N P=0.500 P=0.398N P=0.115N |
|ORDER RESTRICTED | P=0.479N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 17
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 18/53 (34%) 14/53 (26%) 19/53 (36%) 21/53 (40%) 21/53 (40%) |
|POLY-3 RATE (b) | 18/43.25 14/45.06 19/44.70 21/45.77 21/41.51 |
|POLY-3 PERCENT (g) | 41.6% 31.1% 42.5% 45.9% 50.6% |
|TERMINAL (d) | 5/16 (31%) 7/23 (30%) 8/24 (33%) 9/23 (39%) 1/8 (13%) |
|FIRST INCIDENCE | 218 227 203 276 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * P=0.126N P=0.307N P=0.508N P=0.152 |
|POLY 3 | P=0.080 P=0.204N P=0.553 P=0.423 P=0.264 |
|POLY 1.5 | P=0.098 P=0.216N P=0.524 P=0.394 P=0.289 |
|POLY 6 | P=0.066 P=0.205N P=0.585 P=0.455 P=0.233 |
|LOGISTIC REGRESSION| P=0.197 P=0.354N P=0.489 P=0.295 P=0.380 |
|COCH-ARM / FISHERS | P=0.151 P=0.263N P=0.500 P=0.344 P=0.344 |
|ORDER RESTRICTED | P=0.142 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 51/53 (96%) 46/53 (87%) 50/53 (94%) 50/53 (94%) 45/53 (85%) |
|POLY-3 RATE (b) | 51/53.00 46/51.78 50/52.00 50/51.35 45/47.10 |
|POLY-3 PERCENT (g) | 96.2% 88.8% 96.2% 97.4% 95.6% |
|TERMINAL (d) | 14/16 (88%) 18/23 (78%) 22/24 (92%) 22/23 (96%) 8/8 (100%) |
|FIRST INCIDENCE | 176 227 203 276 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.022 * P=0.045N* P=0.054N P=0.094N P=0.196 |
|POLY 3 | P=0.319 P=0.136N P=0.686N P=0.591 P=0.649N |
|POLY 1.5 | P=0.574N P=0.109N P=0.684N P=0.679 P=0.348N |
|POLY 6 | P=0.153 P=0.172N P=0.686N P=0.531 P=0.557 |
|LOGISTIC REGRESSION| P=0.139N P=0.105N P=0.480N P=0.478N P=0.064N |
|COCH-ARM / FISHERS | P=0.081N P=0.080N P=0.500N P=0.500N P=0.046N* |
|ORDER RESTRICTED | P=0.299 (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).