TDMS Study 96007-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE) DATE: 09/29/03
EXPERIMENT: 96007 TEST: 04 TIME: 12:11:18
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 NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE) DATE: 09/29/03
EXPERIMENT: 96007 TEST: 04 TIME: 12:11:18
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
----- ----------
Adrenal Cortex Angiectasis
Atrophy
Degeneration Cystic
Hyperplasia
Hypertrophy
Vacuolization Cytoplasmic
Adrenal Medulla Hyperplasia
Blood Vessel: Aorta Mineralization
Bone Marrow Hyperplasia
Brain Edema
Necrosis
Clitoral Gland Inflammation
Clitoral Gland: Duct Cyst
Heart Cardiomyopathy
Intestine Large, Rectum Parasite Metazoan
Intestine Large, Rectum: Artery Inflammation Chronic
Kidney Calculus Micro Observation Only
Inflammation
Mineralization
Nephropathy
Kidney: Transitional Epithelium Hyperplasia
Liver Basophilic Focus
Cholangiofibrosis
Eosinophilic Focus
Fatty Change Diffuse
Hematopoietic Cell Proliferation
Hyperplasia
Inflammation
Mixed Cell Focus
Necrosis
Pigmentation
Toxic Hepatopathy
Liver: Bile Duct Cyst
Hyperplasia
Liver: Centrilobular Degeneration
Liver: Hepatocyte Hypertrophy
Multinucleated
Liver: Oval Cell Hyperplasia
Liver: Portal Fibrosis
Lung Infiltration Cellular Histiocyte
Metaplasia
Lung: Alveolar Epithelium Hyperplasia
Metaplasia Bronchiolar
Lymph Node, Mandibular Hyperplasia
Lymph Node, Mesenteric Hyperplasia
Lymph Node: Mediastinal Ectasia
Hyperplasia
Hyperplasia Lymphoid
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE) DATE: 09/29/03
EXPERIMENT: 96007 TEST: 04 TIME: 12:11:18
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007B
PATHOLOGIST: SELLS, DONALD CAS: TEFDIOXINMIX
Lymph Node: Pancreatic Hyperplasia
Mammary Gland Hyperplasia
Mesentery Inflammation Chronic
Mesentery: Artery Inflammation Chronic
Nose: Respiratory Epithelium Hyperplasia
Oral Mucosa: Gingival Hyperplasia
Ovary Atrophy
Cyst
Inflammation Chronic
Oviduct Inflammation Chronic
Pancreas Inflammation Chronic
Pancreas: Acinus Atrophy
Vacuolization Cytoplasmic
Pancreas: Artery Inflammation Chronic
Pancreas: Duct Dilatation
Inflammation Chronic
Pituitary Gland Angiectasis
Pituitary Gland: Pars Distalis Hyperplasia
Skin Cyst Epithelial Inclusion
Spleen Hematopoietic Cell Proliferation
Pigmentation
Stomach, Forestomach Hyperplasia
Stomach, Forestomach: Artery Inflammation Chronic
Stomach, Glandular: Artery Inflammation Chronic
Thymus Atrophy
Cyst
Thyroid Gland: C-Cell Hyperplasia
Thyroid Gland: Follicular Cell Hypertrophy
Tooth: Peridontal Tissue Inflammation
Urinary Bladder Inflammation
Urinary Bladder: Transitional Epithelium
Hyperplasia
Uterus Inflammation Chronic
Metaplasia
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 1
Statistical Analysis of Non-neoplastic Lesions 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 Cortex |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 15/52 (29%) 20/53 (38%) 18/53 (34%) 17/53 (32%) 8/51 (16%) |
|POLY-3 RATE (b) | 15/37.13 20/42.36 18/42.67 17/41.89 8/35.64 |
|POLY-3 PERCENT (g) | 40.4% 47.2% 42.2% 40.6% 22.5% |
|TERMINAL (d) | 9/16 (56%) 11/23 (48%) 13/24 (54%) 8/23 (35%) 0/8 (0%) |
|FIRST INCIDENCE | 626 540 540 521 409 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.318N P=0.578N P=0.354N P=0.384N P=0.383N |
|POLY 3 | P=0.022N* P=0.346 P=0.527 P=0.586 P=0.073N |
|POLY 1.5 | P=0.017N* P=0.296 P=0.452 P=0.529 P=0.072N |
|POLY 6 | P=0.031N* P=0.414 P=0.589N P=0.531N P=0.081N |
|LOGISTIC REGRESSION| P=0.049N* P=0.360 P=0.552N P=0.580 P=0.118N |
|COCH-ARM / FISHERS | P=0.019N* P=0.224 P=0.362 P=0.442 P=0.085N |
|ORDER RESTRICTED | P=0.044N* (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 |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 3/53 (6%) 0/53 (0%) 0/53 (0%) 18/51 (35%) |
|POLY-3 RATE (b) | 0/35.78 3/39.99 0/41.29 0/39.44 18/35.67 |
|POLY-3 PERCENT (g) | 0.0% 7.5% 0.0% 0.0% 50.5% |
|TERMINAL (d) | 0/16 (0%) 3/23 (13%) 0/24 (0%) 0/23 (0%) 5/8 (63%) |
|FIRST INCIDENCE | --- 729 (T) --- --- 542 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.189 (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.139 (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.133 (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.145 (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.189 (e) (e) P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.125 (e) (e) P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 2
Statistical Analysis of Non-neoplastic Lesions 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 Cortex |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/52 (17%) 15/53 (28%) 19/53 (36%) 25/53 (47%) 16/51 (31%) |
|POLY-3 RATE (b) | 9/36.94 15/40.83 19/45.42 25/42.75 16/36.44 |
|POLY-3 PERCENT (g) | 24.4% 36.7% 41.8% 58.5% 43.9% |
|TERMINAL (d) | 3/16 (19%) 12/23 (52%) 7/24 (29%) 14/23 (61%) 3/8 (38%) |
|FIRST INCIDENCE | 631 626 322 521 339 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.367 P=0.171 P=0.022 * P=0.016 * |
|POLY 3 | P=0.051 P=0.169 P=0.073 P<0.001 ** P=0.056 |
|POLY 1.5 | P=0.076 P=0.158 P=0.046 * P<0.001 ** P=0.067 |
|POLY 6 | P=0.030 * P=0.177 P=0.116 P=0.002 ** P=0.043 * |
|LOGISTIC REGRESSION| P=0.035 * P=0.217 P=0.041 * P=0.002 ** P=0.043 * |
|COCH-ARM / FISHERS | P=0.108 P=0.134 P=0.026 * P<0.001 ** P=0.075 |
|ORDER RESTRICTED | P=0.012 * (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 |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/52 (23%) 26/53 (49%) 23/53 (43%) 25/53 (47%) 21/51 (41%) |
|POLY-3 RATE (b) | 12/38.26 26/43.34 23/44.01 25/43.25 21/38.22 |
|POLY-3 PERCENT (g) | 31.4% 60.0% 52.3% 57.8% 54.9% |
|TERMINAL (d) | 4/16 (25%) 17/23 (74%) 12/24 (50%) 17/23 (74%) 4/8 (50%) |
|FIRST INCIDENCE | 444 362 540 322 409 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.063 P=0.194 P=0.080 P=0.006 ** |
|POLY 3 | P=0.149 P=0.006 ** P=0.040 * P=0.010 * P=0.024 * |
|POLY 1.5 | P=0.187 P=0.005 ** P=0.028 * P=0.009 ** P=0.031 * |
|POLY 6 | P=0.106 P=0.005 ** P=0.060 P=0.011 * P=0.017 * |
|LOGISTIC REGRESSION| P=0.099 P=0.009 ** P=0.047 * P=0.013 * P=0.026 * |
|COCH-ARM / FISHERS | P=0.220 P=0.005 ** P=0.022 * P=0.008 ** P=0.039 * |
|ORDER RESTRICTED | P=0.017 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 3
Statistical Analysis of Non-neoplastic Lesions 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 Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 44/52 (85%) 45/53 (85%) 47/53 (89%) 46/53 (87%) 45/51 (88%) |
|POLY-3 RATE (b) | 44/46.43 45/48.41 47/49.20 46/47.51 45/48.26 |
|POLY-3 PERCENT (g) | 94.8% 93.0% 95.5% 96.8% 93.2% |
|TERMINAL (d) | 16/16 (100%) 21/23 (91%) 23/24 (96%) 23/23 (100%) 8/8 (100%) |
|FIRST INCIDENCE | 176 456 322 469 339 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.115N P=0.100N P=0.131N P=0.036 * |
|POLY 3 | P=0.524N P=0.530N P=0.641 P=0.510 P=0.558N |
|POLY 1.5 | P=0.576 P=0.586N P=0.442 P=0.483 P=0.663N |
|POLY 6 | P=0.475N P=0.425N P=0.636N P=0.653 P=0.441N |
|LOGISTIC REGRESSION| P=0.238 P=0.377N P=0.555 P=0.556N P=0.408 |
|COCH-ARM / FISHERS | P=0.355 P=0.590 P=0.373 P=0.484 P=0.403 |
|ORDER RESTRICTED | P=0.561N (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 |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 0/53 (0%) 2/53 (4%) 0/53 (0%) 2/51 (4%) |
|POLY-3 RATE (b) | 2/36.52 0/39.99 2/41.70 0/39.44 2/33.02 |
|POLY-3 PERCENT (g) | 5.5% 0.0% 4.8% 0.0% 6.1% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 1/24 (4%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 587 --- 609 --- 542 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.371 P=0.214N P=0.600N P=0.208N P=0.634 |
|POLY 3 | P=0.438 P=0.217N P=0.646N P=0.220N P=0.659 |
|POLY 1.5 | P=0.454 P=0.222N P=0.664N P=0.224N P=0.676 |
|POLY 6 | P=0.418 P=0.212N P=0.627N P=0.216N P=0.628 |
|LOGISTIC REGRESSION| P=0.471 P=0.235N P=0.681N P=0.234N P=0.686 |
|COCH-ARM / FISHERS | P=0.474 P=0.243N P=0.684N P=0.243N P=0.684 |
|ORDER RESTRICTED | P=0.366 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 4
Statistical Analysis of Non-neoplastic Lesions 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 Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/52 (12%) 13/53 (25%) 11/53 (21%) 7/53 (13%) 15/51 (29%) |
|POLY-3 RATE (b) | 6/37.18 13/42.22 11/42.51 7/40.51 15/37.60 |
|POLY-3 PERCENT (g) | 16.1% 30.8% 25.9% 17.3% 39.9% |
|TERMINAL (d) | 3/16 (19%) 7/23 (30%) 5/24 (21%) 5/23 (22%) 2/8 (25%) |
|FIRST INCIDENCE | 508 362 609 276 409 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.191 P=0.359 P=0.540N P=0.006 ** |
|POLY 3 | P=0.055 P=0.099 P=0.215 P=0.568 P=0.017 * |
|POLY 1.5 | P=0.064 P=0.089 P=0.185 P=0.553 P=0.019 * |
|POLY 6 | P=0.045 * P=0.111 P=0.253 P=0.578 P=0.014 * |
|LOGISTIC REGRESSION| P=0.049 * P=0.088 P=0.218 P=0.547 P=0.020 * |
|COCH-ARM / FISHERS | P=0.071 P=0.069 P=0.155 P=0.515 P=0.022 * |
|ORDER RESTRICTED | P=0.014 * (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 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/52 (19%) 21/53 (40%) 12/53 (23%) 15/53 (28%) 9/51 (18%) |
|POLY-3 RATE (b) | 10/38.22 21/44.37 12/42.79 15/42.26 9/34.64 |
|POLY-3 PERCENT (g) | 26.2% 47.3% 28.0% 35.5% 26.0% |
|TERMINAL (d) | 4/16 (25%) 9/23 (39%) 8/24 (33%) 7/23 (30%) 1/8 (13%) |
|FIRST INCIDENCE | 416 456 456 469 387 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.487 P=0.112 P=0.462N P=0.408 P=0.367 |
|POLY 3 | P=0.228N P=0.035 * P=0.524 P=0.250 P=0.600N |
|POLY 1.5 | P=0.174N P=0.026 * P=0.480 P=0.227 P=0.553N |
|POLY 6 | P=0.313N P=0.051 P=0.571 P=0.287 P=0.549 |
|LOGISTIC REGRESSION| P=0.191N P=0.026 * P=0.501 P=0.230 P=0.556N |
|COCH-ARM / FISHERS | P=0.139N P=0.018 * P=0.425 P=0.195 P=0.519N |
|ORDER RESTRICTED | P=0.263N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 5
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/53 (0%) 1/52 (2%) 3/53 (6%) |
|POLY-3 RATE (b) | 0/36.25 0/39.99 0/41.29 1/39.84 3/33.55 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.5% 8.9% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- 585 399 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** (e) (e) P=0.520 P=0.083 |
|POLY 3 | P=0.004 ** (e) (e) P=0.519 P=0.104 |
|POLY 1.5 | P=0.005 ** (e) (e) P=0.511 P=0.110 |
|POLY 6 | P=0.004 ** (e) (e) P=0.529 P=0.093 |
|LOGISTIC REGRESSION| P=0.009 ** (e) (e) P=0.478 P=0.124 |
|COCH-ARM / FISHERS | P=0.006 ** (e) (e) P=0.495 P=0.121 |
|ORDER RESTRICTED | P=0.008 ** (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 |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 36/53 (68%) 36/53 (68%) 34/53 (64%) 41/53 (77%) 48/53 (91%) |
|POLY-3 RATE (b) | 36/50.20 36/50.51 34/50.03 41/50.63 48/49.64 |
|POLY-3 PERCENT (g) | 71.7% 71.3% 68.0% 81.0% 96.7% |
|TERMINAL (d) | 7/16 (44%) 12/23 (52%) 13/24 (54%) 16/23 (70%) 8/8 (100%) |
|FIRST INCIDENCE | 176 227 46 276 2 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.231N P=0.113N P=0.425N P=0.005 ** |
|POLY 3 | P<0.001 ** P=0.570N P=0.423N P=0.187 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.573N P=0.438N P=0.188 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.571N P=0.407N P=0.188 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.456 P=0.531N P=0.135 P=0.005 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.582N P=0.419N P=0.192 P=0.004 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 6
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Brain |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/53 (0%) 1/53 (2%) 3/53 (6%) |
|POLY-3 RATE (b) | 0/36.25 0/39.99 0/41.29 1/39.67 3/32.57 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.5% 9.2% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- 668 689 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.557 P=0.056 |
|POLY 3 | P=0.004 ** (e) (e) P=0.518 P=0.099 |
|POLY 1.5 | P=0.005 ** (e) (e) P=0.511 P=0.107 |
|POLY 6 | P=0.003 ** (e) (e) P=0.527 P=0.087 |
|LOGISTIC REGRESSION| P=0.002 ** (e) (e) P=0.512 P=0.069 |
|COCH-ARM / FISHERS | P=0.006 ** (e) (e) P=0.500 P=0.121 |
|ORDER RESTRICTED | P=0.008 ** (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 |
|=================================================================================================================================|
| |
|Brain |
| Hydrocephalus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 4/53 (8%) 2/53 (4%) 2/53 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 1/36.31 4/40.48 2/41.52 2/40.30 0/32.33 |
|POLY-3 PERCENT (g) | 2.8% 9.9% 4.8% 5.0% 0.0% |
|TERMINAL (d) | 0/16 (0%) 1/23 (4%) 1/24 (4%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 715 652 666 521 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.216N P=0.267 P=0.597 P=0.560 P=0.586N |
|POLY 3 | P=0.161N P=0.212 P=0.547 P=0.536 P=0.523N |
|POLY 1.5 | P=0.148N P=0.199 P=0.526 P=0.522 P=0.513N |
|POLY 6 | P=0.181N P=0.229 P=0.571 P=0.554 P=0.540N |
|LOGISTIC REGRESSION| P=0.155N P=0.221 P=0.569 P=0.503 P=0.570N |
|COCH-ARM / FISHERS | P=0.132N P=0.181 P=0.500 P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.190N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 7
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Brain |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 3/53 (6%) |
|POLY-3 RATE (b) | 0/36.25 0/39.99 0/41.29 0/39.44 3/32.88 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 9.1% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- 631 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.070 |
|POLY 3 | P=0.002 ** (e) (e) (e) P=0.100 |
|POLY 1.5 | P=0.003 ** (e) (e) (e) P=0.108 |
|POLY 6 | P=0.002 ** (e) (e) (e) P=0.089 |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.091 |
|COCH-ARM / FISHERS | P=0.003 ** (e) (e) (e) P=0.121 |
|ORDER RESTRICTED | P=0.003 ** (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 |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 42/51 (82%) 40/53 (75%) 37/53 (70%) 33/51 (65%) 29/50 (58%) |
|POLY-3 RATE (b) | 42/48.64 40/47.16 37/48.66 33/45.67 29/42.47 |
|POLY-3 PERCENT (g) | 86.4% 84.8% 76.0% 72.3% 68.3% |
|TERMINAL (d) | 12/16 (75%) 20/23 (87%) 18/24 (75%) 19/23 (83%) 5/8 (63%) |
|FIRST INCIDENCE | 176 416 203 333 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.432 P=0.081N P=0.026N* P=0.010N* P=0.442N |
|POLY 3 | P=0.009N** P=0.533N P=0.133N P=0.060N P=0.021N* |
|POLY 1.5 | P=0.005N** P=0.443N P=0.130N P=0.050N P=0.011N* |
|POLY 6 | P=0.025N* P=0.602N P=0.144N P=0.079N P=0.055N |
|LOGISTIC REGRESSION| P=0.006N** P=0.212N P=0.101N P=0.035N* P=0.006N** |
|COCH-ARM / FISHERS | P=0.004N** P=0.269N P=0.102N P=0.036N* P=0.007N** |
|ORDER RESTRICTED | P=0.018N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 8
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Clitoral Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 39/51 (76%) 41/53 (77%) 44/53 (83%) 39/51 (76%) 44/50 (88%) |
|POLY-3 RATE (b) | 39/47.81 41/49.28 44/48.86 39/45.91 44/47.66 |
|POLY-3 PERCENT (g) | 81.6% 83.2% 90.1% 85.0% 92.3% |
|TERMINAL (d) | 12/16 (75%) 19/23 (83%) 22/24 (92%) 20/23 (87%) 8/8 (100%) |
|FIRST INCIDENCE | 176 350 203 465 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.214N P=0.226N P=0.134N P=0.022 * |
|POLY 3 | P=0.075 P=0.523 P=0.163 P=0.431 P=0.081 |
|POLY 1.5 | P=0.085 P=0.514 P=0.159 P=0.463 P=0.088 |
|POLY 6 | P=0.065 P=0.555 P=0.198 P=0.436 P=0.078 |
|LOGISTIC REGRESSION| P=0.080 P=0.549 P=0.321 P=0.540N P=0.113 |
|COCH-ARM / FISHERS | P=0.099 P=0.549 P=0.279 P=0.592N P=0.105 |
|ORDER RESTRICTED | P=0.070 (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 |
|=================================================================================================================================|
| |
|Esophagus: Muscularis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/53 (4%) 1/53 (2%) 1/53 (2%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/36.25 2/40.36 1/41.88 1/39.67 0/32.33 |
|POLY-3 PERCENT (g) | 0.0% 5.0% 2.4% 2.5% 0.0% |
|TERMINAL (d) | 0/16 (0%) 1/23 (4%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- 626 540 668 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.428N P=0.299 P=0.528 P=0.557 (e) |
|POLY 3 | P=0.376N P=0.261 P=0.529 P=0.518 (e) |
|POLY 1.5 | P=0.364N P=0.252 P=0.516 P=0.511 (e) |
|POLY 6 | P=0.391N P=0.273 P=0.543 P=0.527 (e) |
|LOGISTIC REGRESSION| P=0.356N P=0.256 P=0.487 P=0.512 (e) |
|COCH-ARM / FISHERS | P=0.349N P=0.248 P=0.500 P=0.500 (e) |
|ORDER RESTRICTED | P=0.415N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 9
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Eye: Retina |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 1/53 (2%) 2/53 (4%) 1/53 (2%) 3/53 (6%) |
|POLY-3 RATE (b) | 1/36.43 1/39.99 2/41.62 1/39.44 3/33.15 |
|POLY-3 PERCENT (g) | 2.7% 2.5% 4.8% 2.5% 9.1% |
|TERMINAL (d) | 0/16 (0%) 1/23 (4%) 0/24 (0%) 1/23 (4%) 1/8 (13%) |
|FIRST INCIDENCE | 682 729 (T) 669 729 (T) 548 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.065 P=0.698N P=0.602 P=0.702N P=0.206 |
|POLY 3 | P=0.153 P=0.740N P=0.546 P=0.744N P=0.270 |
|POLY 1.5 | P=0.166 P=0.747N P=0.526 P=0.750N P=0.285 |
|POLY 6 | P=0.136 P=0.732N P=0.570 P=0.737N P=0.247 |
|LOGISTIC REGRESSION| P=0.131 P=0.729N P=0.544 P=0.734N P=0.270 |
|COCH-ARM / FISHERS | P=0.187 P=0.752N P=0.500 P=0.752N P=0.309 |
|ORDER RESTRICTED | P=0.166 (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 |
|=================================================================================================================================|
| |
|Harderian Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/53 (15%) 11/53 (21%) 4/52 (8%) 5/53 (9%) 7/53 (13%) |
|POLY-3 RATE (b) | 8/37.39 11/42.44 4/41.42 5/39.67 7/34.50 |
|POLY-3 PERCENT (g) | 21.4% 25.9% 9.7% 12.6% 20.3% |
|TERMINAL (d) | 5/16 (31%) 7/23 (30%) 1/24 (4%) 4/23 (17%) 2/8 (25%) |
|FIRST INCIDENCE | 456 350 526 669 392 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.392 P=0.563 P=0.069N P=0.114N P=0.368 |
|POLY 3 | P=0.405N P=0.416 P=0.126N P=0.232N P=0.570N |
|POLY 1.5 | P=0.368N P=0.376 P=0.152N P=0.248N P=0.539N |
|POLY 6 | P=0.453N P=0.464 P=0.100N P=0.213N P=0.619N |
|LOGISTIC REGRESSION| P=0.390N P=0.354 P=0.146N P=0.205N P=0.576N |
|COCH-ARM / FISHERS | P=0.319N P=0.307 P=0.189N P=0.278N P=0.500N |
|ORDER RESTRICTED | P=0.241N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 10
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/53 (21%) 26/53 (49%) 31/53 (58%) 30/52 (58%) 32/53 (60%) |
|POLY-3 RATE (b) | 11/38.34 26/42.78 31/46.88 30/45.60 32/40.84 |
|POLY-3 PERCENT (g) | 28.7% 60.8% 66.1% 65.8% 78.4% |
|TERMINAL (d) | 7/16 (44%) 18/23 (78%) 16/24 (67%) 14/23 (61%) 6/8 (75%) |
|FIRST INCIDENCE | 416 350 203 276 339 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.029 * P=0.009 ** P=0.010 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** 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 |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 4/53 (8%) 5/53 (9%) 1/53 (2%) 0/52 (0%) |
|POLY-3 RATE (b) | 2/36.81 4/41.74 5/41.91 1/39.84 0/31.71 |
|POLY-3 PERCENT (g) | 5.4% 9.6% 11.9% 2.5% 0.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 4/24 (17%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 508 548 526 616 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.078N P=0.405 P=0.350 P=0.467N P=0.268N |
|POLY 3 | P=0.063N P=0.396 P=0.270 P=0.472N P=0.271N |
|POLY 1.5 | P=0.054N P=0.378 P=0.250 P=0.479N P=0.255N |
|POLY 6 | P=0.076N P=0.419 P=0.291 P=0.465N P=0.296N |
|LOGISTIC REGRESSION| P=0.046N* P=0.310 P=0.239 P=0.516N P=0.227N |
|COCH-ARM / FISHERS | P=0.046N* P=0.348 P=0.226 P=0.493N P=0.248N |
|ORDER RESTRICTED | P=0.111N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 11
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Intestine Large, Rectum: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 0/53 (0%) 0/53 (0%) 2/53 (4%) 3/52 (6%) |
|POLY-3 RATE (b) | 0/35.78 0/39.99 0/41.29 2/39.44 3/32.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.1% 9.3% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 2/23 (9%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) 617 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.320 P=0.065 |
|POLY 3 | P=0.005 ** (e) (e) P=0.259 P=0.099 |
|POLY 1.5 | P=0.006 ** (e) (e) P=0.253 P=0.108 |
|POLY 6 | P=0.004 ** (e) (e) P=0.266 P=0.089 |
|LOGISTIC REGRESSION| P=0.003 ** (e) (e) P=0.320 P=0.093 |
|COCH-ARM / FISHERS | P=0.009 ** (e) (e) P=0.252 P=0.121 |
|ORDER RESTRICTED | P=0.015 * (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 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 0/53 (0%) 1/53 (2%) 2/53 (4%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/35.78 0/39.99 1/41.31 2/39.44 0/32.27 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.4% 5.1% 0.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 2/23 (9%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- 723 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.478 (e) P=0.566 P=0.320 (e) |
|POLY 3 | P=0.537 (e) P=0.529 P=0.259 (e) |
|POLY 1.5 | P=0.582 (e) P=0.518 P=0.253 (e) |
|POLY 6 | P=0.465 (e) P=0.541 P=0.266 (e) |
|LOGISTIC REGRESSION| P=0.511 (e) P=0.558 P=0.320 (e) |
|COCH-ARM / FISHERS | P=0.621 (e) P=0.505 P=0.252 (e) |
|ORDER RESTRICTED | P=0.333 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 12
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Kidney |
| Calculus Micro Observation Only |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/52 (17%) 5/53 (9%) 8/53 (15%) 4/53 (8%) 1/51 (2%) |
|POLY-3 RATE (b) | 9/38.17 5/40.94 8/42.43 4/40.36 1/32.78 |
|POLY-3 PERCENT (g) | 23.6% 12.2% 18.9% 9.9% 3.1% |
|TERMINAL (d) | 3/16 (19%) 2/23 (9%) 4/24 (17%) 3/23 (13%) 0/8 (0%) |
|FIRST INCIDENCE | 484 626 548 315 575 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.033N* P=0.102N P=0.268N P=0.057N P=0.040N* |
|POLY 3 | P=0.015N* P=0.149N P=0.403N P=0.089N P=0.014N* |
|POLY 1.5 | P=0.011N* P=0.159N P=0.438N P=0.094N P=0.011N* |
|POLY 6 | P=0.023N* P=0.137N P=0.365N P=0.086N P=0.021N* |
|LOGISTIC REGRESSION| P=0.010N* P=0.161N P=0.429N P=0.105N P=0.012N* |
|COCH-ARM / FISHERS | P=0.009N** P=0.184N P=0.483N P=0.110N P=0.009N** |
|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 |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/52 (6%) 2/53 (4%) 3/53 (6%) 3/53 (6%) 6/51 (12%) |
|POLY-3 RATE (b) | 3/36.39 2/40.02 3/41.98 3/40.84 6/33.36 |
|POLY-3 PERCENT (g) | 8.2% 5.0% 7.2% 7.4% 18.0% |
|TERMINAL (d) | 1/16 (6%) 1/23 (4%) 1/24 (4%) 1/23 (4%) 1/8 (13%) |
|FIRST INCIDENCE | 631 721 592 315 598 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.015 * P=0.390N P=0.521N P=0.566N P=0.105 |
|POLY 3 | P=0.057 P=0.456N P=0.596N P=0.609N P=0.194 |
|POLY 1.5 | P=0.068 P=0.467N P=0.621N P=0.623N P=0.217 |
|POLY 6 | P=0.046 * P=0.447N P=0.568N P=0.595N P=0.161 |
|LOGISTIC REGRESSION| P=0.065 P=0.440N P=0.622N P=0.659 P=0.175 |
|COCH-ARM / FISHERS | P=0.080 P=0.491N P=0.652N P=0.652N P=0.234 |
|ORDER RESTRICTED | P=0.083 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 13
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 41/52 (79%) 48/53 (91%) 47/53 (89%) 42/53 (79%) 35/51 (69%) |
|POLY-3 RATE (b) | 41/49.10 48/50.96 47/52.49 42/49.44 35/47.77 |
|POLY-3 PERCENT (g) | 83.5% 94.2% 89.5% 85.0% 73.3% |
|TERMINAL (d) | 12/16 (75%) 22/23 (96%) 21/24 (88%) 18/23 (78%) 3/8 (38%) |
|FIRST INCIDENCE | 176 227 46 276 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.220 P=0.404N P=0.286N P=0.184N P=0.351 |
|POLY 3 | P=0.006N** P=0.067 P=0.265 P=0.533 P=0.151N |
|POLY 1.5 | P=0.005N** P=0.068 P=0.210 P=0.547 P=0.149N |
|POLY 6 | P=0.010N* P=0.070 P=0.315 P=0.524 P=0.179N |
|LOGISTIC REGRESSION| P=0.006N** P=0.085 P=0.107 P=0.579 P=0.123N |
|COCH-ARM / FISHERS | P=0.008N** P=0.080 P=0.135 P=0.575 P=0.170N |
|ORDER RESTRICTED | P=0.013N* (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 |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 26/52 (50%) 41/53 (77%) 40/53 (75%) 47/53 (89%) 49/51 (96%) |
|POLY-3 RATE (b) | 26/41.83 41/47.66 40/47.07 47/49.32 49/50.00 |
|POLY-3 PERCENT (g) | 62.2% 86.0% 85.0% 95.3% 98.0% |
|TERMINAL (d) | 9/16 (56%) 23/23 (100%) 20/24 (83%) 23/23 (100%) 8/8 (100%) |
|FIRST INCIDENCE | 416 227 203 276 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.188 P=0.319 P=0.048 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.004 ** P=0.007 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.004 ** P=0.005 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.003 ** P=0.012 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.006 ** P=0.013 * P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.003 ** P=0.006 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 14
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 0/53 (0%) 1/53 (2%) 1/53 (2%) 1/51 (2%) |
|POLY-3 RATE (b) | 2/36.75 0/39.99 1/41.29 1/39.44 1/32.65 |
|POLY-3 PERCENT (g) | 5.4% 0.0% 2.4% 2.5% 3.1% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 1/24 (4%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | 484 --- 729 (T) 729 (T) 623 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.579 P=0.215N P=0.416N P=0.426N P=0.558N |
|POLY 3 | P=0.620 P=0.218N P=0.459N P=0.475N P=0.541N |
|POLY 1.5 | P=0.614N P=0.223N P=0.474N P=0.481N P=0.522N |
|POLY 6 | P=0.586 P=0.214N P=0.445N P=0.470N P=0.573N |
|LOGISTIC REGRESSION| P=0.603N P=0.254N P=0.497N P=0.496N P=0.504N |
|COCH-ARM / FISHERS | P=0.595N P=0.243N P=0.493N P=0.493N P=0.507N |
|ORDER RESTRICTED | P=0.338N (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 |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 1/53 (2%) 1/53 (2%) 2/53 (4%) 1/51 (2%) |
|POLY-3 RATE (b) | 2/36.44 1/40.87 1/41.29 2/39.44 1/32.27 |
|POLY-3 PERCENT (g) | 5.5% 2.5% 2.4% 5.1% 3.1% |
|TERMINAL (d) | 1/16 (6%) 0/23 (0%) 1/24 (4%) 2/23 (9%) 1/8 (13%) |
|FIRST INCIDENCE | 508 362 729 (T) 729 (T) 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.562 P=0.446N P=0.391N P=0.587N P=0.660N |
|POLY 3 | P=0.576N P=0.460N P=0.456N P=0.666N P=0.543N |
|POLY 1.5 | P=0.549N P=0.471N P=0.472N P=0.673N P=0.522N |
|POLY 6 | P=0.582 P=0.449N P=0.439N P=0.659N P=0.576N |
|LOGISTIC REGRESSION| P=0.528N P=0.555N P=0.479N P=0.665N P=0.528N |
|COCH-ARM / FISHERS | P=0.519N P=0.493N P=0.493N P=0.684N P=0.507N |
|ORDER RESTRICTED | P=0.537N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 15
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 0/53 (0%) 0/53 (0%) 2/53 (4%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/35.78 0/39.99 0/41.29 2/39.44 0/32.27 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.1% 0.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 2/23 (9%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.405 (e) (e) P=0.320 (e) |
|POLY 3 | P=0.449 (e) (e) P=0.259 (e) |
|POLY 1.5 | P=0.499 (e) (e) P=0.253 (e) |
|POLY 6 | P=0.373 (e) (e) P=0.266 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.320 (e) |
|COCH-ARM / FISHERS | P=0.545 (e) (e) P=0.252 (e) |
|ORDER RESTRICTED | P=0.241 (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 |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/52 (10%) 5/53 (9%) 8/53 (15%) 10/53 (19%) 8/51 (16%) |
|POLY-3 RATE (b) | 5/36.97 5/40.89 8/42.32 10/42.99 8/34.22 |
|POLY-3 PERCENT (g) | 13.5% 12.2% 18.9% 23.3% 23.4% |
|TERMINAL (d) | 2/16 (13%) 1/23 (4%) 4/24 (17%) 4/23 (17%) 2/8 (25%) |
|FIRST INCIDENCE | 484 626 621 276 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.024 * P=0.478N P=0.498 P=0.256 P=0.100 |
|POLY 3 | P=0.104 P=0.567N P=0.366 P=0.203 P=0.218 |
|POLY 1.5 | P=0.134 P=0.584N P=0.331 P=0.181 P=0.246 |
|POLY 6 | P=0.068 P=0.543N P=0.411 P=0.230 P=0.175 |
|LOGISTIC REGRESSION| P=0.149 P=0.581N P=0.351 P=0.128 P=0.233 |
|COCH-ARM / FISHERS | P=0.167 P=0.617N P=0.290 P=0.141 P=0.265 |
|ORDER RESTRICTED | P=0.227 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 16
Statistical Analysis of Non-neoplastic Lesions 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 |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 2/53 (4%) 0/53 (0%) 0/53 (0%) 3/51 (6%) |
|POLY-3 RATE (b) | 3/37.02 2/40.10 0/41.29 0/39.44 3/33.56 |
|POLY-3 PERCENT (g) | 8.1% 5.0% 0.0% 0.0% 8.9% |
|TERMINAL (d) | 2/16 (13%) 1/23 (4%) 0/24 (0%) 0/23 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 444 702 --- --- 409 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.278 P=0.377N P=0.077N P=0.081N P=0.477 |
|POLY 3 | P=0.423 P=0.463N P=0.100N P=0.107N P=0.618 |
|POLY 1.5 | P=0.436 P=0.476N P=0.108N P=0.111N P=0.635 |
|POLY 6 | P=0.410 P=0.447N P=0.090N P=0.101N P=0.588 |
|LOGISTIC REGRESSION| P=0.449 P=0.470N P=0.118N P=0.118N P=0.647 |
|COCH-ARM / FISHERS | P=0.451 P=0.500N P=0.121N P=0.121N P=0.642 |
|ORDER RESTRICTED | P=0.203 (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 |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 24/53 (45%) 26/53 (49%) 13/53 (25%) 12/53 (23%) 16/51 (31%) |
|POLY-3 RATE (b) | 24/40.97 26/46.22 13/44.27 12/42.39 16/38.67 |
|POLY-3 PERCENT (g) | 58.6% 56.3% 29.4% 28.3% 41.4% |
|TERMINAL (d) | 7/16 (44%) 9/23 (39%) 4/24 (17%) 3/23 (13%) 0/8 (0%) |
|FIRST INCIDENCE | 444 362 263 505 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.371N P=0.341N P=0.004N** P=0.004N** P=0.453N |
|POLY 3 | P=0.051N P=0.499N P=0.004N** P=0.003N** P=0.083N |
|POLY 1.5 | P=0.042N* P=0.583N P=0.007N** P=0.005N** P=0.082N |
|POLY 6 | P=0.067N P=0.412N P=0.003N** P=0.002N** P=0.097N |
|LOGISTIC REGRESSION| P=0.053N P=0.532 P=0.011N* P=0.006N** P=0.123N |
|COCH-ARM / FISHERS | P=0.043N* P=0.423 P=0.020N* P=0.012N* P=0.104N |
|ORDER RESTRICTED | P=0.012N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 17
Statistical Analysis of Non-neoplastic Lesions 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 |
| Cholangiofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/53 (4%) 3/53 (6%) 4/53 (8%) 17/51 (33%) |
|POLY-3 RATE (b) | 0/36.25 2/40.10 3/41.39 4/40.46 17/36.02 |
|POLY-3 PERCENT (g) | 0.0% 5.0% 7.3% 9.9% 47.2% |
|TERMINAL (d) | 0/16 (0%) 1/23 (4%) 2/24 (8%) 2/23 (9%) 2/8 (25%) |
|FIRST INCIDENCE | --- 702 702 521 392 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.309 P=0.199 P=0.097 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.260 P=0.143 P=0.074 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.252 P=0.132 P=0.069 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.270 P=0.158 P=0.082 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.278 P=0.170 P=0.066 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.248 P=0.121 P=0.059 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 |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 0/53 (0%) 0/53 (0%) 1/53 (2%) 2/51 (4%) |
|POLY-3 RATE (b) | 1/36.43 0/39.99 0/41.29 1/39.44 2/32.99 |
|POLY-3 PERCENT (g) | 2.7% 0.0% 0.0% 2.5% 6.1% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | 682 --- --- 729 (T) 563 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.063 P=0.462N P=0.443N P=0.702N P=0.421 |
|POLY 3 | P=0.108 P=0.481N P=0.475N P=0.744N P=0.465 |
|POLY 1.5 | P=0.119 P=0.488N P=0.486N P=0.750N P=0.479 |
|POLY 6 | P=0.095 P=0.474N P=0.463N P=0.737N P=0.442 |
|LOGISTIC REGRESSION| P=0.114 P=0.481N P=0.476N P=0.734N P=0.475 |
|COCH-ARM / FISHERS | P=0.132 P=0.500N P=0.500N P=0.752N P=0.485 |
|ORDER RESTRICTED | P=0.119 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 18
Statistical Analysis of Non-neoplastic Lesions 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 |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 9/53 (17%) 11/53 (21%) 20/53 (38%) 19/51 (37%) |
|POLY-3 RATE (b) | 5/36.93 9/41.59 11/44.12 20/44.09 19/39.91 |
|POLY-3 PERCENT (g) | 13.5% 21.6% 24.9% 45.4% 47.6% |
|TERMINAL (d) | 4/16 (25%) 3/23 (13%) 3/24 (13%) 6/23 (26%) 4/8 (50%) |
|FIRST INCIDENCE | 500 455 322 465 387 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.377 P=0.247 P=0.010 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.260 P=0.157 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.234 P=0.122 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.298 P=0.210 P=0.003 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.242 P=0.101 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.195 P=0.087 P<0.001 ** 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 |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 5/53 (9%) 14/53 (26%) 34/53 (64%) 36/51 (71%) |
|POLY-3 RATE (b) | 3/37.54 5/41.40 14/43.52 34/43.92 36/40.75 |
|POLY-3 PERCENT (g) | 8.0% 12.1% 32.2% 77.4% 88.3% |
|TERMINAL (d) | 0/16 (0%) 1/23 (4%) 6/24 (25%) 21/23 (91%) 8/8 (100%) |
|FIRST INCIDENCE | 484 227 456 465 409 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.464 P=0.029 * P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.410 P=0.007 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.394 P=0.005 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.428 P=0.010 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.327 P=0.006 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.358 P=0.003 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 19
Statistical Analysis of Non-neoplastic Lesions 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 |
| Fatty Change Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 4/53 (8%) 7/53 (13%) 2/53 (4%) 1/51 (2%) |
|POLY-3 RATE (b) | 3/37.06 4/41.52 7/41.85 2/39.99 1/33.11 |
|POLY-3 PERCENT (g) | 8.1% 9.6% 16.7% 5.0% 3.0% |
|TERMINAL (d) | 2/16 (13%) 1/23 (4%) 4/24 (17%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 416 455 652 626 399 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.199N P=0.610 P=0.329 P=0.412N P=0.444N |
|POLY 3 | P=0.120N P=0.562 P=0.208 P=0.465N P=0.345N |
|POLY 1.5 | P=0.106N P=0.539 P=0.184 P=0.479N P=0.329N |
|POLY 6 | P=0.143N P=0.592 P=0.242 P=0.446N P=0.374N |
|LOGISTIC REGRESSION| P=0.100N P=0.483 P=0.207 P=0.494N P=0.317N |
|COCH-ARM / FISHERS | P=0.096N P=0.500 P=0.160 P=0.500N P=0.324N |
|ORDER RESTRICTED | P=0.186N (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 |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 16/53 (30%) 18/53 (34%) 19/53 (36%) 8/53 (15%) 9/51 (18%) |
|POLY-3 RATE (b) | 16/43.39 18/46.29 19/47.14 8/42.48 9/36.40 |
|POLY-3 PERCENT (g) | 36.9% 38.9% 40.3% 18.8% 24.7% |
|TERMINAL (d) | 2/16 (13%) 5/23 (22%) 7/24 (29%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | 176 227 263 322 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.104N P=0.503N P=0.507N P=0.036N* P=0.260N |
|POLY 3 | P=0.035N* P=0.509 P=0.452 P=0.048N* P=0.173N |
|POLY 1.5 | P=0.022N* P=0.472 P=0.395 P=0.050N P=0.136N |
|POLY 6 | P=0.059N P=0.558 P=0.518 P=0.045N* P=0.236N |
|LOGISTIC REGRESSION| P=0.008N** P=0.295 P=0.258 P=0.074N P=0.089N |
|COCH-ARM / FISHERS | P=0.013N* P=0.418 P=0.340 P=0.052N P=0.102N |
|ORDER RESTRICTED | P=0.084N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 20
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 1/53 (2%) 3/53 (6%) 11/53 (21%) 38/51 (75%) |
|POLY-3 RATE (b) | 0/36.25 1/40.22 3/41.75 11/41.10 38/42.93 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 7.2% 26.8% 88.5% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 2/24 (8%) 6/23 (26%) 6/8 (75%) |
|FIRST INCIDENCE | --- 668 592 548 392 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.540 P=0.188 P=0.003 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.521 P=0.145 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.513 P=0.133 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.530 P=0.161 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.514 P=0.140 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.121 P<0.001 ** 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 |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 36/53 (68%) 50/53 (94%) 45/53 (85%) 50/53 (94%) 50/51 (98%) |
|POLY-3 RATE (b) | 36/46.12 50/52.12 45/49.17 50/51.02 50/50.79 |
|POLY-3 PERCENT (g) | 78.1% 95.9% 91.5% 98.0% 98.4% |
|TERMINAL (d) | 13/16 (81%) 21/23 (91%) 23/24 (96%) 23/23 (100%) 8/8 (100%) |
|FIRST INCIDENCE | 176 227 203 276 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.337 P=0.406N P=0.332 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.003 ** P=0.039 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P=0.025 * P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.005 ** P=0.019 * P=0.071 P<0.001 ** P=0.002 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P=0.049 * P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P=0.033 * P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 21
Statistical Analysis of Non-neoplastic Lesions 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 |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 21/53 (40%) 32/53 (60%) 35/53 (66%) 36/53 (68%) 17/51 (33%) |
|POLY-3 RATE (b) | 21/38.34 32/44.41 35/45.79 36/44.24 17/38.70 |
|POLY-3 PERCENT (g) | 54.8% 72.1% 76.4% 81.4% 43.9% |
|TERMINAL (d) | 15/16 (94%) 20/23 (87%) 22/24 (92%) 22/23 (96%) 5/8 (63%) |
|FIRST INCIDENCE | 387 455 322 469 339 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.193 P=0.313 P=0.225 P=0.108 P=0.250 |
|POLY 3 | P=0.019N* P=0.061 P=0.019 * P=0.003 ** P=0.219N |
|POLY 1.5 | P=0.019N* P=0.040 * P=0.008 ** P=0.002 ** P=0.246N |
|POLY 6 | P=0.026N* P=0.115 P=0.053 P=0.007 ** P=0.199N |
|LOGISTIC REGRESSION| P=0.121N P=0.056 P=0.021 * P=0.004 ** P=0.377N |
|COCH-ARM / FISHERS | P=0.047N* P=0.026 * P=0.006 ** P=0.003 ** P=0.322N |
|ORDER RESTRICTED | P=0.004N** (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 |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 1/53 (2%) 9/53 (17%) 3/53 (6%) 15/51 (29%) |
|POLY-3 RATE (b) | 3/37.19 1/40.57 9/44.14 3/41.00 15/38.07 |
|POLY-3 PERCENT (g) | 8.1% 2.5% 20.4% 7.3% 39.4% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 1/24 (4%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 625 546 456 490 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.263N P=0.142 P=0.591N P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.274N P=0.105 P=0.618N P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.284N P=0.083 P=0.634N P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.264N P=0.134 P=0.601N P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.311N P=0.062 P=0.646 P=0.002 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.309N P=0.061 P=0.661N P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 22
Statistical Analysis of Non-neoplastic Lesions 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 |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 35/53 (66%) 41/53 (77%) 48/53 (91%) 51/51 (100%) |
|POLY-3 RATE (b) | 4/37.02 35/47.45 41/46.41 48/49.41 51/51.00 |
|POLY-3 PERCENT (g) | 10.8% 73.8% 88.3% 97.1% 100.0% |
|TERMINAL (d) | 0/16 (0%) 14/23 (61%) 23/24 (96%) 23/23 (100%) 8/8 (100%) |
|FIRST INCIDENCE | 631 362 456 322 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** 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 |
|=================================================================================================================================|
| |
|Liver |
| Toxic Hepatopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 5/53 (9%) 14/53 (26%) 38/53 (72%) 47/51 (92%) |
|POLY-3 RATE (b) | 0/36.25 5/40.51 14/42.54 38/44.69 47/48.74 |
|POLY-3 PERCENT (g) | 0.0% 12.3% 32.9% 85.0% 96.4% |
|TERMINAL (d) | 0/16 (0%) 2/23 (9%) 9/24 (38%) 23/23 (100%) 7/8 (88%) |
|FIRST INCIDENCE | --- 627 456 465 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.067 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.040 * P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.036 * P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.045 * P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.045 * P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.028 * P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 23
Statistical Analysis of Non-neoplastic Lesions 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: Bile Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 3/53 (6%) 3/53 (6%) 4/53 (8%) 9/51 (18%) |
|POLY-3 RATE (b) | 1/36.25 3/39.99 3/41.40 4/39.81 9/34.57 |
|POLY-3 PERCENT (g) | 2.8% 7.5% 7.3% 10.1% 26.0% |
|TERMINAL (d) | 1/16 (6%) 3/23 (13%) 2/24 (8%) 3/23 (13%) 1/8 (13%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 699 626 562 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.441 P=0.457 P=0.283 P=0.003 ** |
|POLY 3 | P<0.001 ** P=0.340 P=0.354 P=0.206 P=0.005 ** |
|POLY 1.5 | P<0.001 ** P=0.328 P=0.332 P=0.196 P=0.006 ** |
|POLY 6 | P<0.001 ** P=0.356 P=0.380 P=0.221 P=0.004 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.441 P=0.408 P=0.221 P=0.005 ** |
|COCH-ARM / FISHERS | P=0.002 ** P=0.309 P=0.309 P=0.181 P=0.007 ** |
|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 |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 2/53 (4%) 1/53 (2%) 5/53 (9%) 1/51 (2%) |
|POLY-3 RATE (b) | 3/36.43 2/40.22 1/41.29 5/39.44 1/32.31 |
|POLY-3 PERCENT (g) | 8.2% 5.0% 2.4% 12.7% 3.1% |
|TERMINAL (d) | 2/16 (13%) 1/23 (4%) 1/24 (4%) 5/23 (22%) 0/8 (0%) |
|FIRST INCIDENCE | 682 668 729 (T) 729 (T) 721 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.490 P=0.368N P=0.183N P=0.551 P=0.516N |
|POLY 3 | P=0.519N P=0.455N P=0.261N P=0.399 P=0.348N |
|POLY 1.5 | P=0.472N P=0.471N P=0.280N P=0.384 P=0.330N |
|POLY 6 | P=0.567 P=0.435N P=0.241N P=0.417 P=0.380N |
|LOGISTIC REGRESSION| P=0.585 P=0.427N P=0.214N P=0.459 P=0.433N |
|COCH-ARM / FISHERS | P=0.426N P=0.500N P=0.309N P=0.358 P=0.324N |
|ORDER RESTRICTED | P=0.351N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 24
Statistical Analysis of Non-neoplastic Lesions 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: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 3/53 (6%) 5/53 (9%) 25/53 (47%) 42/51 (82%) |
|POLY-3 RATE (b) | 2/36.25 3/40.21 5/41.76 25/42.11 42/45.06 |
|POLY-3 PERCENT (g) | 5.5% 7.5% 12.0% 59.4% 93.2% |
|TERMINAL (d) | 2/16 (13%) 1/23 (4%) 2/24 (8%) 17/23 (74%) 8/8 (100%) |
|FIRST INCIDENCE | 729 (T) 683 659 505 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.646 P=0.386 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.547 P=0.276 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.530 P=0.248 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.570 P=0.311 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.590 P=0.316 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.219 P<0.001 ** 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 |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 2/53 (4%) 1/53 (2%) 1/53 (2%) 6/51 (12%) |
|POLY-3 RATE (b) | 3/37.69 2/41.10 1/42.28 1/39.84 6/34.96 |
|POLY-3 PERCENT (g) | 8.0% 4.9% 2.4% 2.5% 17.2% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 454 362 46 616 392 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.029 * P=0.453N P=0.278N P=0.276N P=0.174 |
|POLY 3 | P=0.038 * P=0.460N P=0.264N P=0.284N P=0.200 |
|POLY 1.5 | P=0.042 * P=0.473N P=0.279N P=0.291N P=0.216 |
|POLY 6 | P=0.033 * P=0.448N P=0.250N P=0.277N P=0.175 |
|LOGISTIC REGRESSION| P=0.056 P=0.565N P=0.317N P=0.326N P=0.227 |
|COCH-ARM / FISHERS | P=0.050 P=0.500N P=0.309N P=0.309N P=0.225 |
|ORDER RESTRICTED | P=0.023 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 25
Statistical Analysis of Non-neoplastic Lesions 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: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 27/53 (51%) 34/53 (64%) 46/53 (87%) 50/51 (98%) |
|POLY-3 RATE (b) | 1/36.84 27/47.43 34/47.70 46/50.65 50/50.16 |
|POLY-3 PERCENT (g) | 2.7% 56.9% 71.3% 90.8% 99.7% |
|TERMINAL (d) | 0/16 (0%) 9/23 (39%) 15/24 (63%) 19/23 (83%) 8/8 (100%) |
|FIRST INCIDENCE | 540 350 263 276 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** 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 |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Multinucleated |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 12/53 (23%) 10/53 (19%) 39/53 (74%) 51/51 (100%) |
|POLY-3 RATE (b) | 0/36.25 12/41.65 10/42.90 39/46.55 51/51.00 |
|POLY-3 PERCENT (g) | 0.0% 28.8% 23.3% 83.8% 100.0% |
|TERMINAL (d) | 0/16 (0%) 6/23 (26%) 5/24 (21%) 20/23 (87%) 8/8 (100%) |
|FIRST INCIDENCE | --- 546 456 465 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.002 ** P=0.007 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 26
Statistical Analysis of Non-neoplastic Lesions 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: Oval Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 1/53 (2%) 1/53 (2%) 26/53 (49%) 42/51 (82%) |
|POLY-3 RATE (b) | 0/36.25 1/40.04 1/41.29 26/42.56 42/45.01 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 2.4% 61.1% 93.3% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 1/24 (4%) 16/23 (70%) 8/8 (100%) |
|FIRST INCIDENCE | --- 718 729 (T) 505 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.555 P=0.581 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.520 P=0.526 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.513 P=0.514 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.528 P=0.539 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.540 P=0.581 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.500 P<0.001 ** 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 |
|=================================================================================================================================|
| |
|Liver: Portal |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 11/51 (22%) |
|POLY-3 RATE (b) | 0/36.25 0/39.99 0/41.29 0/39.44 11/34.70 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 31.7% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 1/8 (13%) |
|FIRST INCIDENCE | --- --- --- --- 497 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 27
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Lung |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/53 (0%) 2/53 (4%) 2/53 (4%) 1/53 (2%) |
|POLY-3 RATE (b) | 0/36.25 0/39.99 2/42.28 2/40.18 1/33.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.7% 5.0% 3.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 1/24 (4%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- 46 465 392 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.254 (e) P=0.284 P=0.292 P=0.496 |
|POLY 3 | P=0.277 (e) P=0.273 P=0.260 P=0.482 |
|POLY 1.5 | P=0.307 (e) P=0.259 P=0.252 P=0.490 |
|POLY 6 | P=0.234 (e) P=0.289 P=0.271 P=0.468 |
|LOGISTIC REGRESSION| P=0.435 (e) P=0.231 P=0.226 P=0.553 |
|COCH-ARM / FISHERS | P=0.348 (e) P=0.248 P=0.248 P=0.500 |
|ORDER RESTRICTED | P=0.240 (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 |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 43/53 (81%) 50/53 (94%) 48/53 (91%) 48/53 (91%) 50/53 (94%) |
|POLY-3 RATE (b) | 43/48.76 50/51.23 48/50.38 48/49.84 50/50.63 |
|POLY-3 PERCENT (g) | 88.2% 97.6% 95.3% 96.3% 98.8% |
|TERMINAL (d) | 12/16 (75%) 22/23 (96%) 23/24 (96%) 23/23 (100%) 8/8 (100%) |
|FIRST INCIDENCE | 176 227 203 322 2 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.381N P=0.199N P=0.291N P=0.011 * |
|POLY 3 | P=0.045 * P=0.058 P=0.163 P=0.104 P=0.026 * |
|POLY 1.5 | P=0.054 P=0.043 * P=0.130 P=0.114 P=0.024 * |
|POLY 6 | P=0.037 * P=0.084 P=0.190 P=0.086 P=0.031 * |
|LOGISTIC REGRESSION| P=0.037 * P=0.062 P=0.173 P=0.191 P=0.021 * |
|COCH-ARM / FISHERS | P=0.093 P=0.036 * P=0.132 P=0.132 P=0.036 * |
|ORDER RESTRICTED | P=0.004 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 28
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 2/53 (4%) 3/53 (6%) 1/53 (2%) 2/53 (4%) |
|POLY-3 RATE (b) | 4/36.94 2/40.38 3/43.60 1/40.14 2/33.97 |
|POLY-3 PERCENT (g) | 10.8% 5.0% 6.9% 2.5% 5.9% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 627 652 46 490 392 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.393N P=0.251N P=0.403N P=0.143N P=0.467N |
|POLY 3 | P=0.327N P=0.295N P=0.410N P=0.152N P=0.375N |
|POLY 1.5 | P=0.312N P=0.310N P=0.443N P=0.162N P=0.356N |
|POLY 6 | P=0.348N P=0.280N P=0.378N P=0.144N P=0.412N |
|LOGISTIC REGRESSION| P=0.221N P=0.294N P=0.543N P=0.172N P=0.331N |
|COCH-ARM / FISHERS | P=0.286N P=0.339N P=0.500N P=0.181N P=0.339N |
|ORDER RESTRICTED | P=0.217N (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 |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/53 (0%) 2/53 (4%) 8/53 (15%) 11/53 (21%) |
|POLY-3 RATE (b) | 2/36.26 0/39.99 2/41.29 8/39.62 11/35.54 |
|POLY-3 PERCENT (g) | 5.5% 0.0% 4.8% 20.2% 31.0% |
|TERMINAL (d) | 1/16 (6%) 0/23 (0%) 2/24 (8%) 7/23 (30%) 2/8 (25%) |
|FIRST INCIDENCE | 727 --- 729 (T) 682 392 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.170N P=0.547N P=0.123 P=0.002 ** |
|POLY 3 | P<0.001 ** P=0.215N P=0.647N P=0.058 P=0.004 ** |
|POLY 1.5 | P<0.001 ** P=0.223N P=0.668N P=0.053 P=0.005 ** |
|POLY 6 | P<0.001 ** P=0.206N P=0.622N P=0.064 P=0.003 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.177N P=0.547N P=0.074 P=0.005 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.248N P=0.691N P=0.046 * P=0.008 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 29
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 21/53 (40%) 25/53 (47%) 10/53 (19%) 2/53 (4%) 2/53 (4%) |
|POLY-3 RATE (b) | 21/38.66 25/45.19 10/43.44 2/40.34 2/33.72 |
|POLY-3 PERCENT (g) | 54.3% 55.3% 23.0% 5.0% 5.9% |
|TERMINAL (d) | 10/16 (63%) 11/23 (48%) 5/24 (21%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | 435 498 548 333 392 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** P=0.434N P=0.002N** P<0.001N** P<0.001N** |
|POLY 3 | P<0.001N** P=0.553 P=0.002N** P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.431 P=0.005N** P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P=0.475N P<0.001N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.419 P=0.004N** P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.278 P=0.016N* P<0.001N** 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 |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Metaplasia Bronchiolar |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 20/53 (38%) 33/53 (62%) 41/53 (77%) 40/53 (75%) |
|POLY-3 RATE (b) | 0/36.25 20/42.49 33/44.28 41/45.23 40/44.85 |
|POLY-3 PERCENT (g) | 0.0% 47.1% 74.5% 90.6% 89.2% |
|TERMINAL (d) | 0/16 (0%) 11/23 (48%) 19/24 (79%) 22/23 (96%) 8/8 (100%) |
|FIRST INCIDENCE | --- 456 540 521 387 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 30
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 1/53 (2%) 1/53 (2%) 2/53 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/36.25 1/39.99 1/41.55 2/39.44 0/32.33 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 2.4% 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) 659 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.628 P=0.572 P=0.556 P=0.320 (e) |
|POLY 3 | P=0.609N P=0.520 P=0.527 P=0.256 (e) |
|POLY 1.5 | P=0.583N P=0.513 P=0.515 P=0.249 (e) |
|POLY 6 | P=0.597 P=0.528 P=0.541 P=0.264 (e) |
|LOGISTIC REGRESSION| P=0.657N P=0.572 P=0.511 P=0.320 (e) |
|COCH-ARM / FISHERS | P=0.548N P=0.500 P=0.500 P=0.248 (e) |
|ORDER RESTRICTED | P=0.391 (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 |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 31/53 (58%) 42/53 (79%) 30/53 (57%) 22/53 (42%) 27/53 (51%) |
|POLY-3 RATE (b) | 31/42.81 42/46.79 30/44.94 22/42.31 27/42.85 |
|POLY-3 PERCENT (g) | 72.4% 89.8% 66.8% 52.0% 63.0% |
|TERMINAL (d) | 12/16 (75%) 22/23 (96%) 19/24 (79%) 13/23 (57%) 4/8 (50%) |
|FIRST INCIDENCE | 176 227 203 322 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.297 P=0.453 P=0.060N P=0.007N** P=0.254 |
|POLY 3 | P=0.009N** P=0.016 * P=0.355N P=0.031N* P=0.223N |
|POLY 1.5 | P=0.011N* P=0.015 * P=0.414N P=0.037N* P=0.241N |
|POLY 6 | P=0.011N* P=0.022 * P=0.341N P=0.032N* P=0.246N |
|LOGISTIC REGRESSION| P=0.055N P=0.037 * P=0.319N P=0.024N* P=0.344N |
|COCH-ARM / FISHERS | P=0.020N* P=0.018 * P=0.500N P=0.060N P=0.279N |
|ORDER RESTRICTED | P=0.006N** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 31
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 0/53 (0%) 0/53 (0%) 1/53 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/35.78 0/39.99 0/41.29 1/39.44 2/32.31 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.5% 6.2% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) 563 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.008 ** (e) (e) P=0.572 P=0.190 |
|POLY 3 | P=0.023 * (e) (e) P=0.519 P=0.214 |
|POLY 1.5 | P=0.026 * (e) (e) P=0.514 P=0.223 |
|POLY 6 | P=0.019 * (e) (e) P=0.526 P=0.200 |
|LOGISTIC REGRESSION| P=0.025 * (e) (e) P=0.572 P=0.225 |
|COCH-ARM / FISHERS | P=0.030 * (e) (e) P=0.505 P=0.238 |
|ORDER RESTRICTED | P=0.037 * (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 |
|=================================================================================================================================|
| |
|Lymph Node: Lumbar |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/4 (25%) 0/1 (0%) 0/2 (0%) 3/9 (33%) 0/11 (0%) |
|POLY-3 RATE (b) | 1/2.37 0/1.00 0/1.51 3/7.27 0/6.18 |
|POLY-3 PERCENT (g) | 42.3% 0.0% 0.0% 41.3% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/2 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 682 --- --- 322 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.605 P=0.459N P=0.432N P=0.343 P=0.605N |
|POLY 3 | P=0.263N P=0.699N P=0.600N P=0.746N P=0.283N |
|POLY 1.5 | P=0.215N P=0.726N P=0.612N P=0.704 P=0.285N |
|POLY 6 | P=0.356N P=0.647N P=0.598N P=0.708N P=0.283N |
|LOGISTIC REGRESSION| P=0.132N P=0.608N P=0.487N P=0.626 P=0.239N |
|COCH-ARM / FISHERS | P=0.169N P=0.800N P=0.667N P=0.646 P=0.267N |
|ORDER RESTRICTED | P=0.176N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 32
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/4 (0%) 1/1 (100%) 0/2 (0%) 4/9 (44%) 2/11 (18%) |
|POLY-3 RATE (b) | 0/2.19 1/1.00 0/1.51 4/6.87 2/7.20 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% 58.3% 27.8% |
|TERMINAL (d) | 0/0 (0%) 1/1 (100%) 0/0 (0%) 1/2 (50%) 0/2 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 548 498 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.176 P=1.000N (e) P=0.144 P=0.216 |
|POLY 3 | P=0.483N P=0.009 ** (e) P=0.235 P=0.524 |
|POLY 1.5 | P=0.532N P<0.001 ** (e) P=0.186 P=0.497 |
|POLY 6 | P=0.396N P=0.247 (e) P=0.348 P=0.580 |
|LOGISTIC REGRESSION| P=0.608N P=1.000N (e) P=0.182 P=0.479 |
|COCH-ARM / FISHERS | P=0.566N P=0.200 (e) P=0.176 P=0.524 |
|ORDER RESTRICTED | P=0.271 (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 |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/4 (0%) 0/1 (0%) 0/2 (0%) 1/9 (11%) 2/11 (18%) |
|POLY-3 RATE (b) | 0/2.19 0/1.00 0/1.51 1/5.93 2/6.71 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 16.9% 29.8% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/2 (0%) 1/2 (50%) |
|FIRST INCIDENCE | --- --- --- 619 563 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.056 (e) (e) P=0.516 P=0.477 |
|POLY 3 | P=0.207 (e) (e) P=0.693 P=0.506 |
|POLY 1.5 | P=0.226 (e) (e) P=0.674 P=0.488 |
|POLY 6 | P=0.182 (e) (e) P=0.728 P=0.553 |
|LOGISTIC REGRESSION| P=0.206 (e) (e) P=0.679 P=0.493 |
|COCH-ARM / FISHERS | P=0.236 (e) (e) P=0.692 P=0.524 |
|ORDER RESTRICTED | P=0.332 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 33
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/4 (0%) 0/1 (0%) 0/2 (0%) 1/9 (11%) 3/11 (27%) |
|POLY-3 RATE (b) | 0/2.19 0/1.00 0/1.51 1/6.11 3/8.15 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 16.4% 36.8% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/2 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- 548 392 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004 ** (e) (e) P=0.515 P=0.113 |
|POLY 3 | P=0.123 (e) (e) P=0.697 P=0.418 |
|POLY 1.5 | P=0.121 (e) (e) P=0.676 P=0.374 |
|POLY 6 | P=0.123 (e) (e) P=0.732 P=0.495 |
|LOGISTIC REGRESSION| P=0.142 (e) (e) P=0.667 P=0.351 |
|COCH-ARM / FISHERS | P=0.108 (e) (e) P=0.692 P=0.363 |
|ORDER RESTRICTED | P=0.277 (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 |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/4 (0%) 0/1 (0%) 0/2 (0%) 0/9 (0%) 2/11 (18%) |
|POLY-3 RATE (b) | 0/2.19 0/1.00 0/1.51 0/5.54 2/7.61 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 26.3% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/2 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- --- 387 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.020 * (e) (e) (e) P=0.240 |
|POLY 3 | P=0.141 (e) (e) (e) P=0.537 |
|POLY 1.5 | P=0.143 (e) (e) (e) P=0.507 |
|POLY 6 | P=0.136 (e) (e) (e) P=0.591 |
|LOGISTIC REGRESSION| P=0.169 (e) (e) (e) P=0.547 |
|COCH-ARM / FISHERS | P=0.136 (e) (e) (e) P=0.524 |
|ORDER RESTRICTED | P=0.297 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 34
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/4 (0%) 0/1 (0%) 0/2 (0%) 0/9 (0%) 2/11 (18%) |
|POLY-3 RATE (b) | 0/2.19 0/1.00 0/1.51 0/5.54 2/6.50 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 30.8% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/2 (0%) 1/2 (50%) |
|FIRST INCIDENCE | --- --- --- --- 639 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.046 * (e) (e) (e) P=0.462 |
|POLY 3 | P=0.116 (e) (e) (e) P=0.498 |
|POLY 1.5 | P=0.128 (e) (e) (e) P=0.483 |
|POLY 6 | P=0.101 (e) (e) (e) P=0.541 |
|LOGISTIC REGRESSION| P=0.094 (e) (e) (e) P=0.530 |
|COCH-ARM / FISHERS | P=0.136 (e) (e) (e) P=0.524 |
|ORDER RESTRICTED | P=0.227 (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 |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 3/53 (6%) 1/53 (2%) 1/53 (2%) 0/52 (0%) |
|POLY-3 RATE (b) | 0/36.25 3/40.88 1/41.29 1/39.44 0/32.27 |
|POLY-3 PERCENT (g) | 0.0% 7.3% 2.4% 2.5% 0.0% |
|TERMINAL (d) | 0/16 (0%) 2/23 (9%) 1/24 (4%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | --- 350 729 (T) 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.369N P=0.170 P=0.581 P=0.572 (e) |
|POLY 3 | P=0.269N P=0.141 P=0.526 P=0.517 (e) |
|POLY 1.5 | P=0.261N P=0.133 P=0.514 P=0.511 (e) |
|POLY 6 | P=0.282N P=0.150 P=0.539 P=0.524 (e) |
|LOGISTIC REGRESSION| P=0.265N P=0.110 P=0.581 P=0.572 (e) |
|COCH-ARM / FISHERS | P=0.255N P=0.121 P=0.500 P=0.500 (e) |
|ORDER RESTRICTED | P=0.292N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 35
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 22/53 (42%) 7/53 (13%) 14/53 (26%) 12/53 (23%) 9/52 (17%) |
|POLY-3 RATE (b) | 22/41.93 7/42.31 14/43.62 12/40.19 9/35.05 |
|POLY-3 PERCENT (g) | 52.5% 16.6% 32.1% 29.9% 25.7% |
|TERMINAL (d) | 8/16 (50%) 4/23 (17%) 6/24 (25%) 8/23 (35%) 1/8 (13%) |
|FIRST INCIDENCE | 416 362 322 668 497 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.355N P<0.001N** P=0.016N* P=0.006N** P=0.100N |
|POLY 3 | P=0.110N P<0.001N** P=0.039N* P=0.026N* P=0.011N* |
|POLY 1.5 | P=0.080N P<0.001N** P=0.051N P=0.025N* P=0.007N** |
|POLY 6 | P=0.155N P<0.001N** P=0.030N* P=0.027N* P=0.021N* |
|LOGISTIC REGRESSION| P=0.071N P<0.001N** P=0.054N P=0.016N* P=0.008N** |
|COCH-ARM / FISHERS | P=0.050N P<0.001N** P=0.075N P=0.030N* P=0.006N** |
|ORDER RESTRICTED | P=0.008N** (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 |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 4/53 (8%) 1/53 (2%) 3/53 (6%) 1/52 (2%) |
|POLY-3 RATE (b) | 3/38.20 4/41.28 1/41.29 3/40.36 1/32.81 |
|POLY-3 PERCENT (g) | 7.9% 9.7% 2.4% 7.4% 3.1% |
|TERMINAL (d) | 0/16 (0%) 1/23 (4%) 1/24 (4%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | 387 540 729 (T) 465 563 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.301N P=0.576 P=0.251N P=0.601N P=0.330N |
|POLY 3 | P=0.265N P=0.543 P=0.277N P=0.638N P=0.360N |
|POLY 1.5 | P=0.240N P=0.527 P=0.290N P=0.646N P=0.338N |
|POLY 6 | P=0.299N P=0.562 P=0.264N P=0.628N P=0.397N |
|LOGISTIC REGRESSION| P=0.193N P=0.446 P=0.327N P=0.621 P=0.282N |
|COCH-ARM / FISHERS | P=0.209N P=0.500 P=0.309N P=0.661N P=0.316N |
|ORDER RESTRICTED | P=0.291N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 36
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Mesentery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/0 (0%) 0/1 (0%) 0/2 (0%) 0/6 (0%) 2/8 (25%) |
|POLY-3 RATE (b) | 0/0.00 0/0.96 0/1.76 0/5.10 2/7.62 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 26.2% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/4 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- --- --- --- 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.010 * (e) (e) (e) P=0.198 |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.280 (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.181 (e) (e) (e) P=1.000 |
|ORDER RESTRICTED | (e) (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 |
|=================================================================================================================================|
| |
|Mesentery: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/0 (0%) 1/1 (100%) 0/2 (0%) 3/6 (50%) 6/8 (75%) |
|POLY-3 RATE (b) | 0/0.00 1/1.00 0/1.76 3/5.10 6/6.90 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% 58.8% 87.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 3/4 (75%) 3/3 (100%) |
|FIRST INCIDENCE | --- 718 --- 729 (T) 634 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=1.000N P=0.065 |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.118 (e) (e) P=1.000N (e) |
|COCH-ARM / FISHERS | P=0.201 (e) (e) P=1.000 P=1.000 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 37
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/0 (0%) 0/1 (0%) 1/2 (50%) 2/6 (33%) 0/8 (0%) |
|POLY-3 RATE (b) | 0/0.00 0/0.96 1/1.76 2/5.77 0/6.52 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 56.7% 34.7% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 1/1 (100%) 1/4 (25%) 0/3 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 505 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.361N (e) P=1.000N P=0.535 (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.111N (e) P=1.000N (e) (e) |
|COCH-ARM / FISHERS | P=0.131N (e) P=1.000 P=1.000 (e) |
|ORDER RESTRICTED | (e) (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 |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/53 (4%) 2/53 (4%) 1/53 (2%) 1/53 (2%) |
|POLY-3 RATE (b) | 1/36.25 2/40.02 2/41.37 1/39.44 1/32.34 |
|POLY-3 PERCENT (g) | 2.8% 5.0% 4.8% 2.5% 3.1% |
|TERMINAL (d) | 1/16 (6%) 1/23 (4%) 1/24 (4%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | 729 (T) 721 709 729 (T) 728 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.587 P=0.610 P=0.623 P=0.680N P=0.626 |
|POLY 3 | P=0.485N P=0.535 P=0.546 P=0.742N P=0.736 |
|POLY 1.5 | P=0.470N P=0.522 P=0.526 P=0.749N P=0.747 |
|POLY 6 | P=0.504N P=0.550 P=0.569 P=0.734N P=0.717 |
|LOGISTIC REGRESSION| P=0.630 P=0.588 P=0.601 P=0.680N (e) |
|COCH-ARM / FISHERS | P=0.448N P=0.500 P=0.500 P=0.752N P=0.752N |
|ORDER RESTRICTED | P=0.645N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 38
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Nose: Goblet Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/53 (0%) 2/53 (4%) 1/53 (2%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/36.25 0/39.99 2/41.29 1/39.44 0/32.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 2.5% 0.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 2/24 (8%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.670 (e) P=0.330 P=0.572 (e) |
|POLY 3 | P=0.608N (e) P=0.267 P=0.517 (e) |
|POLY 1.5 | P=0.591N (e) P=0.253 P=0.511 (e) |
|POLY 6 | P=0.633N (e) P=0.282 P=0.524 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.330 P=0.572 (e) |
|COCH-ARM / FISHERS | P=0.566N (e) P=0.248 P=0.500 (e) |
|ORDER RESTRICTED | P=0.350 (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 |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 1/53 (2%) 0/53 (0%) 4/53 (8%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/36.25 1/40.53 0/41.29 4/41.30 0/32.33 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 0.0% 9.7% 0.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 2/23 (9%) 0/8 (0%) |
|FIRST INCIDENCE | --- 562 --- 276 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.467 P=0.519 (e) P=0.093 (e) |
|POLY 3 | P=0.409 P=0.522 (e) P=0.078 (e) |
|POLY 1.5 | P=0.473 P=0.514 (e) P=0.072 (e) |
|POLY 6 | P=0.318 P=0.532 (e) P=0.085 (e) |
|LOGISTIC REGRESSION| P=0.613 P=0.475 (e) P=0.040 * (e) |
|COCH-ARM / FISHERS | P=0.556 P=0.500 (e) P=0.059 (e) |
|ORDER RESTRICTED | P=0.143 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 39
Statistical Analysis of Non-neoplastic Lesions 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 Mucosa: Gingival |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/10 (80%) 17/18 (94%) 18/19 (95%) 26/29 (90%) 30/31 (97%) |
|POLY-3 RATE (b) | 8/9.41 17/17.46 18/18.62 26/28.23 30/30.32 |
|POLY-3 PERCENT (g) | 85.1% 97.4% 96.7% 92.1% 99.0% |
|TERMINAL (d) | 1/1 (100%) 6/6 (100%) 9/9 (100%) 12/13 (92%) 5/5 (100%) |
|FIRST INCIDENCE | 387 455 529 315 339 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.354 P=0.564 P=0.165 P<0.001 ** |
|POLY 3 | P=0.202 P=0.313 P=0.340 P=0.502 P=0.123 |
|POLY 1.5 | P=0.197 P=0.295 P=0.303 P=0.448 P=0.118 |
|POLY 6 | P=0.267 P=0.409 P=0.455 P=0.625 P=0.205 |
|LOGISTIC REGRESSION| P=0.194 P=0.310 P=0.300 P=0.361 P=0.149 |
|COCH-ARM / FISHERS | P=0.215 P=0.284 P=0.267 P=0.381 P=0.142 |
|ORDER RESTRICTED | P=0.103 (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 |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 44/52 (85%) 44/52 (85%) 43/53 (81%) 49/53 (92%) 40/51 (78%) |
|POLY-3 RATE (b) | 44/47.70 44/48.76 43/49.42 49/52.38 40/46.65 |
|POLY-3 PERCENT (g) | 92.3% 90.3% 87.0% 93.6% 85.8% |
|TERMINAL (d) | 15/16 (94%) 21/23 (91%) 21/24 (88%) 21/23 (91%) 7/8 (88%) |
|FIRST INCIDENCE | 218 350 263 276 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.015 * P=0.103N P=0.048N* P=0.289N P=0.148 |
|POLY 3 | P=0.255N P=0.505N P=0.290N P=0.560 P=0.218N |
|POLY 1.5 | P=0.222N P=0.539N P=0.364N P=0.416 P=0.212N |
|POLY 6 | P=0.334N P=0.470N P=0.216N P=0.680N P=0.257N |
|LOGISTIC REGRESSION| P=0.356N P=0.450N P=0.308N P=0.208 P=0.296N |
|COCH-ARM / FISHERS | P=0.301N P=0.607N P=0.416N P=0.170 P=0.290N |
|ORDER RESTRICTED | P=0.220N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 40
Statistical Analysis of Non-neoplastic Lesions 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 |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/52 (15%) 16/52 (31%) 20/53 (38%) 14/53 (26%) 7/51 (14%) |
|POLY-3 RATE (b) | 8/37.42 16/42.04 20/44.38 14/41.51 7/33.43 |
|POLY-3 PERCENT (g) | 21.4% 38.1% 45.1% 33.7% 20.9% |
|TERMINAL (d) | 4/16 (25%) 7/23 (30%) 8/24 (33%) 9/23 (39%) 2/8 (25%) |
|FIRST INCIDENCE | 176 546 456 505 589 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.546 P=0.203 P=0.085 P=0.306 P=0.388 |
|POLY 3 | P=0.181N P=0.080 P=0.018 * P=0.161 P=0.598N |
|POLY 1.5 | P=0.129N P=0.065 P=0.011 * P=0.144 P=0.556N |
|POLY 6 | P=0.277N P=0.106 P=0.034 * P=0.185 P=0.576 |
|LOGISTIC REGRESSION| P=0.162N P=0.074 P=0.014 * P=0.153 P=0.572N |
|COCH-ARM / FISHERS | P=0.094N P=0.051 P=0.008 ** P=0.125 P=0.516N |
|ORDER RESTRICTED | P=0.165N (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 |
|=================================================================================================================================|
| |
|Ovary |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 2/52 (4%) 1/53 (2%) 2/53 (4%) 5/51 (10%) |
|POLY-3 RATE (b) | 0/35.78 2/39.98 1/41.29 2/40.14 5/34.86 |
|POLY-3 PERCENT (g) | 0.0% 5.0% 2.4% 5.0% 14.3% |
|TERMINAL (d) | 0/16 (0%) 1/23 (4%) 1/24 (4%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | --- 669 729 (T) 490 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.305 P=0.581 P=0.290 P=0.027 * |
|POLY 3 | P=0.008 ** P=0.262 P=0.528 P=0.263 P=0.027 * |
|POLY 1.5 | P=0.009 ** P=0.253 P=0.518 P=0.255 P=0.029 * |
|POLY 6 | P=0.007 ** P=0.273 P=0.540 P=0.272 P=0.023 * |
|LOGISTIC REGRESSION| P=0.011 * P=0.268 P=0.581 P=0.235 P=0.031 * |
|COCH-ARM / FISHERS | P=0.010 * P=0.248 P=0.505 P=0.252 P=0.027 * |
|ORDER RESTRICTED | P=0.006 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 41
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Oviduct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/0 (0%) 2/2 (100%) 0/0 (0%) 0/2 (0%) 1/5 (20%) |
|POLY-3 RATE (b) | 0/0.00 2/2.00 0/0.00 0/1.89 1/3.03 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% 0.0% 33.0% |
|TERMINAL (d) | 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 702 --- --- 623 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.460 (e) (e) (e) P=0.462 |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.446N (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.143N (e) (e) (e) P=1.000 |
|ORDER RESTRICTED | (e) (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 |
|=================================================================================================================================|
| |
|Oviduct |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/0 (0%) 0/2 (0%) 0/0 (0%) 2/2 (100%) 4/5 (80%) |
|POLY-3 RATE (b) | 0/0.00 0/1.89 0/0.00 2/2.00 4/4.62 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% 86.5% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 702 498 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.046 * |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.446 (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.143 (e) (e) (e) P=1.000 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 42
Statistical Analysis of Non-neoplastic Lesions 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 |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/52 (6%) 1/53 (2%) 6/53 (11%) 7/53 (13%) 16/51 (31%) |
|POLY-3 RATE (b) | 3/36.17 1/39.99 6/42.48 7/40.33 16/36.75 |
|POLY-3 PERCENT (g) | 8.3% 2.5% 14.1% 17.4% 43.5% |
|TERMINAL (d) | 1/16 (6%) 1/23 (4%) 1/24 (4%) 5/23 (22%) 4/8 (50%) |
|FIRST INCIDENCE | 625 729 (T) 526 505 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.218N P=0.408 P=0.298 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.269N P=0.325 P=0.201 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.278N P=0.292 P=0.188 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.259N P=0.366 P=0.216 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.252N P=0.300 P=0.203 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.302N P=0.254 P=0.167 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 |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/52 (6%) 2/53 (4%) 7/53 (13%) 7/53 (13%) 20/51 (39%) |
|POLY-3 RATE (b) | 3/36.18 2/40.89 7/42.48 7/40.91 20/38.26 |
|POLY-3 PERCENT (g) | 8.3% 4.9% 16.5% 17.1% 52.3% |
|TERMINAL (d) | 1/16 (6%) 0/23 (0%) 2/24 (8%) 4/23 (17%) 3/8 (38%) |
|FIRST INCIDENCE | 625 563 526 505 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.414N P=0.313 P=0.282 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.444N P=0.228 P=0.208 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.461N P=0.199 P=0.192 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.424N P=0.264 P=0.228 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.474N P=0.213 P=0.191 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.491N P=0.167 P=0.167 P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 43
Statistical Analysis of Non-neoplastic Lesions 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: Acinus |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 0/53 (0%) 1/53 (2%) 0/53 (0%) 0/51 (0%) |
|POLY-3 RATE (b) | 2/36.13 0/39.99 1/41.29 0/39.44 0/32.27 |
|POLY-3 PERCENT (g) | 5.5% 0.0% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 1/16 (6%) 0/23 (0%) 1/24 (4%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 631 --- 729 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.218N P=0.188N P=0.384N P=0.188N P=0.336N |
|POLY 3 | P=0.185N P=0.214N P=0.453N P=0.217N P=0.262N |
|POLY 1.5 | P=0.182N P=0.220N P=0.471N P=0.222N P=0.249N |
|POLY 6 | P=0.184N P=0.208N P=0.436N P=0.212N P=0.285N |
|LOGISTIC REGRESSION| P=0.192N P=0.214N P=0.438N P=0.217N P=0.269N |
|COCH-ARM / FISHERS | P=0.176N P=0.243N P=0.493N P=0.243N P=0.252N |
|ORDER RESTRICTED | P=0.061N (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: Acinus |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 0/53 (0%) 3/53 (6%) 15/53 (28%) 30/51 (59%) |
|POLY-3 RATE (b) | 1/35.96 0/39.99 3/41.39 15/40.98 30/39.27 |
|POLY-3 PERCENT (g) | 2.8% 0.0% 7.3% 36.6% 76.4% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 2/24 (8%) 10/23 (44%) 7/8 (88%) |
|FIRST INCIDENCE | 682 --- 702 585 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.462N P=0.443 P=0.002 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.479N P=0.357 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.485N P=0.337 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.473N P=0.378 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.478N P=0.389 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.495N P=0.316 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 44
Statistical Analysis of Non-neoplastic Lesions 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: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 6/53 (11%) 3/53 (6%) 8/53 (15%) 14/51 (27%) |
|POLY-3 RATE (b) | 0/35.78 6/40.04 3/41.29 8/40.34 14/36.24 |
|POLY-3 PERCENT (g) | 0.0% 15.0% 7.3% 19.8% 38.6% |
|TERMINAL (d) | 0/16 (0%) 5/23 (22%) 3/24 (13%) 6/23 (26%) 3/8 (38%) |
|FIRST INCIDENCE | --- 718 729 (T) 505 339 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.043 * P=0.199 P=0.015 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.021 * P=0.145 P=0.006 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.020 * P=0.135 P=0.005 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.023 * P=0.158 P=0.007 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.031 * P=0.199 P=0.007 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.014 * P=0.125 P=0.003 ** 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 |
|=================================================================================================================================|
| |
|Pancreas: Duct |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 5/51 (10%) |
|POLY-3 RATE (b) | 0/35.78 0/39.99 0/41.29 0/39.44 5/32.79 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 15.3% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 2/8 (25%) |
|FIRST INCIDENCE | --- --- --- --- 639 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.008 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.022 * |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.026 * |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.017 * |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.014 * |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.027 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 45
Statistical Analysis of Non-neoplastic Lesions 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: Duct |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 2/51 (4%) |
|POLY-3 RATE (b) | 0/35.78 0/39.99 0/41.29 0/39.44 2/32.78 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 6.1% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- 639 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.007 ** (e) (e) (e) P=0.182 |
|POLY 3 | P=0.017 * (e) (e) (e) P=0.217 |
|POLY 1.5 | P=0.018 * (e) (e) (e) P=0.226 |
|POLY 6 | P=0.016 * (e) (e) (e) P=0.202 |
|LOGISTIC REGRESSION| P=0.016 * (e) (e) (e) P=0.216 |
|COCH-ARM / FISHERS | P=0.020 * (e) (e) (e) P=0.243 |
|ORDER RESTRICTED | P=0.013 * (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 |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/53 (11%) 0/53 (0%) 1/53 (2%) 2/53 (4%) 3/53 (6%) |
|POLY-3 RATE (b) | 6/37.22 0/39.99 1/41.40 2/40.17 3/33.28 |
|POLY-3 PERCENT (g) | 16.1% 0.0% 2.4% 5.0% 9.0% |
|TERMINAL (d) | 3/16 (19%) 0/23 (0%) 0/24 (0%) 1/23 (4%) 1/8 (13%) |
|FIRST INCIDENCE | 575 --- 699 469 498 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.427 P=0.008N** P=0.024N* P=0.068N P=0.467N |
|POLY 3 | P=0.555 P=0.011N* P=0.039N* P=0.106N P=0.295N |
|POLY 1.5 | P=0.584 P=0.013N* P=0.046N* P=0.115N P=0.271N |
|POLY 6 | P=0.522 P=0.010N* P=0.033N* P=0.098N P=0.341N |
|LOGISTIC REGRESSION| P=0.586N P=0.012N* P=0.039N* P=0.118N P=0.299N |
|COCH-ARM / FISHERS | P=0.546N P=0.013N* P=0.056N P=0.135N P=0.244N |
|ORDER RESTRICTED | P=0.026N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 46
Statistical Analysis of Non-neoplastic Lesions 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 |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 0/53 (0%) 1/53 (2%) 2/53 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 1/36.43 0/39.99 1/41.29 2/39.44 0/32.33 |
|POLY-3 PERCENT (g) | 2.7% 0.0% 2.4% 5.1% 0.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 1/24 (4%) 2/23 (9%) 0/8 (0%) |
|FIRST INCIDENCE | 682 --- 729 (T) 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.680N P=0.462N P=0.681N P=0.601 P=0.557N |
|POLY 3 | P=0.564N P=0.481N P=0.733N P=0.528 P=0.524N |
|POLY 1.5 | P=0.534N P=0.488N P=0.745N P=0.518 P=0.513N |
|POLY 6 | P=0.604N P=0.474N P=0.719N P=0.539 P=0.541N |
|LOGISTIC REGRESSION| P=0.613N P=0.481N P=0.718N P=0.555 P=0.534N |
|COCH-ARM / FISHERS | P=0.492N P=0.500N P=0.752N P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.396N (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 |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 3/53 (6%) 0/53 (0%) 0/53 (0%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/36.25 3/40.53 0/41.29 0/39.44 0/32.33 |
|POLY-3 PERCENT (g) | 0.0% 7.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/16 (0%) 2/23 (9%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- 563 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.264N P=0.172 (e) (e) (e) |
|POLY 3 | P=0.190N P=0.139 (e) (e) (e) |
|POLY 1.5 | P=0.196N P=0.131 (e) (e) (e) |
|POLY 6 | P=0.180N P=0.149 (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.222N P=0.134 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.209N P=0.121 (e) (e) (e) |
|ORDER RESTRICTED | P=0.176N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 47
Statistical Analysis of Non-neoplastic Lesions 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 |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 1/53 (2%) 2/53 (4%) 3/53 (6%) 1/53 (2%) |
|POLY-3 RATE (b) | 0/36.25 1/40.36 2/42.04 3/39.81 1/32.84 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 4.8% 7.5% 3.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 1/24 (4%) 2/23 (9%) 0/8 (0%) |
|FIRST INCIDENCE | --- 626 456 626 575 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.275 P=0.532 P=0.294 P=0.175 P=0.478 |
|POLY 3 | P=0.338 P=0.521 P=0.271 P=0.135 P=0.480 |
|POLY 1.5 | P=0.378 P=0.514 P=0.256 P=0.129 P=0.489 |
|POLY 6 | P=0.284 P=0.531 P=0.289 P=0.144 P=0.467 |
|LOGISTIC REGRESSION| P=0.422 P=0.498 P=0.228 P=0.139 P=0.507 |
|COCH-ARM / FISHERS | P=0.433 P=0.500 P=0.248 P=0.121 P=0.500 |
|ORDER RESTRICTED | P=0.209 (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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 18/53 (34%) 19/53 (36%) 24/53 (45%) 20/53 (38%) 19/53 (36%) |
|POLY-3 RATE (b) | 18/39.90 19/42.18 24/45.53 20/42.19 19/37.72 |
|POLY-3 PERCENT (g) | 45.1% 45.1% 52.7% 47.4% 50.4% |
|TERMINAL (d) | 9/16 (56%) 12/23 (52%) 12/24 (50%) 9/23 (39%) 6/8 (75%) |
|FIRST INCIDENCE | 454 548 456 619 387 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.031 * P=0.271N P=0.545N P=0.357N P=0.087 |
|POLY 3 | P=0.386 P=0.588N P=0.309 P=0.506 P=0.402 |
|POLY 1.5 | P=0.465 P=0.565 P=0.233 P=0.473 P=0.449 |
|POLY 6 | P=0.279 P=0.573N P=0.405 P=0.557 P=0.313 |
|LOGISTIC REGRESSION| P=0.341 P=0.523N P=0.247 P=0.543 P=0.384 |
|COCH-ARM / FISHERS | P=0.507N P=0.500 P=0.160 P=0.420 P=0.500 |
|ORDER RESTRICTED | P=0.553 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 48
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Salivary Glands |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/53 (0%) 0/53 (0%) 1/53 (2%) 0/53 (0%) |
|POLY-3 RATE (b) | 2/36.83 0/39.99 0/41.29 1/39.92 0/32.33 |
|POLY-3 PERCENT (g) | 5.4% 0.0% 0.0% 2.5% 0.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 631 --- --- 585 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.328N P=0.205N P=0.194N P=0.442N P=0.287N |
|POLY 3 | P=0.326N P=0.219N P=0.212N P=0.472N P=0.266N |
|POLY 1.5 | P=0.313N P=0.225N P=0.223N P=0.482N P=0.253N |
|POLY 6 | P=0.339N P=0.213N P=0.202N P=0.461N P=0.290N |
|LOGISTIC REGRESSION| P=0.290N P=0.229N P=0.229N P=0.500N P=0.254N |
|COCH-ARM / FISHERS | P=0.291N P=0.248N P=0.248N P=0.500N P=0.248N |
|ORDER RESTRICTED | P=0.063N (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 |
| Cyst Epithelial Inclusion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/53 (4%) 1/53 (2%) 3/53 (6%) 3/53 (6%) |
|POLY-3 RATE (b) | 0/36.25 2/39.99 1/41.29 3/39.55 3/32.86 |
|POLY-3 PERCENT (g) | 0.0% 5.0% 2.4% 7.6% 9.1% |
|TERMINAL (d) | 0/16 (0%) 2/23 (9%) 1/24 (4%) 2/23 (9%) 1/8 (13%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 702 589 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * P=0.320 P=0.581 P=0.177 P=0.062 |
|POLY 3 | P=0.070 P=0.259 P=0.526 P=0.134 P=0.100 |
|POLY 1.5 | P=0.083 P=0.251 P=0.514 P=0.128 P=0.108 |
|POLY 6 | P=0.056 P=0.269 P=0.539 P=0.141 P=0.089 |
|LOGISTIC REGRESSION| P=0.036 * P=0.320 P=0.581 P=0.150 P=0.092 |
|COCH-ARM / FISHERS | P=0.104 P=0.248 P=0.500 P=0.121 P=0.121 |
|ORDER RESTRICTED | P=0.065 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 49
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 43/52 (83%) 48/53 (91%) 42/53 (79%) 44/53 (83%) 42/51 (82%) |
|POLY-3 RATE (b) | 43/48.87 48/50.64 42/49.59 44/48.96 42/46.70 |
|POLY-3 PERCENT (g) | 88.0% 94.8% 84.7% 89.9% 89.9% |
|TERMINAL (d) | 15/16 (94%) 22/23 (96%) 21/24 (88%) 21/23 (91%) 7/8 (88%) |
|FIRST INCIDENCE | 176 227 263 276 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.012 * P=0.278N P=0.052N P=0.139N P=0.079 |
|POLY 3 | P=0.561 P=0.166 P=0.422N P=0.511 P=0.511 |
|POLY 1.5 | P=0.488N P=0.157 P=0.471N P=0.529 P=0.546 |
|POLY 6 | P=0.504 P=0.216 P=0.365N P=0.521 P=0.511 |
|LOGISTIC REGRESSION| P=0.432N P=0.215 P=0.381N P=0.577N P=0.594N |
|COCH-ARM / FISHERS | P=0.382N P=0.184 P=0.421N P=0.584 P=0.584N |
|ORDER RESTRICTED | P=0.484N (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 |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 45/52 (87%) 50/53 (94%) 52/53 (98%) 47/53 (89%) 46/51 (90%) |
|POLY-3 RATE (b) | 45/49.91 50/50.93 52/52.25 47/50.57 46/50.20 |
|POLY-3 PERCENT (g) | 90.2% 98.2% 99.5% 92.9% 91.6% |
|TERMINAL (d) | 14/16 (88%) 23/23 (100%) 24/24 (100%) 21/23 (91%) 7/8 (88%) |
|FIRST INCIDENCE | 176 227 46 315 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.009 ** P=0.269N P=0.259N P=0.176N P=0.061 |
|POLY 3 | P=0.243N P=0.074 P=0.029 * P=0.440 P=0.538 |
|POLY 1.5 | P=0.296N P=0.095 P=0.028 * P=0.443 P=0.498 |
|POLY 6 | P=0.217N P=0.065 P=0.036 * P=0.455 P=0.567 |
|LOGISTIC REGRESSION| P=0.464N P=0.192 P=0.035 * P=0.528 P=0.417 |
|COCH-ARM / FISHERS | P=0.436N P=0.152 P=0.028 * P=0.485 P=0.394 |
|ORDER RESTRICTED | P=0.155 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 50
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 2/53 (4%) 3/53 (6%) 2/53 (4%) 3/51 (6%) |
|POLY-3 RATE (b) | 1/35.79 2/41.76 3/42.75 2/40.85 3/33.16 |
|POLY-3 PERCENT (g) | 2.8% 4.8% 7.0% 4.9% 9.1% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 727 350 46 465 409 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.204 P=0.541 P=0.395 P=0.557 P=0.188 |
|POLY 3 | P=0.244 P=0.554 P=0.371 P=0.546 P=0.276 |
|POLY 1.5 | P=0.268 P=0.538 P=0.348 P=0.531 P=0.291 |
|POLY 6 | P=0.212 P=0.570 P=0.399 P=0.563 P=0.250 |
|LOGISTIC REGRESSION| P=0.300 P=0.408 P=0.285 P=0.475 P=0.283 |
|COCH-ARM / FISHERS | P=0.291 P=0.507 P=0.316 P=0.507 P=0.301 |
|ORDER RESTRICTED | P=0.249 (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 |
|=================================================================================================================================|
| |
|Spleen: Red Pulp |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 1/53 (2%) 3/53 (6%) 0/53 (0%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/35.78 1/40.88 3/41.75 0/39.44 0/32.27 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 7.2% 0.0% 0.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 1/24 (4%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- 350 652 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.365N P=0.508 P=0.190 (e) (e) |
|POLY 3 | P=0.301N P=0.527 P=0.148 (e) (e) |
|POLY 1.5 | P=0.295N P=0.519 P=0.136 (e) (e) |
|POLY 6 | P=0.311N P=0.535 P=0.163 (e) (e) |
|LOGISTIC REGRESSION| P=0.289N P=0.381 P=0.145 (e) (e) |
|COCH-ARM / FISHERS | P=0.295N P=0.505 P=0.125 (e) (e) |
|ORDER RESTRICTED | P=0.307N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 51
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/53 (0%) 2/53 (4%) 2/53 (4%) 0/52 (0%) |
|POLY-3 RATE (b) | 0/36.25 0/39.99 2/41.69 2/40.01 0/32.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 5.0% 0.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- 639 619 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.599 (e) P=0.295 P=0.266 (e) |
|POLY 3 | P=0.592 (e) P=0.269 P=0.259 (e) |
|POLY 1.5 | P=0.635 (e) P=0.255 P=0.251 (e) |
|POLY 6 | P=0.522 (e) P=0.287 P=0.271 (e) |
|LOGISTIC REGRESSION| P=0.645N (e) P=0.256 P=0.244 (e) |
|COCH-ARM / FISHERS | P=0.620N (e) P=0.248 P=0.248 (e) |
|ORDER RESTRICTED | P=0.289 (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 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 1/53 (2%) 4/53 (8%) 9/53 (17%) 6/52 (12%) |
|POLY-3 RATE (b) | 5/37.95 1/40.96 4/42.67 9/41.67 6/34.04 |
|POLY-3 PERCENT (g) | 13.2% 2.4% 9.4% 21.6% 17.6% |
|TERMINAL (d) | 1/16 (6%) 0/23 (0%) 1/24 (4%) 3/23 (13%) 1/8 (13%) |
|FIRST INCIDENCE | 484 227 203 505 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.030 * P=0.081N P=0.377N P=0.325 P=0.322 |
|POLY 3 | P=0.056 P=0.083N P=0.426N P=0.243 P=0.422 |
|POLY 1.5 | P=0.078 P=0.088N P=0.455N P=0.224 P=0.457 |
|POLY 6 | P=0.036 * P=0.079N P=0.399N P=0.270 P=0.368 |
|LOGISTIC REGRESSION| P=0.127 P=0.130N P=0.523N P=0.207 P=0.466 |
|COCH-ARM / FISHERS | P=0.117 P=0.103N P=0.500N P=0.195 P=0.486 |
|ORDER RESTRICTED | P=0.103 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 52
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/53 (0%) 2/53 (4%) 1/53 (2%) 3/52 (6%) |
|POLY-3 RATE (b) | 2/37.31 0/39.99 2/42.34 1/39.83 3/34.02 |
|POLY-3 PERCENT (g) | 5.4% 0.0% 4.7% 2.5% 8.8% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 484 --- 203 619 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.155 P=0.220N P=0.642N P=0.470N P=0.459 |
|POLY 3 | P=0.175 P=0.221N P=0.648N P=0.477N P=0.457 |
|POLY 1.5 | P=0.190 P=0.226N P=0.666N P=0.485N P=0.478 |
|POLY 6 | P=0.157 P=0.216N P=0.629N P=0.468N P=0.425 |
|LOGISTIC REGRESSION| P=0.234 P=0.264N P=0.672 P=0.525N P=0.500 |
|COCH-ARM / FISHERS | P=0.209 P=0.248N P=0.691N P=0.500N P=0.491 |
|ORDER RESTRICTED | P=0.168 (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 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 0/53 (0%) 4/53 (8%) 2/53 (4%) 0/52 (0%) |
|POLY-3 RATE (b) | 1/36.53 0/39.99 4/43.15 2/39.67 0/32.33 |
|POLY-3 PERCENT (g) | 2.7% 0.0% 9.3% 5.0% 0.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 1/24 (4%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | 655 --- 263 668 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.430N P=0.475N P=0.250 P=0.595 P=0.553N |
|POLY 3 | P=0.393N P=0.482N P=0.233 P=0.529 P=0.524N |
|POLY 1.5 | P=0.362N P=0.488N P=0.209 P=0.518 P=0.513N |
|POLY 6 | P=0.440N P=0.475N P=0.259 P=0.542 P=0.542N |
|LOGISTIC REGRESSION| P=0.320N P=0.491N P=0.160 P=0.531 P=0.519N |
|COCH-ARM / FISHERS | P=0.331N P=0.500N P=0.181 P=0.500 P=0.505N |
|ORDER RESTRICTED | P=0.307N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 53
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 0/53 (0%) 2/53 (4%) 1/53 (2%) 2/52 (4%) |
|POLY-3 RATE (b) | 3/37.58 0/39.99 2/42.59 1/39.62 2/33.44 |
|POLY-3 PERCENT (g) | 8.0% 0.0% 4.7% 2.5% 6.0% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 484 --- 203 682 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.509 P=0.106N P=0.436N P=0.264N P=0.564N |
|POLY 3 | P=0.522 P=0.107N P=0.443N P=0.285N P=0.554N |
|POLY 1.5 | P=0.547 P=0.111N P=0.465N P=0.292N P=0.528N |
|POLY 6 | P=0.489 P=0.104N P=0.421N P=0.279N P=0.595N |
|LOGISTIC REGRESSION| P=0.605 P=0.131N P=0.534N P=0.312N P=0.498N |
|COCH-ARM / FISHERS | P=0.579 P=0.121N P=0.500N P=0.309N P=0.509N |
|ORDER RESTRICTED | P=0.288N (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 |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/53 (0%) 2/53 (4%) 1/52 (2%) |
|POLY-3 RATE (b) | 0/36.25 0/39.99 0/41.29 2/39.44 1/32.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.1% 3.1% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 2/23 (9%) 1/8 (13%) |
|FIRST INCIDENCE | --- --- --- 729 (T) 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.041 * (e) (e) P=0.320 P=0.362 |
|POLY 3 | P=0.118 (e) (e) P=0.256 P=0.477 |
|POLY 1.5 | P=0.140 (e) (e) P=0.249 P=0.487 |
|POLY 6 | P=0.090 (e) (e) P=0.264 P=0.461 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.320 P=0.362 |
|COCH-ARM / FISHERS | P=0.168 (e) (e) P=0.248 P=0.495 |
|ORDER RESTRICTED | P=0.153 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 54
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 4/53 (8%) 3/53 (6%) 3/53 (6%) 1/52 (2%) |
|POLY-3 RATE (b) | 2/36.53 4/40.36 3/42.24 3/40.15 1/32.69 |
|POLY-3 PERCENT (g) | 5.5% 9.9% 7.1% 7.5% 3.1% |
|TERMINAL (d) | 1/16 (6%) 3/23 (13%) 2/24 (8%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | 655 626 263 585 631 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.418N P=0.477 P=0.627 P=0.615 P=0.627N |
|POLY 3 | P=0.292N P=0.383 P=0.566 P=0.543 P=0.539N |
|POLY 1.5 | P=0.266N P=0.367 P=0.539 P=0.527 P=0.521N |
|POLY 6 | P=0.327N P=0.403 P=0.594 P=0.564 P=0.566N |
|LOGISTIC REGRESSION| P=0.259N P=0.400 P=0.494 P=0.532 P=0.548N |
|COCH-ARM / FISHERS | P=0.239N P=0.339 P=0.500 P=0.500 P=0.507N |
|ORDER RESTRICTED | P=0.400N (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 |
|=================================================================================================================================|
| |
|Stomach, Glandular: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 2/52 (4%) |
|POLY-3 RATE (b) | 0/36.25 0/39.99 0/41.29 0/39.44 2/33.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 6.1% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- 497 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.008 ** (e) (e) (e) P=0.181 |
|POLY 3 | P=0.017 * (e) (e) (e) P=0.216 |
|POLY 1.5 | P=0.018 * (e) (e) (e) P=0.225 |
|POLY 6 | P=0.016 * (e) (e) (e) P=0.201 |
|LOGISTIC REGRESSION| P=0.022 * (e) (e) (e) P=0.233 |
|COCH-ARM / FISHERS | P=0.020 * (e) (e) (e) P=0.243 |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 55
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 32/52 (62%) 43/48 (90%) 45/50 (90%) 50/53 (94%) 48/50 (96%) |
|POLY-3 RATE (b) | 32/43.70 43/46.85 45/46.72 50/51.69 48/48.79 |
|POLY-3 PERCENT (g) | 73.2% 91.8% 96.3% 96.7% 98.4% |
|TERMINAL (d) | 10/16 (63%) 18/21 (86%) 21/22 (96%) 23/23 (100%) 7/7 (100%) |
|FIRST INCIDENCE | 387 227 203 276 287 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.345 P=0.374 P=0.147 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.027 * P=0.002 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** 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 |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 0/48 (0%) 0/50 (0%) 0/53 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/35.84 0/35.89 0/38.91 0/39.44 0/29.87 |
|POLY-3 PERCENT (g) | 5.6% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/16 (6%) 0/21 (0%) 0/22 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 669 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.215N P=0.188N P=0.174N P=0.173N P=0.350N |
|POLY 3 | P=0.185N P=0.236N P=0.219N P=0.216N P=0.279N |
|POLY 1.5 | P=0.188N P=0.242N P=0.230N P=0.222N P=0.264N |
|POLY 6 | P=0.173N P=0.230N P=0.207N P=0.209N P=0.304N |
|LOGISTIC REGRESSION| P=0.204N P=0.229N P=0.207N P=0.208N P=0.308N |
|COCH-ARM / FISHERS | P=0.189N P=0.268N P=0.257N P=0.243N P=0.257N |
|ORDER RESTRICTED | P=0.027N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 56
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 24/53 (45%) 24/53 (45%) 20/51 (39%) 18/52 (35%) 14/51 (27%) |
|POLY-3 RATE (b) | 24/40.35 24/42.46 20/42.10 18/42.50 14/34.91 |
|POLY-3 PERCENT (g) | 59.5% 56.5% 47.5% 42.4% 40.1% |
|TERMINAL (d) | 12/16 (75%) 15/23 (65%) 11/24 (46%) 9/23 (39%) 4/8 (50%) |
|FIRST INCIDENCE | 454 540 540 505 562 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.439N P=0.143N P=0.032N* P=0.029N* P=0.430N |
|POLY 3 | P=0.034N* P=0.479N P=0.181N P=0.079N P=0.060N |
|POLY 1.5 | P=0.023N* P=0.510N P=0.245N P=0.108N P=0.046N* |
|POLY 6 | P=0.057N P=0.434N P=0.120N P=0.052N P=0.092N |
|LOGISTIC REGRESSION| P=0.053N P=0.372N P=0.126N P=0.089N P=0.074N |
|COCH-ARM / FISHERS | P=0.018N* P=0.577N P=0.335N P=0.180N P=0.046N* |
|ORDER RESTRICTED | P=0.067N (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 |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 13/53 (25%) 12/51 (24%) 18/52 (35%) 23/51 (45%) |
|POLY-3 RATE (b) | 4/37.36 13/43.35 12/44.05 18/42.44 23/41.48 |
|POLY-3 PERCENT (g) | 10.7% 30.0% 27.2% 42.4% 55.5% |
|TERMINAL (d) | 2/16 (13%) 4/23 (17%) 4/24 (17%) 10/23 (44%) 6/8 (75%) |
|FIRST INCIDENCE | 454 416 203 333 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.063 P=0.101 P=0.009 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.030 * P=0.054 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.023 * P=0.037 * P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.042 * P=0.081 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.019 * P=0.021 * P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.016 * P=0.022 * P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 57
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 23/24 (96%) 21/23 (91%) 22/27 (81%) 34/37 (92%) 30/30 (100%) |
|POLY-3 RATE (b) | 23/23.65 21/22.74 22/26.16 34/35.13 30/30.00 |
|POLY-3 PERCENT (g) | 97.3% 92.4% 84.1% 96.8% 100.0% |
|TERMINAL (d) | 8/8 (100%) 9/10 (90%) 11/13 (85%) 16/16 (100%) 3/3 (100%) |
|FIRST INCIDENCE | 218 362 529 333 339 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.177N P=0.081N P=0.540 P=0.010 * |
|POLY 3 | P=0.092 P=0.461N P=0.120N P=0.811N P=0.664 |
|POLY 1.5 | P=0.093 P=0.472N P=0.122N P=0.674N P=0.551 |
|POLY 6 | P=0.105 P=0.447N P=0.116N P=0.945 P=0.895 |
|LOGISTIC REGRESSION| P=0.101 P=0.514N P=0.137N P=0.381N P=0.462 |
|COCH-ARM / FISHERS | P=0.114 P=0.484N P=0.124N P=0.484N P=0.444 |
|ORDER RESTRICTED | P=0.093 (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 |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/52 (23%) 3/52 (6%) 4/53 (8%) 8/53 (15%) 5/50 (10%) |
|POLY-3 RATE (b) | 12/38.36 3/40.57 4/42.04 8/40.61 5/32.54 |
|POLY-3 PERCENT (g) | 31.3% 7.4% 9.5% 19.7% 15.4% |
|TERMINAL (d) | 3/16 (19%) 1/23 (4%) 1/24 (4%) 6/23 (26%) 1/8 (13%) |
|FIRST INCIDENCE | 540 540 621 276 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.530 P=0.005N** P=0.009N** P=0.096N P=0.234N |
|POLY 3 | P=0.393N P=0.006N** P=0.013N* P=0.173N P=0.094N |
|POLY 1.5 | P=0.335N P=0.007N** P=0.016N* P=0.180N P=0.073N |
|POLY 6 | P=0.474N P=0.006N** P=0.011N* P=0.181N P=0.150N |
|LOGISTIC REGRESSION| P=0.330N P=0.008N** P=0.016N* P=0.174N P=0.088N |
|COCH-ARM / FISHERS | P=0.278N P=0.012N* P=0.025N* P=0.214N P=0.065N |
|ORDER RESTRICTED | P=0.028N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 58
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 0/52 (0%) 1/53 (2%) 3/53 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/35.78 0/39.75 1/41.29 3/40.38 4/31.75 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.4% 7.4% 12.6% |
|TERMINAL (d) | 0/16 (0%) 0/23 (0%) 1/24 (4%) 2/23 (9%) 1/8 (13%) |
|FIRST INCIDENCE | --- --- 729 (T) 276 715 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.581 P=0.170 P=0.019 * |
|POLY 3 | P=0.002 ** (e) P=0.528 P=0.141 P=0.044 * |
|POLY 1.5 | P=0.003 ** (e) P=0.518 P=0.135 P=0.050 |
|POLY 6 | P=0.002 ** (e) P=0.540 P=0.148 P=0.036 * |
|LOGISTIC REGRESSION| P=0.003 ** (e) P=0.581 P=0.110 P=0.019 * |
|COCH-ARM / FISHERS | P=0.005 ** (e) P=0.505 P=0.125 P=0.054 |
|ORDER RESTRICTED | P=0.010 * (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 |
| Adenomyosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 1/53 (2%) 1/53 (2%) 2/53 (4%) 1/51 (2%) |
|POLY-3 RATE (b) | 0/35.78 1/39.99 1/41.91 2/39.85 1/32.85 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 2.4% 5.0% 3.0% |
|TERMINAL (d) | 0/16 (0%) 1/23 (4%) 0/24 (0%) 0/23 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- 729 (T) 526 668 546 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.305 P=0.572 P=0.531 P=0.289 P=0.500 |
|POLY 3 | P=0.340 P=0.522 P=0.531 P=0.261 P=0.483 |
|POLY 1.5 | P=0.370 P=0.516 P=0.519 P=0.254 P=0.491 |
|POLY 6 | P=0.296 P=0.529 P=0.545 P=0.271 P=0.469 |
|LOGISTIC REGRESSION| P=0.396 P=0.572 P=0.491 P=0.256 P=0.494 |
|COCH-ARM / FISHERS | P=0.396 P=0.505 P=0.505 P=0.252 P=0.495 |
|ORDER RESTRICTED | P=0.269 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 59
Statistical Analysis of Non-neoplastic Lesions 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 |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/52 (12%) 5/53 (9%) 9/53 (17%) 13/53 (25%) 6/51 (12%) |
|POLY-3 RATE (b) | 6/37.08 5/41.55 9/42.08 13/42.94 6/35.30 |
|POLY-3 PERCENT (g) | 16.2% 12.0% 21.4% 30.3% 17.0% |
|TERMINAL (d) | 2/16 (13%) 1/23 (4%) 3/24 (13%) 4/23 (17%) 0/8 (0%) |
|FIRST INCIDENCE | 526 498 669 333 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.143 P=0.357N P=0.545 P=0.175 P=0.452 |
|POLY 3 | P=0.314 P=0.419N P=0.381 P=0.109 P=0.589 |
|POLY 1.5 | P=0.367 P=0.442N P=0.345 P=0.092 P=0.606 |
|POLY 6 | P=0.239 P=0.396N P=0.421 P=0.132 P=0.552 |
|LOGISTIC REGRESSION| P=0.389 P=0.464N P=0.402 P=0.078 P=0.605 |
|COCH-ARM / FISHERS | P=0.414 P=0.486N P=0.303 P=0.069 P=0.606 |
|ORDER RESTRICTED | P=0.242 (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 |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 1/53 (2%) 1/53 (2%) 1/53 (2%) 3/51 (6%) |
|POLY-3 RATE (b) | 1/35.78 1/39.99 1/41.29 1/39.44 3/33.64 |
|POLY-3 PERCENT (g) | 2.8% 2.5% 2.4% 2.5% 8.9% |
|TERMINAL (d) | 1/16 (6%) 1/23 (4%) 1/24 (4%) 1/23 (4%) 0/8 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.037 * P=0.680N P=0.670N P=0.680N P=0.210 |
|POLY 3 | P=0.112 P=0.736N P=0.728N P=0.739N P=0.281 |
|POLY 1.5 | P=0.121 P=0.743N P=0.741N P=0.745N P=0.294 |
|POLY 6 | P=0.100 P=0.728N P=0.714N P=0.732N P=0.259 |
|LOGISTIC REGRESSION| P=0.117 P=0.680N P=0.670N P=0.680N P=0.301 |
|COCH-ARM / FISHERS | P=0.129 P=0.748N P=0.748N P=0.748N P=0.301 |
|ORDER RESTRICTED | P=0.145 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/03 EXPERIMENT: 96007 TEST: 04 Page 60
Statistical Analysis of Non-neoplastic Lesions 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 |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 21/52 (40%) 32/53 (60%) 32/53 (60%) 35/53 (66%) 30/51 (59%) |
|POLY-3 RATE (b) | 21/42.47 32/47.25 32/47.49 35/48.38 30/43.09 |
|POLY-3 PERCENT (g) | 49.4% 67.7% 67.4% 72.3% 69.6% |
|TERMINAL (d) | 6/16 (38%) 14/23 (61%) 16/24 (67%) 16/23 (70%) 5/8 (63%) |
|FIRST INCIDENCE | 387 416 263 276 312 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.264 P=0.342 P=0.145 P=0.011 * |
|POLY 3 | P=0.093 P=0.054 P=0.058 P=0.016 * P=0.036 * |
|POLY 1.5 | P=0.128 P=0.043 * P=0.043 * P=0.012 * P=0.047 * |
|POLY 6 | P=0.048 * P=0.070 P=0.073 P=0.020 * P=0.020 * |
|LOGISTIC REGRESSION| P=0.110 P=0.041 * P=0.041 * P=0.008 ** P=0.046 * |
|COCH-ARM / FISHERS | P=0.129 P=0.032 * P=0.032 * P=0.007 ** P=0.047 * |
|ORDER RESTRICTED | P=0.022 * (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: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 37/52 (71%) 35/53 (66%) 34/53 (64%) 33/53 (62%) 23/51 (45%) |
|POLY-3 RATE (b) | 37/45.66 35/46.77 34/46.84 33/46.63 23/39.74 |
|POLY-3 PERCENT (g) | 81.0% 74.8% 72.6% 70.8% 57.9% |
|TERMINAL (d) | 14/16 (88%) 16/23 (70%) 20/24 (83%) 16/23 (70%) 5/8 (63%) |
|FIRST INCIDENCE | 176 416 263 276 339 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.513N P=0.085N P=0.029N* P=0.052N P=0.360N |
|POLY 3 | P=0.008N** P=0.306N P=0.219N P=0.163N P=0.009N** |
|POLY 1.5 | P=0.004N** P=0.334N P=0.261N P=0.182N P=0.006N** |
|POLY 6 | P=0.026N* P=0.247N P=0.177N P=0.129N P=0.019N* |
|LOGISTIC REGRESSION| P=0.005N** P=0.264N P=0.209N P=0.176N P=0.007N** |
|COCH-ARM / FISHERS | P=0.003N** P=0.362N P=0.289N P=0.224N P=0.006N** |
|ORDER RESTRICTED | P=0.009N** (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).