TDMS Study 96007-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) DATE: 10/01/03
EXPERIMENT: 96007 TEST: 01 TIME: 12:19:51
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-75411 ROUTE: GAVAGE NTP C#: 96007D
PATHOLOGIST: MISSING CAS: 57465-28-8
------------------------------------------------------------------------------------------------------------------------------------
FINAL #3/RATS CONTROL VS. GROUPS 3, 4, & 5
REASONS FOR REMOVAL: 25022 Accidently Killed
25018 Dosing Accident
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 NG/KG
INCLUDE 003 30 NG/KG
INCLUDE 004 100 NG/KG
INCLUDE 005 175 NG/KG
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) DATE: 10/01/03
EXPERIMENT: 96007 TEST: 01 TIME: 12:19:51
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-75411 ROUTE: GAVAGE NTP C#: 96007D
PATHOLOGIST: MISSING CAS: 57465-28-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TOXIC EQUIVALENCY FACTOR EVALUATION (
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Angiectasis
Hyperplasia
Adrenal Medulla Hyperplasia
Blood Vessel: Aorta Mineralization
Bone Marrow Hyperplasia
Clitoral Gland Inflammation
Clitoral Gland: Duct Cyst
Kidney Cyst
Mineralization
Nephropathy
Kidney: Pelvis Inflammation
Liver Angiectasis
Eosinophilic Focus
Fatty Change Diffuse
Fatty Change Focal
Hepatocyte, Multinucleate
Inflammation
Mixed Cell Focus
Necrosis
Pigmentation
Toxic Hepatopathy
Liver: Bile Duct Cyst
Hyperplasia
Liver: Hepatocyte Degeneration
Hypertrophy
Liver: Oval Cell Hyperplasia
Lung Infiltration Cellular Histiocyte
Inflammation Chronic
Inflammation Granulomatous
Lung: Alveolar Epithelium Hyperplasia
Metaplasia Bronchiolar
Lymph Node, Mandibular Hyperplasia
Lymph Node, Mesenteric Hyperplasia
Mammary Gland Cyst
Hyperplasia
Ovary Atrophy
Pancreas Inflammation Chronic
Pancreas: Acinus Vacuolization Cytoplasmic
Spleen Hematopoietic Cell Proliferation
Pigmentation
Spleen: Lymphoid Follicle Atrophy
Spleen: Red Pulp Atrophy
Thymus Atrophy
Thyroid Gland: Follicular Cell Hypertrophy
Uterus Inflammation Chronic
===============================================================
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/52 (21%) 13/55 (24%) 25/53 (47%) 19/53 (36%) |
|POLY-3 RATE (b) | 11/34.50 13/39.17 25/43.24 19/38.60 |
|POLY-3 PERCENT (g) | 31.9% 33.2% 57.8% 49.2% |
|TERMINAL (d) | 4/15 (27%) 12/25 (48%) 16/26 (62%) 14/22 (64%) |
|FIRST INCIDENCE | 541 516 498 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.061 P=0.327N P=0.148 P=0.299 |
|POLY 3 | P=0.018 * P=0.553 P=0.016 * P=0.092 |
|POLY 1.5 | P=0.021 * P=0.519 P=0.009 ** P=0.096 |
|POLY 6 | P=0.013 * P=0.594 P=0.028 * P=0.078 |
|LOGISTIC REGRESSION| P=0.032 * P=0.541N P=0.019 * P=0.167 |
|COCH-ARM / FISHERS | P=0.015 * P=0.470 P=0.004 ** P=0.073 |
|ORDER RESTRICTED | P=0.037 * (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 3/55 (5%) 5/53 (9%) 3/53 (6%) |
|POLY-3 RATE (b) | 1/31.36 3/38.64 5/41.14 3/38.30 |
|POLY-3 PERCENT (g) | 3.2% 7.8% 12.2% 7.8% |
|TERMINAL (d) | 1/15 (7%) 2/25 (8%) 3/26 (12%) 0/22 (0%) |
|FIRST INCIDENCE | 727 (T) 700 300 592 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.312 P=0.502 P=0.218 P=0.410 |
|POLY 3 | P=0.322 P=0.382 P=0.176 P=0.379 |
|POLY 1.5 | P=0.299 P=0.356 P=0.148 P=0.357 |
|POLY 6 | P=0.341 P=0.424 P=0.214 P=0.405 |
|LOGISTIC REGRESSION| P=0.266 P=0.486 P=0.115 P=0.358 |
|COCH-ARM / FISHERS | P=0.236 P=0.330 P=0.107 P=0.316 |
|ORDER RESTRICTED | P=0.249 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/52 (21%) 14/55 (25%) 10/53 (19%) 14/53 (26%) |
|POLY-3 RATE (b) | 11/34.41 14/40.34 10/40.23 14/39.18 |
|POLY-3 PERCENT (g) | 32.0% 34.7% 24.9% 35.7% |
|TERMINAL (d) | 4/15 (27%) 9/25 (36%) 7/26 (27%) 9/22 (41%) |
|FIRST INCIDENCE | 496 516 651 496 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.443N P=0.423N P=0.134N P=0.539N |
|POLY 3 | P=0.511 P=0.498 P=0.334N P=0.462 |
|POLY 1.5 | P=0.499 P=0.446 P=0.379N P=0.437 |
|POLY 6 | P=0.496 P=0.576 P=0.290N P=0.474 |
|LOGISTIC REGRESSION| P=0.525N P=0.526 P=0.277N P=0.506 |
|COCH-ARM / FISHERS | P=0.405 P=0.384 P=0.480N P=0.344 |
|ORDER RESTRICTED | P=0.495 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 23/52 (44%) 21/55 (38%) 27/53 (51%) 25/53 (47%) |
|POLY-3 RATE (b) | 23/38.88 21/40.99 27/43.02 25/42.19 |
|POLY-3 PERCENT (g) | 59.2% 51.2% 62.8% 59.3% |
|TERMINAL (d) | 7/15 (47%) 15/25 (60%) 16/26 (62%) 12/22 (55%) |
|FIRST INCIDENCE | 309 434 531 530 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.490N P=0.046N* P=0.181N P=0.289N |
|POLY 3 | P=0.351 P=0.305N P=0.455 P=0.590 |
|POLY 1.5 | P=0.334 P=0.312N P=0.410 P=0.571 |
|POLY 6 | P=0.355 P=0.300N P=0.510 P=0.594 |
|LOGISTIC REGRESSION| P=0.420 P=0.200N P=0.576 P=0.508N |
|COCH-ARM / FISHERS | P=0.234 P=0.330N P=0.311 P=0.458 |
|ORDER RESTRICTED | P=0.453 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 34/52 (65%) 41/55 (75%) 40/53 (75%) 41/53 (77%) |
|POLY-3 RATE (b) | 34/39.07 41/45.61 40/45.30 41/44.98 |
|POLY-3 PERCENT (g) | 87.0% 89.9% 88.3% 91.2% |
|TERMINAL (d) | 15/15 (100%) 22/25 (88%) 24/26 (92%) 22/22 (100%) |
|FIRST INCIDENCE | 391 356 498 405 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.387N P=0.129N P=0.060N P=0.313N |
|POLY 3 | P=0.350 P=0.464 P=0.575 P=0.360 |
|POLY 1.5 | P=0.307 P=0.290 P=0.381 P=0.278 |
|POLY 6 | P=0.303 P=0.606N P=0.556N P=0.462 |
|LOGISTIC REGRESSION| P=0.514 P=0.369 P=0.539N P=0.477 |
|COCH-ARM / FISHERS | P=0.133 P=0.205 P=0.179 P=0.127 |
|ORDER RESTRICTED | P=0.365 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/52 (10%) 3/55 (5%) 5/53 (9%) 2/53 (4%) |
|POLY-3 RATE (b) | 5/32.65 3/38.73 5/40.96 2/37.58 |
|POLY-3 PERCENT (g) | 15.3% 7.8% 12.2% 5.3% |
|TERMINAL (d) | 3/15 (20%) 1/25 (4%) 2/26 (8%) 1/22 (5%) |
|FIRST INCIDENCE | 496 681 428 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.169N P=0.169N P=0.369N P=0.118N |
|POLY 3 | P=0.212N P=0.263N P=0.483N P=0.159N |
|POLY 1.5 | P=0.217N P=0.291N P=0.532N P=0.171N |
|POLY 6 | P=0.222N P=0.223N P=0.422N P=0.148N |
|LOGISTIC REGRESSION| P=0.210N P=0.256N P=0.560N P=0.161N |
|COCH-ARM / FISHERS | P=0.256N P=0.327N P=0.617N P=0.211N |
|ORDER RESTRICTED | P=0.138N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 0/55 (0%) 2/53 (4%) 1/53 (2%) |
|POLY-3 RATE (b) | 0/31.36 0/38.53 2/39.67 1/37.32 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 5.0% 2.7% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 1/26 (4%) 1/22 (5%) |
|FIRST INCIDENCE | --- --- 709 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.201 (e) P=0.368 P=0.576 |
|POLY 3 | P=0.198 (e) P=0.292 P=0.535 |
|POLY 1.5 | P=0.196 (e) P=0.273 P=0.526 |
|POLY 6 | P=0.195 (e) P=0.318 P=0.543 |
|LOGISTIC REGRESSION| P=0.189 (e) P=0.341 P=0.576 |
|COCH-ARM / FISHERS | P=0.173 (e) P=0.252 P=0.505 |
|ORDER RESTRICTED | P=0.215 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/52 (15%) 18/55 (33%) 11/53 (21%) 11/53 (21%) |
|POLY-3 RATE (b) | 8/33.72 18/40.38 11/41.48 11/39.17 |
|POLY-3 PERCENT (g) | 23.7% 44.6% 26.5% 28.1% |
|TERMINAL (d) | 3/15 (20%) 12/25 (48%) 7/26 (27%) 7/22 (32%) |
|FIRST INCIDENCE | 496 580 376 496 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.246N P=0.208 P=0.511N P=0.566 |
|POLY 3 | P=0.280N P=0.046 * P=0.496 P=0.438 |
|POLY 1.5 | P=0.315N P=0.035 * P=0.434 P=0.409 |
|POLY 6 | P=0.265N P=0.073 P=0.566 P=0.461 |
|LOGISTIC REGRESSION| P=0.313N P=0.066 P=0.445 P=0.438 |
|COCH-ARM / FISHERS | P=0.448N P=0.030 * P=0.323 P=0.323 |
|ORDER RESTRICTED | P=0.312 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 1/55 (2%) 1/53 (2%) 0/53 (0%) |
|POLY-3 RATE (b) | 3/32.76 1/39.50 1/40.46 0/37.32 |
|POLY-3 PERCENT (g) | 9.2% 2.5% 2.5% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 583 223 376 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.063N P=0.255N P=0.239N P=0.097N |
|POLY 3 | P=0.074N P=0.240N P=0.233N P=0.096N |
|POLY 1.5 | P=0.073N P=0.259N P=0.255N P=0.100N |
|POLY 6 | P=0.081N P=0.218N P=0.213N P=0.093N |
|LOGISTIC REGRESSION| P=0.121N P=0.326N P=0.360N P=0.118N |
|COCH-ARM / FISHERS | P=0.078N P=0.295N P=0.309N P=0.121N |
|ORDER RESTRICTED | P=0.027N* (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 47/53 (89%) 37/55 (67%) 35/53 (66%) 44/53 (83%) |
|POLY-3 RATE (b) | 47/52.12 37/50.34 35/50.58 44/52.04 |
|POLY-3 PERCENT (g) | 90.2% 73.5% 69.2% 84.6% |
|TERMINAL (d) | 10/15 (67%) 14/25 (56%) 12/26 (46%) 16/22 (73%) |
|FIRST INCIDENCE | 126 223 188 124 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.175N P=0.004N** P=0.002N** P=0.072N |
|POLY 3 | P=0.376N P=0.022N* P=0.006N** P=0.282N |
|POLY 1.5 | P=0.388N P=0.016N* P=0.005N** P=0.272N |
|POLY 6 | P=0.383N P=0.031N* P=0.008N** P=0.310N |
|LOGISTIC REGRESSION| P=0.465 P=0.010N* P=0.020N* P=0.436N |
|COCH-ARM / FISHERS | P=0.490N P=0.007N** P=0.005N** P=0.289N |
|ORDER RESTRICTED | P=0.041N* (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Brain |
| Hydrocephalus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 0/55 (0%) 2/53 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 1/32.36 0/38.53 2/39.86 0/37.32 |
|POLY-3 PERCENT (g) | 3.1% 0.0% 5.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 201 --- 678 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.508N P=0.489N P=0.623 P=0.496N |
|POLY 3 | P=0.519N P=0.465N P=0.572 P=0.472N |
|POLY 1.5 | P=0.516N P=0.478N P=0.546 P=0.479N |
|POLY 6 | P=0.539N P=0.447N P=0.605 P=0.464N |
|LOGISTIC REGRESSION| P=0.588N P=0.524N P=0.434 P=0.710N |
|COCH-ARM / FISHERS | P=0.535N P=0.491N P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.299N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 28/50 (56%) 36/55 (65%) 39/52 (75%) 28/50 (56%) |
|POLY-3 RATE (b) | 28/40.18 36/47.35 39/48.96 28/42.13 |
|POLY-3 PERCENT (g) | 69.7% 76.0% 79.7% 66.5% |
|TERMINAL (d) | 9/14 (64%) 19/25 (76%) 19/26 (73%) 13/22 (59%) |
|FIRST INCIDENCE | 222 253 188 436 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.130N P=0.325N P=0.406N P=0.134N |
|POLY 3 | P=0.371N P=0.326 P=0.188 P=0.467N |
|POLY 1.5 | P=0.381N P=0.274 P=0.121 P=0.476N |
|POLY 6 | P=0.381N P=0.413 P=0.286 P=0.464N |
|LOGISTIC REGRESSION| P=0.392N P=0.287 P=0.055 P=0.424N |
|COCH-ARM / FISHERS | P=0.526 P=0.214 P=0.035 * P=0.580N |
|ORDER RESTRICTED | P=0.275N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 29/50 (58%) 32/55 (58%) 34/52 (65%) 37/50 (74%) |
|POLY-3 RATE (b) | 29/40.97 32/47.78 34/46.12 37/45.50 |
|POLY-3 PERCENT (g) | 70.8% 67.0% 73.7% 81.3% |
|TERMINAL (d) | 8/14 (57%) 14/25 (56%) 17/26 (65%) 15/22 (68%) |
|FIRST INCIDENCE | 126 202 188 436 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.417 P=0.157N P=0.153N P=0.498N |
|POLY 3 | P=0.072 P=0.435N P=0.472 P=0.170 |
|POLY 1.5 | P=0.052 P=0.497N P=0.402 P=0.117 |
|POLY 6 | P=0.110 P=0.377N P=0.557 P=0.260 |
|LOGISTIC REGRESSION| P=0.055 P=0.562N P=0.383 P=0.113 |
|COCH-ARM / FISHERS | P=0.033 * P=0.571 P=0.287 P=0.069 |
|ORDER RESTRICTED | P=0.135 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Esophagus: Muscularis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 1/55 (2%) 0/53 (0%) 1/53 (2%) |
|POLY-3 RATE (b) | 2/30.96 1/39.04 0/39.60 1/37.32 |
|POLY-3 PERCENT (g) | 6.5% 2.6% 0.0% 2.7% |
|TERMINAL (d) | 1/14 (7%) 0/25 (0%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 547 574 --- 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.266N P=0.400N P=0.157N P=0.378N |
|POLY 3 | P=0.313N P=0.420N P=0.186N P=0.435N |
|POLY 1.5 | P=0.311N P=0.445N P=0.201N P=0.450N |
|POLY 6 | P=0.324N P=0.384N P=0.170N P=0.421N |
|LOGISTIC REGRESSION| P=0.298N P=0.463N P=0.205N P=0.430N |
|COCH-ARM / FISHERS | P=0.321N P=0.479N P=0.243N P=0.493N |
|ORDER RESTRICTED | P=0.165N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Eye: Retina |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 0/55 (0%) 3/53 (6%) 1/53 (2%) |
|POLY-3 RATE (b) | 0/30.21 0/38.53 3/39.60 1/37.32 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.6% 2.7% |
|TERMINAL (d) | 0/14 (0%) 0/25 (0%) 3/26 (12%) 1/22 (5%) |
|FIRST INCIDENCE | --- --- 727 (T) 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.200 (e) P=0.247 P=0.590 |
|POLY 3 | P=0.193 (e) P=0.173 P=0.542 |
|POLY 1.5 | P=0.190 (e) P=0.155 P=0.533 |
|POLY 6 | P=0.188 (e) P=0.198 P=0.551 |
|LOGISTIC REGRESSION| (e) (e) P=0.247 P=0.590 |
|COCH-ARM / FISHERS | P=0.162 (e) P=0.129 P=0.510 |
|ORDER RESTRICTED | P=0.165 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 3/53 (6%) 6/53 (11%) 6/53 (11%) |
|POLY-3 RATE (b) | 2/32.88 3/38.60 6/39.67 6/37.35 |
|POLY-3 PERCENT (g) | 6.1% 7.8% 15.1% 16.1% |
|TERMINAL (d) | 0/15 (0%) 1/25 (4%) 5/26 (19%) 5/22 (23%) |
|FIRST INCIDENCE | 321 652 709 720 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.106 P=0.643 P=0.315 P=0.260 |
|POLY 3 | P=0.079 P=0.573 P=0.199 P=0.173 |
|POLY 1.5 | P=0.080 P=0.543 P=0.175 P=0.165 |
|POLY 6 | P=0.073 P=0.614 P=0.231 P=0.178 |
|LOGISTIC REGRESSION| P=0.086 P=0.500 P=0.180 P=0.178 |
|COCH-ARM / FISHERS | P=0.064 P=0.500 P=0.135 P=0.135 |
|ORDER RESTRICTED | P=0.155 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/52 (17%) 16/54 (30%) 17/53 (32%) 16/53 (30%) |
|POLY-3 RATE (b) | 9/35.59 16/38.84 17/40.82 16/40.33 |
|POLY-3 PERCENT (g) | 25.3% 41.2% 41.7% 39.7% |
|TERMINAL (d) | 2/15 (13%) 10/24 (42%) 14/26 (54%) 9/22 (41%) |
|FIRST INCIDENCE | 201 574 376 448 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.300 P=0.391 P=0.373 P=0.286 |
|POLY 3 | P=0.195 P=0.107 P=0.096 P=0.132 |
|POLY 1.5 | P=0.177 P=0.096 P=0.082 P=0.120 |
|POLY 6 | P=0.201 P=0.139 P=0.115 P=0.144 |
|LOGISTIC REGRESSION| P=0.202 P=0.139 P=0.105 P=0.115 |
|COCH-ARM / FISHERS | P=0.121 P=0.103 P=0.063 P=0.093 |
|ORDER RESTRICTED | P=0.118 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Heart: Epicardium |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 0/54 (0%) 0/53 (0%) 1/53 (2%) |
|POLY-3 RATE (b) | 2/32.82 0/37.53 0/39.60 1/38.32 |
|POLY-3 PERCENT (g) | 6.1% 0.0% 0.0% 2.6% |
|TERMINAL (d) | 0/15 (0%) 0/24 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 126 --- --- 124 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.434N P=0.216N P=0.213N P=0.480N |
|POLY 3 | P=0.448N P=0.207N P=0.197N P=0.446N |
|POLY 1.5 | P=0.442N P=0.218N P=0.210N P=0.458N |
|POLY 6 | P=0.461N P=0.191N P=0.182N P=0.436N |
|LOGISTIC REGRESSION| P=0.613 P=0.245N P=0.351N P=0.737 |
|COCH-ARM / FISHERS | P=0.443N P=0.238N P=0.243N P=0.493N |
|ORDER RESTRICTED | P=0.097N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 1/55 (2%) 2/53 (4%) 1/53 (2%) |
|POLY-3 RATE (b) | 0/31.36 1/38.88 2/39.67 1/37.75 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 5.0% 2.7% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- 630 709 604 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.360 P=0.573 P=0.368 P=0.539 |
|POLY 3 | P=0.376 P=0.543 P=0.292 P=0.537 |
|POLY 1.5 | P=0.363 P=0.528 P=0.273 P=0.527 |
|POLY 6 | P=0.384 P=0.564 P=0.318 P=0.547 |
|LOGISTIC REGRESSION| P=0.345 P=0.522 P=0.341 P=0.506 |
|COCH-ARM / FISHERS | P=0.319 P=0.514 P=0.252 P=0.505 |
|ORDER RESTRICTED | P=0.274 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 2/55 (4%) 3/53 (6%) 0/52 (0%) |
|POLY-3 RATE (b) | 2/30.87 2/38.53 3/39.60 0/36.94 |
|POLY-3 PERCENT (g) | 6.5% 5.2% 7.6% 0.0% |
|TERMINAL (d) | 2/15 (13%) 2/25 (8%) 3/26 (12%) 0/22 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.144N P=0.500N P=0.626N P=0.157N |
|POLY 3 | P=0.180N P=0.612N P=0.612 P=0.198N |
|POLY 1.5 | P=0.187N P=0.638N P=0.577 P=0.209N |
|POLY 6 | P=0.181N P=0.574N P=0.652 P=0.189N |
|LOGISTIC REGRESSION| P=0.144N P=0.500N P=0.626N (e) |
|COCH-ARM / FISHERS | P=0.224N P=0.670N P=0.509 P=0.248N |
|ORDER RESTRICTED | P=0.182N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 2/54 (4%) 1/53 (2%) 1/53 (2%) |
|POLY-3 RATE (b) | 1/31.36 2/39.02 1/40.16 1/37.75 |
|POLY-3 PERCENT (g) | 3.2% 5.1% 2.5% 2.7% |
|TERMINAL (d) | 1/15 (7%) 1/25 (4%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 727 (T) 223 555 604 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.423N P=0.628 P=0.674N P=0.695N |
|POLY 3 | P=0.424N P=0.576 P=0.703N P=0.719N |
|POLY 1.5 | P=0.438N P=0.549 P=0.724N P=0.730N |
|POLY 6 | P=0.417N P=0.613 P=0.676N P=0.706N |
|LOGISTIC REGRESSION| P=0.508N P=0.501 P=0.740N P=0.727N |
|COCH-ARM / FISHERS | P=0.475N P=0.514 P=0.748N P=0.748N |
|ORDER RESTRICTED | P=0.558N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Casts Protein |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 3/55 (5%) 1/53 (2%) 6/53 (11%) |
|POLY-3 RATE (b) | 4/31.53 3/39.63 1/40.59 6/38.91 |
|POLY-3 PERCENT (g) | 12.7% 7.6% 2.5% 15.4% |
|TERMINAL (d) | 3/15 (20%) 0/25 (0%) 0/26 (0%) 2/22 (9%) |
|FIRST INCIDENCE | 688 516 188 546 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.367 P=0.282N P=0.077N P=0.563 |
|POLY 3 | P=0.332 P=0.376N P=0.111N P=0.506 |
|POLY 1.5 | P=0.325 P=0.420N P=0.131N P=0.463 |
|POLY 6 | P=0.327 P=0.317N P=0.091N P=0.556 |
|LOGISTIC REGRESSION| P=0.301 P=0.387N P=0.166N P=0.487 |
|COCH-ARM / FISHERS | P=0.281 P=0.479N P=0.181N P=0.371 |
|ORDER RESTRICTED | P=0.197 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/55 (0%) 0/53 (0%) 2/53 (4%) |
|POLY-3 RATE (b) | 0/31.38 0/38.53 0/39.60 2/37.58 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.3% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | --- --- --- 659 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.049 * (e) (e) P=0.306 |
|POLY 3 | P=0.049 * (e) (e) P=0.279 |
|POLY 1.5 | P=0.048 * (e) (e) P=0.267 |
|POLY 6 | P=0.049 * (e) (e) P=0.291 |
|LOGISTIC REGRESSION| P=0.049 * (e) (e) P=0.285 |
|COCH-ARM / FISHERS | P=0.045 * (e) (e) P=0.248 |
|ORDER RESTRICTED | P=0.047 * (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/55 (0%) 3/53 (6%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/31.38 0/38.53 3/40.41 0/37.32 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.4% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 651 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.430 (e) P=0.205 (e) |
|POLY 3 | P=0.429 (e) P=0.170 (e) |
|POLY 1.5 | P=0.425 (e) P=0.150 (e) |
|POLY 6 | P=0.421 (e) P=0.198 (e) |
|LOGISTIC REGRESSION| P=0.404 (e) P=0.145 (e) |
|COCH-ARM / FISHERS | P=0.381 (e) P=0.121 (e) |
|ORDER RESTRICTED | P=0.215 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 2/55 (4%) 1/53 (2%) 1/53 (2%) |
|POLY-3 RATE (b) | 2/31.89 2/39.21 1/39.60 1/37.58 |
|POLY-3 PERCENT (g) | 6.3% 5.1% 2.5% 2.7% |
|TERMINAL (d) | 1/15 (7%) 1/25 (4%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 574 498 727 (T) 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.239N P=0.572N P=0.353N P=0.398N |
|POLY 3 | P=0.272N P=0.618N P=0.425N P=0.443N |
|POLY 1.5 | P=0.278N P=0.645N P=0.450N P=0.458N |
|POLY 6 | P=0.275N P=0.580N P=0.396N P=0.429N |
|LOGISTIC REGRESSION| P=0.276N P=0.658N P=0.418N P=0.453N |
|COCH-ARM / FISHERS | P=0.306N P=0.677N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.363N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 32/53 (60%) 39/55 (71%) 44/53 (83%) 44/53 (83%) |
|POLY-3 RATE (b) | 32/42.76 39/47.07 44/50.44 44/49.02 |
|POLY-3 PERCENT (g) | 74.8% 82.9% 87.2% 89.8% |
|TERMINAL (d) | 12/15 (80%) 21/25 (84%) 22/26 (85%) 21/22 (96%) |
|FIRST INCIDENCE | 126 328 188 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.260 P=0.241N P=0.416N P=0.438 |
|POLY 3 | P=0.027 * P=0.230 P=0.085 P=0.033 * |
|POLY 1.5 | P=0.014 * P=0.187 P=0.037 * P=0.021 * |
|POLY 6 | P=0.040 * P=0.297 P=0.181 P=0.044 * |
|LOGISTIC REGRESSION| P=0.011 * P=0.258 P=0.020 * P=0.024 * |
|COCH-ARM / FISHERS | P=0.003 ** P=0.171 P=0.008 ** P=0.008 ** |
|ORDER RESTRICTED | P=0.024 * (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 32/53 (60%) 29/55 (53%) 38/53 (72%) 35/53 (66%) |
|POLY-3 RATE (b) | 32/43.26 29/42.29 38/44.90 35/44.58 |
|POLY-3 PERCENT (g) | 74.0% 68.6% 84.6% 78.5% |
|TERMINAL (d) | 11/15 (73%) 20/25 (80%) 26/26 (100%) 21/22 (96%) |
|FIRST INCIDENCE | 126 350 376 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.507N P=0.013N* P=0.111N P=0.218N |
|POLY 3 | P=0.134 P=0.366N P=0.131 P=0.387 |
|POLY 1.5 | P=0.134 P=0.363N P=0.124 P=0.375 |
|POLY 6 | P=0.093 P=0.352N P=0.133 P=0.347 |
|LOGISTIC REGRESSION| P=0.260 P=0.178N P=0.309 P=0.472 |
|COCH-ARM / FISHERS | P=0.105 P=0.272N P=0.153 P=0.344 |
|ORDER RESTRICTED | P=0.150 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/55 (2%) 0/53 (0%) 0/53 (0%) |
|POLY-3 RATE (b) | 2/32.37 1/38.53 0/39.60 0/37.32 |
|POLY-3 PERCENT (g) | 6.2% 2.6% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 1/25 (4%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 574 727 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.065N P=0.406N P=0.195N P=0.206N |
|POLY 3 | P=0.079N P=0.439N P=0.195N P=0.206N |
|POLY 1.5 | P=0.080N P=0.458N P=0.208N P=0.213N |
|POLY 6 | P=0.082N P=0.413N P=0.181N P=0.202N |
|LOGISTIC REGRESSION| P=0.078N P=0.465N P=0.245N P=0.243N |
|COCH-ARM / FISHERS | P=0.084N P=0.486N P=0.248N P=0.248N |
|ORDER RESTRICTED | P=0.056N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/55 (0%) 0/53 (0%) 0/53 (0%) |
|POLY-3 RATE (b) | 2/32.53 0/38.53 0/39.60 0/37.32 |
|POLY-3 PERCENT (g) | 6.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 541 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.100N P=0.211N P=0.201N P=0.206N |
|POLY 3 | P=0.122N P=0.200N P=0.196N P=0.207N |
|POLY 1.5 | P=0.118N P=0.212N P=0.209N P=0.213N |
|POLY 6 | P=0.133N P=0.185N P=0.182N P=0.203N |
|LOGISTIC REGRESSION| P=0.127N P=0.239N P=0.263N P=0.260N |
|COCH-ARM / FISHERS | P=0.115N P=0.238N P=0.248N P=0.248N |
|ORDER RESTRICTED | P=0.020N* (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/55 (4%) 2/53 (4%) 2/53 (4%) |
|POLY-3 RATE (b) | 0/31.38 2/39.16 2/40.08 2/37.84 |
|POLY-3 PERCENT (g) | 0.0% 5.1% 5.0% 5.3% |
|TERMINAL (d) | 0/15 (0%) 1/25 (4%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- 524 586 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.298 P=0.307 P=0.331 P=0.316 |
|POLY 3 | P=0.305 P=0.289 P=0.295 P=0.280 |
|POLY 1.5 | P=0.287 P=0.270 P=0.274 P=0.268 |
|POLY 6 | P=0.321 P=0.317 P=0.322 P=0.295 |
|LOGISTIC REGRESSION| P=0.256 P=0.257 P=0.270 P=0.269 |
|COCH-ARM / FISHERS | P=0.235 P=0.257 P=0.248 P=0.248 |
|ORDER RESTRICTED | P=0.228 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 2/55 (4%) 8/53 (15%) 4/53 (8%) |
|POLY-3 RATE (b) | 4/32.45 2/39.16 8/41.11 4/38.52 |
|POLY-3 PERCENT (g) | 12.3% 5.1% 19.5% 10.4% |
|TERMINAL (d) | 2/15 (13%) 1/25 (4%) 4/26 (15%) 1/22 (5%) |
|FIRST INCIDENCE | 554 524 498 500 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.406 P=0.204N P=0.444 P=0.479N |
|POLY 3 | P=0.354 P=0.253N P=0.308 P=0.547N |
|POLY 1.5 | P=0.346 P=0.279N P=0.258 P=0.573N |
|POLY 6 | P=0.344 P=0.218N P=0.373 P=0.523N |
|LOGISTIC REGRESSION| P=0.332 P=0.281N P=0.269 P=0.585N |
|COCH-ARM / FISHERS | P=0.282 P=0.322N P=0.179 P=0.642N |
|ORDER RESTRICTED | P=0.317 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 8/55 (15%) 4/53 (8%) 1/53 (2%) |
|POLY-3 RATE (b) | 3/31.69 8/38.81 4/39.86 1/37.32 |
|POLY-3 PERCENT (g) | 9.5% 20.6% 10.0% 2.7% |
|TERMINAL (d) | 2/15 (13%) 7/25 (28%) 3/26 (12%) 1/22 (5%) |
|FIRST INCIDENCE | 644 652 659 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.032N* P=0.316 P=0.548N P=0.193N |
|POLY 3 | P=0.040N* P=0.169 P=0.624 P=0.247N |
|POLY 1.5 | P=0.048N* P=0.142 P=0.581 P=0.262N |
|POLY 6 | P=0.035N* P=0.216 P=0.636N P=0.235N |
|LOGISTIC REGRESSION| P=0.041N* P=0.264 P=0.616N P=0.216N |
|COCH-ARM / FISHERS | P=0.082N P=0.113 P=0.500 P=0.309N |
|ORDER RESTRICTED | P=0.069N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/53 (13%) 10/55 (18%) 10/53 (19%) 13/53 (25%) |
|POLY-3 RATE (b) | 7/32.51 10/39.34 10/40.14 13/39.28 |
|POLY-3 PERCENT (g) | 21.5% 25.4% 24.9% 33.1% |
|TERMINAL (d) | 3/15 (20%) 7/25 (28%) 8/26 (31%) 9/22 (41%) |
|FIRST INCIDENCE | 541 574 651 454 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.217 P=0.529N P=0.489N P=0.322 |
|POLY 3 | P=0.170 P=0.457 P=0.476 P=0.201 |
|POLY 1.5 | P=0.153 P=0.401 P=0.412 P=0.171 |
|POLY 6 | P=0.171 P=0.538 P=0.550 P=0.229 |
|LOGISTIC REGRESSION| P=0.160 P=0.538 P=0.589 P=0.207 |
|COCH-ARM / FISHERS | P=0.095 P=0.329 P=0.299 P=0.107 |
|ORDER RESTRICTED | P=0.217 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/55 (2%) 0/53 (0%) 0/53 (0%) |
|POLY-3 RATE (b) | 2/31.38 1/39.30 0/39.60 0/37.32 |
|POLY-3 PERCENT (g) | 6.4% 2.5% 0.0% 0.0% |
|TERMINAL (d) | 2/15 (13%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 727 (T) 448 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.060N P=0.373N P=0.127N P=0.157N |
|POLY 3 | P=0.081N P=0.422N P=0.189N P=0.200N |
|POLY 1.5 | P=0.080N P=0.449N P=0.205N P=0.210N |
|POLY 6 | P=0.087N P=0.385N P=0.171N P=0.190N |
|LOGISTIC REGRESSION| P=0.077N P=0.461N (e) (e) |
|COCH-ARM / FISHERS | P=0.084N P=0.486N P=0.248N P=0.248N |
|ORDER RESTRICTED | P=0.052N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/53 (21%) 10/55 (18%) 13/53 (25%) 21/53 (40%) |
|POLY-3 RATE (b) | 11/34.24 10/39.49 13/42.24 21/43.22 |
|POLY-3 PERCENT (g) | 32.1% 25.3% 30.8% 48.6% |
|TERMINAL (d) | 5/15 (33%) 6/25 (24%) 5/26 (19%) 7/22 (32%) |
|FIRST INCIDENCE | 405 524 509 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.040 * P=0.148N P=0.328N P=0.186 |
|POLY 3 | P=0.023 * P=0.347N P=0.548N P=0.103 |
|POLY 1.5 | P=0.016 * P=0.393N P=0.565 P=0.068 |
|POLY 6 | P=0.032 * P=0.285N P=0.452N P=0.165 |
|LOGISTIC REGRESSION| P=0.014 * P=0.312N P=0.581 P=0.056 |
|COCH-ARM / FISHERS | P=0.007 ** P=0.462N P=0.408 P=0.028 * |
|ORDER RESTRICTED | P=0.044 * (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 7/55 (13%) 14/53 (26%) 22/53 (42%) |
|POLY-3 RATE (b) | 5/33.58 7/40.50 14/43.35 22/41.83 |
|POLY-3 PERCENT (g) | 14.9% 17.3% 32.3% 52.6% |
|TERMINAL (d) | 2/15 (13%) 2/25 (8%) 6/26 (23%) 11/22 (50%) |
|FIRST INCIDENCE | 126 448 376 481 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.614 P=0.142 P=0.005 ** |
|POLY 3 | P<0.001 ** P=0.515 P=0.066 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.462 P=0.042 * P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.594 P=0.111 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.403 P=0.020 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.407 P=0.020 * P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 6/55 (11%) 8/53 (15%) 6/53 (11%) |
|POLY-3 RATE (b) | 2/32.02 6/38.55 8/40.14 6/37.58 |
|POLY-3 PERCENT (g) | 6.3% 15.6% 19.9% 16.0% |
|TERMINAL (d) | 1/15 (7%) 5/25 (20%) 5/26 (19%) 5/22 (23%) |
|FIRST INCIDENCE | 519 722 653 660 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.236 P=0.324 P=0.189 P=0.256 |
|POLY 3 | P=0.213 P=0.197 P=0.091 P=0.186 |
|POLY 1.5 | P=0.197 P=0.174 P=0.073 P=0.172 |
|POLY 6 | P=0.218 P=0.235 P=0.120 P=0.198 |
|LOGISTIC REGRESSION| P=0.196 P=0.250 P=0.110 P=0.209 |
|COCH-ARM / FISHERS | P=0.139 P=0.147 P=0.046 * P=0.135 |
|ORDER RESTRICTED | P=0.140 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocyte, Multinucleate |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/55 (4%) 10/53 (19%) 14/53 (26%) |
|POLY-3 RATE (b) | 0/31.38 2/38.53 10/40.61 14/40.28 |
|POLY-3 PERCENT (g) | 0.0% 5.2% 24.6% 34.8% |
|TERMINAL (d) | 0/15 (0%) 2/25 (8%) 7/26 (27%) 8/22 (36%) |
|FIRST INCIDENCE | --- 727 (T) 509 481 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.356 P=0.012 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.285 P=0.003 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.268 P=0.002 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.310 P=0.006 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.356 P=0.005 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.257 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 36/53 (68%) 40/55 (73%) 49/53 (92%) 50/53 (94%) |
|POLY-3 RATE (b) | 36/42.80 40/46.70 49/50.26 50/50.96 |
|POLY-3 PERCENT (g) | 84.1% 85.7% 97.5% 98.1% |
|TERMINAL (d) | 15/15 (100%) 21/25 (84%) 25/26 (96%) 22/22 (100%) |
|FIRST INCIDENCE | 176 253 188 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.136 P=0.082N P=0.334N P=0.405 |
|POLY 3 | P<0.001 ** P=0.543 P=0.008 ** P=0.004 ** |
|POLY 1.5 | P<0.001 ** P=0.427 P=0.002 ** P<0.001 ** |
|POLY 6 | P=0.004 ** P=0.527N P=0.061 P=0.020 * |
|LOGISTIC REGRESSION| P<0.001 ** P=0.548 P=0.009 ** P=0.003 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.369 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P=0.002 ** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 21/53 (40%) 24/55 (44%) 32/53 (60%) 32/53 (60%) |
|POLY-3 RATE (b) | 21/34.34 24/40.37 32/42.94 32/43.91 |
|POLY-3 PERCENT (g) | 61.2% 59.5% 74.5% 72.9% |
|TERMINAL (d) | 12/15 (80%) 19/25 (76%) 22/26 (85%) 19/22 (86%) |
|FIRST INCIDENCE | 541 546 541 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.081 P=0.087N P=0.449N P=0.349 |
|POLY 3 | P=0.057 P=0.537N P=0.131 P=0.170 |
|POLY 1.5 | P=0.033 * P=0.553 P=0.071 P=0.099 |
|POLY 6 | P=0.073 P=0.398N P=0.257 P=0.261 |
|LOGISTIC REGRESSION| P=0.024 * P=0.313N P=0.257 P=0.104 |
|COCH-ARM / FISHERS | P=0.007 ** P=0.410 P=0.026 * P=0.026 * |
|ORDER RESTRICTED | P=0.136 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 2/55 (4%) 5/53 (9%) 8/53 (15%) |
|POLY-3 RATE (b) | 4/34.03 2/39.44 5/42.49 8/41.14 |
|POLY-3 PERCENT (g) | 11.8% 5.1% 11.8% 19.5% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 176 356 300 481 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.078 P=0.242N P=0.624 P=0.294 |
|POLY 3 | P=0.067 P=0.269N P=0.637 P=0.278 |
|POLY 1.5 | P=0.060 P=0.291N P=0.589 P=0.243 |
|POLY 6 | P=0.072 P=0.240N P=0.583N P=0.320 |
|LOGISTIC REGRESSION| P=0.017 * P=0.373N P=0.320 P=0.101 |
|COCH-ARM / FISHERS | P=0.043 * P=0.322N P=0.500 P=0.179 |
|ORDER RESTRICTED | P=0.109 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 11/55 (20%) 41/53 (77%) 39/53 (74%) |
|POLY-3 RATE (b) | 1/32.06 11/39.46 41/47.21 39/44.38 |
|POLY-3 PERCENT (g) | 3.1% 27.9% 86.9% 87.9% |
|TERMINAL (d) | 0/15 (0%) 7/25 (28%) 23/26 (89%) 21/22 (96%) |
|FIRST INCIDENCE | 496 572 328 405 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.024 * P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Toxic Hepatopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 6/55 (11%) 22/53 (42%) 27/53 (51%) |
|POLY-3 RATE (b) | 0/31.38 6/38.95 22/41.68 27/41.02 |
|POLY-3 PERCENT (g) | 0.0% 15.4% 52.8% 65.8% |
|TERMINAL (d) | 0/15 (0%) 3/25 (12%) 15/26 (58%) 18/22 (82%) |
|FIRST INCIDENCE | --- 652 328 454 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.068 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.029 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.023 * P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.040 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.042 * P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.015 * P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 6/55 (11%) 0/53 (0%) 2/53 (4%) |
|POLY-3 RATE (b) | 3/31.38 6/38.56 0/39.60 2/37.58 |
|POLY-3 PERCENT (g) | 9.6% 15.6% 0.0% 5.3% |
|TERMINAL (d) | 3/15 (20%) 5/25 (20%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 727 (T) 720 --- 659 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.055N P=0.545 P=0.042N* P=0.343N |
|POLY 3 | P=0.068N P=0.350 P=0.082N P=0.418N |
|POLY 1.5 | P=0.078N P=0.311 P=0.094N P=0.441N |
|POLY 6 | P=0.059N P=0.412 P=0.069N P=0.394N |
|LOGISTIC REGRESSION| P=0.063N P=0.568 (e) P=0.373N |
|COCH-ARM / FISHERS | P=0.111N P=0.263 P=0.121N P=0.500N |
|ORDER RESTRICTED | P=0.087N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 4/55 (7%) 3/53 (6%) 2/53 (4%) |
|POLY-3 RATE (b) | 4/32.23 4/38.64 3/39.75 2/38.02 |
|POLY-3 PERCENT (g) | 12.4% 10.4% 7.6% 5.3% |
|TERMINAL (d) | 3/15 (20%) 3/25 (12%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 391 700 709 600 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.144N P=0.382N P=0.253N P=0.223N |
|POLY 3 | P=0.172N P=0.541N P=0.386N P=0.262N |
|POLY 1.5 | P=0.183N P=0.577N P=0.426N P=0.283N |
|POLY 6 | P=0.167N P=0.485N P=0.338N P=0.239N |
|LOGISTIC REGRESSION| P=0.168N P=0.512N P=0.378N P=0.289N |
|COCH-ARM / FISHERS | P=0.225N P=0.621N P=0.500N P=0.339N |
|ORDER RESTRICTED | P=0.243N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 7/55 (13%) 7/53 (13%) 13/53 (25%) |
|POLY-3 RATE (b) | 3/32.67 7/39.97 7/39.86 13/41.26 |
|POLY-3 PERCENT (g) | 9.2% 17.5% 17.6% 31.5% |
|TERMINAL (d) | 1/15 (7%) 4/25 (16%) 6/26 (23%) 5/22 (23%) |
|FIRST INCIDENCE | 496 434 659 405 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.018 * P=0.337 P=0.392 P=0.036 * |
|POLY 3 | P=0.013 * P=0.248 P=0.246 P=0.019 * |
|POLY 1.5 | P=0.010 * P=0.215 P=0.215 P=0.013 * |
|POLY 6 | P=0.016 * P=0.298 P=0.288 P=0.027 * |
|LOGISTIC REGRESSION| P=0.008 ** P=0.205 P=0.264 P=0.009 ** |
|COCH-ARM / FISHERS | P=0.005 ** P=0.176 P=0.160 P=0.006 ** |
|ORDER RESTRICTED | P=0.011 * (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 1/55 (2%) 1/53 (2%) 0/53 (0%) |
|POLY-3 RATE (b) | 3/33.04 1/38.64 1/40.21 0/37.32 |
|POLY-3 PERCENT (g) | 9.1% 2.6% 2.5% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 354 700 533 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.061N P=0.210N P=0.233N P=0.094N |
|POLY 3 | P=0.072N P=0.250N P=0.238N P=0.097N |
|POLY 1.5 | P=0.071N P=0.267N P=0.260N P=0.102N |
|POLY 6 | P=0.077N P=0.224N P=0.213N P=0.093N |
|LOGISTIC REGRESSION| P=0.091N P=0.302N P=0.375N P=0.151N |
|COCH-ARM / FISHERS | P=0.078N P=0.295N P=0.309N P=0.121N |
|ORDER RESTRICTED | P=0.027N* (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 23/55 (42%) 32/53 (60%) 36/53 (68%) |
|POLY-3 RATE (b) | 0/31.38 23/43.50 32/45.22 36/46.82 |
|POLY-3 PERCENT (g) | 0.0% 52.9% 70.8% 76.9% |
|TERMINAL (d) | 0/15 (0%) 10/25 (40%) 18/26 (69%) 17/22 (77%) |
|FIRST INCIDENCE | --- 448 188 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | 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 ** |
|POLY 1.5 | 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 ** |
|LOGISTIC REGRESSION| 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 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver: Oval Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 1/55 (2%) 6/53 (11%) 7/53 (13%) |
|POLY-3 RATE (b) | 0/31.38 1/38.56 6/39.60 7/37.32 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 15.2% 18.8% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 6/26 (23%) 7/22 (32%) |
|FIRST INCIDENCE | --- 720 727 (T) 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.624 P=0.062 P=0.024 * |
|POLY 3 | P<0.001 ** P=0.541 P=0.031 * P=0.013 * |
|POLY 1.5 | P<0.001 ** P=0.527 P=0.025 * P=0.012 * |
|POLY 6 | P<0.001 ** P=0.561 P=0.041 * P=0.015 * |
|LOGISTIC REGRESSION| P<0.001 ** P=0.596 P=0.062 P=0.024 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.509 P=0.013 * P=0.006 ** |
|ORDER RESTRICTED | P=0.006 ** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 41/53 (77%) 49/55 (89%) 45/53 (85%) 48/53 (91%) |
|POLY-3 RATE (b) | 41/47.06 49/51.17 45/47.89 48/49.78 |
|POLY-3 PERCENT (g) | 87.1% 95.8% 94.0% 96.4% |
|TERMINAL (d) | 12/15 (80%) 23/25 (92%) 26/26 (100%) 21/22 (96%) |
|FIRST INCIDENCE | 201 253 328 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.315N P=0.201N P=0.049N* P=0.335N |
|POLY 3 | P=0.088 P=0.099 P=0.185 P=0.069 |
|POLY 1.5 | P=0.091 P=0.062 P=0.192 P=0.058 |
|POLY 6 | P=0.088 P=0.182 P=0.187 P=0.097 |
|LOGISTIC REGRESSION| P=0.308 P=0.128 P=0.479 P=0.144 |
|COCH-ARM / FISHERS | P=0.094 P=0.084 P=0.229 P=0.055 |
|ORDER RESTRICTED | P=0.026 * (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 3/55 (5%) 0/53 (0%) 1/53 (2%) |
|POLY-3 RATE (b) | 5/32.66 3/39.74 0/39.60 1/37.78 |
|POLY-3 PERCENT (g) | 15.3% 7.6% 0.0% 2.7% |
|TERMINAL (d) | 2/15 (13%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 309 356 --- 592 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.017N* P=0.179N P=0.010N* P=0.057N |
|POLY 3 | P=0.022N* P=0.252N P=0.017N* P=0.069N |
|POLY 1.5 | P=0.022N* P=0.286N P=0.021N* P=0.077N |
|POLY 6 | P=0.023N* P=0.207N P=0.013N* P=0.061N |
|LOGISTIC REGRESSION| P=0.027N* P=0.321N P=0.026N* P=0.088N |
|COCH-ARM / FISHERS | P=0.027N* P=0.337N P=0.028N* P=0.103N |
|ORDER RESTRICTED | P=0.010N* (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 0/55 (0%) 2/53 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 3/32.04 0/38.53 2/39.67 0/37.32 |
|POLY-3 PERCENT (g) | 9.4% 0.0% 5.0% 0.0% |
|TERMINAL (d) | 1/15 (7%) 0/25 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 611 --- 709 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.129N P=0.066N P=0.300N P=0.085N |
|POLY 3 | P=0.168N P=0.088N P=0.403N P=0.092N |
|POLY 1.5 | P=0.162N P=0.097N P=0.435N P=0.098N |
|POLY 6 | P=0.185N P=0.076N P=0.368N P=0.088N |
|LOGISTIC REGRESSION| P=0.138N P=0.088N P=0.374N P=0.092N |
|COCH-ARM / FISHERS | P=0.171N P=0.115N P=0.500N P=0.121N |
|ORDER RESTRICTED | P=0.025N* (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 0/55 (0%) 1/53 (2%) 2/53 (4%) |
|POLY-3 RATE (b) | 1/31.53 0/38.53 1/39.60 2/37.32 |
|POLY-3 PERCENT (g) | 3.2% 0.0% 2.5% 5.4% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 1/26 (4%) 2/22 (9%) |
|FIRST INCIDENCE | 688 --- 727 (T) 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.245 P=0.405N P=0.642N P=0.616 |
|POLY 3 | P=0.221 P=0.460N P=0.708N P=0.559 |
|POLY 1.5 | P=0.223 P=0.474N P=0.727N P=0.543 |
|POLY 6 | P=0.213 P=0.441N P=0.685N P=0.572 |
|LOGISTIC REGRESSION| P=0.232 P=0.448N P=0.677N P=0.598 |
|COCH-ARM / FISHERS | P=0.207 P=0.491N P=0.752N P=0.500 |
|ORDER RESTRICTED | P=0.268 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/55 (4%) 0/53 (0%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/31.38 2/38.67 0/39.60 0/37.32 |
|POLY-3 PERCENT (g) | 0.0% 5.2% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- 700 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.245N P=0.374 (e) (e) |
|POLY 3 | P=0.225N P=0.286 (e) (e) |
|POLY 1.5 | P=0.245N P=0.268 (e) (e) |
|POLY 6 | P=0.205N P=0.312 (e) (e) |
|LOGISTIC REGRESSION| P=0.250N P=0.322 (e) (e) |
|COCH-ARM / FISHERS | P=0.284N P=0.257 (e) (e) |
|ORDER RESTRICTED | P=0.258N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/53 (23%) 1/55 (2%) 0/53 (0%) 1/53 (2%) |
|POLY-3 RATE (b) | 12/32.58 1/38.75 0/39.60 1/37.32 |
|POLY-3 PERCENT (g) | 36.8% 2.6% 0.0% 2.7% |
|TERMINAL (d) | 7/15 (47%) 0/25 (0%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 600 671 --- 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 3 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Metaplasia Bronchiolar |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 29/55 (53%) 34/53 (64%) 41/53 (77%) |
|POLY-3 RATE (b) | 0/31.38 29/41.27 34/43.69 41/45.19 |
|POLY-3 PERCENT (g) | 0.0% 70.3% 77.8% 90.7% |
|TERMINAL (d) | 0/15 (0%) 19/25 (76%) 22/26 (85%) 21/22 (96%) |
|FIRST INCIDENCE | --- 516 541 405 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | 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 ** |
|POLY 1.5 | 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 ** |
|LOGISTIC REGRESSION| 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 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung: Serosa |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/55 (0%) 2/53 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/31.38 0/38.53 2/39.88 0/37.32 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 5.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 651 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.502 (e) P=0.358 (e) |
|POLY 3 | P=0.498 (e) P=0.294 (e) |
|POLY 1.5 | P=0.495 (e) P=0.273 (e) |
|POLY 6 | P=0.493 (e) P=0.320 (e) |
|LOGISTIC REGRESSION| P=0.483 (e) P=0.300 (e) |
|COCH-ARM / FISHERS | P=0.454 (e) P=0.248 (e) |
|ORDER RESTRICTED | P=0.296 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung: Serosa |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/55 (0%) 0/53 (0%) 1/53 (2%) |
|POLY-3 RATE (b) | 2/32.84 0/38.53 0/39.60 1/38.32 |
|POLY-3 PERCENT (g) | 6.1% 0.0% 0.0% 2.6% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 126 --- --- 124 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.436N P=0.218N P=0.215N P=0.482N |
|POLY 3 | P=0.459N P=0.202N P=0.197N P=0.446N |
|POLY 1.5 | P=0.451N P=0.214N P=0.211N P=0.459N |
|POLY 6 | P=0.473N P=0.186N P=0.182N P=0.436N |
|LOGISTIC REGRESSION| P=0.583 P=0.267N P=0.371N P=0.703 |
|COCH-ARM / FISHERS | P=0.449N P=0.238N P=0.248N P=0.500N |
|ORDER RESTRICTED | P=0.097N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 1/53 (2%) 4/51 (8%) 4/51 (8%) |
|POLY-3 RATE (b) | 1/31.47 1/37.64 4/38.08 4/36.51 |
|POLY-3 PERCENT (g) | 3.2% 2.7% 10.5% 11.0% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 4/25 (16%) 4/22 (18%) |
|FIRST INCIDENCE | 660 722 727 (T) 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.079 P=0.658N P=0.344 P=0.293 |
|POLY 3 | P=0.068 P=0.720N P=0.240 P=0.224 |
|POLY 1.5 | P=0.067 P=0.736N P=0.215 P=0.210 |
|POLY 6 | P=0.065 P=0.695N P=0.272 P=0.237 |
|LOGISTIC REGRESSION| P=0.066 P=0.709N P=0.309 P=0.264 |
|COCH-ARM / FISHERS | P=0.052 P=0.748N P=0.175 P=0.175 |
|ORDER RESTRICTED | P=0.158 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 18/52 (35%) 24/53 (45%) 31/51 (61%) 21/51 (41%) |
|POLY-3 RATE (b) | 18/36.75 24/45.45 31/41.45 21/38.38 |
|POLY-3 PERCENT (g) | 49.0% 52.8% 74.8% 54.7% |
|TERMINAL (d) | 8/15 (53%) 9/25 (36%) 21/25 (84%) 16/22 (73%) |
|FIRST INCIDENCE | 222 202 531 496 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.457N P=0.485N P=0.366 P=0.347N |
|POLY 3 | P=0.170 P=0.450 P=0.010 * P=0.388 |
|POLY 1.5 | P=0.228 P=0.328 P=0.007 ** P=0.389 |
|POLY 6 | P=0.096 P=0.571N P=0.017 * P=0.369 |
|LOGISTIC REGRESSION| P=0.391 P=0.205 P=0.034 * P=0.544 |
|COCH-ARM / FISHERS | P=0.224 P=0.180 P=0.007 ** P=0.315 |
|ORDER RESTRICTED | P=0.108 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 3/54 (6%) 0/52 (0%) 1/52 (2%) |
|POLY-3 RATE (b) | 2/31.83 3/39.51 0/38.60 1/36.90 |
|POLY-3 PERCENT (g) | 6.3% 7.6% 0.0% 2.7% |
|TERMINAL (d) | 0/15 (0%) 1/25 (4%) 0/25 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 618 498 --- 546 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.140N P=0.642 P=0.150N P=0.427N |
|POLY 3 | P=0.146N P=0.598 P=0.196N P=0.448N |
|POLY 1.5 | P=0.153N P=0.562 P=0.210N P=0.462N |
|POLY 6 | P=0.144N P=0.644 P=0.181N P=0.437N |
|LOGISTIC REGRESSION| P=0.173N P=0.539 P=0.200N P=0.481N |
|COCH-ARM / FISHERS | P=0.175N P=0.518 P=0.248N P=0.500N |
|ORDER RESTRICTED | P=0.197N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/52 (6%) 0/54 (0%) 0/52 (0%) 0/52 (0%) |
|POLY-3 RATE (b) | 3/33.26 0/38.32 0/38.60 0/36.32 |
|POLY-3 PERCENT (g) | 9.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 0/25 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 222 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.043N* P=0.095N P=0.093N P=0.102N |
|POLY 3 | P=0.052N P=0.094N P=0.093N P=0.102N |
|POLY 1.5 | P=0.049N* P=0.102N P=0.102N P=0.106N |
|POLY 6 | P=0.059N P=0.083N P=0.084N P=0.100N |
|LOGISTIC REGRESSION| P=0.070N P=0.130N P=0.171N P=0.172N |
|COCH-ARM / FISHERS | P=0.051N P=0.115N P=0.121N P=0.121N |
|ORDER RESTRICTED | P=0.006N** (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node: Lumbar |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 0/6 (0%) 0/6 (0%) 2/6 (33%) |
|POLY-3 RATE (b) | 0/0.63 0/3.24 0/3.60 2/4.37 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 45.8% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/2 (0%) 0/1 (0%) |
|FIRST INCIDENCE | --- --- --- 496 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.056 (e) (e) P=0.309 |
|POLY 3 | P=0.080 (e) (e) P=0.682 |
|POLY 1.5 | P=0.074 (e) (e) P=0.636 |
|POLY 6 | P=0.099 (e) (e) P=0.740 |
|LOGISTIC REGRESSION| P=0.067 (e) (e) P=0.581 |
|COCH-ARM / FISHERS | P=0.066 (e) (e) P=0.536 |
|ORDER RESTRICTED | P=0.501 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 2/6 (33%) 3/6 (50%) 0/6 (0%) |
|POLY-3 RATE (b) | 0/0.63 2/3.86 3/4.04 0/3.43 |
|POLY-3 PERCENT (g) | 0.0% 51.8% 74.3% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 2/2 (100%) 0/1 (0%) |
|FIRST INCIDENCE | --- 630 602 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.360N P=0.331 P=0.581 (e) |
|POLY 3 | P=0.191N P=0.673 P=0.593 (e) |
|POLY 1.5 | P=0.177N P=0.618 P=0.510 (e) |
|POLY 6 | P=0.281N P=0.742 P=0.784 (e) |
|LOGISTIC REGRESSION| P=0.199N P=0.662 P=0.527 (e) |
|COCH-ARM / FISHERS | P=0.314N P=0.536 P=0.357 (e) |
|ORDER RESTRICTED | P=0.493N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 0/6 (0%) 2/6 (33%) 1/6 (17%) |
|POLY-3 RATE (b) | 0/0.63 0/3.24 2/4.04 1/3.97 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 49.6% 25.2% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 1/2 (50%) 0/1 (0%) |
|FIRST INCIDENCE | --- --- 602 559 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.235 (e) P=0.581 P=0.543 |
|POLY 3 | P=0.429 (e) P=0.677 P=0.796 |
|POLY 1.5 | P=0.393 (e) P=0.629 P=0.775 |
|POLY 6 | P=0.519 (e) P=0.743 P=0.824 |
|LOGISTIC REGRESSION| P=0.311 (e) P=0.709 P=0.783 |
|COCH-ARM / FISHERS | P=0.269 (e) P=0.536 P=0.750 |
|ORDER RESTRICTED | P=0.587 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/52 (15%) 3/55 (5%) 1/53 (2%) 4/53 (8%) |
|POLY-3 RATE (b) | 8/33.57 3/39.34 1/40.40 4/37.83 |
|POLY-3 PERCENT (g) | 23.8% 7.6% 2.5% 10.6% |
|TERMINAL (d) | 3/15 (20%) 1/25 (4%) 0/26 (0%) 3/22 (14%) |
|FIRST INCIDENCE | 405 524 428 576 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.082N P=0.031N* P=0.005N** P=0.077N |
|POLY 3 | P=0.111N P=0.052N P=0.006N** P=0.116N |
|POLY 1.5 | P=0.111N P=0.064N P=0.008N** P=0.128N |
|POLY 6 | P=0.118N P=0.038N* P=0.004N** P=0.108N |
|LOGISTIC REGRESSION| P=0.112N P=0.066N P=0.014N* P=0.117N |
|COCH-ARM / FISHERS | P=0.131N P=0.084N P=0.014N* P=0.170N |
|ORDER RESTRICTED | P=0.012N* (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 32/52 (62%) 33/55 (60%) 30/53 (57%) 29/53 (55%) |
|POLY-3 RATE (b) | 32/43.06 33/45.84 30/46.24 29/43.63 |
|POLY-3 PERCENT (g) | 74.3% 72.0% 64.9% 66.5% |
|TERMINAL (d) | 11/15 (73%) 15/25 (60%) 13/26 (50%) 15/22 (68%) |
|FIRST INCIDENCE | 126 82 328 405 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.082N P=0.082N P=0.031N* P=0.063N |
|POLY 3 | P=0.181N P=0.497N P=0.219N P=0.269N |
|POLY 1.5 | P=0.189N P=0.540N P=0.295N P=0.277N |
|POLY 6 | P=0.195N P=0.374N P=0.127N P=0.267N |
|LOGISTIC REGRESSION| P=0.146N P=0.450N P=0.294N P=0.216N |
|COCH-ARM / FISHERS | P=0.240N P=0.514N P=0.376N P=0.305N |
|ORDER RESTRICTED | P=0.287N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 0/55 (0%) 0/53 (0%) 2/53 (4%) |
|POLY-3 RATE (b) | 1/31.36 0/38.53 0/39.60 2/37.74 |
|POLY-3 PERCENT (g) | 3.2% 0.0% 0.0% 5.3% |
|TERMINAL (d) | 1/15 (7%) 0/25 (0%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 727 (T) --- --- 607 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.265 P=0.398N P=0.390N P=0.607 |
|POLY 3 | P=0.240 P=0.459N P=0.454N P=0.564 |
|POLY 1.5 | P=0.242 P=0.472N P=0.469N P=0.547 |
|POLY 6 | P=0.231 P=0.439N P=0.435N P=0.583 |
|LOGISTIC REGRESSION| P=0.256 (e) (e) P=0.572 |
|COCH-ARM / FISHERS | P=0.234 P=0.486N P=0.495N P=0.507 |
|ORDER RESTRICTED | P=0.167 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 2/55 (4%) 0/53 (0%) 1/53 (2%) |
|POLY-3 RATE (b) | 2/31.43 2/39.32 0/39.60 1/37.83 |
|POLY-3 PERCENT (g) | 6.4% 5.1% 0.0% 2.6% |
|TERMINAL (d) | 1/15 (7%) 1/25 (4%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 709 434 --- 576 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.183N P=0.535N P=0.129N P=0.395N |
|POLY 3 | P=0.210N P=0.611N P=0.189N P=0.435N |
|POLY 1.5 | P=0.215N P=0.640N P=0.204N P=0.453N |
|POLY 6 | P=0.208N P=0.570N P=0.172N P=0.418N |
|LOGISTIC REGRESSION| P=0.219N P=0.643N P=0.141N P=0.439N |
|COCH-ARM / FISHERS | P=0.233N P=0.670N P=0.243N P=0.493N |
|ORDER RESTRICTED | P=0.208N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mesentery: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/1 (0%) 0/0 (0%) 2/4 (50%) 2/2 (100%) |
|POLY-3 RATE (b) | 0/0.16 0/0.00 2/3.52 2/2.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 56.8% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 2/3 (67%) 2/2 (100%) |
|FIRST INCIDENCE | --- --- 727 (T) 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.581 (e) P=1.000 P=1.000 |
|POLY 3 | (e) (e) P=0.800 P=0.333 |
|POLY 1.5 | (e) (e) P=0.731 P=0.333 |
|POLY 6 | (e) (e) P=0.843 P=0.333 |
|LOGISTIC REGRESSION| (e) (e) P=1.000 P=1.000 |
|COCH-ARM / FISHERS | P=0.120 (e) P=0.600 P=0.333 |
|ORDER RESTRICTED | (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/54 (0%) 1/52 (2%) 1/53 (2%) |
|POLY-3 RATE (b) | 2/32.23 0/37.53 1/39.58 1/37.32 |
|POLY-3 PERCENT (g) | 6.2% 0.0% 2.5% 2.7% |
|TERMINAL (d) | 1/15 (7%) 0/24 (0%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 391 --- 709 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.461N P=0.185N P=0.365N P=0.395N |
|POLY 3 | P=0.521N P=0.204N P=0.429N P=0.449N |
|POLY 1.5 | P=0.516N P=0.216N P=0.455N P=0.461N |
|POLY 6 | P=0.540N P=0.186N P=0.398N P=0.437N |
|LOGISTIC REGRESSION| P=0.506N P=0.240N P=0.501N P=0.484N |
|COCH-ARM / FISHERS | P=0.526N P=0.243N P=0.507N P=0.500N |
|ORDER RESTRICTED | P=0.212N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Nose: Turbinate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/54 (0%) 1/52 (2%) 1/53 (2%) |
|POLY-3 RATE (b) | 2/31.81 0/37.53 1/39.51 1/37.32 |
|POLY-3 PERCENT (g) | 6.3% 0.0% 2.5% 2.7% |
|TERMINAL (d) | 1/15 (7%) 0/24 (0%) 1/26 (4%) 1/22 (5%) |
|FIRST INCIDENCE | 603 --- 727 (T) 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.458N P=0.165N P=0.344N P=0.393N |
|POLY 3 | P=0.522N P=0.201N P=0.425N P=0.444N |
|POLY 1.5 | P=0.517N P=0.214N P=0.452N P=0.458N |
|POLY 6 | P=0.542N P=0.184N P=0.396N P=0.433N |
|LOGISTIC REGRESSION| P=0.479N P=0.201N P=0.405N P=0.429N |
|COCH-ARM / FISHERS | P=0.526N P=0.243N P=0.507N P=0.500N |
|ORDER RESTRICTED | P=0.209N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Oral Mucosa: Gingival |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/1 (100%) 0/1 (0%) 2/3 (67%) 2/4 (50%) |
|POLY-3 RATE (b) | 1/1.00 0/0.82 2/2.72 2/4.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 73.6% 50.0% |
|TERMINAL (d) | 1/1 (100%) 0/0 (0%) 0/0 (0%) 1/3 (33%) |
|FIRST INCIDENCE | 727 (T) --- 688 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.478 P=1.000 P=0.377 P=0.729N |
|POLY 3 | P=0.485N P=1.000 P=0.786N P=0.577N |
|POLY 1.5 | P=0.520N P=1.000 P=0.737N P=0.577N |
|POLY 6 | P=0.421N P=1.000 P=0.885N P=0.577N |
|LOGISTIC REGRESSION| P=0.555N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.565N P=0.500N P=0.750N P=0.600N |
|ORDER RESTRICTED | P=0.419N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 45/52 (87%) 49/54 (91%) 46/53 (87%) 45/52 (87%) |
|POLY-3 RATE (b) | 45/46.65 49/52.02 46/50.50 45/49.66 |
|POLY-3 PERCENT (g) | 96.5% 94.2% 91.1% 90.6% |
|TERMINAL (d) | 14/15 (93%) 22/25 (88%) 23/26 (89%) 19/22 (86%) |
|FIRST INCIDENCE | 126 223 188 124 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.104N P=0.075N P=0.020N* P=0.090N |
|POLY 3 | P=0.134N P=0.477N P=0.234N P=0.204N |
|POLY 1.5 | P=0.145N P=0.654N P=0.314N P=0.271N |
|POLY 6 | P=0.174N P=0.376N P=0.217N P=0.218N |
|LOGISTIC REGRESSION| P=0.249N P=0.447 P=0.394N P=0.388N |
|COCH-ARM / FISHERS | P=0.422N P=0.354 P=0.598 P=0.613N |
|ORDER RESTRICTED | P=0.186N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/52 (23%) 17/54 (31%) 17/53 (32%) 15/52 (29%) |
|POLY-3 RATE (b) | 12/33.36 17/41.28 17/40.57 15/38.87 |
|POLY-3 PERCENT (g) | 36.0% 41.2% 41.9% 38.6% |
|TERMINAL (d) | 7/15 (47%) 10/25 (40%) 15/26 (58%) 10/22 (46%) |
|FIRST INCIDENCE | 547 356 541 496 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.433N P=0.505N P=0.411N P=0.481N |
|POLY 3 | P=0.506 P=0.411 P=0.387 P=0.506 |
|POLY 1.5 | P=0.483 P=0.321 P=0.318 P=0.453 |
|POLY 6 | P=0.490 P=0.545 P=0.469 P=0.553 |
|LOGISTIC REGRESSION| P=0.531 P=0.379 P=0.549 P=0.547 |
|COCH-ARM / FISHERS | P=0.354 P=0.226 P=0.208 P=0.328 |
|ORDER RESTRICTED | P=0.542 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/51 (10%) 1/55 (2%) 3/53 (6%) 4/53 (8%) |
|POLY-3 RATE (b) | 5/32.80 1/38.53 3/40.81 4/38.15 |
|POLY-3 PERCENT (g) | 15.2% 2.6% 7.4% 10.5% |
|TERMINAL (d) | 3/15 (20%) 1/25 (4%) 1/26 (4%) 3/22 (14%) |
|FIRST INCIDENCE | 391 727 (T) 300 405 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.525N P=0.041N* P=0.182N P=0.315N |
|POLY 3 | P=0.540 P=0.066N P=0.242N P=0.404N |
|POLY 1.5 | P=0.540 P=0.075N P=0.275N P=0.424N |
|POLY 6 | P=0.524 P=0.053N P=0.203N P=0.385N |
|LOGISTIC REGRESSION| P=0.515 P=0.075N P=0.347N P=0.439N |
|COCH-ARM / FISHERS | P=0.504 P=0.086N P=0.336N P=0.475N |
|ORDER RESTRICTED | P=0.170N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/51 (10%) 3/55 (5%) 2/53 (4%) 7/53 (13%) |
|POLY-3 RATE (b) | 5/31.43 3/38.53 2/40.53 7/38.15 |
|POLY-3 PERCENT (g) | 15.9% 7.8% 4.9% 18.4% |
|TERMINAL (d) | 4/15 (27%) 3/25 (12%) 1/26 (4%) 6/22 (27%) |
|FIRST INCIDENCE | 705 727 (T) 300 405 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.355 P=0.120N P=0.072N P=0.612N |
|POLY 3 | P=0.297 P=0.247N P=0.124N P=0.520 |
|POLY 1.5 | P=0.291 P=0.280N P=0.151N P=0.484 |
|POLY 6 | P=0.289 P=0.201N P=0.097N P=0.558 |
|LOGISTIC REGRESSION| P=0.307 P=0.109N P=0.145N P=0.546 |
|COCH-ARM / FISHERS | P=0.254 P=0.316N P=0.203N P=0.408 |
|ORDER RESTRICTED | P=0.186 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 0/55 (0%) 1/53 (2%) 4/53 (8%) |
|POLY-3 RATE (b) | 0/31.35 0/38.53 1/39.60 4/39.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.5% 10.2% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 727 (T) 595 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.007 ** (e) P=0.610 P=0.092 |
|POLY 3 | P=0.006 ** (e) P=0.546 P=0.092 |
|POLY 1.5 | P=0.006 ** (e) P=0.531 P=0.082 |
|POLY 6 | P=0.007 ** (e) P=0.565 P=0.106 |
|LOGISTIC REGRESSION| P=0.005 ** (e) P=0.610 P=0.065 |
|COCH-ARM / FISHERS | P=0.005 ** (e) P=0.510 P=0.064 |
|ORDER RESTRICTED | P=0.013 * (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pancreas: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 4/55 (7%) 2/53 (4%) 4/53 (8%) |
|POLY-3 RATE (b) | 0/31.35 4/39.52 2/39.60 4/38.50 |
|POLY-3 PERCENT (g) | 0.0% 10.1% 5.1% 10.4% |
|TERMINAL (d) | 0/15 (0%) 2/25 (8%) 2/26 (8%) 2/22 (9%) |
|FIRST INCIDENCE | --- 253 727 (T) 448 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.196 P=0.132 P=0.365 P=0.106 |
|POLY 3 | P=0.207 P=0.094 P=0.292 P=0.089 |
|POLY 1.5 | P=0.187 P=0.082 P=0.273 P=0.081 |
|POLY 6 | P=0.228 P=0.114 P=0.316 P=0.099 |
|LOGISTIC REGRESSION| P=0.160 P=0.074 P=0.365 P=0.073 |
|COCH-ARM / FISHERS | P=0.148 P=0.069 P=0.257 P=0.064 |
|ORDER RESTRICTED | P=0.072 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/47 (0%) 1/50 (2%) 1/48 (2%) 2/46 (4%) |
|POLY-3 RATE (b) | 0/27.62 1/35.62 1/37.40 2/34.68 |
|POLY-3 PERCENT (g) | 0.0% 2.8% 2.7% 5.8% |
|TERMINAL (d) | 0/13 (0%) 1/24 (4%) 0/24 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- 727 (T) 376 559 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.183 P=0.622 P=0.521 P=0.283 |
|POLY 3 | P=0.193 P=0.550 P=0.559 P=0.291 |
|POLY 1.5 | P=0.178 P=0.535 P=0.541 P=0.271 |
|POLY 6 | P=0.207 P=0.571 P=0.580 P=0.313 |
|LOGISTIC REGRESSION| P=0.117 P=0.622 P=0.376 P=0.217 |
|COCH-ARM / FISHERS | P=0.142 P=0.515 P=0.505 P=0.242 |
|ORDER RESTRICTED | P=0.160 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 14/51 (27%) 15/54 (28%) 22/53 (42%) 12/53 (23%) |
|POLY-3 RATE (b) | 14/33.32 15/40.05 22/44.01 12/38.05 |
|POLY-3 PERCENT (g) | 42.0% 37.5% 50.0% 31.5% |
|TERMINAL (d) | 7/15 (47%) 7/25 (28%) 13/26 (50%) 10/22 (46%) |
|FIRST INCIDENCE | 546 434 328 487 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.238N P=0.194N P=0.572 P=0.108N |
|POLY 3 | P=0.337N P=0.436N P=0.317 P=0.243N |
|POLY 1.5 | P=0.331N P=0.507N P=0.223 P=0.262N |
|POLY 6 | P=0.410N P=0.337N P=0.433 P=0.252N |
|LOGISTIC REGRESSION| P=0.295N P=0.422N P=0.225 P=0.176N |
|COCH-ARM / FISHERS | P=0.457N P=0.572 P=0.097 P=0.367N |
|ORDER RESTRICTED | P=0.247N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 3/54 (6%) 1/53 (2%) 1/53 (2%) |
|POLY-3 RATE (b) | 0/30.88 3/38.75 1/39.60 1/37.76 |
|POLY-3 PERCENT (g) | 0.0% 7.7% 2.5% 2.7% |
|TERMINAL (d) | 0/15 (0%) 1/25 (4%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- 448 727 (T) 600 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.497N P=0.187 P=0.610 P=0.531 |
|POLY 3 | P=0.469N P=0.163 P=0.549 P=0.540 |
|POLY 1.5 | P=0.494N P=0.148 P=0.535 P=0.531 |
|POLY 6 | P=0.446N P=0.189 P=0.566 P=0.549 |
|LOGISTIC REGRESSION| P=0.536N P=0.134 P=0.610 P=0.508 |
|COCH-ARM / FISHERS | P=0.550N P=0.132 P=0.510 P=0.510 |
|ORDER RESTRICTED | P=0.276 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 18/51 (35%) 20/54 (37%) 23/53 (43%) 17/53 (32%) |
|POLY-3 RATE (b) | 18/36.64 20/40.01 23/42.91 17/41.61 |
|POLY-3 PERCENT (g) | 49.1% 50.0% 53.6% 40.9% |
|TERMINAL (d) | 4/15 (27%) 13/25 (52%) 15/26 (58%) 8/22 (36%) |
|FIRST INCIDENCE | 400 546 498 436 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.222N P=0.215N P=0.328N P=0.208N |
|POLY 3 | P=0.254N P=0.562 P=0.429 P=0.301N |
|POLY 1.5 | P=0.273N P=0.545 P=0.382 P=0.317N |
|POLY 6 | P=0.279N P=0.593 P=0.465 P=0.318N |
|LOGISTIC REGRESSION| P=0.270N P=0.501N P=0.475 P=0.326N |
|COCH-ARM / FISHERS | P=0.438N P=0.507 P=0.260 P=0.444N |
|ORDER RESTRICTED | P=0.286N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 39/52 (75%) 43/55 (78%) 46/52 (88%) 45/53 (85%) |
|POLY-3 RATE (b) | 39/47.51 43/47.53 46/48.28 45/49.58 |
|POLY-3 PERCENT (g) | 82.1% 90.5% 95.3% 90.8% |
|TERMINAL (d) | 8/15 (53%) 23/25 (92%) 24/25 (96%) 21/22 (96%) |
|FIRST INCIDENCE | 126 223 188 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.442N P=0.112N P=0.174N P=0.336N |
|POLY 3 | P=0.096 P=0.170 P=0.033 * P=0.155 |
|POLY 1.5 | P=0.093 P=0.251 P=0.039 * P=0.168 |
|POLY 6 | P=0.078 P=0.114 P=0.032 * P=0.119 |
|LOGISTIC REGRESSION| P=0.162 P=0.522 P=0.115 P=0.202 |
|COCH-ARM / FISHERS | P=0.068 P=0.436 P=0.063 P=0.153 |
|ORDER RESTRICTED | P=0.035 * (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 49/52 (94%) 50/55 (91%) 51/52 (98%) 51/53 (96%) |
|POLY-3 RATE (b) | 49/49.42 50/52.81 51/51.32 51/52.28 |
|POLY-3 PERCENT (g) | 99.2% 94.7% 99.4% 97.6% |
|TERMINAL (d) | 15/15 (100%) 24/25 (96%) 25/25 (100%) 22/22 (100%) |
|FIRST INCIDENCE | 126 202 188 124 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.208N P=0.030N* P=0.026N* P=0.114N |
|POLY 3 | P=0.518 P=0.209N P=0.972 P=0.575N |
|POLY 1.5 | P=0.449 P=0.266N P=0.743 P=0.634N |
|POLY 6 | P=0.489 P=0.189N P=1.000 P=0.678N |
|LOGISTIC REGRESSION| P=0.295 P=0.320N P=0.493 P=0.672 |
|COCH-ARM / FISHERS | P=0.180 P=0.390N P=0.309 P=0.491 |
|ORDER RESTRICTED | P=0.355N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 5/55 (9%) 3/52 (6%) 2/53 (4%) |
|POLY-3 RATE (b) | 0/31.36 5/42.56 3/40.37 2/38.51 |
|POLY-3 PERCENT (g) | 0.0% 11.8% 7.4% 5.2% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 1/25 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- 202 328 500 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.560 P=0.049 * P=0.167 P=0.272 |
|POLY 3 | P=0.527N P=0.065 P=0.170 P=0.285 |
|POLY 1.5 | P=0.562N P=0.052 P=0.150 P=0.271 |
|POLY 6 | P=0.500N P=0.088 P=0.195 P=0.300 |
|LOGISTIC REGRESSION| P=0.291 P=0.022 * P=0.070 P=0.202 |
|COCH-ARM / FISHERS | P=0.496 P=0.033 * P=0.121 P=0.252 |
|ORDER RESTRICTED | P=0.146 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Spleen: Red Pulp |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 0/55 (0%) 4/52 (8%) 1/53 (2%) |
|POLY-3 RATE (b) | 0/31.36 0/38.53 4/40.50 1/38.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 9.9% 2.6% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 1/25 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 328 500 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.174 (e) P=0.113 P=0.524 |
|POLY 3 | P=0.180 (e) P=0.099 P=0.538 |
|POLY 1.5 | P=0.174 (e) P=0.083 P=0.528 |
|POLY 6 | P=0.178 (e) P=0.122 P=0.549 |
|LOGISTIC REGRESSION| P=0.109 (e) P=0.042 * P=0.453 |
|COCH-ARM / FISHERS | P=0.146 (e) P=0.059 P=0.505 |
|ORDER RESTRICTED | P=0.119 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 3/55 (5%) 1/53 (2%) 1/53 (2%) |
|POLY-3 RATE (b) | 0/31.36 3/38.71 1/39.75 1/37.58 |
|POLY-3 PERCENT (g) | 0.0% 7.8% 2.5% 2.7% |
|TERMINAL (d) | 0/15 (0%) 2/25 (8%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- 681 688 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.499N P=0.226 P=0.595 P=0.568 |
|POLY 3 | P=0.477N P=0.159 P=0.547 P=0.536 |
|POLY 1.5 | P=0.503N P=0.145 P=0.531 P=0.527 |
|POLY 6 | P=0.450N P=0.184 P=0.566 P=0.546 |
|LOGISTIC REGRESSION| P=0.514N P=0.193 P=0.557 P=0.530 |
|COCH-ARM / FISHERS | P=0.558N P=0.132 P=0.505 P=0.505 |
|ORDER RESTRICTED | P=0.273 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/52 (6%) 4/55 (7%) 6/53 (11%) 2/53 (4%) |
|POLY-3 RATE (b) | 3/32.29 4/38.74 6/41.70 2/38.13 |
|POLY-3 PERCENT (g) | 9.3% 10.3% 14.4% 5.3% |
|TERMINAL (d) | 1/15 (7%) 2/25 (8%) 2/26 (8%) 0/22 (0%) |
|FIRST INCIDENCE | 391 681 328 559 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.348N P=0.567N P=0.446 P=0.377N |
|POLY 3 | P=0.357N P=0.600 P=0.381 P=0.424N |
|POLY 1.5 | P=0.376N P=0.567 P=0.331 P=0.444N |
|POLY 6 | P=0.350N P=0.649 P=0.446 P=0.403N |
|LOGISTIC REGRESSION| P=0.417N P=0.605 P=0.246 P=0.483N |
|COCH-ARM / FISHERS | P=0.445N P=0.532 P=0.254 P=0.491N |
|ORDER RESTRICTED | P=0.315N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 1/55 (2%) 2/53 (4%) 1/53 (2%) |
|POLY-3 RATE (b) | 0/31.36 1/38.56 2/40.19 1/37.58 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 5.0% 2.7% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- 720 602 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.361 P=0.624 P=0.328 P=0.568 |
|POLY 3 | P=0.375 P=0.541 P=0.296 P=0.536 |
|POLY 1.5 | P=0.363 P=0.528 P=0.275 P=0.527 |
|POLY 6 | P=0.385 P=0.561 P=0.324 P=0.546 |
|LOGISTIC REGRESSION| P=0.345 P=0.596 P=0.263 P=0.530 |
|COCH-ARM / FISHERS | P=0.319 P=0.514 P=0.252 P=0.505 |
|ORDER RESTRICTED | P=0.276 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 46
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/52 (6%) 1/55 (2%) 0/53 (0%) 1/53 (2%) |
|POLY-3 RATE (b) | 3/32.17 1/38.56 0/39.60 1/37.58 |
|POLY-3 PERCENT (g) | 9.3% 2.6% 0.0% 2.7% |
|TERMINAL (d) | 1/15 (7%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 574 720 --- 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.135N P=0.180N P=0.066N P=0.217N |
|POLY 3 | P=0.170N P=0.242N P=0.085N P=0.250N |
|POLY 1.5 | P=0.169N P=0.260N P=0.095N P=0.262N |
|POLY 6 | P=0.176N P=0.216N P=0.075N P=0.240N |
|LOGISTIC REGRESSION| P=0.153N P=0.239N P=0.094N P=0.258N |
|COCH-ARM / FISHERS | P=0.176N P=0.288N P=0.118N P=0.302N |
|ORDER RESTRICTED | P=0.052N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 37/50 (74%) 34/52 (65%) 41/46 (89%) 45/48 (94%) |
|POLY-3 RATE (b) | 37/45.02 34/44.40 41/43.90 45/45.61 |
|POLY-3 PERCENT (g) | 82.2% 76.6% 93.4% 98.7% |
|TERMINAL (d) | 9/15 (60%) 15/22 (68%) 19/21 (91%) 19/19 (100%) |
|FIRST INCIDENCE | 126 202 300 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.230 P=0.052N P=0.203N P=0.543N |
|POLY 3 | P<0.001 ** P=0.340N P=0.088 P=0.005 ** |
|POLY 1.5 | P<0.001 ** P=0.297N P=0.063 P=0.005 ** |
|POLY 6 | P<0.001 ** P=0.376N P=0.117 P=0.006 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.196N P=0.081 P=0.018 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.233N P=0.050 P=0.008 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 47
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 1/55 (2%) 4/52 (8%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/31.37 1/38.53 4/39.64 0/36.51 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 10.1% 0.0% |
|TERMINAL (d) | 0/15 (0%) 1/25 (4%) 3/26 (12%) 0/22 (0%) |
|FIRST INCIDENCE | --- 727 (T) 709 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.543 P=0.602 P=0.154 (e) |
|POLY 3 | P=0.535 P=0.541 P=0.095 (e) |
|POLY 1.5 | P=0.517 P=0.527 P=0.081 (e) |
|POLY 6 | P=0.542 P=0.561 P=0.114 (e) |
|LOGISTIC REGRESSION| P=0.524 P=0.602 P=0.137 (e) |
|COCH-ARM / FISHERS | P=0.455 P=0.514 P=0.059 (e) |
|ORDER RESTRICTED | P=0.194 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/52 (23%) 21/55 (38%) 17/52 (33%) 19/51 (37%) |
|POLY-3 RATE (b) | 12/33.93 21/40.89 17/42.41 19/40.46 |
|POLY-3 PERCENT (g) | 35.4% 51.4% 40.1% 47.0% |
|TERMINAL (d) | 5/15 (33%) 14/25 (56%) 10/26 (39%) 11/22 (50%) |
|FIRST INCIDENCE | 541 356 428 436 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.478 P=0.427 P=0.463N P=0.384 |
|POLY 3 | P=0.401 P=0.115 P=0.426 P=0.212 |
|POLY 1.5 | P=0.328 P=0.088 P=0.334 P=0.165 |
|POLY 6 | P=0.451 P=0.169 P=0.532 P=0.260 |
|LOGISTIC REGRESSION| P=0.315 P=0.152 P=0.399 P=0.180 |
|COCH-ARM / FISHERS | P=0.171 P=0.069 P=0.191 P=0.088 |
|ORDER RESTRICTED | P=0.250 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 48
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/52 (17%) 13/55 (24%) 13/52 (25%) 17/51 (33%) |
|POLY-3 RATE (b) | 9/37.19 13/42.20 13/42.54 17/40.34 |
|POLY-3 PERCENT (g) | 24.2% 30.8% 30.6% 42.2% |
|TERMINAL (d) | 2/15 (13%) 5/25 (20%) 6/26 (23%) 9/22 (41%) |
|FIRST INCIDENCE | 201 448 498 405 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.159 P=0.517 P=0.549 P=0.210 |
|POLY 3 | P=0.065 P=0.341 P=0.350 P=0.069 |
|POLY 1.5 | P=0.057 P=0.292 P=0.294 P=0.059 |
|POLY 6 | P=0.072 P=0.444 P=0.445 P=0.091 |
|LOGISTIC REGRESSION| P=0.040 * P=0.246 P=0.135 P=0.030 * |
|COCH-ARM / FISHERS | P=0.043 * P=0.285 P=0.236 P=0.050 |
|ORDER RESTRICTED | P=0.067 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/12 (83%) 12/12 (100%) 10/10 (100%) 9/9 (100%) |
|POLY-3 RATE (b) | 10/12.00 12/12.00 10/10.00 9/9.00 |
|POLY-3 PERCENT (g) | 83.3% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 5/7 (71%) 9/9 (100%) 5/5 (100%) 4/4 (100%) |
|FIRST INCIDENCE | 405 253 300 436 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.361 P=0.515N P=0.610 P=0.574 |
|POLY 3 | P=0.133 P=0.229 P=0.272 P=0.297 |
|POLY 1.5 | P=0.133 P=0.229 P=0.272 P=0.297 |
|POLY 6 | P=0.133 P=0.229 P=0.272 P=0.297 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.138 P=0.239 P=0.286 P=0.314 |
|ORDER RESTRICTED | P=0.054 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 49
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/12 (17%) 0/12 (0%) 0/10 (0%) 0/9 (0%) |
|POLY-3 RATE (b) | 2/9.81 0/10.52 0/7.71 0/6.56 |
|POLY-3 PERCENT (g) | 20.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/7 (29%) 0/9 (0%) 0/5 (0%) 0/4 (0%) |
|FIRST INCIDENCE | 727 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.173N P=0.178N P=0.308N P=0.362N |
|POLY 3 | P=0.147N P=0.210N P=0.283N P=0.324N |
|POLY 1.5 | P=0.138N P=0.221N P=0.284N P=0.310N |
|POLY 6 | P=0.162N P=0.196N P=0.277N P=0.346N |
|LOGISTIC REGRESSION| P=0.173N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.138N P=0.239N P=0.286N P=0.314N |
|ORDER RESTRICTED | P=0.072N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/51 (8%) 6/54 (11%) 10/53 (19%) 6/52 (12%) |
|POLY-3 RATE (b) | 4/32.86 6/41.99 10/43.51 6/38.88 |
|POLY-3 PERCENT (g) | 12.2% 14.3% 23.0% 15.4% |
|TERMINAL (d) | 0/15 (0%) 1/25 (4%) 5/26 (19%) 1/22 (5%) |
|FIRST INCIDENCE | 391 350 188 448 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.375 P=0.496 P=0.216 P=0.526 |
|POLY 3 | P=0.331 P=0.530 P=0.183 P=0.478 |
|POLY 1.5 | P=0.321 P=0.479 P=0.146 P=0.451 |
|POLY 6 | P=0.330 P=0.592 P=0.227 P=0.507 |
|LOGISTIC REGRESSION| P=0.182 P=0.356 P=0.052 P=0.374 |
|COCH-ARM / FISHERS | P=0.257 P=0.408 P=0.086 P=0.383 |
|ORDER RESTRICTED | P=0.343 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 50
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/51 (2%) 1/54 (2%) 1/53 (2%) 2/52 (4%) |
|POLY-3 RATE (b) | 1/31.35 1/38.94 1/40.46 2/37.45 |
|POLY-3 PERCENT (g) | 3.2% 2.6% 2.5% 5.3% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 574 524 376 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.396 P=0.730N P=0.727N P=0.598 |
|POLY 3 | P=0.376 P=0.711N P=0.701N P=0.562 |
|POLY 1.5 | P=0.371 P=0.728N P=0.720N P=0.546 |
|POLY 6 | P=0.376 P=0.687N P=0.680N P=0.577 |
|LOGISTIC REGRESSION| P=0.300 P=0.761N P=0.709 P=0.531 |
|COCH-ARM / FISHERS | P=0.340 P=0.738N P=0.743N P=0.507 |
|ORDER RESTRICTED | P=0.448 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/52 (23%) 12/55 (22%) 11/53 (21%) 16/52 (31%) |
|POLY-3 RATE (b) | 12/35.65 12/42.38 11/42.96 16/40.30 |
|POLY-3 PERCENT (g) | 33.7% 28.3% 25.6% 39.7% |
|TERMINAL (d) | 2/15 (13%) 4/25 (16%) 4/26 (15%) 9/22 (41%) |
|FIRST INCIDENCE | 391 328 188 448 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.386 P=0.257N P=0.194N P=0.558 |
|POLY 3 | P=0.264 P=0.395N P=0.296N P=0.377 |
|POLY 1.5 | P=0.256 P=0.445N P=0.350N P=0.348 |
|POLY 6 | P=0.258 P=0.341N P=0.244N P=0.391 |
|LOGISTIC REGRESSION| P=0.220 P=0.507N P=0.452N P=0.351 |
|COCH-ARM / FISHERS | P=0.194 P=0.530N P=0.479N P=0.254 |
|ORDER RESTRICTED | P=0.254 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 51
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 0/55 (0%) 0/53 (0%) 2/52 (4%) |
|POLY-3 RATE (b) | 0/31.36 0/38.53 0/39.60 2/36.94 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.4% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 0/26 (0%) 2/22 (9%) |
|FIRST INCIDENCE | --- --- --- 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.051 (e) (e) P=0.325 |
|POLY 3 | P=0.048 * (e) (e) P=0.274 |
|POLY 1.5 | P=0.047 * (e) (e) P=0.263 |
|POLY 6 | P=0.048 * (e) (e) P=0.286 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.325 |
|COCH-ARM / FISHERS | P=0.044 * (e) (e) P=0.248 |
|ORDER RESTRICTED | P=0.045 * (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 26/52 (50%) 33/55 (60%) 25/53 (47%) 28/52 (54%) |
|POLY-3 RATE (b) | 26/41.07 33/47.72 25/45.60 28/45.56 |
|POLY-3 PERCENT (g) | 63.3% 69.2% 54.8% 61.5% |
|TERMINAL (d) | 7/15 (47%) 16/25 (64%) 11/26 (42%) 12/22 (55%) |
|FIRST INCIDENCE | 321 253 188 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.170N P=0.391N P=0.073N P=0.291N |
|POLY 3 | P=0.263N P=0.356 P=0.275N P=0.518N |
|POLY 1.5 | P=0.291N P=0.306 P=0.313N P=0.557N |
|POLY 6 | P=0.263N P=0.379 P=0.246N P=0.523N |
|LOGISTIC REGRESSION| P=0.394N P=0.240 P=0.362N P=0.494 |
|COCH-ARM / FISHERS | P=0.458N P=0.199 P=0.462N P=0.422 |
|ORDER RESTRICTED | P=0.330N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 52
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 0/55 (0%) 2/53 (4%) 0/52 (0%) |
|POLY-3 RATE (b) | 0/31.36 0/38.53 2/39.98 0/36.94 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 5.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/25 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 621 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.494 (e) P=0.351 (e) |
|POLY 3 | P=0.497 (e) P=0.294 (e) |
|POLY 1.5 | P=0.492 (e) P=0.274 (e) |
|POLY 6 | P=0.493 (e) P=0.321 (e) |
|LOGISTIC REGRESSION| P=0.478 (e) P=0.285 (e) |
|COCH-ARM / FISHERS | P=0.453 (e) P=0.252 (e) |
|ORDER RESTRICTED | P=0.296 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 30 NG/KG 100 175 |
| | NG/KG NG/KG |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 23/52 (44%) 33/55 (60%) 28/53 (53%) 24/52 (46%) |
|POLY-3 RATE (b) | 23/35.31 33/43.07 28/43.94 24/42.67 |
|POLY-3 PERCENT (g) | 65.1% 76.6% 63.7% 56.3% |
|TERMINAL (d) | 12/15 (80%) 22/25 (88%) 16/26 (62%) 11/22 (50%) |
|FIRST INCIDENCE | 496 350 188 385 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.090N P=0.438N P=0.161N P=0.194N |
|POLY 3 | P=0.053N P=0.165 P=0.545N P=0.273N |
|POLY 1.5 | P=0.109N P=0.107 P=0.497 P=0.391N |
|POLY 6 | P=0.029N* P=0.288 P=0.371N P=0.181N |
|LOGISTIC REGRESSION| P=0.144N P=0.187 P=0.556N P=0.389N |
|COCH-ARM / FISHERS | P=0.380N P=0.075 P=0.246 P=0.500 |
|ORDER RESTRICTED | P=0.107N (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).