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: 12:20:03
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 6, 7, & 8
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 006 300 NG/KG
INCLUDE 007 550 NG/KG
INCLUDE 008 1000 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: 12:20:03
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
Atrophy
Hypertrophy
Vacuolization Cytoplasmic
Adrenal Medulla Hyperplasia
Blood Vessel: Aorta Mineralization
Bone Marrow Hyperplasia
Clitoral Gland Inflammation
Clitoral Gland: Duct Cyst
Eye: Cornea Inflammation
Eye: Retina Atrophy
Harderian Gland Inflammation
Heart Cardiomyopathy
Heart: Epicardium Inflammation
Kidney Casts Protein
Mineralization
Nephropathy
Kidney: Transitional Epithelium Hyperplasia
Liver Cholangiofibrosis
Clear Cell Focus
Degeneration Cystic
Eosinophilic Focus
Fatty Change Diffuse
Hepatocyte, Multinucleate
Hyperplasia
Inflammation
Mixed Cell Focus
Necrosis
Pigmentation
Toxic Hepatopathy
Liver: Bile Duct Cyst
Hyperplasia
Liver: Hepatocyte Degeneration
Hypertrophy
Liver: Oval Cell Hyperplasia
Liver: Portal Fibrosis
Lung Infiltration Cellular Histiocyte
Inflammation Chronic
Inflammation Granulomatous
Metaplasia
Lung: Alveolar Epithelium Hyperplasia
Metaplasia Bronchiolar
Lymph Node, Mandibular Hyperplasia
Lymph Node, Mesenteric Hyperplasia Lymphoid
Lymph Node: Mediastinal Ectasia
Hemorrhage
Mammary Gland Cyst
Hyperplasia
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: 12:20:03
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-75411 ROUTE: GAVAGE NTP C#: 96007D
PATHOLOGIST: MISSING CAS: 57465-28-8
Inflammation Granulomatous
Mesentery Inflammation Chronic
Mesentery: Artery Inflammation Chronic
Oral Mucosa: Gingival Hyperplasia
Ovary Atrophy
Pancreas Inflammation Chronic
Pancreas: Acinus Atrophy
Vacuolization Cytoplasmic
Pancreas: Artery Inflammation Chronic
Pancreas: Duct Dilatation
Spleen Hyperplasia Lymphoid
Pigmentation
Spleen: Lymphoid Follicle Atrophy
Stomach, Forestomach Hyperplasia
Thymus Atrophy
Thyroid Gland: C-Cell Hyperplasia
Thyroid Gland: Follicular Cell Hypertrophy
Tooth: Peridontal Tissue Inflammation
Inflammation Chronic
Ureter Metaplasia
Uterus Inflammation
Metaplasia
Uterus: Endometrium Hyperplasia Cystic
===============================================================
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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/52 (21%) 20/53 (38%) 8/52 (15%) 1/53 (2%) |
|POLY-3 RATE (b) | 11/34.50 20/39.31 8/42.81 1/32.22 |
|POLY-3 PERCENT (g) | 31.9% 50.9% 18.7% 3.1% |
|TERMINAL (d) | 4/15 (27%) 12/16 (75%) 6/23 (26%) 0/7 (0%) |
|FIRST INCIDENCE | 541 301 440 642 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** P=0.106 P=0.078N P=0.010N* |
|POLY 3 | P<0.001N** P=0.069 P=0.140N P=0.002N** |
|POLY 1.5 | P<0.001N** P=0.063 P=0.183N P=0.002N** |
|POLY 6 | P<0.001N** P=0.061 P=0.109N P=0.004N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.095 P=0.179N P=0.002N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.049 * P=0.306N P=0.002N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 5/53 (9%) 19/52 (37%) 30/53 (57%) |
|POLY-3 RATE (b) | 1/31.36 5/37.66 19/43.48 30/39.85 |
|POLY-3 PERCENT (g) | 3.2% 13.3% 43.7% 75.3% |
|TERMINAL (d) | 1/15 (7%) 2/16 (13%) 9/23 (39%) 6/7 (86%) |
|FIRST INCIDENCE | 727 (T) 607 554 243 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.150 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.146 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.129 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.167 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.143 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.107 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/52 (21%) 14/53 (26%) 16/52 (31%) 10/53 (19%) |
|POLY-3 RATE (b) | 11/34.41 14/40.61 16/43.78 10/35.87 |
|POLY-3 PERCENT (g) | 32.0% 34.5% 36.5% 27.9% |
|TERMINAL (d) | 4/15 (27%) 0/16 (0%) 8/23 (35%) 0/7 (0%) |
|FIRST INCIDENCE | 496 531 535 309 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.447 P=0.548 P=0.528N P=0.515 |
|POLY 3 | P=0.396N P=0.507 P=0.427 P=0.454N |
|POLY 1.5 | P=0.384N P=0.440 P=0.336 P=0.448N |
|POLY 6 | P=0.452N P=0.581 P=0.525 P=0.504N |
|LOGISTIC REGRESSION| P=0.404N P=0.428 P=0.391 P=0.471N |
|COCH-ARM / FISHERS | P=0.421N P=0.344 P=0.186 P=0.480N |
|ORDER RESTRICTED | P=0.446N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 23/52 (44%) 25/53 (47%) 31/52 (60%) 24/53 (45%) |
|POLY-3 RATE (b) | 23/38.88 25/41.73 31/44.16 24/39.04 |
|POLY-3 PERCENT (g) | 59.2% 59.9% 70.2% 61.5% |
|TERMINAL (d) | 7/15 (47%) 10/16 (63%) 18/23 (78%) 4/7 (57%) |
|FIRST INCIDENCE | 309 331 573 394 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.103 P=0.453N P=0.341N P=0.230 |
|POLY 3 | P=0.370 P=0.566 P=0.191 P=0.509 |
|POLY 1.5 | P=0.411 P=0.534 P=0.155 P=0.538 |
|POLY 6 | P=0.279 P=0.572 P=0.219 P=0.419 |
|LOGISTIC REGRESSION| P=0.467 P=0.565N P=0.363 P=0.567 |
|COCH-ARM / FISHERS | P=0.425 P=0.458 P=0.085 P=0.535 |
|ORDER RESTRICTED | P=0.401 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 34/52 (65%) 40/53 (75%) 41/52 (79%) 41/53 (77%) |
|POLY-3 RATE (b) | 34/39.07 40/45.32 41/46.88 41/44.54 |
|POLY-3 PERCENT (g) | 87.0% 88.3% 87.5% 92.0% |
|TERMINAL (d) | 15/15 (100%) 14/16 (88%) 22/23 (96%) 7/7 (100%) |
|FIRST INCIDENCE | 391 454 185 309 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.010 * P=0.558 P=0.095N P=0.013 * |
|POLY 3 | P=0.251 P=0.575 P=0.625 P=0.299 |
|POLY 1.5 | P=0.179 P=0.341 P=0.383 P=0.188 |
|POLY 6 | P=0.323 P=0.470N P=0.465N P=0.534 |
|LOGISTIC REGRESSION| P=0.158 P=0.446 P=0.538N P=0.176 |
|COCH-ARM / FISHERS | P=0.106 P=0.179 P=0.095 P=0.127 |
|ORDER RESTRICTED | P=0.315 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 1/53 (2%) 1/52 (2%) 2/53 (4%) |
|POLY-3 RATE (b) | 1/31.80 1/36.92 1/41.58 2/32.55 |
|POLY-3 PERCENT (g) | 3.1% 2.7% 2.4% 6.2% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 600 642 714 574 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.311 P=0.706N P=0.648N P=0.503 |
|POLY 3 | P=0.354 P=0.727N P=0.698N P=0.508 |
|POLY 1.5 | P=0.359 P=0.738N P=0.720N P=0.513 |
|POLY 6 | P=0.341 P=0.717N P=0.672N P=0.484 |
|LOGISTIC REGRESSION| P=0.353 P=0.750N P=0.731N P=0.509 |
|COCH-ARM / FISHERS | P=0.354 P=0.748N P=0.752N P=0.507 |
|ORDER RESTRICTED | P=0.381 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/52 (10%) 9/53 (17%) 4/52 (8%) 17/53 (32%) |
|POLY-3 RATE (b) | 5/32.65 9/39.52 4/42.52 17/36.67 |
|POLY-3 PERCENT (g) | 15.3% 22.8% 9.4% 46.4% |
|TERMINAL (d) | 3/15 (20%) 2/16 (13%) 1/23 (4%) 3/7 (43%) |
|FIRST INCIDENCE | 496 163 554 525 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.295 P=0.273N P<0.001 ** |
|POLY 3 | P=0.003 ** P=0.308 P=0.338N P=0.004 ** |
|POLY 1.5 | P=0.003 ** P=0.268 P=0.393N P=0.004 ** |
|POLY 6 | P=0.002 ** P=0.358 P=0.281N P=0.003 ** |
|LOGISTIC REGRESSION| P=0.003 ** P=0.224 P=0.422N P=0.004 ** |
|COCH-ARM / FISHERS | P=0.003 ** P=0.206 P=0.500N P=0.004 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 2/53 (4%) 2/52 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/31.36 2/36.61 2/41.53 0/31.91 |
|POLY-3 PERCENT (g) | 0.0% 5.5% 4.8% 0.0% |
|TERMINAL (d) | 0/15 (0%) 2/16 (13%) 2/23 (9%) 0/7 (0%) |
|FIRST INCIDENCE | --- 727 (T) 727 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.586 P=0.250 P=0.336 (e) |
|POLY 3 | P=0.528N P=0.272 P=0.304 (e) |
|POLY 1.5 | P=0.525N P=0.260 P=0.280 (e) |
|POLY 6 | P=0.551N P=0.283 P=0.333 (e) |
|LOGISTIC REGRESSION| (e) P=0.250 P=0.336 (e) |
|COCH-ARM / FISHERS | P=0.537N P=0.252 P=0.248 (e) |
|ORDER RESTRICTED | P=0.322N (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/52 (15%) 12/53 (23%) 6/52 (12%) 1/53 (2%) |
|POLY-3 RATE (b) | 8/33.72 12/37.67 6/42.16 1/32.28 |
|POLY-3 PERCENT (g) | 23.7% 31.9% 14.2% 3.1% |
|TERMINAL (d) | 3/15 (20%) 5/16 (31%) 3/23 (13%) 0/7 (0%) |
|FIRST INCIDENCE | 496 618 573 621 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.017N* P=0.376 P=0.143N P=0.040N* |
|POLY 3 | P=0.005N** P=0.305 P=0.224N P=0.015N* |
|POLY 1.5 | P=0.004N** P=0.283 P=0.273N P=0.014N* |
|POLY 6 | P=0.006N** P=0.320 P=0.180N P=0.023N* |
|LOGISTIC REGRESSION| P=0.004N** P=0.362 P=0.248N P=0.016N* |
|COCH-ARM / FISHERS | P=0.007N** P=0.243 P=0.387N P=0.014N* |
|ORDER RESTRICTED | P=0.006N** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 0/53 (0%) 2/53 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 3/32.76 0/36.61 2/42.83 0/31.91 |
|POLY-3 PERCENT (g) | 9.2% 0.0% 4.7% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 583 --- 573 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.088N P=0.088N P=0.329N P=0.100N |
|POLY 3 | P=0.117N P=0.098N P=0.380N P=0.121N |
|POLY 1.5 | P=0.113N P=0.104N P=0.418N P=0.116N |
|POLY 6 | P=0.124N P=0.095N P=0.345N P=0.142N |
|LOGISTIC REGRESSION| P=0.111N P=0.118N P=0.512N P=0.119N |
|COCH-ARM / FISHERS | P=0.111N P=0.121N P=0.500N P=0.121N |
|ORDER RESTRICTED | P=0.038N* (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Bone |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/53 (4%) 0/53 (0%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/31.38 2/38.22 0/42.13 0/31.91 |
|POLY-3 PERCENT (g) | 0.0% 5.2% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 40 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.414N P=0.258 (e) (e) |
|POLY 3 | P=0.362N P=0.283 (e) (e) |
|POLY 1.5 | P=0.381N P=0.267 (e) (e) |
|POLY 6 | P=0.340N P=0.299 (e) (e) |
|LOGISTIC REGRESSION| P=0.476N P=0.182 (e) (e) |
|COCH-ARM / FISHERS | P=0.423N P=0.248 (e) (e) |
|ORDER RESTRICTED | P=0.283N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 47/53 (89%) 45/53 (85%) 46/53 (87%) 46/53 (87%) |
|POLY-3 RATE (b) | 47/52.12 45/51.59 46/52.30 46/49.04 |
|POLY-3 PERCENT (g) | 90.2% 87.2% 88.0% 93.8% |
|TERMINAL (d) | 10/15 (67%) 12/16 (75%) 18/23 (78%) 7/7 (100%) |
|FIRST INCIDENCE | 126 40 185 72 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.224 P=0.181N P=0.019N* P=0.265 |
|POLY 3 | P=0.288 P=0.432N P=0.479N P=0.370 |
|POLY 1.5 | P=0.423 P=0.399N P=0.476N P=0.545 |
|POLY 6 | P=0.155 P=0.493N P=0.494N P=0.167 |
|LOGISTIC REGRESSION| P=0.500N P=0.504N P=0.514 P=0.508N |
|COCH-ARM / FISHERS | P=0.483N P=0.388N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.281 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 28/50 (56%) 30/53 (57%) 27/52 (52%) 22/51 (43%) |
|POLY-3 RATE (b) | 28/40.18 30/44.65 27/47.18 22/42.43 |
|POLY-3 PERCENT (g) | 69.7% 67.2% 57.2% 51.9% |
|TERMINAL (d) | 9/14 (64%) 12/16 (75%) 11/23 (48%) 1/7 (14%) |
|FIRST INCIDENCE | 222 301 320 188 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.329N P=0.385N P=0.043N* P=0.393N |
|POLY 3 | P=0.032N* P=0.494N P=0.155N P=0.062N |
|POLY 1.5 | P=0.034N* P=0.527N P=0.214N P=0.064N |
|POLY 6 | P=0.041N* P=0.476N P=0.110N P=0.080N |
|LOGISTIC REGRESSION| P=0.083N P=0.513N P=0.321N P=0.150N |
|COCH-ARM / FISHERS | P=0.088N P=0.554 P=0.415N P=0.137N |
|ORDER RESTRICTED | P=0.064N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 29/50 (58%) 39/53 (74%) 42/52 (81%) 45/51 (88%) |
|POLY-3 RATE (b) | 29/40.97 39/47.23 42/48.69 45/47.03 |
|POLY-3 PERCENT (g) | 70.8% 82.6% 86.3% 95.7% |
|TERMINAL (d) | 8/14 (57%) 11/16 (69%) 18/23 (78%) 6/7 (86%) |
|FIRST INCIDENCE | 126 247 320 188 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.349 P=0.438N P=0.004 ** |
|POLY 3 | P<0.001 ** P=0.126 P=0.049 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.090 P=0.025 * P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.177 P=0.094 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.100 P=0.033 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.072 P=0.011 * P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Esophagus: Muscularis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 1/53 (2%) 2/52 (4%) 0/52 (0%) |
|POLY-3 RATE (b) | 2/30.96 1/36.86 2/41.73 0/31.53 |
|POLY-3 PERCENT (g) | 6.5% 2.7% 4.8% 0.0% |
|TERMINAL (d) | 1/14 (7%) 0/16 (0%) 2/23 (9%) 0/7 (0%) |
|FIRST INCIDENCE | 547 659 727 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.228N P=0.439N P=0.526N P=0.293N |
|POLY 3 | P=0.200N P=0.439N P=0.582N P=0.231N |
|POLY 1.5 | P=0.196N P=0.458N P=0.620N P=0.229N |
|POLY 6 | P=0.212N P=0.421N P=0.540N P=0.247N |
|LOGISTIC REGRESSION| P=0.179N P=0.455N P=0.574N P=0.231N |
|COCH-ARM / FISHERS | P=0.199N P=0.493N P=0.691N P=0.248N |
|ORDER RESTRICTED | P=0.150N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Eye: Cornea |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 0/53 (0%) 1/52 (2%) 2/52 (4%) |
|POLY-3 RATE (b) | 0/30.21 0/36.61 1/41.54 2/31.74 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.4% 6.3% |
|TERMINAL (d) | 0/14 (0%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- 720 663 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.032 * (e) P=0.610 P=0.208 |
|POLY 3 | P=0.065 (e) P=0.562 P=0.246 |
|POLY 1.5 | P=0.068 (e) P=0.543 P=0.249 |
|POLY 6 | P=0.060 (e) P=0.584 P=0.233 |
|LOGISTIC REGRESSION| P=0.051 (e) P=0.619 P=0.231 |
|COCH-ARM / FISHERS | P=0.069 (e) P=0.505 P=0.252 |
|ORDER RESTRICTED | P=0.080 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Eye: Retina |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 0/53 (0%) 1/52 (2%) 4/52 (8%) |
|POLY-3 RATE (b) | 0/30.21 0/36.61 1/41.53 4/32.41 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.4% 12.3% |
|TERMINAL (d) | 0/14 (0%) 0/16 (0%) 0/23 (0%) 1/7 (14%) |
|FIRST INCIDENCE | --- --- 722 484 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.602 P=0.031 * |
|POLY 3 | P=0.006 ** (e) P=0.562 P=0.066 |
|POLY 1.5 | P=0.006 ** (e) P=0.543 P=0.067 |
|POLY 6 | P=0.005 ** (e) P=0.584 P=0.058 |
|LOGISTIC REGRESSION| P=0.005 ** (e) P=0.622 P=0.066 |
|COCH-ARM / FISHERS | P=0.006 ** (e) P=0.505 P=0.061 |
|ORDER RESTRICTED | P=0.007 ** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 3/53 (6%) 3/52 (6%) 6/52 (12%) |
|POLY-3 RATE (b) | 2/32.88 3/37.08 3/42.38 6/33.83 |
|POLY-3 PERCENT (g) | 6.1% 8.1% 7.1% 17.7% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 1/23 (4%) 1/7 (14%) |
|FIRST INCIDENCE | 321 607 574 188 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.048 * P=0.581 P=0.632 P=0.110 |
|POLY 3 | P=0.085 P=0.555 P=0.613 P=0.135 |
|POLY 1.5 | P=0.085 P=0.536 P=0.573 P=0.139 |
|POLY 6 | P=0.080 P=0.573 P=0.657 P=0.116 |
|LOGISTIC REGRESSION| P=0.075 P=0.495 P=0.398 P=0.118 |
|COCH-ARM / FISHERS | P=0.076 P=0.500 P=0.491 P=0.129 |
|ORDER RESTRICTED | P=0.091 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/52 (17%) 24/53 (45%) 28/51 (55%) 32/51 (63%) |
|POLY-3 RATE (b) | 9/35.59 24/41.08 28/45.07 32/39.46 |
|POLY-3 PERCENT (g) | 25.3% 58.4% 62.1% 81.1% |
|TERMINAL (d) | 2/15 (13%) 12/16 (75%) 12/23 (52%) 7/7 (100%) |
|FIRST INCIDENCE | 201 331 554 188 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.012 * P=0.034 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.002 ** P=0.002 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.003 ** 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) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Heart: Epicardium |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 0/53 (0%) 0/51 (0%) 0/51 (0%) |
|POLY-3 RATE (b) | 2/32.82 0/36.61 0/41.13 0/30.95 |
|POLY-3 PERCENT (g) | 6.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 126 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.080N P=0.217N P=0.204N P=0.228N |
|POLY 3 | P=0.080N P=0.212N P=0.191N P=0.249N |
|POLY 1.5 | P=0.084N P=0.221N P=0.208N P=0.244N |
|POLY 6 | P=0.069N P=0.206N P=0.173N P=0.269N |
|LOGISTIC REGRESSION| P=0.111N P=0.256N P=0.431N P=0.247N |
|COCH-ARM / FISHERS | P=0.089N P=0.243N P=0.252N P=0.252N |
|ORDER RESTRICTED | P=0.034N* (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 1/53 (2%) 0/52 (0%) 1/53 (2%) |
|POLY-3 RATE (b) | 2/30.87 1/37.22 0/41.53 1/31.91 |
|POLY-3 PERCENT (g) | 6.5% 2.7% 0.0% 3.1% |
|TERMINAL (d) | 2/15 (13%) 0/16 (0%) 0/23 (0%) 1/7 (14%) |
|FIRST INCIDENCE | 727 (T) 531 --- 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.405N P=0.465N P=0.149N P=0.723 |
|POLY 3 | P=0.304N P=0.435N P=0.178N P=0.488N |
|POLY 1.5 | P=0.312N P=0.455N P=0.196N P=0.482N |
|POLY 6 | P=0.282N P=0.416N P=0.160N P=0.518N |
|LOGISTIC REGRESSION| P=0.316N P=0.448N (e) P=0.723 |
|COCH-ARM / FISHERS | P=0.324N P=0.493N P=0.248N P=0.493N |
|ORDER RESTRICTED | P=0.194N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 0/53 (0%) 0/51 (0%) 2/53 (4%) |
|POLY-3 RATE (b) | 1/31.84 0/36.61 0/41.43 2/32.17 |
|POLY-3 PERCENT (g) | 3.1% 0.0% 0.0% 6.2% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 583 --- --- 694 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.236 P=0.461N P=0.436N P=0.455 |
|POLY 3 | P=0.272 P=0.472N P=0.448N P=0.504 |
|POLY 1.5 | P=0.273 P=0.481N P=0.467N P=0.511 |
|POLY 6 | P=0.274 P=0.465N P=0.429N P=0.475 |
|LOGISTIC REGRESSION| P=0.266 P=0.499N P=0.534N P=0.499 |
|COCH-ARM / FISHERS | P=0.272 P=0.495N P=0.505N P=0.507 |
|ORDER RESTRICTED | P=0.122 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Casts Protein |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 0/53 (0%) 0/52 (0%) 2/53 (4%) |
|POLY-3 RATE (b) | 4/31.53 0/36.61 0/41.53 2/32.74 |
|POLY-3 PERCENT (g) | 12.7% 0.0% 0.0% 6.1% |
|TERMINAL (d) | 3/15 (20%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 688 --- --- 607 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.316N P=0.049N* P=0.020N* P=0.514N |
|POLY 3 | P=0.261N P=0.042N* P=0.033N* P=0.316N |
|POLY 1.5 | P=0.264N P=0.048N* P=0.041N* P=0.316N |
|POLY 6 | P=0.243N P=0.037N* P=0.025N* P=0.338N |
|LOGISTIC REGRESSION| P=0.257N P=0.035N* P=0.016N* P=0.369N |
|COCH-ARM / FISHERS | P=0.268N P=0.059N P=0.061N P=0.339N |
|ORDER RESTRICTED | P=0.024N* (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/53 (0%) 1/52 (2%) 2/53 (4%) |
|POLY-3 RATE (b) | 0/31.38 0/36.61 1/41.91 2/32.93 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.4% 6.1% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- 618 555 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.068 (e) P=0.596 P=0.281 |
|POLY 3 | P=0.067 (e) P=0.557 P=0.246 |
|POLY 1.5 | P=0.069 (e) P=0.536 P=0.247 |
|POLY 6 | P=0.062 (e) P=0.579 P=0.234 |
|LOGISTIC REGRESSION| P=0.069 (e) P=0.501 P=0.237 |
|COCH-ARM / FISHERS | P=0.069 (e) P=0.495 P=0.248 |
|ORDER RESTRICTED | P=0.080 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/53 (2%) 1/52 (2%) 0/53 (0%) |
|POLY-3 RATE (b) | 2/31.89 1/36.86 1/41.53 0/31.91 |
|POLY-3 PERCENT (g) | 6.3% 2.7% 2.4% 0.0% |
|TERMINAL (d) | 1/15 (7%) 0/16 (0%) 1/23 (4%) 0/7 (0%) |
|FIRST INCIDENCE | 574 659 727 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.155N P=0.446N P=0.366N P=0.302N |
|POLY 3 | P=0.140N P=0.449N P=0.409N P=0.235N |
|POLY 1.5 | P=0.140N P=0.467N P=0.441N P=0.231N |
|POLY 6 | P=0.141N P=0.434N P=0.377N P=0.255N |
|LOGISTIC REGRESSION| P=0.130N P=0.459N P=0.408N P=0.236N |
|COCH-ARM / FISHERS | P=0.144N P=0.500N P=0.507N P=0.248N |
|ORDER RESTRICTED | P=0.115N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 32/53 (60%) 44/53 (83%) 39/52 (75%) 37/53 (70%) |
|POLY-3 RATE (b) | 32/42.76 44/50.35 39/47.55 37/45.03 |
|POLY-3 PERCENT (g) | 74.8% 87.4% 82.0% 82.2% |
|TERMINAL (d) | 12/15 (80%) 14/16 (88%) 20/23 (87%) 6/7 (86%) |
|FIRST INCIDENCE | 126 40 320 72 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.085 P=0.224 P=0.183N P=0.068 |
|POLY 3 | P=0.349 P=0.080 P=0.267 P=0.258 |
|POLY 1.5 | P=0.368 P=0.037 * P=0.186 P=0.258 |
|POLY 6 | P=0.276 P=0.161 P=0.366 P=0.218 |
|LOGISTIC REGRESSION| P=0.353 P=0.013 * P=0.250 P=0.234 |
|COCH-ARM / FISHERS | P=0.310 P=0.008 ** P=0.082 P=0.208 |
|ORDER RESTRICTED | P=0.182 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 32/53 (60%) 38/53 (72%) 42/52 (81%) 47/53 (89%) |
|POLY-3 RATE (b) | 32/43.26 38/44.56 42/46.08 47/48.96 |
|POLY-3 PERCENT (g) | 74.0% 85.3% 91.1% 96.0% |
|TERMINAL (d) | 11/15 (73%) 14/16 (88%) 22/23 (96%) 7/7 (100%) |
|FIRST INCIDENCE | 126 331 554 188 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.515 P=0.276N P=0.003 ** |
|POLY 3 | P<0.001 ** P=0.116 P=0.014 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.096 P=0.011 * P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.163 P=0.025 * P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.239 P=0.095 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.153 P=0.018 * P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/53 (0%) 1/52 (2%) 2/53 (4%) |
|POLY-3 RATE (b) | 2/32.37 0/36.61 1/41.91 2/33.30 |
|POLY-3 PERCENT (g) | 6.2% 0.0% 2.4% 6.0% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 574 --- 618 309 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.522 P=0.201N P=0.374N P=0.650N |
|POLY 3 | P=0.488 P=0.210N P=0.411N P=0.686N |
|POLY 1.5 | P=0.494 P=0.218N P=0.442N P=0.680N |
|POLY 6 | P=0.477 P=0.204N P=0.381N P=0.681 |
|LOGISTIC REGRESSION| P=0.474 P=0.239N P=0.534N P=0.681 |
|COCH-ARM / FISHERS | P=0.493 P=0.248N P=0.507N P=0.691N |
|ORDER RESTRICTED | P=0.365N (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 3/53 (6%) 0/52 (0%) 0/53 (0%) |
|POLY-3 RATE (b) | 2/32.53 3/38.48 0/41.53 0/31.91 |
|POLY-3 PERCENT (g) | 6.2% 7.8% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 541 301 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.057N P=0.577 P=0.180N P=0.211N |
|POLY 3 | P=0.058N P=0.577 P=0.187N P=0.240N |
|POLY 1.5 | P=0.061N P=0.551 P=0.204N P=0.233N |
|POLY 6 | P=0.054N P=0.598 P=0.172N P=0.263N |
|LOGISTIC REGRESSION| P=0.088N P=0.454 P=0.284N P=0.241N |
|COCH-ARM / FISHERS | P=0.072N P=0.500 P=0.252N P=0.248N |
|ORDER RESTRICTED | P=0.107N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 8/53 (15%) 8/52 (15%) 11/53 (21%) |
|POLY-3 RATE (b) | 4/32.45 8/38.99 8/42.50 11/35.55 |
|POLY-3 PERCENT (g) | 12.3% 20.5% 18.8% 30.9% |
|TERMINAL (d) | 2/15 (13%) 2/16 (13%) 4/23 (17%) 1/7 (14%) |
|FIRST INCIDENCE | 554 301 618 309 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * P=0.272 P=0.443 P=0.023 * |
|POLY 3 | P=0.053 P=0.273 P=0.331 P=0.054 |
|POLY 1.5 | P=0.052 P=0.237 P=0.270 P=0.054 |
|POLY 6 | P=0.048 * P=0.308 P=0.404 P=0.045 * |
|LOGISTIC REGRESSION| P=0.043 * P=0.210 P=0.323 P=0.050 |
|COCH-ARM / FISHERS | P=0.043 * P=0.179 P=0.170 P=0.046 * |
|ORDER RESTRICTED | P=0.047 * (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 1/53 (2%) 2/51 (4%) 2/53 (4%) |
|POLY-3 RATE (b) | 3/31.69 1/36.76 2/41.43 2/32.00 |
|POLY-3 PERCENT (g) | 9.5% 2.7% 4.8% 6.3% |
|TERMINAL (d) | 2/15 (13%) 0/16 (0%) 2/23 (9%) 1/7 (14%) |
|FIRST INCIDENCE | 644 688 727 (T) 704 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.557 P=0.256N P=0.312N P=0.594 |
|POLY 3 | P=0.470N P=0.252N P=0.380N P=0.495N |
|POLY 1.5 | P=0.467N P=0.270N P=0.425N P=0.487N |
|POLY 6 | P=0.473N P=0.237N P=0.337N P=0.535N |
|LOGISTIC REGRESSION| P=0.538N P=0.232N P=0.291N P=0.625N |
|COCH-ARM / FISHERS | P=0.473N P=0.309N P=0.518N P=0.500N |
|ORDER RESTRICTED | P=0.332N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/53 (13%) 4/53 (8%) 5/51 (10%) 5/53 (9%) |
|POLY-3 RATE (b) | 7/32.51 4/36.97 5/41.49 5/32.77 |
|POLY-3 PERCENT (g) | 21.5% 10.8% 12.1% 15.3% |
|TERMINAL (d) | 3/15 (20%) 1/16 (6%) 4/23 (17%) 2/7 (29%) |
|FIRST INCIDENCE | 541 658 714 525 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.521 P=0.182N P=0.129N P=0.545 |
|POLY 3 | P=0.357N P=0.184N P=0.219N P=0.367N |
|POLY 1.5 | P=0.354N P=0.209N P=0.274N P=0.357N |
|POLY 6 | P=0.373N P=0.166N P=0.173N P=0.427N |
|LOGISTIC REGRESSION| P=0.392N P=0.157N P=0.144N P=0.416N |
|COCH-ARM / FISHERS | P=0.373N P=0.263N P=0.408N P=0.380N |
|ORDER RESTRICTED | P=0.258N (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Cholangiofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 3/53 (6%) 13/51 (25%) 22/53 (42%) |
|POLY-3 RATE (b) | 0/31.38 3/37.59 13/41.80 22/38.60 |
|POLY-3 PERCENT (g) | 0.0% 8.0% 31.1% 57.0% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 10/23 (44%) 3/7 (43%) |
|FIRST INCIDENCE | --- 607 651 531 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.182 P=0.002 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.153 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.140 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.169 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.133 P=0.002 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.121 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/53 (0%) 0/51 (0%) 0/53 (0%) |
|POLY-3 RATE (b) | 2/31.38 0/36.61 0/41.43 0/31.91 |
|POLY-3 PERCENT (g) | 6.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/15 (13%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 727 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.087N P=0.222N P=0.149N P=0.416N |
|POLY 3 | P=0.084N P=0.203N P=0.182N P=0.232N |
|POLY 1.5 | P=0.087N P=0.215N P=0.201N P=0.229N |
|POLY 6 | P=0.075N P=0.193N P=0.163N P=0.248N |
|LOGISTIC REGRESSION| P=0.087N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.089N P=0.248N P=0.257N P=0.248N |
|ORDER RESTRICTED | P=0.028N* (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 1/53 (2%) 1/51 (2%) 2/53 (4%) |
|POLY-3 RATE (b) | 0/31.38 1/36.61 1/41.43 2/32.00 |
|POLY-3 PERCENT (g) | 0.0% 2.7% 2.4% 6.3% |
|TERMINAL (d) | 0/15 (0%) 1/16 (6%) 1/23 (4%) 1/7 (14%) |
|FIRST INCIDENCE | --- 727 (T) 727 (T) 704 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.045 * P=0.513 P=0.585 P=0.105 |
|POLY 3 | P=0.147 P=0.531 P=0.554 P=0.240 |
|POLY 1.5 | P=0.150 P=0.520 P=0.534 P=0.243 |
|POLY 6 | P=0.137 P=0.540 P=0.576 P=0.222 |
|LOGISTIC REGRESSION| P=0.061 P=0.513 P=0.585 P=0.148 |
|COCH-ARM / FISHERS | P=0.143 P=0.500 P=0.490 P=0.248 |
|ORDER RESTRICTED | P=0.119 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/53 (21%) 17/53 (32%) 24/51 (47%) 17/53 (32%) |
|POLY-3 RATE (b) | 11/34.24 17/39.64 24/47.33 17/41.05 |
|POLY-3 PERCENT (g) | 32.1% 42.9% 50.7% 41.4% |
|TERMINAL (d) | 5/15 (33%) 5/16 (31%) 7/23 (30%) 1/7 (14%) |
|FIRST INCIDENCE | 405 531 440 244 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.041 * P=0.301 P=0.194 P=0.096 |
|POLY 3 | P=0.278 P=0.233 P=0.073 P=0.272 |
|POLY 1.5 | P=0.217 P=0.191 P=0.028 * P=0.226 |
|POLY 6 | P=0.300 P=0.287 P=0.171 P=0.291 |
|LOGISTIC REGRESSION| P=0.107 P=0.236 P=0.013 * P=0.135 |
|COCH-ARM / FISHERS | P=0.099 P=0.135 P=0.004 ** P=0.135 |
|ORDER RESTRICTED | P=0.168 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 30/53 (57%) 45/51 (88%) 47/53 (89%) |
|POLY-3 RATE (b) | 5/33.58 30/43.70 45/48.97 47/47.72 |
|POLY-3 PERCENT (g) | 14.9% 68.7% 91.9% 98.5% |
|TERMINAL (d) | 2/15 (13%) 10/16 (63%) 21/23 (91%) 7/7 (100%) |
|FIRST INCIDENCE | 126 163 440 309 |
|-------------------| |
|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) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 3/53 (6%) 2/51 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 2/32.02 3/36.91 2/42.21 0/31.91 |
|POLY-3 PERCENT (g) | 6.3% 8.1% 4.7% 0.0% |
|TERMINAL (d) | 1/15 (7%) 2/16 (13%) 1/23 (4%) 0/7 (0%) |
|FIRST INCIDENCE | 519 645 440 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.178N P=0.554 P=0.576N P=0.302N |
|POLY 3 | P=0.135N P=0.565 P=0.590N P=0.236N |
|POLY 1.5 | P=0.135N P=0.543 P=0.630N P=0.232N |
|POLY 6 | P=0.143N P=0.585 P=0.548N P=0.256N |
|LOGISTIC REGRESSION| P=0.135N P=0.568 P=0.673 P=0.234N |
|COCH-ARM / FISHERS | P=0.146N P=0.500 P=0.676 P=0.248N |
|ORDER RESTRICTED | P=0.157N (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocyte, Multinucleate |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 19/53 (36%) 46/51 (90%) 49/53 (92%) |
|POLY-3 RATE (b) | 0/31.38 19/39.58 46/47.56 49/50.73 |
|POLY-3 PERCENT (g) | 0.0% 48.0% 96.7% 96.6% |
|TERMINAL (d) | 0/15 (0%) 9/16 (56%) 23/23 (100%) 7/7 (100%) |
|FIRST INCIDENCE | --- 331 440 188 |
|-------------------| |
|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) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 3/53 (6%) 26/51 (51%) 39/53 (74%) |
|POLY-3 RATE (b) | 0/31.38 3/36.86 26/43.63 39/42.89 |
|POLY-3 PERCENT (g) | 0.0% 8.1% 59.6% 90.9% |
|TERMINAL (d) | 0/15 (0%) 1/16 (6%) 18/23 (78%) 7/7 (100%) |
|FIRST INCIDENCE | --- 680 535 484 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.163 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.148 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.137 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.160 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.160 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.121 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 36/53 (68%) 51/53 (96%) 51/51 (100%) 51/53 (96%) |
|POLY-3 RATE (b) | 36/42.80 51/51.40 51/51.00 51/52.15 |
|POLY-3 PERCENT (g) | 84.1% 99.2% 100.0% 97.8% |
|TERMINAL (d) | 15/15 (100%) 16/16 (100%) 23/23 (100%) 7/7 (100%) |
|FIRST INCIDENCE | 176 40 185 72 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.148 P=0.428N P=0.002 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P=0.004 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.009 ** P=0.006 ** P=0.004 ** P=0.019 * |
|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) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 21/53 (40%) 30/53 (57%) 29/51 (57%) 9/53 (17%) |
|POLY-3 RATE (b) | 21/34.34 30/42.01 29/43.57 9/34.56 |
|POLY-3 PERCENT (g) | 61.2% 71.4% 66.6% 26.0% |
|TERMINAL (d) | 12/15 (80%) 15/16 (94%) 19/23 (83%) 3/7 (43%) |
|FIRST INCIDENCE | 541 454 574 244 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.062N P=0.201 P=0.343N P=0.137N |
|POLY 3 | P<0.001N** P=0.219 P=0.392 P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.130 P=0.230 P=0.002N** |
|POLY 6 | P<0.001N** P=0.351 P=0.585 P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.198 P=0.480N P=0.005N** |
|COCH-ARM / FISHERS | P=0.004N** P=0.060 P=0.059 P=0.008N** |
|ORDER RESTRICTED | P<0.001N** (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 11/53 (21%) 15/51 (29%) 17/53 (32%) |
|POLY-3 RATE (b) | 4/34.03 11/39.49 15/44.94 17/38.49 |
|POLY-3 PERCENT (g) | 11.8% 27.9% 33.4% 44.2% |
|TERMINAL (d) | 0/15 (0%) 3/16 (19%) 6/23 (26%) 1/7 (14%) |
|FIRST INCIDENCE | 176 403 185 530 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.112 P=0.064 P=0.004 ** |
|POLY 3 | P=0.002 ** P=0.075 P=0.024 * P=0.002 ** |
|POLY 1.5 | P=0.002 ** P=0.061 P=0.013 * P<0.001 ** |
|POLY 6 | P=0.003 ** P=0.093 P=0.045 * P=0.002 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.047 * P=0.002 ** P=0.002 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.046 * P=0.004 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 48/53 (91%) 51/51 (100%) 48/53 (91%) |
|POLY-3 RATE (b) | 1/32.06 48/49.35 51/51.00 48/48.68 |
|POLY-3 PERCENT (g) | 3.1% 97.3% 100.0% 98.6% |
|TERMINAL (d) | 0/15 (0%) 15/16 (94%) 23/23 (100%) 7/7 (100%) |
|FIRST INCIDENCE | 496 247 185 244 |
|-------------------| |
|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 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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Toxic Hepatopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 39/53 (74%) 51/51 (100%) 49/53 (92%) |
|POLY-3 RATE (b) | 0/31.38 39/43.36 51/51.00 49/49.10 |
|POLY-3 PERCENT (g) | 0.0% 90.0% 100.0% 99.8% |
|TERMINAL (d) | 0/15 (0%) 15/16 (94%) 23/23 (100%) 7/7 (100%) |
|FIRST INCIDENCE | --- 541 185 243 |
|-------------------| |
|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) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 3/53 (6%) 8/51 (16%) 12/53 (23%) |
|POLY-3 RATE (b) | 3/31.38 3/36.99 8/41.43 12/35.10 |
|POLY-3 PERCENT (g) | 9.6% 8.1% 19.3% 34.2% |
|TERMINAL (d) | 3/15 (20%) 2/16 (13%) 8/23 (35%) 3/7 (43%) |
|FIRST INCIDENCE | 727 (T) 618 727 (T) 244 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.618N P=0.272 P<0.001 ** |
|POLY 3 | P=0.002 ** P=0.586N P=0.209 P=0.014 * |
|POLY 1.5 | P=0.002 ** P=0.614N P=0.160 P=0.014 * |
|POLY 6 | P<0.001 ** P=0.557N P=0.270 P=0.010 * |
|LOGISTIC REGRESSION| P<0.001 ** P=0.556N P=0.272 P=0.012 * |
|COCH-ARM / FISHERS | P=0.002 ** P=0.661N P=0.089 P=0.012 * |
|ORDER RESTRICTED | P=0.005 ** (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 1/53 (2%) 4/51 (8%) 5/53 (9%) |
|POLY-3 RATE (b) | 4/32.23 1/36.86 4/42.20 5/33.91 |
|POLY-3 PERCENT (g) | 12.4% 2.7% 9.5% 14.8% |
|TERMINAL (d) | 3/15 (20%) 0/16 (0%) 1/23 (4%) 0/7 (0%) |
|FIRST INCIDENCE | 391 658 535 525 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.174 P=0.148N P=0.408N P=0.359 |
|POLY 3 | P=0.274 P=0.137N P=0.489N P=0.533 |
|POLY 1.5 | P=0.278 P=0.152N P=0.550N P=0.528 |
|POLY 6 | P=0.262 P=0.124N P=0.423N P=0.516 |
|LOGISTIC REGRESSION| P=0.276 P=0.149N P=0.564N P=0.512 |
|COCH-ARM / FISHERS | P=0.271 P=0.181N P=0.620 P=0.500 |
|ORDER RESTRICTED | P=0.254 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 14/53 (26%) 45/51 (88%) 45/53 (85%) |
|POLY-3 RATE (b) | 3/32.67 14/39.77 45/47.42 45/45.98 |
|POLY-3 PERCENT (g) | 9.2% 35.2% 94.9% 97.9% |
|TERMINAL (d) | 1/15 (7%) 5/16 (31%) 22/23 (96%) 7/7 (100%) |
|FIRST INCIDENCE | 496 328 535 394 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.015 * P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.003 ** 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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 1/53 (2%) 1/51 (2%) 7/53 (13%) |
|POLY-3 RATE (b) | 3/33.04 1/36.68 1/41.62 7/34.41 |
|POLY-3 PERCENT (g) | 9.1% 2.7% 2.4% 20.3% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 354 709 678 484 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.028 * P=0.256N P=0.191N P=0.129 |
|POLY 3 | P=0.046 * P=0.267N P=0.228N P=0.165 |
|POLY 1.5 | P=0.046 * P=0.279N P=0.256N P=0.169 |
|POLY 6 | P=0.046 * P=0.257N P=0.201N P=0.145 |
|LOGISTIC REGRESSION| P=0.046 * P=0.316N P=0.396N P=0.162 |
|COCH-ARM / FISHERS | P=0.046 * P=0.309N P=0.324N P=0.160 |
|ORDER RESTRICTED | P=0.013 * (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 42/53 (79%) 50/51 (98%) 49/53 (92%) |
|POLY-3 RATE (b) | 0/31.38 42/46.52 50/50.61 49/49.44 |
|POLY-3 PERCENT (g) | 0.0% 90.3% 98.8% 99.1% |
|TERMINAL (d) | 0/15 (0%) 15/16 (94%) 23/23 (100%) 7/7 (100%) |
|FIRST INCIDENCE | --- 328 185 243 |
|-------------------| |
|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 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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver: Oval Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 10/53 (19%) 38/51 (75%) 40/53 (75%) |
|POLY-3 RATE (b) | 0/31.38 10/37.11 38/44.37 40/43.32 |
|POLY-3 PERCENT (g) | 0.0% 27.0% 85.6% 92.3% |
|TERMINAL (d) | 0/15 (0%) 6/16 (38%) 23/23 (100%) 7/7 (100%) |
|FIRST INCIDENCE | --- 630 535 484 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.003 ** 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) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver: Portal |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/53 (4%) 1/51 (2%) 10/53 (19%) |
|POLY-3 RATE (b) | 0/31.38 2/37.17 1/41.55 10/34.71 |
|POLY-3 PERCENT (g) | 0.0% 5.4% 2.4% 28.8% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 1/7 (14%) |
|FIRST INCIDENCE | --- 618 699 574 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.306 P=0.626 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.276 P=0.555 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.261 P=0.534 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.291 P=0.577 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.260 P=0.579 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.248 P=0.490 P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 41/53 (77%) 45/53 (85%) 49/51 (96%) 42/51 (82%) |
|POLY-3 RATE (b) | 41/47.06 45/46.48 49/49.11 42/44.15 |
|POLY-3 PERCENT (g) | 87.1% 96.8% 99.8% 95.1% |
|TERMINAL (d) | 12/15 (80%) 15/16 (94%) 23/23 (100%) 7/7 (100%) |
|FIRST INCIDENCE | 201 454 320 394 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.102 P=0.406N P=0.119N P=0.164 |
|POLY 3 | P=0.041 * P=0.064 P=0.007 ** P=0.133 |
|POLY 1.5 | P=0.053 P=0.070 P=0.004 ** P=0.156 |
|POLY 6 | P=0.039 * P=0.100 P=0.019 * P=0.128 |
|LOGISTIC REGRESSION| P=0.382 P=0.410 P=0.037 * P=0.445 |
|COCH-ARM / FISHERS | P=0.224 P=0.229 P=0.005 ** P=0.349 |
|ORDER RESTRICTED | P=0.006 ** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 1/53 (2%) 0/51 (0%) 2/51 (4%) |
|POLY-3 RATE (b) | 5/32.66 1/37.61 0/41.13 2/31.84 |
|POLY-3 PERCENT (g) | 15.3% 2.7% 0.0% 6.3% |
|TERMINAL (d) | 2/15 (13%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 309 40 --- 484 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.146N P=0.086N P=0.011N* P=0.375N |
|POLY 3 | P=0.119N P=0.069N P=0.015N* P=0.220N |
|POLY 1.5 | P=0.125N P=0.079N P=0.020N* P=0.219N |
|POLY 6 | P=0.105N P=0.062N P=0.011N* P=0.244N |
|LOGISTIC REGRESSION| P=0.152N P=0.121N P=0.027N* P=0.225N |
|COCH-ARM / FISHERS | P=0.133N P=0.103N P=0.031N* P=0.235N |
|ORDER RESTRICTED | P=0.022N* (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 0/53 (0%) 0/51 (0%) 0/51 (0%) |
|POLY-3 RATE (b) | 3/32.04 0/36.61 0/41.13 0/30.95 |
|POLY-3 PERCENT (g) | 9.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/15 (7%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 611 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.026N* P=0.097N P=0.057N P=0.179N |
|POLY 3 | P=0.030N* P=0.095N P=0.080N P=0.122N |
|POLY 1.5 | P=0.032N* P=0.102N P=0.094N P=0.120N |
|POLY 6 | P=0.026N* P=0.090N P=0.069N P=0.137N |
|LOGISTIC REGRESSION| P=0.027N* P=0.095N P=0.082N P=0.127N |
|COCH-ARM / FISHERS | P=0.034N* P=0.121N P=0.129N P=0.129N |
|ORDER RESTRICTED | P=0.009N** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 3/53 (6%) 9/51 (18%) 4/51 (8%) |
|POLY-3 RATE (b) | 1/31.53 3/37.05 9/42.85 4/31.72 |
|POLY-3 PERCENT (g) | 3.2% 8.1% 21.0% 12.6% |
|TERMINAL (d) | 0/15 (0%) 2/16 (13%) 2/23 (9%) 2/7 (29%) |
|FIRST INCIDENCE | 688 599 573 607 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.039 * P=0.365 P=0.066 P=0.092 |
|POLY 3 | P=0.093 P=0.364 P=0.030 * P=0.175 |
|POLY 1.5 | P=0.099 P=0.343 P=0.018 * P=0.177 |
|POLY 6 | P=0.072 P=0.384 P=0.051 P=0.157 |
|LOGISTIC REGRESSION| P=0.090 P=0.372 P=0.021 * P=0.153 |
|COCH-ARM / FISHERS | P=0.099 P=0.309 P=0.007 ** P=0.170 |
|ORDER RESTRICTED | P=0.069 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/53 (23%) 2/53 (4%) 0/51 (0%) 0/51 (0%) |
|POLY-3 RATE (b) | 12/32.58 2/37.28 0/41.13 0/30.95 |
|POLY-3 PERCENT (g) | 36.8% 5.4% 0.0% 0.0% |
|TERMINAL (d) | 7/15 (47%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 600 607 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** P=0.002N** P<0.001N** P=0.005N** |
|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=0.004N** P<0.001N** P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Metaplasia Bronchiolar |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 39/53 (74%) 47/51 (92%) 40/51 (78%) |
|POLY-3 RATE (b) | 0/31.38 39/44.76 47/48.24 40/43.59 |
|POLY-3 PERCENT (g) | 0.0% 87.1% 97.4% 91.8% |
|TERMINAL (d) | 0/15 (0%) 15/16 (94%) 23/23 (100%) 6/7 (86%) |
|FIRST INCIDENCE | --- 454 320 394 |
|-------------------| |
|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 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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung: Serosa |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/53 (2%) 0/51 (0%) 0/51 (0%) |
|POLY-3 RATE (b) | 2/32.84 1/37.59 0/41.13 0/30.95 |
|POLY-3 PERCENT (g) | 6.1% 2.7% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 126 163 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.081N P=0.476N P=0.204N P=0.228N |
|POLY 3 | P=0.080N P=0.453N P=0.191N P=0.249N |
|POLY 1.5 | P=0.084N P=0.468N P=0.209N P=0.244N |
|POLY 6 | P=0.071N P=0.441N P=0.174N P=0.268N |
|LOGISTIC REGRESSION| P=0.125N P=0.584N P=0.449N P=0.270N |
|COCH-ARM / FISHERS | P=0.090N P=0.500N P=0.257N P=0.257N |
|ORDER RESTRICTED | P=0.081N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 4/52 (8%) 4/51 (8%) 3/51 (6%) |
|POLY-3 RATE (b) | 1/31.47 4/35.81 4/41.14 3/30.95 |
|POLY-3 PERCENT (g) | 3.2% 11.2% 9.7% 9.7% |
|TERMINAL (d) | 0/15 (0%) 3/16 (19%) 3/23 (13%) 3/7 (43%) |
|FIRST INCIDENCE | 660 722 722 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.093 P=0.215 P=0.339 P=0.115 |
|POLY 3 | P=0.300 P=0.217 P=0.270 P=0.296 |
|POLY 1.5 | P=0.309 P=0.204 P=0.235 P=0.304 |
|POLY 6 | P=0.266 P=0.228 P=0.311 P=0.265 |
|LOGISTIC REGRESSION| P=0.146 P=0.243 P=0.345 P=0.188 |
|COCH-ARM / FISHERS | P=0.296 P=0.181 P=0.175 P=0.301 |
|ORDER RESTRICTED | P=0.277 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 18/52 (35%) 29/52 (56%) 11/51 (22%) 15/51 (29%) |
|POLY-3 RATE (b) | 18/36.75 29/42.17 11/42.99 15/36.60 |
|POLY-3 PERCENT (g) | 49.0% 68.8% 25.6% 41.0% |
|TERMINAL (d) | 8/15 (53%) 12/16 (75%) 5/23 (22%) 1/7 (14%) |
|FIRST INCIDENCE | 222 163 320 484 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.236N P=0.127 P=0.009N** P=0.552 |
|POLY 3 | P=0.032N* P=0.046 * P=0.023N* P=0.318N |
|POLY 1.5 | P=0.041N* P=0.035 * P=0.038N* P=0.327N |
|POLY 6 | P=0.027N* P=0.065 P=0.013N* P=0.329N |
|LOGISTIC REGRESSION| P=0.064N P=0.043 * P=0.059N P=0.338N |
|COCH-ARM / FISHERS | P=0.078N P=0.024 * P=0.105N P=0.362N |
|ORDER RESTRICTED | P=0.010N* (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 2/52 (4%) 0/51 (0%) 1/51 (2%) |
|POLY-3 RATE (b) | 0/31.21 2/36.75 0/41.11 1/30.95 |
|POLY-3 PERCENT (g) | 0.0% 5.4% 0.0% 3.2% |
|TERMINAL (d) | 0/15 (0%) 1/16 (6%) 0/23 (0%) 1/7 (14%) |
|FIRST INCIDENCE | --- 247 --- 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.423 P=0.254 (e) P=0.348 |
|POLY 3 | P=0.535 P=0.274 (e) P=0.498 |
|POLY 1.5 | P=0.528 P=0.262 (e) P=0.501 |
|POLY 6 | P=0.533 P=0.287 (e) P=0.484 |
|LOGISTIC REGRESSION| P=0.495 P=0.211 (e) P=0.348 |
|COCH-ARM / FISHERS | P=0.502 P=0.248 (e) P=0.495 |
|ORDER RESTRICTED | P=0.322 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 1/53 (2%) 0/51 (0%) 2/53 (4%) |
|POLY-3 RATE (b) | 2/31.83 1/36.68 0/41.43 2/33.24 |
|POLY-3 PERCENT (g) | 6.3% 2.7% 0.0% 6.0% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 618 709 --- 484 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.584 P=0.411N P=0.137N P=0.653 |
|POLY 3 | P=0.576N P=0.450N P=0.184N P=0.681N |
|POLY 1.5 | P=0.585N P=0.466N P=0.202N P=0.677N |
|POLY 6 | P=0.556N P=0.438N P=0.167N P=0.692 |
|LOGISTIC REGRESSION| P=0.600N P=0.441N P=0.192N P=0.688N |
|COCH-ARM / FISHERS | P=0.600N P=0.493N P=0.252N P=0.684N |
|ORDER RESTRICTED | P=0.358N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/52 (6%) 1/53 (2%) 1/51 (2%) 1/53 (2%) |
|POLY-3 RATE (b) | 3/33.26 1/36.61 1/41.46 1/32.33 |
|POLY-3 PERCENT (g) | 9.0% 2.7% 2.4% 3.1% |
|TERMINAL (d) | 0/15 (0%) 1/16 (6%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 222 727 (T) 720 607 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.218N P=0.259N P=0.199N P=0.269N |
|POLY 3 | P=0.205N P=0.270N P=0.231N P=0.313N |
|POLY 1.5 | P=0.208N P=0.280N P=0.257N P=0.302N |
|POLY 6 | P=0.198N P=0.263N P=0.206N P=0.348N |
|LOGISTIC REGRESSION| P=0.220N P=0.322N P=0.433N P=0.309N |
|COCH-ARM / FISHERS | P=0.212N P=0.302N P=0.316N P=0.302N |
|ORDER RESTRICTED | P=0.172N (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 0/53 (0%) 0/51 (0%) 2/53 (4%) |
|POLY-3 RATE (b) | 0/31.36 0/36.61 0/41.43 2/32.53 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.2% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 1/7 (14%) |
|FIRST INCIDENCE | --- --- --- 525 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.028 * (e) (e) P=0.172 |
|POLY 3 | P=0.050 (e) (e) P=0.244 |
|POLY 1.5 | P=0.050 (e) (e) P=0.246 |
|POLY 6 | P=0.050 (e) (e) P=0.228 |
|LOGISTIC REGRESSION| P=0.049 * (e) (e) P=0.243 |
|COCH-ARM / FISHERS | P=0.051 (e) (e) P=0.252 |
|ORDER RESTRICTED | P=0.032 * (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node: Lumbar |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 0/4 (0%) 2/7 (29%) 0/12 (0%) |
|POLY-3 RATE (b) | 0/0.63 0/2.47 2/6.05 0/7.43 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 33.1% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/2 (0%) 0/1 (0%) |
|FIRST INCIDENCE | --- --- 651 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.495 (e) P=0.391 (e) |
|POLY 3 | P=0.369N (e) P=0.710 (e) |
|POLY 1.5 | P=0.366N (e) P=0.673 (e) |
|POLY 6 | P=0.413N (e) P=0.747 (e) |
|LOGISTIC REGRESSION| P=0.454N (e) P=0.800 (e) |
|COCH-ARM / FISHERS | P=0.466N (e) P=0.583 (e) |
|ORDER RESTRICTED | P=0.642N (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 0/4 (0%) 0/7 (0%) 5/12 (42%) |
|POLY-3 RATE (b) | 0/0.63 0/2.47 0/5.66 5/9.34 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 53.5% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/2 (0%) 1/1 (100%) |
|FIRST INCIDENCE | --- --- --- 525 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.066 |
|POLY 3 | P=0.013 * (e) (e) P=0.630 |
|POLY 1.5 | P=0.016 * (e) (e) P=0.567 |
|POLY 6 | P=0.010 * (e) (e) P=0.714 |
|LOGISTIC REGRESSION| P=0.019 * (e) (e) P=0.494 |
|COCH-ARM / FISHERS | P=0.022 * (e) (e) P=0.396 |
|ORDER RESTRICTED | P=0.544 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 1/4 (25%) 0/7 (0%) 6/12 (50%) |
|POLY-3 RATE (b) | 0/0.63 1/2.86 0/5.66 6/10.24 |
|POLY-3 PERCENT (g) | 0.0% 35.0% 0.0% 58.6% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/2 (0%) 0/1 (0%) |
|FIRST INCIDENCE | --- 618 --- 484 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.543 (e) P=0.019 * |
|POLY 3 | P=0.053 P=0.744 (e) P=0.604 |
|POLY 1.5 | P=0.051 P=0.715 (e) P=0.529 |
|POLY 6 | P=0.052 P=0.778 (e) P=0.695 |
|LOGISTIC REGRESSION| P=0.026 * P=0.765 (e) P=0.243 |
|COCH-ARM / FISHERS | P=0.043 * P=0.667 (e) P=0.308 |
|ORDER RESTRICTED | P=0.550 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 0/4 (0%) 0/7 (0%) 2/12 (17%) |
|POLY-3 RATE (b) | 0/0.63 0/2.47 0/5.66 2/8.62 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 23.2% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/2 (0%) 0/1 (0%) |
|FIRST INCIDENCE | --- --- --- 531 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.056 (e) (e) P=0.285 |
|POLY 3 | P=0.216 (e) (e) P=0.782 |
|POLY 1.5 | P=0.217 (e) (e) P=0.757 |
|POLY 6 | P=0.207 (e) (e) P=0.812 |
|LOGISTIC REGRESSION| P=0.108 (e) (e) P=0.590 |
|COCH-ARM / FISHERS | P=0.185 (e) (e) P=0.725 |
|ORDER RESTRICTED | P=0.640 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/52 (15%) 5/53 (9%) 1/52 (2%) 1/53 (2%) |
|POLY-3 RATE (b) | 8/33.57 5/37.22 1/41.88 1/32.31 |
|POLY-3 PERCENT (g) | 23.8% 13.4% 2.4% 3.1% |
|TERMINAL (d) | 3/15 (20%) 4/16 (25%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 405 531 628 611 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004N** P=0.205N P=0.004N** P=0.051N |
|POLY 3 | P=0.002N** P=0.203N P=0.005N** P=0.015N* |
|POLY 1.5 | P=0.002N** P=0.223N P=0.008N** P=0.014N* |
|POLY 6 | P=0.002N** P=0.190N P=0.003N** P=0.021N* |
|LOGISTIC REGRESSION| P=0.003N** P=0.200N P=0.011N* P=0.016N* |
|COCH-ARM / FISHERS | P=0.004N** P=0.265N P=0.016N* P=0.014N* |
|ORDER RESTRICTED | P=0.003N** (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 32/52 (62%) 21/53 (40%) 23/52 (44%) 9/53 (17%) |
|POLY-3 RATE (b) | 32/43.06 21/40.32 23/45.33 9/34.10 |
|POLY-3 PERCENT (g) | 74.3% 52.1% 50.7% 26.4% |
|TERMINAL (d) | 11/15 (73%) 7/16 (44%) 10/23 (44%) 4/7 (57%) |
|FIRST INCIDENCE | 126 531 185 484 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** P=0.016N* P=0.002N** P=0.002N** |
|POLY 3 | P<0.001N** P=0.020N* P=0.013N* P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.022N* P=0.023N* P<0.001N** |
|POLY 6 | P<0.001N** P=0.019N* P=0.007N** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.011N* P=0.045N* P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.020N* P=0.058N P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 2/53 (4%) 0/52 (0%) 0/53 (0%) |
|POLY-3 RATE (b) | 1/31.36 2/36.61 0/41.53 0/31.91 |
|POLY-3 PERCENT (g) | 3.2% 5.5% 0.0% 0.0% |
|TERMINAL (d) | 1/15 (7%) 2/16 (13%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.232N P=0.523 P=0.415N P=0.652N |
|POLY 3 | P=0.158N P=0.554 P=0.445N P=0.497N |
|POLY 1.5 | P=0.167N P=0.536 P=0.464N P=0.493N |
|POLY 6 | P=0.146N P=0.571 P=0.424N P=0.512N |
|LOGISTIC REGRESSION| P=0.232N P=0.523 (e) (e) |
|COCH-ARM / FISHERS | P=0.184N P=0.507 P=0.500N P=0.495N |
|ORDER RESTRICTED | P=0.193N (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 0/53 (0%) 0/52 (0%) 0/53 (0%) |
|POLY-3 RATE (b) | 2/31.43 0/36.61 0/41.53 0/31.91 |
|POLY-3 PERCENT (g) | 6.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/15 (7%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 709 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.082N P=0.203N P=0.137N P=0.410N |
|POLY 3 | P=0.081N P=0.204N P=0.181N P=0.232N |
|POLY 1.5 | P=0.084N P=0.214N P=0.199N P=0.229N |
|POLY 6 | P=0.072N P=0.194N P=0.163N P=0.249N |
|LOGISTIC REGRESSION| P=0.071N P=0.186N P=0.130N P=0.330N |
|COCH-ARM / FISHERS | P=0.086N P=0.243N P=0.248N P=0.243N |
|ORDER RESTRICTED | P=0.028N* (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mesentery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/1 (100%) 0/7 (0%) 0/13 (0%) 3/11 (27%) |
|POLY-3 RATE (b) | 1/1.00 0/6.22 0/10.00 3/8.85 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 33.9% |
|TERMINAL (d) | 0/0 (0%) 0/4 (0%) 0/3 (0%) 1/2 (50%) |
|FIRST INCIDENCE | 391 --- --- 562 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.113 P=0.473N P=0.440N P=0.544 |
|POLY 3 | P=0.345 P<0.001N** P<0.001N** P=0.408N |
|POLY 1.5 | P=0.328 P<0.001N** P<0.001N** P=0.379N |
|POLY 6 | P=0.403 P<0.001N** P<0.001N** P=0.472N |
|LOGISTIC REGRESSION| P=0.270 (e) P=0.168N P=0.983N |
|COCH-ARM / FISHERS | P=0.328 P=0.125N P=0.071N P=0.333N |
|ORDER RESTRICTED | P=0.249N (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Mesentery: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/1 (0%) 6/7 (86%) 10/13 (77%) 7/11 (64%) |
|POLY-3 RATE (b) | 0/0.16 6/6.85 10/11.50 7/9.70 |
|POLY-3 PERCENT (g) | 0.0% 87.6% 87.0% 72.2% |
|TERMINAL (d) | 0/0 (0%) 4/4 (100%) 3/3 (100%) 1/2 (50%) |
|FIRST INCIDENCE | --- 618 573 607 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.008 ** P=0.310 P=0.050 P=0.014 * |
|POLY 3 | P=0.289N P=0.873 P=0.899 P=0.840 |
|POLY 1.5 | P=0.288N P=0.699 P=0.708 P=0.711 |
|POLY 6 | P=0.362N P=0.955 P=0.983 P=0.922 |
|LOGISTIC REGRESSION| P=0.417N (e) P=0.978 P=0.991 |
|COCH-ARM / FISHERS | P=0.484N P=0.250 P=0.286 P=0.417 |
|ORDER RESTRICTED | P=0.682 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 2/52 (4%) 2/53 (4%) 1/53 (2%) |
|POLY-3 RATE (b) | 2/32.23 2/36.06 2/42.16 1/32.29 |
|POLY-3 PERCENT (g) | 6.2% 5.6% 4.7% 3.1% |
|TERMINAL (d) | 1/15 (7%) 1/16 (6%) 1/23 (4%) 0/7 (0%) |
|FIRST INCIDENCE | 391 607 720 618 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.453N P=0.648N P=0.550N P=0.577N |
|POLY 3 | P=0.360N P=0.654N P=0.593N P=0.499N |
|POLY 1.5 | P=0.358N P=0.671N P=0.628N P=0.493N |
|POLY 6 | P=0.369N P=0.639N P=0.555N P=0.526N |
|LOGISTIC REGRESSION| P=0.358N P=0.689N P=0.658N P=0.499N |
|COCH-ARM / FISHERS | P=0.370N P=0.684 P=0.691N P=0.500N |
|ORDER RESTRICTED | P=0.461N (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Nose: Turbinate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 2/52 (4%) 0/53 (0%) 4/53 (8%) |
|POLY-3 RATE (b) | 2/31.81 2/36.29 0/42.13 4/32.97 |
|POLY-3 PERCENT (g) | 6.3% 5.5% 0.0% 12.1% |
|TERMINAL (d) | 1/15 (7%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 603 607 --- 611 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.201 P=0.608N P=0.155N P=0.251 |
|POLY 3 | P=0.275 P=0.647N P=0.181N P=0.350 |
|POLY 1.5 | P=0.271 P=0.666N P=0.198N P=0.354 |
|POLY 6 | P=0.280 P=0.629N P=0.164N P=0.323 |
|LOGISTIC REGRESSION| P=0.256 P=0.665N P=0.184N P=0.333 |
|COCH-ARM / FISHERS | P=0.256 P=0.684 P=0.248N P=0.339 |
|ORDER RESTRICTED | P=0.116 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Oral Mucosa: Gingival |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/1 (100%) 0/2 (0%) 4/6 (67%) 3/11 (27%) |
|POLY-3 RATE (b) | 1/1.00 0/1.61 4/5.29 3/8.09 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 75.6% 37.1% |
|TERMINAL (d) | 1/1 (100%) 0/1 (0%) 3/3 (100%) 1/1 (100%) |
|FIRST INCIDENCE | 727 (T) --- 651 531 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.043 * P=0.500N P=0.627 P=0.247 |
|POLY 3 | P=0.249N P=0.085N P=0.783N P=0.438N |
|POLY 1.5 | P=0.217N P<0.001N** P=0.741N P=0.392N |
|POLY 6 | P=0.375N P=0.303N P=0.822N P=0.546N |
|LOGISTIC REGRESSION| P=0.471N (e) P=0.872N P=0.529N |
|COCH-ARM / FISHERS | P=0.214N P=0.333N P=0.714N P=0.333N |
|ORDER RESTRICTED | P=0.396N (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 45/52 (87%) 47/52 (90%) 46/52 (88%) 33/53 (62%) |
|POLY-3 RATE (b) | 45/46.65 47/49.76 46/50.55 33/43.43 |
|POLY-3 PERCENT (g) | 96.5% 94.5% 91.0% 76.0% |
|TERMINAL (d) | 14/15 (93%) 15/16 (94%) 22/23 (96%) 5/7 (71%) |
|FIRST INCIDENCE | 126 163 320 243 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.254N P=0.310N P=0.016N* P=0.336N |
|POLY 3 | P<0.001N** P=0.508N P=0.232N P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.619N P=0.360N P<0.001N** |
|POLY 6 | P<0.001N** P=0.539N P=0.195N P=0.005N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.492 P=0.388N P=0.002N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.380 P=0.500 P=0.004N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/52 (23%) 16/52 (31%) 18/52 (35%) 11/53 (21%) |
|POLY-3 RATE (b) | 12/33.36 16/40.40 18/44.23 11/35.26 |
|POLY-3 PERCENT (g) | 36.0% 39.6% 40.7% 31.2% |
|TERMINAL (d) | 7/15 (47%) 6/16 (38%) 9/23 (39%) 1/7 (14%) |
|FIRST INCIDENCE | 547 331 498 525 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.366 P=0.419 P=0.552N P=0.380 |
|POLY 3 | P=0.361N P=0.468 P=0.425 P=0.433N |
|POLY 1.5 | P=0.361N P=0.378 P=0.304 P=0.440N |
|POLY 6 | P=0.397N P=0.567 P=0.569 P=0.465N |
|LOGISTIC REGRESSION| P=0.382N P=0.348 P=0.415 P=0.492N |
|COCH-ARM / FISHERS | P=0.402N P=0.254 P=0.140 P=0.479N |
|ORDER RESTRICTED | P=0.408N (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 0/52 (0%) 2/52 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/31.36 0/35.84 2/41.53 0/31.91 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 2/23 (9%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- 727 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.431 (e) P=0.336 (e) |
|POLY 3 | P=0.494 (e) P=0.304 (e) |
|POLY 1.5 | P=0.523 (e) P=0.280 (e) |
|POLY 6 | P=0.422 (e) P=0.333 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.336 (e) |
|COCH-ARM / FISHERS | P=0.542 (e) P=0.248 (e) |
|ORDER RESTRICTED | P=0.303 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Oviduct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/1 (100%) 0/1 (0%) 2/3 (67%) 1/1 (100%) |
|POLY-3 RATE (b) | 1/1.00 0/0.98 2/2.72 1/1.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 73.6% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 2/2 (100%) 1/1 (100%) |
|FIRST INCIDENCE | 709 --- 727 (T) 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.282N P=0.477N P=0.411N (e) |
|POLY 3 | P=0.603 P=1.000N P=0.786N (e) |
|POLY 1.5 | P=0.593 P=1.000N P=0.737N (e) |
|POLY 6 | P=0.627 P=1.000N P=0.885N (e) |
|LOGISTIC REGRESSION| P=0.714 (e) P=0.411N (e) |
|COCH-ARM / FISHERS | P=0.604 P=0.500N P=0.750N (e) |
|ORDER RESTRICTED | P=0.426 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/51 (10%) 4/53 (8%) 6/52 (12%) 13/51 (25%) |
|POLY-3 RATE (b) | 5/32.80 4/37.40 6/43.08 13/35.71 |
|POLY-3 PERCENT (g) | 15.2% 10.7% 13.9% 36.4% |
|TERMINAL (d) | 3/15 (20%) 0/16 (0%) 1/23 (4%) 2/7 (29%) |
|FIRST INCIDENCE | 391 618 573 531 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.405N P=0.478N P=0.019 * |
|POLY 3 | P=0.008 ** P=0.416N P=0.566N P=0.037 * |
|POLY 1.5 | P=0.007 ** P=0.442N P=0.623 P=0.034 * |
|POLY 6 | P=0.008 ** P=0.387N P=0.486N P=0.040 * |
|LOGISTIC REGRESSION| P=0.007 ** P=0.435N P=0.563 P=0.034 * |
|COCH-ARM / FISHERS | P=0.008 ** P=0.475N P=0.514 P=0.034 * |
|ORDER RESTRICTED | P=0.009 ** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/51 (10%) 2/53 (4%) 11/52 (21%) 18/51 (35%) |
|POLY-3 RATE (b) | 5/31.43 2/37.14 11/43.58 18/37.39 |
|POLY-3 PERCENT (g) | 15.9% 5.4% 25.2% 48.1% |
|TERMINAL (d) | 4/15 (27%) 0/16 (0%) 2/23 (9%) 2/7 (29%) |
|FIRST INCIDENCE | 705 618 573 531 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.164N P=0.382 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.149N P=0.248 P=0.003 ** |
|POLY 1.5 | P<0.001 ** P=0.170N P=0.175 P=0.002 ** |
|POLY 6 | P<0.001 ** P=0.128N P=0.359 P=0.005 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.132N P=0.244 P=0.002 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.203N P=0.093 P=0.002 ** |
|ORDER RESTRICTED | P<0.001 ** (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 9/53 (17%) 20/52 (38%) 23/51 (45%) |
|POLY-3 RATE (b) | 0/31.35 9/37.20 20/42.74 23/36.28 |
|POLY-3 PERCENT (g) | 0.0% 24.2% 46.8% 63.4% |
|TERMINAL (d) | 0/15 (0%) 6/16 (38%) 14/23 (61%) 6/7 (86%) |
|FIRST INCIDENCE | --- 607 618 525 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.005 ** 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) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pancreas: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 8/53 (15%) 15/52 (29%) 11/51 (22%) |
|POLY-3 RATE (b) | 0/31.35 8/37.31 15/42.61 11/35.04 |
|POLY-3 PERCENT (g) | 0.0% 21.4% 35.2% 31.4% |
|TERMINAL (d) | 0/15 (0%) 5/16 (31%) 8/23 (35%) 2/7 (29%) |
|FIRST INCIDENCE | --- 618 588 188 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.009 ** P=0.002 ** P<0.001 ** |
|POLY 3 | P=0.002 ** P=0.007 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.002 ** P=0.006 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.002 ** P=0.008 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.010 * P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.002 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pancreas: Duct |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 0/53 (0%) 0/52 (0%) 2/51 (4%) |
|POLY-3 RATE (b) | 0/31.35 0/36.61 0/41.53 2/31.51 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.4% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- 603 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.035 * (e) (e) P=0.230 |
|POLY 3 | P=0.047 * (e) (e) P=0.236 |
|POLY 1.5 | P=0.048 * (e) (e) P=0.239 |
|POLY 6 | P=0.047 * (e) (e) P=0.225 |
|LOGISTIC REGRESSION| P=0.044 * (e) (e) P=0.233 |
|COCH-ARM / FISHERS | P=0.048 * (e) (e) P=0.248 |
|ORDER RESTRICTED | P=0.029 * (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pancreas: Duct |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 0/53 (0%) 2/52 (4%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/31.35 0/36.61 2/41.71 0/30.95 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 1/23 (4%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- 678 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.477 (e) P=0.362 (e) |
|POLY 3 | P=0.484 (e) P=0.305 (e) |
|POLY 1.5 | P=0.512 (e) P=0.281 (e) |
|POLY 6 | P=0.419 (e) P=0.335 (e) |
|LOGISTIC REGRESSION| P=0.517 (e) P=0.329 (e) |
|COCH-ARM / FISHERS | P=0.537 (e) P=0.252 (e) |
|ORDER RESTRICTED | P=0.305 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 14/51 (27%) 16/53 (30%) 19/53 (36%) 9/53 (17%) |
|POLY-3 RATE (b) | 14/33.32 16/38.31 19/44.06 9/33.36 |
|POLY-3 PERCENT (g) | 42.0% 41.8% 43.1% 27.0% |
|TERMINAL (d) | 7/15 (47%) 8/16 (50%) 12/23 (52%) 3/7 (43%) |
|FIRST INCIDENCE | 546 607 588 588 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.498N P=0.557N P=0.410N P=0.573N |
|POLY 3 | P=0.130N P=0.590N P=0.554 P=0.139N |
|POLY 1.5 | P=0.116N P=0.561 P=0.444 P=0.127N |
|POLY 6 | P=0.185N P=0.569N P=0.531N P=0.202N |
|LOGISTIC REGRESSION| P=0.141N P=0.500N P=0.536N P=0.176N |
|COCH-ARM / FISHERS | P=0.135N P=0.464 P=0.239 P=0.147N |
|ORDER RESTRICTED | P=0.157N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 0/53 (0%) 2/53 (4%) 1/53 (2%) |
|POLY-3 RATE (b) | 0/30.88 0/36.61 2/42.60 1/32.52 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.7% 3.1% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 1/23 (4%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- 588 530 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.189 (e) P=0.329 P=0.525 |
|POLY 3 | P=0.205 (e) P=0.314 P=0.510 |
|POLY 1.5 | P=0.219 (e) P=0.290 P=0.513 |
|POLY 6 | P=0.174 (e) P=0.342 P=0.496 |
|LOGISTIC REGRESSION| P=0.225 (e) P=0.278 P=0.503 |
|COCH-ARM / FISHERS | P=0.225 (e) P=0.257 P=0.510 |
|ORDER RESTRICTED | P=0.236 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 3/53 (6%) 1/53 (2%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/30.88 3/36.91 1/42.13 0/31.91 |
|POLY-3 PERCENT (g) | 0.0% 8.1% 2.4% 0.0% |
|TERMINAL (d) | 0/15 (0%) 2/16 (13%) 1/23 (4%) 0/7 (0%) |
|FIRST INCIDENCE | --- 645 727 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.519N P=0.145 P=0.585 (e) |
|POLY 3 | P=0.361N P=0.152 P=0.561 (e) |
|POLY 1.5 | P=0.367N P=0.142 P=0.543 (e) |
|POLY 6 | P=0.368N P=0.161 P=0.579 (e) |
|LOGISTIC REGRESSION| P=0.433N P=0.159 P=0.585 (e) |
|COCH-ARM / FISHERS | P=0.395N P=0.129 P=0.510 (e) |
|ORDER RESTRICTED | P=0.250N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 18/51 (35%) 21/53 (40%) 26/53 (49%) 17/53 (32%) |
|POLY-3 RATE (b) | 18/36.64 21/40.94 26/43.52 17/36.71 |
|POLY-3 PERCENT (g) | 49.1% 51.3% 59.7% 46.3% |
|TERMINAL (d) | 4/15 (27%) 7/16 (44%) 18/23 (78%) 3/7 (43%) |
|FIRST INCIDENCE | 400 541 637 531 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.225 P=0.532N P=0.469N P=0.396 |
|POLY 3 | P=0.501N P=0.515 P=0.224 P=0.497N |
|POLY 1.5 | P=0.435N P=0.483 P=0.200 P=0.445N |
|POLY 6 | P=0.425 P=0.531 P=0.219 P=0.582 |
|LOGISTIC REGRESSION| P=0.406N P=0.538 P=0.434 P=0.425N |
|COCH-ARM / FISHERS | P=0.429N P=0.400 P=0.111 P=0.444N |
|ORDER RESTRICTED | P=0.413N (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 39/52 (75%) 41/53 (77%) 42/52 (81%) 37/52 (71%) |
|POLY-3 RATE (b) | 39/47.51 41/47.65 42/47.95 37/44.38 |
|POLY-3 PERCENT (g) | 82.1% 86.1% 87.6% 83.4% |
|TERMINAL (d) | 8/15 (53%) 15/16 (94%) 22/23 (96%) 6/7 (86%) |
|FIRST INCIDENCE | 126 40 320 72 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.248 P=0.353N P=0.056N P=0.344 |
|POLY 3 | P=0.477 P=0.395 P=0.313 P=0.550 |
|POLY 1.5 | P=0.480N P=0.472 P=0.337 P=0.534N |
|POLY 6 | P=0.256 P=0.258 P=0.260 P=0.327 |
|LOGISTIC REGRESSION| P=0.338N P=0.514 P=0.491 P=0.404N |
|COCH-ARM / FISHERS | P=0.363N P=0.478 P=0.319 P=0.413N |
|ORDER RESTRICTED | P=0.470 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 1/53 (2%) 1/52 (2%) 3/52 (6%) |
|POLY-3 RATE (b) | 0/31.36 1/36.86 1/41.53 3/32.34 |
|POLY-3 PERCENT (g) | 0.0% 2.7% 2.4% 9.3% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 1/23 (4%) 0/7 (0%) |
|FIRST INCIDENCE | --- 659 727 (T) 603 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.034 * P=0.548 P=0.585 P=0.146 |
|POLY 3 | P=0.054 P=0.532 P=0.555 P=0.121 |
|POLY 1.5 | P=0.054 P=0.521 P=0.536 P=0.123 |
|POLY 6 | P=0.052 P=0.543 P=0.576 P=0.112 |
|LOGISTIC REGRESSION| P=0.048 * P=0.526 P=0.585 P=0.121 |
|COCH-ARM / FISHERS | P=0.052 P=0.505 P=0.500 P=0.121 |
|ORDER RESTRICTED | P=0.038 * (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 49/52 (94%) 52/53 (98%) 52/52 (100%) 50/52 (96%) |
|POLY-3 RATE (b) | 49/49.42 52/52.75 52/52.00 50/50.58 |
|POLY-3 PERCENT (g) | 99.2% 98.6% 100.0% 98.9% |
|TERMINAL (d) | 15/15 (100%) 16/16 (100%) 23/23 (100%) 7/7 (100%) |
|FIRST INCIDENCE | 126 40 185 188 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.127 P=0.338N P=0.023N* P=0.149 |
|POLY 3 | P=0.725 P=0.807N P=0.958 P=0.895N |
|POLY 1.5 | P=0.548 P=0.779 P=0.503 P=0.787 |
|POLY 6 | P=0.782N P=0.845N P=1.000 P=0.985N |
|LOGISTIC REGRESSION| P=0.435 P=0.347 P=0.303 P=0.541 |
|COCH-ARM / FISHERS | P=0.391 P=0.302 P=0.121 P=0.500 |
|ORDER RESTRICTED | P=0.540 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 5/53 (9%) 3/52 (6%) 6/52 (12%) |
|POLY-3 RATE (b) | 0/31.36 5/39.29 3/42.88 6/33.93 |
|POLY-3 PERCENT (g) | 0.0% 12.7% 7.0% 17.7% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 163 440 531 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.030 * P=0.056 P=0.210 P=0.028 * |
|POLY 3 | P=0.041 * P=0.053 P=0.185 P=0.018 * |
|POLY 1.5 | P=0.037 * P=0.045 * P=0.159 P=0.017 * |
|POLY 6 | P=0.042 * P=0.064 P=0.218 P=0.016 * |
|LOGISTIC REGRESSION| P=0.031 * P=0.026 * P=0.088 P=0.018 * |
|COCH-ARM / FISHERS | P=0.031 * P=0.030 * P=0.121 P=0.013 * |
|ORDER RESTRICTED | P=0.013 * (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Spleen: Red Pulp |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 1/53 (2%) 0/52 (0%) 2/52 (4%) |
|POLY-3 RATE (b) | 0/31.36 1/36.99 0/41.53 2/32.44 |
|POLY-3 PERCENT (g) | 0.0% 2.7% 0.0% 6.2% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 618 --- 309 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.134 P=0.559 (e) P=0.260 |
|POLY 3 | P=0.148 P=0.533 (e) P=0.243 |
|POLY 1.5 | P=0.145 P=0.522 (e) P=0.244 |
|POLY 6 | P=0.148 P=0.544 (e) P=0.230 |
|LOGISTIC REGRESSION| P=0.137 P=0.511 (e) P=0.227 |
|COCH-ARM / FISHERS | P=0.136 P=0.505 (e) P=0.248 |
|ORDER RESTRICTED | P=0.078 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 3/53 (6%) 1/51 (2%) 2/53 (4%) |
|POLY-3 RATE (b) | 0/31.36 3/37.14 1/41.62 2/32.22 |
|POLY-3 PERCENT (g) | 0.0% 8.1% 2.4% 6.2% |
|TERMINAL (d) | 0/15 (0%) 1/16 (6%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 618 678 681 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.229 P=0.162 P=0.627 P=0.192 |
|POLY 3 | P=0.333 P=0.150 P=0.555 P=0.241 |
|POLY 1.5 | P=0.329 P=0.139 P=0.535 P=0.245 |
|POLY 6 | P=0.325 P=0.163 P=0.577 P=0.226 |
|LOGISTIC REGRESSION| P=0.289 P=0.150 P=0.553 P=0.207 |
|COCH-ARM / FISHERS | P=0.309 P=0.125 P=0.495 P=0.252 |
|ORDER RESTRICTED | P=0.190 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/52 (6%) 5/53 (9%) 6/51 (12%) 8/53 (15%) |
|POLY-3 RATE (b) | 3/32.29 5/38.68 6/42.62 8/34.42 |
|POLY-3 PERCENT (g) | 9.3% 12.9% 14.1% 23.2% |
|TERMINAL (d) | 1/15 (7%) 1/16 (6%) 2/23 (9%) 1/7 (14%) |
|FIRST INCIDENCE | 391 301 320 244 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.026 * P=0.440 P=0.484 P=0.046 * |
|POLY 3 | P=0.077 P=0.458 P=0.395 P=0.109 |
|POLY 1.5 | P=0.079 P=0.423 P=0.336 P=0.113 |
|POLY 6 | P=0.068 P=0.496 P=0.462 P=0.093 |
|LOGISTIC REGRESSION| P=0.073 P=0.362 P=0.257 P=0.109 |
|COCH-ARM / FISHERS | P=0.073 P=0.369 P=0.234 P=0.107 |
|ORDER RESTRICTED | P=0.094 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 0/53 (0%) 1/51 (2%) 2/53 (4%) |
|POLY-3 RATE (b) | 1/32.34 0/36.61 1/41.94 2/33.34 |
|POLY-3 PERCENT (g) | 3.1% 0.0% 2.4% 6.0% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 201 --- 573 72 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.273 P=0.496N P=0.719N P=0.524 |
|POLY 3 | P=0.255 P=0.475N P=0.699N P=0.511 |
|POLY 1.5 | P=0.261 P=0.484N P=0.724N P=0.515 |
|POLY 6 | P=0.243 P=0.467N P=0.670N P=0.489 |
|LOGISTIC REGRESSION| P=0.234 P=0.484N P=0.567 P=0.476 |
|COCH-ARM / FISHERS | P=0.259 P=0.495N P=0.748 P=0.507 |
|ORDER RESTRICTED | P=0.224 (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/52 (6%) 3/53 (6%) 2/51 (4%) 2/53 (4%) |
|POLY-3 RATE (b) | 3/32.17 3/37.14 2/42.54 2/32.69 |
|POLY-3 PERCENT (g) | 9.3% 8.1% 4.7% 6.1% |
|TERMINAL (d) | 1/15 (7%) 1/16 (6%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 574 618 320 603 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.407N P=0.578N P=0.338N P=0.568N |
|POLY 3 | P=0.337N P=0.596N P=0.376N P=0.493N |
|POLY 1.5 | P=0.341N P=0.617N P=0.419N P=0.485N |
|POLY 6 | P=0.338N P=0.577N P=0.334N P=0.528N |
|LOGISTIC REGRESSION| P=0.354N P=0.599N P=0.567N P=0.490N |
|COCH-ARM / FISHERS | P=0.358N P=0.652N P=0.509N P=0.491N |
|ORDER RESTRICTED | P=0.433N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 37/50 (74%) 36/41 (88%) 47/49 (96%) 41/44 (93%) |
|POLY-3 RATE (b) | 37/45.02 36/36.59 47/48.09 41/41.71 |
|POLY-3 PERCENT (g) | 82.2% 98.4% 97.7% 98.3% |
|TERMINAL (d) | 9/15 (60%) 14/14 (100%) 22/23 (96%) 7/7 (100%) |
|FIRST INCIDENCE | 126 531 185 72 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.029 * P=0.293N P=0.233N P=0.115 |
|POLY 3 | P<0.001 ** P=0.014 * P=0.010 * P=0.010 * |
|POLY 1.5 | P<0.001 ** P=0.018 * P=0.005 ** P=0.008 ** |
|POLY 6 | P=0.002 ** P=0.013 * P=0.017 * P=0.012 * |
|LOGISTIC REGRESSION| P=0.005 ** P=0.168 P=0.009 ** P=0.016 * |
|COCH-ARM / FISHERS | P=0.003 ** P=0.082 P=0.002 ** P=0.012 * |
|ORDER RESTRICTED | P<0.001 ** (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 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/52 (23%) 18/52 (35%) 16/50 (32%) 19/48 (40%) |
|POLY-3 RATE (b) | 12/33.93 18/39.59 16/42.33 19/35.88 |
|POLY-3 PERCENT (g) | 35.4% 45.5% 37.8% 53.0% |
|TERMINAL (d) | 5/15 (33%) 6/16 (38%) 12/23 (52%) 2/7 (29%) |
|FIRST INCIDENCE | 541 531 554 484 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.023 * P=0.321 P=0.412N P=0.036 * |
|POLY 3 | P=0.122 P=0.255 P=0.508 P=0.096 |
|POLY 1.5 | P=0.100 P=0.201 P=0.401 P=0.078 |
|POLY 6 | P=0.133 P=0.320 P=0.586N P=0.108 |
|LOGISTIC REGRESSION| P=0.078 P=0.229 P=0.591N P=0.066 |
|COCH-ARM / FISHERS | P=0.065 P=0.140 P=0.216 P=0.058 |
|ORDER RESTRICTED | P=0.106 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/52 (17%) 28/52 (54%) 26/50 (52%) 16/48 (33%) |
|POLY-3 RATE (b) | 9/37.19 28/42.67 26/45.46 16/37.59 |
|POLY-3 PERCENT (g) | 24.2% 65.6% 57.2% 42.6% |
|TERMINAL (d) | 2/15 (13%) 12/16 (75%) 15/23 (65%) 2/7 (29%) |
|FIRST INCIDENCE | 201 247 320 72 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.059 P=0.002 ** P=0.030 * P=0.053 |
|POLY 3 | P=0.229 P<0.001 ** P<0.001 ** P=0.066 |
|POLY 1.5 | P=0.198 P<0.001 ** P<0.001 ** P=0.064 |
|POLY 6 | P=0.236 P<0.001 ** P=0.005 ** P=0.060 |
|LOGISTIC REGRESSION| P=0.122 P<0.001 ** P<0.001 ** P=0.025 * |
|COCH-ARM / FISHERS | P=0.130 P<0.001 ** P<0.001 ** P=0.053 |
|ORDER RESTRICTED | P=0.003 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 53
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/12 (83%) 10/10 (100%) 8/9 (89%) 18/19 (95%) |
|POLY-3 RATE (b) | 10/12.00 10/10.00 8/9.00 18/18.62 |
|POLY-3 PERCENT (g) | 83.3% 100.0% 88.9% 96.7% |
|TERMINAL (d) | 5/7 (71%) 4/4 (100%) 5/6 (83%) 4/4 (100%) |
|FIRST INCIDENCE | 405 531 573 188 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.480 P=0.285N P=0.011 * |
|POLY 3 | P=0.225 P=0.272 P=0.602 P=0.258 |
|POLY 1.5 | P=0.263 P=0.272 P=0.602 P=0.294 |
|POLY 6 | P=0.175 P=0.272 P=0.602 P=0.208 |
|LOGISTIC REGRESSION| P=0.412 (e) (e) P=0.450 |
|COCH-ARM / FISHERS | P=0.311 P=0.286 P=0.612 P=0.328 |
|ORDER RESTRICTED | P=0.100 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/12 (17%) 0/10 (0%) 1/9 (11%) 0/19 (0%) |
|POLY-3 RATE (b) | 2/9.81 0/8.18 1/8.19 0/12.13 |
|POLY-3 PERCENT (g) | 20.4% 0.0% 12.2% 0.0% |
|TERMINAL (d) | 2/7 (29%) 0/4 (0%) 1/6 (17%) 0/4 (0%) |
|FIRST INCIDENCE | 727 (T) --- 727 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.229N P=0.362N P=0.558N P=0.362N |
|POLY 3 | P=0.126N P=0.268N P=0.566N P=0.174N |
|POLY 1.5 | P=0.120N P=0.267N P=0.579N P=0.158N |
|POLY 6 | P=0.141N P=0.277N P=0.553N P=0.202N |
|LOGISTIC REGRESSION| P=0.229N (e) P=0.558N (e) |
|COCH-ARM / FISHERS | P=0.106N P=0.286N P=0.612N P=0.142N |
|ORDER RESTRICTED | P=0.041N* (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 54
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Ureter |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/3 (67%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 0/0.00 2/2.75 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 72.8% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 309 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.042 * (e) (e) P=0.245 |
|POLY 3 | (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=1.000N (e) (e) P=1.000 |
|ORDER RESTRICTED | (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Ureter |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/3 (67%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 0/0.00 2/2.08 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 96.3% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 588 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.164 (e) (e) P=0.471 |
|POLY 3 | (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=1.000N (e) (e) P=1.000 |
|ORDER RESTRICTED | (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 55
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Ureter: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/3 (100%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 0/0.00 3/3.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 309 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/51 (8%) 7/52 (13%) 4/52 (8%) 6/53 (11%) |
|POLY-3 RATE (b) | 4/32.86 7/39.11 4/42.47 6/34.02 |
|POLY-3 PERCENT (g) | 12.2% 17.9% 9.4% 17.6% |
|TERMINAL (d) | 0/15 (0%) 2/16 (13%) 1/23 (4%) 1/7 (14%) |
|FIRST INCIDENCE | 391 301 573 309 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.338 P=0.358 P=0.421N P=0.276 |
|POLY 3 | P=0.443 P=0.366 P=0.497N P=0.387 |
|POLY 1.5 | P=0.452 P=0.331 P=0.543N P=0.402 |
|POLY 6 | P=0.417 P=0.398 P=0.448N P=0.337 |
|LOGISTIC REGRESSION| P=0.429 P=0.247 P=0.639 P=0.395 |
|COCH-ARM / FISHERS | P=0.435 P=0.274 P=0.631N P=0.395 |
|ORDER RESTRICTED | P=0.427 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 56
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/51 (2%) 1/52 (2%) 2/52 (4%) 2/53 (4%) |
|POLY-3 RATE (b) | 1/31.35 1/36.79 2/41.91 2/32.25 |
|POLY-3 PERCENT (g) | 3.2% 2.7% 4.8% 6.2% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 1/23 (4%) 0/7 (0%) |
|FIRST INCIDENCE | 574 301 618 660 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.265 P=0.734N P=0.642 P=0.425 |
|POLY 3 | P=0.322 P=0.725N P=0.599 P=0.510 |
|POLY 1.5 | P=0.335 P=0.736N P=0.568 P=0.518 |
|POLY 6 | P=0.296 P=0.716N P=0.631 P=0.481 |
|LOGISTIC REGRESSION| P=0.337 P=0.741 P=0.540 P=0.510 |
|COCH-ARM / FISHERS | P=0.338 P=0.748N P=0.507 P=0.515 |
|ORDER RESTRICTED | P=0.428 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Adenomyosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 0/53 (0%) 2/52 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/31.36 0/36.61 2/41.91 0/31.91 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/16 (0%) 1/23 (4%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- 618 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.489 (e) P=0.344 (e) |
|POLY 3 | P=0.491 (e) P=0.307 (e) |
|POLY 1.5 | P=0.521 (e) P=0.281 (e) |
|POLY 6 | P=0.419 (e) P=0.338 (e) |
|LOGISTIC REGRESSION| P=0.541 (e) P=0.286 (e) |
|COCH-ARM / FISHERS | P=0.541 (e) P=0.248 (e) |
|ORDER RESTRICTED | P=0.305 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 57
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 2/53 (4%) 1/52 (2%) 1/53 (2%) |
|POLY-3 RATE (b) | 0/31.36 2/36.91 1/42.13 1/32.01 |
|POLY-3 PERCENT (g) | 0.0% 5.4% 2.4% 3.1% |
|TERMINAL (d) | 0/15 (0%) 1/16 (6%) 0/23 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 645 535 700 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.393 P=0.275 P=0.552 P=0.413 |
|POLY 3 | P=0.474 P=0.274 P=0.558 P=0.504 |
|POLY 1.5 | P=0.476 P=0.261 P=0.537 P=0.507 |
|POLY 6 | P=0.454 P=0.288 P=0.580 P=0.490 |
|LOGISTIC REGRESSION| P=0.464 P=0.278 P=0.442 P=0.456 |
|COCH-ARM / FISHERS | P=0.463 P=0.252 P=0.500 P=0.505 |
|ORDER RESTRICTED | P=0.329 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/52 (23%) 10/53 (19%) 6/52 (12%) 4/53 (8%) |
|POLY-3 RATE (b) | 12/35.65 10/39.29 6/42.51 4/33.98 |
|POLY-3 PERCENT (g) | 33.7% 25.5% 14.1% 11.8% |
|TERMINAL (d) | 2/15 (13%) 3/16 (19%) 4/23 (17%) 0/7 (0%) |
|FIRST INCIDENCE | 391 331 535 244 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.025N* P=0.264N P=0.018N* P=0.065N |
|POLY 3 | P=0.010N* P=0.296N P=0.035N* P=0.025N* |
|POLY 1.5 | P=0.009N** P=0.319N P=0.049N* P=0.021N* |
|POLY 6 | P=0.012N* P=0.298N P=0.027N* P=0.042N* |
|LOGISTIC REGRESSION| P=0.011N* P=0.344N P=0.064N P=0.025N* |
|COCH-ARM / FISHERS | P=0.012N* P=0.386N P=0.097N P=0.025N* |
|ORDER RESTRICTED | P=0.018N* (e) (e) (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 58
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 26/52 (50%) 29/53 (55%) 27/52 (52%) 11/53 (21%) |
|POLY-3 RATE (b) | 26/41.07 29/45.96 27/46.70 11/35.60 |
|POLY-3 PERCENT (g) | 63.3% 63.1% 57.8% 30.9% |
|TERMINAL (d) | 7/15 (47%) 8/16 (50%) 12/23 (52%) 2/7 (29%) |
|FIRST INCIDENCE | 321 247 440 555 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.016N* P=0.476N P=0.098N P=0.023N* |
|POLY 3 | P=0.002N** P=0.583N P=0.377N P=0.002N** |
|POLY 1.5 | P<0.001N** P=0.545 P=0.449N P<0.001N** |
|POLY 6 | P=0.011N* P=0.582N P=0.329N P=0.010N* |
|LOGISTIC REGRESSION| P<0.001N** P=0.433 P=0.490N P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.387 P=0.500 P=0.002N** |
|ORDER RESTRICTED | P=0.002N** (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 300 550 1000 |
| | NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 23/52 (44%) 26/53 (49%) 32/52 (62%) 9/53 (17%) |
|POLY-3 RATE (b) | 23/35.31 26/41.15 32/45.02 9/34.37 |
|POLY-3 PERCENT (g) | 65.1% 63.2% 71.1% 26.2% |
|TERMINAL (d) | 12/15 (80%) 12/16 (75%) 21/23 (91%) 3/7 (43%) |
|FIRST INCIDENCE | 496 403 327 244 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.063N P=0.537N P=0.369N P=0.065N |
|POLY 3 | P<0.001N** P=0.527N P=0.361 P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.560 P=0.213 P<0.001N** |
|POLY 6 | P=0.002N** P=0.434N P=0.543 P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.504N P=0.493 P<0.001N** |
|COCH-ARM / FISHERS | P=0.003N** P=0.382 P=0.058 P=0.002N** |
|ORDER RESTRICTED | P<0.001N** (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).