TDMS Study 96021-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) DATE: 10/09/03
EXPERIMENT: 96021 TEST: 01 TIME: 11:58:02
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96021
PATHOLOGIST: SELLS, DONALD CAS: 35065-27-1
------------------------------------------------------------------------------------------------------------------------------------
FINAL #3 CONTROL VS. STOP
REASONS FOR REMOVAL: 25018 Dosing Accident
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 UG/KG
INCLUDE 007 3000 UG/KG STOP
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) DATE: 10/09/03
EXPERIMENT: 96021 TEST: 01 TIME: 11:58:02
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96021
PATHOLOGIST: SELLS, DONALD CAS: 35065-27-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TOXIC EQUIVALENCY FACTOR EVALUATION (
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Angiectasis
Degeneration Cystic
Hematopoietic Cell Proliferation
Hyperplasia
Hypertrophy
Vacuolization Cytoplasmic
Adrenal Medulla Hyperplasia
Blood Vessel: Aorta Mineralization
Bone Marrow Hyperplasia
Clitoral Gland Inflammation
Clitoral Gland: Duct Cyst
Esophagus: Muscularis Inflammation
Eye: Retina Atrophy
Harderian Gland Inflammation
Heart Cardiomyopathy
Intestine Large, Rectum Parasite Metazoan
Kidney Calculus Micro Observation Only
Casts Protein
Inflammation
Inflammation Chronic
Mineralization
Nephropathy
Kidney: Pelvis Inflammation
Kidney: Transitional Epithelium Hyperplasia
Liver Angiectasis
Basophilic Focus
Clear Cell Focus
Eosinophilic Focus
Fatty Change Diffuse
Fatty Change Focal
Hematopoietic Cell Proliferation
Hepatodiaphragmatic Nodule
Hyperplasia
Inflammation
Mixed Cell Focus
Necrosis
Pigmentation
Liver: Bile Duct Cyst
Fibrosis
Hyperplasia
Liver: Centrilobular Degeneration
Liver: Hepatocyte Hypertrophy
Liver: Oval Cell Hyperplasia
Lung Infiltration Cellular Histiocyte
Inflammation
Lung: Alveolar Epithelium Hyperplasia
Lymph Node, Mandibular Hyperplasia
Lymph Node: Mediastinal Congestion
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) DATE: 10/09/03
EXPERIMENT: 96021 TEST: 01 TIME: 11:58:02
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96021
PATHOLOGIST: SELLS, DONALD CAS: 35065-27-1
Hyperplasia
Mammary Gland Cyst
Hyperplasia
Inflammation Granulomatous
Nose Inflammation
Nose: Nasolacrimal Duct Inflammation
Nose: Septum Inflammation
Nose: Turbinate Inflammation
Ovary Atrophy
Cyst
Oviduct Inflammation Chronic
Pancreas Inflammation Chronic
Pancreas: Acinus Atrophy
Hyperplasia
Parathyroid Gland Hyperplasia
Pituitary Gland Angiectasis
Cytoplasmic Alteration
Pituitary Gland: Pars Distalis Hyperplasia
Spleen Hematopoietic Cell Proliferation
Pigmentation
Spleen: Lymphoid Follicle Atrophy
Stomach, Forestomach Hyperkeratosis
Hyperplasia
Inflammation
Mineralization
Stomach, Glandular Mineralization
Thymus Atrophy
Thyroid Gland: C-Cell Hyperplasia
Thyroid Gland: Follicular Cell Hypertrophy
Tooth: Peridontal Tissue Inflammation
Urinary Bladder Inflammation
Urinary Bladder: Transitional Epithelium
Hyperplasia
Uterus Adenomyosis
Inflammation
Inflammation Chronic
Metaplasia
Uterus: Cervix Hyperplasia Stromal
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 21/53 (40%) 20/50 (40%) |
|POLY-3 RATE (b) | 21/42.96 20/39.75 |
|POLY-3 PERCENT (g) | 48.9% 50.3% |
|TERMINAL (d) | 12/24 (50%) 13/20 (65%) |
|FIRST INCIDENCE | 502 400 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.451 |
|POLY 3 | P=0.540 |
|POLY 1.5 | P=0.537 |
|POLY 6 | P=0.543 |
|LOGISTIC REGRESSION| P=0.541 |
|COCH-ARM / FISHERS | P=0.564 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/53 (17%) 7/50 (14%) |
|POLY-3 RATE (b) | 9/40.67 7/36.86 |
|POLY-3 PERCENT (g) | 22.1% 19.0% |
|TERMINAL (d) | 5/24 (21%) 5/20 (25%) |
|FIRST INCIDENCE | 437 591 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.513N |
|POLY 3 | P=0.482N |
|POLY 1.5 | P=0.477N |
|POLY 6 | P=0.484N |
|LOGISTIC REGRESSION| P=0.449N |
|COCH-ARM / FISHERS | P=0.443N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/39.01 2/37.02 |
|POLY-3 PERCENT (g) | 0.0% 5.4% |
|TERMINAL (d) | 0/24 (0%) 0/20 (0%) |
|FIRST INCIDENCE | --- 611 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.229 |
|POLY 3 | P=0.230 |
|POLY 1.5 | P=0.229 |
|POLY 6 | P=0.233 |
|LOGISTIC REGRESSION| P=0.224 |
|COCH-ARM / FISHERS | P=0.233 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 18/53 (34%) 18/50 (36%) |
|POLY-3 RATE (b) | 18/42.09 18/38.69 |
|POLY-3 PERCENT (g) | 42.8% 46.5% |
|TERMINAL (d) | 11/24 (46%) 11/20 (55%) |
|FIRST INCIDENCE | 418 528 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.392 |
|POLY 3 | P=0.457 |
|POLY 1.5 | P=0.455 |
|POLY 6 | P=0.472 |
|LOGISTIC REGRESSION| P=0.478 |
|COCH-ARM / FISHERS | P=0.496 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 48/53 (91%) 35/50 (70%) |
|POLY-3 RATE (b) | 48/49.83 35/41.93 |
|POLY-3 PERCENT (g) | 96.3% 83.5% |
|TERMINAL (d) | 24/24 (100%) 19/20 (95%) |
|FIRST INCIDENCE | 211 400 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.137N |
|POLY 3 | P=0.020N* |
|POLY 1.5 | P=0.015N* |
|POLY 6 | P=0.026N* |
|LOGISTIC REGRESSION| P=0.008N** |
|COCH-ARM / FISHERS | P=0.008N** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/53 (19%) 12/50 (24%) |
|POLY-3 RATE (b) | 10/39.40 12/39.05 |
|POLY-3 PERCENT (g) | 25.4% 30.7% |
|TERMINAL (d) | 8/24 (33%) 6/20 (30%) |
|FIRST INCIDENCE | 656 400 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.284 |
|POLY 3 | P=0.390 |
|POLY 1.5 | P=0.360 |
|POLY 6 | P=0.439 |
|LOGISTIC REGRESSION| P=0.334 |
|COCH-ARM / FISHERS | P=0.346 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 18/53 (34%) 19/50 (38%) |
|POLY-3 RATE (b) | 18/41.52 19/39.68 |
|POLY-3 PERCENT (g) | 43.4% 47.9% |
|TERMINAL (d) | 11/24 (46%) 10/20 (50%) |
|FIRST INCIDENCE | 502 437 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.331 |
|POLY 3 | P=0.426 |
|POLY 1.5 | P=0.403 |
|POLY 6 | P=0.464 |
|LOGISTIC REGRESSION| P=0.390 |
|COCH-ARM / FISHERS | P=0.412 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/39.69 0/36.38 |
|POLY-3 PERCENT (g) | 5.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/20 (0%) |
|FIRST INCIDENCE | 551 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.260N |
|POLY 3 | P=0.267N |
|POLY 1.5 | P=0.264N |
|POLY 6 | P=0.269N |
|LOGISTIC REGRESSION| P=0.234N |
|COCH-ARM / FISHERS | P=0.257N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 34/53 (64%) 40/50 (80%) |
|POLY-3 RATE (b) | 34/49.96 40/48.69 |
|POLY-3 PERCENT (g) | 68.1% 82.2% |
|TERMINAL (d) | 11/24 (46%) 13/20 (65%) |
|FIRST INCIDENCE | 399 183 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.135 |
|POLY 3 | P=0.077 |
|POLY 1.5 | P=0.070 |
|POLY 6 | P=0.094 |
|LOGISTIC REGRESSION| P=0.060 |
|COCH-ARM / FISHERS | P=0.058 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 52/53 (98%) 44/48 (92%) |
|POLY-3 RATE (b) | 52/52.22 44/46.77 |
|POLY-3 PERCENT (g) | 99.6% 94.1% |
|TERMINAL (d) | 24/24 (100%) 19/20 (95%) |
|FIRST INCIDENCE | 211 183 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.414N |
|POLY 3 | P=0.136N |
|POLY 1.5 | P=0.135N |
|POLY 6 | P=0.156N |
|LOGISTIC REGRESSION| P=0.164N |
|COCH-ARM / FISHERS | P=0.152N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Clitoral Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 49/53 (92%) 41/48 (85%) |
|POLY-3 RATE (b) | 49/52.16 41/46.08 |
|POLY-3 PERCENT (g) | 93.9% 89.0% |
|TERMINAL (d) | 22/24 (92%) 18/20 (90%) |
|FIRST INCIDENCE | 211 183 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.396N |
|POLY 3 | P=0.295N |
|POLY 1.5 | P=0.252N |
|POLY 6 | P=0.374N |
|LOGISTIC REGRESSION| P=0.199N |
|COCH-ARM / FISHERS | P=0.208N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Esophagus: Muscularis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 3/49 (6%) |
|POLY-3 RATE (b) | 0/39.01 3/37.96 |
|POLY-3 PERCENT (g) | 0.0% 7.9% |
|TERMINAL (d) | 0/24 (0%) 0/20 (0%) |
|FIRST INCIDENCE | --- 191 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.114 |
|POLY 3 | P=0.114 |
|POLY 1.5 | P=0.111 |
|POLY 6 | P=0.119 |
|LOGISTIC REGRESSION| P=0.161 |
|COCH-ARM / FISHERS | P=0.107 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Eye: Retina |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/39.23 2/36.61 |
|POLY-3 PERCENT (g) | 5.1% 5.5% |
|TERMINAL (d) | 1/24 (4%) 1/20 (5%) |
|FIRST INCIDENCE | 672 668 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.653 |
|POLY 3 | P=0.677 |
|POLY 1.5 | P=0.674 |
|POLY 6 | P=0.682 |
|LOGISTIC REGRESSION| P=0.675 |
|COCH-ARM / FISHERS | P=0.669 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Harderian Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 20/53 (38%) 15/50 (30%) |
|POLY-3 RATE (b) | 20/42.61 15/38.36 |
|POLY-3 PERCENT (g) | 46.9% 39.1% |
|TERMINAL (d) | 11/24 (46%) 8/20 (40%) |
|FIRST INCIDENCE | 211 575 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.357N |
|POLY 3 | P=0.313N |
|POLY 1.5 | P=0.317N |
|POLY 6 | P=0.296N |
|LOGISTIC REGRESSION| P=0.279N |
|COCH-ARM / FISHERS | P=0.268N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 22/52 (42%) 15/50 (30%) |
|POLY-3 RATE (b) | 22/42.16 15/37.84 |
|POLY-3 PERCENT (g) | 52.2% 39.6% |
|TERMINAL (d) | 14/24 (58%) 8/20 (40%) |
|FIRST INCIDENCE | 399 590 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.235N |
|POLY 3 | P=0.179N |
|POLY 1.5 | P=0.172N |
|POLY 6 | P=0.182N |
|LOGISTIC REGRESSION| P=0.144N |
|COCH-ARM / FISHERS | P=0.139N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/39.01 3/36.38 |
|POLY-3 PERCENT (g) | 2.6% 8.3% |
|TERMINAL (d) | 1/24 (4%) 2/20 (10%) |
|FIRST INCIDENCE | 731 (T) 730 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.247 |
|POLY 3 | P=0.285 |
|POLY 1.5 | P=0.284 |
|POLY 6 | P=0.288 |
|LOGISTIC REGRESSION| P=0.268 |
|COCH-ARM / FISHERS | P=0.287 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Kidney |
| Calculus Micro Observation Only |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/39.32 0/36.38 |
|POLY-3 PERCENT (g) | 7.6% 0.0% |
|TERMINAL (d) | 2/24 (8%) 0/20 (0%) |
|FIRST INCIDENCE | 644 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.146N |
|POLY 3 | P=0.137N |
|POLY 1.5 | P=0.139N |
|POLY 6 | P=0.134N |
|LOGISTIC REGRESSION| P=0.130N |
|COCH-ARM / FISHERS | P=0.132N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Kidney |
| Casts Protein |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 3/39.60 4/38.31 |
|POLY-3 PERCENT (g) | 7.6% 10.4% |
|TERMINAL (d) | 1/24 (4%) 1/20 (5%) |
|FIRST INCIDENCE | 590 400 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.451 |
|POLY 3 | P=0.484 |
|POLY 1.5 | P=0.474 |
|POLY 6 | P=0.497 |
|LOGISTIC REGRESSION| P=0.480 |
|COCH-ARM / FISHERS | P=0.467 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/39.01 2/36.38 |
|POLY-3 PERCENT (g) | 2.6% 5.5% |
|TERMINAL (d) | 1/24 (4%) 2/20 (10%) |
|FIRST INCIDENCE | 731 (T) 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.436 |
|POLY 3 | P=0.484 |
|POLY 1.5 | P=0.482 |
|POLY 6 | P=0.487 |
|LOGISTIC REGRESSION| P=0.436 |
|COCH-ARM / FISHERS | P=0.478 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/39.01 3/37.26 |
|POLY-3 PERCENT (g) | 0.0% 8.1% |
|TERMINAL (d) | 0/24 (0%) 1/20 (5%) |
|FIRST INCIDENCE | --- 360 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.101 |
|POLY 3 | P=0.112 |
|POLY 1.5 | P=0.111 |
|POLY 6 | P=0.114 |
|LOGISTIC REGRESSION| P=0.114 |
|COCH-ARM / FISHERS | P=0.111 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 40/53 (75%) 38/50 (76%) |
|POLY-3 RATE (b) | 40/47.84 38/44.00 |
|POLY-3 PERCENT (g) | 83.6% 86.4% |
|TERMINAL (d) | 21/24 (88%) 19/20 (95%) |
|FIRST INCIDENCE | 399 245 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.395 |
|POLY 3 | P=0.472 |
|POLY 1.5 | P=0.476 |
|POLY 6 | P=0.497 |
|LOGISTIC REGRESSION| P=0.494 |
|COCH-ARM / FISHERS | P=0.567 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 34/53 (64%) 22/50 (44%) |
|POLY-3 RATE (b) | 34/46.35 22/38.29 |
|POLY-3 PERCENT (g) | 73.4% 57.5% |
|TERMINAL (d) | 18/24 (75%) 16/20 (80%) |
|FIRST INCIDENCE | 211 590 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.087N |
|POLY 3 | P=0.084N |
|POLY 1.5 | P=0.063N |
|POLY 6 | P=0.119N |
|LOGISTIC REGRESSION| P=0.030N* |
|COCH-ARM / FISHERS | P=0.032N* |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/39.13 3/37.73 |
|POLY-3 PERCENT (g) | 2.6% 8.0% |
|TERMINAL (d) | 0/24 (0%) 1/20 (5%) |
|FIRST INCIDENCE | 701 360 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.278 |
|POLY 3 | P=0.294 |
|POLY 1.5 | P=0.290 |
|POLY 6 | P=0.301 |
|LOGISTIC REGRESSION| P=0.297 |
|COCH-ARM / FISHERS | P=0.287 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/39.13 4/37.49 |
|POLY-3 PERCENT (g) | 2.6% 10.7% |
|TERMINAL (d) | 0/24 (0%) 2/20 (10%) |
|FIRST INCIDENCE | 701 360 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.155 |
|POLY 3 | P=0.166 |
|POLY 1.5 | P=0.163 |
|POLY 6 | P=0.170 |
|LOGISTIC REGRESSION| P=0.162 |
|COCH-ARM / FISHERS | P=0.164 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 8/50 (16%) |
|POLY-3 RATE (b) | 5/40.04 8/37.12 |
|POLY-3 PERCENT (g) | 12.5% 21.6% |
|TERMINAL (d) | 2/24 (8%) 6/20 (30%) |
|FIRST INCIDENCE | 442 528 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.196 |
|POLY 3 | P=0.226 |
|POLY 1.5 | P=0.226 |
|POLY 6 | P=0.229 |
|LOGISTIC REGRESSION| P=0.232 |
|COCH-ARM / FISHERS | P=0.240 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 16/53 (30%) 10/50 (20%) |
|POLY-3 RATE (b) | 16/42.46 10/37.74 |
|POLY-3 PERCENT (g) | 37.7% 26.5% |
|TERMINAL (d) | 7/24 (29%) 5/20 (25%) |
|FIRST INCIDENCE | 502 528 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.230N |
|POLY 3 | P=0.204N |
|POLY 1.5 | P=0.196N |
|POLY 6 | P=0.213N |
|LOGISTIC REGRESSION| P=0.174N |
|COCH-ARM / FISHERS | P=0.168N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/53 (11%) 1/50 (2%) |
|POLY-3 RATE (b) | 6/39.13 1/36.85 |
|POLY-3 PERCENT (g) | 15.3% 2.7% |
|TERMINAL (d) | 5/24 (21%) 0/20 (0%) |
|FIRST INCIDENCE | 701 591 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.084N |
|POLY 3 | P=0.065N |
|POLY 1.5 | P=0.069N |
|POLY 6 | P=0.059N |
|LOGISTIC REGRESSION| P=0.065N |
|COCH-ARM / FISHERS | P=0.066N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/53 (23%) 14/50 (28%) |
|POLY-3 RATE (b) | 12/40.39 14/40.54 |
|POLY-3 PERCENT (g) | 29.7% 34.5% |
|TERMINAL (d) | 8/24 (33%) 4/20 (20%) |
|FIRST INCIDENCE | 507 183 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.299 |
|POLY 3 | P=0.409 |
|POLY 1.5 | P=0.375 |
|POLY 6 | P=0.459 |
|LOGISTIC REGRESSION| P=0.334 |
|COCH-ARM / FISHERS | P=0.345 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 15/50 (30%) |
|POLY-3 RATE (b) | 3/39.88 15/38.34 |
|POLY-3 PERCENT (g) | 7.5% 39.1% |
|TERMINAL (d) | 0/24 (0%) 8/20 (40%) |
|FIRST INCIDENCE | 608 575 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** |
|POLY 3 | P<0.001 ** |
|POLY 1.5 | P<0.001 ** |
|POLY 6 | P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 6/50 (12%) |
|POLY-3 RATE (b) | 4/39.26 6/37.79 |
|POLY-3 PERCENT (g) | 10.2% 15.9% |
|TERMINAL (d) | 2/24 (8%) 2/20 (10%) |
|FIRST INCIDENCE | 696 452 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.315 |
|POLY 3 | P=0.345 |
|POLY 1.5 | P=0.335 |
|POLY 6 | P=0.362 |
|LOGISTIC REGRESSION| P=0.326 |
|COCH-ARM / FISHERS | P=0.334 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 20/53 (38%) 17/50 (34%) |
|POLY-3 RATE (b) | 20/46.75 17/42.49 |
|POLY-3 PERCENT (g) | 42.8% 40.0% |
|TERMINAL (d) | 5/24 (21%) 5/20 (25%) |
|FIRST INCIDENCE | 399 183 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.484N |
|POLY 3 | P=0.484N |
|POLY 1.5 | P=0.468N |
|POLY 6 | P=0.493N |
|LOGISTIC REGRESSION| P=0.381N |
|COCH-ARM / FISHERS | P=0.425N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/39.01 2/36.50 |
|POLY-3 PERCENT (g) | 0.0% 5.5% |
|TERMINAL (d) | 0/24 (0%) 1/20 (5%) |
|FIRST INCIDENCE | --- 701 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.216 |
|POLY 3 | P=0.229 |
|POLY 1.5 | P=0.228 |
|POLY 6 | P=0.230 |
|LOGISTIC REGRESSION| P=0.225 |
|COCH-ARM / FISHERS | P=0.233 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/39.01 2/37.36 |
|POLY-3 PERCENT (g) | 0.0% 5.4% |
|TERMINAL (d) | 0/24 (0%) 1/20 (5%) |
|FIRST INCIDENCE | --- 183 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.214 |
|POLY 3 | P=0.231 |
|POLY 1.5 | P=0.230 |
|POLY 6 | P=0.233 |
|LOGISTIC REGRESSION| P=0.280 |
|COCH-ARM / FISHERS | P=0.233 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 44/53 (83%) 44/50 (88%) |
|POLY-3 RATE (b) | 44/49.23 44/47.40 |
|POLY-3 PERCENT (g) | 89.4% 92.8% |
|TERMINAL (d) | 20/24 (83%) 20/20 (100%) |
|FIRST INCIDENCE | 399 183 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.287 |
|POLY 3 | P=0.397 |
|POLY 1.5 | P=0.411 |
|POLY 6 | P=0.307 |
|LOGISTIC REGRESSION| P=0.286 |
|COCH-ARM / FISHERS | P=0.332 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 29/53 (55%) 20/50 (40%) |
|POLY-3 RATE (b) | 29/42.75 20/39.11 |
|POLY-3 PERCENT (g) | 67.8% 51.1% |
|TERMINAL (d) | 20/24 (83%) 13/20 (65%) |
|FIRST INCIDENCE | 418 514 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.178N |
|POLY 3 | P=0.080N |
|POLY 1.5 | P=0.096N |
|POLY 6 | P=0.059N |
|LOGISTIC REGRESSION| P=0.085N |
|COCH-ARM / FISHERS | P=0.097N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/53 (13%) 9/50 (18%) |
|POLY-3 RATE (b) | 7/42.63 9/40.31 |
|POLY-3 PERCENT (g) | 16.4% 22.3% |
|TERMINAL (d) | 0/24 (0%) 0/20 (0%) |
|FIRST INCIDENCE | 442 183 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.346 |
|POLY 3 | P=0.346 |
|POLY 1.5 | P=0.345 |
|POLY 6 | P=0.349 |
|LOGISTIC REGRESSION| P=0.407 |
|COCH-ARM / FISHERS | P=0.345 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/39.56 3/36.61 |
|POLY-3 PERCENT (g) | 2.5% 8.2% |
|TERMINAL (d) | 0/24 (0%) 2/20 (10%) |
|FIRST INCIDENCE | 557 670 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.269 |
|POLY 3 | P=0.283 |
|POLY 1.5 | P=0.283 |
|POLY 6 | P=0.285 |
|LOGISTIC REGRESSION| P=0.280 |
|COCH-ARM / FISHERS | P=0.287 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 3/50 (6%) |
|POLY-3 RATE (b) | 3/39.38 3/36.50 |
|POLY-3 PERCENT (g) | 7.6% 8.2% |
|TERMINAL (d) | 1/24 (4%) 2/20 (10%) |
|FIRST INCIDENCE | 664 701 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.612 |
|POLY 3 | P=0.634 |
|POLY 1.5 | P=0.632 |
|POLY 6 | P=0.639 |
|LOGISTIC REGRESSION| P=0.640 |
|COCH-ARM / FISHERS | P=0.633 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 2/39.48 5/37.75 |
|POLY-3 PERCENT (g) | 5.1% 13.2% |
|TERMINAL (d) | 1/24 (4%) 2/20 (10%) |
|FIRST INCIDENCE | 590 437 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.183 |
|POLY 3 | P=0.198 |
|POLY 1.5 | P=0.194 |
|POLY 6 | P=0.205 |
|LOGISTIC REGRESSION| P=0.192 |
|COCH-ARM / FISHERS | P=0.195 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 12/50 (24%) |
|POLY-3 RATE (b) | 5/39.38 12/37.83 |
|POLY-3 PERCENT (g) | 12.7% 31.7% |
|TERMINAL (d) | 3/24 (13%) 9/20 (45%) |
|FIRST INCIDENCE | 664 575 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.027 * |
|POLY 3 | P=0.037 * |
|POLY 1.5 | P=0.036 * |
|POLY 6 | P=0.040 * |
|LOGISTIC REGRESSION| P=0.038 * |
|COCH-ARM / FISHERS | P=0.042 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 2/39.58 5/39.06 |
|POLY-3 PERCENT (g) | 5.1% 12.8% |
|TERMINAL (d) | 1/24 (4%) 0/20 (0%) |
|FIRST INCIDENCE | 551 191 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.194 |
|POLY 3 | P=0.209 |
|POLY 1.5 | P=0.203 |
|POLY 6 | P=0.218 |
|LOGISTIC REGRESSION| P=0.239 |
|COCH-ARM / FISHERS | P=0.195 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 32/50 (64%) |
|POLY-3 RATE (b) | 0/39.01 32/41.91 |
|POLY-3 PERCENT (g) | 0.0% 76.4% |
|TERMINAL (d) | 0/24 (0%) 19/20 (95%) |
|FIRST INCIDENCE | --- 400 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** |
|POLY 3 | P<0.001 ** |
|POLY 1.5 | P<0.001 ** |
|POLY 6 | P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver: Oval Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/39.01 2/36.38 |
|POLY-3 PERCENT (g) | 0.0% 5.5% |
|TERMINAL (d) | 0/24 (0%) 2/20 (10%) |
|FIRST INCIDENCE | --- 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.198 |
|POLY 3 | P=0.228 |
|POLY 1.5 | P=0.228 |
|POLY 6 | P=0.229 |
|LOGISTIC REGRESSION| P=0.198 |
|COCH-ARM / FISHERS | P=0.233 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 45/52 (87%) 37/50 (74%) |
|POLY-3 RATE (b) | 45/48.19 37/44.85 |
|POLY-3 PERCENT (g) | 93.4% 82.5% |
|TERMINAL (d) | 23/24 (96%) 16/20 (80%) |
|FIRST INCIDENCE | 410 183 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.371N |
|POLY 3 | P=0.073N |
|POLY 1.5 | P=0.071N |
|POLY 6 | P=0.088N |
|LOGISTIC REGRESSION| P=0.119N |
|COCH-ARM / FISHERS | P=0.089N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/52 (12%) 9/50 (18%) |
|POLY-3 RATE (b) | 6/40.63 9/37.34 |
|POLY-3 PERCENT (g) | 14.8% 24.1% |
|TERMINAL (d) | 3/24 (13%) 6/20 (30%) |
|FIRST INCIDENCE | 410 590 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.201 |
|POLY 3 | P=0.226 |
|POLY 1.5 | P=0.233 |
|POLY 6 | P=0.225 |
|LOGISTIC REGRESSION| P=0.245 |
|COCH-ARM / FISHERS | P=0.261 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 20/52 (38%) 4/50 (8%) |
|POLY-3 RATE (b) | 20/41.45 4/36.53 |
|POLY-3 PERCENT (g) | 48.3% 11.0% |
|TERMINAL (d) | 13/24 (54%) 3/20 (15%) |
|FIRST INCIDENCE | 555 691 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** |
|POLY 3 | P<0.001N** |
|POLY 1.5 | P<0.001N** |
|POLY 6 | P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 37/51 (73%) 37/48 (77%) |
|POLY-3 RATE (b) | 37/46.48 37/43.23 |
|POLY-3 PERCENT (g) | 79.6% 85.6% |
|TERMINAL (d) | 18/24 (75%) 17/20 (85%) |
|FIRST INCIDENCE | 211 191 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.313 |
|POLY 3 | P=0.311 |
|POLY 1.5 | P=0.313 |
|POLY 6 | P=0.315 |
|LOGISTIC REGRESSION| P=0.331 |
|COCH-ARM / FISHERS | P=0.387 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/3 (100%) 0/1 (0%) |
|POLY-3 RATE (b) | 3/3.00 0/1.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) |
|FIRST INCIDENCE | 399 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.154N |
|POLY 3 | P=0.250 |
|POLY 1.5 | P=0.250 |
|POLY 6 | P=0.250 |
|LOGISTIC REGRESSION| (e) |
|COCH-ARM / FISHERS | P=0.250N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/3 (67%) 0/1 (0%) |
|POLY-3 RATE (b) | 2/2.43 0/1.00 |
|POLY-3 PERCENT (g) | 82.4% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) |
|FIRST INCIDENCE | 399 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.269N |
|POLY 3 | P=0.577N |
|POLY 1.5 | P=0.635N |
|POLY 6 | P=0.470N |
|LOGISTIC REGRESSION| (e) |
|COCH-ARM / FISHERS | P=0.500N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 2/39.84 4/37.45 |
|POLY-3 PERCENT (g) | 5.0% 10.7% |
|TERMINAL (d) | 1/24 (4%) 0/20 (0%) |
|FIRST INCIDENCE | 399 611 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.313 |
|POLY 3 | P=0.312 |
|POLY 1.5 | P=0.307 |
|POLY 6 | P=0.323 |
|LOGISTIC REGRESSION| P=0.313 |
|COCH-ARM / FISHERS | P=0.312 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 22/53 (42%) 27/50 (54%) |
|POLY-3 RATE (b) | 22/43.38 27/41.08 |
|POLY-3 PERCENT (g) | 50.7% 65.7% |
|TERMINAL (d) | 12/24 (50%) 15/20 (75%) |
|FIRST INCIDENCE | 211 437 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.107 |
|POLY 3 | P=0.108 |
|POLY 1.5 | P=0.105 |
|POLY 6 | P=0.116 |
|LOGISTIC REGRESSION| P=0.118 |
|COCH-ARM / FISHERS | P=0.142 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/39.01 2/36.53 |
|POLY-3 PERCENT (g) | 0.0% 5.5% |
|TERMINAL (d) | 0/24 (0%) 1/20 (5%) |
|FIRST INCIDENCE | --- 691 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.212 |
|POLY 3 | P=0.229 |
|POLY 1.5 | P=0.228 |
|POLY 6 | P=0.230 |
|LOGISTIC REGRESSION| P=0.225 |
|COCH-ARM / FISHERS | P=0.233 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/39.01 2/36.75 |
|POLY-3 PERCENT (g) | 2.6% 5.4% |
|TERMINAL (d) | 1/24 (4%) 1/20 (5%) |
|FIRST INCIDENCE | 731 (T) 627 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.461 |
|POLY 3 | P=0.486 |
|POLY 1.5 | P=0.483 |
|POLY 6 | P=0.491 |
|LOGISTIC REGRESSION| P=0.478 |
|COCH-ARM / FISHERS | P=0.478 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/39.01 0/36.38 |
|POLY-3 PERCENT (g) | 5.1% 0.0% |
|TERMINAL (d) | 2/24 (8%) 0/20 (0%) |
|FIRST INCIDENCE | 731 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.278N |
|POLY 3 | P=0.260N |
|POLY 1.5 | P=0.263N |
|POLY 6 | P=0.254N |
|LOGISTIC REGRESSION| (e) |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Nose: Septum |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 4/50 (8%) |
|POLY-3 RATE (b) | 4/40.77 4/37.52 |
|POLY-3 PERCENT (g) | 9.8% 10.7% |
|TERMINAL (d) | 1/24 (4%) 1/20 (5%) |
|FIRST INCIDENCE | 211 452 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.585 |
|POLY 3 | P=0.604 |
|POLY 1.5 | P=0.601 |
|POLY 6 | P=0.612 |
|LOGISTIC REGRESSION| P=0.638 |
|COCH-ARM / FISHERS | P=0.609 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Nose: Turbinate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/53 (15%) 5/50 (10%) |
|POLY-3 RATE (b) | 8/42.11 5/38.15 |
|POLY-3 PERCENT (g) | 19.0% 13.1% |
|TERMINAL (d) | 2/24 (8%) 1/20 (5%) |
|FIRST INCIDENCE | 211 452 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.350N |
|POLY 3 | P=0.346N |
|POLY 1.5 | P=0.347N |
|POLY 6 | P=0.341N |
|LOGISTIC REGRESSION| P=0.286N |
|COCH-ARM / FISHERS | P=0.317N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Oral Mucosa: Gingival |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 21/21 (100%) 15/15 (100%) |
|POLY-3 RATE (b) | 21/21.00 15/15.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% |
|TERMINAL (d) | 10/10 (100%) 7/7 (100%) |
|FIRST INCIDENCE | 211 360 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) |
|POLY 3 | (e) |
|POLY 1.5 | (e) |
|POLY 6 | (e) |
|LOGISTIC REGRESSION| (e) |
|COCH-ARM / FISHERS | (e) |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 47/53 (89%) 41/49 (84%) |
|POLY-3 RATE (b) | 47/51.19 41/45.06 |
|POLY-3 PERCENT (g) | 91.8% 91.0% |
|TERMINAL (d) | 22/24 (92%) 20/20 (100%) |
|FIRST INCIDENCE | 211 191 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.507N |
|POLY 3 | P=0.609N |
|POLY 1.5 | P=0.514N |
|POLY 6 | P=0.678 |
|LOGISTIC REGRESSION| P=0.366N |
|COCH-ARM / FISHERS | P=0.328N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 14/53 (26%) 16/49 (33%) |
|POLY-3 RATE (b) | 14/41.40 16/36.86 |
|POLY-3 PERCENT (g) | 33.8% 43.4% |
|TERMINAL (d) | 6/24 (25%) 10/20 (50%) |
|FIRST INCIDENCE | 557 591 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.285 |
|POLY 3 | P=0.261 |
|POLY 1.5 | P=0.273 |
|POLY 6 | P=0.249 |
|LOGISTIC REGRESSION| P=0.293 |
|COCH-ARM / FISHERS | P=0.318 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Oviduct |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/46 (4%) |
|POLY-3 RATE (b) | 1/37.44 2/32.91 |
|POLY-3 PERCENT (g) | 2.7% 6.1% |
|TERMINAL (d) | 1/24 (4%) 1/19 (5%) |
|FIRST INCIDENCE | 731 (T) 730 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.431 |
|POLY 3 | P=0.471 |
|POLY 1.5 | P=0.472 |
|POLY 6 | P=0.471 |
|LOGISTIC REGRESSION| P=0.441 |
|COCH-ARM / FISHERS | P=0.468 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/39.01 2/36.60 |
|POLY-3 PERCENT (g) | 5.1% 5.5% |
|TERMINAL (d) | 2/24 (8%) 1/20 (5%) |
|FIRST INCIDENCE | 731 (T) 671 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.638 |
|POLY 3 | P=0.678 |
|POLY 1.5 | P=0.675 |
|POLY 6 | P=0.685 |
|LOGISTIC REGRESSION| P=0.679 |
|COCH-ARM / FISHERS | P=0.669 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/39.01 3/37.37 |
|POLY-3 PERCENT (g) | 2.6% 8.0% |
|TERMINAL (d) | 1/24 (4%) 1/20 (5%) |
|FIRST INCIDENCE | 731 (T) 452 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.264 |
|POLY 3 | P=0.292 |
|POLY 1.5 | P=0.288 |
|POLY 6 | P=0.299 |
|LOGISTIC REGRESSION| P=0.282 |
|COCH-ARM / FISHERS | P=0.287 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/39.01 2/36.38 |
|POLY-3 PERCENT (g) | 7.7% 5.5% |
|TERMINAL (d) | 3/24 (13%) 2/20 (10%) |
|FIRST INCIDENCE | 731 (T) 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.585N |
|POLY 3 | P=0.539N |
|POLY 1.5 | P=0.542N |
|POLY 6 | P=0.530N |
|LOGISTIC REGRESSION| P=0.585N |
|COCH-ARM / FISHERS | P=0.528N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 1/45 (2%) |
|POLY-3 RATE (b) | 2/36.68 1/34.50 |
|POLY-3 PERCENT (g) | 5.5% 2.9% |
|TERMINAL (d) | 2/23 (9%) 0/20 (0%) |
|FIRST INCIDENCE | 731 (T) 467 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.543N |
|POLY 3 | P=0.528N |
|POLY 1.5 | P=0.536N |
|POLY 6 | P=0.517N |
|LOGISTIC REGRESSION| P=0.530N |
|COCH-ARM / FISHERS | P=0.532N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 15/53 (28%) 24/50 (48%) |
|POLY-3 RATE (b) | 15/41.30 24/39.27 |
|POLY-3 PERCENT (g) | 36.3% 61.1% |
|TERMINAL (d) | 8/24 (33%) 15/20 (75%) |
|FIRST INCIDENCE | 211 452 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.023 * |
|POLY 3 | P=0.017 * |
|POLY 1.5 | P=0.017 * |
|POLY 6 | P=0.018 * |
|LOGISTIC REGRESSION| P=0.023 * |
|COCH-ARM / FISHERS | P=0.031 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/39.01 0/36.38 |
|POLY-3 PERCENT (g) | 5.1% 0.0% |
|TERMINAL (d) | 2/24 (8%) 0/20 (0%) |
|FIRST INCIDENCE | 731 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.278N |
|POLY 3 | P=0.260N |
|POLY 1.5 | P=0.263N |
|POLY 6 | P=0.254N |
|LOGISTIC REGRESSION| (e) |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 23/53 (43%) 18/50 (36%) |
|POLY-3 RATE (b) | 23/43.52 18/40.30 |
|POLY-3 PERCENT (g) | 52.9% 44.7% |
|TERMINAL (d) | 13/24 (54%) 7/20 (35%) |
|FIRST INCIDENCE | 507 183 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.384N |
|POLY 3 | P=0.295N |
|POLY 1.5 | P=0.299N |
|POLY 6 | P=0.286N |
|LOGISTIC REGRESSION| P=0.303N |
|COCH-ARM / FISHERS | P=0.286N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 46/53 (87%) 44/50 (88%) |
|POLY-3 RATE (b) | 46/50.02 44/47.81 |
|POLY-3 PERCENT (g) | 92.0% 92.0% |
|TERMINAL (d) | 23/24 (96%) 20/20 (100%) |
|FIRST INCIDENCE | 399 183 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.363 |
|POLY 3 | P=0.663 |
|POLY 1.5 | P=0.632 |
|POLY 6 | P=0.703N |
|LOGISTIC REGRESSION| P=0.515 |
|COCH-ARM / FISHERS | P=0.545 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 47/53 (89%) 50/50 (100%) |
|POLY-3 RATE (b) | 47/51.94 50/50.00 |
|POLY-3 PERCENT (g) | 90.5% 100.0% |
|TERMINAL (d) | 22/24 (92%) 20/20 (100%) |
|FIRST INCIDENCE | 211 183 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.162 |
|POLY 3 | P=0.027 * |
|POLY 1.5 | P=0.023 * |
|POLY 6 | P=0.038 * |
|LOGISTIC REGRESSION| P=0.021 * |
|COCH-ARM / FISHERS | P=0.016 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/39.45 4/37.18 |
|POLY-3 PERCENT (g) | 2.5% 10.8% |
|TERMINAL (d) | 0/24 (0%) 0/20 (0%) |
|FIRST INCIDENCE | 603 575 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.175 |
|POLY 3 | P=0.162 |
|POLY 1.5 | P=0.161 |
|POLY 6 | P=0.166 |
|LOGISTIC REGRESSION| P=0.159 |
|COCH-ARM / FISHERS | P=0.164 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/39.01 2/37.78 |
|POLY-3 PERCENT (g) | 0.0% 5.3% |
|TERMINAL (d) | 0/24 (0%) 0/20 (0%) |
|FIRST INCIDENCE | --- 191 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.228 |
|POLY 3 | P=0.233 |
|POLY 1.5 | P=0.231 |
|POLY 6 | P=0.235 |
|LOGISTIC REGRESSION| P=0.308 |
|COCH-ARM / FISHERS | P=0.233 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 5/50 (10%) |
|POLY-3 RATE (b) | 3/39.67 5/39.10 |
|POLY-3 PERCENT (g) | 7.6% 12.8% |
|TERMINAL (d) | 2/24 (8%) 1/20 (5%) |
|FIRST INCIDENCE | 507 183 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.308 |
|POLY 3 | P=0.347 |
|POLY 1.5 | P=0.339 |
|POLY 6 | P=0.361 |
|LOGISTIC REGRESSION| P=0.382 |
|COCH-ARM / FISHERS | P=0.325 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/39.01 4/39.10 |
|POLY-3 PERCENT (g) | 0.0% 10.2% |
|TERMINAL (d) | 0/24 (0%) 0/20 (0%) |
|FIRST INCIDENCE | --- 183 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.062 |
|POLY 3 | P=0.059 |
|POLY 1.5 | P=0.057 |
|POLY 6 | P=0.063 |
|LOGISTIC REGRESSION| P=0.089 |
|COCH-ARM / FISHERS | P=0.052 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/39.01 3/38.25 |
|POLY-3 PERCENT (g) | 0.0% 7.8% |
|TERMINAL (d) | 0/24 (0%) 0/20 (0%) |
|FIRST INCIDENCE | --- 191 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.110 |
|POLY 3 | P=0.115 |
|POLY 1.5 | P=0.113 |
|POLY 6 | P=0.118 |
|LOGISTIC REGRESSION| P=0.151 |
|COCH-ARM / FISHERS | P=0.111 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 3/50 (6%) |
|POLY-3 RATE (b) | 5/40.87 3/38.28 |
|POLY-3 PERCENT (g) | 12.2% 7.8% |
|TERMINAL (d) | 1/24 (4%) 0/20 (0%) |
|FIRST INCIDENCE | 551 191 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.406N |
|POLY 3 | P=0.396N |
|POLY 1.5 | P=0.398N |
|POLY 6 | P=0.398N |
|LOGISTIC REGRESSION| P=0.335N |
|COCH-ARM / FISHERS | P=0.391N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 38/48 (79%) 29/49 (59%) |
|POLY-3 RATE (b) | 38/45.92 29/44.08 |
|POLY-3 PERCENT (g) | 82.8% 65.8% |
|TERMINAL (d) | 19/23 (83%) 11/20 (55%) |
|FIRST INCIDENCE | 211 191 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.244N |
|POLY 3 | P=0.046N* |
|POLY 1.5 | P=0.039N* |
|POLY 6 | P=0.051N |
|LOGISTIC REGRESSION| P=0.026N* |
|COCH-ARM / FISHERS | P=0.028N* |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 19/51 (37%) 13/49 (27%) |
|POLY-3 RATE (b) | 19/40.16 13/36.92 |
|POLY-3 PERCENT (g) | 47.3% 35.2% |
|TERMINAL (d) | 12/24 (50%) 10/20 (50%) |
|FIRST INCIDENCE | 555 591 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.276N |
|POLY 3 | P=0.194N |
|POLY 1.5 | P=0.196N |
|POLY 6 | P=0.192N |
|LOGISTIC REGRESSION| P=0.170N |
|COCH-ARM / FISHERS | P=0.175N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/51 (10%) 12/49 (24%) |
|POLY-3 RATE (b) | 5/39.16 12/39.43 |
|POLY-3 PERCENT (g) | 12.8% 30.4% |
|TERMINAL (d) | 3/24 (13%) 6/20 (30%) |
|FIRST INCIDENCE | 507 191 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.036 * |
|POLY 3 | P=0.048 * |
|POLY 1.5 | P=0.045 * |
|POLY 6 | P=0.052 |
|LOGISTIC REGRESSION| P=0.049 * |
|COCH-ARM / FISHERS | P=0.045 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 33/34 (97%) 27/27 (100%) |
|POLY-3 RATE (b) | 33/33.44 27/27.00 |
|POLY-3 PERCENT (g) | 98.7% 100.0% |
|TERMINAL (d) | 14/14 (100%) 11/11 (100%) |
|FIRST INCIDENCE | 211 360 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.440N |
|POLY 3 | P=0.945 |
|POLY 1.5 | P=0.781 |
|POLY 6 | P=1.000 |
|LOGISTIC REGRESSION| P=0.554 |
|COCH-ARM / FISHERS | P=0.557 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/53 (15%) 10/49 (20%) |
|POLY-3 RATE (b) | 8/41.11 10/38.89 |
|POLY-3 PERCENT (g) | 19.5% 25.7% |
|TERMINAL (d) | 3/24 (13%) 3/20 (15%) |
|FIRST INCIDENCE | 442 183 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.336 |
|POLY 3 | P=0.346 |
|POLY 1.5 | P=0.335 |
|POLY 6 | P=0.363 |
|LOGISTIC REGRESSION| P=0.341 |
|COCH-ARM / FISHERS | P=0.329 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 3/49 (6%) |
|POLY-3 RATE (b) | 0/39.01 3/35.85 |
|POLY-3 PERCENT (g) | 0.0% 8.4% |
|TERMINAL (d) | 0/24 (0%) 1/20 (5%) |
|FIRST INCIDENCE | --- 669 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.111 |
|POLY 3 | P=0.107 |
|POLY 1.5 | P=0.107 |
|POLY 6 | P=0.109 |
|LOGISTIC REGRESSION| P=0.104 |
|COCH-ARM / FISHERS | P=0.107 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Uterus |
| Adenomyosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/39.39 0/35.39 |
|POLY-3 PERCENT (g) | 5.1% 0.0% |
|TERMINAL (d) | 1/24 (4%) 0/20 (0%) |
|FIRST INCIDENCE | 621 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.256N |
|POLY 3 | P=0.274N |
|POLY 1.5 | P=0.274N |
|POLY 6 | P=0.272N |
|LOGISTIC REGRESSION| P=0.259N |
|COCH-ARM / FISHERS | P=0.268N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 9/49 (18%) |
|POLY-3 RATE (b) | 5/40.20 9/38.88 |
|POLY-3 PERCENT (g) | 12.4% 23.2% |
|TERMINAL (d) | 3/24 (13%) 2/20 (10%) |
|FIRST INCIDENCE | 442 191 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.157 |
|POLY 3 | P=0.169 |
|POLY 1.5 | P=0.160 |
|POLY 6 | P=0.185 |
|LOGISTIC REGRESSION| P=0.166 |
|COCH-ARM / FISHERS | P=0.153 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 2/39.39 1/35.39 |
|POLY-3 PERCENT (g) | 5.1% 2.8% |
|TERMINAL (d) | 1/24 (4%) 1/20 (5%) |
|FIRST INCIDENCE | 621 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.539N |
|POLY 3 | P=0.550N |
|POLY 1.5 | P=0.550N |
|POLY 6 | P=0.549N |
|LOGISTIC REGRESSION| P=0.532N |
|COCH-ARM / FISHERS | P=0.530N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Uterus |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 23/53 (43%) 24/49 (49%) |
|POLY-3 RATE (b) | 23/45.42 24/39.43 |
|POLY-3 PERCENT (g) | 50.6% 60.9% |
|TERMINAL (d) | 11/24 (46%) 16/20 (80%) |
|FIRST INCIDENCE | 399 400 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.289 |
|POLY 3 | P=0.230 |
|POLY 1.5 | P=0.264 |
|POLY 6 | P=0.191 |
|LOGISTIC REGRESSION| P=0.329 |
|COCH-ARM / FISHERS | P=0.357 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Uterus: Cervix |
| Hyperplasia Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/49 (4%) |
|POLY-3 RATE (b) | 1/39.28 2/35.39 |
|POLY-3 PERCENT (g) | 2.6% 5.7% |
|TERMINAL (d) | 0/24 (0%) 2/20 (10%) |
|FIRST INCIDENCE | 656 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.458 |
|POLY 3 | P=0.476 |
|POLY 1.5 | P=0.476 |
|POLY 6 | P=0.477 |
|LOGISTIC REGRESSION| P=0.469 |
|COCH-ARM / FISHERS | P=0.470 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/09/03 EXPERIMENT: 96021 TEST: 01 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 3000 UG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 37/53 (70%) 23/49 (47%) |
|POLY-3 RATE (b) | 37/47.57 23/40.48 |
|POLY-3 PERCENT (g) | 77.8% 56.8% |
|TERMINAL (d) | 18/24 (75%) 13/20 (65%) |
|FIRST INCIDENCE | 410 191 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.066N |
|POLY 3 | P=0.023N* |
|POLY 1.5 | P=0.019N* |
|POLY 6 | P=0.029N* |
|LOGISTIC REGRESSION| P=0.018N* |
|COCH-ARM / FISHERS | P=0.016N* |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).