TDMS Study 96007-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) DATE: 10/01/03
EXPERIMENT: 96007 TEST: 01 TIME: 12:23:07
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-75411 ROUTE: GAVAGE NTP C#: 96007D
PATHOLOGIST: MISSING CAS: 57465-28-8
------------------------------------------------------------------------------------------------------------------------------------
FINAL #3/RATS CONTROL VS. STOP
REASONS FOR REMOVAL: 25022 Accidently Killed
25018 Dosing Accident
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 NG/KG
INCLUDE 009 1000 NG/KG/STOP
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) DATE: 10/01/03
EXPERIMENT: 96007 TEST: 01 TIME: 12:23:07
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-75411 ROUTE: GAVAGE NTP C#: 96007D
PATHOLOGIST: MISSING CAS: 57465-28-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TOXIC EQUIVALENCY FACTOR EVALUATION (
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Angiectasis
Atrophy
Degeneration Cystic
Hyperplasia
Hypertrophy
Necrosis
Vacuolization Cytoplasmic
Adrenal Medulla Hyperplasia
Blood Vessel: Aorta Mineralization
Bone Marrow Hyperplasia
Clitoral Gland Inflammation
Clitoral Gland: Duct Cyst
Esophagus: Muscularis Inflammation
Harderian Gland Inflammation
Heart Cardiomyopathy
Heart: Epicardium Inflammation
Intestine Large, Rectum Parasite Metazoan
Kidney Casts Protein
Inflammation Chronic
Mineralization
Nephropathy
Kidney: Pelvis Dilatation
Inflammation
Kidney: Transitional Epithelium Hyperplasia
Liver Angiectasis
Basophilic Focus
Clear Cell Focus
Degeneration Cystic
Eosinophilic Focus
Fatty Change Diffuse
Fatty Change Focal
Hepatocyte, Multinucleate
Inflammation
Mixed Cell Focus
Necrosis
Pigmentation
Toxic Hepatopathy
Liver: Bile Duct Cyst
Fibrosis
Hyperplasia
Liver: Hepatocyte Degeneration
Hypertrophy
Lung Infiltration Cellular Histiocyte
Inflammation Chronic
Inflammation Granulomatous
Lung: Alveolar Epithelium Hyperplasia
Metaplasia Bronchiolar
Lung: Serosa Inflammation
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) DATE: 10/01/03
EXPERIMENT: 96007 TEST: 01 TIME: 12:23:07
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-75411 ROUTE: GAVAGE NTP C#: 96007D
PATHOLOGIST: MISSING CAS: 57465-28-8
Lymph Node, Mandibular Ectasia
Hyperplasia
Lymph Node, Mesenteric Atrophy
Hemorrhage
Hyperplasia
Mammary Gland Cyst
Hyperplasia
Inflammation Granulomatous
Nose: Respiratory Epithelium Hyperplasia
Nose: Turbinate Inflammation
Oral Mucosa: Gingival Hyperplasia
Ovary Atrophy
Cyst
Pancreas Inflammation Chronic
Pancreas: Acinus Atrophy
Parathyroid Gland Hyperplasia
Pituitary Gland Angiectasis
Pituitary Gland: Pars Distalis Hyperplasia
Salivary Glands Cyst
Skin Cyst
Spleen Hematopoietic Cell Proliferation
Pigmentation
Spleen: Lymphoid Follicle Atrophy
Stomach, Forestomach Edema
Hyperplasia
Ulcer
Thymus Atrophy
Thyroid Gland: C-Cell Hyperplasia
Thyroid Gland: Follicular Cell Hypertrophy
Tooth: Peridontal Tissue Inflammation
Inflammation Chronic
Urinary Bladder Inflammation
Uterus Inflammation
Metaplasia
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/52 (21%) 14/50 (28%) |
|POLY-3 RATE (b) | 11/34.50 14/39.70 |
|POLY-3 PERCENT (g) | 31.9% 35.3% |
|TERMINAL (d) | 4/15 (27%) 10/28 (36%) |
|FIRST INCIDENCE | 541 320 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.367N |
|POLY 3 | P=0.470 |
|POLY 1.5 | P=0.411 |
|POLY 6 | P=0.534 |
|LOGISTIC REGRESSION| P=0.459 |
|COCH-ARM / FISHERS | P=0.283 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 9/50 (18%) |
|POLY-3 RATE (b) | 1/31.36 9/39.83 |
|POLY-3 PERCENT (g) | 3.2% 22.6% |
|TERMINAL (d) | 1/15 (7%) 6/28 (21%) |
|FIRST INCIDENCE | 727 (T) 328 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.054 |
|POLY 3 | P=0.020 * |
|POLY 1.5 | P=0.014 * |
|POLY 6 | P=0.032 * |
|LOGISTIC REGRESSION| P=0.012 * |
|COCH-ARM / FISHERS | P=0.007 ** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/52 (21%) 20/50 (40%) |
|POLY-3 RATE (b) | 11/34.41 20/41.28 |
|POLY-3 PERCENT (g) | 32.0% 48.5% |
|TERMINAL (d) | 4/15 (27%) 12/28 (43%) |
|FIRST INCIDENCE | 496 454 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.390 |
|POLY 3 | P=0.103 |
|POLY 1.5 | P=0.068 |
|POLY 6 | P=0.165 |
|LOGISTIC REGRESSION| P=0.085 |
|COCH-ARM / FISHERS | P=0.032 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 23/52 (44%) 26/50 (52%) |
|POLY-3 RATE (b) | 23/38.88 26/41.59 |
|POLY-3 PERCENT (g) | 59.2% 62.5% |
|TERMINAL (d) | 7/15 (47%) 17/28 (61%) |
|FIRST INCIDENCE | 309 454 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.147N |
|POLY 3 | P=0.464 |
|POLY 1.5 | P=0.409 |
|POLY 6 | P=0.526 |
|LOGISTIC REGRESSION| P=0.515 |
|COCH-ARM / FISHERS | P=0.279 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 34/52 (65%) 42/50 (84%) |
|POLY-3 RATE (b) | 34/39.07 42/45.97 |
|POLY-3 PERCENT (g) | 87.0% 91.4% |
|TERMINAL (d) | 15/15 (100%) 25/28 (89%) |
|FIRST INCIDENCE | 391 328 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.112N |
|POLY 3 | P=0.351 |
|POLY 1.5 | P=0.137 |
|POLY 6 | P=0.621N |
|LOGISTIC REGRESSION| P=0.165 |
|COCH-ARM / FISHERS | P=0.026 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/31.80 2/38.11 |
|POLY-3 PERCENT (g) | 3.1% 5.3% |
|TERMINAL (d) | 0/15 (0%) 1/28 (4%) |
|FIRST INCIDENCE | 600 625 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.626 |
|POLY 3 | P=0.546 |
|POLY 1.5 | P=0.526 |
|POLY 6 | P=0.573 |
|LOGISTIC REGRESSION| P=0.533 |
|COCH-ARM / FISHERS | P=0.485 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/52 (10%) 6/50 (12%) |
|POLY-3 RATE (b) | 5/32.65 6/39.42 |
|POLY-3 PERCENT (g) | 15.3% 15.2% |
|TERMINAL (d) | 3/15 (20%) 2/28 (7%) |
|FIRST INCIDENCE | 496 537 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.493N |
|POLY 3 | P=0.615N |
|POLY 1.5 | P=0.569 |
|POLY 6 | P=0.535N |
|LOGISTIC REGRESSION| P=0.550 |
|COCH-ARM / FISHERS | P=0.472 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/52 (15%) 9/50 (18%) |
|POLY-3 RATE (b) | 8/33.72 9/38.38 |
|POLY-3 PERCENT (g) | 23.7% 23.5% |
|TERMINAL (d) | 3/15 (20%) 7/28 (25%) |
|FIRST INCIDENCE | 496 618 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.312N |
|POLY 3 | P=0.593N |
|POLY 1.5 | P=0.567 |
|POLY 6 | P=0.533N |
|LOGISTIC REGRESSION| P=0.563N |
|COCH-ARM / FISHERS | P=0.464 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/32.76 1/38.15 |
|POLY-3 PERCENT (g) | 9.2% 2.6% |
|TERMINAL (d) | 0/15 (0%) 0/28 (0%) |
|FIRST INCIDENCE | 583 611 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.231N |
|POLY 3 | P=0.242N |
|POLY 1.5 | P=0.268N |
|POLY 6 | P=0.215N |
|LOGISTIC REGRESSION| P=0.328N |
|COCH-ARM / FISHERS | P=0.331N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 47/53 (89%) 34/50 (68%) |
|POLY-3 RATE (b) | 47/52.12 34/49.61 |
|POLY-3 PERCENT (g) | 90.2% 68.5% |
|TERMINAL (d) | 10/15 (67%) 13/28 (46%) |
|FIRST INCIDENCE | 126 284 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002N** |
|POLY 3 | P=0.005N** |
|POLY 1.5 | P=0.006N** |
|POLY 6 | P=0.006N** |
|LOGISTIC REGRESSION| P=0.068N |
|COCH-ARM / FISHERS | P=0.010N* |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 28/50 (56%) 32/48 (67%) |
|POLY-3 RATE (b) | 28/40.18 32/44.43 |
|POLY-3 PERCENT (g) | 69.7% 72.0% |
|TERMINAL (d) | 9/14 (64%) 18/28 (64%) |
|FIRST INCIDENCE | 222 328 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.131N |
|POLY 3 | P=0.497 |
|POLY 1.5 | P=0.394 |
|POLY 6 | P=0.581N |
|LOGISTIC REGRESSION| P=0.294 |
|COCH-ARM / FISHERS | P=0.191 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Clitoral Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 29/50 (58%) 39/48 (81%) |
|POLY-3 RATE (b) | 29/40.97 39/46.84 |
|POLY-3 PERCENT (g) | 70.8% 83.3% |
|TERMINAL (d) | 8/14 (57%) 21/28 (75%) |
|FIRST INCIDENCE | 126 284 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.352N |
|POLY 3 | P=0.112 |
|POLY 1.5 | P=0.053 |
|POLY 6 | P=0.213 |
|LOGISTIC REGRESSION| P=0.014 * |
|COCH-ARM / FISHERS | P=0.011 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Esophagus: Muscularis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/30.96 1/37.75 |
|POLY-3 PERCENT (g) | 6.5% 2.7% |
|TERMINAL (d) | 1/14 (7%) 1/28 (4%) |
|FIRST INCIDENCE | 547 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.326N |
|POLY 3 | P=0.413N |
|POLY 1.5 | P=0.447N |
|POLY 6 | P=0.375N |
|LOGISTIC REGRESSION| P=0.435N |
|COCH-ARM / FISHERS | P=0.515N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Harderian Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 9/50 (18%) |
|POLY-3 RATE (b) | 2/32.88 9/38.56 |
|POLY-3 PERCENT (g) | 6.1% 23.3% |
|TERMINAL (d) | 0/15 (0%) 7/28 (25%) |
|FIRST INCIDENCE | 321 554 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.123 |
|POLY 3 | P=0.042 * |
|POLY 1.5 | P=0.033 * |
|POLY 6 | P=0.058 |
|LOGISTIC REGRESSION| P=0.036 * |
|COCH-ARM / FISHERS | P=0.020 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/52 (17%) 15/50 (30%) |
|POLY-3 RATE (b) | 9/35.59 15/39.99 |
|POLY-3 PERCENT (g) | 25.3% 37.5% |
|TERMINAL (d) | 2/15 (13%) 12/28 (43%) |
|FIRST INCIDENCE | 201 284 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.501 |
|POLY 3 | P=0.178 |
|POLY 1.5 | P=0.150 |
|POLY 6 | P=0.218 |
|LOGISTIC REGRESSION| P=0.110 |
|COCH-ARM / FISHERS | P=0.101 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Heart: Epicardium |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/32.82 1/38.66 |
|POLY-3 PERCENT (g) | 6.1% 2.6% |
|TERMINAL (d) | 0/15 (0%) 0/28 (0%) |
|FIRST INCIDENCE | 126 320 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.473N |
|POLY 3 | P=0.428N |
|POLY 1.5 | P=0.459N |
|POLY 6 | P=0.391N |
|LOGISTIC REGRESSION| P=0.709 |
|COCH-ARM / FISHERS | P=0.515N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/30.87 1/38.13 |
|POLY-3 PERCENT (g) | 6.5% 2.6% |
|TERMINAL (d) | 2/15 (13%) 0/28 (0%) |
|FIRST INCIDENCE | 727 (T) 618 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.325N |
|POLY 3 | P=0.408N |
|POLY 1.5 | P=0.444N |
|POLY 6 | P=0.367N |
|LOGISTIC REGRESSION| P=0.409N |
|COCH-ARM / FISHERS | P=0.515N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Kidney |
| Casts Protein |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 3/50 (6%) |
|POLY-3 RATE (b) | 4/31.53 3/39.40 |
|POLY-3 PERCENT (g) | 12.7% 7.6% |
|TERMINAL (d) | 3/15 (20%) 0/28 (0%) |
|FIRST INCIDENCE | 688 337 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.289N |
|POLY 3 | P=0.367N |
|POLY 1.5 | P=0.424N |
|POLY 6 | P=0.304N |
|LOGISTIC REGRESSION| P=0.476N |
|COCH-ARM / FISHERS | P=0.533N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/31.89 0/37.75 |
|POLY-3 PERCENT (g) | 6.3% 0.0% |
|TERMINAL (d) | 1/15 (7%) 0/28 (0%) |
|FIRST INCIDENCE | 574 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.155N |
|POLY 3 | P=0.188N |
|POLY 1.5 | P=0.208N |
|POLY 6 | P=0.167N |
|LOGISTIC REGRESSION| P=0.213N |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 32/53 (60%) 45/50 (90%) |
|POLY-3 RATE (b) | 32/42.76 45/47.81 |
|POLY-3 PERCENT (g) | 74.8% 94.1% |
|TERMINAL (d) | 12/15 (80%) 27/28 (96%) |
|FIRST INCIDENCE | 126 320 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.427N |
|POLY 3 | P=0.004 ** |
|POLY 1.5 | P=0.002 ** |
|POLY 6 | P=0.011 * |
|LOGISTIC REGRESSION| P=0.002 ** |
|COCH-ARM / FISHERS | P<0.001 ** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 32/53 (60%) 38/50 (76%) |
|POLY-3 RATE (b) | 32/43.26 38/42.94 |
|POLY-3 PERCENT (g) | 74.0% 88.5% |
|TERMINAL (d) | 11/15 (73%) 26/28 (93%) |
|FIRST INCIDENCE | 126 454 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.108N |
|POLY 3 | P=0.046 * |
|POLY 1.5 | P=0.044 * |
|POLY 6 | P=0.072 |
|LOGISTIC REGRESSION| P=0.185 |
|COCH-ARM / FISHERS | P=0.068 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/32.37 1/38.50 |
|POLY-3 PERCENT (g) | 6.2% 2.6% |
|TERMINAL (d) | 0/15 (0%) 0/28 (0%) |
|FIRST INCIDENCE | 574 454 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.444N |
|POLY 3 | P=0.424N |
|POLY 1.5 | P=0.456N |
|POLY 6 | P=0.389N |
|LOGISTIC REGRESSION| P=0.593N |
|COCH-ARM / FISHERS | P=0.522N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/32.53 0/37.75 |
|POLY-3 PERCENT (g) | 6.2% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/28 (0%) |
|FIRST INCIDENCE | 541 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.208N |
|POLY 3 | P=0.193N |
|POLY 1.5 | P=0.211N |
|POLY 6 | P=0.174N |
|LOGISTIC REGRESSION| P=0.280N |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/32.45 2/37.75 |
|POLY-3 PERCENT (g) | 12.3% 5.3% |
|TERMINAL (d) | 2/15 (13%) 2/28 (7%) |
|FIRST INCIDENCE | 554 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.150N |
|POLY 3 | P=0.260N |
|POLY 1.5 | P=0.292N |
|POLY 6 | P=0.224N |
|LOGISTIC REGRESSION| P=0.258N |
|COCH-ARM / FISHERS | P=0.367N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 8/50 (16%) |
|POLY-3 RATE (b) | 3/31.69 8/37.75 |
|POLY-3 PERCENT (g) | 9.5% 21.2% |
|TERMINAL (d) | 2/15 (13%) 8/28 (29%) |
|FIRST INCIDENCE | 644 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.380 |
|POLY 3 | P=0.152 |
|POLY 1.5 | P=0.125 |
|POLY 6 | P=0.191 |
|LOGISTIC REGRESSION| P=0.287 |
|COCH-ARM / FISHERS | P=0.083 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/53 (13%) 16/50 (32%) |
|POLY-3 RATE (b) | 7/32.51 16/39.85 |
|POLY-3 PERCENT (g) | 21.5% 40.2% |
|TERMINAL (d) | 3/15 (20%) 11/28 (39%) |
|FIRST INCIDENCE | 541 537 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.275 |
|POLY 3 | P=0.068 |
|POLY 1.5 | P=0.044 * |
|POLY 6 | P=0.116 |
|LOGISTIC REGRESSION| P=0.080 |
|COCH-ARM / FISHERS | P=0.020 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 2/31.38 5/37.75 |
|POLY-3 PERCENT (g) | 6.4% 13.3% |
|TERMINAL (d) | 2/15 (13%) 5/28 (18%) |
|FIRST INCIDENCE | 727 (T) 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.520 |
|POLY 3 | P=0.285 |
|POLY 1.5 | P=0.252 |
|POLY 6 | P=0.332 |
|LOGISTIC REGRESSION| P=0.520 |
|COCH-ARM / FISHERS | P=0.195 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/31.38 3/38.35 |
|POLY-3 PERCENT (g) | 0.0% 7.8% |
|TERMINAL (d) | 0/15 (0%) 1/28 (4%) |
|FIRST INCIDENCE | --- 618 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.213 |
|POLY 3 | P=0.148 |
|POLY 1.5 | P=0.133 |
|POLY 6 | P=0.170 |
|LOGISTIC REGRESSION| P=0.147 |
|COCH-ARM / FISHERS | P=0.111 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/53 (21%) 12/50 (24%) |
|POLY-3 RATE (b) | 11/34.24 12/41.51 |
|POLY-3 PERCENT (g) | 32.1% 28.9% |
|TERMINAL (d) | 5/15 (33%) 5/28 (18%) |
|FIRST INCIDENCE | 405 328 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.300N |
|POLY 3 | P=0.472N |
|POLY 1.5 | P=0.566N |
|POLY 6 | P=0.362N |
|LOGISTIC REGRESSION| P=0.531 |
|COCH-ARM / FISHERS | P=0.437 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 12/50 (24%) |
|POLY-3 RATE (b) | 5/33.58 12/40.50 |
|POLY-3 PERCENT (g) | 14.9% 29.6% |
|TERMINAL (d) | 2/15 (13%) 8/28 (29%) |
|FIRST INCIDENCE | 126 320 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.242 |
|POLY 3 | P=0.105 |
|POLY 1.5 | P=0.076 |
|POLY 6 | P=0.151 |
|LOGISTIC REGRESSION| P=0.037 * |
|COCH-ARM / FISHERS | P=0.042 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 11/50 (22%) |
|POLY-3 RATE (b) | 2/32.02 11/40.35 |
|POLY-3 PERCENT (g) | 6.3% 27.3% |
|TERMINAL (d) | 1/15 (7%) 5/28 (18%) |
|FIRST INCIDENCE | 519 454 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.057 |
|POLY 3 | P=0.020 * |
|POLY 1.5 | P=0.012 * |
|POLY 6 | P=0.036 * |
|LOGISTIC REGRESSION| P=0.012 * |
|COCH-ARM / FISHERS | P=0.005 ** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Hepatocyte, Multinucleate |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 20/50 (40%) |
|POLY-3 RATE (b) | 0/31.38 20/42.63 |
|POLY-3 PERCENT (g) | 0.0% 46.9% |
|TERMINAL (d) | 0/15 (0%) 12/28 (43%) |
|FIRST INCIDENCE | --- 320 |
|-------------------| |
|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: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 36/53 (68%) 46/50 (92%) |
|POLY-3 RATE (b) | 36/42.80 46/47.33 |
|POLY-3 PERCENT (g) | 84.1% 97.2% |
|TERMINAL (d) | 15/15 (100%) 27/28 (96%) |
|FIRST INCIDENCE | 176 328 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.187N |
|POLY 3 | P=0.011 * |
|POLY 1.5 | P=0.004 ** |
|POLY 6 | P=0.069 |
|LOGISTIC REGRESSION| P=0.018 * |
|COCH-ARM / FISHERS | P=0.002 ** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 21/53 (40%) 36/50 (72%) |
|POLY-3 RATE (b) | 21/34.34 36/42.34 |
|POLY-3 PERCENT (g) | 61.2% 85.0% |
|TERMINAL (d) | 12/15 (80%) 27/28 (96%) |
|FIRST INCIDENCE | 541 328 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.513 |
|POLY 3 | P=0.006 ** |
|POLY 1.5 | P=0.003 ** |
|POLY 6 | P=0.014 * |
|LOGISTIC REGRESSION| P=0.014 * |
|COCH-ARM / FISHERS | P<0.001 ** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 4/50 (8%) |
|POLY-3 RATE (b) | 4/34.03 4/40.42 |
|POLY-3 PERCENT (g) | 11.8% 9.9% |
|TERMINAL (d) | 0/15 (0%) 0/28 (0%) |
|FIRST INCIDENCE | 176 284 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.561N |
|POLY 3 | P=0.536N |
|POLY 1.5 | P=0.584N |
|POLY 6 | P=0.480N |
|LOGISTIC REGRESSION| P=0.336 |
|COCH-ARM / FISHERS | P=0.609 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 48/50 (96%) |
|POLY-3 RATE (b) | 1/32.06 48/48.85 |
|POLY-3 PERCENT (g) | 3.1% 98.3% |
|TERMINAL (d) | 0/15 (0%) 28/28 (100%) |
|FIRST INCIDENCE | 496 284 |
|-------------------| |
|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: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Toxic Hepatopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 15/50 (30%) |
|POLY-3 RATE (b) | 0/31.38 15/41.40 |
|POLY-3 PERCENT (g) | 0.0% 36.2% |
|TERMINAL (d) | 0/15 (0%) 9/28 (32%) |
|FIRST INCIDENCE | --- 328 |
|-------------------| |
|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) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 5/50 (10%) |
|POLY-3 RATE (b) | 3/31.38 5/38.42 |
|POLY-3 PERCENT (g) | 9.6% 13.0% |
|TERMINAL (d) | 3/15 (20%) 4/28 (14%) |
|FIRST INCIDENCE | 727 (T) 502 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.629N |
|POLY 3 | P=0.460 |
|POLY 1.5 | P=0.412 |
|POLY 6 | P=0.522 |
|LOGISTIC REGRESSION| P=0.521 |
|COCH-ARM / FISHERS | P=0.325 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 4/50 (8%) |
|POLY-3 RATE (b) | 4/32.23 4/38.16 |
|POLY-3 PERCENT (g) | 12.4% 10.5% |
|TERMINAL (d) | 3/15 (20%) 3/28 (11%) |
|FIRST INCIDENCE | 391 607 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.354N |
|POLY 3 | P=0.538N |
|POLY 1.5 | P=0.587N |
|POLY 6 | P=0.474N |
|LOGISTIC REGRESSION| P=0.556N |
|COCH-ARM / FISHERS | P=0.609 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 16/50 (32%) |
|POLY-3 RATE (b) | 3/32.67 16/42.48 |
|POLY-3 PERCENT (g) | 9.2% 37.7% |
|TERMINAL (d) | 1/15 (7%) 9/28 (32%) |
|FIRST INCIDENCE | 496 284 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.018 * |
|POLY 3 | P=0.004 ** |
|POLY 1.5 | P=0.002 ** |
|POLY 6 | P=0.009 ** |
|LOGISTIC REGRESSION| P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/33.04 0/37.75 |
|POLY-3 PERCENT (g) | 9.1% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/28 (0%) |
|FIRST INCIDENCE | 354 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.092N |
|POLY 3 | P=0.090N |
|POLY 1.5 | P=0.102N |
|POLY 6 | P=0.077N |
|LOGISTIC REGRESSION| P=0.170N |
|COCH-ARM / FISHERS | P=0.132N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 21/50 (42%) |
|POLY-3 RATE (b) | 0/31.38 21/42.58 |
|POLY-3 PERCENT (g) | 0.0% 49.3% |
|TERMINAL (d) | 0/15 (0%) 13/28 (46%) |
|FIRST INCIDENCE | --- 328 |
|-------------------| |
|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: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 41/53 (77%) 42/50 (84%) |
|POLY-3 RATE (b) | 41/47.06 42/45.67 |
|POLY-3 PERCENT (g) | 87.1% 92.0% |
|TERMINAL (d) | 12/15 (80%) 25/28 (89%) |
|FIRST INCIDENCE | 201 328 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.024N* |
|POLY 3 | P=0.324 |
|POLY 1.5 | P=0.300 |
|POLY 6 | P=0.403 |
|LOGISTIC REGRESSION| P=0.536 |
|COCH-ARM / FISHERS | P=0.274 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/32.66 0/37.75 |
|POLY-3 PERCENT (g) | 15.3% 0.0% |
|TERMINAL (d) | 2/15 (13%) 0/28 (0%) |
|FIRST INCIDENCE | 309 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.010N* |
|POLY 3 | P=0.018N* |
|POLY 1.5 | P=0.023N* |
|POLY 6 | P=0.013N* |
|LOGISTIC REGRESSION| P=0.030N* |
|COCH-ARM / FISHERS | P=0.033N* |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/32.04 0/37.75 |
|POLY-3 PERCENT (g) | 9.4% 0.0% |
|TERMINAL (d) | 1/15 (7%) 0/28 (0%) |
|FIRST INCIDENCE | 611 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.062N |
|POLY 3 | P=0.085N |
|POLY 1.5 | P=0.098N |
|POLY 6 | P=0.072N |
|LOGISTIC REGRESSION| P=0.092N |
|COCH-ARM / FISHERS | P=0.132N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/53 (23%) 0/50 (0%) |
|POLY-3 RATE (b) | 12/32.58 0/37.75 |
|POLY-3 PERCENT (g) | 36.8% 0.0% |
|TERMINAL (d) | 7/15 (47%) 0/28 (0%) |
|FIRST INCIDENCE | 600 --- |
|-------------------| |
|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: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Metaplasia Bronchiolar |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 32/50 (64%) |
|POLY-3 RATE (b) | 0/31.38 32/44.16 |
|POLY-3 PERCENT (g) | 0.0% 72.5% |
|TERMINAL (d) | 0/15 (0%) 19/28 (68%) |
|FIRST INCIDENCE | --- 328 |
|-------------------| |
|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) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lung: Serosa |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/32.84 1/38.66 |
|POLY-3 PERCENT (g) | 6.1% 2.6% |
|TERMINAL (d) | 0/15 (0%) 0/28 (0%) |
|FIRST INCIDENCE | 126 320 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.476N |
|POLY 3 | P=0.428N |
|POLY 1.5 | P=0.461N |
|POLY 6 | P=0.392N |
|LOGISTIC REGRESSION| P=0.693 |
|COCH-ARM / FISHERS | P=0.522N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 3/49 (6%) |
|POLY-3 RATE (b) | 1/31.47 3/37.57 |
|POLY-3 PERCENT (g) | 3.2% 8.0% |
|TERMINAL (d) | 0/15 (0%) 3/28 (11%) |
|FIRST INCIDENCE | 660 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.513 |
|POLY 3 | P=0.357 |
|POLY 1.5 | P=0.333 |
|POLY 6 | P=0.389 |
|LOGISTIC REGRESSION| P=0.440 |
|COCH-ARM / FISHERS | P=0.287 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 18/52 (35%) 21/49 (43%) |
|POLY-3 RATE (b) | 18/36.75 21/42.70 |
|POLY-3 PERCENT (g) | 49.0% 49.2% |
|TERMINAL (d) | 8/15 (53%) 11/28 (39%) |
|FIRST INCIDENCE | 222 337 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.253N |
|POLY 3 | P=0.578 |
|POLY 1.5 | P=0.464 |
|POLY 6 | P=0.453N |
|LOGISTIC REGRESSION| P=0.366 |
|COCH-ARM / FISHERS | P=0.259 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/31.36 2/39.10 |
|POLY-3 PERCENT (g) | 0.0% 5.1% |
|TERMINAL (d) | 0/15 (0%) 0/28 (0%) |
|FIRST INCIDENCE | --- 454 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.264 |
|POLY 3 | P=0.269 |
|POLY 1.5 | P=0.254 |
|POLY 6 | P=0.292 |
|LOGISTIC REGRESSION| P=0.152 |
|COCH-ARM / FISHERS | P=0.238 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/31.83 0/37.75 |
|POLY-3 PERCENT (g) | 6.3% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/28 (0%) |
|FIRST INCIDENCE | 618 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.157N |
|POLY 3 | P=0.187N |
|POLY 1.5 | P=0.207N |
|POLY 6 | P=0.166N |
|LOGISTIC REGRESSION| P=0.205N |
|COCH-ARM / FISHERS | P=0.257N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/52 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/33.26 2/38.16 |
|POLY-3 PERCENT (g) | 9.0% 5.2% |
|TERMINAL (d) | 0/15 (0%) 1/28 (4%) |
|FIRST INCIDENCE | 222 607 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.378N |
|POLY 3 | P=0.427N |
|POLY 1.5 | P=0.459N |
|POLY 6 | P=0.386N |
|LOGISTIC REGRESSION| P=0.597N |
|COCH-ARM / FISHERS | P=0.519N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/52 (15%) 13/50 (26%) |
|POLY-3 RATE (b) | 8/33.57 13/39.81 |
|POLY-3 PERCENT (g) | 23.8% 32.7% |
|TERMINAL (d) | 3/15 (20%) 9/28 (32%) |
|FIRST INCIDENCE | 405 454 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.567 |
|POLY 3 | P=0.275 |
|POLY 1.5 | P=0.221 |
|POLY 6 | P=0.353 |
|LOGISTIC REGRESSION| P=0.244 |
|COCH-ARM / FISHERS | P=0.140 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 32/52 (62%) 22/50 (44%) |
|POLY-3 RATE (b) | 32/43.06 22/42.25 |
|POLY-3 PERCENT (g) | 74.3% 52.1% |
|TERMINAL (d) | 11/15 (73%) 14/28 (50%) |
|FIRST INCIDENCE | 126 320 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** |
|POLY 3 | P=0.020N* |
|POLY 1.5 | P=0.029N* |
|POLY 6 | P=0.013N* |
|LOGISTIC REGRESSION| P=0.045N* |
|COCH-ARM / FISHERS | P=0.057N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/31.43 0/37.75 |
|POLY-3 PERCENT (g) | 6.4% 0.0% |
|TERMINAL (d) | 1/15 (7%) 0/28 (0%) |
|FIRST INCIDENCE | 709 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.122N |
|POLY 3 | P=0.184N |
|POLY 1.5 | P=0.205N |
|POLY 6 | P=0.161N |
|LOGISTIC REGRESSION| P=0.144N |
|COCH-ARM / FISHERS | P=0.257N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/32.23 1/37.75 |
|POLY-3 PERCENT (g) | 6.2% 2.7% |
|TERMINAL (d) | 1/15 (7%) 1/28 (4%) |
|FIRST INCIDENCE | 391 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.353N |
|POLY 3 | P=0.430N |
|POLY 1.5 | P=0.461N |
|POLY 6 | P=0.392N |
|LOGISTIC REGRESSION| P=0.508N |
|COCH-ARM / FISHERS | P=0.522N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Nose: Turbinate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/31.81 1/38.13 |
|POLY-3 PERCENT (g) | 6.3% 2.6% |
|TERMINAL (d) | 1/15 (7%) 0/28 (0%) |
|FIRST INCIDENCE | 603 618 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.368N |
|POLY 3 | P=0.421N |
|POLY 1.5 | P=0.455N |
|POLY 6 | P=0.381N |
|LOGISTIC REGRESSION| P=0.469N |
|COCH-ARM / FISHERS | P=0.522N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Oral Mucosa: Gingival |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/1 (100%) 3/6 (50%) |
|POLY-3 RATE (b) | 1/1.00 3/5.40 |
|POLY-3 PERCENT (g) | 100.0% 55.6% |
|TERMINAL (d) | 1/1 (100%) 2/3 (67%) |
|FIRST INCIDENCE | 727 (T) 659 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.711 |
|POLY 3 | P=0.305N |
|POLY 1.5 | P=0.295N |
|POLY 6 | P=0.327N |
|LOGISTIC REGRESSION| P=0.753N |
|COCH-ARM / FISHERS | P=0.571N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 45/52 (87%) 47/50 (94%) |
|POLY-3 RATE (b) | 45/46.65 47/49.79 |
|POLY-3 PERCENT (g) | 96.5% 94.4% |
|TERMINAL (d) | 14/15 (93%) 26/28 (93%) |
|FIRST INCIDENCE | 126 284 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.026N* |
|POLY 3 | P=0.496N |
|POLY 1.5 | P=0.680 |
|POLY 6 | P=0.417N |
|LOGISTIC REGRESSION| P=0.363 |
|COCH-ARM / FISHERS | P=0.176 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/52 (23%) 17/50 (34%) |
|POLY-3 RATE (b) | 12/33.36 17/40.39 |
|POLY-3 PERCENT (g) | 36.0% 42.1% |
|TERMINAL (d) | 7/15 (47%) 12/28 (43%) |
|FIRST INCIDENCE | 547 454 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.424N |
|POLY 3 | P=0.375 |
|POLY 1.5 | P=0.285 |
|POLY 6 | P=0.496 |
|LOGISTIC REGRESSION| P=0.371 |
|COCH-ARM / FISHERS | P=0.158 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Oviduct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/1 (100%) 2/2 (100%) |
|POLY-3 RATE (b) | 1/1.00 2/2.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% |
|TERMINAL (d) | 0/0 (0%) 1/1 (100%) |
|FIRST INCIDENCE | 709 454 |
|-------------------| |
|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) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/51 (10%) 4/48 (8%) |
|POLY-3 RATE (b) | 5/32.80 4/38.24 |
|POLY-3 PERCENT (g) | 15.2% 10.5% |
|TERMINAL (d) | 3/15 (20%) 3/28 (11%) |
|FIRST INCIDENCE | 391 454 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.244N |
|POLY 3 | P=0.395N |
|POLY 1.5 | P=0.446N |
|POLY 6 | P=0.334N |
|LOGISTIC REGRESSION| P=0.490N |
|COCH-ARM / FISHERS | P=0.539N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/51 (10%) 7/48 (15%) |
|POLY-3 RATE (b) | 5/31.43 7/38.69 |
|POLY-3 PERCENT (g) | 15.9% 18.1% |
|TERMINAL (d) | 4/15 (27%) 5/28 (18%) |
|FIRST INCIDENCE | 705 454 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.483N |
|POLY 3 | P=0.521 |
|POLY 1.5 | P=0.451 |
|POLY 6 | P=0.608 |
|LOGISTIC REGRESSION| P=0.553 |
|COCH-ARM / FISHERS | P=0.337 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/47 (0%) 2/44 (5%) |
|POLY-3 RATE (b) | 0/27.62 2/34.33 |
|POLY-3 PERCENT (g) | 0.0% 5.8% |
|TERMINAL (d) | 0/13 (0%) 1/25 (4%) |
|FIRST INCIDENCE | --- 660 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.355 |
|POLY 3 | P=0.269 |
|POLY 1.5 | P=0.253 |
|POLY 6 | P=0.291 |
|LOGISTIC REGRESSION| P=0.299 |
|COCH-ARM / FISHERS | P=0.231 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 14/51 (27%) 14/48 (29%) |
|POLY-3 RATE (b) | 14/33.32 14/38.62 |
|POLY-3 PERCENT (g) | 42.0% 36.3% |
|TERMINAL (d) | 7/15 (47%) 9/27 (33%) |
|FIRST INCIDENCE | 546 592 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.126N |
|POLY 3 | P=0.391N |
|POLY 1.5 | P=0.479N |
|POLY 6 | P=0.295N |
|LOGISTIC REGRESSION| P=0.363N |
|COCH-ARM / FISHERS | P=0.513 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 18/51 (35%) 17/48 (35%) |
|POLY-3 RATE (b) | 18/36.64 17/38.07 |
|POLY-3 PERCENT (g) | 49.1% 44.7% |
|TERMINAL (d) | 4/15 (27%) 13/27 (48%) |
|FIRST INCIDENCE | 400 607 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.084N |
|POLY 3 | P=0.435N |
|POLY 1.5 | P=0.459N |
|POLY 6 | P=0.429N |
|LOGISTIC REGRESSION| P=0.327N |
|COCH-ARM / FISHERS | P=0.578 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Salivary Glands |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/29.97 2/37.57 |
|POLY-3 PERCENT (g) | 0.0% 5.3% |
|TERMINAL (d) | 0/14 (0%) 2/28 (7%) |
|FIRST INCIDENCE | --- 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.400 |
|POLY 3 | P=0.270 |
|POLY 1.5 | P=0.255 |
|POLY 6 | P=0.291 |
|LOGISTIC REGRESSION| P=0.400 |
|COCH-ARM / FISHERS | P=0.238 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Skin |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/31.84 2/37.75 |
|POLY-3 PERCENT (g) | 3.1% 5.3% |
|TERMINAL (d) | 0/15 (0%) 2/28 (7%) |
|FIRST INCIDENCE | 583 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.664 |
|POLY 3 | P=0.543 |
|POLY 1.5 | P=0.524 |
|POLY 6 | P=0.568 |
|LOGISTIC REGRESSION| P=0.569 |
|COCH-ARM / FISHERS | P=0.485 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 39/52 (75%) 37/50 (74%) |
|POLY-3 RATE (b) | 39/47.51 37/45.78 |
|POLY-3 PERCENT (g) | 82.1% 80.8% |
|TERMINAL (d) | 8/15 (53%) 21/28 (75%) |
|FIRST INCIDENCE | 126 328 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.025N* |
|POLY 3 | P=0.547N |
|POLY 1.5 | P=0.524N |
|POLY 6 | P=0.572N |
|LOGISTIC REGRESSION| P=0.472N |
|COCH-ARM / FISHERS | P=0.544N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 49/52 (94%) 50/50 (100%) |
|POLY-3 RATE (b) | 49/49.42 50/50.00 |
|POLY-3 PERCENT (g) | 99.2% 100.0% |
|TERMINAL (d) | 15/15 (100%) 28/28 (100%) |
|FIRST INCIDENCE | 126 284 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.013N* |
|POLY 3 | P=0.958 |
|POLY 1.5 | P=0.514 |
|POLY 6 | P=1.000 |
|LOGISTIC REGRESSION| P=0.307 |
|COCH-ARM / FISHERS | P=0.129 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/52 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/31.36 4/40.76 |
|POLY-3 PERCENT (g) | 0.0% 9.8% |
|TERMINAL (d) | 0/15 (0%) 0/28 (0%) |
|FIRST INCIDENCE | --- 284 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.082 |
|POLY 3 | P=0.093 |
|POLY 1.5 | P=0.078 |
|POLY 6 | P=0.115 |
|LOGISTIC REGRESSION| P=0.008 ** |
|COCH-ARM / FISHERS | P=0.054 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/31.67 2/39.26 |
|POLY-3 PERCENT (g) | 3.2% 5.1% |
|TERMINAL (d) | 0/15 (0%) 0/28 (0%) |
|FIRST INCIDENCE | 644 454 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.546 |
|POLY 3 | P=0.555 |
|POLY 1.5 | P=0.531 |
|POLY 6 | P=0.585 |
|LOGISTIC REGRESSION| P=0.394 |
|COCH-ARM / FISHERS | P=0.485 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/52 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/32.29 2/39.26 |
|POLY-3 PERCENT (g) | 9.3% 5.1% |
|TERMINAL (d) | 1/15 (7%) 0/28 (0%) |
|FIRST INCIDENCE | 391 454 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.382N |
|POLY 3 | P=0.398N |
|POLY 1.5 | P=0.440N |
|POLY 6 | P=0.348N |
|LOGISTIC REGRESSION| P=0.599N |
|COCH-ARM / FISHERS | P=0.519N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/52 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/32.17 0/37.75 |
|POLY-3 PERCENT (g) | 9.3% 0.0% |
|TERMINAL (d) | 1/15 (7%) 0/28 (0%) |
|FIRST INCIDENCE | 574 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.070N |
|POLY 3 | P=0.085N |
|POLY 1.5 | P=0.098N |
|POLY 6 | P=0.073N |
|LOGISTIC REGRESSION| P=0.102N |
|COCH-ARM / FISHERS | P=0.129N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 37/50 (74%) 39/43 (91%) |
|POLY-3 RATE (b) | 37/45.02 39/42.09 |
|POLY-3 PERCENT (g) | 82.2% 92.7% |
|TERMINAL (d) | 9/15 (60%) 23/26 (89%) |
|FIRST INCIDENCE | 126 284 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.083N |
|POLY 3 | P=0.118 |
|POLY 1.5 | P=0.081 |
|POLY 6 | P=0.162 |
|LOGISTIC REGRESSION| P=0.052 |
|COCH-ARM / FISHERS | P=0.033 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/52 (23%) 18/47 (38%) |
|POLY-3 RATE (b) | 12/33.93 18/40.66 |
|POLY-3 PERCENT (g) | 35.4% 44.3% |
|TERMINAL (d) | 5/15 (33%) 12/28 (43%) |
|FIRST INCIDENCE | 541 337 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.526N |
|POLY 3 | P=0.285 |
|POLY 1.5 | P=0.197 |
|POLY 6 | P=0.391 |
|LOGISTIC REGRESSION| P=0.213 |
|COCH-ARM / FISHERS | P=0.077 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/52 (17%) 22/47 (47%) |
|POLY-3 RATE (b) | 9/37.19 22/42.68 |
|POLY-3 PERCENT (g) | 24.2% 51.5% |
|TERMINAL (d) | 2/15 (13%) 13/28 (46%) |
|FIRST INCIDENCE | 201 328 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.094 |
|POLY 3 | P=0.008 ** |
|POLY 1.5 | P=0.004 ** |
|POLY 6 | P=0.021 * |
|LOGISTIC REGRESSION| P<0.001 ** |
|COCH-ARM / FISHERS | P=0.002 ** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/12 (83%) 11/12 (92%) |
|POLY-3 RATE (b) | 10/12.00 11/11.24 |
|POLY-3 PERCENT (g) | 83.3% 97.8% |
|TERMINAL (d) | 5/7 (71%) 7/7 (100%) |
|FIRST INCIDENCE | 405 537 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.596N |
|POLY 3 | P=0.320 |
|POLY 1.5 | P=0.384 |
|POLY 6 | P=0.275 |
|LOGISTIC REGRESSION| P=0.489 |
|COCH-ARM / FISHERS | P=0.500 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/12 (17%) 0/12 (0%) |
|POLY-3 RATE (b) | 2/9.81 0/9.21 |
|POLY-3 PERCENT (g) | 20.4% 0.0% |
|TERMINAL (d) | 2/7 (29%) 0/7 (0%) |
|FIRST INCIDENCE | 727 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.231N |
|POLY 3 | P=0.248N |
|POLY 1.5 | P=0.238N |
|POLY 6 | P=0.261N |
|LOGISTIC REGRESSION| (e) |
|COCH-ARM / FISHERS | P=0.239N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/51 (8%) 3/50 (6%) |
|POLY-3 RATE (b) | 4/32.86 3/38.55 |
|POLY-3 PERCENT (g) | 12.2% 7.8% |
|TERMINAL (d) | 0/15 (0%) 1/28 (4%) |
|FIRST INCIDENCE | 391 607 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.344N |
|POLY 3 | P=0.402N |
|POLY 1.5 | P=0.438N |
|POLY 6 | P=0.359N |
|LOGISTIC REGRESSION| P=0.529N |
|COCH-ARM / FISHERS | P=0.511N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/52 (23%) 11/50 (22%) |
|POLY-3 RATE (b) | 12/35.65 11/39.62 |
|POLY-3 PERCENT (g) | 33.7% 27.8% |
|TERMINAL (d) | 2/15 (13%) 8/28 (29%) |
|FIRST INCIDENCE | 391 454 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.155N |
|POLY 3 | P=0.375N |
|POLY 1.5 | P=0.422N |
|POLY 6 | P=0.333N |
|LOGISTIC REGRESSION| P=0.437N |
|COCH-ARM / FISHERS | P=0.543N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 10/01/03 EXPERIMENT: 96007 TEST: 01 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Uterus |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 26/52 (50%) 28/50 (56%) |
|POLY-3 RATE (b) | 26/41.07 28/45.45 |
|POLY-3 PERCENT (g) | 63.3% 61.6% |
|TERMINAL (d) | 7/15 (47%) 14/28 (50%) |
|FIRST INCIDENCE | 321 320 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.161N |
|POLY 3 | P=0.520N |
|POLY 1.5 | P=0.572 |
|POLY 6 | P=0.460N |
|LOGISTIC REGRESSION| P=0.409 |
|COCH-ARM / FISHERS | P=0.342 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 1000 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 23/52 (44%) 31/50 (62%) |
|POLY-3 RATE (b) | 23/35.31 31/42.28 |
|POLY-3 PERCENT (g) | 65.1% 73.3% |
|TERMINAL (d) | 12/15 (80%) 22/28 (79%) |
|FIRST INCIDENCE | 496 328 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.233N |
|POLY 3 | P=0.273 |
|POLY 1.5 | P=0.163 |
|POLY 6 | P=0.447 |
|LOGISTIC REGRESSION| P=0.274 |
|COCH-ARM / FISHERS | P=0.055 |
|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).