TDMS Study 96007-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) DATE: 09/30/03
EXPERIMENT: 96007 TEST: 03 TIME: 08:58:59
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007G
PATHOLOGIST: SELLS, DONALD CAS: 1746-01-6
------------------------------------------------------------------------------------------------------------------------------------
FINAL # 3 RATS CONTROL VS STOP
REASONS FOR REMOVAL: 25018 Dosing Accident
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 NG/KG
INCLUDE 007 100 NG/ KG/STOP
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) DATE: 09/30/03
EXPERIMENT: 96007 TEST: 03 TIME: 08:58:59
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007G
PATHOLOGIST: SELLS, DONALD CAS: 1746-01-6
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
Bone Marrow Hyperplasia
Clitoral Gland Inflammation
Clitoral Gland: Duct Cyst
Eye: Retina Atrophy
Harderian Gland Inflammation
Heart Cardiomyopathy
Heart: Atrium Thrombosis
Intestine Large, Rectum Parasite Metazoan
Kidney Accumulation, Hyaline Droplet
Casts Protein
Cyst
Inflammation Chronic
Mineralization
Nephropathy
Kidney: Pelvis Dilatation
Inflammation
Kidney: Transitional Epithelium Hyperplasia
Liver Angiectasis
Basophilic Focus
Clear Cell Focus
Congestion
Eosinophilic Focus
Fatty Change Diffuse
Fatty Change Focal
Hematopoietic Cell Proliferation
Inflammation
Mixed Cell Focus
Necrosis
Pigmentation
Toxic Hepatopathy
Liver: Bile Duct Cyst
Fibrosis
Hyperplasia
Liver: Centrilobular Degeneration
Liver: Hepatocyte Hypertrophy
Multinucleated
Lung Infiltration Cellular Histiocyte
Inflammation Granulomatous
Metaplasia
Lung: Alveolar Epithelium Hyperplasia
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) DATE: 09/30/03
EXPERIMENT: 96007 TEST: 03 TIME: 08:58:59
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007G
PATHOLOGIST: SELLS, DONALD CAS: 1746-01-6
Metaplasia Bronchiolar
Lymph Node, Mandibular Ectasia
Hyperplasia
Hyperplasia Lymphoid
Lymph Node: Lumbar Ectasia
Hyperplasia
Mammary Gland Cyst
Hyperplasia
Nose Inflammation
Nose: Nasolacrimal Duct Inflammation
Oral Mucosa: Gingival Hyperplasia
Ovary Atrophy
Cyst
Pancreas Inflammation Chronic
Pancreas: Acinus Atrophy
Hyperplasia
Pancreas: Artery Inflammation Chronic
Pituitary Gland Angiectasis
Vacuolization Cytoplasmic
Pituitary Gland: Pars Distalis Hyperplasia
Pituitary Gland: Pars Intermedia Hyperplasia
Salivary Glands Atrophy
Spleen Hematopoietic Cell Proliferation
Pigmentation
Spleen: Lymphoid Follicle Atrophy
Stomach, Forestomach Hyperplasia
Inflammation
Ulcer
Stomach, Glandular Mineralization
Thymus Atrophy
Thyroid Gland: C-Cell Hyperplasia
Thyroid Gland: Follicular Cell Hyperplasia
Hypertrophy
Tooth: Peridontal Tissue Inflammation
Urinary Bladder Inflammation
Uterus Inflammation
Metaplasia
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/53 (21%) 15/50 (30%) |
|POLY-3 RATE (b) | 11/40.84 15/38.86 |
|POLY-3 PERCENT (g) | 26.9% 38.6% |
|TERMINAL (d) | 6/25 (24%) 10/21 (48%) |
|FIRST INCIDENCE | 645 641 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.146 |
|POLY 3 | P=0.188 |
|POLY 1.5 | P=0.201 |
|POLY 6 | P=0.164 |
|LOGISTIC REGRESSION| P=0.192 |
|COCH-ARM / FISHERS | P=0.197 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 2/39.86 4/38.66 |
|POLY-3 PERCENT (g) | 5.0% 10.4% |
|TERMINAL (d) | 1/25 (4%) 3/21 (14%) |
|FIRST INCIDENCE | 646 578 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.277 |
|POLY 3 | P=0.324 |
|POLY 1.5 | P=0.324 |
|POLY 6 | P=0.320 |
|LOGISTIC REGRESSION| P=0.318 |
|COCH-ARM / FISHERS | P=0.312 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/53 (21%) 17/50 (34%) |
|POLY-3 RATE (b) | 11/41.19 17/40.19 |
|POLY-3 PERCENT (g) | 26.7% 42.3% |
|TERMINAL (d) | 4/25 (16%) 10/21 (48%) |
|FIRST INCIDENCE | 646 474 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.086 |
|POLY 3 | P=0.101 |
|POLY 1.5 | P=0.105 |
|POLY 6 | P=0.089 |
|LOGISTIC REGRESSION| P=0.104 |
|COCH-ARM / FISHERS | P=0.099 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 16/53 (30%) 20/50 (40%) |
|POLY-3 RATE (b) | 16/41.46 20/40.70 |
|POLY-3 PERCENT (g) | 38.6% 49.1% |
|TERMINAL (d) | 10/25 (40%) 11/21 (52%) |
|FIRST INCIDENCE | 487 578 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.155 |
|POLY 3 | P=0.223 |
|POLY 1.5 | P=0.222 |
|POLY 6 | P=0.219 |
|LOGISTIC REGRESSION| P=0.214 |
|COCH-ARM / FISHERS | P=0.201 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 41/53 (77%) 46/50 (92%) |
|POLY-3 RATE (b) | 41/44.21 46/48.07 |
|POLY-3 PERCENT (g) | 92.8% 95.7% |
|TERMINAL (d) | 25/25 (100%) 21/21 (100%) |
|FIRST INCIDENCE | 474 215 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.076 |
|POLY 3 | P=0.404 |
|POLY 1.5 | P=0.181 |
|POLY 6 | P=0.769 |
|LOGISTIC REGRESSION| P=0.038 * |
|COCH-ARM / FISHERS | P=0.036 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/39.55 3/39.47 |
|POLY-3 PERCENT (g) | 0.0% 7.6% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- 578 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.119 |
|POLY 3 | P=0.117 |
|POLY 1.5 | P=0.116 |
|POLY 6 | P=0.119 |
|LOGISTIC REGRESSION| P=0.103 |
|COCH-ARM / FISHERS | P=0.111 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/53 (21%) 13/50 (26%) |
|POLY-3 RATE (b) | 11/40.73 13/40.76 |
|POLY-3 PERCENT (g) | 27.0% 31.9% |
|TERMINAL (d) | 9/25 (36%) 6/21 (29%) |
|FIRST INCIDENCE | 366 345 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.275 |
|POLY 3 | P=0.404 |
|POLY 1.5 | P=0.387 |
|POLY 6 | P=0.424 |
|LOGISTIC REGRESSION| P=0.364 |
|COCH-ARM / FISHERS | P=0.346 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 19/53 (36%) 15/50 (30%) |
|POLY-3 RATE (b) | 19/41.29 15/39.68 |
|POLY-3 PERCENT (g) | 46.0% 37.8% |
|TERMINAL (d) | 11/25 (44%) 9/21 (43%) |
|FIRST INCIDENCE | 487 578 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.429N |
|POLY 3 | P=0.297N |
|POLY 1.5 | P=0.302N |
|POLY 6 | P=0.305N |
|LOGISTIC REGRESSION| P=0.303N |
|COCH-ARM / FISHERS | P=0.337N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 36/53 (68%) 36/50 (72%) |
|POLY-3 RATE (b) | 36/52.64 36/49.61 |
|POLY-3 PERCENT (g) | 68.4% 72.6% |
|TERMINAL (d) | 9/25 (36%) 9/21 (43%) |
|FIRST INCIDENCE | 169 215 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.411 |
|POLY 3 | P=0.405 |
|POLY 1.5 | P=0.408 |
|POLY 6 | P=0.399 |
|LOGISTIC REGRESSION| P=0.396 |
|COCH-ARM / FISHERS | P=0.407 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 41/50 (82%) 35/49 (71%) |
|POLY-3 RATE (b) | 41/46.36 35/46.06 |
|POLY-3 PERCENT (g) | 88.4% 76.0% |
|TERMINAL (d) | 22/25 (88%) 15/21 (71%) |
|FIRST INCIDENCE | 169 215 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.445N |
|POLY 3 | P=0.080N |
|POLY 1.5 | P=0.094N |
|POLY 6 | P=0.091N |
|LOGISTIC REGRESSION| P=0.150N |
|COCH-ARM / FISHERS | P=0.157N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Clitoral Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 34/50 (68%) 35/49 (71%) |
|POLY-3 RATE (b) | 34/44.15 35/46.42 |
|POLY-3 PERCENT (g) | 77.0% 75.4% |
|TERMINAL (d) | 19/25 (76%) 14/21 (67%) |
|FIRST INCIDENCE | 169 215 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.287 |
|POLY 3 | P=0.525N |
|POLY 1.5 | P=0.575N |
|POLY 6 | P=0.502N |
|LOGISTIC REGRESSION| P=0.467 |
|COCH-ARM / FISHERS | P=0.440 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Eye: Retina |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 6/50 (12%) |
|POLY-3 RATE (b) | 5/39.55 6/38.82 |
|POLY-3 PERCENT (g) | 12.6% 15.5% |
|TERMINAL (d) | 5/25 (20%) 2/21 (10%) |
|FIRST INCIDENCE | 731 (T) 645 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.403 |
|POLY 3 | P=0.488 |
|POLY 1.5 | P=0.482 |
|POLY 6 | P=0.492 |
|LOGISTIC REGRESSION| P=0.463 |
|COCH-ARM / FISHERS | P=0.459 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Harderian Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/53 (23%) 9/50 (18%) |
|POLY-3 RATE (b) | 12/42.07 9/39.34 |
|POLY-3 PERCENT (g) | 28.5% 22.9% |
|TERMINAL (d) | 6/25 (24%) 5/21 (24%) |
|FIRST INCIDENCE | 366 629 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.443N |
|POLY 3 | P=0.373N |
|POLY 1.5 | P=0.365N |
|POLY 6 | P=0.388N |
|LOGISTIC REGRESSION| P=0.349N |
|COCH-ARM / FISHERS | P=0.368N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/53 (19%) 22/50 (44%) |
|POLY-3 RATE (b) | 10/41.81 22/41.80 |
|POLY-3 PERCENT (g) | 23.9% 52.6% |
|TERMINAL (d) | 6/25 (24%) 9/21 (43%) |
|FIRST INCIDENCE | 169 520 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.007 ** |
|POLY 3 | P=0.004 ** |
|POLY 1.5 | P=0.004 ** |
|POLY 6 | P=0.005 ** |
|LOGISTIC REGRESSION| P=0.006 ** |
|COCH-ARM / FISHERS | P=0.005 ** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/39.55 2/38.98 |
|POLY-3 PERCENT (g) | 0.0% 5.1% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- 484 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.241 |
|POLY 3 | P=0.235 |
|POLY 1.5 | P=0.234 |
|POLY 6 | P=0.235 |
|LOGISTIC REGRESSION| P=0.213 |
|COCH-ARM / FISHERS | P=0.233 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/52 (12%) 5/50 (10%) |
|POLY-3 RATE (b) | 6/39.78 5/38.80 |
|POLY-3 PERCENT (g) | 15.1% 12.9% |
|TERMINAL (d) | 2/25 (8%) 3/21 (14%) |
|FIRST INCIDENCE | 645 641 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.587N |
|POLY 3 | P=0.519N |
|POLY 1.5 | P=0.515N |
|POLY 6 | P=0.534N |
|LOGISTIC REGRESSION| P=0.518N |
|COCH-ARM / FISHERS | P=0.528N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Kidney |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/39.55 2/39.00 |
|POLY-3 PERCENT (g) | 0.0% 5.1% |
|TERMINAL (d) | 0/25 (0%) 1/21 (5%) |
|FIRST INCIDENCE | --- 394 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.221 |
|POLY 3 | P=0.235 |
|POLY 1.5 | P=0.234 |
|POLY 6 | P=0.234 |
|LOGISTIC REGRESSION| P=0.204 |
|COCH-ARM / FISHERS | P=0.233 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Kidney |
| Casts Protein |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/40.58 1/38.66 |
|POLY-3 PERCENT (g) | 7.4% 2.6% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 512 578 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.319N |
|POLY 3 | P=0.326N |
|POLY 1.5 | P=0.324N |
|POLY 6 | P=0.334N |
|LOGISTIC REGRESSION| P=0.335N |
|COCH-ARM / FISHERS | P=0.331N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/39.90 0/38.16 |
|POLY-3 PERCENT (g) | 5.0% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/21 (0%) |
|FIRST INCIDENCE | 631 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.271N |
|POLY 3 | P=0.252N |
|POLY 1.5 | P=0.250N |
|POLY 6 | P=0.257N |
|LOGISTIC REGRESSION| P=0.246N |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/40.43 0/38.16 |
|POLY-3 PERCENT (g) | 12.4% 0.0% |
|TERMINAL (d) | 4/25 (16%) 0/21 (0%) |
|FIRST INCIDENCE | 361 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.047N* |
|POLY 3 | P=0.036N* |
|POLY 1.5 | P=0.035N* |
|POLY 6 | P=0.037N* |
|LOGISTIC REGRESSION| P=0.038N* |
|COCH-ARM / FISHERS | P=0.033N* |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 40/53 (75%) 42/50 (84%) |
|POLY-3 RATE (b) | 40/47.18 42/46.21 |
|POLY-3 PERCENT (g) | 84.8% 90.9% |
|TERMINAL (d) | 22/25 (88%) 19/21 (91%) |
|FIRST INCIDENCE | 169 394 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.202 |
|POLY 3 | P=0.256 |
|POLY 1.5 | P=0.207 |
|POLY 6 | P=0.358 |
|LOGISTIC REGRESSION| P=0.247 |
|COCH-ARM / FISHERS | P=0.204 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 34/53 (64%) 41/50 (82%) |
|POLY-3 RATE (b) | 34/45.60 41/45.19 |
|POLY-3 PERCENT (g) | 74.6% 90.7% |
|TERMINAL (d) | 21/25 (84%) 20/21 (95%) |
|FIRST INCIDENCE | 169 215 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.047 * |
|POLY 3 | P=0.023 * |
|POLY 1.5 | P=0.024 * |
|POLY 6 | P=0.028 * |
|LOGISTIC REGRESSION| P=0.041 * |
|COCH-ARM / FISHERS | P=0.034 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/40.16 1/38.87 |
|POLY-3 PERCENT (g) | 5.0% 2.6% |
|TERMINAL (d) | 1/25 (4%) 0/21 (0%) |
|FIRST INCIDENCE | 533 484 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.520N |
|POLY 3 | P=0.515N |
|POLY 1.5 | P=0.515N |
|POLY 6 | P=0.520N |
|LOGISTIC REGRESSION| P=0.542N |
|COCH-ARM / FISHERS | P=0.522N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/39.55 0/38.16 |
|POLY-3 PERCENT (g) | 5.1% 0.0% |
|TERMINAL (d) | 2/25 (8%) 0/21 (0%) |
|FIRST INCIDENCE | 731 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.277N |
|POLY 3 | P=0.248N |
|POLY 1.5 | P=0.249N |
|POLY 6 | P=0.251N |
|LOGISTIC REGRESSION| (e) |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 5/50 (10%) |
|POLY-3 RATE (b) | 3/40.54 5/39.18 |
|POLY-3 PERCENT (g) | 7.4% 12.8% |
|TERMINAL (d) | 2/25 (8%) 1/21 (5%) |
|FIRST INCIDENCE | 169 584 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.318 |
|POLY 3 | P=0.338 |
|POLY 1.5 | P=0.335 |
|POLY 6 | P=0.341 |
|LOGISTIC REGRESSION| P=0.316 |
|COCH-ARM / FISHERS | P=0.325 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 2/39.55 4/38.16 |
|POLY-3 PERCENT (g) | 5.1% 10.5% |
|TERMINAL (d) | 2/25 (8%) 4/21 (19%) |
|FIRST INCIDENCE | 731 (T) 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.254 |
|POLY 3 | P=0.322 |
|POLY 1.5 | P=0.323 |
|POLY 6 | P=0.317 |
|LOGISTIC REGRESSION| P=0.254 |
|COCH-ARM / FISHERS | P=0.312 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/53 (23%) 16/50 (32%) |
|POLY-3 RATE (b) | 12/42.33 16/39.93 |
|POLY-3 PERCENT (g) | 28.4% 40.1% |
|TERMINAL (d) | 4/25 (16%) 7/21 (33%) |
|FIRST INCIDENCE | 492 520 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.183 |
|POLY 3 | P=0.184 |
|POLY 1.5 | P=0.199 |
|POLY 6 | P=0.162 |
|LOGISTIC REGRESSION| P=0.213 |
|COCH-ARM / FISHERS | P=0.199 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 8/50 (16%) |
|POLY-3 RATE (b) | 5/40.18 8/38.16 |
|POLY-3 PERCENT (g) | 12.4% 21.0% |
|TERMINAL (d) | 3/25 (12%) 8/21 (38%) |
|FIRST INCIDENCE | 548 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.180 |
|POLY 3 | P=0.240 |
|POLY 1.5 | P=0.247 |
|POLY 6 | P=0.225 |
|LOGISTIC REGRESSION| P=0.236 |
|COCH-ARM / FISHERS | P=0.240 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/39.85 0/38.16 |
|POLY-3 PERCENT (g) | 5.0% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/21 (0%) |
|FIRST INCIDENCE | 648 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.269N |
|POLY 3 | P=0.251N |
|POLY 1.5 | P=0.250N |
|POLY 6 | P=0.257N |
|LOGISTIC REGRESSION| P=0.246N |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/53 (21%) 27/50 (54%) |
|POLY-3 RATE (b) | 11/40.67 27/43.77 |
|POLY-3 PERCENT (g) | 27.1% 61.7% |
|TERMINAL (d) | 6/25 (24%) 12/21 (57%) |
|FIRST INCIDENCE | 645 215 |
|-------------------| |
|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: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 10/50 (20%) |
|POLY-3 RATE (b) | 0/39.55 10/40.49 |
|POLY-3 PERCENT (g) | 0.0% 24.7% |
|TERMINAL (d) | 0/25 (0%) 3/21 (14%) |
|FIRST INCIDENCE | --- 520 |
|-------------------| |
|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 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 8/50 (16%) |
|POLY-3 RATE (b) | 2/39.69 8/38.49 |
|POLY-3 PERCENT (g) | 5.0% 20.8% |
|TERMINAL (d) | 1/25 (4%) 6/21 (29%) |
|FIRST INCIDENCE | 694 645 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.028 * |
|POLY 3 | P=0.038 * |
|POLY 1.5 | P=0.039 * |
|POLY 6 | P=0.035 * |
|LOGISTIC REGRESSION| P=0.036 * |
|COCH-ARM / FISHERS | P=0.037 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/39.86 2/38.27 |
|POLY-3 PERCENT (g) | 2.5% 5.2% |
|TERMINAL (d) | 0/25 (0%) 1/21 (5%) |
|FIRST INCIDENCE | 646 702 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.464 |
|POLY 3 | P=0.490 |
|POLY 1.5 | P=0.491 |
|POLY 6 | P=0.487 |
|LOGISTIC REGRESSION| P=0.486 |
|COCH-ARM / FISHERS | P=0.478 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 33/53 (62%) 43/50 (86%) |
|POLY-3 RATE (b) | 33/47.21 43/46.89 |
|POLY-3 PERCENT (g) | 69.9% 91.7% |
|TERMINAL (d) | 17/25 (68%) 20/21 (95%) |
|FIRST INCIDENCE | 351 215 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.026 * |
|POLY 3 | P=0.004 ** |
|POLY 1.5 | P=0.004 ** |
|POLY 6 | P=0.004 ** |
|LOGISTIC REGRESSION| P=0.007 ** |
|COCH-ARM / FISHERS | P=0.005 ** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 30/53 (57%) 29/50 (58%) |
|POLY-3 RATE (b) | 30/41.81 29/41.58 |
|POLY-3 PERCENT (g) | 71.8% 69.8% |
|TERMINAL (d) | 22/25 (88%) 19/21 (91%) |
|FIRST INCIDENCE | 492 474 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.333 |
|POLY 3 | P=0.518N |
|POLY 1.5 | P=0.555N |
|POLY 6 | P=0.479N |
|LOGISTIC REGRESSION| P=0.590 |
|COCH-ARM / FISHERS | P=0.522 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 8/50 (16%) |
|POLY-3 RATE (b) | 1/39.67 8/40.81 |
|POLY-3 PERCENT (g) | 2.5% 19.6% |
|TERMINAL (d) | 0/25 (0%) 1/21 (5%) |
|FIRST INCIDENCE | 701 215 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.019 * |
|POLY 3 | P=0.016 * |
|POLY 1.5 | P=0.016 * |
|POLY 6 | P=0.016 * |
|LOGISTIC REGRESSION| P=0.012 * |
|COCH-ARM / FISHERS | P=0.012 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 45/50 (90%) |
|POLY-3 RATE (b) | 4/40.41 45/47.82 |
|POLY-3 PERCENT (g) | 9.9% 94.1% |
|TERMINAL (d) | 1/25 (4%) 20/21 (95%) |
|FIRST INCIDENCE | 533 215 |
|-------------------| |
|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 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver |
| Toxic Hepatopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 16/50 (32%) |
|POLY-3 RATE (b) | 0/39.55 16/40.19 |
|POLY-3 PERCENT (g) | 0.0% 39.8% |
|TERMINAL (d) | 0/25 (0%) 9/21 (43%) |
|FIRST INCIDENCE | --- 215 |
|-------------------| |
|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: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 6/50 (12%) |
|POLY-3 RATE (b) | 3/39.85 6/38.64 |
|POLY-3 PERCENT (g) | 7.5% 15.5% |
|TERMINAL (d) | 2/25 (8%) 3/21 (14%) |
|FIRST INCIDENCE | 648 643 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.194 |
|POLY 3 | P=0.225 |
|POLY 1.5 | P=0.226 |
|POLY 6 | P=0.221 |
|LOGISTIC REGRESSION| P=0.218 |
|COCH-ARM / FISHERS | P=0.216 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 5/50 (10%) |
|POLY-3 RATE (b) | 0/39.55 5/38.27 |
|POLY-3 PERCENT (g) | 0.0% 13.1% |
|TERMINAL (d) | 0/25 (0%) 4/21 (19%) |
|FIRST INCIDENCE | --- 702 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.023 * |
|POLY 3 | P=0.027 * |
|POLY 1.5 | P=0.028 * |
|POLY 6 | P=0.026 * |
|LOGISTIC REGRESSION| P=0.026 * |
|COCH-ARM / FISHERS | P=0.024 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 7/50 (14%) |
|POLY-3 RATE (b) | 5/40.16 7/39.33 |
|POLY-3 PERCENT (g) | 12.5% 17.8% |
|TERMINAL (d) | 4/25 (16%) 2/21 (10%) |
|FIRST INCIDENCE | 533 215 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.318 |
|POLY 3 | P=0.363 |
|POLY 1.5 | P=0.364 |
|POLY 6 | P=0.356 |
|LOGISTIC REGRESSION| P=0.349 |
|COCH-ARM / FISHERS | P=0.339 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/39.97 0/38.16 |
|POLY-3 PERCENT (g) | 5.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 648 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.250N |
|POLY 3 | P=0.252N |
|POLY 1.5 | P=0.251N |
|POLY 6 | P=0.259N |
|LOGISTIC REGRESSION| P=0.247N |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 22/50 (44%) |
|POLY-3 RATE (b) | 0/39.55 22/43.28 |
|POLY-3 PERCENT (g) | 0.0% 50.8% |
|TERMINAL (d) | 0/25 (0%) 9/21 (43%) |
|FIRST INCIDENCE | --- 215 |
|-------------------| |
|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 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Multinucleated |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 32/50 (64%) |
|POLY-3 RATE (b) | 0/39.55 32/43.19 |
|POLY-3 PERCENT (g) | 0.0% 74.1% |
|TERMINAL (d) | 0/25 (0%) 16/21 (76%) |
|FIRST INCIDENCE | --- 215 |
|-------------------| |
|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: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 41/53 (77%) 41/50 (82%) |
|POLY-3 RATE (b) | 41/48.55 41/44.42 |
|POLY-3 PERCENT (g) | 84.5% 92.3% |
|TERMINAL (d) | 19/25 (76%) 19/21 (91%) |
|FIRST INCIDENCE | 351 520 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.314 |
|POLY 3 | P=0.185 |
|POLY 1.5 | P=0.261 |
|POLY 6 | P=0.141 |
|LOGISTIC REGRESSION| P=0.463 |
|COCH-ARM / FISHERS | P=0.368 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/39.90 0/38.16 |
|POLY-3 PERCENT (g) | 5.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 645 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.260N |
|POLY 3 | P=0.251N |
|POLY 1.5 | P=0.250N |
|POLY 6 | P=0.257N |
|LOGISTIC REGRESSION| P=0.246N |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lung |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/39.55 3/39.10 |
|POLY-3 PERCENT (g) | 2.5% 7.7% |
|TERMINAL (d) | 1/25 (4%) 0/21 (0%) |
|FIRST INCIDENCE | 731 (T) 578 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.293 |
|POLY 3 | P=0.301 |
|POLY 1.5 | P=0.298 |
|POLY 6 | P=0.303 |
|LOGISTIC REGRESSION| P=0.289 |
|COCH-ARM / FISHERS | P=0.287 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/53 (23%) 0/50 (0%) |
|POLY-3 RATE (b) | 12/40.71 0/38.16 |
|POLY-3 PERCENT (g) | 29.5% 0.0% |
|TERMINAL (d) | 6/25 (24%) 0/21 (0%) |
|FIRST INCIDENCE | 645 --- |
|-------------------| |
|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: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Metaplasia Bronchiolar |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 31/50 (62%) |
|POLY-3 RATE (b) | 2/39.55 31/41.68 |
|POLY-3 PERCENT (g) | 5.1% 74.4% |
|TERMINAL (d) | 2/25 (8%) 16/21 (76%) |
|FIRST INCIDENCE | 731 (T) 578 |
|-------------------| |
|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 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/38.56 2/37.52 |
|POLY-3 PERCENT (g) | 0.0% 5.3% |
|TERMINAL (d) | 0/25 (0%) 2/21 (10%) |
|FIRST INCIDENCE | --- 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.200 |
|POLY 3 | P=0.233 |
|POLY 1.5 | P=0.234 |
|POLY 6 | P=0.231 |
|LOGISTIC REGRESSION| P=0.200 |
|COCH-ARM / FISHERS | P=0.238 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 25/51 (49%) 30/49 (61%) |
|POLY-3 RATE (b) | 25/42.13 30/42.19 |
|POLY-3 PERCENT (g) | 59.3% 71.1% |
|TERMINAL (d) | 16/25 (64%) 15/21 (71%) |
|FIRST INCIDENCE | 366 410 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.105 |
|POLY 3 | P=0.169 |
|POLY 1.5 | P=0.170 |
|POLY 6 | P=0.160 |
|LOGISTIC REGRESSION| P=0.163 |
|COCH-ARM / FISHERS | P=0.153 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/38.56 2/37.52 |
|POLY-3 PERCENT (g) | 0.0% 5.3% |
|TERMINAL (d) | 0/25 (0%) 2/21 (10%) |
|FIRST INCIDENCE | --- 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.200 |
|POLY 3 | P=0.233 |
|POLY 1.5 | P=0.234 |
|POLY 6 | P=0.231 |
|LOGISTIC REGRESSION| P=0.200 |
|COCH-ARM / FISHERS | P=0.238 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lymph Node: Lumbar |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/2 (50%) 2/5 (40%) |
|POLY-3 RATE (b) | 1/2.00 2/3.67 |
|POLY-3 PERCENT (g) | 50.0% 54.5% |
|TERMINAL (d) | 0/1 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 717 578 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.484 |
|POLY 3 | P=0.668 |
|POLY 1.5 | P=0.666N |
|POLY 6 | P=0.625 |
|LOGISTIC REGRESSION| P=0.842N |
|COCH-ARM / FISHERS | P=0.714N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Lymph Node: Lumbar |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 2/5 (40%) |
|POLY-3 RATE (b) | 0/1.94 2/3.89 |
|POLY-3 PERCENT (g) | 0.0% 51.4% |
|TERMINAL (d) | 0/1 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 474 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.256 |
|POLY 3 | P=0.245 |
|POLY 1.5 | P=0.276 |
|POLY 6 | P=0.199 |
|LOGISTIC REGRESSION| P=0.999 |
|COCH-ARM / FISHERS | P=0.476 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 4/50 (8%) |
|POLY-3 RATE (b) | 4/41.40 4/38.27 |
|POLY-3 PERCENT (g) | 9.7% 10.5% |
|TERMINAL (d) | 0/25 (0%) 3/21 (14%) |
|FIRST INCIDENCE | 366 702 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.577 |
|POLY 3 | P=0.606 |
|POLY 1.5 | P=0.614 |
|POLY 6 | P=0.591 |
|LOGISTIC REGRESSION| P=0.613 |
|COCH-ARM / FISHERS | P=0.609 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 25/53 (47%) 19/50 (38%) |
|POLY-3 RATE (b) | 25/44.58 19/40.90 |
|POLY-3 PERCENT (g) | 56.1% 46.5% |
|TERMINAL (d) | 13/25 (52%) 9/21 (43%) |
|FIRST INCIDENCE | 487 410 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.340N |
|POLY 3 | P=0.247N |
|POLY 1.5 | P=0.223N |
|POLY 6 | P=0.297N |
|LOGISTIC REGRESSION| P=0.198N |
|COCH-ARM / FISHERS | P=0.229N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/40.42 1/38.16 |
|POLY-3 PERCENT (g) | 5.0% 2.6% |
|TERMINAL (d) | 0/25 (0%) 1/21 (5%) |
|FIRST INCIDENCE | 474 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.530N |
|POLY 3 | P=0.527N |
|POLY 1.5 | P=0.522N |
|POLY 6 | P=0.537N |
|LOGISTIC REGRESSION| P=0.523N |
|COCH-ARM / FISHERS | P=0.522N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/40.42 1/38.80 |
|POLY-3 PERCENT (g) | 5.0% 2.6% |
|TERMINAL (d) | 1/25 (4%) 0/21 (0%) |
|FIRST INCIDENCE | 366 520 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.520N |
|POLY 3 | P=0.519N |
|POLY 1.5 | P=0.519N |
|POLY 6 | P=0.522N |
|LOGISTIC REGRESSION| P=0.562N |
|COCH-ARM / FISHERS | P=0.522N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Oral Mucosa: Gingival |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/2 (50%) 8/11 (73%) |
|POLY-3 RATE (b) | 1/1.13 8/10.01 |
|POLY-3 PERCENT (g) | 88.9% 80.0% |
|TERMINAL (d) | 1/1 (100%) 2/2 (100%) |
|FIRST INCIDENCE | 731 (T) 345 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.019 * |
|POLY 3 | P=0.551N |
|POLY 1.5 | P=0.586 |
|POLY 6 | P=0.522N |
|LOGISTIC REGRESSION| P=0.663 |
|COCH-ARM / FISHERS | P=0.538 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 49/51 (96%) 45/49 (92%) |
|POLY-3 RATE (b) | 49/50.31 45/46.77 |
|POLY-3 PERCENT (g) | 97.4% 96.2% |
|TERMINAL (d) | 24/25 (96%) 20/21 (95%) |
|FIRST INCIDENCE | 169 345 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.497 |
|POLY 3 | P=0.617N |
|POLY 1.5 | P=0.529N |
|POLY 6 | P=0.682N |
|LOGISTIC REGRESSION| P=0.266N |
|COCH-ARM / FISHERS | P=0.320N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 14/51 (27%) 16/49 (33%) |
|POLY-3 RATE (b) | 14/40.42 16/40.78 |
|POLY-3 PERCENT (g) | 34.6% 39.2% |
|TERMINAL (d) | 10/25 (40%) 5/21 (24%) |
|FIRST INCIDENCE | 533 578 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.298 |
|POLY 3 | P=0.420 |
|POLY 1.5 | P=0.401 |
|POLY 6 | P=0.449 |
|LOGISTIC REGRESSION| P=0.376 |
|COCH-ARM / FISHERS | P=0.363 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Oviduct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/2 (100%) 2/2 (100%) |
|POLY-3 RATE (b) | 2/2.00 2/2.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% |
|TERMINAL (d) | 1/1 (100%) 1/1 (100%) |
|FIRST INCIDENCE | 717 643 |
|-------------------| |
|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: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 4/49 (8%) |
|POLY-3 RATE (b) | 0/38.86 4/37.98 |
|POLY-3 PERCENT (g) | 0.0% 10.5% |
|TERMINAL (d) | 0/25 (0%) 3/21 (14%) |
|FIRST INCIDENCE | --- 673 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.046 * |
|POLY 3 | P=0.057 |
|POLY 1.5 | P=0.057 |
|POLY 6 | P=0.056 |
|LOGISTIC REGRESSION| P=0.055 |
|COCH-ARM / FISHERS | P=0.054 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/51 (2%) 4/49 (8%) |
|POLY-3 RATE (b) | 1/38.86 4/37.98 |
|POLY-3 PERCENT (g) | 2.6% 10.5% |
|TERMINAL (d) | 1/25 (4%) 3/21 (14%) |
|FIRST INCIDENCE | 731 (T) 673 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.136 |
|POLY 3 | P=0.171 |
|POLY 1.5 | P=0.172 |
|POLY 6 | P=0.168 |
|LOGISTIC REGRESSION| P=0.161 |
|COCH-ARM / FISHERS | P=0.169 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/51 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/39.17 0/37.76 |
|POLY-3 PERCENT (g) | 5.1% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/21 (0%) |
|FIRST INCIDENCE | 646 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.279N |
|POLY 3 | P=0.249N |
|POLY 1.5 | P=0.247N |
|POLY 6 | P=0.255N |
|LOGISTIC REGRESSION| P=0.244N |
|COCH-ARM / FISHERS | P=0.258N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Pancreas: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/38.86 2/38.73 |
|POLY-3 PERCENT (g) | 0.0% 5.2% |
|TERMINAL (d) | 0/25 (0%) 1/21 (5%) |
|FIRST INCIDENCE | --- 215 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.219 |
|POLY 3 | P=0.236 |
|POLY 1.5 | P=0.236 |
|POLY 6 | P=0.235 |
|LOGISTIC REGRESSION| P=0.180 |
|COCH-ARM / FISHERS | P=0.238 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 25/53 (47%) 15/50 (30%) |
|POLY-3 RATE (b) | 25/42.71 15/39.36 |
|POLY-3 PERCENT (g) | 58.5% 38.1% |
|TERMINAL (d) | 14/25 (56%) 8/21 (38%) |
|FIRST INCIDENCE | 474 614 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.115N |
|POLY 3 | P=0.044N* |
|POLY 1.5 | P=0.043N* |
|POLY 6 | P=0.055N |
|LOGISTIC REGRESSION| P=0.037N* |
|COCH-ARM / FISHERS | P=0.056N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/39.55 3/38.38 |
|POLY-3 PERCENT (g) | 0.0% 7.8% |
|TERMINAL (d) | 0/25 (0%) 2/21 (10%) |
|FIRST INCIDENCE | --- 673 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.099 |
|POLY 3 | P=0.114 |
|POLY 1.5 | P=0.114 |
|POLY 6 | P=0.113 |
|LOGISTIC REGRESSION| P=0.111 |
|COCH-ARM / FISHERS | P=0.111 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 19/53 (36%) 18/50 (36%) |
|POLY-3 RATE (b) | 19/43.37 18/40.67 |
|POLY-3 PERCENT (g) | 43.8% 44.3% |
|TERMINAL (d) | 11/25 (44%) 9/21 (43%) |
|FIRST INCIDENCE | 487 578 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.497 |
|POLY 3 | P=0.575 |
|POLY 1.5 | P=0.587 |
|POLY 6 | P=0.558 |
|LOGISTIC REGRESSION| P=0.559N |
|COCH-ARM / FISHERS | P=0.575 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/40.18 0/38.16 |
|POLY-3 PERCENT (g) | 5.0% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/21 (0%) |
|FIRST INCIDENCE | 526 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.259N |
|POLY 3 | P=0.254N |
|POLY 1.5 | P=0.252N |
|POLY 6 | P=0.260N |
|LOGISTIC REGRESSION| P=0.253N |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/51 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/38.56 2/37.63 |
|POLY-3 PERCENT (g) | 0.0% 5.3% |
|TERMINAL (d) | 0/25 (0%) 1/21 (5%) |
|FIRST INCIDENCE | --- 702 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.224 |
|POLY 3 | P=0.234 |
|POLY 1.5 | P=0.234 |
|POLY 6 | P=0.232 |
|LOGISTIC REGRESSION| P=0.225 |
|COCH-ARM / FISHERS | P=0.238 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 46/51 (90%) 42/49 (86%) |
|POLY-3 RATE (b) | 46/47.32 42/45.72 |
|POLY-3 PERCENT (g) | 97.2% 91.9% |
|TERMINAL (d) | 25/25 (100%) 21/21 (100%) |
|FIRST INCIDENCE | 185 215 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.491 |
|POLY 3 | P=0.198N |
|POLY 1.5 | P=0.225N |
|POLY 6 | P=0.213N |
|LOGISTIC REGRESSION| P=0.273N |
|COCH-ARM / FISHERS | P=0.352N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 45/51 (88%) 42/49 (86%) |
|POLY-3 RATE (b) | 45/49.73 42/45.30 |
|POLY-3 PERCENT (g) | 90.5% 92.7% |
|TERMINAL (d) | 23/25 (92%) 20/21 (95%) |
|FIRST INCIDENCE | 169 215 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.447 |
|POLY 3 | P=0.499 |
|POLY 1.5 | P=0.592 |
|POLY 6 | P=0.447 |
|LOGISTIC REGRESSION| P=0.446N |
|COCH-ARM / FISHERS | P=0.469N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/51 (8%) 1/49 (2%) |
|POLY-3 RATE (b) | 4/42.10 1/38.40 |
|POLY-3 PERCENT (g) | 9.5% 2.6% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 169 520 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.198N |
|POLY 3 | P=0.213N |
|POLY 1.5 | P=0.205N |
|POLY 6 | P=0.223N |
|LOGISTIC REGRESSION| P=0.238N |
|COCH-ARM / FISHERS | P=0.194N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 5/50 (10%) |
|POLY-3 RATE (b) | 3/39.67 5/40.27 |
|POLY-3 PERCENT (g) | 7.6% 12.4% |
|TERMINAL (d) | 2/25 (8%) 1/21 (5%) |
|FIRST INCIDENCE | 701 474 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.314 |
|POLY 3 | P=0.362 |
|POLY 1.5 | P=0.352 |
|POLY 6 | P=0.371 |
|LOGISTIC REGRESSION| P=0.324 |
|COCH-ARM / FISHERS | P=0.325 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/40.42 4/40.11 |
|POLY-3 PERCENT (g) | 2.5% 10.0% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 366 474 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.170 |
|POLY 3 | P=0.175 |
|POLY 1.5 | P=0.172 |
|POLY 6 | P=0.178 |
|LOGISTIC REGRESSION| P=0.123 |
|COCH-ARM / FISHERS | P=0.164 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 2/40.54 4/40.51 |
|POLY-3 PERCENT (g) | 4.9% 9.9% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 366 474 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.331 |
|POLY 3 | P=0.336 |
|POLY 1.5 | P=0.330 |
|POLY 6 | P=0.340 |
|LOGISTIC REGRESSION| P=0.252 |
|COCH-ARM / FISHERS | P=0.312 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/41.09 0/38.16 |
|POLY-3 PERCENT (g) | 7.3% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 169 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.144N |
|POLY 3 | P=0.136N |
|POLY 1.5 | P=0.134N |
|POLY 6 | P=0.143N |
|LOGISTIC REGRESSION| P=0.158N |
|COCH-ARM / FISHERS | P=0.132N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 36/51 (71%) 45/49 (92%) |
|POLY-3 RATE (b) | 36/45.37 45/46.27 |
|POLY-3 PERCENT (g) | 79.3% 97.3% |
|TERMINAL (d) | 20/25 (80%) 21/21 (100%) |
|FIRST INCIDENCE | 169 410 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.031 * |
|POLY 3 | P=0.004 ** |
|POLY 1.5 | P=0.003 ** |
|POLY 6 | P=0.009 ** |
|LOGISTIC REGRESSION| P=0.008 ** |
|COCH-ARM / FISHERS | P=0.006 ** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 19/52 (37%) 15/49 (31%) |
|POLY-3 RATE (b) | 19/40.39 15/42.18 |
|POLY-3 PERCENT (g) | 47.0% 35.6% |
|TERMINAL (d) | 12/25 (48%) 4/21 (19%) |
|FIRST INCIDENCE | 646 410 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.417N |
|POLY 3 | P=0.196N |
|POLY 1.5 | P=0.239N |
|POLY 6 | P=0.164N |
|LOGISTIC REGRESSION| P=0.310N |
|COCH-ARM / FISHERS | P=0.338N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/52 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/38.90 0/37.52 |
|POLY-3 PERCENT (g) | 5.1% 0.0% |
|TERMINAL (d) | 2/25 (8%) 0/21 (0%) |
|FIRST INCIDENCE | 731 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.277N |
|POLY 3 | P=0.249N |
|POLY 1.5 | P=0.249N |
|POLY 6 | P=0.251N |
|LOGISTIC REGRESSION| (e) |
|COCH-ARM / FISHERS | P=0.263N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/52 (6%) 6/49 (12%) |
|POLY-3 RATE (b) | 3/39.78 6/38.56 |
|POLY-3 PERCENT (g) | 7.5% 15.6% |
|TERMINAL (d) | 2/25 (8%) 3/21 (14%) |
|FIRST INCIDENCE | 361 474 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.196 |
|POLY 3 | P=0.225 |
|POLY 1.5 | P=0.225 |
|POLY 6 | P=0.223 |
|LOGISTIC REGRESSION| P=0.217 |
|COCH-ARM / FISHERS | P=0.215 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 15/16 (94%) 12/12 (100%) |
|POLY-3 RATE (b) | 15/15.64 12/12.00 |
|POLY-3 PERCENT (g) | 95.9% 100.0% |
|TERMINAL (d) | 9/9 (100%) 5/5 (100%) |
|FIRST INCIDENCE | 185 345 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.461 |
|POLY 3 | P=0.810 |
|POLY 1.5 | P=0.709 |
|POLY 6 | P=0.964 |
|LOGISTIC REGRESSION| P=0.550 |
|COCH-ARM / FISHERS | P=0.571 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/52 (12%) 2/50 (4%) |
|POLY-3 RATE (b) | 6/39.16 2/38.52 |
|POLY-3 PERCENT (g) | 15.3% 5.2% |
|TERMINAL (d) | 4/25 (16%) 0/21 (0%) |
|FIRST INCIDENCE | 697 645 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.179N |
|POLY 3 | P=0.136N |
|POLY 1.5 | P=0.137N |
|POLY 6 | P=0.138N |
|LOGISTIC REGRESSION| P=0.144N |
|COCH-ARM / FISHERS | P=0.148N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/52 (13%) 9/50 (18%) |
|POLY-3 RATE (b) | 7/40.38 9/40.44 |
|POLY-3 PERCENT (g) | 17.3% 22.3% |
|TERMINAL (d) | 4/25 (16%) 4/21 (19%) |
|FIRST INCIDENCE | 185 484 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.307 |
|POLY 3 | P=0.391 |
|POLY 1.5 | P=0.381 |
|POLY 6 | P=0.399 |
|LOGISTIC REGRESSION| P=0.362 |
|COCH-ARM / FISHERS | P=0.360 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
|=================================================================================================================================|
| |
|Uterus |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 29/52 (56%) 33/50 (66%) |
|POLY-3 RATE (b) | 29/45.30 33/45.46 |
|POLY-3 PERCENT (g) | 64.0% 72.6% |
|TERMINAL (d) | 15/25 (60%) 16/21 (76%) |
|FIRST INCIDENCE | 351 394 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.161 |
|POLY 3 | P=0.248 |
|POLY 1.5 | P=0.230 |
|POLY 6 | P=0.275 |
|LOGISTIC REGRESSION| P=0.212 |
|COCH-ARM / FISHERS | P=0.196 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 03 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION
Terminal Sacrifice at 105 weeks
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| | |
| | Females |
|Dose | 0 NG/KG 100 NG/ |
| | KG/STOP |
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| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 30/52 (58%) 32/50 (64%) |
|POLY-3 RATE (b) | 30/44.70 32/42.21 |
|POLY-3 PERCENT (g) | 67.1% 75.8% |
|TERMINAL (d) | 15/25 (60%) 18/21 (86%) |
|FIRST INCIDENCE | 361 474 |
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|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.226 |
|POLY 3 | P=0.244 |
|POLY 1.5 | P=0.294 |
|POLY 6 | P=0.180 |
|LOGISTIC REGRESSION| P=0.372 |
|COCH-ARM / FISHERS | P=0.327 |
|ORDER RESTRICTED | (e) |
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(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).