TDMS Study 96007-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) DATE: 09/30/03
EXPERIMENT: 96007 TEST: 05 TIME: 11:38:42
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007F
PATHOLOGIST: SELLS, DONALD CAS: 57117-31-4
------------------------------------------------------------------------------------------------------------------------------------
FINAL #3/CONTROL VS. STOP GROUPS
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 007 200 NG/ KG STOP
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) DATE: 09/30/03
EXPERIMENT: 96007 TEST: 05 TIME: 11:38:42
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007F
PATHOLOGIST: SELLS, DONALD CAS: 57117-31-4
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
Harderian Gland Inflammation
Heart Cardiomyopathy
Hemorrhage
Intestine Large, Colon Parasite Metazoan
Intestine Large, Rectum Parasite Metazoan
Kidney Accumulation, Hyaline Droplet
Calculus Micro Observation Only
Inflammation
Mineralization
Nephropathy
Pigmentation
Kidney: Transitional Epithelium Hyperplasia
Liver Angiectasis
Basophilic Focus
Cholangiofibrosis
Clear Cell Focus
Eosinophilic Focus
Fatty Change Diffuse
Fatty Change Focal
Hematopoietic Cell Proliferation
Hepatodiaphragmatic Nodule
Inflammation
Mixed Cell Focus
Necrosis
Pigmentation
Toxic Hepatopathy
Liver: Bile Duct Cyst
Hyperplasia
Liver: Centrilobular Degeneration
Liver: Hepatocyte Hypertrophy
Multinucleated
Liver: Oval Cell Hyperplasia
Lung Hemorrhage
Infiltration Cellular Histiocyte
Inflammation
Lung: Alveolar Epithelium Hyperplasia
Metaplasia Bronchiolar
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) DATE: 09/30/03
EXPERIMENT: 96007 TEST: 05 TIME: 11:38:42
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007F
PATHOLOGIST: SELLS, DONALD CAS: 57117-31-4
Lymph Node, Mandibular Hyperplasia
Lymph Node: Lumbar Ectasia
Hemorrhage
Mammary Gland Cyst
Hyperplasia
Inflammation Granulomatous
Nose Inflammation
Nose: Respiratory Epithelium Hyperplasia
Oral Mucosa: Gingival Hyperplasia
Ovary Atrophy
Cyst
Pancreas Inflammation Chronic
Pancreas: Acinus Atrophy
Vacuolization Cytoplasmic
Pituitary Gland Angiectasis
Cyst
Cytoplasmic Alteration
Vacuolization Cytoplasmic
Pituitary Gland: Pars Distalis Hyperplasia
Skin Inflammation
Ulcer
Spleen Hematopoietic Cell Proliferation
Pigmentation
Spleen: Lymphoid Follicle Atrophy
Spleen: Red Pulp Atrophy
Stomach, Forestomach Hyperplasia
Stomach, Glandular Mineralization
Thymus Atrophy
Thyroid Gland: C-Cell Hyperplasia
Thyroid Gland: Follicular Cell Hypertrophy
Urinary Bladder Inflammation
Urinary Bladder: Transitional Epithelium
Hyperplasia
Uterus Inflammation
Inflammation Chronic
Metaplasia
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 31/53 (58%) 29/48 (60%) |
|POLY-3 RATE (b) | 31/44.10 29/40.00 |
|POLY-3 PERCENT (g) | 70.3% 72.5% |
|TERMINAL (d) | 20/25 (80%) 13/15 (87%) |
|FIRST INCIDENCE | 588 276 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.045 * |
|POLY 3 | P=0.513 |
|POLY 1.5 | P=0.518 |
|POLY 6 | P=0.498 |
|LOGISTIC REGRESSION| P=0.251 |
|COCH-ARM / FISHERS | P=0.503 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 0/48 (0%) |
|POLY-3 RATE (b) | 3/42.22 0/32.61 |
|POLY-3 PERCENT (g) | 7.1% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/15 (0%) |
|FIRST INCIDENCE | 619 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.207N |
|POLY 3 | P=0.194N |
|POLY 1.5 | P=0.171N |
|POLY 6 | P=0.223N |
|LOGISTIC REGRESSION| P=0.166N |
|COCH-ARM / FISHERS | P=0.141N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 12/48 (25%) |
|POLY-3 RATE (b) | 4/42.40 12/35.26 |
|POLY-3 PERCENT (g) | 9.4% 34.0% |
|TERMINAL (d) | 2/25 (8%) 7/15 (47%) |
|FIRST INCIDENCE | 603 240 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** |
|POLY 3 | P=0.007 ** |
|POLY 1.5 | P=0.010 * |
|POLY 6 | P=0.004 ** |
|LOGISTIC REGRESSION| P=0.013 * |
|COCH-ARM / FISHERS | P=0.016 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/53 (15%) 7/48 (15%) |
|POLY-3 RATE (b) | 8/42.51 7/35.22 |
|POLY-3 PERCENT (g) | 18.8% 19.9% |
|TERMINAL (d) | 6/25 (24%) 2/15 (13%) |
|FIRST INCIDENCE | 588 370 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.393 |
|POLY 3 | P=0.580 |
|POLY 1.5 | P=0.604 |
|POLY 6 | P=0.555 |
|LOGISTIC REGRESSION| P=0.598 |
|COCH-ARM / FISHERS | P=0.583N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 42/53 (79%) 36/48 (75%) |
|POLY-3 RATE (b) | 42/48.81 36/41.10 |
|POLY-3 PERCENT (g) | 86.1% 87.6% |
|TERMINAL (d) | 23/25 (92%) 14/15 (93%) |
|FIRST INCIDENCE | 377 240 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.095 |
|POLY 3 | P=0.557 |
|POLY 1.5 | P=0.577N |
|POLY 6 | P=0.396 |
|LOGISTIC REGRESSION| P=0.571 |
|COCH-ARM / FISHERS | P=0.393N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 3/48 (6%) |
|POLY-3 RATE (b) | 4/43.02 3/33.19 |
|POLY-3 PERCENT (g) | 9.3% 9.0% |
|TERMINAL (d) | 0/25 (0%) 0/15 (0%) |
|FIRST INCIDENCE | 500 605 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.608 |
|POLY 3 | P=0.661N |
|POLY 1.5 | P=0.622N |
|POLY 6 | P=0.663 |
|LOGISTIC REGRESSION| P=0.575N |
|COCH-ARM / FISHERS | P=0.556N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/53 (17%) 10/48 (21%) |
|POLY-3 RATE (b) | 9/42.91 10/33.82 |
|POLY-3 PERCENT (g) | 21.0% 29.6% |
|TERMINAL (d) | 5/25 (20%) 6/15 (40%) |
|FIRST INCIDENCE | 536 525 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.147 |
|POLY 3 | P=0.286 |
|POLY 1.5 | P=0.334 |
|POLY 6 | P=0.237 |
|LOGISTIC REGRESSION| P=0.252 |
|COCH-ARM / FISHERS | P=0.405 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/53 (21%) 7/48 (15%) |
|POLY-3 RATE (b) | 11/42.90 7/35.03 |
|POLY-3 PERCENT (g) | 25.6% 20.0% |
|TERMINAL (d) | 7/25 (28%) 3/15 (20%) |
|FIRST INCIDENCE | 500 370 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.570N |
|POLY 3 | P=0.386N |
|POLY 1.5 | P=0.348N |
|POLY 6 | P=0.430N |
|LOGISTIC REGRESSION| P=0.344N |
|COCH-ARM / FISHERS | P=0.293N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 38/53 (72%) 43/50 (86%) |
|POLY-3 RATE (b) | 38/52.51 43/49.89 |
|POLY-3 PERCENT (g) | 72.4% 86.2% |
|TERMINAL (d) | 12/25 (48%) 9/15 (60%) |
|FIRST INCIDENCE | 289 215 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.017 * |
|POLY 3 | P=0.068 |
|POLY 1.5 | P=0.065 |
|POLY 6 | P=0.072 |
|LOGISTIC REGRESSION| P=0.223 |
|COCH-ARM / FISHERS | P=0.062 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 52/53 (98%) 48/50 (96%) |
|POLY-3 RATE (b) | 52/52.72 48/49.33 |
|POLY-3 PERCENT (g) | 98.6% 97.3% |
|TERMINAL (d) | 25/25 (100%) 14/15 (93%) |
|FIRST INCIDENCE | 289 215 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.043 * |
|POLY 3 | P=0.609N |
|POLY 1.5 | P=0.563N |
|POLY 6 | P=0.634N |
|LOGISTIC REGRESSION| P=0.482N |
|COCH-ARM / FISHERS | P=0.478N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Clitoral Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 40/53 (75%) 39/50 (78%) |
|POLY-3 RATE (b) | 40/50.78 39/44.51 |
|POLY-3 PERCENT (g) | 78.8% 87.6% |
|TERMINAL (d) | 18/25 (72%) 12/15 (80%) |
|FIRST INCIDENCE | 289 215 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.045 * |
|POLY 3 | P=0.183 |
|POLY 1.5 | P=0.264 |
|POLY 6 | P=0.134 |
|LOGISTIC REGRESSION| P=0.401 |
|COCH-ARM / FISHERS | P=0.473 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Harderian Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 16/53 (30%) 6/49 (12%) |
|POLY-3 RATE (b) | 16/42.80 6/34.36 |
|POLY-3 PERCENT (g) | 37.4% 17.5% |
|TERMINAL (d) | 11/25 (44%) 2/15 (13%) |
|FIRST INCIDENCE | 610 500 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.154N |
|POLY 3 | P=0.046N* |
|POLY 1.5 | P=0.036N* |
|POLY 6 | P=0.060N |
|LOGISTIC REGRESSION| P=0.061N |
|COCH-ARM / FISHERS | P=0.024N* |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 15/53 (28%) 13/50 (26%) |
|POLY-3 RATE (b) | 15/43.14 13/35.36 |
|POLY-3 PERCENT (g) | 34.8% 36.8% |
|TERMINAL (d) | 9/25 (36%) 5/15 (33%) |
|FIRST INCIDENCE | 500 503 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.261 |
|POLY 3 | P=0.533 |
|POLY 1.5 | P=0.591 |
|POLY 6 | P=0.478 |
|LOGISTIC REGRESSION| P=0.465 |
|COCH-ARM / FISHERS | P=0.484N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Heart |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/43.24 0/32.95 |
|POLY-3 PERCENT (g) | 4.6% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/15 (0%) |
|FIRST INCIDENCE | 377 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.283N |
|POLY 3 | P=0.345N |
|POLY 1.5 | P=0.308N |
|POLY 6 | P=0.388N |
|LOGISTIC REGRESSION| P=0.149N |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/42.66 0/32.31 |
|POLY-3 PERCENT (g) | 4.7% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/15 (0%) |
|FIRST INCIDENCE | 536 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.320N |
|POLY 3 | P=0.346N |
|POLY 1.5 | P=0.312N |
|POLY 6 | P=0.388N |
|LOGISTIC REGRESSION| P=0.227N |
|COCH-ARM / FISHERS | P=0.268N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/41.97 2/32.95 |
|POLY-3 PERCENT (g) | 9.5% 6.1% |
|TERMINAL (d) | 3/25 (12%) 2/15 (13%) |
|FIRST INCIDENCE | 678 728 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.574N |
|POLY 3 | P=0.478N |
|POLY 1.5 | P=0.434N |
|POLY 6 | P=0.528N |
|LOGISTIC REGRESSION| P=0.527N |
|COCH-ARM / FISHERS | P=0.367N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Kidney |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 3/48 (6%) |
|POLY-3 RATE (b) | 0/41.78 3/33.51 |
|POLY-3 PERCENT (g) | 0.0% 9.0% |
|TERMINAL (d) | 0/25 (0%) 1/15 (7%) |
|FIRST INCIDENCE | --- 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.072 |
|POLY 3 | P=0.094 |
|POLY 1.5 | P=0.099 |
|POLY 6 | P=0.090 |
|LOGISTIC REGRESSION| P=0.111 |
|COCH-ARM / FISHERS | P=0.104 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Kidney |
| Calculus Micro Observation Only |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 1/48 (2%) |
|POLY-3 RATE (b) | 5/41.89 1/33.46 |
|POLY-3 PERCENT (g) | 11.9% 3.0% |
|TERMINAL (d) | 4/25 (16%) 0/15 (0%) |
|FIRST INCIDENCE | 699 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.221N |
|POLY 3 | P=0.173N |
|POLY 1.5 | P=0.154N |
|POLY 6 | P=0.198N |
|LOGISTIC REGRESSION| P=0.146N |
|COCH-ARM / FISHERS | P=0.127N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 3/48 (6%) |
|POLY-3 RATE (b) | 2/42.16 3/32.66 |
|POLY-3 PERCENT (g) | 4.7% 9.2% |
|TERMINAL (d) | 1/25 (4%) 2/15 (13%) |
|FIRST INCIDENCE | 619 715 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.302 |
|POLY 3 | P=0.411 |
|POLY 1.5 | P=0.432 |
|POLY 6 | P=0.389 |
|LOGISTIC REGRESSION| P=0.357 |
|COCH-ARM / FISHERS | P=0.453 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 37/53 (70%) 41/48 (85%) |
|POLY-3 RATE (b) | 37/49.64 41/44.94 |
|POLY-3 PERCENT (g) | 74.5% 91.2% |
|TERMINAL (d) | 20/25 (80%) 13/15 (87%) |
|FIRST INCIDENCE | 289 276 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006 ** |
|POLY 3 | P=0.023 * |
|POLY 1.5 | P=0.027 * |
|POLY 6 | P=0.026 * |
|LOGISTIC REGRESSION| P=0.045 * |
|COCH-ARM / FISHERS | P=0.051 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 34/53 (64%) 35/48 (73%) |
|POLY-3 RATE (b) | 34/45.99 35/41.66 |
|POLY-3 PERCENT (g) | 73.9% 84.0% |
|TERMINAL (d) | 20/25 (80%) 15/15 (100%) |
|FIRST INCIDENCE | 377 240 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * |
|POLY 3 | P=0.164 |
|POLY 1.5 | P=0.204 |
|POLY 6 | P=0.118 |
|LOGISTIC REGRESSION| P=0.101 |
|COCH-ARM / FISHERS | P=0.233 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Kidney |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/42.16 0/32.61 |
|POLY-3 PERCENT (g) | 4.7% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/15 (0%) |
|FIRST INCIDENCE | 619 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.334N |
|POLY 3 | P=0.336N |
|POLY 1.5 | P=0.308N |
|POLY 6 | P=0.371N |
|LOGISTIC REGRESSION| P=0.282N |
|COCH-ARM / FISHERS | P=0.273N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 3/48 (6%) |
|POLY-3 RATE (b) | 2/41.78 3/33.23 |
|POLY-3 PERCENT (g) | 4.8% 9.0% |
|TERMINAL (d) | 2/25 (8%) 2/15 (13%) |
|FIRST INCIDENCE | 728 (T) 525 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.295 |
|POLY 3 | P=0.420 |
|POLY 1.5 | P=0.437 |
|POLY 6 | P=0.402 |
|LOGISTIC REGRESSION| P=0.384 |
|COCH-ARM / FISHERS | P=0.453 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/53 (11%) 1/50 (2%) |
|POLY-3 RATE (b) | 6/42.92 1/33.52 |
|POLY-3 PERCENT (g) | 14.0% 3.0% |
|TERMINAL (d) | 1/25 (4%) 0/15 (0%) |
|FIRST INCIDENCE | 610 547 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.149N |
|POLY 3 | P=0.117N |
|POLY 1.5 | P=0.095N |
|POLY 6 | P=0.148N |
|LOGISTIC REGRESSION| P=0.081N |
|COCH-ARM / FISHERS | P=0.066N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 22/53 (42%) 13/50 (26%) |
|POLY-3 RATE (b) | 22/44.73 13/36.12 |
|POLY-3 PERCENT (g) | 49.2% 36.0% |
|TERMINAL (d) | 10/25 (40%) 5/15 (33%) |
|FIRST INCIDENCE | 513 451 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.431N |
|POLY 3 | P=0.169N |
|POLY 1.5 | P=0.122N |
|POLY 6 | P=0.242N |
|LOGISTIC REGRESSION| P=0.158N |
|COCH-ARM / FISHERS | P=0.073N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Cholangiofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/41.78 3/33.14 |
|POLY-3 PERCENT (g) | 0.0% 9.1% |
|TERMINAL (d) | 0/25 (0%) 1/15 (7%) |
|FIRST INCIDENCE | --- 692 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.060 |
|POLY 3 | P=0.095 |
|POLY 1.5 | P=0.100 |
|POLY 6 | P=0.090 |
|LOGISTIC REGRESSION| P=0.065 |
|COCH-ARM / FISHERS | P=0.111 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 13/53 (25%) 6/50 (12%) |
|POLY-3 RATE (b) | 13/43.13 6/32.95 |
|POLY-3 PERCENT (g) | 30.1% 18.2% |
|TERMINAL (d) | 9/25 (36%) 6/15 (40%) |
|FIRST INCIDENCE | 321 728 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.322N |
|POLY 3 | P=0.188N |
|POLY 1.5 | P=0.140N |
|POLY 6 | P=0.257N |
|LOGISTIC REGRESSION| P=0.196N |
|COCH-ARM / FISHERS | P=0.082N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 15/53 (28%) 22/50 (44%) |
|POLY-3 RATE (b) | 15/45.03 22/38.92 |
|POLY-3 PERCENT (g) | 33.3% 56.5% |
|TERMINAL (d) | 6/25 (24%) 6/15 (40%) |
|FIRST INCIDENCE | 289 370 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.013 * |
|POLY 3 | P=0.024 * |
|POLY 1.5 | P=0.034 * |
|POLY 6 | P=0.019 * |
|LOGISTIC REGRESSION| P=0.048 * |
|COCH-ARM / FISHERS | P=0.073 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 6/50 (12%) |
|POLY-3 RATE (b) | 1/41.78 6/34.86 |
|POLY-3 PERCENT (g) | 2.4% 17.2% |
|TERMINAL (d) | 1/25 (4%) 3/15 (20%) |
|FIRST INCIDENCE | 728 (T) 413 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.019 * |
|POLY 3 | P=0.033 * |
|POLY 1.5 | P=0.038 * |
|POLY 6 | P=0.029 * |
|LOGISTIC REGRESSION| P=0.046 * |
|COCH-ARM / FISHERS | P=0.048 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 7/50 (14%) |
|POLY-3 RATE (b) | 5/42.06 7/34.54 |
|POLY-3 PERCENT (g) | 11.9% 20.3% |
|TERMINAL (d) | 4/25 (16%) 2/15 (13%) |
|FIRST INCIDENCE | 651 476 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.140 |
|POLY 3 | P=0.257 |
|POLY 1.5 | P=0.287 |
|POLY 6 | P=0.231 |
|LOGISTIC REGRESSION| P=0.233 |
|COCH-ARM / FISHERS | P=0.339 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 24/53 (45%) 31/50 (62%) |
|POLY-3 RATE (b) | 24/48.52 31/42.24 |
|POLY-3 PERCENT (g) | 49.5% 73.4% |
|TERMINAL (d) | 10/25 (40%) 10/15 (67%) |
|FIRST INCIDENCE | 289 240 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.008 ** |
|POLY 3 | P=0.014 * |
|POLY 1.5 | P=0.024 * |
|POLY 6 | P=0.008 ** |
|LOGISTIC REGRESSION| P=0.072 |
|COCH-ARM / FISHERS | P=0.066 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/41.97 1/32.95 |
|POLY-3 PERCENT (g) | 7.2% 3.0% |
|TERMINAL (d) | 2/25 (8%) 1/15 (7%) |
|FIRST INCIDENCE | 678 728 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.484N |
|POLY 3 | P=0.425N |
|POLY 1.5 | P=0.387N |
|POLY 6 | P=0.469N |
|LOGISTIC REGRESSION| P=0.443N |
|COCH-ARM / FISHERS | P=0.331N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 47/53 (89%) 48/50 (96%) |
|POLY-3 RATE (b) | 47/51.32 48/48.98 |
|POLY-3 PERCENT (g) | 91.6% 98.0% |
|TERMINAL (d) | 23/25 (92%) 15/15 (100%) |
|FIRST INCIDENCE | 289 240 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.010 * |
|POLY 3 | P=0.145 |
|POLY 1.5 | P=0.123 |
|POLY 6 | P=0.194 |
|LOGISTIC REGRESSION| P=0.112 |
|COCH-ARM / FISHERS | P=0.154 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 33/53 (62%) 24/50 (48%) |
|POLY-3 RATE (b) | 33/45.39 24/36.74 |
|POLY-3 PERCENT (g) | 72.7% 65.3% |
|TERMINAL (d) | 21/25 (84%) 11/15 (73%) |
|FIRST INCIDENCE | 500 451 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.352 |
|POLY 3 | P=0.312N |
|POLY 1.5 | P=0.206N |
|POLY 6 | P=0.457N |
|LOGISTIC REGRESSION| P=0.406N |
|COCH-ARM / FISHERS | P=0.104N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 11/50 (22%) |
|POLY-3 RATE (b) | 4/44.47 11/39.94 |
|POLY-3 PERCENT (g) | 9.0% 27.5% |
|TERMINAL (d) | 0/25 (0%) 0/15 (0%) |
|FIRST INCIDENCE | 377 240 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.027 * |
|POLY 3 | P=0.024 * |
|POLY 1.5 | P=0.028 * |
|POLY 6 | P=0.021 * |
|LOGISTIC REGRESSION| P=0.120 |
|COCH-ARM / FISHERS | P=0.035 * |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 13/53 (25%) 48/50 (96%) |
|POLY-3 RATE (b) | 13/43.77 48/48.40 |
|POLY-3 PERCENT (g) | 29.7% 99.2% |
|TERMINAL (d) | 7/25 (28%) 15/15 (100%) |
|FIRST INCIDENCE | 321 240 |
|-------------------| |
|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: 05 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver |
| Toxic Hepatopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 9/50 (18%) |
|POLY-3 RATE (b) | 0/41.78 9/33.65 |
|POLY-3 PERCENT (g) | 0.0% 26.7% |
|TERMINAL (d) | 0/25 (0%) 5/15 (33%) |
|FIRST INCIDENCE | --- 610 |
|-------------------| |
|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 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/53 (13%) 2/50 (4%) |
|POLY-3 RATE (b) | 7/42.31 2/33.05 |
|POLY-3 PERCENT (g) | 16.6% 6.1% |
|TERMINAL (d) | 4/25 (16%) 1/15 (7%) |
|FIRST INCIDENCE | 651 701 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.242N |
|POLY 3 | P=0.164N |
|POLY 1.5 | P=0.134N |
|POLY 6 | P=0.203N |
|LOGISTIC REGRESSION| P=0.182N |
|COCH-ARM / FISHERS | P=0.095N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/42.17 1/32.95 |
|POLY-3 PERCENT (g) | 7.1% 3.0% |
|TERMINAL (d) | 1/25 (4%) 1/15 (7%) |
|FIRST INCIDENCE | 619 728 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.484N |
|POLY 3 | P=0.427N |
|POLY 1.5 | P=0.388N |
|POLY 6 | P=0.473N |
|LOGISTIC REGRESSION| P=0.416N |
|COCH-ARM / FISHERS | P=0.331N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 7/50 (14%) |
|POLY-3 RATE (b) | 4/43.64 7/36.67 |
|POLY-3 PERCENT (g) | 9.2% 19.1% |
|TERMINAL (d) | 0/25 (0%) 2/15 (13%) |
|FIRST INCIDENCE | 310 240 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.145 |
|POLY 3 | P=0.175 |
|POLY 1.5 | P=0.196 |
|POLY 6 | P=0.154 |
|LOGISTIC REGRESSION| P=0.388 |
|COCH-ARM / FISHERS | P=0.230 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 14/50 (28%) |
|POLY-3 RATE (b) | 2/42.11 14/38.76 |
|POLY-3 PERCENT (g) | 4.8% 36.1% |
|TERMINAL (d) | 0/25 (0%) 3/15 (20%) |
|FIRST INCIDENCE | 651 240 |
|-------------------| |
|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 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Multinucleated |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 25/50 (50%) |
|POLY-3 RATE (b) | 0/41.78 25/42.04 |
|POLY-3 PERCENT (g) | 0.0% 59.5% |
|TERMINAL (d) | 0/25 (0%) 7/15 (47%) |
|FIRST INCIDENCE | --- 276 |
|-------------------| |
|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: 05 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Liver: Oval Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/41.78 3/33.20 |
|POLY-3 PERCENT (g) | 2.4% 9.0% |
|TERMINAL (d) | 1/25 (4%) 1/15 (7%) |
|FIRST INCIDENCE | 728 (T) 689 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.175 |
|POLY 3 | P=0.249 |
|POLY 1.5 | P=0.263 |
|POLY 6 | P=0.236 |
|LOGISTIC REGRESSION| P=0.188 |
|COCH-ARM / FISHERS | P=0.287 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/41.78 2/34.31 |
|POLY-3 PERCENT (g) | 0.0% 5.8% |
|TERMINAL (d) | 0/25 (0%) 0/15 (0%) |
|FIRST INCIDENCE | --- 495 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.194 |
|POLY 3 | P=0.218 |
|POLY 1.5 | P=0.222 |
|POLY 6 | P=0.215 |
|LOGISTIC REGRESSION| P=0.297 |
|COCH-ARM / FISHERS | P=0.233 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 44/53 (83%) 30/50 (60%) |
|POLY-3 RATE (b) | 44/49.96 30/41.31 |
|POLY-3 PERCENT (g) | 88.1% 72.6% |
|TERMINAL (d) | 22/25 (88%) 10/15 (67%) |
|FIRST INCIDENCE | 310 276 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.534 |
|POLY 3 | P=0.044N* |
|POLY 1.5 | P=0.022N* |
|POLY 6 | P=0.078N |
|LOGISTIC REGRESSION| P=0.026N* |
|COCH-ARM / FISHERS | P=0.008N** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 5/50 (10%) |
|POLY-3 RATE (b) | 5/43.26 5/33.26 |
|POLY-3 PERCENT (g) | 11.6% 15.0% |
|TERMINAL (d) | 1/25 (4%) 2/15 (13%) |
|FIRST INCIDENCE | 377 689 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.378 |
|POLY 3 | P=0.480 |
|POLY 1.5 | P=0.524 |
|POLY 6 | P=0.436 |
|LOGISTIC REGRESSION| P=0.517 |
|COCH-ARM / FISHERS | P=0.592 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 14/53 (26%) 6/50 (12%) |
|POLY-3 RATE (b) | 14/42.58 6/33.73 |
|POLY-3 PERCENT (g) | 32.9% 17.8% |
|TERMINAL (d) | 11/25 (44%) 3/15 (20%) |
|FIRST INCIDENCE | 610 547 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.259N |
|POLY 3 | P=0.114N |
|POLY 1.5 | P=0.086N |
|POLY 6 | P=0.151N |
|LOGISTIC REGRESSION| P=0.152N |
|COCH-ARM / FISHERS | P=0.054N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Metaplasia Bronchiolar |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/53 (9%) 7/50 (14%) |
|POLY-3 RATE (b) | 5/41.78 7/33.80 |
|POLY-3 PERCENT (g) | 12.0% 20.7% |
|TERMINAL (d) | 5/25 (20%) 4/15 (27%) |
|FIRST INCIDENCE | 728 (T) 512 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.115 |
|POLY 3 | P=0.249 |
|POLY 1.5 | P=0.282 |
|POLY 6 | P=0.218 |
|LOGISTIC REGRESSION| P=0.175 |
|COCH-ARM / FISHERS | P=0.339 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 38/53 (72%) 29/49 (59%) |
|POLY-3 RATE (b) | 38/46.17 29/40.93 |
|POLY-3 PERCENT (g) | 82.3% 70.9% |
|TERMINAL (d) | 24/25 (96%) 10/15 (67%) |
|FIRST INCIDENCE | 321 240 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.284 |
|POLY 3 | P=0.136N |
|POLY 1.5 | P=0.130N |
|POLY 6 | P=0.144N |
|LOGISTIC REGRESSION| P=0.284N |
|COCH-ARM / FISHERS | P=0.131N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Lymph Node: Lumbar |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/5 (40%) 1/3 (33%) |
|POLY-3 RATE (b) | 2/4.62 1/2.95 |
|POLY-3 PERCENT (g) | 43.3% 33.9% |
|TERMINAL (d) | 1/3 (33%) 1/2 (50%) |
|FIRST INCIDENCE | 678 728 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.662N |
|POLY 3 | P=0.720N |
|POLY 1.5 | P=0.731N |
|POLY 6 | P=0.705N |
|LOGISTIC REGRESSION| P=0.689N |
|COCH-ARM / FISHERS | P=0.714N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Lymph Node: Lumbar |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/5 (40%) 0/3 (0%) |
|POLY-3 RATE (b) | 2/4.42 0/2.95 |
|POLY-3 PERCENT (g) | 45.2% 0.0% |
|TERMINAL (d) | 2/3 (67%) 0/2 (0%) |
|FIRST INCIDENCE | 728 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.309N |
|POLY 3 | P=0.357N |
|POLY 1.5 | P=0.386N |
|POLY 6 | P=0.313N |
|LOGISTIC REGRESSION| (e) |
|COCH-ARM / FISHERS | P=0.357N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/41.81 3/33.91 |
|POLY-3 PERCENT (g) | 2.4% 8.9% |
|TERMINAL (d) | 0/25 (0%) 1/15 (7%) |
|FIRST INCIDENCE | 720 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.185 |
|POLY 3 | P=0.253 |
|POLY 1.5 | P=0.266 |
|POLY 6 | P=0.240 |
|LOGISTIC REGRESSION| P=0.278 |
|COCH-ARM / FISHERS | P=0.287 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 33/53 (62%) 19/50 (38%) |
|POLY-3 RATE (b) | 33/46.61 19/36.27 |
|POLY-3 PERCENT (g) | 70.8% 52.4% |
|TERMINAL (d) | 19/25 (76%) 7/15 (47%) |
|FIRST INCIDENCE | 289 413 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.350N |
|POLY 3 | P=0.060N |
|POLY 1.5 | P=0.033N* |
|POLY 6 | P=0.099N |
|LOGISTIC REGRESSION| P=0.046N* |
|COCH-ARM / FISHERS | P=0.012N* |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/41.97 1/33.80 |
|POLY-3 PERCENT (g) | 4.8% 3.0% |
|TERMINAL (d) | 1/25 (4%) 0/15 (0%) |
|FIRST INCIDENCE | 678 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.605N |
|POLY 3 | P=0.604N |
|POLY 1.5 | P=0.574N |
|POLY 6 | P=0.638N |
|LOGISTIC REGRESSION| P=0.487N |
|COCH-ARM / FISHERS | P=0.522N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/53 (15%) 7/50 (14%) |
|POLY-3 RATE (b) | 8/44.12 7/34.45 |
|POLY-3 PERCENT (g) | 18.1% 20.3% |
|TERMINAL (d) | 2/25 (8%) 1/15 (7%) |
|FIRST INCIDENCE | 321 370 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.437 |
|POLY 3 | P=0.535 |
|POLY 1.5 | P=0.587 |
|POLY 6 | P=0.478 |
|LOGISTIC REGRESSION| P=0.571N |
|COCH-ARM / FISHERS | P=0.549N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/42.34 2/33.05 |
|POLY-3 PERCENT (g) | 2.4% 6.1% |
|TERMINAL (d) | 0/25 (0%) 1/15 (7%) |
|FIRST INCIDENCE | 554 701 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.365 |
|POLY 3 | P=0.449 |
|POLY 1.5 | P=0.462 |
|POLY 6 | P=0.437 |
|LOGISTIC REGRESSION| P=0.446 |
|COCH-ARM / FISHERS | P=0.478 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Oral Mucosa: Gingival |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 15/52 (29%) 14/50 (28%) |
|POLY-3 RATE (b) | 15/42.71 14/36.02 |
|POLY-3 PERCENT (g) | 35.1% 38.9% |
|TERMINAL (d) | 9/24 (38%) 5/15 (33%) |
|FIRST INCIDENCE | 500 491 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.225 |
|POLY 3 | P=0.465 |
|POLY 1.5 | P=0.523 |
|POLY 6 | P=0.414 |
|LOGISTIC REGRESSION| P=0.445 |
|COCH-ARM / FISHERS | P=0.550N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 43/53 (81%) 39/47 (83%) |
|POLY-3 RATE (b) | 43/50.40 39/43.66 |
|POLY-3 PERCENT (g) | 85.3% 89.3% |
|TERMINAL (d) | 21/25 (84%) 13/15 (87%) |
|FIRST INCIDENCE | 310 276 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.072 |
|POLY 3 | P=0.396 |
|POLY 1.5 | P=0.422 |
|POLY 6 | P=0.395 |
|LOGISTIC REGRESSION| P=0.427 |
|COCH-ARM / FISHERS | P=0.510 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/53 (21%) 12/47 (26%) |
|POLY-3 RATE (b) | 11/42.65 12/36.25 |
|POLY-3 PERCENT (g) | 25.8% 33.1% |
|TERMINAL (d) | 8/25 (32%) 4/15 (27%) |
|FIRST INCIDENCE | 554 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.148 |
|POLY 3 | P=0.327 |
|POLY 1.5 | P=0.345 |
|POLY 6 | P=0.309 |
|LOGISTIC REGRESSION| P=0.327 |
|COCH-ARM / FISHERS | P=0.371 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/42.25 0/32.92 |
|POLY-3 PERCENT (g) | 4.7% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/15 (0%) |
|FIRST INCIDENCE | 588 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.331N |
|POLY 3 | P=0.333N |
|POLY 1.5 | P=0.303N |
|POLY 6 | P=0.372N |
|LOGISTIC REGRESSION| P=0.268N |
|COCH-ARM / FISHERS | P=0.268N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/42.64 0/32.92 |
|POLY-3 PERCENT (g) | 7.0% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/15 (0%) |
|FIRST INCIDENCE | 588 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.197N |
|POLY 3 | P=0.195N |
|POLY 1.5 | P=0.169N |
|POLY 6 | P=0.230N |
|LOGISTIC REGRESSION| P=0.137N |
|COCH-ARM / FISHERS | P=0.136N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/41.78 2/34.20 |
|POLY-3 PERCENT (g) | 0.0% 5.9% |
|TERMINAL (d) | 0/25 (0%) 0/15 (0%) |
|FIRST INCIDENCE | --- 370 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.204 |
|POLY 3 | P=0.217 |
|POLY 1.5 | P=0.221 |
|POLY 6 | P=0.214 |
|LOGISTIC REGRESSION| P=0.281 |
|COCH-ARM / FISHERS | P=0.228 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 20/53 (38%) 13/49 (27%) |
|POLY-3 RATE (b) | 20/42.80 13/34.10 |
|POLY-3 PERCENT (g) | 46.7% 38.1% |
|TERMINAL (d) | 14/25 (56%) 6/15 (40%) |
|FIRST INCIDENCE | 651 500 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.550 |
|POLY 3 | P=0.305N |
|POLY 1.5 | P=0.243N |
|POLY 6 | P=0.381N |
|LOGISTIC REGRESSION| P=0.435N |
|COCH-ARM / FISHERS | P=0.159N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 2/41.83 1/32.63 |
|POLY-3 PERCENT (g) | 4.8% 3.1% |
|TERMINAL (d) | 1/25 (4%) 1/15 (7%) |
|FIRST INCIDENCE | 715 728 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.664N |
|POLY 3 | P=0.619N |
|POLY 1.5 | P=0.587N |
|POLY 6 | P=0.654N |
|LOGISTIC REGRESSION| P=0.648N |
|COCH-ARM / FISHERS | P=0.530N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/53 (2%) 2/49 (4%) |
|POLY-3 RATE (b) | 1/41.78 2/32.96 |
|POLY-3 PERCENT (g) | 2.4% 6.1% |
|TERMINAL (d) | 1/25 (4%) 1/15 (7%) |
|FIRST INCIDENCE | 728 (T) 638 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.342 |
|POLY 3 | P=0.450 |
|POLY 1.5 | P=0.461 |
|POLY 6 | P=0.440 |
|LOGISTIC REGRESSION| P=0.397 |
|COCH-ARM / FISHERS | P=0.470 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 2/49 (4%) |
|POLY-3 RATE (b) | 2/42.16 2/32.63 |
|POLY-3 PERCENT (g) | 4.7% 6.1% |
|TERMINAL (d) | 1/25 (4%) 2/15 (13%) |
|FIRST INCIDENCE | 619 728 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.520 |
|POLY 3 | P=0.628 |
|POLY 1.5 | P=0.645 |
|POLY 6 | P=0.611 |
|LOGISTIC REGRESSION| P=0.582 |
|COCH-ARM / FISHERS | P=0.661 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 22/53 (42%) 19/49 (39%) |
|POLY-3 RATE (b) | 22/43.51 19/37.38 |
|POLY-3 PERCENT (g) | 50.6% 50.8% |
|TERMINAL (d) | 16/25 (64%) 8/15 (53%) |
|FIRST INCIDENCE | 610 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.187 |
|POLY 3 | P=0.589 |
|POLY 1.5 | P=0.563N |
|POLY 6 | P=0.562 |
|LOGISTIC REGRESSION| P=0.460 |
|COCH-ARM / FISHERS | P=0.469N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Skin |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.17 0/32.95 |
|POLY-3 PERCENT (g) | 4.7% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/15 (0%) |
|FIRST INCIDENCE | 619 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.338N |
|POLY 3 | P=0.333N |
|POLY 1.5 | P=0.301N |
|POLY 6 | P=0.372N |
|LOGISTIC REGRESSION| P=0.278N |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Skin |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.17 0/32.95 |
|POLY-3 PERCENT (g) | 4.7% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/15 (0%) |
|FIRST INCIDENCE | 619 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.338N |
|POLY 3 | P=0.333N |
|POLY 1.5 | P=0.301N |
|POLY 6 | P=0.372N |
|LOGISTIC REGRESSION| P=0.278N |
|COCH-ARM / FISHERS | P=0.262N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 49/53 (92%) 49/49 (100%) |
|POLY-3 RATE (b) | 49/51.40 49/49.00 |
|POLY-3 PERCENT (g) | 95.3% 100.0% |
|TERMINAL (d) | 25/25 (100%) 15/15 (100%) |
|FIRST INCIDENCE | 289 240 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * |
|POLY 3 | P=0.164 |
|POLY 1.5 | P=0.119 |
|POLY 6 | P=0.237 |
|LOGISTIC REGRESSION| P=0.053 |
|COCH-ARM / FISHERS | P=0.069 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 52/53 (98%) 48/49 (98%) |
|POLY-3 RATE (b) | 52/53.00 48/48.57 |
|POLY-3 PERCENT (g) | 98.1% 98.8% |
|TERMINAL (d) | 24/25 (96%) 15/15 (100%) |
|FIRST INCIDENCE | 289 240 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.041 * |
|POLY 3 | P=0.724 |
|POLY 1.5 | P=0.756 |
|POLY 6 | P=0.661 |
|LOGISTIC REGRESSION| P=0.726N |
|COCH-ARM / FISHERS | P=0.732N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/53 (13%) 2/49 (4%) |
|POLY-3 RATE (b) | 7/44.55 2/33.47 |
|POLY-3 PERCENT (g) | 15.7% 6.0% |
|TERMINAL (d) | 1/25 (4%) 0/15 (0%) |
|FIRST INCIDENCE | 310 625 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.189N |
|POLY 3 | P=0.183N |
|POLY 1.5 | P=0.147N |
|POLY 6 | P=0.231N |
|LOGISTIC REGRESSION| P=0.077N |
|COCH-ARM / FISHERS | P=0.100N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Spleen: Red Pulp |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/42.70 0/32.92 |
|POLY-3 PERCENT (g) | 4.7% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/15 (0%) |
|FIRST INCIDENCE | 310 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.308N |
|POLY 3 | P=0.338N |
|POLY 1.5 | P=0.307N |
|POLY 6 | P=0.376N |
|LOGISTIC REGRESSION| P=0.197N |
|COCH-ARM / FISHERS | P=0.268N |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/53 (8%) 5/50 (10%) |
|POLY-3 RATE (b) | 4/42.72 5/35.15 |
|POLY-3 PERCENT (g) | 9.4% 14.2% |
|TERMINAL (d) | 2/25 (8%) 2/15 (13%) |
|FIRST INCIDENCE | 289 370 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.296 |
|POLY 3 | P=0.394 |
|POLY 1.5 | P=0.419 |
|POLY 6 | P=0.368 |
|LOGISTIC REGRESSION| P=0.538 |
|COCH-ARM / FISHERS | P=0.463 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 2/41.98 3/34.03 |
|POLY-3 PERCENT (g) | 4.8% 8.8% |
|TERMINAL (d) | 1/25 (4%) 1/15 (7%) |
|FIRST INCIDENCE | 675 215 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.340 |
|POLY 3 | P=0.427 |
|POLY 1.5 | P=0.447 |
|POLY 6 | P=0.405 |
|LOGISTIC REGRESSION| P=0.501 |
|COCH-ARM / FISHERS | P=0.472 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 43/53 (81%) 44/49 (90%) |
|POLY-3 RATE (b) | 43/48.07 44/45.76 |
|POLY-3 PERCENT (g) | 89.5% 96.2% |
|TERMINAL (d) | 23/25 (92%) 14/15 (93%) |
|FIRST INCIDENCE | 377 240 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.009 ** |
|POLY 3 | P=0.166 |
|POLY 1.5 | P=0.152 |
|POLY 6 | P=0.218 |
|LOGISTIC REGRESSION| P=0.036 * |
|COCH-ARM / FISHERS | P=0.170 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 15/53 (28%) 15/48 (31%) |
|POLY-3 RATE (b) | 15/43.91 15/35.37 |
|POLY-3 PERCENT (g) | 34.2% 42.4% |
|TERMINAL (d) | 10/25 (40%) 5/15 (33%) |
|FIRST INCIDENCE | 513 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.148 |
|POLY 3 | P=0.309 |
|POLY 1.5 | P=0.367 |
|POLY 6 | P=0.260 |
|LOGISTIC REGRESSION| P=0.305 |
|COCH-ARM / FISHERS | P=0.457 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/53 (13%) 23/48 (48%) |
|POLY-3 RATE (b) | 7/42.51 23/41.15 |
|POLY-3 PERCENT (g) | 16.5% 55.9% |
|TERMINAL (d) | 3/25 (12%) 6/15 (40%) |
|FIRST INCIDENCE | 651 276 |
|-------------------| |
|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: 05 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 33/33 (100%) 24/24 (100%) |
|POLY-3 RATE (b) | 33/33.00 24/24.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% |
|TERMINAL (d) | 19/19 (100%) 9/9 (100%) |
|FIRST INCIDENCE | 289 276 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) |
|POLY 3 | (e) |
|POLY 1.5 | (e) |
|POLY 6 | (e) |
|LOGISTIC REGRESSION| (e) |
|COCH-ARM / FISHERS | (e) |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/41.83 2/33.62 |
|POLY-3 PERCENT (g) | 4.8% 6.0% |
|TERMINAL (d) | 1/25 (4%) 1/15 (7%) |
|FIRST INCIDENCE | 715 500 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.537 |
|POLY 3 | P=0.638 |
|POLY 1.5 | P=0.652 |
|POLY 6 | P=0.623 |
|LOGISTIC REGRESSION| P=0.632 |
|COCH-ARM / FISHERS | P=0.669 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/41.78 3/33.67 |
|POLY-3 PERCENT (g) | 0.0% 8.9% |
|TERMINAL (d) | 0/25 (0%) 1/15 (7%) |
|FIRST INCIDENCE | --- 500 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.065 |
|POLY 3 | P=0.096 |
|POLY 1.5 | P=0.101 |
|POLY 6 | P=0.091 |
|LOGISTIC REGRESSION| P=0.098 |
|COCH-ARM / FISHERS | P=0.111 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 3/49 (6%) |
|POLY-3 RATE (b) | 3/42.38 3/33.17 |
|POLY-3 PERCENT (g) | 7.1% 9.1% |
|TERMINAL (d) | 2/25 (8%) 0/15 (0%) |
|FIRST INCIDENCE | 536 491 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.478 |
|POLY 3 | P=0.569 |
|POLY 1.5 | P=0.592 |
|POLY 6 | P=0.548 |
|LOGISTIC REGRESSION| P=0.600 |
|COCH-ARM / FISHERS | P=0.623 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 7/49 (14%) |
|POLY-3 RATE (b) | 0/41.78 7/34.56 |
|POLY-3 PERCENT (g) | 0.0% 20.3% |
|TERMINAL (d) | 0/25 (0%) 2/15 (13%) |
|FIRST INCIDENCE | --- 276 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** |
|POLY 3 | P=0.003 ** |
|POLY 1.5 | P=0.004 ** |
|POLY 6 | P=0.003 ** |
|LOGISTIC REGRESSION| P=0.008 ** |
|COCH-ARM / FISHERS | P=0.005 ** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Uterus |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 17/53 (32%) 28/49 (57%) |
|POLY-3 RATE (b) | 17/45.44 28/39.23 |
|POLY-3 PERCENT (g) | 37.4% 71.4% |
|TERMINAL (d) | 8/25 (32%) 12/15 (80%) |
|FIRST INCIDENCE | 321 451 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** |
|POLY 3 | P<0.001 ** |
|POLY 1.5 | P=0.002 ** |
|POLY 6 | P<0.001 ** |
|LOGISTIC REGRESSION| P=0.003 ** |
|COCH-ARM / FISHERS | P=0.009 ** |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
Date: 09/30/03 EXPERIMENT: 96007 TEST: 05 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 200 NG/ |
| | KG STOP |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 31/53 (58%) 35/49 (71%) |
|POLY-3 RATE (b) | 31/47.62 35/43.22 |
|POLY-3 PERCENT (g) | 65.1% 81.0% |
|TERMINAL (d) | 16/25 (64%) 12/15 (80%) |
|FIRST INCIDENCE | 310 215 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * |
|POLY 3 | P=0.062 |
|POLY 1.5 | P=0.080 |
|POLY 6 | P=0.049 * |
|LOGISTIC REGRESSION| P=0.084 |
|COCH-ARM / FISHERS | P=0.123 |
|ORDER RESTRICTED | (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).