P10 - Statistical Analysis of Non-Neoplastic Lesions (Mice)
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus ESTRAGOLE DATE: 10/08/03
EXPERIMENT: 60946 TEST: 02 TIME: 08:04:23
TEST TYPE: SUBCHRON 90-DAY CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-15460 ROUTE: GAVAGE NTP C#: C60946
PATHOLOGIST: MISSING CAS: 140-67-0
------------------------------------------------------------------------------------------------------------------------------------
FINAL/MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus ESTRAGOLE DATE: 10/08/03
EXPERIMENT: 60946 TEST: 02 TIME: 08:04:23
TEST TYPE: SUBCHRON 90-DAY CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-15460 ROUTE: GAVAGE NTP C#: C60946
PATHOLOGIST: MISSING CAS: 140-67-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF ESTRAGOLE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Kidney: Renal Tubule Vacuolization Cytoplasmic
Liver Inflammation Chronic
Liver: Hepatocyte Degeneration
Hypertrophy
Liver: Oval Cell Hyperplasia
Nose: Olfactory Epithelium Degeneration
Spleen Hematopoietic Cell Proliferation
Stomach, Glandular Infiltration Cellular Polymorphonuclear
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex: Subcapsular Hyperplasia
Kidney Nephropathy
Liver Fatty Change Diffuse
Inflammation Chronic
Necrosis
Liver: Bile Duct Hyperplasia
Liver: Hepatocyte Degeneration
Hypertrophy
Liver: Oval Cell Hyperplasia
Lymph Node, Mandibular Atrophy
Lymph Node, Mesenteric Atrophy
Nose: Olfactory Epithelium Degeneration
Salivary Glands Cytoplasmic Alteration
Spleen Hematopoietic Cell Proliferation
Spleen: Lymphoid Follicle Atrophy
Spleen: Red Pulp Depletion Cellular
Stomach, Forestomach Hyperplasia
Mineralization
Ulcer
Stomach, Glandular Mineralization
Stomach, Glandular: Epithelium, Glands
Degeneration
Thymus Necrosis Lymphoid
===============================================================
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/10 (60%) |
|POLY-3 RATE (b) | 5/10.00 0/0.00 0/0.00 0/0.00 0/0.00 6/9.28 |
|POLY-3 PERCENT (g) | 50.0% 0.0% 0.0% 0.0% 0.0% 64.6% |
|TERMINAL (d) | 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/9 (67%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.313 P=1.000N P=1.000N P=1.000N P=1.000N P=0.397 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.428 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.454 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.406 |
|LOGISTIC REGRESSION| P=0.313 (e) (e) (e) (e) P=0.397 |
|COCH-ARM / FISHERS | P=0.411 P=1.000 P=1.000 P=1.000 P=1.000 P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) 6/10 (60%) |
|POLY-3 RATE (b) | 10/10.00 0/0.00 0/0.00 0/0.00 10/10.00 6/6.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- 93 (T) 3 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.003 ** |
|POLY 3 | (e) (e) (e) (e) (e) P=1.000N |
|POLY 1.5 | (e) (e) (e) (e) (e) P=1.000N |
|POLY 6 | (e) (e) (e) (e) (e) P=1.000N |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.011N* (e) (e) (e) (e) P=0.043N* |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 5/10 (50%) 2/10 (20%) 4/10 (40%) 4/10 (40%) 2/10 (20%) |
|POLY-3 RATE (b) | 3/10.00 5/10.00 2/10.00 4/10.00 4/10.00 2/9.28 |
|POLY-3 PERCENT (g) | 30.0% 50.0% 20.0% 40.0% 40.0% 21.6% |
|TERMINAL (d) | 3/10 (30%) 5/10 (50%) 2/10 (20%) 4/10 (40%) 4/10 (40%) 2/9 (22%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.367N P=0.328 P=0.500N P=0.500 P=0.500 P=0.553N |
|POLY 3 | P=0.356N P=0.329 P=0.500N P=0.500 P=0.500 P=0.537N |
|POLY 1.5 | P=0.339N P=0.329 P=0.500N P=0.500 P=0.500 P=0.524N |
|POLY 6 | P=0.371N P=0.329 P=0.500N P=0.500 P=0.500 P=0.548N |
|LOGISTIC REGRESSION| P=0.367N P=0.328 P=0.500N P=0.500 P=0.500 P=0.553N |
|COCH-ARM / FISHERS | P=0.303N P=0.325 P=0.500N P=0.500 P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.372N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) |
|POLY-3 RATE (b) | 5/10.00 0/9.00 0/9.00 0/10.00 1/10.00 1/1.00 |
|POLY-3 PERCENT (g) | 50.0% 0.0% 0.0% 0.0% 10.0% 99.9% |
|TERMINAL (d) | 5/10 (50%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 1/10 (10%) 0/0 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- 93 (T) 4 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.653 P=0.029N* P=0.029N* P=0.022N* P=0.077N P=0.479 |
|POLY 3 | P=0.101N P=0.013N* P=0.013N* P=0.008N** P=0.061N P=0.516 |
|POLY 1.5 | P=0.104N P=0.013N* P=0.013N* P=0.008N** P=0.061N P=0.531 |
|POLY 6 | P=0.101N P=0.013N* P=0.013N* P=0.008N** P=0.061N P=0.516 |
|LOGISTIC REGRESSION| P=0.166N (e) (e) (e) P=0.077N (e) |
|COCH-ARM / FISHERS | P=0.255N P=0.022N* P=0.022N* P=0.016N* P=0.070N P=0.070N |
|ORDER RESTRICTED | P=0.283 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/10 (90%) 9/10 (90%) 2/10 (20%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 9/10.00 9/10.00 2/10.00 1/10.00 0/10.00 0/9.28 |
|POLY-3 PERCENT (g) | 90.0% 90.0% 20.0% 10.0% 0.0% 0.0% |
|TERMINAL (d) | 9/10 (90%) 9/10 (90%) 2/10 (20%) 1/10 (10%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** P=0.766 P=0.004N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 3 | P<0.001N** P=0.760 P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.760 P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P=0.760 P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.766 P=0.004N** P<0.001N** (e) (e) |
|COCH-ARM / FISHERS | P<0.001N** P=0.763N P=0.003N** P<0.001N** P<0.001N** P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/9.00 0/9.00 0/10.00 0/10.00 0/0.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/9.28 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 5/5.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 3 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.006 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.016 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 2/10 (20%) 4/10 (40%) 4/10 (40%) 7/10 (70%) 7/10 (70%) |
|POLY-3 RATE (b) | 2/10.00 2/10.00 4/10.00 4/10.00 7/10.00 7/9.28 |
|POLY-3 PERCENT (g) | 20.0% 20.0% 40.0% 40.0% 70.0% 75.4% |
|TERMINAL (d) | 2/10 (20%) 2/10 (20%) 4/10 (40%) 4/10 (40%) 7/10 (70%) 7/9 (78%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.707 P=0.317 P=0.317 P=0.040 * P=0.023 * |
|POLY 3 | P<0.001 ** P=0.702 P=0.318 P=0.318 P=0.024 * P=0.012 * |
|POLY 1.5 | P=0.002 ** P=0.702 P=0.318 P=0.318 P=0.024 * P=0.016 * |
|POLY 6 | P<0.001 ** P=0.702 P=0.318 P=0.318 P=0.024 * P=0.010 * |
|LOGISTIC REGRESSION| P=0.002 ** P=0.707 P=0.317 P=0.317 P=0.040 * P=0.023 * |
|COCH-ARM / FISHERS | P=0.004 ** P=0.709N P=0.314 P=0.314 P=0.035 * P=0.035 * |
|ORDER RESTRICTED | P=0.008 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 9/10 (90%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 2/10 (20%) |
|POLY-3 RATE (b) | 10/10.00 9/10.00 10/10.00 10/10.00 10/10.00 2/2.00 |
|POLY-3 PERCENT (g) | 100.0% 90.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 10/10 (100%) 9/10 (90%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 3 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500N (e) (e) (e) P=0.057 |
|POLY 3 | P=0.485 P=0.500N (e) (e) (e) P=1.000N |
|POLY 1.5 | P=0.511 P=0.500N (e) (e) (e) P=1.000N |
|POLY 6 | P=0.485 P=0.500N (e) (e) (e) P=1.000N |
|LOGISTIC REGRESSION| P=0.763 P=0.500N (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001N** P=0.500N (e) (e) (e) P<0.001N** |
|ORDER RESTRICTED | P=0.710 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/9.28 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 3 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/9.28 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 1/10.00 2/10.00 0/0.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 10.0% 20.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.072 (e) (e) P=0.500 P=0.234 (e) |
|POLY 3 | P=0.018 * (e) (e) P=0.500 P=0.227 (e) |
|POLY 1.5 | P=0.018 * (e) (e) P=0.500 P=0.227 (e) |
|POLY 6 | P=0.018 * (e) (e) P=0.500 P=0.227 (e) |
|LOGISTIC REGRESSION| P=0.070 (e) (e) P=0.500 P=0.234 (e) |
|COCH-ARM / FISHERS | P=0.478 (e) (e) P=0.500 P=0.237 (e) |
|ORDER RESTRICTED | P=0.831 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 5/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 50.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) 9/9 (100%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.022 * P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.008 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.008 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.008 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.022 * (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.016 * P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 3/10 (30%) 10/10 (100%) 10/10 (100%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 1/10.00 3/10.00 10/10.00 10/10.00 0/0.00 |
|POLY-3 PERCENT (g) | 0.0% 10.0% 30.0% 100.0% 100.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 1/10 (10%) 3/10 (30%) 10/10 (100%) 10/10 (100%) 0/0 (0%) |
|FIRST INCIDENCE | --- 93 (T) 93 (T) 93 (T) 93 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500 P=0.111 P<0.001 ** P<0.001 ** (e) |
|POLY 3 | P<0.001 ** P=0.500 P=0.095 P<0.001 ** P<0.001 ** (e) |
|POLY 1.5 | P<0.001 ** P=0.500 P=0.095 P<0.001 ** P<0.001 ** (e) |
|POLY 6 | P<0.001 ** P=0.500 P=0.095 P<0.001 ** P<0.001 ** (e) |
|LOGISTIC REGRESSION| (e) P=0.500 P=0.111 P<0.001 ** P<0.001 ** (e) |
|COCH-ARM / FISHERS | P=0.519 P=0.500 P=0.105 P<0.001 ** P<0.001 ** (e) |
|ORDER RESTRICTED | P=0.830 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 8/10 (80%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 8/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 80.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 8/10 (80%) 9/9 (100%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001N** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001N** |
|POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001N** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P<0.001 ** (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 3/10 (30%) 10/10 (100%) 10/10 (100%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 3/10.00 10/10.00 10/10.00 0/0.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 30.0% 100.0% 100.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 3/10 (30%) 10/10 (100%) 10/10 (100%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 93 (T) 93 (T) 93 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.111 P<0.001 ** P<0.001 ** (e) |
|POLY 3 | P<0.001 ** (e) P=0.095 P<0.001 ** P<0.001 ** (e) |
|POLY 1.5 | P<0.001 ** (e) P=0.095 P<0.001 ** P<0.001 ** (e) |
|POLY 6 | P<0.001 ** (e) P=0.095 P<0.001 ** P<0.001 ** (e) |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.111 P<0.001 ** P<0.001 ** (e) |
|COCH-ARM / FISHERS | P=0.439 (e) P=0.105 P<0.001 ** P<0.001 ** (e) |
|ORDER RESTRICTED | P=0.830 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Oval Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 10/10.00 9/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 100.0% 90.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 8/9 (89%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P<0.001 ** (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Oval Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 5/10 (50%) |
|POLY-3 RATE (b) | 0/10.00 1/10.00 10/10.00 10/10.00 10/10.00 5/5.00 |
|POLY-3 PERCENT (g) | 0.0% 10.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 1/10 (10%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 0/0 (0%) |
|FIRST INCIDENCE | --- 93 (T) 93 (T) 93 (T) 93 (T) 3 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** P=0.006 ** |
|POLY 3 | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** (e) |
|COCH-ARM / FISHERS | P=0.068 P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** P=0.016 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 3 | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 1.5 | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 6 | P=0.107 (e) (e) (e) (e) P=0.500 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.105 (e) (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.064 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 7/8 (88%) |
|POLY-3 RATE (b) | 0/10.00 0/9.00 0/9.00 0/10.00 0/9.00 7/7.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 3 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 3 | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 1.5 | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 6 | P=0.107 (e) (e) (e) (e) P=0.500 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.105 (e) (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.064 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 9/9.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 3 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 1/10.00 2/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.0% 20.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 10/10 (100%) 9/9 (100%) |
|FIRST INCIDENCE | --- --- 93 (T) 93 (T) 93 (T) 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.500 P=0.234 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.500 P=0.227 P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001 ** (e) P=0.500 P=0.227 P<0.001N** P<0.001N** |
|POLY 6 | P<0.001 ** (e) P=0.500 P=0.227 P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| (e) (e) P=0.500 P=0.234 P<0.001 ** (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 P=0.237 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 2/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 20.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 10/10 (100%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) 3 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.234 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.227 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.227 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.227 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.234 P<0.001 ** (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.237 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Salivary Glands |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.500 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.500 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.500 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.267 (e) (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Salivary Glands |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 3 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 8/10 (80%) |
|POLY-3 RATE (b) | 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 8/9.28 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% 100.0% 86.2% |
|TERMINAL (d) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 8/9 (89%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.095N (e) (e) (e) (e) P=0.479N |
|POLY 3 | P=0.035N* (e) (e) (e) (e) P=0.373N |
|POLY 1.5 | P=0.016N* (e) (e) (e) (e) P=0.302N |
|POLY 6 | P=0.073N (e) (e) (e) (e) P=0.447N |
|LOGISTIC REGRESSION| P=0.095N (e) (e) (e) (e) P=0.479N |
|COCH-ARM / FISHERS | P=0.010N* (e) (e) (e) (e) P=0.237N |
|ORDER RESTRICTED | P=0.014N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 2/10 (20%) |
|POLY-3 RATE (b) | 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 2/2.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 4 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.008 ** (e) (e) (e) (e) P=0.210 |
|POLY 3 | P=1.000N (e) (e) (e) (e) P=1.000N |
|POLY 1.5 | P=1.000N (e) (e) (e) (e) P=1.000N |
|POLY 6 | P=1.000N (e) (e) (e) (e) P=1.000N |
|LOGISTIC REGRESSION| P=0.008 ** (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001N** (e) (e) (e) (e) P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 3 | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 1.5 | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 6 | P=0.107 (e) (e) (e) (e) P=0.500 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.105 (e) (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.064 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 3 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen: Red Pulp |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/9.28 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen: Red Pulp |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 9/9.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 4 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 1/9.28 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 10.8% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/9 (11%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.095 (e) (e) (e) (e) P=0.479 |
|POLY 3 | P=0.100 (e) (e) (e) (e) P=0.485 |
|POLY 1.5 | P=0.102 (e) (e) (e) (e) P=0.490 |
|POLY 6 | P=0.098 (e) (e) (e) (e) P=0.481 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.479 |
|COCH-ARM / FISHERS | P=0.105 (e) (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.054 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 6/10 (60%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/9.00 0/10.00 6/6.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 4 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.002 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.005 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/9.28 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.427N P=0.500N P=0.500N P=0.500N P=0.500N P=0.521N |
|POLY 3 | P=0.401N P=0.500N P=0.500N P=0.500N P=0.500N P=0.515N |
|POLY 1.5 | P=0.407N P=0.500N P=0.500N P=0.500N P=0.500N P=0.510N |
|POLY 6 | P=0.396N P=0.500N P=0.500N P=0.500N P=0.500N P=0.519N |
|LOGISTIC REGRESSION| P=0.427N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.415N P=0.500N P=0.500N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.075N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 6/10 (60%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/9.00 0/10.00 6/6.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 3 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.003 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.005 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/9.28 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 6/10 (60%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/9.00 0/10.00 6/6.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 4 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.002 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.005 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Infiltration Cellular Polymorphonuclear |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 3/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/9.28 |
|POLY-3 PERCENT (g) | 30.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/10 (30%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.115N P=0.111N P=0.111N P=0.111N P=0.111N P=0.129N |
|POLY 3 | P=0.082N P=0.095N P=0.095N P=0.095N P=0.095N P=0.109N |
|POLY 1.5 | P=0.083N P=0.095N P=0.095N P=0.095N P=0.095N P=0.104N |
|POLY 6 | P=0.081N P=0.095N P=0.095N P=0.095N P=0.095N P=0.114N |
|LOGISTIC REGRESSION| P=0.115N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.107N P=0.105N P=0.105N P=0.105N P=0.105N P=0.105N |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Infiltration Cellular Polymorphonuclear |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 1/10.00 0/0.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 10.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.362 (e) (e) (e) P=0.500 (e) |
|POLY 3 | P=0.123 (e) (e) (e) P=0.500 (e) |
|POLY 1.5 | P=0.123 (e) (e) (e) P=0.500 (e) |
|POLY 6 | P=0.123 (e) (e) (e) P=0.500 (e) |
|LOGISTIC REGRESSION| P=0.360 (e) (e) (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.585 (e) (e) (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.831 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 1/10.00 0/9.28 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 10.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.573 (e) (e) (e) P=0.500 (e) |
|POLY 3 | P=0.539 (e) (e) (e) P=0.500 (e) |
|POLY 1.5 | P=0.555 (e) (e) (e) P=0.500 (e) |
|POLY 6 | P=0.525 (e) (e) (e) P=0.500 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.585 (e) (e) (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.349 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 1/10.00 2/10.00 0/0.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 10.0% 20.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.072 (e) (e) P=0.500 P=0.234 (e) |
|POLY 3 | P=0.018 * (e) (e) P=0.500 P=0.227 (e) |
|POLY 1.5 | P=0.018 * (e) (e) P=0.500 P=0.227 (e) |
|POLY 6 | P=0.018 * (e) (e) P=0.500 P=0.227 (e) |
|LOGISTIC REGRESSION| P=0.070 (e) (e) P=0.500 P=0.234 (e) |
|COCH-ARM / FISHERS | P=0.478 (e) (e) P=0.500 P=0.237 (e) |
|ORDER RESTRICTED | P=0.831 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular: Epithelium, Glands |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 61 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 3 | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 1.5 | P=0.107 (e) (e) (e) (e) P=0.500 |
|POLY 6 | P=0.107 (e) (e) (e) (e) P=0.500 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.105 (e) (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.064 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular: Epithelium, Glands |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 5/10 (50%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 1/10.00 5/5.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 10.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) 3 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.500 P=0.006 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.500 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.500 P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.500 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.360 (e) (e) (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.500 P=0.016 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 02 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Necrosis Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/9.28 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Necrosis Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 3 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).