TDMS Study 05187-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus METHYLEUGENOL DATE: 07/20/98
EXPERIMENT: 05187 TEST: 06 TIME: 10:26:20
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-25337 ROUTE: GAVAGE NTP C#: 60991B
PATHOLOGIST: TOFT, J. CAS: 93-15-2
------------------------------------------------------------------------------------------------------------------------------------
CORE STUDY
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus METHYLEUGENOL DATE: 07/20/98
EXPERIMENT: 05187 TEST: 06 TIME: 10:26:20
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25337 ROUTE: GAVAGE NTP C#: 60991B
PATHOLOGIST: TOFT, J. CAS: 93-15-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF METHYLEUGENOL
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hypertrophy
Bone Marrow Hyperplasia
Islets, Pancreatic Hyperplasia
Kidney Infiltration Cellular Lymphocyte
Mineralization
Nephropathy
Kidney: Cortex Cyst
Liver Clear Cell Focus
Eosinophilic Focus
Inflammation Chronic
Liver: Hepatocyte Necrosis
Liver: Hepatocyte, Centrilobular Necrosis
Liver: Oval Cell Hyperplasia
Liver: Portal Hypertrophy
Pancreas: Acinus Atrophy
Pituitary Gland: Pars Distalis Cyst
Spleen: Red Pulp Hematopoietic Cell Proliferation
Stomach, Glandular Atrophy
Ectasia
Hyperplasia
Inflammation Chronic
Mineralization
Stomach, Glandular: Neuroendocrine Cell
Hyperplasia
Thymus Cyst
Thyroid Gland Inflammation Chronic
Urinary Bladder Infiltration Cellular Lymphocyte
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hematopoietic Cell Proliferation
Adrenal Cortex: Subcapsular Hyperplasia
Adrenal Medulla Hyperplasia
Bone Marrow Hyperplasia
Myelofibrosis
Heart: Atrium Thrombosis
Islets, Pancreatic Hyperplasia
Kidney Hydronephrosis
Infiltration Cellular Lymphocyte
Nephropathy
Kidney: Cortex Cyst
Kidney: Renal Tubule Pigmentation Hemosiderin
Liver Basophilic Focus
Eosinophilic Focus
Hematopoietic Cell Proliferation
Infiltration Cellular Lymphocyte
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus METHYLEUGENOL DATE: 07/20/98
EXPERIMENT: 05187 TEST: 06 TIME: 10:26:20
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25337 ROUTE: GAVAGE NTP C#: 60991B
PATHOLOGIST: TOFT, J. CAS: 93-15-2
Inflammation Chronic
Mixed Cell Focus
Pigmentation Hemosiderin
Liver: Bile Duct Cyst
Hyperplasia
Liver: Hepatocyte Necrosis
Vacuolization Cytoplasmic
Liver: Oval Cell Hyperplasia
Liver: Portal Hypertrophy
Lung: Alveolus Infiltration Cellular Histiocyte
Nose Inflammation
Nose: Nasolacrimal Duct Inflammation
Ovary Thrombosis
Pancreas Infiltration Cellular Lymphocyte
Pituitary Gland: Pars Distalis Angiectasis
Salivary Glands Infiltration Cellular Lymphocyte
Skeletal Muscle Infiltration Cellular Lymphocyte
Skin: Subcutaneous Tissue Infiltration Cellular Lymphocyte
Spleen: Lymphoid Follicle Hyperplasia Lymphoid
Necrosis
Spleen: Red Pulp Hematopoietic Cell Proliferation
Stomach, Glandular Atrophy
Ectasia
Hyperplasia
Inflammation Chronic
Thymus Cyst
Thyroid Gland: Follicular Cell Hyperplasia
Urinary Bladder Infiltration Cellular Lymphocyte
Uterus Hydrometra
Hyperplasia Cystic
===============================================================
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.4% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 2/36 (6%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- 730 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.415N P=0.226 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.398N P=0.249 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.398N P=0.247 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.400N P=0.250 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.226 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.398N P=0.253 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 8/50 (16%) 17/50 (34%) 14/49 (29%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.5% 19.2% 41.7% 35.6% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |2/31 (7%) 1/18 (6%) 8/18 (44%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) 519 619 450 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P<0.001 ** P=0.019 * P<0.001 ** P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) |P<0.001 ** P=0.033 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) |P<0.001 ** P=0.039 * P<0.001 ** P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) |P<0.001 ** P=0.027 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.002 ** P=0.066 P<0.001 ** P=0.004 ** |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P<0.001 ** P=0.046 * P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 5/50 (10%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 10.9% 6.9% 4.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 5/36 (14%) 2/37 (5%) 2/35 (6%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- 730 (T) 691 730 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.427 P=0.029 * P=0.120 P=0.220 |(e) (e) (e) (e) |
|POLY 3 | P=0.449 P=0.035 * P=0.119 P=0.236 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.456 P=0.034 * P=0.119 P=0.238 |(e) (e) (e) (e) |
|POLY 6 | P=0.441 P=0.035 * P=0.119 P=0.234 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.438 P=0.029 * P=0.120 P=0.220 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.467 P=0.030 * P=0.125 P=0.253 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 38/49 (78%) 42/50 (84%) 44/50 (88%) 43/50 (86%) |47/50 (94%) 48/50 (96%) 49/50 (98%) 48/49 (98%) |
|POLY-3 ADJUSTED (b)| 79.3% 86.3% 90.8% 88.6% |95.6% 97.2% 99.7% 98.9% |
|TERMINAL (d) | 29/38 (76%) 32/36 (89%) 33/37 (89%) 30/35 (86%) |31/31 (100%) 18/18 (100%) 18/18 (100%) 2/2 (100%) |
|FIRST INCIDENCE | 430 488 326 459 |178 477 465 379 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.109 P=0.229 P=0.148 P=0.130 |P<0.001 ** P=0.002 ** P=0.002 ** P<0.001 ** |
|POLY 3 | P=0.123 P=0.257 P=0.093 P=0.161 |P=0.149 P=0.551 P=0.205 P=0.323 |
|POLY 1.5 | P=0.127 P=0.274 P=0.089 P=0.167 |P=0.165 P=0.523 P=0.216 P=0.312 |
|POLY 6 | P=0.135 P=0.225 P=0.100 P=0.167 |P=0.147 P=0.627 P=0.272 P=0.383 |
|LOGISTIC REGRESSION| P=0.143 P=0.303 P=0.111 P=0.195 |P=0.143 P=0.462 P=0.253 P=0.255 |
|COCH-ARM / FISHERS | P=0.171 P=0.288 P=0.133 P=0.204 |P=0.204 P=0.500 P=0.309 P=0.316 |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 7/50 (14%) 5/49 (10%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 2.6% 17.5% 14.6% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 1/18 (6%) 4/18 (22%) 1/2 (50%) |
|FIRST INCIDENCE | --- --- --- --- |--- 731 (T) 659 676 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P<0.001 ** P=0.392 P<0.001 ** P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) |P=0.003 ** P=0.471 P=0.004 ** P=0.014 * |
|POLY 1.5 | (e) (e) (e) (e) |P=0.006 ** P=0.485 P=0.006 ** P=0.020 * |
|POLY 6 | (e) (e) (e) (e) |P<0.001 ** P=0.450 P=0.003 ** P=0.008 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P<0.001 ** P=0.392 P=0.005 ** P=0.003 ** |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.013 * P=0.500 P=0.006 ** P=0.027 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/49 (29%) 26/49 (53%) 33/50 (66%) 35/50 (70%) |18/50 (36%) 47/50 (94%) 46/48 (96%) 50/50 (100%) |
|POLY-3 ADJUSTED (b)| 29.9% 54.7% 71.2% 74.7% |37.5% 96.0% 97.1% 100.0% |
|TERMINAL (d) | 8/38 (21%) 18/36 (50%) 27/37 (73%) 25/35 (71%) |4/31 (13%) 17/18 (94%) 18/18 (100%) 2/2 (100%) |
|FIRST INCIDENCE | 477 488 326 512 |564 477 465 379 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.023 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |10/50 (20%) 6/50 (12%) 3/48 (6%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |22.2% 15.6% 7.7% 8.4% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |9/31 (29%) 5/18 (28%) 2/18 (11%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- --- |630 720 637 505 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.533 P=0.609 P=0.183N P=0.411 |
|POLY 3 | (e) (e) (e) (e) |P=0.033N* P=0.311N P=0.060N P=0.083N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.025N* P=0.257N P=0.050N P=0.055N |
|POLY 6 | (e) (e) (e) (e) |P=0.050N P=0.401N P=0.076N P=0.149N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.079N P=0.522N P=0.087N P=0.076N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.020N* P=0.207N P=0.042N* P=0.036N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/47 (0%) 2/47 (4%) 0/46 (0%) 0/44 (0%) |
|POLY-3 ADJUSTED (b)| |0.0% 5.5% 0.0% 0.0% |
|TERMINAL (d) | |0/30 (0%) 0/17 (0%) 0/17 (0%) 0/0 (0%) |
|FIRST INCIDENCE | |--- 604 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.449N P=0.202 (e) (e) |
|POLY 3 | |P=0.480N P=0.207 (e) (e) |
|POLY 1.5 | |P=0.448N P=0.221 (e) (e) |
|POLY 6 | |P=0.526N P=0.188 (e) (e) |
|LOGISTIC REGRESSION| |P=0.389N P=0.252 (e) (e) |
|COCH-ARM / FISHERS | |P=0.415N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Epididymis |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 2.3% 2.2% 0.0% 4.6% | |
|TERMINAL (d) | 1/38 (3%) 1/36 (3%) 0/37 (0%) 2/35 (6%) | |
|FIRST INCIDENCE | 730 (T) 730 (T) --- 730 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347 P=0.750 P=0.505N P=0.471 | |
|POLY 3 | P=0.362 P=0.749N P=0.500N P=0.499 | |
|POLY 1.5 | P=0.365 P=0.751N P=0.500N P=0.502 | |
|POLY 6 | P=0.359 P=0.748N P=0.500N P=0.495 | |
|LOGISTIC REGRESSION| P=0.347 P=0.750 (e) P=0.471 | |
|COCH-ARM / FISHERS | P=0.371 P=0.747N P=0.495N P=0.508 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/48 (0%) 0/44 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 1/36 (3%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- 730 (T) --- 459 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.135 P=0.489 (e) P=0.240 |(e) (e) (e) (e) |
|POLY 3 | P=0.142 P=0.511 (e) P=0.243 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.142 P=0.509 (e) P=0.242 |(e) (e) (e) (e) |
|POLY 6 | P=0.142 P=0.511 (e) P=0.243 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.156 P=0.489 (e) P=0.304 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.142 P=0.505 (e) P=0.253 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 1/48 (2%) 0/44 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 0.0% 2.3% |4.5% 2.6% 2.6% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- 546 --- 561 |663 664 582 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.405 P=0.517 (e) P=0.504 |P=0.281N P=0.667N P=0.614N P=0.540N |
|POLY 3 | P=0.407 P=0.513 (e) P=0.502 |P=0.206N P=0.551N P=0.557N P=0.330N |
|POLY 1.5 | P=0.408 P=0.510 (e) P=0.503 |P=0.190N P=0.526N P=0.538N P=0.298N |
|POLY 6 | P=0.406 P=0.515 (e) P=0.501 |P=0.233N P=0.586N P=0.582N P=0.382N |
|LOGISTIC REGRESSION| P=0.446 P=0.340 (e) P=0.555 |P=0.161N P=0.513N P=0.491N P=0.322N |
|COCH-ARM / FISHERS | P=0.410 P=0.505 (e) P=0.505 |P=0.174N P=0.500N P=0.515N P=0.280N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 3/50 (6%) 6/48 (13%) 9/44 (20%) |
|POLY-3 ADJUSTED (b)| 2.3% 2.2% 0.0% 4.6% |2.2% 7.7% 15.5% 27.7% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 1/35 (3%) |0/31 (0%) 0/18 (0%) 2/18 (11%) 1/2 (50%) |
|FIRST INCIDENCE | 670 670 --- 579 |663 627 582 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.351 P=0.746N P=0.505N P=0.488 |P<0.001 ** P=0.183 P=0.020 * P<0.001 ** |
|POLY 3 | P=0.363 P=0.749N P=0.501N P=0.501 |P<0.001 ** P=0.258 P=0.035 * P<0.001 ** |
|POLY 1.5 | P=0.366 P=0.751N P=0.501N P=0.503 |P<0.001 ** P=0.280 P=0.041 * P=0.002 ** |
|POLY 6 | P=0.361 P=0.748N P=0.502N P=0.498 |P<0.001 ** P=0.227 P=0.028 * P<0.001 ** |
|LOGISTIC REGRESSION| P=0.383 P=0.748 P=0.491N P=0.520 |P<0.001 ** P=0.314 P=0.050 P=0.003 ** |
|COCH-ARM / FISHERS | P=0.371 P=0.747N P=0.495N P=0.508 |P<0.001 ** P=0.309 P=0.050 P=0.004 ** |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 32/49 (65%) 26/49 (53%) 18/50 (36%) 17/50 (34%) |8/49 (16%) 3/50 (6%) 1/46 (2%) 2/47 (4%) |
|POLY-3 ADJUSTED (b)| 68.1% 53.1% 37.1% 35.7% |18.0% 7.5% 2.7% 6.0% |
|TERMINAL (d) | 25/38 (66%) 13/36 (36%) 7/37 (19%) 6/35 (17%) |7/31 (23%) 0/18 (0%) 1/18 (6%) 0/2 (0%) |
|FIRST INCIDENCE | 430 488 326 459 |670 582 731 (T) 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.011N* P=0.222N P=0.018N* P=0.018N* |P=0.274N P=0.292N P=0.085N P=0.525 |
|POLY 3 | P<0.001N** P=0.095N P=0.002N** P<0.001N** |P=0.037N* P=0.134N P=0.030N* P=0.114N |
|POLY 1.5 | P<0.001N** P=0.115N P=0.002N** P<0.001N** |P=0.032N* P=0.112N P=0.025N* P=0.080N |
|POLY 6 | P<0.001N** P=0.077N P<0.001N** P<0.001N** |P=0.047N* P=0.170N P=0.040N* P=0.187N |
|LOGISTIC REGRESSION| P<0.001N** P=0.184N P=0.002N** P<0.001N** |P=0.043N* P=0.104N P=0.053N P=0.247N |
|COCH-ARM / FISHERS | P<0.001N** P=0.152N P=0.003N** P=0.002N** |P=0.030N* P=0.094N P=0.019N* P=0.053N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.2% 7.6% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- --- |695 578 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.281N P=0.215 P=0.570N P=0.759N |
|POLY 3 | (e) (e) (e) (e) |P=0.204N P=0.261 P=0.526N P=0.556N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.178N P=0.282 P=0.514N P=0.531N |
|POLY 6 | (e) (e) (e) (e) |P=0.248N P=0.232 P=0.542N P=0.594N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.136N P=0.332 P=0.517N P=0.585N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.154N P=0.309 P=0.500N P=0.505N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 5.8% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 592 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.040 * (e) (e) P=0.202 |
|POLY 3 | (e) (e) (e) (e) |P=0.037 * (e) (e) P=0.185 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.040 * (e) (e) P=0.207 |
|POLY 6 | (e) (e) (e) (e) |P=0.034 * (e) (e) P=0.155 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.058 (e) (e) P=0.279 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.242 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 29/49 (59%) 32/50 (64%) 27/50 (54%) 40/50 (80%) |28/50 (56%) 29/50 (58%) 29/50 (58%) 23/49 (47%) |
|POLY-3 ADJUSTED (b)| 64.2% 67.4% 60.1% 85.7% |59.8% 65.7% 64.1% 56.3% |
|TERMINAL (d) | 25/38 (66%) 27/36 (75%) 23/37 (62%) 31/35 (89%) |21/31 (68%) 14/18 (78%) 12/18 (67%) 0/2 (0%) |
|FIRST INCIDENCE | 537 546 486 459 |178 477 465 505 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.008 ** P=0.270 P=0.471N P=0.008 ** |P<0.001 ** P=0.013 * P=0.022 * P<0.001 ** |
|POLY 3 | P=0.012 * P=0.458 P=0.425N P=0.011 * |P=0.361N P=0.351 P=0.415 P=0.452N |
|POLY 1.5 | P=0.014 * P=0.435 P=0.424N P=0.013 * |P=0.275N P=0.417 P=0.444 P=0.355N |
|POLY 6 | P=0.011 * P=0.463 P=0.430N P=0.010 * |P=0.496N P=0.266 P=0.394 P=0.593 |
|LOGISTIC REGRESSION| P=0.010 * P=0.479 P=0.418N P=0.011 * |P=0.252N P=0.418 P=0.467 P=0.313N |
|COCH-ARM / FISHERS | P=0.023 * P=0.387 P=0.376N P=0.021 * |P=0.179N P=0.500 P=0.500 P=0.242N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 2.3% 6.5% 0.0% 2.3% |4.5% 2.6% 0.0% 3.0% |
|TERMINAL (d) | 1/38 (3%) 2/36 (6%) 0/37 (0%) 1/35 (3%) |2/31 (7%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 730 (T) 655 --- 730 (T) |731 (T) 658 --- 717 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.427N P=0.301 P=0.505N P=0.743 |P=0.574 P=0.668N P=0.364N P=0.339 |
|POLY 3 | P=0.407N P=0.327 P=0.500N P=0.760 |P=0.386N P=0.549N P=0.267N P=0.596N |
|POLY 1.5 | P=0.405N P=0.322 P=0.500N P=0.759N |P=0.380N P=0.525N P=0.253N P=0.554N |
|POLY 6 | P=0.409N P=0.329 P=0.500N P=0.758 |P=0.392N P=0.582N P=0.286N P=0.660N |
|LOGISTIC REGRESSION| P=0.414N P=0.322 (e) P=0.743 |P=0.539N P=0.580N (e) P=0.544 |
|COCH-ARM / FISHERS | P=0.401N P=0.316 P=0.495N P=0.747N |P=0.372N P=0.500N P=0.247N P=0.508N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 3/50 (6%) 4/50 (8%) |1/50 (2%) 3/50 (6%) 2/50 (4%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 6.8% 9.0% |2.2% 7.7% 5.0% 5.8% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 2/37 (5%) 2/35 (6%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- 694 572 561 |728 629 582 592 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.023 * P=0.510 P=0.123 P=0.062 |P=0.208 P=0.171 P=0.377 P=0.233 |
|POLY 3 | P=0.025 * P=0.511 P=0.120 P=0.063 |P=0.370 P=0.260 P=0.459 P=0.411 |
|POLY 1.5 | P=0.025 * P=0.509 P=0.119 P=0.063 |P=0.428 P=0.281 P=0.478 P=0.450 |
|POLY 6 | P=0.025 * P=0.512 P=0.121 P=0.063 |P=0.284 P=0.231 P=0.435 P=0.352 |
|LOGISTIC REGRESSION| P=0.029 * P=0.501 P=0.125 P=0.071 |P=0.510 P=0.290 P=0.501 P=0.527 |
|COCH-ARM / FISHERS | P=0.026 * P=0.505 P=0.125 P=0.061 |P=0.492 P=0.309 P=0.500 P=0.492 |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 43/49 (88%) 45/50 (90%) 45/50 (90%) 48/50 (96%) |10/50 (20%) 13/50 (26%) 9/50 (18%) 10/49 (20%) |
|POLY-3 ADJUSTED (b)| 92.6% 92.4% 95.1% 97.7% |22.3% 31.7% 22.2% 27.6% |
|TERMINAL (d) | 38/38 (100%) 35/36 (97%) 36/37 (97%) 35/35 (100%)|9/31 (29%) 6/18 (33%) 5/18 (28%) 2/2 (100%) |
|FIRST INCIDENCE | 430 488 326 339 |665 477 465 518 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.048 * P=0.270 P=0.306 P=0.049 * |P=0.002 ** P=0.044 * P=0.261 P<0.001 ** |
|POLY 3 | P=0.108 P=0.659N P=0.463 P=0.196 |P=0.438 P=0.227 P=0.600N P=0.384 |
|POLY 1.5 | P=0.094 P=0.593 P=0.411 P=0.154 |P=0.537 P=0.272 P=0.553N P=0.478 |
|POLY 6 | P=0.154 P=0.587N P=0.593 P=0.317 |P=0.291 P=0.168 P=0.546 P=0.251 |
|LOGISTIC REGRESSION| P=0.042 * P=0.585N P=0.336 P=0.082 |P=0.458 P=0.216 P=0.553 P=0.292 |
|COCH-ARM / FISHERS | P=0.100 P=0.486 P=0.486 P=0.128 |P=0.450N P=0.318 P=0.500N P=0.579 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 0.0% 0.0% |0.0% 5.1% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 1/36 (3%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 1/18 (6%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- 730 (T) --- --- |--- 632 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.575N P=0.489 (e) (e) |P=0.616N P=0.152 (e) (e) |
|POLY 3 | P=0.561N P=0.511 (e) (e) |P=0.472N P=0.207 (e) (e) |
|POLY 1.5 | P=0.562N P=0.509 (e) (e) |P=0.440N P=0.222 (e) (e) |
|POLY 6 | P=0.561N P=0.511 (e) (e) |P=0.517N P=0.188 (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.489 (e) (e) |P=0.434N P=0.229 (e) (e) |
|COCH-ARM / FISHERS | P=0.562N P=0.505 (e) (e) |P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Cortex |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/49 (20%) 27/50 (54%) 20/50 (40%) 14/50 (28%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 22.7% 56.5% 45.6% 31.1% |0.0% 2.6% 0.0% 5.9% |
|TERMINAL (d) | 8/38 (21%) 23/36 (64%) 19/37 (51%) 11/35 (31%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 540 488 575 339 |--- 721 --- 676 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.497 P<0.001 ** P=0.019 * P=0.193 |P=0.026 * P=0.406 (e) P=0.076 |
|POLY 3 | P=0.484N P<0.001 ** P=0.018 * P=0.253 |P=0.105 P=0.471 (e) P=0.182 |
|POLY 1.5 | P=0.473N P<0.001 ** P=0.019 * P=0.257 |P=0.119 P=0.485 (e) P=0.205 |
|POLY 6 | P=0.501N P<0.001 ** P=0.016 * P=0.246 |P=0.087 P=0.450 (e) P=0.150 |
|LOGISTIC REGRESSION| P=0.504N P<0.001 ** P=0.022 * P=0.254 |P=0.066 P=0.424 (e) P=0.135 |
|COCH-ARM / FISHERS | P=0.460N P<0.001 ** P=0.028 * P=0.259 |P=0.137 P=0.500 (e) P=0.242 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.3% |0.0% 0.0% 5.1% 5.9% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 0/18 (0%) 1/18 (6%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- 554 |--- --- 704 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.198 (e) (e) P=0.504 |P=0.006 ** (e) P=0.150 P=0.066 |
|POLY 3 | P=0.197 (e) (e) P=0.502 |P=0.052 (e) P=0.210 P=0.182 |
|POLY 1.5 | P=0.198 (e) (e) P=0.503 |P=0.065 (e) P=0.222 P=0.205 |
|POLY 6 | P=0.196 (e) (e) P=0.501 |P=0.036 * (e) P=0.195 P=0.151 |
|LOGISTIC REGRESSION| P=0.205 (e) (e) P=0.559 |P=0.033 * (e) P=0.179 P=0.167 |
|COCH-ARM / FISHERS | P=0.199 (e) (e) P=0.505 |P=0.082 (e) P=0.247 P=0.242 |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/49 (10%) 3/50 (6%) 1/50 (2%) 3/50 (6%) |5/50 (10%) 2/50 (4%) 0/49 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 11.2% 6.5% 2.3% 6.9% |11.2% 5.1% 0.0% 8.6% |
|TERMINAL (d) | 3/38 (8%) 2/36 (6%) 1/37 (3%) 3/35 (9%) |4/31 (13%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 554 593 730 (T) 730 (T) |717 596 --- 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.301N P=0.354N P=0.110N P=0.391N |P=0.320 P=0.430N P=0.096N P=0.086 |
|POLY 3 | P=0.285N P=0.335N P=0.107N P=0.371N |P=0.316N P=0.274N P=0.043N* P=0.496N |
|POLY 1.5 | P=0.279N P=0.338N P=0.105N P=0.361N |P=0.305N P=0.245N P=0.038N* P=0.428N |
|POLY 6 | P=0.292N P=0.337N P=0.110N P=0.384N |P=0.332N P=0.320N P=0.052N P=0.605N |
|LOGISTIC REGRESSION| P=0.266N P=0.393N P=0.094N P=0.345N |P=0.483N P=0.317N P=0.072N P=0.508 |
|COCH-ARM / FISHERS | P=0.266N P=0.346N P=0.098N P=0.346N |P=0.294N P=0.218N P=0.030N* P=0.357N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/49 (33%) 8/50 (16%) 2/50 (4%) 6/50 (12%) |1/50 (2%) 2/50 (4%) 0/49 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 36.9% 17.0% 4.6% 13.8% |2.2% 5.1% 0.0% 2.9% |
|TERMINAL (d) | 16/38 (42%) 6/36 (17%) 2/37 (5%) 5/35 (14%) |1/31 (3%) 1/18 (6%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 730 (T) 488 730 (T) 705 |731 (T) 519 --- 634 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009N** P=0.061N P<0.001N** P=0.022N* |P=0.514 P=0.371 P=0.608N P=0.475 |
|POLY 3 | P=0.006N** P=0.027N* P<0.001N** P=0.011N* |P=0.545N P=0.454 P=0.526N P=0.702 |
|POLY 1.5 | P=0.005N** P=0.032N* P<0.001N** P=0.011N* |P=0.523N P=0.477 P=0.516N P=0.731 |
|POLY 6 | P=0.006N** P=0.023N* P<0.001N** P=0.011N* |P=0.574N P=0.421 P=0.541N P=0.652 |
|LOGISTIC REGRESSION| P=0.007N** P=0.035N* P<0.001N** P=0.015N* |P=0.474N P=0.522 (e) P=0.746 |
|COCH-ARM / FISHERS | P=0.006N** P=0.044N* P<0.001N** P=0.012N* |P=0.499N P=0.500 P=0.505N P=0.753N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/49 (20%) 20/50 (40%) 25/50 (50%) 19/50 (38%) |5/50 (10%) 9/50 (18%) 4/49 (8%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 23.0% 43.2% 55.3% 42.1% |11.1% 22.6% 9.9% 23.7% |
|TERMINAL (d) | 10/38 (26%) 19/36 (53%) 21/37 (57%) 15/35 (43%) |4/31 (13%) 6/18 (33%) 1/18 (6%) 1/2 (50%) |
|FIRST INCIDENCE | 730 (T) 593 486 459 |652 493 590 379 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.034 * P=0.013 * P<0.001 ** P=0.023 * |P=0.004 ** P=0.034 * P=0.538 P=0.002 ** |
|POLY 3 | P=0.065 P=0.033 * P<0.001 ** P=0.043 * |P=0.157 P=0.129 P=0.568N P=0.108 |
|POLY 1.5 | P=0.064 P=0.031 * P<0.001 ** P=0.042 * |P=0.202 P=0.159 P=0.541N P=0.146 |
|POLY 6 | P=0.068 P=0.033 * P<0.001 ** P=0.044 * |P=0.098 P=0.092 P=0.604N P=0.061 |
|LOGISTIC REGRESSION| P=0.049 * P=0.029 * P<0.001 ** P=0.037 * |P=0.289 P=0.125 P=0.515N P=0.266 |
|COCH-ARM / FISHERS | P=0.071 P=0.028 * P=0.002 ** P=0.044 * |P=0.254 P=0.194 P=0.513N P=0.194 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 4/50 (8%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 3/49 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 8.7% 2.3% 0.0% |2.2% 5.1% 7.5% 0.0% |
|TERMINAL (d) | 0/38 (0%) 3/36 (8%) 1/37 (3%) 0/35 (0%) |0/31 (0%) 1/18 (6%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 430 614 730 (T) --- |632 633 521 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.175N P=0.182 P=0.753 P=0.504N |P=0.562N P=0.367 P=0.233 P=0.581N |
|POLY 3 | P=0.167N P=0.192 P=0.756 P=0.504N |P=0.464N P=0.449 P=0.265 P=0.552N |
|POLY 1.5 | P=0.163N P=0.190 P=0.757 P=0.501N |P=0.401N P=0.474 P=0.281 P=0.527N |
|POLY 6 | P=0.171N P=0.193 P=0.755 P=0.507N |P=0.570N P=0.414 P=0.244 P=0.591N |
|LOGISTIC REGRESSION| P=0.145N P=0.122 P=0.713N P=0.313N |P=0.296N P=0.518 P=0.320 P=0.468N |
|COCH-ARM / FISHERS | P=0.157N P=0.187 P=0.747N P=0.495N |P=0.338N P=0.500 P=0.301 P=0.500N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 9/50 (18%) 7/50 (14%) 9/50 (18%) |4/50 (8%) 14/50 (28%) 23/49 (47%) 24/50 (48%) |
|POLY-3 ADJUSTED (b)| 6.8% 19.7% 15.6% 20.0% |8.9% 34.1% 53.2% 58.8% |
|TERMINAL (d) | 1/38 (3%) 9/36 (25%) 5/37 (14%) 5/35 (14%) |2/31 (7%) 4/18 (22%) 10/18 (56%) 2/2 (100%) |
|FIRST INCIDENCE | 570 730 (T) 326 459 |673 582 484 505 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.093 P=0.057 P=0.163 P=0.061 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.107 P=0.066 P=0.160 P=0.062 |P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.109 P=0.067 P=0.160 P=0.063 |P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.105 P=0.063 P=0.159 P=0.060 |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.122 P=0.070 P=0.194 P=0.073 |P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.115 P=0.065 P=0.167 P=0.065 |P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/49 (12%) 5/50 (10%) 12/50 (24%) 10/50 (20%) |23/50 (46%) 18/50 (36%) 21/49 (43%) 19/50 (38%) |
|POLY-3 ADJUSTED (b)| 13.8% 10.7% 27.2% 22.9% |50.3% 44.6% 48.5% 47.9% |
|TERMINAL (d) | 6/38 (16%) 3/36 (8%) 11/37 (30%) 8/35 (23%) |19/31 (61%) 14/18 (78%) 10/18 (56%) 1/2 (50%) |
|FIRST INCIDENCE | 730 (T) 546 486 604 |632 477 465 505 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.070 P=0.522N P=0.084 P=0.163 |P<0.001 ** P=0.178 P=0.108 P<0.001 ** |
|POLY 3 | P=0.080 P=0.451N P=0.097 P=0.208 |P=0.498N P=0.374N P=0.518N P=0.501N |
|POLY 1.5 | P=0.085 P=0.464N P=0.096 P=0.211 |P=0.410N P=0.280N P=0.479N P=0.381N |
|POLY 6 | P=0.075 P=0.443N P=0.098 P=0.203 |P=0.435 P=0.541N P=0.577N P=0.496 |
|LOGISTIC REGRESSION| P=0.083 P=0.468N P=0.093 P=0.192 |P=0.457 P=0.580 P=0.546N P=0.541 |
|COCH-ARM / FISHERS | P=0.099 P=0.486N P=0.104 P=0.220 |P=0.327N P=0.208N P=0.455N P=0.272N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/49 (37%) 21/50 (42%) 28/50 (56%) 28/50 (56%) |24/50 (48%) 25/50 (50%) 16/49 (33%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 38.6% 45.0% 62.3% 62.9% |51.0% 58.3% 38.6% 25.9% |
|TERMINAL (d) | 13/38 (34%) 19/36 (53%) 24/37 (65%) 24/35 (69%) |18/31 (58%) 14/18 (78%) 8/18 (44%) 1/2 (50%) |
|FIRST INCIDENCE | 430 488 572 569 |178 477 521 450 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** P=0.295 P=0.037 * P=0.022 * |P=0.210 P=0.020 * P=0.533 P=0.115 |
|POLY 3 | P=0.005 ** P=0.338 P=0.017 * P=0.014 * |P=0.003N** P=0.308 P=0.165N P=0.013N* |
|POLY 1.5 | P=0.009 ** P=0.354 P=0.021 * P=0.021 * |P<0.001N** P=0.393 P=0.127N P=0.006N** |
|POLY 6 | P=0.003 ** P=0.309 P=0.015 * P=0.010 * |P=0.011N* P=0.201 P=0.224N P=0.040N* |
|LOGISTIC REGRESSION| P=0.014 * P=0.352 P=0.037 * P=0.038 * |P<0.001N** P=0.444 P=0.106N P<0.001N** |
|COCH-ARM / FISHERS | P=0.022 * P=0.371 P=0.042 * P=0.042 * |P<0.001N** P=0.500 P=0.088N P=0.003N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.5% 2.3% 0.0% |2.2% 5.1% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 2/36 (6%) 1/37 (3%) 0/35 (0%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- 655 730 (T) --- |632 658 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.380N P=0.122 P=0.495 (e) |P=0.264N P=0.370 P=0.539N P=0.581N |
|POLY 3 | P=0.364N P=0.130 P=0.500 (e) |P=0.226N P=0.451 P=0.528N P=0.552N |
|POLY 1.5 | P=0.362N P=0.127 P=0.500 (e) |P=0.207N P=0.474 P=0.516N P=0.527N |
|POLY 6 | P=0.367N P=0.131 P=0.500 (e) |P=0.256N P=0.417 P=0.544N P=0.591N |
|LOGISTIC REGRESSION| P=0.368N P=0.126 P=0.495 (e) |P=0.169N P=0.527 P=0.493N P=0.468N |
|COCH-ARM / FISHERS | P=0.358N P=0.125 P=0.505 (e) |P=0.188N P=0.500 P=0.505N P=0.500N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/49 (18%) 13/50 (26%) 9/50 (18%) 7/50 (14%) |7/50 (14%) 3/50 (6%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 20.5% 27.5% 20.8% 16.1% |15.6% 7.8% 0.0% 0.0% |
|TERMINAL (d) | 8/38 (21%) 10/36 (28%) 9/37 (24%) 6/35 (17%) |5/31 (16%) 2/18 (11%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 583 488 730 (T) 705 |665 721 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.262N P=0.220 P=0.582 P=0.455N |P=0.038N* P=0.446N P=0.044N* P=0.368N |
|POLY 3 | P=0.237N P=0.297 P=0.592 P=0.401N |P=0.002N** P=0.225N P=0.013N* P=0.020N* |
|POLY 1.5 | P=0.224N P=0.281 P=0.596 P=0.391N |P<0.001N** P=0.190N P=0.010N* P=0.013N* |
|POLY 6 | P=0.252N P=0.308 P=0.587 P=0.414N |P=0.002N** P=0.283N P=0.017N* P=0.042N* |
|LOGISTIC REGRESSION| P=0.226N P=0.256 P=0.603 P=0.401N |P=0.011N* P=0.356N P=0.022N* P=0.096N |
|COCH-ARM / FISHERS | P=0.201N P=0.251 P=0.584N P=0.376N |P=0.002N** P=0.159N P=0.007N** P=0.006N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 5/50 (10%) 6/50 (12%) 5/50 (10%) |0/50 (0%) 11/50 (22%) 24/49 (49%) 19/50 (38%) |
|POLY-3 ADJUSTED (b)| 6.7% 10.8% 13.7% 11.4% |0.0% 27.3% 57.5% 48.8% |
|TERMINAL (d) | 1/38 (3%) 4/36 (11%) 4/37 (11%) 3/35 (9%) |0/31 (0%) 5/18 (28%) 12/18 (67%) 2/2 (100%) |
|FIRST INCIDENCE | 430 488 614 569 |--- 605 484 505 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.297 P=0.350 P=0.244 P=0.334 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.302 P=0.378 P=0.231 P=0.346 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.314 P=0.375 P=0.234 P=0.354 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.293 P=0.376 P=0.229 P=0.339 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.351 P=0.247 P=0.268 P=0.394 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.337 P=0.369 P=0.254 P=0.369 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Tension Lipidosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 0.0% 0.0% |4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 1/36 (3%) 0/37 (0%) 0/35 (0%) |2/31 (7%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- 730 (T) --- --- |731 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.575N P=0.489 (e) (e) |P=0.283N P=0.364N P=0.364N P=0.873N |
|POLY 3 | P=0.561N P=0.511 (e) (e) |P=0.101N P=0.271N P=0.268N P=0.299N |
|POLY 1.5 | P=0.562N P=0.509 (e) (e) |P=0.107N P=0.254N P=0.255N P=0.268N |
|POLY 6 | P=0.561N P=0.511 (e) (e) |P=0.091N P=0.298N P=0.286N P=0.353N |
|LOGISTIC REGRESSION| (e) P=0.489 (e) (e) |P=0.283N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.562N P=0.505 (e) (e) |P=0.117N P=0.247N P=0.253N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 6/49 (12%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 2.3% 0.0% |2.2% 2.6% 15.3% 8.4% |
|TERMINAL (d) | 0/38 (0%) 1/36 (3%) 1/37 (3%) 0/35 (0%) |1/31 (3%) 1/18 (6%) 3/18 (17%) 0/2 (0%) |
|FIRST INCIDENCE | --- 730 (T) 730 (T) --- |731 (T) 731 (T) 714 379 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.608N P=0.489 P=0.495 (e) |P<0.001 ** P=0.636 P=0.012 * P=0.029 * |
|POLY 3 | P=0.596N P=0.511 P=0.500 (e) |P=0.082 P=0.727 P=0.037 * P=0.229 |
|POLY 1.5 | P=0.594N P=0.509 P=0.500 (e) |P=0.115 P=0.744 P=0.044 * P=0.265 |
|POLY 6 | P=0.599N P=0.511 P=0.500 (e) |P=0.043 * P=0.701 P=0.028 * P=0.178 |
|LOGISTIC REGRESSION| (e) P=0.489 P=0.495 (e) |P=0.077 P=0.636 P=0.015 * P=0.368 |
|COCH-ARM / FISHERS | P=0.590N P=0.505 P=0.505 (e) |P=0.159 P=0.753N P=0.053 P=0.309 |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 11/49 (22%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 0.0% 2.3% |2.2% 2.6% 27.1% 24.3% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |1/31 (3%) 1/18 (6%) 6/18 (33%) 1/2 (50%) |
|FIRST INCIDENCE | --- 614 --- 660 |731 (T) 731 (T) 597 518 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.398 P=0.528 (e) P=0.500 |P<0.001 ** P=0.636 P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.405 P=0.512 (e) P=0.501 |P<0.001 ** P=0.727 P<0.001 ** P=0.003 ** |
|POLY 1.5 | P=0.407 P=0.510 (e) P=0.502 |P<0.001 ** P=0.744 P<0.001 ** P=0.005 ** |
|POLY 6 | P=0.403 P=0.514 (e) P=0.499 |P<0.001 ** P=0.701 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.425 P=0.429 (e) P=0.512 |P<0.001 ** P=0.636 P<0.001 ** P=0.010 * |
|COCH-ARM / FISHERS | P=0.410 P=0.505 (e) P=0.505 |P<0.001 ** P=0.753N P=0.002 ** P=0.008 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/49 (16%) 14/50 (28%) 8/50 (16%) 10/50 (20%) |5/50 (10%) 9/50 (18%) 16/49 (33%) 17/50 (34%) |
|POLY-3 ADJUSTED (b)| 17.3% 28.8% 17.6% 22.6% |11.0% 21.6% 37.2% 42.3% |
|TERMINAL (d) | 3/38 (8%) 5/36 (14%) 4/37 (11%) 7/35 (20%) |2/31 (7%) 1/18 (6%) 3/18 (17%) 0/2 (0%) |
|FIRST INCIDENCE | 430 488 522 512 |632 493 465 450 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.497 P=0.148 P=0.587 P=0.358 |P<0.001 ** P=0.077 P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.486 P=0.141 P=0.594 P=0.359 |P<0.001 ** P=0.145 P=0.003 ** P<0.001 ** |
|POLY 1.5 | P=0.514 P=0.134 P=0.597 P=0.380 |P<0.001 ** P=0.168 P=0.004 ** P<0.001 ** |
|POLY 6 | P=0.458 P=0.147 P=0.594 P=0.337 |P<0.001 ** P=0.115 P=0.002 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.474N P=0.041 * P=0.513N P=0.444 |P=0.006 ** P=0.256 P=0.008 ** P=0.008 ** |
|COCH-ARM / FISHERS | P=0.528N P=0.124 P=0.590N P=0.416 |P=0.002 ** P=0.194 P=0.005 ** P=0.004 ** |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 7/50 (14%) 2/50 (4%) 13/50 (26%) |20/50 (40%) 14/50 (28%) 11/49 (22%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 15.8% 14.8% 4.6% 29.6% |42.5% 33.6% 25.5% 30.7% |
|TERMINAL (d) | 6/38 (16%) 3/36 (8%) 2/37 (5%) 12/35 (34%) |13/31 (42%) 7/18 (39%) 2/18 (11%) 0/2 (0%) |
|FIRST INCIDENCE | 430 488 730 (T) 512 |178 477 465 505 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.050 P=0.600 P=0.089N P=0.074 |P=0.155 P=0.484 P=0.321N P=0.046 * |
|POLY 3 | P=0.051 P=0.561N P=0.083N P=0.097 |P=0.117N P=0.258N P=0.066N P=0.179N |
|POLY 1.5 | P=0.055 P=0.575N P=0.082N P=0.103 |P=0.088N P=0.201N P=0.057N P=0.117N |
|POLY 6 | P=0.047 * P=0.549N P=0.083N P=0.091 |P=0.178N P=0.359N P=0.080N P=0.311N |
|LOGISTIC REGRESSION| P=0.064 P=0.574 P=0.079N P=0.107 |P=0.023N* P=0.121N P=0.020N* P=0.035N* |
|COCH-ARM / FISHERS | P=0.068 P=0.597N P=0.075N P=0.115 |P=0.061N P=0.146N P=0.047N* P=0.066N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte, Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- 554 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.046 * (e) (e) P=0.242 |(e) (e) (e) (e) |
|POLY 3 | P=0.045 * (e) (e) P=0.241 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.045 * (e) (e) P=0.241 |(e) (e) (e) (e) |
|POLY 6 | P=0.045 * (e) (e) P=0.241 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.049 * (e) (e) P=0.267 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.047 * (e) (e) P=0.253 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Oval Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 8/50 (16%) 27/50 (54%) 46/50 (92%) |0/50 (0%) 46/50 (92%) 36/49 (73%) 38/50 (76%) |
|POLY-3 ADJUSTED (b)| 0.0% 17.2% 58.1% 96.2% |0.0% 94.3% 76.0% 80.5% |
|TERMINAL (d) | 0/38 (0%) 4/36 (11%) 19/37 (51%) 34/35 (97%) |0/31 (0%) 17/18 (94%) 11/18 (61%) 1/2 (50%) |
|FIRST INCIDENCE | --- 670 486 512 |--- 477 465 379 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Portal |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 7/50 (14%) 46/50 (92%) |0/50 (0%) 10/50 (20%) 7/49 (14%) 23/50 (46%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 15.8% 95.5% |0.0% 24.6% 16.9% 54.4% |
|TERMINAL (d) | 0/38 (0%) 1/36 (3%) 4/37 (11%) 34/35 (97%) |0/31 (0%) 4/18 (22%) 1/18 (6%) 1/2 (50%) |
|FIRST INCIDENCE | --- 730 (T) 575 512 |--- 516 465 379 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.489 P=0.011 * P<0.001 ** |P<0.001 ** P<0.001 ** P=0.004 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.511 P=0.008 ** P<0.001 ** |P<0.001 ** P<0.001 ** P=0.005 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.509 P=0.008 ** P<0.001 ** |P<0.001 ** P<0.001 ** P=0.006 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.511 P=0.008 ** P<0.001 ** |P<0.001 ** P<0.001 ** P=0.004 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.489 P=0.010 * P<0.001 ** |P<0.001 ** P=0.002 ** P=0.010 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.505 P=0.007 ** P<0.001 ** |P<0.001 ** P<0.001 ** P=0.006 ** P<0.001 ** |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/48 (0%) 2/45 (4%) |
|POLY-3 ADJUSTED (b)| 4.6% 4.4% 0.0% 0.0% |0.0% 2.6% 0.0% 6.3% |
|TERMINAL (d) | 2/38 (5%) 2/36 (6%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 730 (T) 730 (T) --- --- |--- 596 --- 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.093N P=0.676 P=0.244N P=0.257N |P=0.102 P=0.473 (e) P=0.148 |
|POLY 3 | P=0.086N P=0.675N P=0.237N P=0.238N |P=0.095 P=0.473 (e) P=0.168 |
|POLY 1.5 | P=0.085N P=0.678N P=0.238N P=0.236N |P=0.106 P=0.486 (e) P=0.189 |
|POLY 6 | P=0.086N P=0.674N P=0.237N P=0.240N |P=0.080 P=0.454 (e) P=0.141 |
|LOGISTIC REGRESSION| P=0.093N P=0.676 (e) (e) |P=0.138 P=0.507 (e) P=0.209 |
|COCH-ARM / FISHERS | P=0.083N P=0.684N P=0.242N P=0.242N |P=0.122 P=0.500 (e) P=0.222 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/48 (0%) 0/45 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.3% 0.0% 2.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 1/36 (3%) 0/37 (0%) 1/35 (3%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- 614 --- 730 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.526 P=0.249 (e) P=0.484 |(e) (e) (e) (e) |
|POLY 3 | P=0.540 P=0.251 (e) P=0.499 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.542 P=0.248 (e) P=0.501 |(e) (e) (e) (e) |
|POLY 6 | P=0.536 P=0.253 (e) P=0.497 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.546 P=0.218 (e) P=0.484 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.546 P=0.253 (e) P=0.505 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 6/50 (12%) 5/50 (10%) 5/50 (10%) |2/50 (4%) 1/50 (2%) 0/48 (0%) 0/45 (0%) |
|POLY-3 ADJUSTED (b)| 15.9% 13.1% 11.5% 11.4% |4.5% 2.6% 0.0% 0.0% |
|TERMINAL (d) | 6/38 (16%) 6/36 (17%) 5/37 (14%) 4/35 (11%) |2/31 (7%) 1/18 (6%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 554 730 (T) 730 (T) 554 |731 (T) 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.355N P=0.535N P=0.396N P=0.426N |P=0.338N P=0.687N P=0.364N P=0.873N |
|POLY 3 | P=0.324N P=0.468N P=0.389N P=0.380N |P=0.117N P=0.551N P=0.277N P=0.323N |
|POLY 1.5 | P=0.318N P=0.473N P=0.386N P=0.375N |P=0.114N P=0.526N P=0.263N P=0.293N |
|POLY 6 | P=0.330N P=0.472N P=0.393N P=0.388N |P=0.122N P=0.587N P=0.296N P=0.376N |
|LOGISTIC REGRESSION| P=0.328N P=0.458N P=0.379N P=0.373N |P=0.338N P=0.687N (e) (e) |
|COCH-ARM / FISHERS | P=0.302N P=0.484N P=0.365N P=0.365N |P=0.111N P=0.500N P=0.258N P=0.274N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 2/48 (4%) 4/45 (9%) |
|POLY-3 ADJUSTED (b)| 4.6% 2.2% 0.0% 4.6% |2.2% 2.6% 5.3% 12.6% |
|TERMINAL (d) | 1/38 (3%) 1/36 (3%) 0/37 (0%) 2/35 (6%) |1/31 (3%) 1/18 (6%) 1/18 (6%) 0/2 (0%) |
|FIRST INCIDENCE | 670 730 (T) --- 730 (T) |731 (T) 731 (T) 652 678 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.569 P=0.504N P=0.245N P=0.669 |P<0.001 ** P=0.636 P=0.347 P=0.003 ** |
|POLY 3 | P=0.584 P=0.483N P=0.239N P=0.691 |P=0.034 * P=0.727 P=0.443 P=0.092 |
|POLY 1.5 | P=0.587 P=0.486N P=0.238N P=0.693N |P=0.042 * P=0.744 P=0.462 P=0.116 |
|POLY 6 | P=0.581 P=0.484N P=0.239N P=0.686 |P=0.024 * P=0.701 P=0.419 P=0.064 |
|LOGISTIC REGRESSION| P=0.581 P=0.484N P=0.236N P=0.693 |P=0.012 * P=0.636 P=0.433 P=0.030 * |
|COCH-ARM / FISHERS | P=0.596 P=0.492N P=0.242N P=0.684N |P=0.054 P=0.753N P=0.485 P=0.150 |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/46 (0%) 2/47 (4%) 0/45 (0%) |1/49 (2%) 0/43 (0%) 0/41 (0%) 0/32 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.8% 0.0% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/34 (0%) 2/37 (5%) 0/34 (0%) |0/30 (0%) 0/18 (0%) 0/17 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- 730 (T) --- |652 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.578 (e) P=0.232 (e) |P=0.352N P=0.576N P=0.551N P=0.583N |
|POLY 3 | P=0.579 (e) P=0.229 (e) |P=0.318N P=0.551N P=0.561N P=0.634N |
|POLY 1.5 | P=0.580 (e) P=0.228 (e) |P=0.335N P=0.539N P=0.550N P=0.612N |
|POLY 6 | P=0.578 (e) P=0.232 (e) |P=0.285N P=0.567N P=0.574N P=0.665N |
|LOGISTIC REGRESSION| (e) (e) P=0.232 (e) |P=0.339N P=0.514N P=0.520N P=0.567N |
|COCH-ARM / FISHERS | P=0.583 (e) P=0.242 (e) |P=0.354N P=0.533N P=0.544N P=0.605N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |2/31 (7%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.283N P=0.364N P=0.364N P=0.873N |
|POLY 3 | (e) (e) (e) (e) |P=0.101N P=0.271N P=0.267N P=0.299N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.107N P=0.254N P=0.253N P=0.268N |
|POLY 6 | (e) (e) (e) (e) |P=0.092N P=0.298N P=0.286N P=0.353N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.283N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.116N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/46 (2%) 1/49 (2%) 0/50 (0%) |1/47 (2%) 2/48 (4%) 1/43 (2%) 0/36 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.4% 2.3% 0.0% |2.4% 5.3% 2.9% 0.0% |
|TERMINAL (d) | 0/38 (0%) 1/34 (3%) 1/37 (3%) 0/35 (0%) |1/29 (3%) 1/18 (6%) 1/17 (6%) 0/2 (0%) |
|FIRST INCIDENCE | --- 730 (T) 730 (T) --- |731 (T) 632 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.604N P=0.478 P=0.495 (e) |P=0.623N P=0.356 P=0.638 P=0.962N |
|POLY 3 | P=0.590N P=0.493 P=0.500 (e) |P=0.371N P=0.464 P=0.719 P=0.596N |
|POLY 1.5 | P=0.587N P=0.491 P=0.500 (e) |P=0.340N P=0.485 P=0.730 P=0.575N |
|POLY 6 | P=0.593N P=0.493 P=0.500 (e) |P=0.422N P=0.434 P=0.704 P=0.628N |
|LOGISTIC REGRESSION| (e) P=0.478 P=0.495 (e) |P=0.410N P=0.463 P=0.638 (e) |
|COCH-ARM / FISHERS | P=0.584N P=0.484 P=0.500 (e) |P=0.309N P=0.508 P=0.730 P=0.566N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/46 (0%) 1/49 (2%) 0/50 (0%) |0/47 (0%) 1/48 (2%) 1/43 (2%) 0/36 (0%) |
|POLY-3 ADJUSTED (b)| 4.5% 0.0% 2.3% 0.0% |0.0% 2.7% 2.9% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/34 (0%) 1/37 (3%) 0/35 (0%) |0/29 (0%) 1/18 (6%) 1/17 (6%) 0/2 (0%) |
|FIRST INCIDENCE | 570 --- 730 (T) --- |--- 731 (T) 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.199N P=0.218N P=0.500N P=0.245N |P=0.449 P=0.405 P=0.393 (e) |
|POLY 3 | P=0.190N P=0.250N P=0.509N P=0.243N |P=0.630 P=0.477 P=0.463 (e) |
|POLY 1.5 | P=0.188N P=0.250N P=0.505N P=0.239N |P=0.679 P=0.491 P=0.473 (e) |
|POLY 6 | P=0.191N P=0.252N P=0.513N P=0.248N |P=0.537 P=0.459 P=0.451 (e) |
|LOGISTIC REGRESSION| P=0.157N P=0.361N P=0.480N P=0.183N |(e) P=0.405 P=0.393 (e) |
|COCH-ARM / FISHERS | P=0.184N P=0.263N P=0.500N P=0.242N |P=0.655N P=0.505 P=0.478 (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/46 (0%) 2/49 (4%) 1/50 (2%) |0/47 (0%) 0/48 (0%) 0/43 (0%) 0/36 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.6% 2.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/34 (0%) 2/37 (5%) 0/35 (0%) |0/29 (0%) 0/18 (0%) 0/17 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- 730 (T) 660 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.237 (e) P=0.232 P=0.500 |(e) (e) (e) (e) |
|POLY 3 | P=0.245 (e) P=0.237 P=0.501 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.248 (e) P=0.237 P=0.502 |(e) (e) (e) (e) |
|POLY 6 | P=0.242 (e) P=0.237 P=0.499 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.249 (e) P=0.232 P=0.512 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.255 (e) P=0.247 P=0.505 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/46 (4%) 0/49 (0%) 1/50 (2%) |1/47 (2%) 1/48 (2%) 0/43 (0%) 0/36 (0%) |
|POLY-3 ADJUSTED (b)| 4.5% 4.7% 0.0% 2.3% |2.4% 2.6% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/34 (0%) 0/37 (0%) 0/35 (0%) |0/29 (0%) 0/18 (0%) 0/17 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 430 673 --- 339 |695 493 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.306N P=0.673N P=0.244N P=0.505N |P=0.316N P=0.709 P=0.570N P=0.759N |
|POLY 3 | P=0.292N P=0.674 P=0.244N P=0.504N |P=0.285N P=0.739 P=0.537N P=0.596N |
|POLY 1.5 | P=0.289N P=0.673 P=0.242N P=0.499N |P=0.280N P=0.752 P=0.528N P=0.575N |
|POLY 6 | P=0.295N P=0.674 P=0.246N P=0.511N |P=0.289N P=0.717 P=0.550N P=0.629N |
|LOGISTIC REGRESSION| P=0.165N P=0.522 P=0.148N P=0.324N |P=0.264N P=0.759N P=0.527N P=0.616N |
|COCH-ARM / FISHERS | P=0.285N P=0.667 P=0.247N P=0.492N |P=0.274N P=0.747N P=0.522N P=0.566N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 0/2 (0%) 1/1 (100%) 0/1 (0%) |6/13 (46%) 3/7 (43%) 1/3 (33%) 1/3 (33%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 100.0% 0.0% |48.6% 54.0% 49.4% 44.4% |
|TERMINAL (d) | 0/1 (0%) 0/2 (0%) 1/1 (100%) 0/0 (0%) |3/6 (50%) 1/1 (100%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 730 (T) --- |632 617 641 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.496 (e) P=0.500 (e) |P=0.397N P=0.548 P=0.422N P=0.579N |
|POLY 3 | P=1.000N (e) P=1.000 (e) |P=0.603N P=0.612 P=0.736 P=0.706N |
|POLY 1.5 | P=1.000N (e) P=1.000 (e) |P=0.523N P=0.662 P=0.687N P=0.654N |
|POLY 6 | P=1.000N (e) P=1.000 (e) |P=0.537 P=0.539 P=0.680 P=0.718 |
|LOGISTIC REGRESSION| (e) (e) P=0.250 (e) |P=0.614N P=0.667 P=0.803N P=0.591N |
|COCH-ARM / FISHERS | P=0.688 (e) P=0.500 (e) |P=0.429N P=0.630N P=0.600N P=0.600N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/49 (18%) 13/50 (26%) 11/50 (22%) 10/50 (20%) |8/50 (16%) 11/50 (22%) 13/49 (27%) 11/47 (23%) |
|POLY-3 ADJUSTED (b)| 20.2% 27.0% 24.0% 23.1% |17.4% 27.5% 30.5% 31.9% |
|TERMINAL (d) | 7/38 (18%) 7/36 (19%) 6/37 (16%) 10/35 (29%) |3/31 (10%) 3/18 (17%) 3/18 (17%) 1/2 (50%) |
|FIRST INCIDENCE | 540 546 522 730 (T) |630 605 484 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.495 P=0.253 P=0.395 P=0.429 |P=0.002 ** P=0.075 P=0.052 P<0.001 ** |
|POLY 3 | P=0.502 P=0.303 P=0.431 P=0.473 |P=0.082 P=0.194 P=0.115 P=0.105 |
|POLY 1.5 | P=0.530 P=0.283 P=0.417 P=0.492 |P=0.139 P=0.245 P=0.130 P=0.165 |
|POLY 6 | P=0.469 P=0.323 P=0.448 P=0.449 |P=0.032 * P=0.135 P=0.100 P=0.047 * |
|LOGISTIC REGRESSION| P=0.509N P=0.205 P=0.439 P=0.497 |P=0.178 P=0.231 P=0.200 P=0.122 |
|COCH-ARM / FISHERS | P=0.516N P=0.251 P=0.421 P=0.520 |P=0.230 P=0.306 P=0.150 P=0.254 |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 2/50 (4%) 8/50 (16%) 2/50 (4%) |4/50 (8%) 15/50 (30%) 11/49 (22%) 12/47 (26%) |
|POLY-3 ADJUSTED (b)| 9.1% 4.4% 18.1% 4.5% |8.8% 35.6% 28.0% 33.5% |
|TERMINAL (d) | 3/38 (8%) 1/36 (3%) 5/37 (14%) 0/35 (0%) |1/31 (3%) 4/18 (22%) 5/18 (28%) 0/2 (0%) |
|FIRST INCIDENCE | 583 729 572 569 |665 562 637 518 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.468N P=0.348N P=0.181 P=0.359N |P<0.001 ** P<0.001 ** P=0.007 ** P<0.001 ** |
|POLY 3 | P=0.437N P=0.318N P=0.179 P=0.332N |P=0.018 * P=0.002 ** P=0.020 * P=0.005 ** |
|POLY 1.5 | P=0.433N P=0.320N P=0.178 P=0.331N |P=0.037 * P=0.003 ** P=0.027 * P=0.009 ** |
|POLY 6 | P=0.439N P=0.319N P=0.182 P=0.334N |P=0.005 ** P<0.001 ** P=0.012 * P=0.002 ** |
|LOGISTIC REGRESSION| P=0.416N P=0.320N P=0.182 P=0.305N |P=0.044 * P=0.007 ** P=0.015 * P=0.020 * |
|COCH-ARM / FISHERS | P=0.422N P=0.329N P=0.188 P=0.329N |P=0.078 P=0.005 ** P=0.041 * P=0.019 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |12/50 (24%) 7/49 (14%) 7/48 (15%) 4/41 (10%) |
|POLY-3 ADJUSTED (b)| |26.6% 18.2% 17.9% 14.0% |
|TERMINAL (d) | |10/31 (32%) 5/17 (29%) 2/18 (11%) 0/2 (0%) |
|FIRST INCIDENCE | |630 519 521 654 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.375 P=0.600N P=0.508N P=0.191 |
|POLY 3 | |P=0.118N P=0.256N P=0.246N P=0.164N |
|POLY 1.5 | |P=0.086N P=0.207N P=0.213N P=0.109N |
|POLY 6 | |P=0.182N P=0.339N P=0.289N P=0.280N |
|LOGISTIC REGRESSION| |P=0.163N P=0.344N P=0.249N P=0.435N |
|COCH-ARM / FISHERS | |P=0.059N P=0.166N P=0.178N P=0.065N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/49 (0%) 0/48 (0%) 2/41 (5%) |
|POLY-3 ADJUSTED (b)| |0.0% 0.0% 0.0% 7.1% |
|TERMINAL (d) | |0/31 (0%) 0/17 (0%) 0/18 (0%) 1/2 (50%) |
|FIRST INCIDENCE | |--- --- --- 603 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.006 ** (e) (e) P=0.035 * |
|POLY 3 | |P=0.028 * (e) (e) P=0.148 |
|POLY 1.5 | |P=0.029 * (e) (e) P=0.168 |
|POLY 6 | |P=0.026 * (e) (e) P=0.122 |
|LOGISTIC REGRESSION| |P=0.028 * (e) (e) P=0.180 |
|COCH-ARM / FISHERS | |P=0.033 * (e) (e) P=0.200 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pancreas |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 4/49 (8%) 0/50 (0%) 4/50 (8%) |10/49 (20%) 15/50 (30%) 13/46 (28%) 2/46 (4%) |
|POLY-3 ADJUSTED (b)| 2.3% 8.9% 0.0% 9.2% |22.6% 38.4% 32.7% 6.1% |
|TERMINAL (d) | 1/38 (3%) 4/36 (11%) 0/37 (0%) 4/35 (11%) |10/31 (32%) 13/18 (72%) 7/18 (39%) 0/2 (0%) |
|FIRST INCIDENCE | 730 (T) 730 (T) --- 730 (T) |731 (T) 596 520 505 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.203 P=0.163 P=0.505N P=0.155 |P=0.143 P=0.002 ** P=0.043 * P=0.397 |
|POLY 3 | P=0.226 P=0.189 P=0.500N P=0.177 |P=0.050N P=0.087 P=0.214 P=0.046N* |
|POLY 1.5 | P=0.229 P=0.186 P=0.500N P=0.180 |P=0.025N* P=0.132 P=0.237 P=0.030N* |
|POLY 6 | P=0.222 P=0.190 P=0.500N P=0.174 |P=0.138N P=0.042 * P=0.184 P=0.090N |
|LOGISTIC REGRESSION| P=0.203 P=0.163 (e) P=0.155 |P=0.081N P=0.009 ** P=0.212 P=0.139N |
|COCH-ARM / FISHERS | P=0.237 P=0.181 P=0.495N P=0.187 |P=0.013N* P=0.193 P=0.257 P=0.018N* |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 1/50 (2%) 0/46 (0%) 0/46 (0%) |
|POLY-3 ADJUSTED (b)| 6.9% 0.0% 0.0% 0.0% |0.0% 2.6% 0.0% 0.0% |
|TERMINAL (d) | 3/38 (8%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 1/18 (6%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 730 (T) --- --- --- |--- 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.052N P=0.131N P=0.126N P=0.136N |P=0.823 P=0.392 (e) (e) |
|POLY 3 | P=0.046N* P=0.112N P=0.119N P=0.119N |P=0.604N P=0.473 (e) (e) |
|POLY 1.5 | P=0.046N* P=0.114N P=0.119N P=0.118N |P=0.592N P=0.488 (e) (e) |
|POLY 6 | P=0.046N* P=0.111N P=0.118N P=0.121N |P=0.616N P=0.451 (e) (e) |
|LOGISTIC REGRESSION| P=0.052N (e) (e) (e) |(e) P=0.392 (e) (e) |
|COCH-ARM / FISHERS | P=0.047N* P=0.121N P=0.117N P=0.117N |P=0.576N P=0.505 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/45 (0%) 0/48 (0%) 0/44 (0%) 0/45 (0%) |7/48 (15%) 0/44 (0%) 0/44 (0%) 0/40 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |16.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/34 (0%) 0/34 (0%) 0/33 (0%) |7/30 (23%) 0/18 (0%) 0/17 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.017N* P=0.038N* P=0.043N* P=0.543N |
|POLY 3 | (e) (e) (e) (e) |P<0.001N** P=0.017N* P=0.016N* P=0.032N* |
|POLY 1.5 | (e) (e) (e) (e) |P=0.002N** P=0.013N* P=0.013N* P=0.022N* |
|POLY 6 | (e) (e) (e) (e) |P<0.001N** P=0.022N* P=0.021N* P=0.056N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.017N* (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.003N** P=0.008N** P=0.008N** P=0.012N* |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/45 (11%) 7/48 (15%) 3/44 (7%) 1/45 (2%) |1/48 (2%) 0/44 (0%) 1/44 (2%) 1/40 (3%) |
|POLY-3 ADJUSTED (b)| 12.3% 16.0% 7.7% 2.5% |2.3% 0.0% 2.9% 3.5% |
|TERMINAL (d) | 4/36 (11%) 7/34 (21%) 3/34 (9%) 1/33 (3%) |1/30 (3%) 0/18 (0%) 0/17 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 580 730 (T) 730 (T) 730 (T) |731 (T) --- 661 676 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.047N* P=0.348 P=0.384N P=0.123N |P=0.314 P=0.602N P=0.654 P=0.460 |
|POLY 3 | P=0.042N* P=0.432 P=0.376N P=0.104N |P=0.439 P=0.544N P=0.713 P=0.662 |
|POLY 1.5 | P=0.041N* P=0.432 P=0.378N P=0.102N |P=0.466 P=0.531N P=0.726 P=0.690 |
|POLY 6 | P=0.044N* P=0.422 P=0.376N P=0.108N |P=0.395 P=0.560N P=0.696 P=0.617 |
|LOGISTIC REGRESSION| P=0.042N* P=0.438 P=0.370N P=0.103N |P=0.443 (e) P=0.729 P=0.638 |
|COCH-ARM / FISHERS | P=0.041N* P=0.426 P=0.370N P=0.101N |P=0.495 P=0.522N P=0.731 P=0.705 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/45 (0%) 0/48 (0%) 0/44 (0%) 0/45 (0%) |6/48 (13%) 8/44 (18%) 3/44 (7%) 3/40 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |13.9% 23.0% 8.6% 10.5% |
|TERMINAL (d) | 0/36 (0%) 0/34 (0%) 0/34 (0%) 0/33 (0%) |5/30 (17%) 7/18 (39%) 1/17 (6%) 1/2 (50%) |
|FIRST INCIDENCE | --- --- --- --- |670 620 659 615 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.188 P=0.091 P=0.528N P=0.113 |
|POLY 3 | (e) (e) (e) (e) |P=0.258N P=0.230 P=0.355N P=0.476N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.205N P=0.272 P=0.323N P=0.409N |
|POLY 6 | (e) (e) (e) (e) |P=0.353N P=0.180 P=0.399N P=0.579N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.440N P=0.144 P=0.417N P=0.645 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.156N P=0.320 P=0.288N P=0.342N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 6/50 (12%) 10/50 (20%) 5/50 (10%) | |
|POLY-3 ADJUSTED (b)| 15.9% 13.1% 22.3% 11.5% | |
|TERMINAL (d) | 6/38 (16%) 5/36 (14%) 6/37 (16%) 4/35 (11%) | |
|FIRST INCIDENCE | 580 694 572 673 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.445N P=0.525N P=0.296 P=0.430N | |
|POLY 3 | P=0.414N P=0.465N P=0.313 P=0.385N | |
|POLY 1.5 | P=0.403N P=0.471N P=0.305 P=0.378N | |
|POLY 6 | P=0.425N P=0.466N P=0.326 P=0.394N | |
|LOGISTIC REGRESSION| P=0.398N P=0.459N P=0.304 P=0.381N | |
|COCH-ARM / FISHERS | P=0.379N P=0.484N P=0.314 P=0.365N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/49 (35%) 15/50 (30%) 14/50 (28%) 18/50 (36%) | |
|POLY-3 ADJUSTED (b)| 37.4% 31.7% 31.8% 40.2% | |
|TERMINAL (d) | 13/38 (34%) 11/36 (31%) 13/37 (35%) 15/35 (43%) | |
|FIRST INCIDENCE | 537 488 522 339 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.339 P=0.444N P=0.363N P=0.408 | |
|POLY 3 | P=0.369 P=0.361N P=0.372N P=0.476 | |
|POLY 1.5 | P=0.398 P=0.368N P=0.355N P=0.502 | |
|POLY 6 | P=0.332 P=0.366N P=0.395N P=0.436 | |
|LOGISTIC REGRESSION| P=0.417 P=0.403N P=0.329N P=0.521 | |
|COCH-ARM / FISHERS | P=0.441 P=0.388N P=0.308N P=0.530 | |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 4/50 (8%) 8/50 (16%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 6.9% 8.7% 18.0% 4.6% | |
|TERMINAL (d) | 3/38 (8%) 4/36 (11%) 6/37 (16%) 2/35 (6%) | |
|FIRST INCIDENCE | 730 (T) 730 (T) 572 730 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491N P=0.470 P=0.099 P=0.538N | |
|POLY 3 | P=0.467N P=0.529 P=0.104 P=0.501N | |
|POLY 1.5 | P=0.457N P=0.523 P=0.101 P=0.497N | |
|POLY 6 | P=0.477N P=0.531 P=0.108 P=0.506N | |
|LOGISTIC REGRESSION| P=0.462N P=0.470 P=0.101 P=0.538N | |
|COCH-ARM / FISHERS | P=0.439N P=0.511 P=0.106 P=0.490N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 4.5% 4.3% 0.0% 0.0% | |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) | |
|FIRST INCIDENCE | 570 614 --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091N P=0.664N P=0.240N P=0.248N | |
|POLY 3 | P=0.087N P=0.676N P=0.241N P=0.241N | |
|POLY 1.5 | P=0.086N P=0.679N P=0.240N P=0.238N | |
|POLY 6 | P=0.089N P=0.675N P=0.243N P=0.246N | |
|LOGISTIC REGRESSION| P=0.073N P=0.628 P=0.204N P=0.213N | |
|COCH-ARM / FISHERS | P=0.083N P=0.684N P=0.242N P=0.242N | |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Salivary Glands |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 31/49 (63%) 29/50 (58%) 28/50 (56%) 34/50 (68%) |33/50 (66%) 29/45 (64%) 27/44 (61%) 18/42 (43%) |
|POLY-3 ADJUSTED (b)| 67.0% 61.5% 62.4% 74.2% |71.0% 73.7% 64.8% 50.8% |
|TERMINAL (d) | 25/38 (66%) 24/36 (67%) 24/37 (65%) 26/35 (74%) |24/31 (77%) 16/18 (89%) 9/18 (50%) 1/2 (50%) |
|FIRST INCIDENCE | 537 614 486 554 |610 477 371 505 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.164 P=0.490N P=0.399N P=0.222 |P=0.013 * P=0.042 * P=0.206 P=0.002 ** |
|POLY 3 | P=0.198 P=0.366N P=0.405N P=0.291 |P=0.019N* P=0.486 P=0.345N P=0.041N* |
|POLY 1.5 | P=0.227 P=0.362N P=0.378N P=0.325 |P=0.014N* P=0.577 P=0.360N P=0.028N* |
|POLY 6 | P=0.177 P=0.385N P=0.441N P=0.264 |P=0.030N* P=0.354 P=0.312N P=0.075N |
|LOGISTIC REGRESSION| P=0.218 P=0.308N P=0.338N P=0.343 |P=0.027N* P=0.263 P=0.450N P=0.072N |
|COCH-ARM / FISHERS | P=0.296 P=0.371N P=0.298N P=0.388 |P=0.012N* P=0.522N P=0.400N P=0.022N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skeletal Muscle |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/2 (50%) 0/1 (0%) 2/3 (67%) 1/3 (33%) |0/2 (0%) 5/8 (63%) 1/3 (33%) 2/3 (67%) |
|POLY-3 ADJUSTED (b)| 50.0% 0.0% 66.7% 35.2% |0.0% 66.9% 34.0% 69.0% |
|TERMINAL (d) | 1/2 (50%) 0/1 (0%) 2/3 (67%) 1/2 (50%) |0/0 (0%) 4/5 (80%) 1/1 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 730 (T) --- 730 (T) 730 (T) |--- 720 731 (T) 607 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.589 P=0.638N P=0.691 P=0.807 |P=0.040 * P=0.396 P=1.000N P=0.149 |
|POLY 3 | P=0.601N P=0.614N P=0.670 P=0.687N |P=0.449 P=0.260 P=0.618 P=0.345 |
|POLY 1.5 | P=0.591N P=0.614N P=0.670 P=0.679N |P=0.402 P=0.231 P=0.598 P=0.312 |
|POLY 6 | P=0.618N P=0.614N P=0.670 P=0.702N |P=0.534 P=0.334 P=0.654 P=0.417 |
|LOGISTIC REGRESSION| P=0.589 (e) P=0.691 P=0.807 |P=0.271 (e) P=1.000N (e) |
|COCH-ARM / FISHERS | P=0.598N P=0.667N P=0.700 P=0.700N |P=0.349 P=0.222 P=0.600 P=0.300 |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 34
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.2% 0.0% 5.1% 5.7% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |1/31 (3%) 0/18 (0%) 2/18 (11%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) --- 731 (T) 537 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.032 * P=0.608N P=0.313 P=0.245 |
|POLY 3 | (e) (e) (e) (e) |P=0.189 P=0.529N P=0.455 P=0.417 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.212 P=0.515N P=0.476 P=0.453 |
|POLY 6 | (e) (e) (e) (e) |P=0.152 P=0.550N P=0.428 P=0.360 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.232 (e) P=0.313 P=0.559 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.238 P=0.500N P=0.500 P=0.492 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/46 (0%) 1/46 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.5% 0.0% |0.0% 0.0% 0.0% 3.1% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- 37 --- |--- --- --- 379 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.590 (e) P=0.242 (e) |P=0.200 (e) (e) P=0.504 |
|POLY 3 | P=0.579 (e) P=0.244 (e) |P=0.166 (e) (e) P=0.438 |
|POLY 1.5 | P=0.586 (e) P=0.243 (e) |P=0.177 (e) (e) P=0.460 |
|POLY 6 | P=0.571 (e) P=0.246 (e) |P=0.150 (e) (e) P=0.403 |
|LOGISTIC REGRESSION| P=0.719N (e) P=0.526 (e) |P=0.087 (e) (e) P=0.393 |
|COCH-ARM / FISHERS | P=0.598 (e) P=0.253 (e) |P=0.187 (e) (e) P=0.479 |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 35
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/46 (0%) 2/46 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 2.6% 0.0% 6.2% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 633 --- 676 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.083 P=0.436 (e) P=0.121 |
|POLY 3 | (e) (e) (e) (e) |P=0.098 P=0.472 (e) P=0.171 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.110 P=0.486 (e) P=0.192 |
|POLY 6 | (e) (e) (e) (e) |P=0.083 P=0.453 (e) P=0.142 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.125 P=0.516 (e) P=0.178 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.126 P=0.500 (e) P=0.227 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/49 (0%) 1/50 (2%) 3/50 (6%) |8/50 (16%) 3/50 (6%) 2/46 (4%) 0/46 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 0.0% 2.3% 6.9% |17.9% 7.8% 5.4% 0.0% |
|TERMINAL (d) | 1/38 (3%) 0/36 (0%) 1/37 (3%) 1/35 (3%) |7/31 (23%) 3/18 (17%) 2/18 (11%) 0/2 (0%) |
|FIRST INCIDENCE | 730 (T) --- 730 (T) 705 |718 731 (T) 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.089 P=0.511N P=0.756 P=0.287 |P=0.123N P=0.344N P=0.196N P=0.466N |
|POLY 3 | P=0.093 P=0.493N P=0.760 P=0.305 |P=0.004N** P=0.150N P=0.082N P=0.015N* |
|POLY 1.5 | P=0.095 P=0.495N P=0.760 P=0.308 |P=0.003N** P=0.123N P=0.071N P=0.009N** |
|POLY 6 | P=0.091 P=0.492N P=0.761 P=0.302 |P=0.007N** P=0.198N P=0.100N P=0.033N* |
|LOGISTIC REGRESSION| P=0.089 (e) P=0.756 P=0.297 |P=0.069N P=0.303N P=0.153N P=0.232N |
|COCH-ARM / FISHERS | P=0.099 P=0.500N P=0.747N P=0.316 |P=0.003N** P=0.100N P=0.060N P=0.004N** |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 36
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 6/49 (12%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 2/50 (4%) 4/46 (9%) 1/46 (2%) |
|POLY-3 ADJUSTED (b)| 6.7% 12.8% 2.3% 4.5% |0.0% 5.1% 10.2% 3.1% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 430 488 589 339 |--- 493 465 607 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.228N P=0.283 P=0.310N P=0.509N |P=0.327 P=0.213 P=0.053 P=0.447 |
|POLY 3 | P=0.210N P=0.264 P=0.314N P=0.501N |P=0.233 P=0.211 P=0.045 * P=0.435 |
|POLY 1.5 | P=0.206N P=0.256 P=0.311N P=0.497N |P=0.302 P=0.224 P=0.048 * P=0.458 |
|POLY 6 | P=0.216N P=0.272 P=0.316N P=0.508N |P=0.141 P=0.194 P=0.040 * P=0.401 |
|LOGISTIC REGRESSION| P=0.128N P=0.086 P=0.201N P=0.377N |P=0.503 P=0.218 P=0.043 * P=0.524 |
|COCH-ARM / FISHERS | P=0.200N P=0.243 P=0.301N P=0.490N |P=0.386 P=0.247 P=0.049 * P=0.479 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen: Red Pulp |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/49 (20%) 20/49 (41%) 25/50 (50%) 19/50 (38%) |29/50 (58%) 40/50 (80%) 45/46 (98%) 44/46 (96%) |
|POLY-3 ADJUSTED (b)| 21.5% 42.7% 52.3% 40.5% |61.9% 82.8% 98.1% 98.9% |
|TERMINAL (d) | 4/38 (11%) 12/36 (33%) 16/37 (43%) 11/35 (31%) |17/31 (55%) 13/18 (72%) 18/18 (100%) 2/2 (100%) |
|FIRST INCIDENCE | 477 593 326 512 |632 477 465 450 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.063 P=0.042 * P=0.005 ** P=0.045 * |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.060 P=0.023 * P<0.001 ** P=0.038 * |P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.062 P=0.023 * P<0.001 ** P=0.039 * |P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.059 P=0.022 * P<0.001 ** P=0.037 * |P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.090 P=0.014 * P=0.003 ** P=0.049 * |P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.075 P=0.024 * P=0.002 ** P=0.044 * |P<0.001 ** P=0.015 * P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 37
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 4/50 (8%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 0/48 (0%) 3/46 (7%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 8.9% 0.0% |2.2% 7.7% 0.0% 9.1% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- 694 522 --- |670 617 --- 518 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.578 P=0.510 P=0.069 (e) |P=0.104 P=0.188 P=0.564N P=0.129 |
|POLY 3 | P=0.573 P=0.511 P=0.065 (e) |P=0.229 P=0.257 P=0.529N P=0.206 |
|POLY 1.5 | P=0.582 P=0.509 P=0.063 (e) |P=0.259 P=0.280 P=0.519N P=0.238 |
|POLY 6 | P=0.562 P=0.512 P=0.067 (e) |P=0.188 P=0.225 P=0.544N P=0.160 |
|LOGISTIC REGRESSION| P=0.615N P=0.501 P=0.080 (e) |P=0.312 P=0.294 P=0.501N P=0.325 |
|COCH-ARM / FISHERS | P=0.596 P=0.505 P=0.061 (e) |P=0.293 P=0.309 P=0.510N P=0.278 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/48 (2%) 0/46 (0%) |
|POLY-3 ADJUSTED (b)| 4.6% 0.0% 6.8% 0.0% |0.0% 5.1% 2.6% 0.0% |
|TERMINAL (d) | 2/38 (5%) 0/36 (0%) 1/37 (3%) 0/35 (0%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 730 (T) --- 522 --- |--- 582 694 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.314N P=0.250N P=0.495 P=0.257N |P=0.580N P=0.204 P=0.444 (e) |
|POLY 3 | P=0.308N P=0.225N P=0.510 P=0.238N |P=0.570N P=0.210 P=0.473 (e) |
|POLY 1.5 | P=0.302N P=0.228N P=0.505 P=0.236N |P=0.527N P=0.223 P=0.482 (e) |
|POLY 6 | P=0.312N P=0.225N P=0.515 P=0.240N |P=0.596 P=0.193 P=0.460 (e) |
|LOGISTIC REGRESSION| P=0.282N (e) P=0.523 (e) |P=0.441N P=0.245 P=0.483 (e) |
|COCH-ARM / FISHERS | P=0.293N P=0.242N P=0.510 P=0.242N |P=0.481N P=0.247 P=0.490 (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 38
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/49 (10%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |1/50 (2%) 3/50 (6%) 2/48 (4%) 1/46 (2%) |
|POLY-3 ADJUSTED (b)| 11.5% 4.4% 6.8% 4.6% |2.2% 7.6% 5.1% 3.1% |
|TERMINAL (d) | 5/38 (13%) 1/36 (3%) 1/37 (3%) 2/35 (6%) |0/31 (0%) 1/18 (6%) 1/18 (6%) 0/2 (0%) |
|FIRST INCIDENCE | 730 (T) 729 522 730 (T) |728 582 694 518 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.237N P=0.239N P=0.368N P=0.249N |P=0.377 P=0.191 P=0.348 P=0.545 |
|POLY 3 | P=0.219N P=0.194N P=0.345N P=0.216N |P=0.576 P=0.262 P=0.452 P=0.687 |
|POLY 1.5 | P=0.215N P=0.199N P=0.350N P=0.214N |P=0.559N P=0.283 P=0.469 P=0.715 |
|POLY 6 | P=0.221N P=0.193N P=0.337N P=0.220N |P=0.474 P=0.233 P=0.429 P=0.639 |
|LOGISTIC REGRESSION| P=0.213N P=0.222N P=0.349N P=0.249N |P=0.480N P=0.323 P=0.408 P=0.744N |
|COCH-ARM / FISHERS | P=0.205N P=0.210N P=0.346N P=0.210N |P=0.508N P=0.309 P=0.485 P=0.731 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/48 (0%) 0/46 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.3% 0.0% |0.0% 5.1% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- 522 --- |--- 582 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.692 (e) P=0.500 (e) |P=0.442N P=0.204 (e) (e) |
|POLY 3 | P=0.682 (e) P=0.503 (e) |P=0.477N P=0.210 (e) (e) |
|POLY 1.5 | P=0.688 (e) P=0.501 (e) |P=0.449N P=0.223 (e) (e) |
|POLY 6 | P=0.677 (e) P=0.504 (e) |P=0.518N P=0.193 (e) (e) |
|LOGISTIC REGRESSION| P=0.741 (e) P=0.594 (e) |P=0.388N P=0.245 (e) (e) |
|COCH-ARM / FISHERS | P=0.696 (e) P=0.505 (e) |P=0.419N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 39
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 3/48 (6%) 35/49 (71%) 45/50 (90%) |0/45 (0%) 0/49 (0%) 10/46 (22%) 10/45 (22%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.7% 79.2% 91.2% |0.0% 0.0% 26.2% 28.7% |
|TERMINAL (d) | 0/38 (0%) 3/36 (8%) 32/37 (87%) 33/35 (94%) |0/31 (0%) 0/18 (0%) 6/18 (33%) 0/2 (0%) |
|FIRST INCIDENCE | --- 730 (T) 572 339 |--- --- 619 505 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.111 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.123 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.120 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.125 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.111 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P=0.002 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.117 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/49 (27%) 25/48 (52%) 40/49 (82%) 49/50 (98%) |14/45 (31%) 33/49 (67%) 31/46 (67%) 38/45 (84%) |
|POLY-3 ADJUSTED (b)| 29.2% 54.7% 88.0% 99.1% |33.7% 78.4% 74.7% 89.8% |
|TERMINAL (d) | 11/38 (29%) 21/36 (58%) 34/37 (92%) 35/35 (100%)|12/31 (39%) 18/18 (100%) 17/18 (94%) 2/2 (100%) |
|FIRST INCIDENCE | 537 488 486 339 |652 493 465 505 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.010 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.010 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 40
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/48 (2%) 15/49 (31%) 20/50 (40%) |0/45 (0%) 1/49 (2%) 5/46 (11%) 2/45 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 33.6% 44.3% |0.0% 2.7% 13.4% 6.3% |
|TERMINAL (d) | 0/38 (0%) 1/36 (3%) 12/37 (32%) 15/35 (43%) |0/31 (0%) 1/18 (6%) 5/18 (28%) 1/2 (50%) |
|FIRST INCIDENCE | --- 730 (T) 486 554 |--- 731 (T) 731 (T) 717 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.489 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.392 P=0.005 ** P=0.002 ** |
|POLY 3 | P<0.001 ** P=0.505 P<0.001 ** P<0.001 ** |P=0.073 P=0.483 P=0.022 * P=0.185 |
|POLY 1.5 | P<0.001 ** P=0.502 P<0.001 ** P<0.001 ** |P=0.107 P=0.500 P=0.027 * P=0.209 |
|POLY 6 | P<0.001 ** P=0.507 P<0.001 ** P<0.001 ** |P=0.035 * P=0.460 P=0.017 * P=0.152 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.489 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.392 P=0.005 ** P=0.020 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.495 P<0.001 ** P<0.001 ** |P=0.154 P=0.521 P=0.029 * P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Hyperplasia Atypical |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/48 (0%) 1/49 (2%) 2/50 (4%) |0/45 (0%) 0/49 (0%) 0/46 (0%) 1/45 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.3% 4.6% |0.0% 0.0% 0.0% 3.1% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 1/37 (3%) 1/35 (3%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- 730 (T) 705 |--- --- --- 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.065 (e) P=0.495 P=0.228 |P=0.169 (e) (e) P=0.434 |
|POLY 3 | P=0.069 (e) P=0.500 P=0.237 |P=0.171 (e) (e) P=0.451 |
|POLY 1.5 | P=0.070 (e) P=0.500 P=0.239 |P=0.181 (e) (e) P=0.475 |
|POLY 6 | P=0.067 (e) P=0.500 P=0.235 |P=0.155 (e) (e) P=0.415 |
|LOGISTIC REGRESSION| P=0.066 (e) P=0.495 P=0.235 |P=0.213 (e) (e) P=0.535 |
|COCH-ARM / FISHERS | P=0.073 (e) P=0.500 P=0.253 |P=0.193 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 41
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/49 (20%) 11/48 (23%) 25/49 (51%) 33/50 (66%) |17/45 (38%) 21/49 (43%) 12/46 (26%) 14/45 (31%) |
|POLY-3 ADJUSTED (b)| 23.0% 24.4% 57.2% 71.6% |40.4% 50.4% 31.3% 39.2% |
|TERMINAL (d) | 10/38 (26%) 9/36 (25%) 23/37 (62%) 25/35 (71%) |13/31 (42%) 10/18 (56%) 9/18 (50%) 1/2 (50%) |
|FIRST INCIDENCE | 730 (T) 614 639 459 |610 493 465 505 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.456 P<0.001 ** P<0.001 ** |P=0.003 ** P=0.014 * P=0.435 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.538 P<0.001 ** P<0.001 ** |P=0.327N P=0.237 P=0.268N P=0.552N |
|POLY 1.5 | P<0.001 ** P=0.516 P<0.001 ** P<0.001 ** |P=0.239N P=0.309 P=0.211N P=0.440N |
|POLY 6 | P<0.001 ** P=0.557 P<0.001 ** P<0.001 ** |P=0.500N P=0.150 P=0.367N P=0.462 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.537 P<0.001 ** P<0.001 ** |P=0.293N P=0.271 P=0.290N P=0.466N |
|COCH-ARM / FISHERS | P<0.001 ** P=0.479 P<0.001 ** P<0.001 ** |P=0.168N P=0.386 P=0.166N P=0.329N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/48 (2%) 1/49 (2%) 4/50 (8%) |2/45 (4%) 1/49 (2%) 2/46 (4%) 3/45 (7%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 2.3% 9.1% |4.9% 2.6% 5.3% 9.2% |
|TERMINAL (d) | 0/38 (0%) 1/36 (3%) 1/37 (3%) 2/35 (6%) |1/31 (3%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- 730 (T) 730 (T) 512 |728 596 590 596 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.016 * P=0.489 P=0.495 P=0.059 |P=0.094 P=0.642N P=0.565 P=0.061 |
|POLY 3 | P=0.018 * P=0.505 P=0.500 P=0.062 |P=0.239 P=0.525N P=0.667 P=0.395 |
|POLY 1.5 | P=0.018 * P=0.502 P=0.500 P=0.062 |P=0.268 P=0.498N P=0.684 P=0.445 |
|POLY 6 | P=0.017 * P=0.507 P=0.500 P=0.061 |P=0.195 P=0.562N P=0.642 P=0.319 |
|LOGISTIC REGRESSION| P=0.019 * P=0.489 P=0.495 P=0.067 |P=0.325 P=0.480N P=0.673N P=0.410 |
|COCH-ARM / FISHERS | P=0.019 * P=0.495 P=0.500 P=0.061 |P=0.299 P=0.468N P=0.683N P=0.500 |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 42
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/48 (0%) 1/49 (2%) 0/50 (0%) |0/45 (0%) 1/49 (2%) 3/46 (7%) 2/45 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.3% 0.0% |0.0% 2.6% 7.9% 6.2% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |0/31 (0%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- 691 --- |--- 664 582 676 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.687 (e) P=0.500 (e) |P=0.073 P=0.412 P=0.091 P=0.141 |
|POLY 3 | P=0.681 (e) P=0.500 (e) |P=0.091 P=0.485 P=0.105 P=0.187 |
|POLY 1.5 | P=0.686 (e) P=0.500 (e) |P=0.119 P=0.500 P=0.114 P=0.210 |
|POLY 6 | P=0.675 (e) P=0.501 (e) |P=0.057 P=0.463 P=0.095 P=0.155 |
|LOGISTIC REGRESSION| P=0.697 (e) P=0.500 (e) |P=0.171 P=0.531 P=0.133 P=0.211 |
|COCH-ARM / FISHERS | P=0.696 (e) P=0.500 (e) |P=0.154 P=0.521 P=0.125 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular: Neuroendocrine Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/49 (0%) 4/50 (8%) |0/45 (0%) 1/49 (2%) 0/46 (0%) 0/45 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 9.2% |0.0% 2.7% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 3/35 (9%) |0/31 (0%) 1/18 (6%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- 660 |--- 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** (e) (e) P=0.057 |P=0.823 P=0.392 (e) (e) |
|POLY 3 | P=0.003 ** (e) (e) P=0.060 |P=0.599N P=0.483 (e) (e) |
|POLY 1.5 | P=0.003 ** (e) (e) P=0.061 |P=0.585N P=0.500 (e) (e) |
|POLY 6 | P=0.003 ** (e) (e) P=0.059 |P=0.613N P=0.460 (e) (e) |
|LOGISTIC REGRESSION| P=0.003 ** (e) (e) P=0.062 |(e) P=0.392 (e) (e) |
|COCH-ARM / FISHERS | P=0.003 ** (e) (e) P=0.061 |P=0.569N P=0.521 (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 43
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/37 (27%) 19/40 (48%) 16/38 (42%) 12/45 (27%) |14/45 (31%) 9/43 (21%) 5/40 (13%) 7/33 (21%) |
|POLY-3 ADJUSTED (b)| 30.1% 50.5% 48.6% 30.8% |34.1% 26.9% 15.4% 28.8% |
|TERMINAL (d) | 9/29 (31%) 14/28 (50%) 13/26 (50%) 11/31 (36%) |9/27 (33%) 7/15 (47%) 2/15 (13%) 2/2 (100%) |
|FIRST INCIDENCE | 583 593 575 569 |632 620 521 676 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.439N P=0.035 * P=0.070 P=0.466 |P=0.124 P=0.510 P=0.173N P=0.029 * |
|POLY 3 | P=0.340N P=0.063 P=0.094 P=0.575 |P=0.238N P=0.337N P=0.057N P=0.432N |
|POLY 1.5 | P=0.313N P=0.058 P=0.098 P=0.590 |P=0.196N P=0.264N P=0.045N* P=0.331N |
|POLY 6 | P=0.374N P=0.066 P=0.091 P=0.555 |P=0.315N P=0.459N P=0.074N P=0.598N |
|LOGISTIC REGRESSION| P=0.329N P=0.056 P=0.090 P=0.566 |P=0.418N P=0.492N P=0.053N P=0.517 |
|COCH-ARM / FISHERS | P=0.273N P=0.052 P=0.129 P=0.583N |P=0.160N P=0.200N P=0.035N* P=0.238N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thymus: Thymocyte |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/37 (3%) 1/40 (3%) 0/38 (0%) 1/45 (2%) |0/45 (0%) 2/43 (5%) 3/40 (8%) 0/33 (0%) |
|POLY-3 ADJUSTED (b)| 3.0% 2.7% 0.0% 2.6% |0.0% 5.9% 9.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/26 (0%) 0/31 (0%) |0/27 (0%) 0/15 (0%) 0/15 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 580 488 --- 660 |--- 620 465 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.624N P=0.744N P=0.500N P=0.758 |P=0.591N P=0.180 P=0.114 (e) |
|POLY 3 | P=0.577N P=0.739N P=0.509N P=0.727N |P=0.470 P=0.200 P=0.086 (e) |
|POLY 1.5 | P=0.574N P=0.740N P=0.505N P=0.723N |P=0.544 P=0.213 P=0.091 (e) |
|POLY 6 | P=0.580N P=0.742N P=0.513N P=0.732N |P=0.349 P=0.184 P=0.081 (e) |
|LOGISTIC REGRESSION| P=0.530N P=0.655 P=0.439N P=0.692N |P=0.594N P=0.243 P=0.104 (e) |
|COCH-ARM / FISHERS | P=0.568N P=0.733N P=0.493N P=0.702N |P=0.616 P=0.236 P=0.100 (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 44
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 1/46 (2%) 0/46 (0%) 0/42 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 0.0% 6.7% |0.0% 2.8% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 1/36 (3%) 0/37 (0%) 1/35 (3%) |0/31 (0%) 1/18 (6%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- 730 (T) --- 339 |--- 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.043 * P=0.489 (e) P=0.119 |P=0.823 P=0.392 (e) (e) |
|POLY 3 | P=0.044 * P=0.511 (e) P=0.125 |P=0.617N P=0.456 (e) (e) |
|POLY 1.5 | P=0.044 * P=0.509 (e) P=0.124 |P=0.604N P=0.469 (e) (e) |
|POLY 6 | P=0.044 * P=0.511 (e) P=0.124 |P=0.630N P=0.437 (e) (e) |
|LOGISTIC REGRESSION| P=0.051 P=0.489 (e) P=0.156 |(e) P=0.392 (e) (e) |
|COCH-ARM / FISHERS | P=0.045 * P=0.505 (e) P=0.125 |P=0.589N P=0.479 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 1/46 (2%) 1/46 (2%) 0/42 (0%) |
|POLY-3 ADJUSTED (b)| 4.5% 4.3% 4.6% 4.6% |0.0% 2.8% 2.8% 0.0% |
|TERMINAL (d) | 1/38 (3%) 1/36 (3%) 2/37 (5%) 2/35 (6%) |0/31 (0%) 1/18 (6%) 1/18 (6%) 0/2 (0%) |
|FIRST INCIDENCE | 554 614 730 (T) 730 (T) |--- 731 (T) 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.572 P=0.684N P=0.686 P=0.673 |P=0.443 P=0.392 P=0.392 (e) |
|POLY 3 | P=0.580 P=0.676N P=0.689 P=0.689 |P=0.642 P=0.456 P=0.457 (e) |
|POLY 1.5 | P=0.588 P=0.679N P=0.690 P=0.693 |P=0.660N P=0.469 P=0.469 (e) |
|POLY 6 | P=0.571 P=0.676N P=0.687 P=0.682 |P=0.553 P=0.437 P=0.443 (e) |
|LOGISTIC REGRESSION| P=0.592N P=0.651 P=0.688N P=0.687N |(e) P=0.392 P=0.392 (e) |
|COCH-ARM / FISHERS | P=0.590N P=0.684N P=0.684N P=0.684N |P=0.627N P=0.479 P=0.479 (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 45
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 7/50 (14%) 6/50 (12%) 5/50 (10%) |8/50 (16%) 10/46 (22%) 7/46 (15%) 5/42 (12%) |
|POLY-3 ADJUSTED (b)| 4.5% 15.3% 13.8% 11.4% |17.9% 27.8% 19.4% 16.8% |
|TERMINAL (d) | 1/38 (3%) 7/36 (19%) 6/37 (16%) 3/35 (9%) |7/31 (23%) 8/18 (44%) 7/18 (39%) 2/2 (100%) |
|FIRST INCIDENCE | 537 730 (T) 730 (T) 604 |695 687 731 (T) 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.279 P=0.072 P=0.127 P=0.201 |P=0.002 ** P=0.058 P=0.278 P=0.002 ** |
|POLY 3 | P=0.301 P=0.088 P=0.127 P=0.213 |P=0.433N P=0.211 P=0.542 P=0.573N |
|POLY 1.5 | P=0.310 P=0.087 P=0.129 P=0.217 |P=0.340N P=0.263 P=0.592 P=0.489N |
|POLY 6 | P=0.292 P=0.086 P=0.125 P=0.208 |P=0.501 P=0.150 P=0.477 P=0.540 |
|LOGISTIC REGRESSION| P=0.302 P=0.091 P=0.134 P=0.227 |P=0.119 P=0.082 P=0.372 P=0.146 |
|COCH-ARM / FISHERS | P=0.328 P=0.085 P=0.141 P=0.226 |P=0.251N P=0.323 P=0.571N P=0.400N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Tooth |
| Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/23 (96%) 12/13 (92%) 4/4 (100%) 4/5 (80%) |0/2 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 95.7% 92.3% 100.0% 80.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 19/20 (95%) 8/9 (89%) 2/2 (100%) 2/3 (67%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 537 488 575 554 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.181N P=0.626 P=0.527N P=0.272N |(e) (e) (e) (e) |
|POLY 3 | P=0.279N P=0.629N P=0.835 P=0.393N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.279N P=0.629N P=0.835 P=0.393N |(e) (e) (e) (e) |
|POLY 6 | P=0.279N P=0.629N P=0.835 P=0.393N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.275N P=0.598N P=0.852 P=0.331N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 46
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/49 (12%) 5/50 (10%) 9/50 (18%) 14/50 (28%) |20/50 (40%) 29/49 (59%) 27/47 (57%) 25/46 (54%) |
|POLY-3 ADJUSTED (b)| 13.5% 10.7% 20.5% 32.1% |43.5% 66.6% 61.8% 62.9% |
|TERMINAL (d) | 4/38 (11%) 3/36 (8%) 8/37 (22%) 12/35 (34%) |15/31 (48%) 14/18 (78%) 13/18 (72%) 1/2 (50%) |
|FIRST INCIDENCE | 554 593 575 660 |610 477 465 505 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.007 ** P=0.492N P=0.278 P=0.030 * |P<0.001 ** P<0.001 ** P=0.003 ** P<0.001 ** |
|POLY 3 | P=0.006 ** P=0.465N P=0.276 P=0.031 * |P=0.075 P=0.018 * P=0.057 P=0.050 |
|POLY 1.5 | P=0.007 ** P=0.472N P=0.280 P=0.035 * |P=0.111 P=0.029 * P=0.064 P=0.075 |
|POLY 6 | P=0.005 ** P=0.464N P=0.271 P=0.027 * |P=0.040 * P=0.009 ** P=0.048 * P=0.027 * |
|LOGISTIC REGRESSION| P=0.008 ** P=0.540N P=0.292 P=0.038 * |P=0.146 P=0.021 * P=0.065 P=0.080 |
|COCH-ARM / FISHERS | P=0.010 * P=0.486N P=0.303 P=0.044 * |P=0.165 P=0.044 * P=0.065 P=0.114 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/49 (0%) 0/47 (0%) 0/46 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 0.0% 0.0% 0.0% |4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/36 (0%) 0/37 (0%) 0/35 (0%) |1/31 (3%) 0/18 (0%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 570 --- --- --- |706 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.311N P=0.483N P=0.496N P=0.505N |P=0.248N P=0.350N P=0.345N P=0.692N |
|POLY 3 | P=0.305N P=0.492N P=0.503N P=0.503N |P=0.108N P=0.276N P=0.279N P=0.319N |
|POLY 1.5 | P=0.306N P=0.493N P=0.502N P=0.500N |P=0.114N P=0.259N P=0.265N P=0.288N |
|POLY 6 | P=0.303N P=0.493N P=0.504N P=0.506N |P=0.099N P=0.302N P=0.298N P=0.372N |
|LOGISTIC REGRESSION| P=0.273N P=0.625N P=0.438N P=0.450N |P=0.183N P=0.316N P=0.305N P=0.476N |
|COCH-ARM / FISHERS | P=0.304N P=0.495N P=0.495N P=0.495N |P=0.124N P=0.253N P=0.263N P=0.269N |
|=================================================================================================================================|
Date: 07/20/98 EXPERIMENT: 05187 TEST: 06 Page 47
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - METHYLEUGENOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |25/50 (50%) 24/50 (48%) 15/49 (31%) 5/47 (11%) |
|POLY-3 ADJUSTED (b)| |53.4% 56.3% 36.3% 14.5% |
|TERMINAL (d) | |15/31 (48%) 12/18 (67%) 4/18 (22%) 0/2 (0%) |
|FIRST INCIDENCE | |564 516 521 505 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.215N P=0.067 P=0.437N P=0.493N |
|POLY 3 | |P<0.001N** P=0.476 P=0.076N P<0.001N** |
|POLY 1.5 | |P<0.001N** P=0.570 P=0.055N P<0.001N** |
|POLY 6 | |P<0.001N** P=0.345 P=0.110N P<0.001N** |
|LOGISTIC REGRESSION| |P<0.001N** P=0.468 P=0.065N P<0.001N** |
|COCH-ARM / FISHERS | |P<0.001N** P=0.500N P=0.039N* P<0.001N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 37 MG/KG 75 MG/KG 150 |0 MG/KG 37 MG/KG 75 MG/KG 150 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |19/50 (38%) 10/50 (20%) 0/49 (0%) 2/47 (4%) |
|POLY-3 ADJUSTED (b)| |41.6% 24.2% 0.0% 6.0% |
|TERMINAL (d) | |15/31 (48%) 3/18 (17%) 0/18 (0%) 0/2 (0%) |
|FIRST INCIDENCE | |630 477 --- 477 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.004N** P=0.347N P<0.001N** P=0.328N |
|POLY 3 | |P<0.001N** P=0.062N P<0.001N** P<0.001N** |
|POLY 1.5 | |P<0.001N** P=0.047N* P<0.001N** P<0.001N** |
|POLY 6 | |P<0.001N** P=0.096N P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| |P<0.001N** P=0.053N P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | |P<0.001N** P=0.038N* P<0.001N** P<0.001N** |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Poly-3 adjusted lifetime tumor incidence.
(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.
(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).