TDMS Study 92013-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst 4-METHYLIMIDAZOLE DATE: 01/12/04
EXPERIMENT: 92013 TEST: 06 TIME: 14:42:31
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92013B
PATHOLOGIST: HEATH, JAMES CAS: 822-36-6
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1 MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst 4-METHYLIMIDAZOLE DATE: 01/12/04
EXPERIMENT: 92013 TEST: 06 TIME: 14:42:31
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92013B
PATHOLOGIST: HEATH, JAMES CAS: 822-36-6
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF 4-METHYLIMIDAZOLE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Accessory Adrenal Cortical Nodule
Adrenal Cortex: Capsule Hyperplasia
Islets, Pancreatic Hyperplasia
Liver Eosinophilic Focus
Mixed Cell Focus
Liver: Hepatocyte Vacuolization Cytoplasmic
Lung Infiltration Cellular Histiocyte
Lung: Alveolar Epithelium Hyperplasia
Lymph Node, Mesenteric Hemorrhage
Preputial Gland Cyst
Spleen: Lymphoid Follicle Hyperplasia
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Heart Mineralization
Intestine Small, Jejunum Hyperplasia Lymphoid
Liver Cyst
Hematopoietic Cell Proliferation
Lung Infiltration Cellular Histiocyte
Lung: Alveolar Epithelium Hyperplasia
Lymph Node, Mandibular Hemorrhage
Hyperplasia Lymphoid
Lymph Node, Mesenteric Hyperplasia Lymphoid
Mammary Gland Hyperplasia
Pancreas Cyst
Parathyroid Gland Cyst
Salivary Glands Atrophy
Stomach, Forestomach Diverticulum
Thyroid Gland: Follicle Cyst
===============================================================
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 6/50 (12%) 8/50 (16%) |9/50 (18%) 9/50 (18%) 9/50 (18%) 5/50 (10%) |
|POLY-3 RATE (b) | 2/48.24 4/48.80 6/46.57 8/47.85 |9/47.07 9/47.90 9/48.22 5/46.05 |
|POLY-3 PERCENT (g) | 4.2% 8.2% 12.9% 16.7% |19.1% 18.8% 18.7% 10.9% |
|TERMINAL (d) | 2/45 (4%) 3/44 (7%) 5/42 (12%) 8/46 (17%) |8/43 (19%) 8/40 (20%) 7/43 (16%) 5/40 (13%) |
|FIRST INCIDENCE | 729 (T) 335 348 729 (T) |593 702 684 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.033 * P=0.330 P=0.118 P=0.052 |P=0.177N P=0.545 P=0.595N P=0.233N |
|POLY 3 | P=0.026 * P=0.343 P=0.122 P=0.044 * |P=0.162N P=0.587N P=0.581N P=0.205N |
|POLY 1.5 | P=0.026 * P=0.342 P=0.127 P=0.045 * |P=0.155N P=0.585N P=0.583N P=0.197N |
|POLY 6 | P=0.025 * P=0.343 P=0.117 P=0.044 * |P=0.172N P=0.595N P=0.581N P=0.216N |
|LOGISTIC REGRESSION| P=0.029 * P=0.366 P=0.166 P=0.052 |P=0.158N P=0.582N P=0.583N P=0.200N |
|COCH-ARM / FISHERS | P=0.028 * P=0.339 P=0.134 P=0.046 * |P=0.148N P=0.602N P=0.602N P=0.194N |
|ORDER RESTRICTED | P=0.029 * (e) (e) (e) |P=0.233N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/48.24 2/47.90 1/45.68 1/47.85 |0/46.61 0/47.80 1/48.01 2/46.05 |
|POLY-3 PERCENT (g) | 6.2% 4.2% 2.2% 2.1% |0.0% 0.0% 2.1% 4.3% |
|TERMINAL (d) | 3/45 (7%) 2/44 (5%) 1/42 (2%) 1/46 (2%) |0/43 (0%) 0/40 (0%) 1/43 (2%) 2/40 (5%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.196N P=0.510N P=0.330N P=0.298N |P=0.065 (e) P=0.500 P=0.223 |
|POLY 3 | P=0.204N P=0.503N P=0.325N P=0.308N |P=0.068 (e) P=0.506 P=0.235 |
|POLY 1.5 | P=0.203N P=0.502N P=0.318N P=0.308N |P=0.069 (e) P=0.505 P=0.237 |
|POLY 6 | P=0.205N P=0.504N P=0.333N P=0.309N |P=0.066 (e) P=0.506 P=0.231 |
|LOGISTIC REGRESSION| P=0.196N P=0.510N P=0.330N P=0.298N |(e) (e) P=0.500 P=0.223 |
|COCH-ARM / FISHERS | P=0.199N P=0.500N P=0.309N P=0.309N |P=0.070 (e) P=0.500 P=0.247 |
|ORDER RESTRICTED | P=0.223N (e) (e) (e) |P=0.073 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 11/50 (22%) 10/50 (20%) 14/50 (28%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 17/48.24 11/48.10 10/45.68 14/48.73 |0/46.61 0/47.80 0/48.01 0/46.05 |
|POLY-3 PERCENT (g) | 35.2% 22.9% 21.9% 28.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 17/45 (38%) 10/44 (23%) 10/42 (24%) 13/46 (28%) |0/43 (0%) 0/40 (0%) 0/43 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 676 729 (T) 355 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.348N P=0.147N P=0.121N P=0.307N |(e) (e) (e) (e) |
|POLY 3 | P=0.368N P=0.132N P=0.114N P=0.320N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.368N P=0.133N P=0.103N P=0.324N |(e) (e) (e) (e) |
|POLY 6 | P=0.370N P=0.131N P=0.126N P=0.318N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.384N P=0.139N P=0.121N P=0.334N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.372N P=0.133N P=0.088N P=0.333N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.181N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex: Capsule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 5/50 (10%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/48.24 1/47.90 2/45.68 5/47.85 |0/46.61 2/47.80 0/48.01 0/46.05 |
|POLY-3 PERCENT (g) | 2.1% 2.1% 4.4% 10.5% |0.0% 4.2% 0.0% 0.0% |
|TERMINAL (d) | 1/45 (2%) 1/44 (2%) 2/42 (5%) 5/46 (11%) |0/43 (0%) 2/40 (5%) 0/43 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.032 * P=0.757 P=0.476 P=0.109 |P=0.414N P=0.223 (e) (e) |
|POLY 3 | P=0.027 * P=0.759 P=0.481 P=0.100 |P=0.400N P=0.243 (e) (e) |
|POLY 1.5 | P=0.027 * P=0.759 P=0.488 P=0.101 |P=0.399N P=0.243 (e) (e) |
|POLY 6 | P=0.027 * P=0.758 P=0.474 P=0.100 |P=0.403N P=0.242 (e) (e) |
|LOGISTIC REGRESSION| P=0.032 * P=0.757 P=0.476 P=0.109 |(e) P=0.223 (e) (e) |
|COCH-ARM / FISHERS | P=0.029 * P=0.753N P=0.500 P=0.102 |P=0.405N P=0.247 (e) (e) |
|ORDER RESTRICTED | P=0.035 * (e) (e) (e) |P=0.254N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/48.24 0/47.90 0/45.68 0/47.85 |0/46.61 0/47.80 1/48.01 2/46.22 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 2.1% 4.3% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 0/46 (0%) |0/43 (0%) 0/40 (0%) 1/43 (2%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) 685 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.066 (e) P=0.500 P=0.227 |
|POLY 3 | (e) (e) (e) (e) |P=0.068 (e) P=0.506 P=0.235 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.069 (e) P=0.505 P=0.237 |
|POLY 6 | (e) (e) (e) (e) |P=0.067 (e) P=0.506 P=0.233 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.069 (e) P=0.500 P=0.238 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.070 (e) P=0.500 P=0.247 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.073 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Hyperostosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |10/50 (20%) 12/50 (24%) 10/50 (20%) 6/50 (12%) |
|POLY-3 RATE (b) | 0/48.24 0/47.90 0/45.68 0/47.85 |10/46.61 12/48.15 10/48.01 6/46.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |21.5% 24.9% 20.8% 13.0% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 0/46 (0%) |10/43 (23%) 10/40 (25%) 10/43 (23%) 6/40 (15%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 668 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.148N P=0.341 P=0.600 P=0.251N |
|POLY 3 | (e) (e) (e) (e) |P=0.132N P=0.438 P=0.570N P=0.213N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.126N P=0.433 P=0.574N P=0.207N |
|POLY 6 | (e) (e) (e) (e) |P=0.140N P=0.440 P=0.569N P=0.221N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.142N P=0.423 P=0.600 P=0.251N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.123N P=0.405 P=0.598N P=0.207N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.175N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 15/50 (30%) 14/50 (28%) 15/50 (30%) |13/50 (26%) 13/50 (26%) 10/50 (20%) 17/50 (34%) |
|POLY-3 RATE (b) | 13/48.95 15/49.04 14/49.40 15/48.52 |13/47.98 13/49.63 10/48.60 17/46.46 |
|POLY-3 PERCENT (g) | 26.6% 30.6% 28.3% 30.9% |27.1% 26.2% 20.6% 36.6% |
|TERMINAL (d) | 11/45 (24%) 11/44 (25%) 7/42 (17%) 13/46 (28%) |9/43 (21%) 6/40 (15%) 9/43 (21%) 15/40 (38%) |
|FIRST INCIDENCE | 513 586 348 628 |539 525 539 665 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.430 P=0.397 P=0.432 P=0.437 |P=0.188 P=0.539 P=0.321N P=0.203 |
|POLY 3 | P=0.395 P=0.415 P=0.511 P=0.401 |P=0.181 P=0.551N P=0.305N P=0.221 |
|POLY 1.5 | P=0.398 P=0.411 P=0.507 P=0.403 |P=0.198 P=0.558N P=0.303N P=0.240 |
|POLY 6 | P=0.396 P=0.422 P=0.516 P=0.404 |P=0.163 P=0.546N P=0.312N P=0.199 |
|LOGISTIC REGRESSION| P=0.430 P=0.420 P=0.504N P=0.414 |P=0.217 P=0.535 P=0.336N P=0.255 |
|COCH-ARM / FISHERS | P=0.406 P=0.412 P=0.500 P=0.412 |P=0.216 P=0.590N P=0.318N P=0.257 |
|ORDER RESTRICTED | P=0.503 (e) (e) (e) |P=0.152 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/48.89 0/47.90 0/45.68 0/47.85 |0/46.61 2/48.27 1/48.01 2/46.42 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 0.0% |0.0% 4.1% 2.1% 4.3% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 0/46 (0%) |0/43 (0%) 0/40 (0%) 1/43 (2%) 0/40 (0%) |
|FIRST INCIDENCE | 513 --- --- --- |--- 632 729 (T) 647 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.307N P=0.500N P=0.504N P=0.500N |P=0.237 P=0.247 P=0.500 P=0.235 |
|POLY 3 | P=0.306N P=0.504N P=0.514N P=0.504N |P=0.245 P=0.245 P=0.506 P=0.236 |
|POLY 1.5 | P=0.306N P=0.503N P=0.509N P=0.503N |P=0.247 P=0.244 P=0.505 P=0.238 |
|POLY 6 | P=0.306N P=0.506N P=0.519N P=0.506N |P=0.242 P=0.246 P=0.506 P=0.234 |
|LOGISTIC REGRESSION| P=0.244N P=0.375N P=0.312N P=0.377N |P=0.240 P=0.199 P=0.500 P=0.232 |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.246 P=0.247 P=0.500 P=0.247 |
|ORDER RESTRICTED | P=0.124N (e) (e) (e) |P=0.155 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 3/49 (6%) 5/50 (10%) 3/50 (6%) |
|POLY-3 RATE (b) | |1/46.61 3/46.84 5/48.52 3/46.05 |
|POLY-3 PERCENT (g) | |2.2% 6.4% 10.3% 6.5% |
|TERMINAL (d) | |1/43 (2%) 2/40 (5%) 3/43 (7%) 3/40 (8%) |
|FIRST INCIDENCE | |729 (T) 721 635 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.255 P=0.284 P=0.112 P=0.280 |
|POLY 3 | |P=0.266 P=0.307 P=0.111 P=0.301 |
|POLY 1.5 | |P=0.273 P=0.307 P=0.109 P=0.305 |
|POLY 6 | |P=0.257 P=0.305 P=0.114 P=0.296 |
|LOGISTIC REGRESSION| |P=0.272 P=0.296 P=0.099 P=0.280 |
|COCH-ARM / FISHERS | |P=0.276 P=0.301 P=0.102 P=0.309 |
|ORDER RESTRICTED | |P=0.168 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/48.29 0/47.90 0/45.68 2/47.85 |0/46.61 0/47.80 2/48.01 1/46.05 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 4.2% |0.0% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 2/46 (4%) |0/43 (0%) 0/40 (0%) 2/43 (5%) 1/40 (3%) |
|FIRST INCIDENCE | 715 --- --- 729 (T) |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.252 P=0.500N P=0.518N P=0.505 |P=0.235 (e) P=0.238 P=0.486 |
|POLY 3 | P=0.244 P=0.502N P=0.511N P=0.497 |P=0.237 (e) P=0.244 P=0.498 |
|POLY 1.5 | P=0.244 P=0.501N P=0.507N P=0.498 |P=0.241 (e) P=0.243 P=0.500 |
|POLY 6 | P=0.243 P=0.502N P=0.515N P=0.496 |P=0.231 (e) P=0.244 P=0.495 |
|LOGISTIC REGRESSION| P=0.244 P=0.500N P=0.506N P=0.497 |(e) (e) P=0.238 P=0.486 |
|COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.500N P=0.500 |P=0.246 (e) P=0.247 P=0.500 |
|ORDER RESTRICTED | P=0.131 (e) (e) (e) |P=0.173 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |2/50 (4%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/48.24 1/47.90 1/45.68 3/48.21 |2/46.61 3/47.80 2/48.01 0/46.05 |
|POLY-3 PERCENT (g) | 2.1% 2.1% 2.2% 6.2% |4.3% 6.3% 4.2% 0.0% |
|TERMINAL (d) | 1/45 (2%) 1/44 (2%) 1/42 (2%) 2/46 (4%) |2/43 (5%) 3/40 (8%) 2/43 (5%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 628 |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.172 P=0.757 P=0.746 P=0.313 |P=0.144N P=0.467 P=0.695 P=0.254N |
|POLY 3 | P=0.163 P=0.759 P=0.748 P=0.305 |P=0.138N P=0.511 P=0.683N P=0.240N |
|POLY 1.5 | P=0.163 P=0.759 P=0.753 P=0.305 |P=0.135N P=0.511 P=0.685N P=0.238N |
|POLY 6 | P=0.164 P=0.758 P=0.744 P=0.307 |P=0.141N P=0.509 P=0.683N P=0.243N |
|LOGISTIC REGRESSION| P=0.163 P=0.757 P=0.746 P=0.310 |P=0.144N P=0.467 P=0.695 (e) |
|COCH-ARM / FISHERS | P=0.163 P=0.753N P=0.753N P=0.309 |P=0.134N P=0.500 P=0.691N P=0.247N |
|ORDER RESTRICTED | P=0.189 (e) (e) (e) |P=0.141N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/48.24 0/47.90 2/45.68 1/47.85 |1/46.61 0/47.80 1/48.01 0/46.05 |
|POLY-3 PERCENT (g) | 4.2% 0.0% 4.4% 2.1% |2.2% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 2/45 (4%) 0/44 (0%) 2/42 (5%) 1/46 (2%) |1/43 (2%) 0/40 (0%) 1/43 (2%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.523N P=0.243N P=0.670 P=0.492N |P=0.415N P=0.514N P=0.762 P=0.514N |
|POLY 3 | P=0.533N P=0.239N P=0.674 P=0.503N |P=0.410N P=0.495N P=0.754N P=0.502N |
|POLY 1.5 | P=0.532N P=0.239N P=0.681 P=0.502N |P=0.409N P=0.495N P=0.755N P=0.500N |
|POLY 6 | P=0.533N P=0.239N P=0.667 P=0.503N |P=0.412N P=0.496N P=0.754N P=0.505N |
|LOGISTIC REGRESSION| P=0.523N (e) P=0.670 P=0.492N |P=0.415N (e) P=0.762 (e) |
|COCH-ARM / FISHERS | P=0.531N P=0.247N P=0.691N P=0.500N |P=0.405N P=0.500N P=0.753N P=0.500N |
|ORDER RESTRICTED | P=0.418N (e) (e) (e) |P=0.254N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/48.24 0/47.90 2/46.66 0/47.85 |0/46.61 0/47.80 0/48.01 4/47.24 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.3% 0.0% |0.0% 0.0% 0.0% 8.5% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 0/46 (0%) |0/43 (0%) 0/40 (0%) 0/43 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- 522 --- |--- --- --- 409 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.593 (e) P=0.230 (e) |P=0.003 ** (e) (e) P=0.064 |
|POLY 3 | P=0.594 (e) P=0.230 (e) |P=0.003 ** (e) (e) P=0.062 |
|POLY 1.5 | P=0.594 (e) P=0.232 (e) |P=0.003 ** (e) (e) P=0.062 |
|POLY 6 | P=0.594 (e) P=0.228 (e) |P=0.003 ** (e) (e) P=0.061 |
|LOGISTIC REGRESSION| P=0.643 (e) P=0.350 (e) |P=0.002 ** (e) (e) P=0.045 * |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.003 ** (e) (e) P=0.059 |
|ORDER RESTRICTED | P=0.241 (e) (e) (e) |P=0.002 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/49 (2%) 3/47 (6%) 4/50 (8%) |3/49 (6%) 4/48 (8%) 2/46 (4%) 2/46 (4%) |
|POLY-3 RATE (b) | 3/48.24 1/47.38 3/43.85 4/47.85 |3/46.61 4/46.78 2/44.63 2/42.28 |
|POLY-3 PERCENT (g) | 6.2% 2.1% 6.8% 8.4% |6.4% 8.6% 4.5% 4.7% |
|TERMINAL (d) | 3/45 (7%) 1/44 (2%) 3/42 (7%) 4/46 (9%) |3/43 (7%) 3/40 (8%) 2/41 (5%) 2/38 (5%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 525 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.294 P=0.314N P=0.631 P=0.512 |P=0.364N P=0.468 P=0.522N P=0.556N |
|POLY 3 | P=0.279 P=0.312N P=0.617 P=0.496 |P=0.363N P=0.502 P=0.520N P=0.544N |
|POLY 1.5 | P=0.281 P=0.313N P=0.622 P=0.497 |P=0.359N P=0.497 P=0.523N P=0.539N |
|POLY 6 | P=0.278 P=0.311N P=0.614 P=0.495 |P=0.368N P=0.505 P=0.517N P=0.550N |
|LOGISTIC REGRESSION| P=0.294 P=0.314N P=0.631 P=0.512 |P=0.339N P=0.462 P=0.522N P=0.556N |
|COCH-ARM / FISHERS | P=0.284 P=0.316N P=0.631 P=0.500 |P=0.348N P=0.488 P=0.530N P=0.530N |
|ORDER RESTRICTED | P=0.301 (e) (e) (e) |P=0.455N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 2/47 (4%) 3/48 (6%) 1/50 (2%) |4/50 (8%) 2/48 (4%) 2/47 (4%) 0/47 (0%) |
|POLY-3 RATE (b) | 2/46.29 2/46.49 3/44.48 1/47.85 |4/46.61 2/45.93 2/45.13 0/43.28 |
|POLY-3 PERCENT (g) | 4.3% 4.3% 6.8% 2.1% |8.6% 4.4% 4.4% 0.0% |
|TERMINAL (d) | 2/44 (5%) 2/44 (5%) 3/42 (7%) 1/46 (2%) |4/43 (9%) 2/40 (5%) 2/42 (5%) 0/39 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.388N P=0.695 P=0.479 P=0.484N |P=0.051N P=0.371N P=0.348N P=0.076N |
|POLY 3 | P=0.393N P=0.692N P=0.482 P=0.489N |P=0.051N P=0.344N P=0.352N P=0.070N |
|POLY 1.5 | P=0.391N P=0.692 P=0.488 P=0.488N |P=0.051N P=0.345N P=0.355N P=0.069N |
|POLY 6 | P=0.396N P=0.690N P=0.476 P=0.489N |P=0.052N P=0.346N P=0.351N P=0.072N |
|LOGISTIC REGRESSION| P=0.388N P=0.695 P=0.479 P=0.484N |P=0.051N P=0.371N P=0.348N (e) |
|COCH-ARM / FISHERS | P=0.384N P=0.684 P=0.500 P=0.485N |P=0.050N P=0.359N P=0.369N P=0.066N |
|ORDER RESTRICTED | P=0.374N (e) (e) (e) |P=0.033N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 2/49 (4%) 0/50 (0%) 1/50 (2%) |1/49 (2%) 0/48 (0%) 0/47 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 4/47.37 2/47.38 0/45.68 1/47.85 |1/46.61 0/46.15 0/45.13 2/45.05 |
|POLY-3 PERCENT (g) | 8.4% 4.2% 0.0% 2.1% |2.2% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 4/45 (9%) 2/44 (5%) 0/42 (0%) 1/46 (2%) |1/43 (2%) 0/40 (0%) 0/42 (0%) 2/39 (5%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |729 (T) --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.085N P=0.348N P=0.072N P=0.174N |P=0.229 P=0.514N P=0.505N P=0.466 |
|POLY 3 | P=0.084N P=0.337N P=0.065N P=0.176N |P=0.242 P=0.502N P=0.506N P=0.488 |
|POLY 1.5 | P=0.083N P=0.338N P=0.062N P=0.175N |P=0.244 P=0.503N P=0.507N P=0.493 |
|POLY 6 | P=0.086N P=0.337N P=0.068N P=0.177N |P=0.241 P=0.502N P=0.506N P=0.483 |
|LOGISTIC REGRESSION| P=0.085N P=0.348N (e) P=0.174N |P=0.229 (e) (e) P=0.466 |
|COCH-ARM / FISHERS | P=0.083N P=0.339N P=0.056N P=0.175N |P=0.247 P=0.505N P=0.510N P=0.500 |
|ORDER RESTRICTED | P=0.038N* (e) (e) (e) |P=0.124 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 12/50 (24%) 12/50 (24%) 7/50 (14%) |1/49 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 13/48.24 12/48.10 12/45.84 7/47.85 |1/46.61 1/47.80 0/48.01 0/46.05 |
|POLY-3 PERCENT (g) | 27.0% 25.0% 26.2% 14.6% |2.2% 2.1% 0.0% 0.0% |
|TERMINAL (d) | 13/45 (29%) 11/44 (25%) 11/42 (26%) 7/46 (15%) |1/43 (2%) 1/40 (3%) 0/43 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 676 686 729 (T) |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.077N P=0.526N P=0.580N P=0.094N |P=0.243N P=0.746 P=0.500N P=0.514N |
|POLY 3 | P=0.087N P=0.503N P=0.559N P=0.107N |P=0.234N P=0.755N P=0.494N P=0.502N |
|POLY 1.5 | P=0.086N P=0.504N P=0.538N P=0.107N |P=0.234N P=0.755N P=0.495N P=0.500N |
|POLY 6 | P=0.088N P=0.502N P=0.578N P=0.108N |P=0.234N P=0.756N P=0.494N P=0.505N |
|LOGISTIC REGRESSION| P=0.090N P=0.513N P=0.585 P=0.094N |P=0.243N P=0.746 (e) (e) |
|COCH-ARM / FISHERS | P=0.083N P=0.500N P=0.500N P=0.105N |P=0.233N P=0.747N P=0.495N P=0.495N |
|ORDER RESTRICTED | P=0.114N (e) (e) (e) |P=0.254N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |1/49 (2%) 2/50 (4%) 6/50 (12%) 3/50 (6%) |
|POLY-3 RATE (b) | 2/48.24 2/47.90 0/45.68 2/47.85 |1/46.61 2/47.80 6/48.01 3/46.46 |
|POLY-3 PERCENT (g) | 4.2% 4.2% 0.0% 4.2% |2.2% 4.2% 12.5% 6.5% |
|TERMINAL (d) | 2/45 (4%) 2/44 (5%) 0/42 (0%) 2/46 (4%) |1/43 (2%) 1/40 (3%) 6/43 (14%) 1/40 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |729 (T) 727 729 (T) 665 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.546N P=0.686 P=0.254N P=0.687N |P=0.194 P=0.478 P=0.058 P=0.289 |
|POLY 3 | P=0.561N P=0.691 P=0.250N P=0.691 |P=0.200 P=0.509 P=0.061 P=0.304 |
|POLY 1.5 | P=0.559N P=0.692 P=0.245N P=0.691 |P=0.205 P=0.509 P=0.061 P=0.307 |
|POLY 6 | P=0.563N P=0.690 P=0.254N P=0.690 |P=0.197 P=0.507 P=0.061 P=0.302 |
|LOGISTIC REGRESSION| P=0.546N P=0.686 (e) P=0.687N |P=0.203 P=0.491 P=0.058 P=0.319 |
|COCH-ARM / FISHERS | P=0.556N P=0.691N P=0.247N P=0.691N |P=0.216 P=0.508 P=0.059 P=0.316 |
|ORDER RESTRICTED | P=0.451N (e) (e) (e) |P=0.111 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/50 (0%) 2/50 (4%) |1/49 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/48.24 3/47.90 0/45.68 2/47.85 |1/46.61 1/47.80 0/48.01 1/46.05 |
|POLY-3 PERCENT (g) | 4.2% 6.3% 0.0% 4.2% |2.2% 2.1% 0.0% 2.2% |
|TERMINAL (d) | 2/45 (4%) 3/44 (7%) 0/42 (0%) 2/46 (4%) |1/43 (2%) 1/40 (3%) 0/43 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |729 (T) 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.465N P=0.490 P=0.254N P=0.687N |P=0.629N P=0.746 P=0.500N P=0.746 |
|POLY 3 | P=0.481N P=0.497 P=0.250N P=0.691 |P=0.613N P=0.755N P=0.494N P=0.758 |
|POLY 1.5 | P=0.479N P=0.498 P=0.245N P=0.691 |P=0.612N P=0.755N P=0.495N P=0.760 |
|POLY 6 | P=0.483N P=0.496 P=0.254N P=0.690 |P=0.613N P=0.756N P=0.494N P=0.755 |
|LOGISTIC REGRESSION| P=0.465N P=0.490 (e) P=0.687N |P=0.629N P=0.746 (e) P=0.746 |
|COCH-ARM / FISHERS | P=0.474N P=0.500 P=0.247N P=0.691N |P=0.612N P=0.747N P=0.495N P=0.747N |
|ORDER RESTRICTED | P=0.337N (e) (e) (e) |P=0.535N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/48.24 0/47.90 2/46.19 0/47.85 |0/46.61 0/47.80 0/48.01 0/46.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.3% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 0/46 (0%) |0/43 (0%) 0/40 (0%) 0/43 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- 632 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.588 (e) P=0.221 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.595 (e) P=0.228 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.595 (e) P=0.231 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.595 (e) P=0.225 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.611 (e) P=0.276 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.239 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 40/50 (80%) 38/50 (76%) 35/50 (70%) |21/49 (43%) 20/50 (40%) 17/50 (34%) 25/50 (50%) |
|POLY-3 RATE (b) | 34/49.05 40/49.06 38/47.00 35/48.21 |21/47.38 20/49.07 17/48.34 25/49.53 |
|POLY-3 PERCENT (g) | 69.3% 81.5% 80.9% 72.6% |44.3% 40.8% 35.2% 50.5% |
|TERMINAL (d) | 32/45 (71%) 37/44 (84%) 35/42 (83%) 34/46 (74%) |18/43 (42%) 14/40 (35%) 16/43 (37%) 17/40 (43%) |
|FIRST INCIDENCE | 459 335 441 628 |539 525 635 409 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.418N P=0.101 P=0.114 P=0.562 |P=0.190 P=0.558 P=0.270N P=0.217 |
|POLY 3 | P=0.518 P=0.117 P=0.137 P=0.447 |P=0.270 P=0.441N P=0.240N P=0.344 |
|POLY 1.5 | P=0.540 P=0.122 P=0.173 P=0.461 |P=0.261 P=0.450N P=0.241N P=0.329 |
|POLY 6 | P=0.507 P=0.111 P=0.109 P=0.441 |P=0.280 P=0.437N P=0.242N P=0.358 |
|LOGISTIC REGRESSION| P=0.524N P=0.120 P=0.146 P=0.478 |P=0.286 P=0.469N P=0.232N P=0.351 |
|COCH-ARM / FISHERS | P=0.489N P=0.127 P=0.252 P=0.500 |P=0.247 P=0.466N P=0.242N P=0.305 |
|ORDER RESTRICTED | P=0.226 (e) (e) (e) |P=0.238 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/49 (6%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/48.24 0/47.90 0/45.68 0/47.85 |3/46.61 2/48.78 1/48.01 2/46.12 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.4% 4.1% 2.1% 4.3% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 0/46 (0%) |3/43 (7%) 0/40 (0%) 1/43 (2%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 525 729 (T) 711 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.420N P=0.510N P=0.305N P=0.530N |
|POLY 3 | (e) (e) (e) (e) |P=0.408N P=0.479N P=0.295N P=0.505N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.404N P=0.483N P=0.296N P=0.500N |
|POLY 6 | (e) (e) (e) (e) |P=0.412N P=0.477N P=0.294N P=0.511N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.343N P=0.557N P=0.305N P=0.517N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.397N P=0.490N P=0.301N P=0.490N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.354N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/48.24 0/47.90 0/45.68 0/47.85 |0/46.61 0/47.80 2/48.01 0/46.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.2% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 0/46 (0%) |0/43 (0%) 0/40 (0%) 2/43 (5%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.585 (e) P=0.238 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.582 (e) P=0.244 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.589 (e) P=0.243 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.574 (e) P=0.244 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.238 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.595 (e) P=0.247 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.254 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/48.24 3/47.90 2/45.68 3/47.85 |0/46.61 0/47.80 0/48.01 0/46.05 |
|POLY-3 PERCENT (g) | 6.2% 6.3% 4.4% 6.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/45 (7%) 3/44 (7%) 2/42 (5%) 3/46 (7%) |0/43 (0%) 0/40 (0%) 0/43 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.550N P=0.652 P=0.531N P=0.653N |(e) (e) (e) (e) |
|POLY 3 | P=0.569N P=0.659 P=0.525N P=0.658 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.567N P=0.659 P=0.516N P=0.659 |(e) (e) (e) (e) |
|POLY 6 | P=0.571N P=0.658 P=0.534N P=0.658 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.550N P=0.652 P=0.531N P=0.653N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.562N P=0.661N P=0.500N P=0.661N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.656N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/48.24 1/47.90 0/45.68 1/47.85 |3/46.61 0/47.80 0/48.01 1/46.05 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 2.1% |6.4% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/45 (0%) 1/44 (2%) 0/42 (0%) 1/46 (2%) |3/43 (7%) 0/40 (0%) 0/43 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |729 (T) --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.411 P=0.496 (e) P=0.504 |P=0.258N P=0.134N P=0.121N P=0.331N |
|POLY 3 | P=0.402 P=0.499 (e) P=0.498 |P=0.248N P=0.114N P=0.114N P=0.310N |
|POLY 1.5 | P=0.403 P=0.499 (e) P=0.499 |P=0.249N P=0.115N P=0.115N P=0.306N |
|POLY 6 | P=0.401 P=0.498 (e) P=0.498 |P=0.247N P=0.115N P=0.113N P=0.315N |
|LOGISTIC REGRESSION| (e) P=0.496 (e) P=0.504 |P=0.258N (e) (e) P=0.331N |
|COCH-ARM / FISHERS | P=0.405 P=0.500 (e) P=0.500 |P=0.248N P=0.121N P=0.121N P=0.309N |
|ORDER RESTRICTED | P=0.250 (e) (e) (e) |P=0.038N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/48.24 2/48.10 1/45.68 1/47.85 |1/46.61 2/47.80 1/48.18 0/46.05 |
|POLY-3 PERCENT (g) | 10.4% 4.2% 2.2% 2.1% |2.2% 4.2% 2.1% 0.0% |
|TERMINAL (d) | 5/45 (11%) 1/44 (2%) 1/42 (2%) 1/46 (2%) |1/43 (2%) 2/40 (5%) 0/43 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 676 729 (T) 729 (T) |729 (T) 729 (T) 685 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.061N P=0.228N P=0.120N P=0.099N |P=0.258N P=0.475 P=0.758N P=0.514N |
|POLY 3 | P=0.061N P=0.218N P=0.115N P=0.104N |P=0.250N P=0.509 P=0.753N P=0.502N |
|POLY 1.5 | P=0.060N P=0.218N P=0.110N P=0.103N |P=0.248N P=0.508 P=0.754N P=0.500N |
|POLY 6 | P=0.062N P=0.217N P=0.120N P=0.104N |P=0.253N P=0.507 P=0.752N P=0.505N |
|LOGISTIC REGRESSION| P=0.063N P=0.218N P=0.120N P=0.099N |P=0.248N P=0.475 P=0.762 (e) |
|COCH-ARM / FISHERS | P=0.060N P=0.218N P=0.102N P=0.102N |P=0.247N P=0.500 P=0.753N P=0.500N |
|ORDER RESTRICTED | P=0.037N* (e) (e) (e) |P=0.234N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |6/50 (12%) 0/50 (0%) 5/50 (10%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/48.24 0/47.90 0/45.68 0/47.85 |6/47.21 0/47.80 5/48.60 3/46.22 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |12.7% 0.0% 10.3% 6.5% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 0/46 (0%) |5/43 (12%) 0/40 (0%) 4/43 (9%) 2/40 (5%) |
|FIRST INCIDENCE | --- --- --- --- |539 --- 539 685 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.415N P=0.022N* P=0.497N P=0.278N |
|POLY 3 | (e) (e) (e) (e) |P=0.403N P=0.015N* P=0.480N P=0.253N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.397N P=0.015N* P=0.483N P=0.246N |
|POLY 6 | (e) (e) (e) (e) |P=0.407N P=0.015N* P=0.479N P=0.261N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.392N P=0.018N* P=0.531N P=0.242N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.390N P=0.013N* P=0.500N P=0.243N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.147N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/48.24 0/47.90 0/45.68 1/47.85 |2/46.61 3/47.80 1/48.01 0/46.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.1% |4.3% 6.3% 2.1% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 1/46 (2%) |2/43 (5%) 3/40 (8%) 1/43 (2%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.205 (e) (e) P=0.504 |P=0.111N P=0.467 P=0.500N P=0.254N |
|POLY 3 | P=0.198 (e) (e) P=0.498 |P=0.105N P=0.511 P=0.490N P=0.240N |
|POLY 1.5 | P=0.198 (e) (e) P=0.499 |P=0.103N P=0.511 P=0.491N P=0.238N |
|POLY 6 | P=0.198 (e) (e) P=0.498 |P=0.107N P=0.509 P=0.489N P=0.243N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.504 |P=0.111N P=0.467 P=0.500N (e) |
|COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.500 |P=0.104N P=0.500 P=0.500N P=0.247N |
|ORDER RESTRICTED | P=0.119 (e) (e) (e) |P=0.114N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/48.24 0/47.90 3/45.68 1/47.85 |1/46.61 3/47.80 1/48.01 1/46.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.6% 2.1% |2.2% 6.3% 2.1% 2.2% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 3/42 (7%) 1/46 (2%) |1/43 (2%) 3/40 (8%) 1/43 (2%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.256 (e) P=0.109 P=0.504 |P=0.462N P=0.280 P=0.762 P=0.746 |
|POLY 3 | P=0.245 (e) P=0.109 P=0.498 |P=0.446N P=0.315 P=0.754N P=0.758 |
|POLY 1.5 | P=0.245 (e) P=0.113 P=0.499 |P=0.443N P=0.314 P=0.755N P=0.760 |
|POLY 6 | P=0.245 (e) P=0.106 P=0.498 |P=0.451N P=0.313 P=0.754N P=0.755 |
|LOGISTIC REGRESSION| (e) (e) P=0.109 P=0.504 |P=0.462N P=0.280 P=0.762 P=0.746 |
|COCH-ARM / FISHERS | P=0.247 (e) P=0.121 P=0.500 |P=0.444N P=0.309 P=0.753N P=0.753N |
|ORDER RESTRICTED | P=0.106 (e) (e) (e) |P=0.449N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 7/50 (14%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/48.24 7/47.90 2/45.68 0/47.85 |1/46.61 0/47.80 1/48.01 0/46.05 |
|POLY-3 PERCENT (g) | 6.2% 14.6% 4.4% 0.0% |2.2% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 3/45 (7%) 7/44 (16%) 2/42 (5%) 0/46 (0%) |1/43 (2%) 0/40 (0%) 1/43 (2%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.034N* P=0.149 P=0.531N P=0.118N |P=0.415N P=0.514N P=0.762 P=0.514N |
|POLY 3 | P=0.035N* P=0.155 P=0.525N P=0.120N |P=0.410N P=0.495N P=0.754N P=0.502N |
|POLY 1.5 | P=0.034N* P=0.156 P=0.516N P=0.120N |P=0.409N P=0.495N P=0.755N P=0.500N |
|POLY 6 | P=0.035N* P=0.154 P=0.534N P=0.121N |P=0.412N P=0.496N P=0.754N P=0.505N |
|LOGISTIC REGRESSION| P=0.034N* P=0.149 P=0.531N (e) |P=0.415N (e) P=0.762 (e) |
|COCH-ARM / FISHERS | P=0.035N* P=0.159 P=0.500N P=0.121N |P=0.405N P=0.500N P=0.753N P=0.500N |
|ORDER RESTRICTED | P=0.022N* (e) (e) (e) |P=0.254N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |4/50 (8%) 3/50 (6%) 2/50 (4%) 6/50 (12%) |
|POLY-3 RATE (b) | 2/49.12 3/47.90 2/45.68 0/47.85 |4/46.70 3/48.42 2/48.01 6/46.74 |
|POLY-3 PERCENT (g) | 4.1% 6.3% 4.4% 0.0% |8.6% 6.2% 4.2% 12.8% |
|TERMINAL (d) | 0/45 (0%) 3/44 (7%) 2/42 (5%) 0/46 (0%) |3/43 (7%) 2/40 (5%) 2/43 (5%) 3/40 (8%) |
|FIRST INCIDENCE | 459 729 (T) 729 (T) --- |707 525 729 (T) 640 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.137N P=0.490 P=0.666 P=0.244N |P=0.232 P=0.530N P=0.337N P=0.342 |
|POLY 3 | P=0.142N P=0.489 P=0.667 P=0.243N |P=0.244 P=0.480N P=0.325N P=0.370 |
|POLY 1.5 | P=0.140N P=0.492 P=0.677 P=0.241N |P=0.247 P=0.484N P=0.327N P=0.373 |
|POLY 6 | P=0.145N P=0.484 P=0.657 P=0.245N |P=0.242 P=0.481N P=0.325N P=0.367 |
|LOGISTIC REGRESSION| P=0.124N P=0.533 P=0.618N P=0.156N |P=0.248 P=0.520N P=0.323N P=0.369 |
|COCH-ARM / FISHERS | P=0.134N P=0.500 P=0.691N P=0.247N |P=0.248 P=0.500N P=0.339N P=0.370 |
|ORDER RESTRICTED | P=0.135N (e) (e) (e) |P=0.191 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/48.24 5/47.90 2/45.68 0/47.85 |1/46.70 1/47.90 1/48.18 1/46.87 |
|POLY-3 PERCENT (g) | 8.3% 10.4% 4.4% 0.0% |2.1% 2.1% 2.1% 2.1% |
|TERMINAL (d) | 4/45 (9%) 5/44 (11%) 2/42 (5%) 0/46 (0%) |0/43 (0%) 0/40 (0%) 0/43 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |707 702 684 409 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.026N* P=0.486 P=0.369N P=0.061N |P=0.622 P=0.753 P=0.753N P=0.755 |
|POLY 3 | P=0.027N* P=0.496 P=0.363N P=0.062N |P=0.632 P=0.755N P=0.753N P=0.760N |
|POLY 1.5 | P=0.026N* P=0.497 P=0.354N P=0.061N |P=0.631N P=0.755N P=0.755N P=0.758N |
|POLY 6 | P=0.027N* P=0.494 P=0.373N P=0.062N |P=0.628 P=0.756N P=0.753N P=0.759 |
|LOGISTIC REGRESSION| P=0.026N* P=0.486 P=0.369N (e) |P=0.581 P=0.761 P=0.756 P=0.713 |
|COCH-ARM / FISHERS | P=0.026N* P=0.500 P=0.339N P=0.059N |P=0.634 P=0.753N P=0.753N P=0.753N |
|ORDER RESTRICTED | P=0.032N* (e) (e) (e) |P=0.741N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Kupffer Cell |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/48.24 0/47.90 0/45.68 0/47.85 |1/47.17 1/47.83 2/48.34 0/46.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.1% 2.1% 4.1% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 0/46 (0%) |0/43 (0%) 0/40 (0%) 1/43 (2%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- |555 721 635 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.375N P=0.758N P=0.510 P=0.500N |
|POLY 3 | (e) (e) (e) (e) |P=0.377N P=0.757N P=0.509 P=0.505N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.371N P=0.757N P=0.508 P=0.502N |
|POLY 6 | (e) (e) (e) (e) |P=0.383N P=0.760N P=0.509 P=0.509N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.392N P=0.721 P=0.419 P=0.564N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.366N P=0.753N P=0.500 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.281N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 5/50 (10%) |1/50 (2%) 2/50 (4%) 3/50 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 3/48.24 2/47.90 1/45.68 5/47.85 |1/46.61 2/47.80 3/48.01 4/47.36 |
|POLY-3 PERCENT (g) | 6.2% 4.2% 2.2% 10.5% |2.2% 4.2% 6.3% 8.5% |
|TERMINAL (d) | 3/45 (7%) 2/44 (5%) 1/42 (2%) 5/46 (11%) |1/43 (2%) 2/40 (5%) 3/43 (7%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) 447 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.227 P=0.510N P=0.330N P=0.369 |P=0.107 P=0.475 P=0.305 P=0.176 |
|POLY 3 | P=0.211 P=0.503N P=0.325N P=0.352 |P=0.117 P=0.509 P=0.316 P=0.184 |
|POLY 1.5 | P=0.213 P=0.502N P=0.318N P=0.354 |P=0.117 P=0.508 P=0.315 P=0.184 |
|POLY 6 | P=0.210 P=0.504N P=0.333N P=0.352 |P=0.118 P=0.507 P=0.317 P=0.184 |
|LOGISTIC REGRESSION| P=0.227 P=0.510N P=0.330N P=0.369 |P=0.111 P=0.475 P=0.305 P=0.153 |
|COCH-ARM / FISHERS | P=0.216 P=0.500N P=0.309N P=0.357 |P=0.114 P=0.500 P=0.309 P=0.181 |
|ORDER RESTRICTED | P=0.147 (e) (e) (e) |P=0.136 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 6/50 (12%) 2/50 (4%) |6/50 (12%) 6/50 (12%) 8/50 (16%) 8/50 (16%) |
|POLY-3 RATE (b) | 3/48.24 2/47.90 6/45.68 2/47.85 |6/46.61 6/47.80 8/48.01 8/46.05 |
|POLY-3 PERCENT (g) | 6.2% 4.2% 13.1% 4.2% |12.9% 12.6% 16.7% 17.4% |
|TERMINAL (d) | 3/45 (7%) 2/44 (5%) 6/42 (14%) 2/46 (4%) |6/43 (14%) 6/40 (15%) 8/43 (19%) 8/40 (20%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.507N P=0.510N P=0.209 P=0.490N |P=0.252 P=0.570 P=0.386 P=0.330 |
|POLY 3 | P=0.524N P=0.503N P=0.216 P=0.504N |P=0.277 P=0.603N P=0.410 P=0.377 |
|POLY 1.5 | P=0.523N P=0.502N P=0.226 P=0.503N |P=0.286 P=0.604N P=0.406 P=0.386 |
|POLY 6 | P=0.525N P=0.504N P=0.207 P=0.504N |P=0.267 P=0.606N P=0.411 P=0.366 |
|LOGISTIC REGRESSION| P=0.507N P=0.510N P=0.209 P=0.490N |P=0.252 P=0.570 P=0.386 P=0.330 |
|COCH-ARM / FISHERS | P=0.519N P=0.500N P=0.243 P=0.500N |P=0.291 P=0.620N P=0.387 P=0.387 |
|ORDER RESTRICTED | P=0.385N (e) (e) (e) |P=0.422 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 6/50 (12%) 5/50 (10%) 11/50 (22%) |1/50 (2%) 5/50 (10%) 1/50 (2%) 8/50 (16%) |
|POLY-3 RATE (b) | 5/48.89 6/48.36 5/45.68 11/48.45 |1/46.61 5/47.92 1/48.01 8/46.91 |
|POLY-3 PERCENT (g) | 10.2% 12.4% 11.0% 22.7% |2.2% 10.4% 2.1% 17.1% |
|TERMINAL (d) | 4/45 (9%) 4/44 (9%) 5/42 (12%) 10/46 (22%) |1/43 (2%) 4/40 (10%) 1/43 (2%) 4/40 (10%) |
|FIRST INCIDENCE | 513 613 729 (T) 537 |729 (T) 697 729 (T) 640 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.060 P=0.489 P=0.589 P=0.098 |P=0.015 * P=0.092 P=0.762 P=0.018 * |
|POLY 3 | P=0.046 * P=0.492 P=0.587 P=0.082 |P=0.015 * P=0.108 P=0.754N P=0.016 * |
|POLY 1.5 | P=0.047 * P=0.494 P=0.602 P=0.083 |P=0.015 * P=0.108 P=0.755N P=0.016 * |
|POLY 6 | P=0.045 * P=0.492 P=0.570 P=0.081 |P=0.015 * P=0.107 P=0.754N P=0.016 * |
|LOGISTIC REGRESSION| P=0.050 P=0.516 P=0.629N P=0.090 |P=0.016 * P=0.107 P=0.762 P=0.018 * |
|COCH-ARM / FISHERS | P=0.050 P=0.500 P=0.630N P=0.086 |P=0.016 * P=0.102 P=0.753N P=0.015 * |
|ORDER RESTRICTED | P=0.052 (e) (e) (e) |P=0.004 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 3/50 (6%) 1/50 (2%) 9/50 (18%) |3/50 (6%) 2/50 (4%) 3/50 (6%) 11/50 (22%) |
|POLY-3 RATE (b) | 7/48.37 3/47.90 1/46.28 9/48.21 |3/46.79 2/47.80 3/48.01 11/46.05 |
|POLY-3 PERCENT (g) | 14.5% 6.3% 2.2% 18.7% |6.4% 4.2% 6.3% 23.9% |
|TERMINAL (d) | 6/45 (13%) 3/44 (7%) 0/42 (0%) 8/46 (17%) |1/43 (2%) 2/40 (5%) 3/43 (7%) 11/40 (28%) |
|FIRST INCIDENCE | 695 729 (T) 535 628 |706 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.228 P=0.170N P=0.044N* P=0.409 |P<0.001 ** P=0.530N P=0.659N P=0.016 * |
|POLY 3 | P=0.206 P=0.162N P=0.035N* P=0.390 |P<0.001 ** P=0.490N P=0.650N P=0.018 * |
|POLY 1.5 | P=0.207 P=0.161N P=0.034N* P=0.390 |P<0.001 ** P=0.490N P=0.651N P=0.019 * |
|POLY 6 | P=0.206 P=0.164N P=0.037N* P=0.391 |P<0.001 ** P=0.494N P=0.651N P=0.016 * |
|LOGISTIC REGRESSION| P=0.212 P=0.162N P=0.028N* P=0.388 |P<0.001 ** P=0.490N P=0.651N P=0.017 * |
|COCH-ARM / FISHERS | P=0.213 P=0.159N P=0.030N* P=0.393 |P=0.002 ** P=0.500N P=0.661N P=0.020 * |
|ORDER RESTRICTED | P=0.052 (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 2/50 (4%) 0/48 (0%) 1/45 (2%) |1/47 (2%) 0/47 (0%) 2/48 (4%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/46.24 2/47.90 0/43.68 1/43.21 |1/43.70 0/45.20 2/46.34 0/44.35 |
|POLY-3 PERCENT (g) | 0.0% 4.2% 0.0% 2.3% |2.3% 0.0% 4.3% 0.0% |
|TERMINAL (d) | 0/43 (0%) 2/44 (5%) 0/40 (0%) 1/42 (2%) |1/41 (2%) 0/40 (0%) 1/41 (2%) 0/39 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |729 (T) --- 635 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.529 P=0.244 (e) P=0.495 |P=0.467N P=0.505N P=0.507 P=0.510N |
|POLY 3 | P=0.516 P=0.245 (e) P=0.486 |P=0.463N P=0.493N P=0.520 P=0.497N |
|POLY 1.5 | P=0.516 P=0.245 (e) P=0.486 |P=0.459N P=0.494N P=0.518 P=0.495N |
|POLY 6 | P=0.516 P=0.245 (e) P=0.487 |P=0.467N P=0.493N P=0.522 P=0.499N |
|LOGISTIC REGRESSION| (e) P=0.244 (e) P=0.495 |P=0.457N (e) P=0.496 (e) |
|COCH-ARM / FISHERS | P=0.519 P=0.258 (e) P=0.484 |P=0.455N P=0.500N P=0.508 P=0.495N |
|ORDER RESTRICTED | P=0.313 (e) (e) (e) |P=0.322N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/48 (0%) 0/45 (0%) |0/47 (0%) 0/47 (0%) 1/48 (2%) 3/48 (6%) |
|POLY-3 RATE (b) | 0/46.24 0/47.90 0/43.68 0/43.21 |0/43.70 0/45.20 1/46.18 3/44.35 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 2.2% 6.8% |
|TERMINAL (d) | 0/43 (0%) 0/44 (0%) 0/40 (0%) 0/42 (0%) |0/41 (0%) 0/40 (0%) 0/41 (0%) 3/39 (8%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 684 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.019 * (e) P=0.509 P=0.112 |
|POLY 3 | (e) (e) (e) (e) |P=0.020 * (e) P=0.511 P=0.121 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.020 * (e) P=0.510 P=0.123 |
|POLY 6 | (e) (e) (e) (e) |P=0.019 * (e) P=0.512 P=0.119 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.020 * (e) P=0.489 P=0.112 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.021 * (e) P=0.505 P=0.125 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.021 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/48 (21%) 8/50 (16%) 9/48 (19%) 12/45 (27%) |6/47 (13%) 8/47 (17%) 7/48 (15%) 13/48 (27%) |
|POLY-3 RATE (b) | 10/46.24 8/47.90 9/45.09 12/43.21 |6/44.30 8/45.90 7/46.01 13/44.52 |
|POLY-3 PERCENT (g) | 21.6% 16.7% 20.0% 27.8% |13.5% 17.4% 15.2% 29.2% |
|TERMINAL (d) | 10/43 (23%) 8/44 (18%) 7/40 (18%) 12/42 (29%) |5/41 (12%) 5/40 (13%) 7/41 (17%) 12/39 (31%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 441 729 (T) |539 632 729 (T) 685 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.250 P=0.375N P=0.563N P=0.378 |P=0.035 * P=0.382 P=0.501 P=0.051 |
|POLY 3 | P=0.210 P=0.366N P=0.524N P=0.335 |P=0.041 * P=0.414 P=0.529 P=0.060 |
|POLY 1.5 | P=0.211 P=0.365N P=0.515N P=0.335 |P=0.044 * P=0.409 P=0.530 P=0.064 |
|POLY 6 | P=0.211 P=0.367N P=0.535N P=0.338 |P=0.037 * P=0.418 P=0.525 P=0.055 |
|LOGISTIC REGRESSION| P=0.211 P=0.375N P=0.481N P=0.378 |P=0.045 * P=0.366 P=0.528 P=0.067 |
|COCH-ARM / FISHERS | P=0.214 P=0.361N P=0.500N P=0.338 |P=0.048 * P=0.387 P=0.517 P=0.068 |
|ORDER RESTRICTED | P=0.258 (e) (e) (e) |P=0.042 * (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/48 (21%) 5/50 (10%) 7/48 (15%) 12/45 (27%) |12/47 (26%) 19/47 (40%) 18/48 (38%) 19/48 (40%) |
|POLY-3 RATE (b) | 10/46.54 5/48.58 7/44.97 12/44.40 |12/43.70 19/46.16 18/46.22 19/45.11 |
|POLY-3 PERCENT (g) | 21.5% 10.3% 15.6% 27.0% |27.5% 41.2% 39.0% 42.1% |
|TERMINAL (d) | 8/43 (19%) 3/44 (7%) 4/40 (10%) 10/42 (24%) |12/41 (29%) 16/40 (40%) 16/41 (39%) 16/39 (41%) |
|FIRST INCIDENCE | 685 586 441 355 |729 (T) 525 684 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.190 P=0.134N P=0.365N P=0.385 |P=0.103 P=0.086 P=0.137 P=0.072 |
|POLY 3 | P=0.153 P=0.111N P=0.324N P=0.356 |P=0.146 P=0.125 P=0.175 P=0.108 |
|POLY 1.5 | P=0.152 P=0.112N P=0.314N P=0.350 |P=0.152 P=0.117 P=0.171 P=0.110 |
|POLY 6 | P=0.154 P=0.111N P=0.335N P=0.361 |P=0.142 P=0.132 P=0.178 P=0.107 |
|LOGISTIC REGRESSION| P=0.157 P=0.111N P=0.267N P=0.347 |P=0.135 P=0.110 P=0.166 P=0.097 |
|COCH-ARM / FISHERS | P=0.150 P=0.113N P=0.297N P=0.338 |P=0.151 P=0.094 P=0.151 P=0.107 |
|ORDER RESTRICTED | P=0.128 (e) (e) (e) |P=0.120 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) |0/49 (0%) 2/47 (4%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.29 0/47.28 0/44.48 0/47.85 |0/46.61 2/46.24 0/47.01 0/46.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 0/46 (0%) |0/43 (0%) 0/40 (0%) 0/42 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 525 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.416N P=0.239 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.397N P=0.235 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.397N P=0.233 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.398N P=0.238 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.248N P=0.115 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.398N P=0.237 (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.248N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/48 (0%) 1/50 (2%) |2/49 (4%) 1/47 (2%) 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.29 0/47.28 0/44.48 1/47.85 |2/47.20 1/45.51 2/47.01 0/46.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.1% |4.2% 2.2% 4.3% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 1/46 (2%) |1/43 (2%) 1/40 (3%) 2/42 (5%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |539 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.205 (e) (e) P=0.504 |P=0.211N P=0.517N P=0.689 P=0.250N |
|POLY 3 | P=0.201 (e) (e) P=0.502 |P=0.206N P=0.513N P=0.692 P=0.243N |
|POLY 1.5 | P=0.202 (e) (e) P=0.503 |P=0.202N P=0.513N P=0.693 P=0.239N |
|POLY 6 | P=0.201 (e) (e) P=0.502 |P=0.211N P=0.513N P=0.691 P=0.247N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.504 |P=0.165N P=0.594N P=0.674 P=0.160N |
|COCH-ARM / FISHERS | P=0.203 (e) (e) P=0.505 |P=0.193N P=0.516N P=0.691N P=0.242N |
|ORDER RESTRICTED | P=0.122 (e) (e) (e) |P=0.160N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 7/48 (15%) 4/48 (8%) 14/50 (28%) |0/49 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/47.43 7/47.28 4/44.48 14/48.15 |0/46.61 0/45.51 0/47.01 0/46.05 |
|POLY-3 PERCENT (g) | 8.4% 14.8% 9.0% 29.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/45 (7%) 7/44 (16%) 4/42 (10%) 13/46 (28%) |0/43 (0%) 0/40 (0%) 0/42 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 695 729 (T) 729 (T) 645 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** P=0.251 P=0.601 P=0.012 * |(e) (e) (e) (e) |
|POLY 3 | P=0.004 ** P=0.260 P=0.607 P=0.009 ** |(e) (e) (e) (e) |
|POLY 1.5 | P=0.004 ** P=0.257 P=0.616 P=0.009 ** |(e) (e) (e) (e) |
|POLY 6 | P=0.004 ** P=0.260 P=0.598 P=0.009 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.005 ** P=0.261 P=0.605 P=0.010 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.005 ** P=0.250 P=0.631 P=0.010 * |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.002 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 4/48 (8%) 4/48 (8%) 7/50 (14%) |3/49 (6%) 8/47 (17%) 9/49 (18%) 10/50 (20%) |
|POLY-3 RATE (b) | 7/47.47 4/47.28 4/45.37 7/47.85 |3/46.61 8/45.51 9/47.01 10/46.46 |
|POLY-3 PERCENT (g) | 14.8% 8.5% 8.8% 14.6% |6.4% 17.6% 19.2% 21.5% |
|TERMINAL (d) | 6/45 (13%) 4/44 (9%) 3/42 (7%) 7/46 (15%) |3/43 (7%) 8/40 (20%) 9/42 (21%) 8/40 (20%) |
|FIRST INCIDENCE | 685 729 (T) 348 729 (T) |729 (T) 729 (T) 729 (T) 665 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.484 P=0.277N P=0.305N P=0.599N |P=0.036 * P=0.078 P=0.056 P=0.030 * |
|POLY 3 | P=0.473 P=0.264N P=0.288N P=0.607N |P=0.047 * P=0.091 P=0.061 P=0.034 * |
|POLY 1.5 | P=0.478 P=0.267N P=0.282N P=0.603N |P=0.050 P=0.089 P=0.061 P=0.035 * |
|POLY 6 | P=0.468 P=0.263N P=0.296N P=0.611N |P=0.045 * P=0.092 P=0.061 P=0.032 * |
|LOGISTIC REGRESSION| P=0.498 P=0.262N P=0.231N P=0.606N |P=0.040 * P=0.078 P=0.056 P=0.034 * |
|COCH-ARM / FISHERS | P=0.488 P=0.274N P=0.274N P=0.597N |P=0.056 P=0.087 P=0.060 P=0.039 * |
|ORDER RESTRICTED | P=0.424N (e) (e) (e) |P=0.032 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/2 (0%) 0/2 (0%) 0/1 (0%) 0/2 (0%) |0/3 (0%) 2/9 (22%) 1/12 (8%) 1/7 (14%) |
|POLY-3 RATE (b) | 0/1.83 0/1.95 0/1.00 0/2.00 |0/3.00 2/7.79 1/11.40 1/4.78 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 25.7% 8.8% 20.9% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/1 (0%) 0/2 (0%) |0/3 (0%) 0/3 (0%) 1/9 (11%) 1/3 (33%) |
|FIRST INCIDENCE | --- --- --- --- |--- 632 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.521 P=0.242 P=0.718 P=0.500 |
|POLY 3 | (e) (e) (e) (e) |P=0.529 P=0.461 P=0.762 P=0.598 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.571 P=0.479 P=0.764 P=0.626 |
|POLY 6 | (e) (e) (e) (e) |P=0.494 P=0.436 P=0.757 P=0.563 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.583 P=0.544 P=0.718 P=0.500 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.645 P=0.545 P=0.800 P=0.700 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.452 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Inguinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/2 (0%) 0/2 (0%) 0/1 (0%) 1/2 (50%) |0/3 (0%) 2/9 (22%) 1/12 (8%) 0/7 (0%) |
|POLY-3 RATE (b) | 0/1.83 0/1.95 0/1.00 1/2.00 |0/3.00 2/7.79 1/11.40 0/4.78 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 50.0% |0.0% 25.7% 8.8% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/1 (0%) 1/2 (50%) |0/3 (0%) 1/3 (33%) 1/9 (11%) 0/3 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- 632 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.308 (e) (e) P=0.638 |P=0.424N P=0.247 P=0.718 (e) |
|POLY 3 | P=0.236 (e) (e) P=0.518 |P=0.407N P=0.461 P=0.762 (e) |
|POLY 1.5 | P=0.231 (e) (e) P=0.509 |P=0.380N P=0.479 P=0.764 (e) |
|POLY 6 | P=0.246 (e) (e) P=0.533 |P=0.451N P=0.435 P=0.757 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.638 |P=0.357N P=0.540 P=0.718 (e) |
|COCH-ARM / FISHERS | P=0.189 (e) (e) P=0.500 |P=0.331N P=0.545 P=0.800 (e) |
|ORDER RESTRICTED | P=0.141 (e) (e) (e) |P=0.449N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/2 (0%) 0/2 (0%) 0/1 (0%) 0/2 (0%) |0/3 (0%) 2/9 (22%) 0/12 (0%) 0/7 (0%) |
|POLY-3 RATE (b) | 0/1.83 0/1.95 0/1.00 0/2.00 |0/3.00 2/7.91 0/11.40 0/4.78 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 25.3% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/1 (0%) 0/2 (0%) |0/3 (0%) 0/3 (0%) 0/9 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 632 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.412N P=0.244 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.312N P=0.466 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.305N P=0.481 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.332N P=0.445 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.234N P=0.603 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.293N P=0.545 (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.382N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |16/50 (32%) 10/50 (20%) 14/49 (29%) 24/49 (49%) |
|POLY-3 RATE (b) | 0/48.24 0/47.90 0/45.68 0/47.85 |16/47.77 10/49.04 14/47.94 24/48.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |33.5% 20.4% 29.2% 49.7% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 0/46 (0%) |14/43 (33%) 6/40 (15%) 12/42 (29%) 18/40 (45%) |
|FIRST INCIDENCE | --- --- --- --- |539 525 539 409 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.014 * P=0.173N P=0.436N P=0.061 |
|POLY 3 | (e) (e) (e) (e) |P=0.013 * P=0.110N P=0.409N P=0.079 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.013 * P=0.112N P=0.412N P=0.076 |
|POLY 6 | (e) (e) (e) (e) |P=0.013 * P=0.109N P=0.408N P=0.079 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.013 * P=0.140N P=0.446N P=0.063 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.012 * P=0.127N P=0.440N P=0.064 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.010 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/4 (75%) 3/7 (43%) 2/2 (100%) 2/3 (67%) |3/3 (100%) 3/7 (43%) 3/7 (43%) 3/4 (75%) |
|POLY-3 RATE (b) | 3/4.00 3/6.74 2/2.00 2/3.00 |3/3.00 3/6.15 3/6.74 3/4.00 |
|POLY-3 PERCENT (g) | 75.0% 44.5% 100.0% 66.7% |100.0% 48.8% 44.5% 75.0% |
|TERMINAL (d) | 3/4 (75%) 3/5 (60%) 2/2 (100%) 2/3 (67%) |3/3 (100%) 3/4 (75%) 2/4 (50%) 3/4 (75%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 720 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.653 P=0.588N P=0.638 P=0.712N |P=0.465N P=0.557N P=0.567N P=0.557N |
|POLY 3 | P=0.568 P=0.372N P=0.631 P=0.696N |P=0.566N P=0.188N P=0.156N P=0.556N |
|POLY 1.5 | P=0.561 P=0.362N P=0.631 P=0.696N |P=0.587N P=0.167N P=0.152N P=0.556N |
|POLY 6 | P=0.580 P=0.392N P=0.631 P=0.696N |P=0.539N P=0.224N P=0.165N P=0.556N |
|LOGISTIC REGRESSION| P=0.653 P=0.588N P=0.638 P=0.712N |P=0.437N P=0.557N P=0.347N P=0.557N |
|COCH-ARM / FISHERS | P=0.556 P=0.348N P=0.667 P=0.714N |P=0.617N P=0.167N P=0.167N P=0.571N |
|ORDER RESTRICTED | P=0.435 (e) (e) (e) |P=0.239N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/48.89 0/47.90 2/45.84 0/47.85 |1/47.21 0/46.80 0/48.01 0/46.05 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 4.4% 0.0% |2.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 1/42 (2%) 0/46 (0%) |0/43 (0%) 0/39 (0%) 0/43 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 513 --- 686 --- |539 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.462N P=0.500N P=0.479 P=0.500N |P=0.308N P=0.500N P=0.496N P=0.504N |
|POLY 3 | P=0.464N P=0.504N P=0.478 P=0.504N |P=0.303N P=0.502N P=0.497N P=0.505N |
|POLY 1.5 | P=0.463N P=0.503N P=0.486 P=0.503N |P=0.305N P=0.501N P=0.497N P=0.502N |
|POLY 6 | P=0.465N P=0.506N P=0.470 P=0.506N |P=0.300N P=0.504N P=0.497N P=0.509N |
|LOGISTIC REGRESSION| P=0.436N P=0.375N P=0.596 P=0.377N |P=0.378N P=0.632N P=0.628N P=0.574N |
|COCH-ARM / FISHERS | P=0.461N P=0.500N P=0.500 P=0.500N |P=0.305N P=0.505N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.319N (e) (e) (e) |P=0.125N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |9/48 (19%) 9/49 (18%) 7/49 (14%) 6/50 (12%) |
|POLY-3 RATE (b) | |9/44.70 9/47.65 7/47.01 6/46.05 |
|POLY-3 PERCENT (g) | |20.1% 18.9% 14.9% 13.0% |
|TERMINAL (d) | |8/41 (20%) 7/39 (18%) 7/42 (17%) 6/40 (15%) |
|FIRST INCIDENCE | |706 525 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.210N P=0.562 P=0.374N P=0.309N |
|POLY 3 | |P=0.195N P=0.544N P=0.351N P=0.266N |
|POLY 1.5 | |P=0.187N P=0.552N P=0.354N P=0.259N |
|POLY 6 | |P=0.204N P=0.541N P=0.350N P=0.276N |
|LOGISTIC REGRESSION| |P=0.188N P=0.574N P=0.351N P=0.290N |
|COCH-ARM / FISHERS | |P=0.182N P=0.584N P=0.375N P=0.259N |
|ORDER RESTRICTED | |P=0.295N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |16/48 (33%) 20/49 (41%) 14/49 (29%) 19/50 (38%) |
|POLY-3 RATE (b) | |16/45.70 20/47.52 14/47.01 19/46.22 |
|POLY-3 PERCENT (g) | |35.0% 42.1% 29.8% 41.1% |
|TERMINAL (d) | |14/41 (34%) 18/39 (46%) 14/42 (33%) 18/40 (45%) |
|FIRST INCIDENCE | |114 525 729 (T) 685 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.397 P=0.213 P=0.385N P=0.302 |
|POLY 3 | |P=0.415 P=0.313 P=0.376N P=0.349 |
|POLY 1.5 | |P=0.433 P=0.306 P=0.380N P=0.365 |
|POLY 6 | |P=0.395 P=0.312 P=0.376N P=0.330 |
|LOGISTIC REGRESSION| |P=0.458 P=0.276 P=0.391N P=0.394 |
|COCH-ARM / FISHERS | |P=0.466 P=0.290 P=0.387N P=0.393 |
|ORDER RESTRICTED | |P=0.432 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |3/49 (6%) 1/48 (2%) 0/48 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/47.37 0/47.38 1/45.68 0/47.85 |3/46.61 1/46.15 0/46.09 0/45.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 0.0% |6.4% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 1/42 (2%) 0/46 (0%) |3/43 (7%) 1/40 (3%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.694 (e) P=0.486 (e) |P=0.049N* P=0.331N P=0.125N P=0.139N |
|POLY 3 | P=0.696 (e) P=0.493 (e) |P=0.044N* P=0.309N P=0.121N P=0.125N |
|POLY 1.5 | P=0.696 (e) P=0.497 (e) |P=0.044N* P=0.310N P=0.121N P=0.123N |
|POLY 6 | P=0.696 (e) P=0.488 (e) |P=0.044N* P=0.309N P=0.120N P=0.128N |
|LOGISTIC REGRESSION| (e) (e) P=0.486 (e) |P=0.049N* P=0.331N (e) (e) |
|COCH-ARM / FISHERS | P=0.697 (e) P=0.505 (e) |P=0.044N* P=0.316N P=0.125N P=0.121N |
|ORDER RESTRICTED | P=0.374 (e) (e) (e) |P=0.023N* (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 0/49 (0%) 1/49 (2%) 1/49 (2%) |0/49 (0%) 1/49 (2%) 5/48 (10%) 2/47 (4%) |
|POLY-3 RATE (b) | 1/45.29 0/47.10 1/44.68 1/47.45 |0/46.21 1/46.90 5/46.26 2/43.35 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 2.2% 2.1% |0.0% 2.1% 10.8% 4.6% |
|TERMINAL (d) | 1/43 (2%) 0/44 (0%) 1/41 (2%) 1/46 (2%) |0/43 (0%) 0/40 (0%) 5/43 (12%) 2/38 (5%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |--- 705 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.553 P=0.495N P=0.751 P=0.747N |P=0.138 P=0.491 P=0.033 * P=0.212 |
|POLY 3 | P=0.549 P=0.492N P=0.757 P=0.750N |P=0.137 P=0.503 P=0.031 * P=0.223 |
|POLY 1.5 | P=0.548 P=0.492N P=0.759N P=0.751N |P=0.143 P=0.503 P=0.031 * P=0.226 |
|POLY 6 | P=0.550 P=0.492N P=0.753 P=0.749N |P=0.131 P=0.501 P=0.031 * P=0.219 |
|LOGISTIC REGRESSION| P=0.553 (e) P=0.751 P=0.747N |P=0.138 P=0.497 P=0.033 * P=0.212 |
|COCH-ARM / FISHERS | P=0.548 P=0.490N P=0.742N P=0.742N |P=0.152 P=0.500 P=0.027 * P=0.237 |
|ORDER RESTRICTED | P=0.533 (e) (e) (e) |P=0.051 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 3/48 (6%) 3/49 (6%) 2/50 (4%) |1/49 (2%) 3/46 (7%) 4/49 (8%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.37 3/46.38 3/44.68 2/47.85 |1/45.61 3/44.25 4/47.04 0/46.05 |
|POLY-3 PERCENT (g) | 2.1% 6.5% 6.7% 4.2% |2.2% 6.8% 8.5% 0.0% |
|TERMINAL (d) | 1/45 (2%) 3/43 (7%) 3/41 (7%) 2/46 (4%) |1/42 (2%) 3/38 (8%) 4/43 (9%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.490 P=0.289 P=0.273 P=0.508 |P=0.317N P=0.270 P=0.187 P=0.510N |
|POLY 3 | P=0.482 P=0.298 P=0.285 P=0.503 |P=0.306N P=0.294 P=0.188 P=0.498N |
|POLY 1.5 | P=0.485 P=0.298 P=0.292 P=0.505 |P=0.299N P=0.293 P=0.187 P=0.496N |
|POLY 6 | P=0.480 P=0.298 P=0.277 P=0.502 |P=0.314N P=0.295 P=0.189 P=0.501N |
|LOGISTIC REGRESSION| P=0.490 P=0.289 P=0.273 P=0.508 |P=0.317N P=0.270 P=0.187 (e) |
|COCH-ARM / FISHERS | P=0.490 P=0.301 P=0.309 P=0.508 |P=0.298N P=0.285 P=0.181 P=0.495N |
|ORDER RESTRICTED | P=0.320 (e) (e) (e) |P=0.131N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) |2/49 (4%) 4/46 (9%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.37 0/46.38 0/44.68 0/47.85 |2/45.61 4/44.26 1/47.04 0/46.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.4% 9.0% 2.1% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/43 (0%) 0/41 (0%) 0/46 (0%) |2/42 (5%) 3/38 (8%) 1/43 (2%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 727 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.089N P=0.297 P=0.492N P=0.249N |
|POLY 3 | (e) (e) (e) (e) |P=0.081N P=0.323 P=0.489N P=0.235N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.079N P=0.321 P=0.491N P=0.233N |
|POLY 6 | (e) (e) (e) (e) |P=0.082N P=0.324 P=0.488N P=0.238N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.088N P=0.307 P=0.492N (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.081N P=0.309 P=0.500N P=0.242N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.069N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 27/50 (54%) 31/50 (62%) 36/50 (72%) | |
|POLY-3 RATE (b) | 29/49.12 27/48.43 31/47.00 36/48.81 | |
|POLY-3 PERCENT (g) | 59.0% 55.8% 66.0% 73.8% | |
|TERMINAL (d) | 26/45 (58%) 25/44 (57%) 28/42 (67%) 34/46 (74%) | |
|FIRST INCIDENCE | 513 586 441 537 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.076 P=0.468N P=0.277 P=0.145 | |
|POLY 3 | P=0.040 * P=0.451N P=0.312 P=0.090 | |
|POLY 1.5 | P=0.042 * P=0.442N P=0.350 P=0.093 | |
|POLY 6 | P=0.038 * P=0.462N P=0.274 P=0.089 | |
|LOGISTIC REGRESSION| P=0.042 * P=0.431N P=0.333 P=0.097 | |
|COCH-ARM / FISHERS | P=0.050 P=0.420N P=0.419 P=0.104 | |
|ORDER RESTRICTED | P=0.064 (e) (e) (e) | |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 19/50 (38%) 24/50 (48%) 23/50 (46%) | |
|POLY-3 RATE (b) | 17/48.95 19/47.95 24/48.25 23/48.45 | |
|POLY-3 PERCENT (g) | 34.7% 39.6% 49.7% 47.5% | |
|TERMINAL (d) | 15/45 (33%) 18/44 (41%) 20/42 (48%) 22/46 (48%) | |
|FIRST INCIDENCE | 513 716 348 537 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.136 P=0.390 P=0.080 P=0.181 | |
|POLY 3 | P=0.100 P=0.387 P=0.097 P=0.141 | |
|POLY 1.5 | P=0.103 P=0.397 P=0.103 P=0.145 | |
|POLY 6 | P=0.099 P=0.376 P=0.090 P=0.139 | |
|LOGISTIC REGRESSION| P=0.107 P=0.409 P=0.135 P=0.150 | |
|COCH-ARM / FISHERS | P=0.108 P=0.418 P=0.111 P=0.154 | |
|ORDER RESTRICTED | P=0.127 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/48 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/48.24 0/47.90 0/45.68 0/47.85 |0/46.61 0/46.16 0/48.01 2/45.35 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 0/46 (0%) |0/43 (0%) 0/40 (0%) 0/43 (0%) 2/40 (5%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.223 |
|POLY 3 | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.231 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.233 |
|POLY 6 | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.229 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.223 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.242 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.027 * (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 4/48 (8%) 3/50 (6%) 3/49 (6%) |
|POLY-3 RATE (b) | 0/48.24 0/47.90 0/45.68 0/47.85 |3/46.61 4/46.20 3/48.01 3/45.35 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.4% 8.7% 6.3% 6.6% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 0/46 (0%) |3/43 (7%) 3/40 (8%) 3/43 (7%) 3/40 (8%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 721 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.547N P=0.463 P=0.663 P=0.629 |
|POLY 3 | (e) (e) (e) (e) |P=0.529N P=0.495 P=0.648N P=0.649 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.524N P=0.492 P=0.650N P=0.653 |
|POLY 6 | (e) (e) (e) (e) |P=0.534N P=0.495 P=0.648N P=0.645 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.549N P=0.480 P=0.663 P=0.629 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.523N P=0.477 P=0.661N P=0.651 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.646N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/48.24 2/49.28 0/45.68 0/46.85 |0/46.61 0/47.80 1/48.18 1/46.12 |
|POLY-3 PERCENT (g) | 0.0% 4.1% 0.0% 0.0% |0.0% 0.0% 2.1% 2.2% |
|TERMINAL (d) | 0/45 (0%) 0/44 (0%) 0/42 (0%) 0/45 (0%) |0/43 (0%) 0/40 (0%) 0/43 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 335 --- --- |--- --- 685 711 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.407N P=0.242 (e) (e) |P=0.228 (e) P=0.504 P=0.490 |
|POLY 3 | P=0.411N P=0.242 (e) (e) |P=0.230 (e) P=0.507 P=0.498 |
|POLY 1.5 | P=0.410N P=0.241 (e) (e) |P=0.234 (e) P=0.505 P=0.500 |
|POLY 6 | P=0.412N P=0.243 (e) (e) |P=0.227 (e) P=0.507 P=0.495 |
|LOGISTIC REGRESSION| P=0.290N P=0.236 (e) (e) |P=0.236 (e) P=0.485 P=0.500 |
|COCH-ARM / FISHERS | P=0.409N P=0.247 (e) (e) |P=0.235 (e) P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.257N (e) (e) (e) |P=0.249 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin: Epidermis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 0/49 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/48.24 0/47.90 2/45.68 0/46.85 |0/46.61 1/47.80 0/48.01 0/46.05 |
|POLY-3 PERCENT (g) | 4.2% 0.0% 4.4% 0.0% |0.0% 2.1% 0.0% 0.0% |
|TERMINAL (d) | 2/45 (4%) 0/44 (0%) 2/42 (5%) 0/45 (0%) |0/43 (0%) 1/40 (3%) 0/43 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.250N P=0.243N P=0.670 P=0.239N |P=0.574N P=0.486 (e) (e) |
|POLY 3 | P=0.253N P=0.239N P=0.674 P=0.244N |P=0.562N P=0.505 (e) (e) |
|POLY 1.5 | P=0.253N P=0.239N P=0.681 P=0.243N |P=0.563N P=0.505 (e) (e) |
|POLY 6 | P=0.253N P=0.239N P=0.667 P=0.244N |P=0.563N P=0.504 (e) (e) |
|LOGISTIC REGRESSION| P=0.250N (e) P=0.670 (e) |(e) P=0.486 (e) (e) |
|COCH-ARM / FISHERS | P=0.252N P=0.247N P=0.691N P=0.253N |P=0.567N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.122N (e) (e) (e) |P=0.388N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/49 (20%) 14/49 (29%) 9/50 (18%) 12/50 (24%) |15/49 (31%) 16/49 (33%) 13/49 (27%) 11/49 (22%) |
|POLY-3 RATE (b) | 10/48.83 14/48.04 9/47.70 12/48.76 |15/47.38 16/48.53 13/48.15 11/45.92 |
|POLY-3 PERCENT (g) | 20.5% 29.1% 18.9% 24.6% |31.7% 33.0% 27.0% 24.0% |
|TERMINAL (d) | 6/44 (14%) 11/44 (25%) 5/42 (12%) 10/46 (22%) |12/43 (28%) 12/40 (30%) 10/43 (23%) 8/40 (20%) |
|FIRST INCIDENCE | 459 613 441 537 |539 525 539 665 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.516 P=0.253 P=0.547N P=0.440 |P=0.212N P=0.431 P=0.410N P=0.323N |
|POLY 3 | P=0.488 P=0.227 P=0.522N P=0.403 |P=0.190N P=0.532 P=0.392N P=0.275N |
|POLY 1.5 | P=0.496 P=0.230 P=0.509N P=0.410 |P=0.180N P=0.520 P=0.400N P=0.266N |
|POLY 6 | P=0.482 P=0.227 P=0.534N P=0.399 |P=0.198N P=0.542 P=0.385N P=0.284N |
|LOGISTIC REGRESSION| P=0.543 P=0.234 P=0.320N P=0.447 |P=0.142N P=0.472 P=0.425N P=0.258N |
|COCH-ARM / FISHERS | P=0.515 P=0.241 P=0.480N P=0.426 |P=0.160N P=0.500 P=0.412N P=0.246N |
|ORDER RESTRICTED | P=0.496 (e) (e) (e) |P=0.300N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/49 (2%) 2/50 (4%) 2/50 (4%) |8/49 (16%) 11/49 (22%) 8/49 (16%) 11/49 (22%) |
|POLY-3 RATE (b) | 1/47.24 1/47.38 2/45.68 2/47.85 |8/46.61 11/47.15 8/47.04 11/45.52 |
|POLY-3 PERCENT (g) | 2.1% 2.1% 4.4% 4.2% |17.2% 23.3% 17.0% 24.2% |
|TERMINAL (d) | 1/44 (2%) 1/44 (2%) 2/42 (5%) 2/46 (4%) |8/43 (19%) 11/40 (28%) 8/43 (19%) 10/40 (25%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) 685 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.353 P=0.762 P=0.484 P=0.516 |P=0.287 P=0.243 P=0.609 P=0.247 |
|POLY 3 | P=0.342 P=0.760N P=0.488 P=0.504 |P=0.311 P=0.314 P=0.600N P=0.284 |
|POLY 1.5 | P=0.343 P=0.760N P=0.495 P=0.505 |P=0.319 P=0.312 P=0.602N P=0.291 |
|POLY 6 | P=0.341 P=0.759N P=0.481 P=0.504 |P=0.304 P=0.313 P=0.598N P=0.278 |
|LOGISTIC REGRESSION| P=0.353 P=0.762 P=0.484 P=0.516 |P=0.278 P=0.243 P=0.609 P=0.262 |
|COCH-ARM / FISHERS | P=0.345 P=0.753N P=0.508 P=0.508 |P=0.335 P=0.305 P=0.607N P=0.305 |
|ORDER RESTRICTED | P=0.435 (e) (e) (e) |P=0.324 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/49 (20%) 8/49 (16%) 2/50 (4%) 7/50 (14%) |14/49 (29%) 12/49 (24%) 12/49 (24%) 13/49 (27%) |
|POLY-3 RATE (b) | 10/47.24 8/47.38 2/45.68 7/47.85 |14/46.61 12/47.42 12/47.04 13/46.15 |
|POLY-3 PERCENT (g) | 21.2% 16.9% 4.4% 14.6% |30.0% 25.3% 25.5% 28.2% |
|TERMINAL (d) | 10/44 (23%) 8/44 (18%) 2/42 (5%) 7/46 (15%) |14/43 (33%) 11/40 (28%) 12/43 (28%) 11/40 (28%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 656 729 (T) 552 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.170N P=0.396N P=0.019N* P=0.262N |P=0.541 P=0.489N P=0.408N P=0.581N |
|POLY 3 | P=0.185N P=0.395N P=0.016N* P=0.287N |P=0.507N P=0.389N P=0.398N P=0.512N |
|POLY 1.5 | P=0.182N P=0.397N P=0.014N* P=0.286N |P=0.502N P=0.397N P=0.403N P=0.510N |
|POLY 6 | P=0.188N P=0.392N P=0.017N* P=0.288N |P=0.509N P=0.384N P=0.396N P=0.512N |
|LOGISTIC REGRESSION| P=0.170N P=0.396N P=0.019N* P=0.262N |P=0.533N P=0.401N P=0.408N P=0.533N |
|COCH-ARM / FISHERS | P=0.178N P=0.397N P=0.013N* P=0.282N |P=0.489N P=0.410N P=0.410N P=0.500N |
|ORDER RESTRICTED | P=0.078N (e) (e) (e) |P=0.541N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 34
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Diverticulum |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.24 2/47.90 1/45.68 1/47.85 |2/46.61 0/47.80 0/48.01 0/46.05 |
|POLY-3 PERCENT (g) | 0.0% 4.2% 2.2% 2.1% |4.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 2/44 (5%) 1/42 (2%) 1/46 (2%) |2/43 (5%) 0/40 (0%) 0/43 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.512 P=0.238 P=0.491 P=0.509 |P=0.119N P=0.254N P=0.238N P=0.254N |
|POLY 3 | P=0.501 P=0.240 P=0.493 P=0.503 |P=0.114N P=0.232N P=0.231N P=0.240N |
|POLY 1.5 | P=0.502 P=0.241 P=0.497 P=0.503 |P=0.115N P=0.232N P=0.232N P=0.238N |
|POLY 6 | P=0.500 P=0.240 P=0.489 P=0.502 |P=0.113N P=0.233N P=0.230N P=0.243N |
|LOGISTIC REGRESSION| (e) P=0.238 P=0.491 P=0.509 |P=0.119N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.505 P=0.253 P=0.505 P=0.505 |P=0.115N P=0.247N P=0.247N P=0.247N |
|ORDER RESTRICTED | P=0.269 (e) (e) (e) |P=0.030N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/47.24 0/47.90 2/45.68 0/47.85 |0/46.61 0/47.80 1/48.01 1/46.12 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.4% 0.0% |0.0% 0.0% 2.1% 2.2% |
|TERMINAL (d) | 0/44 (0%) 0/44 (0%) 2/42 (5%) 0/46 (0%) |0/43 (0%) 0/40 (0%) 1/43 (2%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- --- 729 (T) 711 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.602 (e) P=0.228 (e) |P=0.228 (e) P=0.500 P=0.490 |
|POLY 3 | P=0.599 (e) P=0.230 (e) |P=0.230 (e) P=0.506 P=0.498 |
|POLY 1.5 | P=0.599 (e) P=0.234 (e) |P=0.234 (e) P=0.505 P=0.500 |
|POLY 6 | P=0.600 (e) P=0.226 (e) |P=0.227 (e) P=0.506 P=0.495 |
|LOGISTIC REGRESSION| (e) (e) P=0.228 (e) |P=0.231 (e) P=0.500 P=0.500 |
|COCH-ARM / FISHERS | P=0.598 (e) P=0.253 (e) |P=0.235 (e) P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.241 (e) (e) (e) |P=0.249 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 35
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 2/50 (4%) 4/50 (8%) 0/50 (0%) |3/50 (6%) 5/50 (10%) 2/50 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 3/47.29 2/48.10 4/46.57 0/47.85 |3/47.17 5/47.90 2/48.01 5/47.71 |
|POLY-3 PERCENT (g) | 6.3% 4.2% 8.6% 0.0% |6.4% 10.4% 4.2% 10.5% |
|TERMINAL (d) | 2/44 (5%) 1/44 (2%) 3/42 (7%) 0/46 (0%) |2/43 (5%) 4/40 (10%) 2/43 (5%) 2/40 (5%) |
|FIRST INCIDENCE | 715 676 348 --- |555 702 729 (T) 409 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.137N P=0.502N P=0.475 P=0.118N |P=0.354 P=0.331 P=0.498N P=0.340 |
|POLY 3 | P=0.135N P=0.492N P=0.492 P=0.117N |P=0.381 P=0.365 P=0.492N P=0.363 |
|POLY 1.5 | P=0.134N P=0.492N P=0.500 P=0.116N |P=0.383 P=0.366 P=0.492N P=0.365 |
|POLY 6 | P=0.135N P=0.492N P=0.482 P=0.117N |P=0.377 P=0.360 P=0.494N P=0.357 |
|LOGISTIC REGRESSION| P=0.119N P=0.491N P=0.589 P=0.118N |P=0.360 P=0.347 P=0.521N P=0.312 |
|COCH-ARM / FISHERS | P=0.132N P=0.490N P=0.511 P=0.117N |P=0.376 P=0.357 P=0.500N P=0.357 |
|ORDER RESTRICTED | P=0.109N (e) (e) (e) |P=0.364 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) 1/49 (2%) 1/50 (2%) |0/49 (0%) 0/49 (0%) 2/50 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 2/47.41 0/47.90 1/45.19 1/48.21 |0/46.61 0/46.80 2/48.27 1/45.57 |
|POLY-3 PERCENT (g) | 4.2% 0.0% 2.2% 2.1% |0.0% 0.0% 4.1% 2.2% |
|TERMINAL (d) | 1/44 (2%) 0/44 (0%) 0/42 (0%) 0/46 (0%) |0/43 (0%) 0/40 (0%) 0/43 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 685 --- 632 628 |--- --- 684 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.502N P=0.244N P=0.531N P=0.500N |P=0.239 (e) P=0.247 P=0.504 |
|POLY 3 | P=0.497N P=0.235N P=0.517N P=0.494N |P=0.236 (e) P=0.245 P=0.496 |
|POLY 1.5 | P=0.497N P=0.234N P=0.511N P=0.494N |P=0.239 (e) P=0.244 P=0.497 |
|POLY 6 | P=0.496N P=0.236N P=0.522N P=0.494N |P=0.232 (e) P=0.247 P=0.494 |
|LOGISTIC REGRESSION| P=0.481N P=0.231N P=0.463N P=0.474N |P=0.333 (e) P=0.232 P=0.645 |
|COCH-ARM / FISHERS | P=0.496N P=0.242N P=0.500N P=0.492N |P=0.245 (e) P=0.253 P=0.500 |
|ORDER RESTRICTED | P=0.271N (e) (e) (e) |P=0.174 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 36
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 3/50 (6%) | |
|POLY-3 RATE (b) | 0/48.24 3/47.90 1/45.68 3/48.15 | |
|POLY-3 PERCENT (g) | 0.0% 6.3% 2.2% 6.2% | |
|TERMINAL (d) | 0/45 (0%) 3/44 (7%) 1/42 (2%) 2/46 (4%) | |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 645 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.173 P=0.117 P=0.486 P=0.125 | |
|POLY 3 | P=0.162 P=0.118 P=0.489 P=0.119 | |
|POLY 1.5 | P=0.163 P=0.118 P=0.493 P=0.119 | |
|POLY 6 | P=0.163 P=0.117 P=0.485 P=0.119 | |
|LOGISTIC REGRESSION| P=0.164 P=0.117 P=0.486 P=0.123 | |
|COCH-ARM / FISHERS | P=0.165 P=0.121 P=0.500 P=0.121 | |
|ORDER RESTRICTED | P=0.076 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/48 (15%) 7/49 (14%) 5/45 (11%) 8/45 (18%) |3/49 (6%) 6/49 (12%) 2/50 (4%) 5/48 (10%) |
|POLY-3 RATE (b) | 7/48.00 7/48.54 5/44.40 8/44.12 |3/47.26 6/48.01 2/48.52 5/44.94 |
|POLY-3 PERCENT (g) | 14.6% 14.4% 11.3% 18.1% |6.4% 12.5% 4.1% 11.1% |
|TERMINAL (d) | 3/44 (7%) 4/44 (9%) 1/40 (3%) 5/41 (12%) |0/42 (0%) 0/39 (0%) 0/43 (0%) 2/38 (5%) |
|FIRST INCIDENCE | 459 335 348 537 |114 525 635 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.424 P=0.603 P=0.437N P=0.467 |P=0.408 P=0.250 P=0.486N P=0.342 |
|POLY 3 | P=0.379 P=0.604N P=0.435N P=0.430 |P=0.401 P=0.251 P=0.488N P=0.329 |
|POLY 1.5 | P=0.382 P=0.601N P=0.431N P=0.434 |P=0.407 P=0.248 P=0.489N P=0.335 |
|POLY 6 | P=0.378 P=0.609N P=0.439N P=0.428 |P=0.395 P=0.252 P=0.487N P=0.324 |
|LOGISTIC REGRESSION| P=0.542 P=0.521N P=0.094N P=0.546 |P=0.455 P=0.073 P=0.659 P=0.301 |
|COCH-ARM / FISHERS | P=0.392 P=0.597N P=0.426N P=0.445 |P=0.418 P=0.243 P=0.490N P=0.346 |
|ORDER RESTRICTED | P=0.421 (e) (e) (e) |P=0.330 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 37
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/45 (0%) 0/45 (0%) |3/49 (6%) 1/49 (2%) 2/50 (4%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/46.89 0/47.38 0/41.85 0/42.85 |3/45.61 1/46.80 2/48.01 0/44.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.6% 2.1% 4.2% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/40 (0%) 0/41 (0%) |3/42 (7%) 1/39 (3%) 2/43 (5%) 0/38 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.113N P=0.332N P=0.489N P=0.139N |
|POLY 3 | (e) (e) (e) (e) |P=0.109N P=0.296N P=0.477N P=0.125N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.108N P=0.297N P=0.479N P=0.123N |
|POLY 6 | (e) (e) (e) (e) |P=0.111N P=0.298N P=0.476N P=0.128N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.113N P=0.332N P=0.489N (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.105N P=0.309N P=0.490N P=0.125N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.061N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 13/50 (26%) 13/50 (26%) 14/50 (28%) |20/50 (40%) 22/49 (45%) 29/50 (58%) 30/48 (63%) |
|POLY-3 RATE (b) | 13/48.41 13/48.31 13/46.83 14/48.52 |20/47.17 22/48.14 29/49.28 30/45.68 |
|POLY-3 PERCENT (g) | 26.9% 26.9% 27.8% 28.9% |42.4% 45.7% 58.8% 65.7% |
|TERMINAL (d) | 12/45 (27%) 12/44 (27%) 11/42 (26%) 12/46 (26%) |18/43 (42%) 17/40 (43%) 25/43 (58%) 26/39 (67%) |
|FIRST INCIDENCE | 685 613 441 628 |593 525 539 447 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.471 P=0.563 P=0.510 P=0.520 |P=0.009 ** P=0.333 P=0.067 P=0.015 * |
|POLY 3 | P=0.445 P=0.588 P=0.552 P=0.503 |P=0.008 ** P=0.453 P=0.077 P=0.018 * |
|POLY 1.5 | P=0.444 P=0.587 P=0.566 P=0.500 |P=0.009 ** P=0.439 P=0.071 P=0.020 * |
|POLY 6 | P=0.451 P=0.587 P=0.536 P=0.509 |P=0.007 ** P=0.461 P=0.084 P=0.016 * |
|LOGISTIC REGRESSION| P=0.441 P=0.583 P=0.573 P=0.494 |P=0.009 ** P=0.414 P=0.066 P=0.019 * |
|COCH-ARM / FISHERS | P=0.446 P=0.590N P=0.590N P=0.500 |P=0.010 * P=0.386 P=0.055 P=0.021 * |
|ORDER RESTRICTED | P=0.640 (e) (e) (e) |P=0.016 * (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 38
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/4 (75%) 0/0 (0%) 0/0 (0%) 2/3 (67%) |0/0 (0%) 0/1 (0%) 0/0 (0%) 0/1 (0%) |
|POLY-3 RATE (b) | 3/4.00 0/0.00 0/0.00 2/3.00 |0/0.00 0/0.99 0/0.00 0/1.00 |
|POLY-3 PERCENT (g) | 75.0% 0.0% 0.0% 66.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/4 (75%) 0/0 (0%) 0/0 (0%) 2/3 (67%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.567N P=1.000 P=1.000N P=0.712N |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) P=0.696N |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) P=0.696N |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) P=0.696N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.567N (e) (e) P=0.712N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.572N P=1.000 P=1.000 P=0.714N |(e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 4/50 (8%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/48.24 0/46.90 0/44.68 0/47.85 |1/46.61 3/47.80 4/48.78 3/46.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 6.3% 8.2% 6.5% |
|TERMINAL (d) | 0/45 (0%) 0/43 (0%) 0/41 (0%) 0/46 (0%) |1/43 (2%) 3/40 (8%) 2/43 (5%) 3/40 (8%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 539 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.263 P=0.280 P=0.188 P=0.280 |
|POLY 3 | (e) (e) (e) (e) |P=0.274 P=0.315 P=0.193 P=0.301 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.280 P=0.314 P=0.190 P=0.305 |
|POLY 6 | (e) (e) (e) (e) |P=0.266 P=0.313 P=0.196 P=0.296 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.283 P=0.280 P=0.150 P=0.280 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.282 P=0.309 P=0.181 P=0.309 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.228 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 39
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 3/50 (6%) 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | |0/46.61 3/47.80 0/48.01 3/46.05 |
|POLY-3 PERCENT (g) | |0.0% 6.3% 0.0% 6.5% |
|TERMINAL (d) | |0/43 (0%) 3/40 (8%) 0/43 (0%) 3/40 (8%) |
|FIRST INCIDENCE | |--- 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.151 P=0.109 (e) P=0.109 |
|POLY 3 | |P=0.161 P=0.123 (e) P=0.117 |
|POLY 1.5 | |P=0.163 P=0.123 (e) P=0.119 |
|POLY 6 | |P=0.158 P=0.122 (e) P=0.114 |
|LOGISTIC REGRESSION| |(e) P=0.109 (e) P=0.109 |
|COCH-ARM / FISHERS | |P=0.164 P=0.121 (e) P=0.121 |
|ORDER RESTRICTED | |P=0.053 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |45/50 (90%) 47/50 (94%) 46/50 (92%) 47/50 (94%) |
|POLY-3 RATE (b) | |45/48.32 47/49.99 46/48.98 47/48.41 |
|POLY-3 PERCENT (g) | |93.1% 94.0% 93.9% 97.1% |
|TERMINAL (d) | |41/43 (95%) 38/40 (95%) 42/43 (98%) 39/40 (98%) |
|FIRST INCIDENCE | |539 525 539 552 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.193 P=0.179 P=0.512 P=0.150 |
|POLY 3 | |P=0.245 P=0.593 P=0.607 P=0.322 |
|POLY 1.5 | |P=0.300 P=0.541 P=0.612 P=0.360 |
|POLY 6 | |P=0.214 P=0.645 P=0.578 P=0.315 |
|LOGISTIC REGRESSION| |P=0.266 P=0.508 P=0.599N P=0.311 |
|COCH-ARM / FISHERS | |P=0.342 P=0.357 P=0.500 P=0.357 |
|ORDER RESTRICTED | |P=0.294 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/12/04 EXPERIMENT: 92013 TEST: 06 Page 40
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 4-METHYLIMIDAZOLE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | |1/46.61 1/47.80 1/48.01 3/46.87 |
|POLY-3 PERCENT (g) | |2.2% 2.1% 2.1% 6.4% |
|TERMINAL (d) | |1/43 (2%) 1/40 (3%) 1/43 (2%) 2/40 (5%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 409 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.155 P=0.746 P=0.762 P=0.290 |
|POLY 3 | |P=0.164 P=0.755N P=0.754N P=0.307 |
|POLY 1.5 | |P=0.165 P=0.755N P=0.755N P=0.309 |
|POLY 6 | |P=0.162 P=0.756N P=0.754N P=0.303 |
|LOGISTIC REGRESSION| |P=0.155 P=0.746 P=0.762 P=0.278 |
|COCH-ARM / FISHERS | |P=0.163 P=0.753N P=0.753N P=0.309 |
|ORDER RESTRICTED | |P=0.187 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 3/50 (6%) 1/50 (2%) 5/50 (10%) |
|POLY-3 RATE (b) | |2/46.61 3/47.80 1/48.01 5/46.05 |
|POLY-3 PERCENT (g) | |4.3% 6.3% 2.1% 10.9% |
|TERMINAL (d) | |2/43 (5%) 3/40 (8%) 1/43 (2%) 5/40 (13%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.143 P=0.467 P=0.500N P=0.188 |
|POLY 3 | |P=0.156 P=0.511 P=0.490N P=0.211 |
|POLY 1.5 | |P=0.159 P=0.511 P=0.491N P=0.216 |
|POLY 6 | |P=0.153 P=0.509 P=0.489N P=0.205 |
|LOGISTIC REGRESSION| |P=0.143 P=0.467 P=0.500N P=0.188 |
|COCH-ARM / FISHERS | |P=0.160 P=0.500 P=0.500N P=0.218 |
|ORDER RESTRICTED | |P=0.136 (e) (e) (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).