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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).
Web page last updated on August 07, 2005
The National Institute of Environmental Health Sciences is one of the National Institutes of Health within the U.S. Department of Health and Human Services. The National Toxicology Program is headquartered on the NIEHS campus in Research Triangle Park, NC.