TDMS Study 96020-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) DATE: 03/03/04 EXPERIMENT: 96020 TEST: 01 TIME: 10:01:10 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96020 PATHOLOGIST: SELLS, DONALD CAS: TEFBINARYMIX ------------------------------------------------------------------------------------------------------------------------------------ FINAL #1 REASONS FOR REMOVAL: 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 0 NG / 0 UG INCLUDE 002 10 NG / 10 UG INCLUDE 003 100 NG /100 UG INCLUDE 005 300 NG /300 UG INCLUDE 007 1000 NG/1000 UG NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) DATE: 03/03/04 EXPERIMENT: 96020 TEST: 01 TIME: 10:01:10 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96020 PATHOLOGIST: SELLS, DONALD CAS: TEFBINARYMIX SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF TEF EVALUATION (BINARY MIXTURE; PCB 126 =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Adrenal Cortex Angiectasis Atrophy Hyperplasia Hypertrophy Adrenal Medulla Hyperplasia Bone Marrow Hyperplasia Clitoral Gland Inflammation Clitoral Gland: Duct Cyst Esophagus Perforation Eye: Anterior Chamber, Ciliary Body, Cornea Inflammation Heart: Coronary Artery Inflammation Chronic Kidney Calculus Micro Observation Only Nephropathy Pigmentation Kidney: Transitional Epithelium Hyperplasia Liver Angiectasis Basophilic Focus Cholangiofibrosis Clear Cell Focus Eosinophilic Focus Fatty Change Diffuse Fatty Change Focal Hematopoietic Cell Proliferation Hyperplasia Mixed Cell Focus Necrosis Pigmentation Toxic Hepatopathy Liver: Bile Duct Cyst Hyperplasia Liver: Hepatocyte Hypertrophy Multinucleated Liver: Oval Cell Hyperplasia Liver: Portal Fibrosis Lung Inflammation Metaplasia Lung: Alveolar Epithelium Hyperplasia Metaplasia Bronchiolar Lymph Node, Mandibular Ectasia Hyperplasia Lymphoid Lymph Node, Mesenteric Hyperplasia Lymph Node: Lumbar Ectasia Hyperplasia Lymph Node: Mediastinal Ectasia Hemorrhage Hyperplasia NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) DATE: 03/03/04 EXPERIMENT: 96020 TEST: 01 TIME: 10:01:10 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96020 PATHOLOGIST: SELLS, DONALD CAS: TEFBINARYMIX Mammary Gland Hyperplasia Inflammation Granulomatous Mesentery: Artery Inflammation Chronic Nose Inflammation Nose: Glands Hyperplasia Nose: Olfactory Epithelium Metaplasia Nose: Respiratory Epithelium Hyperplasia Ovary Atrophy Oviduct Cyst Inflammation Chronic Pancreas Inflammation Chronic Pancreas: Acinus Atrophy Vacuolization Cytoplasmic Pituitary Gland Angiectasis Pituitary Gland: Pars Intermedia Hyperplasia Spleen Hematopoietic Cell Proliferation Spleen: Lymphoid Follicle Atrophy Spleen: Red Pulp Atrophy Stomach, Forestomach Hyperplasia Stomach, Glandular Erosion Mineralization Thymus Atrophy Hyperplasia Lymphoid Thyroid Gland: Follicle Cyst Thyroid Gland: Follicular Cell Hypertrophy Urinary Bladder Inflammation Uterus Inflammation Metaplasia Uterus: Endometrium Hyperplasia Cystic =============================================================== Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 17/53 (32%) 26/53 (49%) 33/52 (63%) 23/52 (44%) 5/51 (10%) | |POLY-3 RATE (b) | 17/41.18 26/40.40 33/44.42 23/42.61 5/36.82 | |POLY-3 PERCENT (g) | 41.3% 64.4% 74.3% 54.0% 13.6% | |TERMINAL (d) | 11/22 (50%) 17/21 (81%) 19/22 (86%) 11/24 (46%) 4/24 (17%) | |FIRST INCIDENCE | 418 469 254 499 558 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.041 * P=0.004 ** P=0.229 P=0.003N** | |POLY 3 | P<0.001N** P=0.023 * P<0.001 ** P=0.164 P=0.005N** | |POLY 1.5 | P<0.001N** P=0.028 * P<0.001 ** P=0.141 P=0.005N** | |POLY 6 | P<0.001N** P=0.022 * P<0.001 ** P=0.220 P=0.004N** | |LOGISTIC REGRESSION| P<0.001N** P=0.037 * P<0.001 ** P=0.132 P=0.006N** | |COCH-ARM / FISHERS | P<0.001N** P=0.057 P<0.001 ** P=0.140 P=0.005N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/52 (0%) 3/52 (6%) 35/51 (69%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 0/38.82 3/37.99 35/41.50 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.9% 84.4% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 2/24 (8%) 21/24 (88%) | |FIRST INCIDENCE | --- --- --- 539 485 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.133 P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.117 P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.115 P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.119 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.117 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.118 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 13/53 (25%) 12/53 (23%) 13/52 (25%) 14/52 (27%) 16/51 (31%) | |POLY-3 RATE (b) | 13/40.95 12/37.55 13/40.77 14/39.87 16/39.37 | |POLY-3 PERCENT (g) | 31.7% 32.0% 31.9% 35.1% 40.6% | |TERMINAL (d) | 6/22 (27%) 11/21 (52%) 6/22 (27%) 7/24 (29%) 10/24 (42%) | |FIRST INCIDENCE | 556 689 581 505 477 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.261 P=0.548N P=0.580N P=0.521 P=0.354 | |POLY 3 | P=0.188 P=0.589 P=0.590 P=0.465 P=0.271 | |POLY 1.5 | P=0.173 P=0.566N P=0.583 P=0.466 P=0.264 | |POLY 6 | P=0.207 P=0.541 P=0.593 P=0.469 P=0.277 | |LOGISTIC REGRESSION| P=0.157 P=0.520N P=0.581N P=0.473 P=0.267 | |COCH-ARM / FISHERS | P=0.179 P=0.500N P=0.567 P=0.477 P=0.288 | |ORDER RESTRICTED | P=0.338 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/53 (21%) 18/53 (34%) 23/52 (44%) 25/52 (48%) 18/51 (35%) | |POLY-3 RATE (b) | 11/39.56 18/39.96 23/43.38 25/42.59 18/39.46 | |POLY-3 PERCENT (g) | 27.8% 45.1% 53.0% 58.7% 45.6% | |TERMINAL (d) | 7/22 (32%) 10/21 (48%) 10/22 (46%) 14/24 (58%) 11/24 (46%) | |FIRST INCIDENCE | 499 469 458 254 477 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.470 P=0.089 P=0.023 * P=0.010 * P=0.129 | |POLY 3 | P=0.330 P=0.079 P=0.013 * P=0.003 ** P=0.072 | |POLY 1.5 | P=0.304 P=0.078 P=0.010 * P=0.002 ** P=0.065 | |POLY 6 | P=0.367 P=0.086 P=0.021 * P=0.004 ** P=0.088 | |LOGISTIC REGRESSION| P=0.294 P=0.077 P=0.010 * P=0.002 ** P=0.063 | |COCH-ARM / FISHERS | P=0.326 P=0.095 P=0.009 ** P=0.003 ** P=0.076 | |ORDER RESTRICTED | P=0.015 * (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 47/53 (89%) 38/53 (72%) 44/52 (85%) 41/52 (79%) 32/51 (63%) | |POLY-3 RATE (b) | 47/49.32 38/45.04 44/47.46 41/44.30 32/42.27 | |POLY-3 PERCENT (g) | 95.3% 84.4% 92.7% 92.6% 75.7% | |TERMINAL (d) | 21/22 (96%) 19/21 (91%) 20/22 (91%) 24/24 (100%) 17/24 (71%) | |FIRST INCIDENCE | 418 296 461 479 485 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.016N* P=0.165N P=0.358N P=0.163N P=0.016N* | |POLY 3 | P=0.003N** P=0.055N P=0.453N P=0.441N P=0.003N** | |POLY 1.5 | P=0.003N** P=0.033N* P=0.409N P=0.258N P=0.002N** | |POLY 6 | P=0.005N** P=0.087N P=0.502N P=0.667N P=0.008N** | |LOGISTIC REGRESSION| P=0.002N** P=0.027N* P=0.270N P=0.103N P<0.001N** | |COCH-ARM / FISHERS | P=0.005N** P=0.025N* P=0.373N P=0.135N P=0.002N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/53 (21%) 12/53 (23%) 14/52 (27%) 10/52 (19%) 13/51 (25%) | |POLY-3 RATE (b) | 11/40.49 12/41.50 14/41.16 10/40.66 13/37.17 | |POLY-3 PERCENT (g) | 27.2% 28.9% 34.0% 24.6% 35.0% | |TERMINAL (d) | 6/22 (27%) 4/21 (19%) 6/22 (27%) 3/24 (13%) 9/24 (38%) | |FIRST INCIDENCE | 451 367 458 330 606 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.500 P=0.472 P=0.359 P=0.469N P=0.458 | |POLY 3 | P=0.329 P=0.528 P=0.331 P=0.495N P=0.306 | |POLY 1.5 | P=0.350 P=0.508 P=0.320 P=0.509N P=0.316 | |POLY 6 | P=0.310 P=0.559 P=0.346 P=0.472N P=0.302 | |LOGISTIC REGRESSION| P=0.397 P=0.494 P=0.325 P=0.521N P=0.350 | |COCH-ARM / FISHERS | P=0.415 P=0.500 P=0.304 P=0.520N P=0.367 | |ORDER RESTRICTED | P=0.396 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 15/52 (29%) 13/53 (25%) 14/52 (27%) 13/52 (25%) 3/51 (6%) | |POLY-3 RATE (b) | 15/38.71 13/39.25 14/41.19 13/39.45 3/37.96 | |POLY-3 PERCENT (g) | 38.8% 33.1% 34.0% 33.0% 7.9% | |TERMINAL (d) | 9/21 (43%) 8/21 (38%) 8/22 (36%) 9/24 (38%) 0/24 (0%) | |FIRST INCIDENCE | 556 534 458 479 314 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.428N P=0.456N P=0.321N P=0.002N** | |POLY 3 | P<0.001N** P=0.386N P=0.415N P=0.380N P<0.001N** | |POLY 1.5 | P<0.001N** P=0.399N P=0.448N P=0.397N P<0.001N** | |POLY 6 | P<0.001N** P=0.363N P=0.387N P=0.360N P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.393N P=0.443N P=0.399N P=0.002N** | |COCH-ARM / FISHERS | P=0.002N** P=0.390N P=0.500N P=0.413N P=0.002N** | |ORDER RESTRICTED | P=0.002N** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 39/53 (74%) 38/53 (72%) 42/53 (79%) 48/53 (91%) 49/53 (92%) | |POLY-3 RATE (b) | 39/51.35 38/51.35 42/53.00 48/53.00 49/50.85 | |POLY-3 PERCENT (g) | 76.0% 74.0% 79.3% 90.6% 96.4% | |TERMINAL (d) | 12/22 (55%) 10/21 (48%) 11/22 (50%) 19/24 (79%) 23/24 (96%) | |FIRST INCIDENCE | 85 167 125 96 71 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.087 P=0.548 P=0.439 P=0.186 P=0.131 | |POLY 3 | P<0.001 ** P=0.500N P=0.433 P=0.037 * P=0.002 ** | |POLY 1.5 | P<0.001 ** P=0.502N P=0.391 P=0.029 * P=0.003 ** | |POLY 6 | P<0.001 ** P=0.497N P=0.479 P=0.048 * P=0.002 ** | |LOGISTIC REGRESSION| P=0.002 ** P=0.476N P=0.282 P=0.019 * P=0.012 * | |COCH-ARM / FISHERS | P=0.002 ** P=0.500N P=0.324 P=0.020 * P=0.009 ** | |ORDER RESTRICTED | P=0.003 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 45/53 (85%) 49/53 (92%) 46/53 (87%) 40/53 (75%) 23/50 (46%) | |POLY-3 RATE (b) | 45/50.91 49/50.52 46/51.41 40/48.52 23/41.02 | |POLY-3 PERCENT (g) | 88.4% 97.0% 89.5% 82.4% 56.1% | |TERMINAL (d) | 18/22 (82%) 21/21 (100%) 20/22 (91%) 17/24 (71%) 12/24 (50%) | |FIRST INCIDENCE | 345 178 125 254 479 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.282 P=0.534 P=0.253N P<0.001N** | |POLY 3 | P<0.001N** P=0.085 P=0.558 P=0.282N P<0.001N** | |POLY 1.5 | P<0.001N** P=0.110 P=0.575 P=0.244N P<0.001N** | |POLY 6 | P<0.001N** P=0.065 P=0.526 P=0.313N P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.153 P=0.501 P=0.180N P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.179 P=0.500 P=0.165N P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Clitoral Gland: Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 38/53 (72%) 40/53 (75%) 48/53 (91%) 43/53 (81%) 43/50 (86%) | |POLY-3 RATE (b) | 38/50.38 40/47.56 48/50.11 43/48.31 43/46.44 | |POLY-3 PERCENT (g) | 75.4% 84.1% 95.8% 89.0% 92.6% | |TERMINAL (d) | 13/22 (59%) 18/21 (86%) 21/22 (96%) 21/24 (88%) 21/24 (88%) | |FIRST INCIDENCE | 345 178 254 254 206 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.472 P=0.379 P=0.141 P=0.346 P=0.310 | |POLY 3 | P=0.058 P=0.198 P=0.002 ** P=0.057 P=0.018 * | |POLY 1.5 | P=0.052 P=0.267 P=0.004 ** P=0.084 P=0.019 * | |POLY 6 | P=0.078 P=0.141 P=0.002 ** P=0.038 * P=0.020 * | |LOGISTIC REGRESSION| P=0.095 P=0.403 P=0.013 * P=0.168 P=0.054 | |COCH-ARM / FISHERS | P=0.124 P=0.413 P=0.012 * P=0.180 P=0.062 | |ORDER RESTRICTED | P=0.005 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Esophagus | | Perforation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 1/52 (2%) 0/53 (0%) 2/52 (4%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 1/39.82 0/37.40 2/38.26 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.5% 0.0% 5.2% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- --- 125 --- 71 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.079 (e) P=0.504 (e) P=0.238 | |POLY 3 | P=0.081 (e) P=0.508 (e) P=0.237 | |POLY 1.5 | P=0.080 (e) P=0.505 (e) P=0.234 | |POLY 6 | P=0.083 (e) P=0.511 (e) P=0.241 | |LOGISTIC REGRESSION| P=0.463 (e) P=0.425 (e) (e) | |COCH-ARM / FISHERS | P=0.079 (e) P=0.495 (e) P=0.243 | |ORDER RESTRICTED | P=0.047 * (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Esophagus: Muscularis | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 1/53 (2%) 1/52 (2%) 3/53 (6%) 3/52 (6%) | |POLY-3 RATE (b) | 3/39.27 1/37.65 1/38.82 3/39.07 3/37.26 | |POLY-3 PERCENT (g) | 7.6% 2.7% 2.6% 7.7% 8.1% | |TERMINAL (d) | 1/22 (5%) 0/21 (0%) 1/22 (5%) 0/24 (0%) 2/24 (8%) | |FIRST INCIDENCE | 85 661 729 (T) 499 76 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.331 P=0.320N P=0.301N P=0.649N P=0.642N | |POLY 3 | P=0.307 P=0.319N P=0.308N P=0.661 P=0.639 | |POLY 1.5 | P=0.306 P=0.320N P=0.312N P=0.653 P=0.636 | |POLY 6 | P=0.309 P=0.316N P=0.306N P=0.653N P=0.645 | |LOGISTIC REGRESSION| P=0.358 P=0.286N P=0.324N P=0.630N P=0.608N | |COCH-ARM / FISHERS | P=0.316 P=0.309N P=0.316N P=0.661N P=0.652 | |ORDER RESTRICTED | P=0.422 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Eye: Anterior Chamber, Ciliary Body, Cornea | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/53 (0%) 1/52 (2%) 3/52 (6%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 0/39.03 1/37.28 3/37.17 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.7% 8.1% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- --- --- 580 563 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.006 ** (e) (e) P=0.500 P=0.121 | |POLY 3 | P=0.006 ** (e) (e) P=0.495 P=0.113 | |POLY 1.5 | P=0.006 ** (e) (e) P=0.493 P=0.110 | |POLY 6 | P=0.006 ** (e) (e) P=0.500 P=0.118 | |LOGISTIC REGRESSION| P=0.007 ** (e) (e) P=0.502 P=0.114 | |COCH-ARM / FISHERS | P=0.007 ** (e) (e) P=0.495 P=0.118 | |ORDER RESTRICTED | P=0.010 * (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Eye: Retina | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 3/53 (6%) 4/53 (8%) 2/52 (4%) 5/52 (10%) | |POLY-3 RATE (b) | 1/38.18 3/37.65 4/39.09 2/36.79 5/36.27 | |POLY-3 PERCENT (g) | 2.6% 8.0% 10.2% 5.4% 13.8% | |TERMINAL (d) | 1/22 (5%) 2/21 (10%) 3/22 (14%) 2/24 (8%) 5/24 (21%) | |FIRST INCIDENCE | 729 (T) 661 715 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.183 P=0.293 P=0.188 P=0.531 P=0.118 | |POLY 3 | P=0.130 P=0.299 P=0.184 P=0.487 P=0.087 | |POLY 1.5 | P=0.130 P=0.298 P=0.182 P=0.485 P=0.087 | |POLY 6 | P=0.131 P=0.303 P=0.185 P=0.492 P=0.088 | |LOGISTIC REGRESSION| P=0.147 P=0.299 P=0.191 P=0.531 P=0.118 | |COCH-ARM / FISHERS | P=0.144 P=0.309 P=0.181 P=0.493 P=0.098 | |ORDER RESTRICTED | P=0.056 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Harderian Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 20/53 (38%) 14/53 (26%) 16/53 (30%) 14/52 (27%) 16/52 (31%) | |POLY-3 RATE (b) | 20/41.85 14/39.14 16/42.74 14/39.15 16/39.43 | |POLY-3 PERCENT (g) | 47.8% 35.8% 37.4% 35.8% 40.6% | |TERMINAL (d) | 10/22 (46%) 7/21 (33%) 7/22 (32%) 10/24 (42%) 9/24 (38%) | |FIRST INCIDENCE | 418 580 254 330 314 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.414N P=0.200N P=0.275N P=0.131N P=0.265N | |POLY 3 | P=0.527N P=0.185N P=0.223N P=0.185N P=0.329N | |POLY 1.5 | P=0.535N P=0.175N P=0.235N P=0.181N P=0.335N | |POLY 6 | P=0.524N P=0.190N P=0.214N P=0.194N P=0.327N | |LOGISTIC REGRESSION| P=0.543N P=0.155N P=0.253N P=0.176N P=0.331N | |COCH-ARM / FISHERS | P=0.493N P=0.149N P=0.269N P=0.165N P=0.293N | |ORDER RESTRICTED | P=0.279N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 22/53 (42%) 19/52 (37%) 22/52 (42%) 26/53 (49%) 15/52 (29%) | |POLY-3 RATE (b) | 22/41.41 19/38.93 22/41.36 26/41.49 15/39.21 | |POLY-3 PERCENT (g) | 53.1% 48.8% 53.2% 62.7% 38.3% | |TERMINAL (d) | 14/22 (64%) 10/21 (48%) 13/22 (59%) 17/24 (71%) 8/24 (33%) | |FIRST INCIDENCE | 449 589 458 96 314 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.074N P=0.391N P=0.551N P=0.374 P=0.096N | |POLY 3 | P=0.094N P=0.433N P=0.589 P=0.243 P=0.123N | |POLY 1.5 | P=0.110N P=0.427N P=0.574 P=0.249 P=0.135N | |POLY 6 | P=0.085N P=0.408N P=0.596N P=0.248 P=0.110N | |LOGISTIC REGRESSION| P=0.127N P=0.394N P=0.554N P=0.233 P=0.143N | |COCH-ARM / FISHERS | P=0.107N P=0.374N P=0.546 P=0.279 P=0.124N | |ORDER RESTRICTED | P=0.097N (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Heart: Coronary Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/52 (0%) 1/52 (2%) 0/53 (0%) 6/52 (12%) | |POLY-3 RATE (b) | 0/38.18 0/36.71 1/38.82 0/37.40 6/36.27 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.6% 0.0% 16.5% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 1/22 (5%) 0/24 (0%) 6/24 (25%) | |FIRST INCIDENCE | --- --- 729 (T) --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.500 (e) P=0.020 * | |POLY 3 | P<0.001 ** (e) P=0.503 (e) P=0.012 * | |POLY 1.5 | P<0.001 ** (e) P=0.501 (e) P=0.012 * | |POLY 6 | P<0.001 ** (e) P=0.506 (e) P=0.012 * | |LOGISTIC REGRESSION| (e) (e) P=0.500 (e) P=0.020 * | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.495 (e) P=0.013 * | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Intestine Large, Colon | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/53 (4%) 0/53 (0%) 0/52 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 0/38.18 2/38.33 0/39.03 0/37.39 0/35.41 | |POLY-3 PERCENT (g) | 0.0% 5.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- 499 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.370N P=0.240 (e) (e) (e) | |POLY 3 | P=0.371N P=0.237 (e) (e) (e) | |POLY 1.5 | P=0.373N P=0.235 (e) (e) (e) | |POLY 6 | P=0.365N P=0.242 (e) (e) (e) | |LOGISTIC REGRESSION| P=0.365N P=0.243 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.370N P=0.248 (e) (e) (e) | |ORDER RESTRICTED | P=0.234N (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Intestine Large, Rectum | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/53 (0%) 0/53 (0%) 1/53 (2%) 3/50 (6%) | |POLY-3 RATE (b) | 2/38.76 0/37.40 0/39.03 1/37.45 3/35.82 | |POLY-3 PERCENT (g) | 5.2% 0.0% 0.0% 2.7% 8.4% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 3/24 (13%) | |FIRST INCIDENCE | 636 --- --- 715 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.086 P=0.250N P=0.250N P=0.514N P=0.496 | |POLY 3 | P=0.069 P=0.244N P=0.235N P=0.512N P=0.464 | |POLY 1.5 | P=0.069 P=0.243N P=0.235N P=0.510N P=0.462 | |POLY 6 | P=0.070 P=0.246N P=0.236N P=0.513N P=0.466 | |LOGISTIC REGRESSION| P=0.072 P=0.240N P=0.236N P=0.506N P=0.476 | |COCH-ARM / FISHERS | P=0.072 P=0.248N P=0.248N P=0.500N P=0.472 | |ORDER RESTRICTED | P=0.079 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Intestine Small, Jejunum | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 1/52 (2%) 2/52 (4%) 1/49 (2%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 1/39.07 2/38.30 1/35.41 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.6% 5.2% 2.8% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 1/24 (4%) 1/24 (4%) | |FIRST INCIDENCE | --- --- 664 330 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.386 (e) P=0.487 P=0.243 P=0.517 | |POLY 3 | P=0.362 (e) P=0.505 P=0.237 P=0.485 | |POLY 1.5 | P=0.355 (e) P=0.501 P=0.235 P=0.482 | |POLY 6 | P=0.371 (e) P=0.508 P=0.240 P=0.490 | |LOGISTIC REGRESSION| P=0.361 (e) P=0.500 P=0.237 P=0.517 | |COCH-ARM / FISHERS | P=0.359 (e) P=0.495 P=0.243 P=0.480 | |ORDER RESTRICTED | P=0.194 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Kidney | | Accumulation, Hyaline Droplet | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/53 (0%) 1/52 (2%) 1/52 (2%) 1/51 (2%) | |POLY-3 RATE (b) | 2/39.63 0/37.40 1/39.26 1/38.39 1/37.24 | |POLY-3 PERCENT (g) | 5.1% 0.0% 2.6% 2.6% 2.7% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | 449 --- 603 142 206 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.653 P=0.247N P=0.492N P=0.497N P=0.514N | |POLY 3 | P=0.663 P=0.250N P=0.503N P=0.511N P=0.522N | |POLY 1.5 | P=0.660 P=0.247N P=0.504N P=0.509N P=0.521N | |POLY 6 | P=0.664N P=0.252N P=0.502N P=0.512N P=0.522N | |LOGISTIC REGRESSION| P=0.557N P=0.212N P=0.526N P=0.480N P=0.406N | |COCH-ARM / FISHERS | P=0.658 P=0.248N P=0.507N P=0.507N P=0.515N | |ORDER RESTRICTED | P=0.346N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Kidney | | Calculus Micro Observation Only | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/53 (13%) 4/53 (8%) 1/52 (2%) 4/52 (8%) 1/51 (2%) | |POLY-3 RATE (b) | 7/38.73 4/37.96 1/39.26 4/39.34 1/36.26 | |POLY-3 PERCENT (g) | 18.1% 10.5% 2.6% 10.2% 2.8% | |TERMINAL (d) | 5/22 (23%) 1/21 (5%) 0/22 (0%) 0/24 (0%) 1/24 (4%) | |FIRST INCIDENCE | 647 603 603 499 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.079N P=0.291N P=0.035N* P=0.253N P=0.029N* | |POLY 3 | P=0.089N P=0.268N P=0.027N* P=0.248N P=0.035N* | |POLY 1.5 | P=0.090N P=0.271N P=0.029N* P=0.261N P=0.037N* | |POLY 6 | P=0.089N P=0.261N P=0.025N* P=0.229N P=0.034N* | |LOGISTIC REGRESSION| P=0.089N P=0.266N P=0.029N* P=0.274N P=0.033N* | |COCH-ARM / FISHERS | P=0.087N P=0.263N P=0.032N* P=0.274N P=0.034N* | |ORDER RESTRICTED | P=0.014N* (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Kidney | | Casts Protein | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 1/53 (2%) 0/52 (0%) 0/52 (0%) 0/51 (0%) | |POLY-3 RATE (b) | 2/39.30 1/37.40 0/38.82 0/37.39 0/36.26 | |POLY-3 PERCENT (g) | 5.1% 2.7% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/22 (0%) 1/21 (5%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | 345 729 (T) --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.227N P=0.511N P=0.242N P=0.249N P=0.255N | |POLY 3 | P=0.232N P=0.517N P=0.239N P=0.248N P=0.255N | |POLY 1.5 | P=0.232N P=0.514N P=0.240N P=0.246N P=0.255N | |POLY 6 | P=0.231N P=0.519N P=0.239N P=0.248N P=0.254N | |LOGISTIC REGRESSION| P=0.226N P=0.491N P=0.252N P=0.234N P=0.218N | |COCH-ARM / FISHERS | P=0.231N P=0.500N P=0.252N P=0.252N P=0.257N | |ORDER RESTRICTED | P=0.057N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Kidney | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/53 (9%) 3/53 (6%) 1/52 (2%) 5/52 (10%) 1/51 (2%) | |POLY-3 RATE (b) | 5/38.24 3/37.40 1/39.26 5/37.96 1/36.26 | |POLY-3 PERCENT (g) | 13.1% 8.0% 2.6% 13.2% 2.8% | |TERMINAL (d) | 4/22 (18%) 3/21 (14%) 0/22 (0%) 4/24 (17%) 1/24 (4%) | |FIRST INCIDENCE | 714 729 (T) 603 552 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.156N P=0.379N P=0.099N P=0.584N P=0.083N | |POLY 3 | P=0.207N P=0.367N P=0.093N P=0.628 P=0.111N | |POLY 1.5 | P=0.209N P=0.368N P=0.098N P=0.621 P=0.114N | |POLY 6 | P=0.205N P=0.362N P=0.088N P=0.628N P=0.107N | |LOGISTIC REGRESSION| P=0.197N P=0.359N P=0.095N P=0.630 P=0.087N | |COCH-ARM / FISHERS | P=0.200N P=0.358N P=0.107N P=0.617 P=0.112N | |ORDER RESTRICTED | P=0.075N (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 42/53 (79%) 38/53 (72%) 39/52 (75%) 42/52 (81%) 35/51 (69%) | |POLY-3 RATE (b) | 42/50.36 38/47.49 39/49.00 42/48.93 35/45.19 | |POLY-3 PERCENT (g) | 83.4% 80.0% 79.6% 85.8% 77.5% | |TERMINAL (d) | 15/22 (68%) 16/21 (76%) 19/22 (86%) 19/24 (79%) 17/24 (71%) | |FIRST INCIDENCE | 85 178 125 254 71 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.192N P=0.404N P=0.372N P=0.498N P=0.191N | |POLY 3 | P=0.348N P=0.429N P=0.404N P=0.476 P=0.309N | |POLY 1.5 | P=0.317N P=0.381N P=0.385N P=0.466 P=0.266N | |POLY 6 | P=0.373N P=0.479N P=0.466N P=0.481 P=0.361N | |LOGISTIC REGRESSION| P=0.222N P=0.257N P=0.400N P=0.519 P=0.163N | |COCH-ARM / FISHERS | P=0.211N P=0.249N P=0.388N P=0.520 P=0.156N | |ORDER RESTRICTED | P=0.379N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 29/53 (55%) 22/53 (42%) 29/52 (56%) 34/52 (65%) 43/51 (84%) | |POLY-3 RATE (b) | 29/44.67 22/40.11 29/41.95 34/43.59 43/44.94 | |POLY-3 PERCENT (g) | 64.9% 54.9% 69.1% 78.0% 95.7% | |TERMINAL (d) | 17/22 (77%) 14/21 (67%) 18/22 (82%) 23/24 (96%) 24/24 (100%) | |FIRST INCIDENCE | 345 337 469 142 314 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.175N P=0.539N P=0.320 P=0.023 * | |POLY 3 | P<0.001 ** P=0.222N P=0.420 P=0.108 P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.186N P=0.465 P=0.137 P<0.001 ** | |POLY 6 | P<0.001 ** P=0.246N P=0.368 P=0.084 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.132N P=0.567N P=0.165 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.122N P=0.535 P=0.180 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 14 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Kidney | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 1/53 (2%) 3/52 (6%) 7/52 (13%) 35/51 (69%) | |POLY-3 RATE (b) | 0/38.18 1/37.40 3/39.12 7/38.16 35/40.29 | |POLY-3 PERCENT (g) | 0.0% 2.7% 7.7% 18.3% 86.9% | |TERMINAL (d) | 0/22 (0%) 1/21 (5%) 1/22 (5%) 6/24 (25%) 23/24 (96%) | |FIRST INCIDENCE | --- 729 (T) 664 451 563 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.491 P=0.130 P=0.011 * P<0.001 ** | |POLY 3 | P<0.001 ** P=0.496 P=0.122 P=0.007 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.496 P=0.119 P=0.007 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.497 P=0.125 P=0.007 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.491 P=0.124 P=0.008 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.118 P=0.006 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Kidney: Pelvis | | Dilatation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 0/53 (0%) 0/52 (0%) 2/52 (4%) 1/51 (2%) | |POLY-3 RATE (b) | 1/38.18 0/37.40 0/38.82 2/37.83 1/36.94 | |POLY-3 PERCENT (g) | 2.6% 0.0% 0.0% 5.3% 2.7% | |TERMINAL (d) | 1/22 (5%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | 729 (T) --- --- 618 499 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.434 P=0.509N P=0.500N P=0.506 P=0.753N | |POLY 3 | P=0.425 P=0.504N P=0.497N P=0.497 P=0.754 | |POLY 1.5 | P=0.420 P=0.504N P=0.499N P=0.493 P=0.750 | |POLY 6 | P=0.432 P=0.503N P=0.494N P=0.504 P=0.760 | |LOGISTIC REGRESSION| P=0.422 (e) (e) P=0.494 P=0.755 | |COCH-ARM / FISHERS | P=0.424 P=0.500N P=0.505N P=0.493 P=0.743 | |ORDER RESTRICTED | P=0.297 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 15 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Kidney: Pelvis | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 0/53 (0%) 4/52 (8%) 3/52 (6%) 5/51 (10%) | |POLY-3 RATE (b) | 3/39.42 0/37.40 4/39.96 3/38.07 5/37.95 | |POLY-3 PERCENT (g) | 7.6% 0.0% 10.0% 7.9% 13.2% | |TERMINAL (d) | 1/22 (5%) 0/21 (0%) 1/22 (5%) 2/24 (8%) 2/24 (8%) | |FIRST INCIDENCE | 499 --- 531 499 485 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.119 P=0.128N P=0.500 P=0.637N P=0.364 | |POLY 3 | P=0.105 P=0.127N P=0.507 P=0.648 P=0.334 | |POLY 1.5 | P=0.100 P=0.125N P=0.500 P=0.648 P=0.327 | |POLY 6 | P=0.111 P=0.129N P=0.516 P=0.649 P=0.343 | |LOGISTIC REGRESSION| P=0.100 P=0.117N P=0.486 P=0.654 P=0.340 | |COCH-ARM / FISHERS | P=0.100 P=0.121N P=0.489 P=0.652 P=0.336 | |ORDER RESTRICTED | P=0.097 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 1/52 (2%) 2/52 (4%) 1/51 (2%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 1/38.82 2/37.67 1/36.26 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.6% 5.3% 2.8% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 1/22 (5%) 1/24 (4%) 1/24 (4%) | |FIRST INCIDENCE | --- --- 729 (T) 654 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.397 (e) P=0.500 P=0.239 P=0.517 | |POLY 3 | P=0.368 (e) P=0.503 P=0.233 P=0.490 | |POLY 1.5 | P=0.365 (e) P=0.501 P=0.232 P=0.488 | |POLY 6 | P=0.372 (e) P=0.506 P=0.237 P=0.492 | |LOGISTIC REGRESSION| P=0.371 (e) P=0.500 P=0.233 P=0.517 | |COCH-ARM / FISHERS | P=0.372 (e) P=0.495 P=0.243 P=0.490 | |ORDER RESTRICTED | P=0.190 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 16 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Kidney: Transitional Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 2/53 (4%) 4/52 (8%) 11/52 (21%) 6/51 (12%) | |POLY-3 RATE (b) | 2/38.18 2/38.38 4/39.07 11/39.29 6/38.65 | |POLY-3 PERCENT (g) | 5.2% 5.2% 10.2% 28.0% 15.5% | |TERMINAL (d) | 2/22 (9%) 1/21 (5%) 3/22 (14%) 7/24 (29%) 2/24 (8%) | |FIRST INCIDENCE | 729 (T) 178 664 539 485 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.118 P=0.682 P=0.330 P=0.012 * P=0.148 | |POLY 3 | P=0.093 P=0.693N P=0.346 P=0.007 ** P=0.133 | |POLY 1.5 | P=0.081 P=0.694 P=0.339 P=0.006 ** P=0.124 | |POLY 6 | P=0.110 P=0.690N P=0.354 P=0.008 ** P=0.147 | |LOGISTIC REGRESSION| P=0.080 P=0.688N P=0.352 P=0.007 ** P=0.121 | |COCH-ARM / FISHERS | P=0.084 P=0.691N P=0.330 P=0.007 ** P=0.123 | |ORDER RESTRICTED | P=0.018 * (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 1/53 (2%) 1/52 (2%) 2/52 (4%) 5/51 (10%) | |POLY-3 RATE (b) | 3/38.74 1/37.40 1/38.82 2/37.66 5/36.26 | |POLY-3 PERCENT (g) | 7.7% 2.7% 2.6% 5.3% 13.8% | |TERMINAL (d) | 2/22 (9%) 1/21 (5%) 1/22 (5%) 1/24 (4%) 5/24 (21%) | |FIRST INCIDENCE | 556 729 (T) 729 (T) 659 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.073 P=0.320N P=0.303N P=0.487N P=0.395 | |POLY 3 | P=0.048 * P=0.317N P=0.303N P=0.513N P=0.318 | |POLY 1.5 | P=0.049 * P=0.315N P=0.306N P=0.513N P=0.319 | |POLY 6 | P=0.048 * P=0.317N P=0.302N P=0.510N P=0.318 | |LOGISTIC REGRESSION| P=0.050 P=0.311N P=0.299N P=0.509N P=0.334 | |COCH-ARM / FISHERS | P=0.053 P=0.309N P=0.316N P=0.509N P=0.336 | |ORDER RESTRICTED | P=0.070 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 17 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 22/53 (42%) 22/53 (42%) 14/52 (27%) 3/52 (6%) 6/51 (12%) | |POLY-3 RATE (b) | 22/43.23 22/40.41 14/41.62 3/37.45 6/36.96 | |POLY-3 PERCENT (g) | 50.9% 54.5% 33.6% 8.0% 16.2% | |TERMINAL (d) | 9/22 (41%) 14/21 (67%) 7/22 (32%) 2/24 (8%) 5/24 (21%) | |FIRST INCIDENCE | 377 296 254 715 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.530 P=0.092N P<0.001N** P<0.001N** | |POLY 3 | P<0.001N** P=0.456 P=0.075N P<0.001N** P<0.001N** | |POLY 1.5 | P<0.001N** P=0.496 P=0.075N P<0.001N** P<0.001N** | |POLY 6 | P<0.001N** P=0.418 P=0.081N P<0.001N** P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.547 P=0.077N P<0.001N** P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.578N P=0.085N P<0.001N** P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Cholangiofibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 1/53 (2%) 0/52 (0%) 7/52 (13%) 39/51 (76%) | |POLY-3 RATE (b) | 0/38.18 1/38.22 0/38.82 7/37.86 39/41.56 | |POLY-3 PERCENT (g) | 0.0% 2.6% 0.0% 18.5% 93.8% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 5/24 (21%) 24/24 (100%) | |FIRST INCIDENCE | --- 407 --- 612 540 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.483 (e) P=0.012 * P<0.001 ** | |POLY 3 | P<0.001 ** P=0.500 (e) P=0.007 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.498 (e) P=0.007 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.503 (e) P=0.007 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.527 (e) P=0.008 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.500 (e) P=0.006 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 18 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 9/53 (17%) 3/53 (6%) 3/52 (6%) 3/52 (6%) 1/51 (2%) | |POLY-3 RATE (b) | 9/38.43 3/37.40 3/38.82 3/37.39 1/37.26 | |POLY-3 PERCENT (g) | 23.4% 8.0% 7.7% 8.0% 2.7% | |TERMINAL (d) | 8/22 (36%) 3/21 (14%) 3/22 (14%) 3/24 (13%) 0/24 (0%) | |FIRST INCIDENCE | 664 729 (T) 729 (T) 729 (T) 71 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.025N* P=0.062N P=0.053N P=0.039N* P=0.007N** | |POLY 3 | P=0.036N* P=0.060N P=0.052N P=0.060N P=0.008N** | |POLY 1.5 | P=0.038N* P=0.062N P=0.057N P=0.063N P=0.009N** | |POLY 6 | P=0.034N* P=0.057N P=0.049N* P=0.056N P=0.007N** | |LOGISTIC REGRESSION| P=0.042N* P=0.054N P=0.043N* P=0.045N* P=0.012N* | |COCH-ARM / FISHERS | P=0.043N* P=0.061N P=0.066N P=0.066N P=0.009N** | |ORDER RESTRICTED | P=0.002N** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 14/53 (26%) 16/53 (30%) 30/52 (58%) 40/52 (77%) 18/51 (35%) | |POLY-3 RATE (b) | 14/42.00 16/40.12 30/45.64 40/47.53 18/42.64 | |POLY-3 PERCENT (g) | 33.3% 39.9% 65.7% 84.2% 42.2% | |TERMINAL (d) | 4/22 (18%) 10/21 (48%) 11/22 (50%) 18/24 (75%) 5/24 (21%) | |FIRST INCIDENCE | 451 296 254 330 169 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.494N P=0.378 P=0.010 * P<0.001 ** P=0.297 | |POLY 3 | P=0.450N P=0.347 P<0.001 ** P<0.001 ** P=0.265 | |POLY 1.5 | P=0.544N P=0.373 P<0.001 ** P<0.001 ** P=0.236 | |POLY 6 | P=0.344N P=0.312 P=0.002 ** P<0.001 ** P=0.303 | |LOGISTIC REGRESSION| P=0.465 P=0.396 P<0.001 ** P<0.001 ** P=0.222 | |COCH-ARM / FISHERS | P=0.485 P=0.415 P<0.001 ** P<0.001 ** P=0.221 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 19 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Fatty Change Diffuse | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 1/53 (2%) 9/52 (17%) 31/52 (60%) 38/51 (75%) | |POLY-3 RATE (b) | 3/39.19 1/37.87 9/40.34 31/45.69 38/47.97 | |POLY-3 PERCENT (g) | 7.7% 2.6% 22.3% 67.8% 79.2% | |TERMINAL (d) | 1/22 (5%) 0/21 (0%) 6/22 (27%) 15/24 (63%) 16/24 (67%) | |FIRST INCIDENCE | 449 589 125 254 71 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.322N P=0.068 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.317N P=0.062 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.315N P=0.061 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.315N P=0.062 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.302N P=0.059 P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.309N P=0.057 P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Fatty Change Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 4/53 (8%) 7/52 (13%) 1/52 (2%) 12/51 (24%) | |POLY-3 RATE (b) | 3/38.27 4/37.52 7/39.16 1/37.83 12/37.11 | |POLY-3 PERCENT (g) | 7.8% 10.7% 17.9% 2.6% 32.3% | |TERMINAL (d) | 2/22 (9%) 3/21 (14%) 5/22 (23%) 0/24 (0%) 9/24 (38%) | |FIRST INCIDENCE | 708 698 654 603 563 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.005 ** P=0.472 P=0.169 P=0.288N P=0.018 * | |POLY 3 | P<0.001 ** P=0.489 P=0.162 P=0.308N P=0.007 ** | |POLY 1.5 | P<0.001 ** P=0.489 P=0.158 P=0.312N P=0.007 ** | |POLY 6 | P<0.001 ** P=0.494 P=0.167 P=0.301N P=0.007 ** | |LOGISTIC REGRESSION| P=0.002 ** P=0.493 P=0.167 P=0.310N P=0.008 ** | |COCH-ARM / FISHERS | P=0.002 ** P=0.500 P=0.152 P=0.316N P=0.009 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 27/53 (51%) 29/53 (55%) 30/52 (58%) 19/52 (37%) 11/51 (22%) | |POLY-3 RATE (b) | 27/49.38 29/45.61 30/48.78 19/44.94 11/40.88 | |POLY-3 PERCENT (g) | 54.7% 63.6% 61.5% 42.3% 26.9% | |TERMINAL (d) | 5/22 (23%) 11/21 (52%) 8/22 (36%) 6/24 (25%) 5/24 (21%) | |FIRST INCIDENCE | 85 167 254 142 169 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.406 P=0.422 P=0.143N P=0.007N** | |POLY 3 | P<0.001N** P=0.247 P=0.314 P=0.156N P=0.005N** | |POLY 1.5 | P<0.001N** P=0.298 P=0.308 P=0.130N P=0.003N** | |POLY 6 | P<0.001N** P=0.205 P=0.310 P=0.189N P=0.012N* | |LOGISTIC REGRESSION| P<0.001N** P=0.445 P=0.256 P=0.083N P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.423 P=0.309 P=0.098N P=0.002N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/53 (4%) 0/52 (0%) 0/52 (0%) 0/51 (0%) | |POLY-3 RATE (b) | 0/38.18 2/38.54 0/38.82 0/37.39 0/36.26 | |POLY-3 PERCENT (g) | 0.0% 5.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- 178 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.360N P=0.252 (e) (e) (e) | |POLY 3 | P=0.364N P=0.238 (e) (e) (e) | |POLY 1.5 | P=0.365N P=0.237 (e) (e) (e) | |POLY 6 | P=0.361N P=0.242 (e) (e) (e) | |LOGISTIC REGRESSION| P=0.321N P=0.261 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.363N P=0.248 (e) (e) (e) | |ORDER RESTRICTED | P=0.229N (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 21 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 2/52 (4%) 24/52 (46%) 42/51 (82%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 2/39.12 24/39.96 42/43.59 | |POLY-3 PERCENT (g) | 0.0% 0.0% 5.1% 60.1% 96.4% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 16/24 (67%) 24/24 (100%) | |FIRST INCIDENCE | --- --- 664 552 477 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.250 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.242 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.238 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.246 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.241 P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.243 P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 44/53 (83%) 41/53 (77%) 46/52 (88%) 48/52 (92%) 46/51 (90%) | |POLY-3 RATE (b) | 44/50.14 41/48.11 46/50.19 48/50.71 46/49.13 | |POLY-3 PERCENT (g) | 87.8% 85.2% 91.7% 94.7% 93.6% | |TERMINAL (d) | 19/22 (86%) 18/21 (86%) 20/22 (91%) 23/24 (96%) 23/24 (96%) | |FIRST INCIDENCE | 85 178 125 254 169 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.415 P=0.456N P=0.481 P=0.407 P=0.479 | |POLY 3 | P=0.140 P=0.469N P=0.369 P=0.175 P=0.240 | |POLY 1.5 | P=0.103 P=0.441N P=0.326 P=0.129 P=0.195 | |POLY 6 | P=0.183 P=0.467N P=0.417 P=0.238 P=0.302 | |LOGISTIC REGRESSION| P=0.082 P=0.333N P=0.309 P=0.123 P=0.203 | |COCH-ARM / FISHERS | P=0.096 P=0.313N P=0.303 P=0.125 P=0.217 | |ORDER RESTRICTED | P=0.133 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 22 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 26/53 (49%) 22/53 (42%) 30/52 (58%) 26/52 (50%) 3/51 (6%) | |POLY-3 RATE (b) | 26/43.18 22/40.56 30/44.57 26/38.98 3/36.26 | |POLY-3 PERCENT (g) | 60.2% 54.2% 67.3% 66.7% 8.3% | |TERMINAL (d) | 16/22 (73%) 16/21 (76%) 17/22 (77%) 23/24 (96%) 3/24 (13%) | |FIRST INCIDENCE | 377 330 254 499 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.343N P=0.315 P=0.456N P<0.001N** | |POLY 3 | P<0.001N** P=0.363N P=0.309 P=0.341 P<0.001N** | |POLY 1.5 | P<0.001N** P=0.335N P=0.285 P=0.424 P<0.001N** | |POLY 6 | P<0.001N** P=0.401N P=0.338 P=0.238 P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.303N P=0.272 P=0.536 P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.279N P=0.245 P=0.539 P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 8/53 (15%) 5/52 (10%) 4/52 (8%) 20/51 (39%) | |POLY-3 RATE (b) | 4/39.53 8/40.10 5/40.50 4/38.13 20/44.06 | |POLY-3 PERCENT (g) | 10.1% 20.0% 12.4% 10.5% 45.4% | |TERMINAL (d) | 0/22 (0%) 1/21 (5%) 0/22 (0%) 2/24 (8%) 8/24 (33%) | |FIRST INCIDENCE | 533 499 469 552 71 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.186 P=0.514 P=0.636 P<0.001 ** | |POLY 3 | P<0.001 ** P=0.179 P=0.515 P=0.625 P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.173 P=0.506 P=0.626 P<0.001 ** | |POLY 6 | P<0.001 ** P=0.191 P=0.521 P=0.624 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.178 P=0.485 P=0.632 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.179 P=0.488 P=0.631 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 23 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 5/53 (9%) 38/52 (73%) 50/52 (96%) 50/51 (98%) | |POLY-3 RATE (b) | 2/38.18 5/39.17 38/45.72 50/50.05 50/50.00 | |POLY-3 PERCENT (g) | 5.2% 12.8% 83.1% 99.9% 100.0% | |TERMINAL (d) | 2/22 (9%) 1/21 (5%) 20/22 (91%) 24/24 (100%) 24/24 (100%) | |FIRST INCIDENCE | 729 (T) 407 458 310 169 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.219 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.224 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.217 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.237 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.213 P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.219 P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Toxic Hepatopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/53 (4%) 34/52 (65%) 48/52 (92%) 49/51 (96%) | |POLY-3 RATE (b) | 0/38.18 2/38.48 34/45.02 48/48.25 49/49.02 | |POLY-3 PERCENT (g) | 0.0% 5.2% 75.5% 99.5% 100.0% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 17/22 (77%) 24/24 (100%) 24/24 (100%) | |FIRST INCIDENCE | --- 407 461 330 169 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.231 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.238 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.236 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.242 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.249 P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.248 P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 24 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver: Bile Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 3/53 (6%) 1/52 (2%) 5/52 (10%) 23/51 (45%) | |POLY-3 RATE (b) | 4/38.46 3/38.22 1/38.82 5/37.44 23/36.69 | |POLY-3 PERCENT (g) | 10.4% 7.9% 2.6% 13.4% 62.7% | |TERMINAL (d) | 3/22 (14%) 2/21 (10%) 1/22 (5%) 4/24 (17%) 20/24 (83%) | |FIRST INCIDENCE | 654 407 729 (T) 719 654 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.529N P=0.179N P=0.542 P<0.001 ** | |POLY 3 | P<0.001 ** P=0.503N P=0.174N P=0.483 P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.506N P=0.178N P=0.483 P<0.001 ** | |POLY 6 | P<0.001 ** P=0.499N P=0.171N P=0.485 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.510N P=0.166N P=0.510 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.187N P=0.488 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver: Bile Duct | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 3/53 (6%) 3/52 (6%) 4/52 (8%) 0/51 (0%) | |POLY-3 RATE (b) | 1/38.41 3/38.00 3/39.97 4/38.64 0/36.26 | |POLY-3 PERCENT (g) | 2.6% 7.9% 7.5% 10.4% 0.0% | |TERMINAL (d) | 0/22 (0%) 2/21 (10%) 1/22 (5%) 1/24 (4%) 0/24 (0%) | |FIRST INCIDENCE | 670 534 499 506 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.159N P=0.304 P=0.315 P=0.188 P=0.507N | |POLY 3 | P=0.174N P=0.300 P=0.319 P=0.178 P=0.511N | |POLY 1.5 | P=0.175N P=0.299 P=0.311 P=0.175 P=0.512N | |POLY 6 | P=0.173N P=0.303 P=0.326 P=0.186 P=0.510N | |LOGISTIC REGRESSION| P=0.168N P=0.299 P=0.296 P=0.173 P=0.511N | |COCH-ARM / FISHERS | P=0.167N P=0.309 P=0.302 P=0.176 P=0.510N | |ORDER RESTRICTED | P=0.156N (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 25 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/53 (15%) 2/53 (4%) 9/52 (17%) 29/52 (56%) 46/51 (90%) | |POLY-3 RATE (b) | 8/39.10 2/37.94 9/40.07 29/42.15 46/46.37 | |POLY-3 PERCENT (g) | 20.5% 5.3% 22.5% 68.8% 99.2% | |TERMINAL (d) | 5/22 (23%) 1/21 (5%) 4/22 (18%) 17/24 (71%) 24/24 (100%) | |FIRST INCIDENCE | 533 563 588 505 314 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.055N P=0.519 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.047N* P=0.523 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.048N* P=0.507 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.045N* P=0.542 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.050N P=0.517 P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.046N* P=0.483 P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver: Centrilobular | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/53 (9%) 7/53 (13%) 2/52 (4%) 4/52 (8%) 3/51 (6%) | |POLY-3 RATE (b) | 5/39.53 7/40.74 2/39.46 4/38.67 3/38.89 | |POLY-3 PERCENT (g) | 12.7% 17.2% 5.1% 10.3% 7.7% | |TERMINAL (d) | 1/22 (5%) 1/21 (5%) 0/22 (0%) 1/24 (4%) 0/24 (0%) | |FIRST INCIDENCE | 449 407 531 552 181 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.271N P=0.380 P=0.217N P=0.501N P=0.370N | |POLY 3 | P=0.262N P=0.399 P=0.214N P=0.514N P=0.364N | |POLY 1.5 | P=0.267N P=0.384 P=0.218N P=0.516N P=0.372N | |POLY 6 | P=0.260N P=0.420 P=0.214N P=0.507N P=0.359N | |LOGISTIC REGRESSION| P=0.246N P=0.388 P=0.223N P=0.513N P=0.325N | |COCH-ARM / FISHERS | P=0.271N P=0.380 P=0.226N P=0.512N P=0.380N | |ORDER RESTRICTED | P=0.253N (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 26 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 7/53 (13%) 17/52 (33%) 33/52 (63%) 50/51 (98%) | |POLY-3 RATE (b) | 1/38.74 7/39.50 17/44.38 33/47.28 50/50.00 | |POLY-3 PERCENT (g) | 2.6% 17.7% 38.3% 69.8% 100.0% | |TERMINAL (d) | 0/22 (0%) 2/21 (10%) 6/22 (27%) 14/24 (58%) 24/24 (100%) | |FIRST INCIDENCE | 556 378 125 254 169 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.035 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.030 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.029 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.033 * P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.033 * P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.030 * P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Multinucleated | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 14/52 (27%) 46/52 (88%) 48/51 (94%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 14/40.64 46/47.78 48/50.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 34.5% 96.3% 96.0% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 9/22 (41%) 23/24 (96%) 22/24 (92%) | |FIRST INCIDENCE | --- --- 531 310 169 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 27 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver: Oval Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 2/53 (4%) 15/52 (29%) 39/52 (75%) 46/51 (90%) | |POLY-3 RATE (b) | 2/38.18 2/37.40 15/40.18 39/43.48 46/46.37 | |POLY-3 PERCENT (g) | 5.2% 5.4% 37.3% 89.7% 99.2% | |TERMINAL (d) | 2/22 (9%) 2/21 (10%) 8/22 (36%) 22/24 (92%) 24/24 (100%) | |FIRST INCIDENCE | 729 (T) 729 (T) 603 499 314 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.681 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.688 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.687 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.691 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.681 P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.691N P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver: Portal | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/52 (0%) 7/52 (13%) 34/51 (67%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 0/38.82 7/37.83 34/41.62 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 18.5% 81.7% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 6/24 (25%) 19/24 (79%) | |FIRST INCIDENCE | --- --- --- 603 540 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.011 * P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.007 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.007 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.007 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.008 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.006 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 28 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 47/53 (89%) 41/53 (77%) 47/52 (90%) 46/53 (87%) 45/52 (87%) | |POLY-3 RATE (b) | 47/48.79 41/47.13 47/48.37 46/46.97 45/46.54 | |POLY-3 PERCENT (g) | 96.3% 87.0% 97.2% 97.9% 96.7% | |TERMINAL (d) | 22/22 (100%) 17/21 (81%) 22/22 (100%) 24/24 (100%) 24/24 (100%) | |FIRST INCIDENCE | 345 167 461 254 314 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.466N P=0.306N P=0.524N P=0.413N P=0.392N | |POLY 3 | P=0.201 P=0.068N P=0.669 P=0.583 P=0.714 | |POLY 1.5 | P=0.156 P=0.071N P=0.561 P=0.593 P=0.585 | |POLY 6 | P=0.290 P=0.069N P=0.821 P=0.697 P=0.726N | |LOGISTIC REGRESSION| P=0.177 P=0.120N P=0.629 P=0.584 P=0.478 | |COCH-ARM / FISHERS | P=0.445 P=0.098N P=0.514 P=0.500N P=0.485N | |ORDER RESTRICTED | P=0.103 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lung | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/53 (15%) 5/53 (9%) 2/52 (4%) 4/53 (8%) 1/52 (2%) | |POLY-3 RATE (b) | 8/40.26 5/38.99 2/39.57 4/38.58 1/36.33 | |POLY-3 PERCENT (g) | 19.9% 12.8% 5.1% 10.4% 2.8% | |TERMINAL (d) | 4/22 (18%) 3/21 (14%) 1/22 (5%) 2/24 (8%) 0/24 (0%) | |FIRST INCIDENCE | 85 178 461 330 714 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.038N* P=0.304N P=0.052N P=0.181N P=0.020N* | |POLY 3 | P=0.047N* P=0.292N P=0.045N* P=0.193N P=0.022N* | |POLY 1.5 | P=0.047N* P=0.292N P=0.047N* P=0.194N P=0.022N* | |POLY 6 | P=0.046N* P=0.293N P=0.045N* P=0.191N P=0.022N* | |LOGISTIC REGRESSION| P=0.038N* P=0.267N P=0.054N P=0.175N P=0.020N* | |COCH-ARM / FISHERS | P=0.041N* P=0.278N P=0.049N* P=0.179N P=0.017N* | |ORDER RESTRICTED | P=0.010N* (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 29 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lung | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 1/52 (2%) 2/53 (4%) 11/52 (21%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 1/38.82 2/37.40 11/38.97 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.6% 5.4% 28.2% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 1/22 (5%) 2/24 (8%) 5/24 (21%) | |FIRST INCIDENCE | --- --- 729 (T) 729 (T) 477 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.500 P=0.257 P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.503 P=0.232 P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.501 P=0.232 P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.506 P=0.233 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.500 P=0.257 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.495 P=0.248 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 23/53 (43%) 20/53 (38%) 17/52 (33%) 5/53 (9%) 5/52 (10%) | |POLY-3 RATE (b) | 23/41.69 20/39.33 17/41.13 5/38.38 5/36.54 | |POLY-3 PERCENT (g) | 55.2% 50.9% 41.3% 13.0% 13.7% | |TERMINAL (d) | 15/22 (68%) 13/21 (62%) 10/22 (46%) 2/24 (8%) 4/24 (17%) | |FIRST INCIDENCE | 345 534 461 505 654 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.399N P=0.156N P<0.001N** P<0.001N** | |POLY 3 | P<0.001N** P=0.431N P=0.139N P<0.001N** P<0.001N** | |POLY 1.5 | P<0.001N** P=0.412N P=0.153N P<0.001N** P<0.001N** | |POLY 6 | P<0.001N** P=0.439N P=0.127N P<0.001N** P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.365N P=0.135N P<0.001N** P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.346N P=0.177N P<0.001N** P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 30 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Metaplasia Bronchiolar | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 6/53 (11%) 23/52 (44%) 34/53 (64%) 32/52 (62%) | |POLY-3 RATE (b) | 0/38.18 6/37.53 23/43.10 34/41.55 32/41.06 | |POLY-3 PERCENT (g) | 0.0% 16.0% 53.4% 81.8% 77.9% | |TERMINAL (d) | 0/22 (0%) 4/21 (19%) 11/22 (50%) 23/24 (96%) 21/24 (88%) | |FIRST INCIDENCE | --- 698 491 505 477 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.013 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.013 * P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.015 * P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.013 * P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 3/51 (6%) 6/52 (12%) 3/50 (6%) 6/51 (12%) | |POLY-3 RATE (b) | 0/38.18 3/37.12 6/39.91 3/35.88 6/36.73 | |POLY-3 PERCENT (g) | 0.0% 8.1% 15.0% 8.4% 16.3% | |TERMINAL (d) | 0/22 (0%) 2/21 (10%) 2/22 (9%) 2/24 (8%) 4/23 (17%) | |FIRST INCIDENCE | --- 589 469 603 314 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.091 P=0.118 P=0.023 * P=0.131 P=0.020 * | |POLY 3 | P=0.072 P=0.112 P=0.017 * P=0.106 P=0.012 * | |POLY 1.5 | P=0.070 P=0.111 P=0.016 * P=0.105 P=0.012 * | |POLY 6 | P=0.075 P=0.115 P=0.018 * P=0.111 P=0.013 * | |LOGISTIC REGRESSION| P=0.068 P=0.113 P=0.018 * P=0.108 P=0.015 * | |COCH-ARM / FISHERS | P=0.079 P=0.114 P=0.013 * P=0.111 P=0.012 * | |ORDER RESTRICTED | P=0.011 * (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 31 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 37/53 (70%) 37/51 (73%) 40/52 (77%) 36/50 (72%) 31/51 (61%) | |POLY-3 RATE (b) | 37/46.61 37/44.00 40/48.42 36/42.27 31/41.45 | |POLY-3 PERCENT (g) | 79.4% 84.1% 82.6% 85.2% 74.8% | |TERMINAL (d) | 18/22 (82%) 19/21 (91%) 19/22 (86%) 23/24 (96%) 18/23 (78%) | |FIRST INCIDENCE | 418 337 125 363 169 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.092N P=0.493 P=0.416 P=0.399N P=0.210N | |POLY 3 | P=0.194N P=0.369 P=0.441 P=0.317 P=0.391N | |POLY 1.5 | P=0.154N P=0.386 P=0.381 P=0.346 P=0.348N | |POLY 6 | P=0.245N P=0.385 P=0.519 P=0.312 P=0.428N | |LOGISTIC REGRESSION| P=0.123N P=0.425 P=0.295 P=0.403 P=0.300N | |COCH-ARM / FISHERS | P=0.073N P=0.464 P=0.273 P=0.489 P=0.223N | |ORDER RESTRICTED | P=0.260N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 2/51 (4%) 3/52 (6%) 2/50 (4%) 5/51 (10%) | |POLY-3 RATE (b) | 1/38.18 2/37.38 3/40.46 2/36.99 5/36.79 | |POLY-3 PERCENT (g) | 2.6% 5.4% 7.4% 5.4% 13.6% | |TERMINAL (d) | 1/22 (5%) 1/21 (5%) 1/22 (5%) 0/24 (0%) 3/23 (13%) | |FIRST INCIDENCE | 729 (T) 469 254 363 169 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.080 P=0.492 P=0.310 P=0.508 P=0.112 | |POLY 3 | P=0.064 P=0.493 P=0.325 P=0.489 P=0.090 | |POLY 1.5 | P=0.064 P=0.488 P=0.316 P=0.481 P=0.088 | |POLY 6 | P=0.065 P=0.500 P=0.334 P=0.502 P=0.094 | |LOGISTIC REGRESSION| P=0.092 P=0.485 P=0.282 P=0.508 P=0.096 | |COCH-ARM / FISHERS | P=0.070 P=0.485 P=0.302 P=0.478 P=0.094 | |ORDER RESTRICTED | P=0.044 * (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 32 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/52 (0%) 1/52 (2%) 2/49 (4%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 0/38.82 1/38.06 2/35.41 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.6% 5.7% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 2/24 (8%) | |FIRST INCIDENCE | --- --- --- 506 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.049 * (e) (e) P=0.500 P=0.257 | |POLY 3 | P=0.036 * (e) (e) P=0.499 P=0.220 | |POLY 1.5 | P=0.035 * (e) (e) P=0.497 P=0.216 | |POLY 6 | P=0.037 * (e) (e) P=0.503 P=0.224 | |LOGISTIC REGRESSION| P=0.036 * (e) (e) P=0.501 P=0.257 | |COCH-ARM / FISHERS | P=0.037 * (e) (e) P=0.495 P=0.228 | |ORDER RESTRICTED | P=0.040 * (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lymph Node: Lumbar | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/4 (100%) 4/7 (57%) 0/2 (0%) 1/7 (14%) 0/14 (0%) | |POLY-3 RATE (b) | 4/4.00 4/4.24 0/0.91 1/4.32 0/10.53 | |POLY-3 PERCENT (g) | 100.0% 94.4% 0.0% 23.2% 0.0% | |TERMINAL (d) | 1/1 (100%) 3/3 (100%) 0/0 (0%) 0/2 (0%) 0/9 (0%) | |FIRST INCIDENCE | 449 469 --- 552 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002N** P=0.322N P=0.118N P=0.150N P=0.022N* | |POLY 3 | P<0.001N** P=1.000N P=0.047N* P=0.009N** P<0.001N** | |POLY 1.5 | P<0.001N** P=0.719N P<0.001N** P=0.002N** P<0.001N** | |POLY 6 | P<0.001N** P=1.000N P=0.638N P=0.043N* P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** (e) P=0.064N P=0.017N* P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.212N P=0.067N P=0.015N* P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 33 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lymph Node: Lumbar | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/4 (0%) 2/7 (29%) 0/2 (0%) 0/7 (0%) 0/14 (0%) | |POLY-3 RATE (b) | 0/2.13 2/4.24 0/0.91 0/3.75 0/10.53 | |POLY-3 PERCENT (g) | 0.0% 47.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/1 (0%) 1/3 (33%) 0/0 (0%) 0/2 (0%) 0/9 (0%) | |FIRST INCIDENCE | --- 469 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.169N P=0.353 (e) (e) (e) | |POLY 3 | P=0.083N P=0.381 (e) (e) (e) | |POLY 1.5 | P=0.129N P=0.341 (e) (e) (e) | |POLY 6 | P=0.040N* P=0.461 (e) (e) (e) | |LOGISTIC REGRESSION| P=0.147N P=0.332 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.166N P=0.382 (e) (e) (e) | |ORDER RESTRICTED | P=0.212N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lymph Node: Lumbar | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/4 (100%) 2/7 (29%) 0/2 (0%) 0/7 (0%) 0/14 (0%) | |POLY-3 RATE (b) | 4/4.00 2/3.51 0/0.91 0/3.75 0/10.53 | |POLY-3 PERCENT (g) | 100.0% 57.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/1 (100%) 2/3 (67%) 0/0 (0%) 0/2 (0%) 0/9 (0%) | |FIRST INCIDENCE | 449 729 (T) --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.007N** P=0.105N P=0.118N P=0.048N* P=0.022N* | |POLY 3 | P<0.001N** P=0.259N P=0.047N* P<0.001N** P<0.001N** | |POLY 1.5 | P<0.001N** P=0.102N P<0.001N** P<0.001N** P<0.001N** | |POLY 6 | P<0.001N** P=0.404N P=0.638N P<0.001N** P<0.001N** | |LOGISTIC REGRESSION| P=0.002N** P=0.054N P=0.064N P=0.004N** P<0.001N** | |COCH-ARM / FISHERS | P=0.006N** P=0.045N* P=0.067N P=0.003N** P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 34 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/4 (0%) 0/7 (0%) 0/2 (0%) 0/7 (0%) 3/14 (21%) | |POLY-3 RATE (b) | 0/2.13 0/3.51 0/0.91 0/3.75 3/12.45 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 24.1% | |TERMINAL (d) | 0/1 (0%) 0/3 (0%) 0/0 (0%) 0/2 (0%) 0/9 (0%) | |FIRST INCIDENCE | --- --- --- --- 314 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.003 ** (e) (e) (e) P=0.129 | |POLY 3 | P=0.139 (e) (e) (e) P=0.536 | |POLY 1.5 | P=0.093 (e) (e) (e) P=0.477 | |POLY 6 | P=0.193 (e) (e) (e) P=0.593 | |LOGISTIC REGRESSION| P=0.035 * (e) (e) (e) P=0.377 | |COCH-ARM / FISHERS | P=0.051 (e) (e) (e) P=0.446 | |ORDER RESTRICTED | P=0.417 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/4 (0%) 0/7 (0%) 0/2 (0%) 1/7 (14%) 2/14 (14%) | |POLY-3 RATE (b) | 0/2.13 0/3.51 0/0.91 1/4.66 2/11.80 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 21.5% 16.9% | |TERMINAL (d) | 0/1 (0%) 0/3 (0%) 0/0 (0%) 0/2 (0%) 0/9 (0%) | |FIRST INCIDENCE | --- --- --- 330 477 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.041 * (e) (e) P=0.488 P=0.232 | |POLY 3 | P=0.459 (e) (e) P=0.653 P=0.631 | |POLY 1.5 | P=0.369 (e) (e) P=0.635 P=0.588 | |POLY 6 | P=0.539 (e) (e) P=0.673 P=0.673 | |LOGISTIC REGRESSION| P=0.192 (e) (e) (e) P=0.526 | |COCH-ARM / FISHERS | P=0.247 (e) (e) P=0.636 P=0.595 | |ORDER RESTRICTED | P=0.522 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 35 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/4 (0%) 1/7 (14%) 0/2 (0%) 1/7 (14%) 5/14 (36%) | |POLY-3 RATE (b) | 0/2.13 1/4.41 0/0.91 1/4.42 5/12.36 | |POLY-3 PERCENT (g) | 0.0% 22.7% 0.0% 22.6% 40.5% | |TERMINAL (d) | 0/1 (0%) 0/3 (0%) 0/0 (0%) 0/2 (0%) 2/9 (22%) | |FIRST INCIDENCE | --- 337 --- 506 76 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.014 * P=0.492 (e) P=0.500 P=0.105 | |POLY 3 | P=0.195 P=0.643 (e) P=0.645 P=0.380 | |POLY 1.5 | P=0.129 P=0.617 (e) P=0.627 P=0.305 | |POLY 6 | P=0.281 P=0.681 (e) P=0.669 P=0.465 | |LOGISTIC REGRESSION| P=0.039 * P=0.805 (e) P=0.625 P=0.197 | |COCH-ARM / FISHERS | P=0.065 P=0.636 (e) P=0.636 P=0.234 | |ORDER RESTRICTED | P=0.340 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lymph Node: Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/4 (0%) 0/7 (0%) 0/2 (0%) 1/7 (14%) 3/14 (21%) | |POLY-3 RATE (b) | 0/2.13 0/3.51 0/0.91 1/3.75 3/10.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 26.6% 28.5% | |TERMINAL (d) | 0/1 (0%) 0/3 (0%) 0/0 (0%) 1/2 (50%) 3/9 (33%) | |FIRST INCIDENCE | --- --- --- 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.315 (e) (e) P=0.638 P=0.669 | |POLY 3 | P=0.225 (e) (e) P=0.619 P=0.497 | |POLY 1.5 | P=0.171 (e) (e) P=0.613 P=0.445 | |POLY 6 | P=0.278 (e) (e) P=0.626 P=0.555 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.638 P=0.669 | |COCH-ARM / FISHERS | P=0.111 (e) (e) P=0.636 P=0.446 | |ORDER RESTRICTED | P=0.399 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 36 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lymph Node: Renal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/4 (0%) 1/7 (14%) 0/2 (0%) 2/7 (29%) 2/14 (14%) | |POLY-3 RATE (b) | 0/2.13 1/3.51 0/0.91 2/4.81 2/10.53 | |POLY-3 PERCENT (g) | 0.0% 28.5% 0.0% 41.6% 19.0% | |TERMINAL (d) | 0/1 (0%) 1/3 (33%) 0/0 (0%) 0/2 (0%) 2/9 (22%) | |FIRST INCIDENCE | --- 729 (T) --- 506 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.591 P=0.718 (e) P=0.227 P=0.773 | |POLY 3 | P=0.562N P=0.605 (e) P=0.422 P=0.613 | |POLY 1.5 | P=0.643N P=0.590 (e) P=0.386 P=0.575 | |POLY 6 | P=0.474N P=0.643 (e) P=0.478 P=0.655 | |LOGISTIC REGRESSION| P=0.595N P=0.718 (e) P=0.356 P=0.773 | |COCH-ARM / FISHERS | P=0.564 P=0.636 (e) P=0.382 P=0.595 | |ORDER RESTRICTED | P=0.466 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Mammary Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 2/53 (4%) 2/52 (4%) 3/53 (6%) 1/52 (2%) | |POLY-3 RATE (b) | 3/39.88 2/38.20 2/39.26 3/38.06 1/36.59 | |POLY-3 PERCENT (g) | 7.5% 5.2% 5.1% 7.9% 2.7% | |TERMINAL (d) | 1/22 (5%) 0/21 (0%) 1/22 (5%) 2/24 (8%) 0/24 (0%) | |FIRST INCIDENCE | 345 589 603 506 640 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.310N P=0.522N P=0.499N P=0.650N P=0.329N | |POLY 3 | P=0.331N P=0.520N P=0.507N P=0.642 P=0.336N | |POLY 1.5 | P=0.330N P=0.518N P=0.509N P=0.644 P=0.335N | |POLY 6 | P=0.329N P=0.515N P=0.505N P=0.646 P=0.332N | |LOGISTIC REGRESSION| P=0.300N P=0.477N P=0.525N P=0.649N P=0.272N | |COCH-ARM / FISHERS | P=0.308N P=0.500N P=0.509N P=0.661N P=0.316N | |ORDER RESTRICTED | P=0.322N (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 37 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 29/53 (55%) 29/53 (55%) 25/52 (48%) 22/53 (42%) 3/52 (6%) | |POLY-3 RATE (b) | 29/44.60 29/41.84 25/41.84 22/41.66 3/36.97 | |POLY-3 PERCENT (g) | 65.0% 69.3% 59.8% 52.8% 8.1% | |TERMINAL (d) | 16/22 (73%) 16/21 (76%) 15/22 (68%) 11/24 (46%) 1/24 (4%) | |FIRST INCIDENCE | 418 469 469 499 606 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.504 P=0.272N P=0.117N P<0.001N** | |POLY 3 | P<0.001N** P=0.418 P=0.382N P=0.164N P<0.001N** | |POLY 1.5 | P<0.001N** P=0.458 P=0.348N P=0.157N P<0.001N** | |POLY 6 | P<0.001N** P=0.418 P=0.428N P=0.154N P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.532 P=0.259N P=0.134N P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.577N P=0.314N P=0.122N P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Mammary Gland | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/53 (9%) 0/53 (0%) 4/52 (8%) 3/53 (6%) 0/52 (0%) | |POLY-3 RATE (b) | 5/39.94 0/37.40 4/39.50 3/37.73 0/36.27 | |POLY-3 PERCENT (g) | 12.5% 0.0% 10.1% 8.0% 0.0% | |TERMINAL (d) | 2/22 (9%) 0/21 (0%) 2/22 (9%) 1/24 (4%) 0/24 (0%) | |FIRST INCIDENCE | 345 --- 603 650 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.085N P=0.042N* P=0.496N P=0.345N P=0.034N* | |POLY 3 | P=0.090N P=0.035N* P=0.507N P=0.387N P=0.038N* | |POLY 1.5 | P=0.092N P=0.035N* P=0.510N P=0.382N P=0.038N* | |POLY 6 | P=0.088N P=0.035N* P=0.501N P=0.384N P=0.038N* | |LOGISTIC REGRESSION| P=0.091N P=0.031N* P=0.513N P=0.359N P=0.032N* | |COCH-ARM / FISHERS | P=0.088N P=0.028N* P=0.512N P=0.358N P=0.030N* | |ORDER RESTRICTED | P=0.016N* (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 38 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Mesentery: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/47 (2%) 1/47 (2%) 1/46 (2%) 2/47 (4%) 4/42 (10%) | |POLY-3 RATE (b) | 1/34.51 1/32.95 1/34.30 2/33.24 4/32.89 | |POLY-3 PERCENT (g) | 2.9% 3.0% 2.9% 6.0% 12.2% | |TERMINAL (d) | 0/19 (0%) 1/18 (6%) 0/20 (0%) 2/21 (10%) 2/22 (9%) | |FIRST INCIDENCE | 688 729 (T) 531 729 (T) 563 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.062 P=0.758N P=0.749N P=0.528 P=0.197 | |POLY 3 | P=0.040 * P=0.751 P=0.760 P=0.487 P=0.161 | |POLY 1.5 | P=0.037 * P=0.751 P=0.756 P=0.487 P=0.150 | |POLY 6 | P=0.045 * P=0.754 P=0.759N P=0.491 P=0.176 | |LOGISTIC REGRESSION| P=0.039 * P=0.758 P=0.763 P=0.503 P=0.150 | |COCH-ARM / FISHERS | P=0.034 * P=0.753N P=0.747 P=0.500 P=0.147 | |ORDER RESTRICTED | P=0.067 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/47 (0%) 2/47 (4%) 2/46 (4%) 1/47 (2%) 0/42 (0%) | |POLY-3 RATE (b) | 0/34.35 2/33.28 2/33.74 1/33.92 0/32.03 | |POLY-3 PERCENT (g) | 0.0% 6.0% 5.9% 3.0% 0.0% | |TERMINAL (d) | 0/19 (0%) 1/18 (6%) 1/20 (5%) 0/21 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 636 715 499 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.252N P=0.231 P=0.259 P=0.509 (e) | |POLY 3 | P=0.269N P=0.229 P=0.232 P=0.497 (e) | |POLY 1.5 | P=0.278N P=0.228 P=0.230 P=0.495 (e) | |POLY 6 | P=0.258N P=0.233 P=0.235 P=0.503 (e) | |LOGISTIC REGRESSION| P=0.275N P=0.229 P=0.241 P=0.564 (e) | |COCH-ARM / FISHERS | P=0.282N P=0.247 P=0.242 P=0.500 (e) | |ORDER RESTRICTED | P=0.299N (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 39 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 22/53 (42%) 13/53 (25%) 13/53 (25%) 13/53 (25%) 31/53 (58%) | |POLY-3 RATE (b) | 22/43.64 13/40.23 13/42.58 13/40.22 31/43.98 | |POLY-3 PERCENT (g) | 50.4% 32.3% 30.5% 32.3% 70.5% | |TERMINAL (d) | 10/22 (46%) 7/21 (33%) 4/22 (18%) 5/24 (21%) 17/24 (71%) | |FIRST INCIDENCE | 418 178 407 539 71 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.085N P=0.069N P=0.067N P=0.106 | |POLY 3 | P<0.001 ** P=0.066N P=0.043N* P=0.067N P=0.036 * | |POLY 1.5 | P<0.001 ** P=0.057N P=0.043N* P=0.062N P=0.034 * | |POLY 6 | P<0.001 ** P=0.076N P=0.043N* P=0.069N P=0.044 * | |LOGISTIC REGRESSION| P<0.001 ** P=0.052N P=0.047N* P=0.053N P=0.041 * | |COCH-ARM / FISHERS | P<0.001 ** P=0.049N* P=0.049N* P=0.049N* P=0.060 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Nose: Glands | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 8/53 (15%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 0/39.03 0/37.40 8/37.65 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 21.3% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 5/24 (21%) | |FIRST INCIDENCE | --- --- --- --- 595 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.006 ** | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.003 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.003 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.003 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.004 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.003 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 40 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 2/53 (4%) | |POLY-3 RATE (b) | 1/38.18 0/37.40 0/39.03 0/37.40 2/37.98 | |POLY-3 PERCENT (g) | 2.6% 0.0% 0.0% 0.0% 5.3% | |TERMINAL (d) | 1/22 (5%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | 729 (T) --- --- --- 71 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.110 P=0.509N P=0.500N P=0.483N P=0.507 | |POLY 3 | P=0.105 P=0.504N P=0.496N P=0.504N P=0.498 | |POLY 1.5 | P=0.105 P=0.504N P=0.497N P=0.505N P=0.494 | |POLY 6 | P=0.106 P=0.503N P=0.494N P=0.502N P=0.506 | |LOGISTIC REGRESSION| P=0.152 (e) (e) (e) P=0.587 | |COCH-ARM / FISHERS | P=0.106 P=0.500N P=0.500N P=0.500N P=0.500 | |ORDER RESTRICTED | P=0.081 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 3/53 (6%) 5/53 (9%) 6/53 (11%) 15/53 (28%) | |POLY-3 RATE (b) | 4/38.51 3/37.55 5/39.70 6/38.67 15/37.97 | |POLY-3 PERCENT (g) | 10.4% 8.0% 12.6% 15.5% 39.5% | |TERMINAL (d) | 2/22 (9%) 2/21 (10%) 2/22 (9%) 1/24 (4%) 11/24 (46%) | |FIRST INCIDENCE | 664 689 636 603 595 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.517N P=0.510 P=0.388 P=0.007 ** | |POLY 3 | P<0.001 ** P=0.514N P=0.519 P=0.370 P=0.002 ** | |POLY 1.5 | P<0.001 ** P=0.513N P=0.511 P=0.361 P=0.002 ** | |POLY 6 | P<0.001 ** P=0.513N P=0.529 P=0.389 P=0.003 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.507N P=0.517 P=0.357 P=0.003 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.500 P=0.371 P=0.005 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 41 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/53 (19%) 5/53 (9%) 7/53 (13%) 11/53 (21%) 20/53 (38%) | |POLY-3 RATE (b) | 10/39.82 5/37.87 7/40.47 11/40.12 20/41.12 | |POLY-3 PERCENT (g) | 25.1% 13.2% 17.3% 27.4% 48.6% | |TERMINAL (d) | 6/22 (27%) 4/21 (19%) 2/22 (9%) 3/24 (13%) 11/24 (46%) | |FIRST INCIDENCE | 418 589 581 539 477 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.154N P=0.293N P=0.529 P=0.039 * | |POLY 3 | P<0.001 ** P=0.146N P=0.278N P=0.508 P=0.020 * | |POLY 1.5 | P<0.001 ** P=0.144N P=0.287N P=0.489 P=0.017 * | |POLY 6 | P<0.001 ** P=0.146N P=0.264N P=0.549 P=0.029 * | |LOGISTIC REGRESSION| P<0.001 ** P=0.137N P=0.284N P=0.481 P=0.018 * | |COCH-ARM / FISHERS | P<0.001 ** P=0.132N P=0.299N P=0.500 P=0.026 * | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Oral Mucosa: Gingival | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/12 (67%) 8/11 (73%) 18/25 (72%) 22/30 (73%) 24/36 (67%) | |POLY-3 RATE (b) | 8/11.04 8/10.69 18/23.89 22/27.81 24/32.83 | |POLY-3 PERCENT (g) | 72.5% 74.9% 75.3% 79.1% 73.1% | |TERMINAL (d) | 2/3 (67%) 2/4 (50%) 8/11 (73%) 12/15 (80%) 14/17 (82%) | |FIRST INCIDENCE | 451 499 469 451 479 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.110 P=0.552N P=0.232 P=0.188 P=0.172 | |POLY 3 | P=0.489N P=0.642 P=0.595 P=0.491 P=0.646 | |POLY 1.5 | P=0.436N P=0.602 P=0.558 P=0.480 P=0.642 | |POLY 6 | P=0.582N P=0.697 P=0.654 P=0.525 P=0.648 | |LOGISTIC REGRESSION| P=0.389N P=0.535 P=0.510 P=0.491 P=0.635N | |COCH-ARM / FISHERS | P=0.386N P=0.556 P=0.513 P=0.469 P=0.631 | |ORDER RESTRICTED | P=0.706 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 42 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Ovary | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 45/53 (85%) 44/53 (83%) 45/52 (87%) 43/52 (83%) 16/49 (33%) | |POLY-3 RATE (b) | 45/49.16 44/48.17 45/50.01 43/48.11 16/37.95 | |POLY-3 PERCENT (g) | 91.5% 91.4% 90.0% 89.4% 42.2% | |TERMINAL (d) | 21/22 (96%) 19/21 (91%) 20/22 (91%) 22/24 (92%) 9/24 (38%) | |FIRST INCIDENCE | 345 330 254 254 485 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.539 P=0.526N P=0.363N P<0.001N** | |POLY 3 | P<0.001N** P=0.644N P=0.535N P=0.493N P<0.001N** | |POLY 1.5 | P<0.001N** P=0.637N P=0.611N P=0.480N P<0.001N** | |POLY 6 | P<0.001N** P=0.583N P=0.438N P=0.514N P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.583N P=0.547 P=0.499N P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.500N P=0.516 P=0.483N P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 14/53 (26%) 7/53 (13%) 17/52 (33%) 14/52 (27%) 13/49 (27%) | |POLY-3 RATE (b) | 14/40.50 7/38.46 17/42.41 14/39.03 13/37.89 | |POLY-3 PERCENT (g) | 34.6% 18.2% 40.1% 35.9% 34.3% | |TERMINAL (d) | 8/22 (36%) 3/21 (14%) 6/22 (27%) 11/24 (46%) 7/24 (29%) | |FIRST INCIDENCE | 451 580 469 330 477 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.516 P=0.091N P=0.366 P=0.519N P=0.467N | |POLY 3 | P=0.379 P=0.077N P=0.383 P=0.546 P=0.586N | |POLY 1.5 | P=0.352 P=0.077N P=0.352 P=0.554 P=0.577 | |POLY 6 | P=0.417 P=0.075N P=0.419 P=0.532 P=0.551N | |LOGISTIC REGRESSION| P=0.344 P=0.074N P=0.335 P=0.563 P=0.579 | |COCH-ARM / FISHERS | P=0.353 P=0.071N P=0.312 P=0.564 P=0.583 | |ORDER RESTRICTED | P=0.278 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 43 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Oviduct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/1 (100%) 0/0 (0%) 1/1 (100%) 2/2 (100%) 0/3 (0%) | |POLY-3 RATE (b) | 1/1.00 0/0.00 1/1.00 2/2.00 0/1.60 | |POLY-3 PERCENT (g) | 100.0% 0.0% 100.0% 100.0% 0.0% | |TERMINAL (d) | 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) | |FIRST INCIDENCE | 729 (T) --- 603 539 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.367N (e) (e) (e) P=0.500N | |POLY 3 | (e) (e) (e) (e) P=0.207N | |POLY 1.5 | (e) (e) (e) (e) P=0.008N** | |POLY 6 | (e) (e) (e) (e) P=0.429N | |LOGISTIC REGRESSION| P=0.030N* (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.026N* (e) (e) (e) P=0.250N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Oviduct | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/1 (0%) 0/0 (0%) 1/1 (100%) 0/2 (0%) 3/3 (100%) | |POLY-3 RATE (b) | 0/1.00 0/0.00 1/1.00 0/1.14 3/3.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 100.0% 0.0% 100.0% | |TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/1 (100%) | |FIRST INCIDENCE | --- --- 603 --- 485 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.041 * (e) P=0.500 (e) P=0.127 | |POLY 3 | (e) (e) P=1.000N (e) P=0.250 | |POLY 1.5 | (e) (e) P=1.000N (e) P=0.250 | |POLY 6 | (e) (e) P=1.000N (e) P=0.250 | |LOGISTIC REGRESSION| P=0.173 (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.124 (e) P=0.500 (e) P=0.250 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 44 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Pancreas | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 3/53 (6%) 3/52 (6%) 1/52 (2%) 4/50 (8%) | |POLY-3 RATE (b) | 0/38.18 3/37.40 3/39.29 1/37.39 4/36.68 | |POLY-3 PERCENT (g) | 0.0% 8.0% 7.6% 2.7% 10.9% | |TERMINAL (d) | 0/22 (0%) 3/21 (14%) 2/22 (9%) 1/24 (4%) 2/24 (8%) | |FIRST INCIDENCE | --- 729 (T) 589 729 (T) 563 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.187 P=0.110 P=0.125 P=0.517 P=0.067 | |POLY 3 | P=0.148 P=0.114 P=0.123 P=0.496 P=0.054 | |POLY 1.5 | P=0.143 P=0.114 P=0.120 P=0.495 P=0.052 | |POLY 6 | P=0.156 P=0.114 P=0.126 P=0.498 P=0.058 | |LOGISTIC REGRESSION| P=0.144 P=0.110 P=0.122 P=0.517 P=0.054 | |COCH-ARM / FISHERS | P=0.147 P=0.121 P=0.118 P=0.495 P=0.052 | |ORDER RESTRICTED | P=0.030 * (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/53 (4%) 1/52 (2%) 1/52 (2%) 8/50 (16%) | |POLY-3 RATE (b) | 0/38.18 2/37.40 1/39.29 1/37.39 8/38.53 | |POLY-3 PERCENT (g) | 0.0% 5.4% 2.5% 2.7% 20.8% | |TERMINAL (d) | 0/22 (0%) 2/21 (10%) 0/22 (0%) 1/24 (4%) 3/24 (13%) | |FIRST INCIDENCE | --- 729 (T) 589 729 (T) 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.227 P=0.511 P=0.517 P=0.007 ** | |POLY 3 | P<0.001 ** P=0.232 P=0.506 P=0.496 P=0.003 ** | |POLY 1.5 | P<0.001 ** P=0.232 P=0.502 P=0.495 P=0.003 ** | |POLY 6 | P<0.001 ** P=0.233 P=0.510 P=0.498 P=0.004 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.227 P=0.491 P=0.517 P=0.004 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.248 P=0.495 P=0.495 P=0.002 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 45 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Pancreas: Acinus | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/53 (0%) 0/52 (0%) 1/52 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 2/38.18 0/37.40 0/38.82 1/37.39 0/35.82 | |POLY-3 PERCENT (g) | 5.2% 0.0% 0.0% 2.7% 0.0% | |TERMINAL (d) | 2/22 (9%) 0/21 (0%) 0/22 (0%) 1/24 (4%) 0/24 (0%) | |FIRST INCIDENCE | 729 (T) --- --- 729 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.355N P=0.247N P=0.237N P=0.469N P=0.218N | |POLY 3 | P=0.394N P=0.241N P=0.233N P=0.507N P=0.251N | |POLY 1.5 | P=0.395N P=0.242N P=0.236N P=0.509N P=0.254N | |POLY 6 | P=0.393N P=0.239N P=0.230N P=0.504N P=0.246N | |LOGISTIC REGRESSION| P=0.355N (e) (e) P=0.469N (e) | |COCH-ARM / FISHERS | P=0.393N P=0.248N P=0.252N P=0.507N P=0.262N | |ORDER RESTRICTED | P=0.054N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Pancreas: Acinus | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/52 (0%) 7/52 (13%) 40/50 (80%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 0/38.82 7/38.39 40/42.41 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 18.2% 94.3% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 5/24 (21%) 24/24 (100%) | |FIRST INCIDENCE | --- --- --- 552 314 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.012 * P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.007 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.007 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.008 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.008 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.006 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 46 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Pancreas: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 1/52 (2%) 2/52 (4%) 2/50 (4%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 1/38.86 2/38.06 2/36.36 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.6% 5.3% 5.5% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 1/24 (4%) 1/24 (4%) | |FIRST INCIDENCE | --- --- 720 506 563 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.140 (e) P=0.517 P=0.249 P=0.252 | |POLY 3 | P=0.119 (e) P=0.504 P=0.236 P=0.225 | |POLY 1.5 | P=0.115 (e) P=0.501 P=0.234 P=0.222 | |POLY 6 | P=0.124 (e) P=0.506 P=0.240 P=0.231 | |LOGISTIC REGRESSION| P=0.114 (e) P=0.508 P=0.234 P=0.223 | |COCH-ARM / FISHERS | P=0.116 (e) P=0.495 P=0.243 P=0.233 | |ORDER RESTRICTED | P=0.112 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Pituitary Gland | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 17/53 (32%) 20/53 (38%) 15/53 (28%) 17/52 (33%) 1/52 (2%) | |POLY-3 RATE (b) | 17/40.84 20/40.36 15/40.14 17/39.38 1/36.27 | |POLY-3 PERCENT (g) | 41.6% 49.6% 37.4% 43.2% 2.8% | |TERMINAL (d) | 11/22 (50%) 9/21 (43%) 10/22 (46%) 9/24 (38%) 1/24 (4%) | |FIRST INCIDENCE | 418 563 588 506 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.318 P=0.400N P=0.519N P<0.001N** | |POLY 3 | P<0.001N** P=0.305 P=0.433N P=0.535 P<0.001N** | |POLY 1.5 | P<0.001N** P=0.298 P=0.426N P=0.521 P<0.001N** | |POLY 6 | P<0.001N** P=0.352 P=0.439N P=0.581 P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.307 P=0.380N P=0.531 P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.342 P=0.416N P=0.556 P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 47 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Pituitary Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 3/53 (6%) 0/53 (0%) 0/52 (0%) 0/52 (0%) | |POLY-3 RATE (b) | 1/38.18 3/39.59 0/39.03 0/36.79 0/36.27 | |POLY-3 PERCENT (g) | 2.6% 7.6% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/22 (5%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | 729 (T) 178 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.159N P=0.309 P=0.500N P=0.483N P=0.483N | |POLY 3 | P=0.159N P=0.317 P=0.496N P=0.507N P=0.510N | |POLY 1.5 | P=0.161N P=0.311 P=0.497N P=0.508N P=0.512N | |POLY 6 | P=0.156N P=0.327 P=0.494N P=0.504N P=0.508N | |LOGISTIC REGRESSION| P=0.130N P=0.335 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.160N P=0.309 P=0.500N P=0.505N P=0.505N | |ORDER RESTRICTED | P=0.095N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Pituitary Gland | | Cytoplasmic Alteration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 3/53 (6%) 0/52 (0%) 0/52 (0%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 3/39.90 0/36.79 0/36.27 | |POLY-3 PERCENT (g) | 0.0% 0.0% 7.5% 0.0% 0.0% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- --- 589 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.402N (e) P=0.135 (e) (e) | |POLY 3 | P=0.379N (e) P=0.126 (e) (e) | |POLY 1.5 | P=0.384N (e) P=0.123 (e) (e) | |POLY 6 | P=0.372N (e) P=0.130 (e) (e) | |LOGISTIC REGRESSION| P=0.390N (e) P=0.122 (e) (e) | |COCH-ARM / FISHERS | P=0.385N (e) P=0.121 (e) (e) | |ORDER RESTRICTED | P=0.307 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 48 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 13/53 (25%) 13/53 (25%) 19/53 (36%) 20/52 (38%) 13/52 (25%) | |POLY-3 RATE (b) | 13/41.27 13/39.68 19/43.31 20/40.07 13/37.42 | |POLY-3 PERCENT (g) | 31.5% 32.8% 43.9% 49.9% 34.7% | |TERMINAL (d) | 6/22 (27%) 7/21 (33%) 10/22 (46%) 11/24 (46%) 9/24 (38%) | |FIRST INCIDENCE | 451 534 469 505 606 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.368N P=0.549 P=0.174 P=0.147 P=0.566N | |POLY 3 | P=0.533 P=0.547 P=0.166 P=0.065 P=0.474 | |POLY 1.5 | P=0.550N P=0.554 P=0.156 P=0.066 P=0.489 | |POLY 6 | P=0.509 P=0.547 P=0.176 P=0.072 P=0.460 | |LOGISTIC REGRESSION| P=0.491N P=0.570 P=0.150 P=0.077 P=0.531 | |COCH-ARM / FISHERS | P=0.443N P=0.589N P=0.145 P=0.092 P=0.567 | |ORDER RESTRICTED | P=0.243 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) 2/52 (4%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 0/39.03 0/36.79 2/37.68 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 5.3% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- --- --- --- 314 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.017 * (e) (e) (e) P=0.225 | |POLY 3 | P=0.018 * (e) (e) (e) P=0.233 | |POLY 1.5 | P=0.018 * (e) (e) (e) P=0.229 | |POLY 6 | P=0.019 * (e) (e) (e) P=0.239 | |LOGISTIC REGRESSION| P=0.032 * (e) (e) (e) P=0.284 | |COCH-ARM / FISHERS | P=0.019 * (e) (e) (e) P=0.243 | |ORDER RESTRICTED | P=0.015 * (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 49 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Skin | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 2/53 (4%) 0/53 (0%) 1/53 (2%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 2/39.13 0/37.40 1/36.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 5.1% 0.0% 2.7% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 1/22 (5%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- --- 705 --- 714 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.520 (e) P=0.252 (e) P=0.516 | |POLY 3 | P=0.490 (e) P=0.242 (e) P=0.491 | |POLY 1.5 | P=0.488 (e) P=0.240 (e) P=0.491 | |POLY 6 | P=0.493 (e) P=0.244 (e) P=0.493 | |LOGISTIC REGRESSION| P=0.491 (e) P=0.245 (e) P=0.495 | |COCH-ARM / FISHERS | P=0.498 (e) P=0.248 (e) P=0.500 | |ORDER RESTRICTED | P=0.297 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 51/53 (96%) 51/53 (96%) 49/52 (94%) 47/52 (90%) 44/50 (88%) | |POLY-3 RATE (b) | 51/51.98 51/52.01 49/50.88 47/50.21 44/46.03 | |POLY-3 PERCENT (g) | 98.1% 98.1% 96.3% 93.6% 95.6% | |TERMINAL (d) | 22/22 (100%) 21/21 (100%) 22/22 (100%) 24/24 (100%) 24/24 (100%) | |FIRST INCIDENCE | 85 167 125 142 169 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.105N P=0.474 P=0.409N P=0.267N P=0.161N | |POLY 3 | P=0.313N P=0.791N P=0.518N P=0.228N P=0.427N | |POLY 1.5 | P=0.189N P=0.754 P=0.493N P=0.215N P=0.282N | |POLY 6 | P=0.541N P=0.808N P=0.591N P=0.263N P=0.737N | |LOGISTIC REGRESSION| P=0.061N P=0.677 P=0.480N P=0.212N P=0.153N | |COCH-ARM / FISHERS | P=0.047N* P=0.691N P=0.491N P=0.211N P=0.117N | |ORDER RESTRICTED | P=0.227N (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 50 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Spleen | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 47/53 (89%) 46/53 (87%) 43/52 (83%) 51/52 (98%) 46/50 (92%) | |POLY-3 RATE (b) | 47/50.25 46/50.00 43/48.90 51/51.01 46/47.94 | |POLY-3 PERCENT (g) | 93.5% 92.0% 87.9% 100.0% 96.0% | |TERMINAL (d) | 21/22 (96%) 20/21 (95%) 21/22 (96%) 24/24 (100%) 23/24 (96%) | |FIRST INCIDENCE | 85 178 125 254 71 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.483N P=0.537 P=0.306N P=0.417 P=0.460N | |POLY 3 | P=0.153 P=0.541N P=0.240N P=0.055 P=0.461 | |POLY 1.5 | P=0.101 P=0.563N P=0.255N P=0.033 * P=0.341 | |POLY 6 | P=0.300 P=0.510N P=0.236N P=0.156 P=0.670 | |LOGISTIC REGRESSION| P=0.133 P=0.528N P=0.262N P=0.053 P=0.351 | |COCH-ARM / FISHERS | P=0.163 P=0.500N P=0.276N P=0.059 P=0.408 | |ORDER RESTRICTED | P=0.082 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 2/52 (4%) 4/52 (8%) 5/50 (10%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 2/39.85 4/38.83 5/37.92 | |POLY-3 PERCENT (g) | 0.0% 0.0% 5.0% 10.3% 13.2% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- --- 491 310 574 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.006 ** (e) P=0.242 P=0.068 P=0.028 * | |POLY 3 | P=0.006 ** (e) P=0.246 P=0.061 P=0.029 * | |POLY 1.5 | P=0.005 ** (e) P=0.241 P=0.060 P=0.026 * | |POLY 6 | P=0.008 ** (e) P=0.252 P=0.064 P=0.034 * | |LOGISTIC REGRESSION| P=0.006 ** (e) P=0.225 P=0.061 P=0.029 * | |COCH-ARM / FISHERS | P=0.006 ** (e) P=0.243 P=0.057 P=0.024 * | |ORDER RESTRICTED | P=0.009 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 51 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Spleen: Red Pulp | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 0/53 (0%) 1/52 (2%) 0/52 (0%) 5/50 (10%) | |POLY-3 RATE (b) | 1/38.41 0/37.40 1/39.52 0/37.39 5/38.10 | |POLY-3 PERCENT (g) | 2.6% 0.0% 2.5% 0.0% 13.1% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | 670 --- 491 --- 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002 ** P=0.493N P=0.755N P=0.500N P=0.091 | |POLY 3 | P=0.002 ** P=0.505N P=0.755N P=0.505N P=0.097 | |POLY 1.5 | P<0.001 ** P=0.505N P=0.759N P=0.505N P=0.090 | |POLY 6 | P=0.002 ** P=0.505N P=0.752N P=0.505N P=0.109 | |LOGISTIC REGRESSION| P=0.002 ** P=0.503N P=0.752 P=0.504N P=0.093 | |COCH-ARM / FISHERS | P=0.002 ** P=0.500N P=0.748 P=0.505N P=0.090 | |ORDER RESTRICTED | P=0.004 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 1/52 (2%) 2/52 (4%) 0/51 (0%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 1/38.86 2/37.84 0/36.26 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.6% 5.3% 0.0% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- --- 720 612 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.628N (e) P=0.517 P=0.239 (e) | |POLY 3 | P=0.636N (e) P=0.504 P=0.234 (e) | |POLY 1.5 | P=0.639N (e) P=0.501 P=0.233 (e) | |POLY 6 | P=0.633N (e) P=0.506 P=0.239 (e) | |LOGISTIC REGRESSION| P=0.637N (e) P=0.508 P=0.233 (e) | |COCH-ARM / FISHERS | P=0.633N (e) P=0.495 P=0.243 (e) | |ORDER RESTRICTED | P=0.306 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 52 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 1/53 (2%) 2/52 (4%) 7/52 (13%) 8/51 (16%) | |POLY-3 RATE (b) | 1/38.18 1/37.89 2/39.13 7/39.86 8/37.61 | |POLY-3 PERCENT (g) | 2.6% 2.6% 5.1% 17.6% 21.3% | |TERMINAL (d) | 1/22 (5%) 0/21 (0%) 0/22 (0%) 1/24 (4%) 6/24 (25%) | |FIRST INCIDENCE | 729 (T) 580 654 479 314 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002 ** P=0.758 P=0.505 P=0.041 * P=0.021 * | |POLY 3 | P<0.001 ** P=0.760 P=0.509 P=0.033 * P=0.013 * | |POLY 1.5 | P<0.001 ** P=0.758 P=0.503 P=0.030 * P=0.013 * | |POLY 6 | P<0.001 ** P=0.760N P=0.515 P=0.038 * P=0.014 * | |LOGISTIC REGRESSION| P<0.001 ** P=0.759 P=0.509 P=0.031 * P=0.014 * | |COCH-ARM / FISHERS | P<0.001 ** P=0.752N P=0.493 P=0.028 * P=0.013 * | |ORDER RESTRICTED | P=0.004 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 1/52 (2%) 2/52 (4%) 1/51 (2%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 1/38.82 2/37.86 1/36.65 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.6% 5.3% 2.7% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 1/22 (5%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- --- 729 (T) 618 619 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.377 (e) P=0.500 P=0.240 P=0.471 | |POLY 3 | P=0.373 (e) P=0.503 P=0.234 P=0.492 | |POLY 1.5 | P=0.367 (e) P=0.501 P=0.233 P=0.489 | |POLY 6 | P=0.381 (e) P=0.506 P=0.239 P=0.496 | |LOGISTIC REGRESSION| P=0.367 (e) P=0.500 P=0.233 P=0.493 | |COCH-ARM / FISHERS | P=0.372 (e) P=0.495 P=0.243 P=0.490 | |ORDER RESTRICTED | P=0.191 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 53 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Stomach, Glandular | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/52 (0%) 1/52 (2%) 2/51 (4%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 0/38.82 1/37.39 2/37.97 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.7% 5.3% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 1/24 (4%) 0/24 (0%) | |FIRST INCIDENCE | --- --- --- 729 (T) 71 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.047 * (e) (e) P=0.517 P=0.240 | |POLY 3 | P=0.042 * (e) (e) P=0.496 P=0.235 | |POLY 1.5 | P=0.041 * (e) (e) P=0.495 P=0.231 | |POLY 6 | P=0.044 * (e) (e) P=0.498 P=0.240 | |LOGISTIC REGRESSION| P=0.064 (e) (e) P=0.517 P=0.324 | |COCH-ARM / FISHERS | P=0.040 * (e) (e) P=0.495 P=0.238 | |ORDER RESTRICTED | P=0.047 * (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Stomach, Glandular | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 3/53 (6%) 3/52 (6%) 1/52 (2%) 0/51 (0%) | |POLY-3 RATE (b) | 4/38.98 3/39.05 3/39.36 1/37.99 0/36.26 | |POLY-3 PERCENT (g) | 10.3% 7.7% 7.6% 2.6% 0.0% | |TERMINAL (d) | 2/22 (9%) 0/21 (0%) 1/22 (5%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | 556 534 654 539 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.045N* P=0.510N P=0.505N P=0.183N P=0.065N | |POLY 3 | P=0.046N* P=0.499N P=0.495N P=0.184N P=0.069N | |POLY 1.5 | P=0.045N* P=0.505N P=0.500N P=0.186N P=0.069N | |POLY 6 | P=0.046N* P=0.489N P=0.490N P=0.182N P=0.068N | |LOGISTIC REGRESSION| P=0.044N* P=0.499N P=0.496N P=0.186N P=0.069N | |COCH-ARM / FISHERS | P=0.043N* P=0.500N P=0.511N P=0.187N P=0.064N | |ORDER RESTRICTED | P=0.041N* (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 54 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 33/53 (62%) 33/50 (66%) 43/48 (90%) 42/50 (84%) 49/51 (96%) | |POLY-3 RATE (b) | 33/43.47 33/41.83 43/45.48 42/43.09 49/49.02 | |POLY-3 PERCENT (g) | 75.9% 78.9% 94.6% 97.5% 100.0% | |TERMINAL (d) | 18/22 (82%) 14/19 (74%) 18/19 (95%) 24/24 (100%) 24/24 (100%) | |FIRST INCIDENCE | 449 167 125 479 71 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.026 * P=0.409 P=0.047 * P=0.142 P=0.017 * | |POLY 3 | P<0.001 ** P=0.470 P=0.006 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.439 P=0.002 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.519 P=0.020 * P=0.002 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.322 P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.425 P<0.001 ** P=0.011 * P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Thymus | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 0/50 (0%) 0/48 (0%) 3/50 (6%) 1/51 (2%) | |POLY-3 RATE (b) | 1/39.00 0/34.71 0/34.86 3/38.30 1/36.76 | |POLY-3 PERCENT (g) | 2.6% 0.0% 0.0% 7.8% 2.7% | |TERMINAL (d) | 0/22 (0%) 0/19 (0%) 0/19 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | 418 --- --- 96 76 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.420 P=0.521N P=0.500N P=0.296 P=0.751 | |POLY 3 | P=0.439 P=0.523N P=0.522N P=0.298 P=0.748 | |POLY 1.5 | P=0.432 P=0.521N P=0.521N P=0.292 P=0.746 | |POLY 6 | P=0.451 P=0.524N P=0.525N P=0.307 P=0.752 | |LOGISTIC REGRESSION| P=0.610N P=0.479N P=0.527N P=0.429 P=0.613N | |COCH-ARM / FISHERS | P=0.436 P=0.515N P=0.525N P=0.287 P=0.743 | |ORDER RESTRICTED | P=0.191 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 55 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Thymus | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/51 (0%) | |POLY-3 RATE (b) | 2/39.43 0/34.71 0/34.86 0/35.50 0/35.76 | |POLY-3 PERCENT (g) | 5.1% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/22 (0%) 0/19 (0%) 0/19 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | 85 --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.355N P=0.247N P=0.247N P=0.251N P=0.259N | |POLY 3 | P=0.331N P=0.266N P=0.264N P=0.260N P=0.259N | |POLY 1.5 | P=0.334N P=0.263N P=0.263N P=0.261N P=0.260N | |POLY 6 | P=0.327N P=0.267N P=0.267N P=0.258N P=0.256N | |LOGISTIC REGRESSION| P=0.262N P=0.195N P=0.254N P=0.180N P=0.146N | |COCH-ARM / FISHERS | P=0.342N P=0.262N P=0.273N P=0.262N P=0.257N | |ORDER RESTRICTED | P=0.022N* (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 15/53 (28%) 19/53 (36%) 22/51 (43%) 12/52 (23%) 15/52 (29%) | |POLY-3 RATE (b) | 15/41.78 19/39.63 22/42.21 12/38.36 15/39.51 | |POLY-3 PERCENT (g) | 35.9% 48.0% 52.1% 31.3% 38.0% | |TERMINAL (d) | 7/22 (32%) 13/21 (62%) 13/22 (59%) 7/24 (29%) 7/24 (29%) | |FIRST INCIDENCE | 377 407 407 552 479 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.199N P=0.235 P=0.140 P=0.307N P=0.565N | |POLY 3 | P=0.264N P=0.183 P=0.093 P=0.419N P=0.515 | |POLY 1.5 | P=0.282N P=0.205 P=0.091 P=0.405N P=0.504 | |POLY 6 | P=0.236N P=0.164 P=0.095 P=0.422N P=0.537 | |LOGISTIC REGRESSION| P=0.289N P=0.238 P=0.103 P=0.367N P=0.526 | |COCH-ARM / FISHERS | P=0.245N P=0.266 P=0.084 P=0.349N P=0.561 | |ORDER RESTRICTED | P=0.268N (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 56 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Thyroid Gland: Follicle | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/53 (0%) 0/51 (0%) 0/52 (0%) 0/52 (0%) | |POLY-3 RATE (b) | 2/38.43 0/37.40 0/38.82 0/36.79 0/36.27 | |POLY-3 PERCENT (g) | 5.2% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/22 (5%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | 664 --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.342N P=0.252N P=0.247N P=0.241N P=0.245N | |POLY 3 | P=0.346N P=0.242N P=0.234N P=0.246N P=0.249N | |POLY 1.5 | P=0.346N P=0.242N P=0.237N P=0.247N P=0.251N | |POLY 6 | P=0.346N P=0.242N P=0.233N P=0.244N P=0.247N | |LOGISTIC REGRESSION| P=0.350N P=0.241N P=0.232N P=0.243N P=0.247N | |COCH-ARM / FISHERS | P=0.345N P=0.248N P=0.257N P=0.252N P=0.252N | |ORDER RESTRICTED | P=0.019N* (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 14/53 (26%) 17/53 (32%) 34/51 (67%) 35/52 (67%) 42/52 (81%) | |POLY-3 RATE (b) | 14/43.47 17/41.12 34/46.24 35/45.78 42/45.75 | |POLY-3 PERCENT (g) | 32.2% 41.3% 73.5% 76.5% 91.8% | |TERMINAL (d) | 5/22 (23%) 8/21 (38%) 17/22 (77%) 20/24 (83%) 23/24 (96%) | |FIRST INCIDENCE | 418 330 254 142 71 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.325 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.256 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.277 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.242 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.330 P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.335 P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 57 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Tooth: Peridontal Tissue | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 23/23 (100%) 14/14 (100%) 33/33 (100%) 35/35 (100%) 31/31 (100%) | |POLY-3 RATE (b) | 23/23.00 14/14.00 33/33.00 35/35.00 31/31.00 | |POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% 100.0% | |TERMINAL (d) | 10/10 (100%) 8/8 (100%) 16/16 (100%) 17/17 (100%) 17/17 (100%) | |FIRST INCIDENCE | 451 499 407 254 169 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Urinary Bladder | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/53 (13%) 8/53 (15%) 5/53 (9%) 7/52 (13%) 0/50 (0%) | |POLY-3 RATE (b) | 7/40.77 8/40.04 5/41.06 7/39.03 0/35.82 | |POLY-3 PERCENT (g) | 17.2% 20.0% 12.2% 17.9% 0.0% | |TERMINAL (d) | 3/22 (14%) 1/21 (5%) 2/22 (9%) 4/24 (17%) 0/24 (0%) | |FIRST INCIDENCE | 345 469 254 499 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.008N** P=0.488 P=0.388N P=0.589N P=0.011N* | |POLY 3 | P=0.010N* P=0.485 P=0.372N P=0.581 P=0.012N* | |POLY 1.5 | P=0.010N* P=0.479 P=0.373N P=0.582 P=0.012N* | |POLY 6 | P=0.010N* P=0.507 P=0.373N P=0.589 P=0.012N* | |LOGISTIC REGRESSION| P=0.008N** P=0.506 P=0.391N P=0.599 P=0.011N* | |COCH-ARM / FISHERS | P=0.008N** P=0.500 P=0.380N P=0.598 P=0.008N** | |ORDER RESTRICTED | P=0.013N* (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 58 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Uterus | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 5/53 (9%) 8/53 (15%) 10/52 (19%) 5/50 (10%) | |POLY-3 RATE (b) | 3/39.57 5/38.45 8/39.64 10/39.56 5/36.31 | |POLY-3 PERCENT (g) | 7.6% 13.0% 20.2% 25.3% 13.8% | |TERMINAL (d) | 0/22 (0%) 3/21 (14%) 6/22 (27%) 6/24 (25%) 4/24 (17%) | |FIRST INCIDENCE | 345 337 638 506 581 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.560N P=0.341 P=0.101 P=0.046 * P=0.352 | |POLY 3 | P=0.477 P=0.339 P=0.094 P=0.031 * P=0.308 | |POLY 1.5 | P=0.470 P=0.342 P=0.096 P=0.031 * P=0.306 | |POLY 6 | P=0.488 P=0.337 P=0.093 P=0.033 * P=0.311 | |LOGISTIC REGRESSION| P=0.490 P=0.360 P=0.105 P=0.035 * P=0.320 | |COCH-ARM / FISHERS | P=0.497 P=0.358 P=0.101 P=0.033 * P=0.325 | |ORDER RESTRICTED | P=0.113 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Uterus | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 0/53 (0%) 1/53 (2%) 7/52 (13%) 2/50 (4%) | |POLY-3 RATE (b) | 3/38.79 0/37.40 1/39.09 7/39.10 2/36.51 | |POLY-3 PERCENT (g) | 7.7% 0.0% 2.6% 17.9% 5.5% | |TERMINAL (d) | 2/22 (9%) 0/21 (0%) 0/22 (0%) 2/24 (8%) 1/24 (4%) | |FIRST INCIDENCE | 533 --- 715 310 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.452 P=0.128N P=0.293N P=0.181 P=0.479N | |POLY 3 | P=0.419 P=0.124N P=0.301N P=0.156 P=0.528N | |POLY 1.5 | P=0.407 P=0.124N P=0.303N P=0.153 P=0.534N | |POLY 6 | P=0.436 P=0.124N P=0.301N P=0.165 P=0.519N | |LOGISTIC REGRESSION| P=0.407 P=0.123N P=0.298N P=0.151 P=0.530N | |COCH-ARM / FISHERS | P=0.411 P=0.121N P=0.309N P=0.152 P=0.528N | |ORDER RESTRICTED | P=0.113 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 59 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Uterus | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 27/53 (51%) 30/53 (57%) 35/53 (66%) 36/52 (69%) 14/50 (28%) | |POLY-3 RATE (b) | 27/44.63 30/45.71 35/49.50 36/44.30 14/38.69 | |POLY-3 PERCENT (g) | 60.5% 65.6% 70.7% 81.3% 36.2% | |TERMINAL (d) | 12/22 (55%) 13/21 (62%) 15/22 (68%) 21/24 (88%) 7/24 (29%) | |FIRST INCIDENCE | 345 330 254 310 477 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.329 P=0.164 P=0.133 P=0.017N* | |POLY 3 | P<0.001N** P=0.382 P=0.196 P=0.018 * P=0.018N* | |POLY 1.5 | P<0.001N** P=0.356 P=0.144 P=0.024 * P=0.017N* | |POLY 6 | P=0.002N** P=0.411 P=0.251 P=0.012 * P=0.021N* | |LOGISTIC REGRESSION| P<0.001N** P=0.329 P=0.085 P=0.036 * P=0.016N* | |COCH-ARM / FISHERS | P<0.001N** P=0.349 P=0.084 P=0.043 * P=0.014N* | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 28/53 (53%) 23/53 (43%) 34/53 (64%) 18/52 (35%) 12/50 (24%) | |POLY-3 RATE (b) | 28/44.64 23/42.81 34/46.65 18/41.18 12/36.59 | |POLY-3 PERCENT (g) | 62.7% 53.7% 72.9% 43.7% 32.8% | |TERMINAL (d) | 13/22 (59%) 12/21 (57%) 19/22 (86%) 13/24 (54%) 10/24 (42%) | |FIRST INCIDENCE | 345 296 254 142 581 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.299N P=0.223 P=0.040N* P=0.002N** | |POLY 3 | P<0.001N** P=0.253N P=0.193 P=0.051N P=0.004N** | |POLY 1.5 | P<0.001N** P=0.248N P=0.177 P=0.044N* P=0.003N** | |POLY 6 | P<0.001N** P=0.253N P=0.213 P=0.066N P=0.006N** | |LOGISTIC REGRESSION| P<0.001N** P=0.234N P=0.169 P=0.046N* P=0.002N** | |COCH-ARM / FISHERS | P<0.001N** P=0.218N P=0.162 P=0.046N* P=0.002N** | |ORDER RESTRICTED | P=0.003N** (e) (e) (e) (e) | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Number of tumor-bearing animals / Poly-3 number (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates For all tests a negative trend is indicated by N (e) Value of Statistic cannot be computed. (g) Poly-3 adjusted lifetime tumor incidence. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).