NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 11/15/04 EXPERIMENT: 96022 TEST: 02 TIME: 11:36:07 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX ------------------------------------------------------------------------------------------------------------------------------------ CONTROL + TREATED GRPS. FINAL #1; REVISION #1 RATS 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 TEQ/KG INCLUDE 002 7 NG TEQ/KG INCLUDE 003 22 NG TEQ/KG INCLUDE 004 72 NG TEQ/KG INCLUDE 005 216 NG TEQ/KG INCLUDE 006 360 NG TEQ/KG NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 11/15/04 EXPERIMENT: 96022 TEST: 02 TIME: 11:36:07 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF TEF EVALUATION (PCB MIXTURE;PCB 126/P =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Adrenal Cortex Angiectasis Atrophy Degeneration Cystic Hyperplasia Hypertrophy Necrosis Vacuolization Cytoplasmic Adrenal Medulla Hyperplasia Blood Vessel: Aorta, Adventitia Inflammation Bone Marrow Atrophy Hyperplasia Brain Hemorrhage Clitoral Gland Inflammation Clitoral Gland: Duct Cyst Esophagus: Muscularis Inflammation Eye: Retina Atrophy Harderian Gland Inflammation Heart Cardiomyopathy Heart: Coronary Artery Inflammation Chronic Heart: Epicardium Inflammation Heart: Myocardium Hemorrhage Necrosis Intestine Large, Cecum Edema Inflammation Intestine Large, Colon Parasite Metazoan Intestine Large, Rectum Parasite Metazoan Kidney Calculus Micro Observation Only Inflammation Mineralization Nephropathy Kidney: Pelvis Inflammation Kidney: Transitional Epithelium Hyperplasia Liver Angiectasis Basophilic Focus Cholangiofibrosis Clear Cell Focus Eosinophilic Focus Fatty Change Diffuse Fatty Change Focal Hematopoietic Cell Proliferation Hyperplasia Inflammation Metaplasia Mixed Cell Focus Necrosis Pigmentation Toxic Hepatopathy Liver: Bile Duct Cyst NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 11/15/04 EXPERIMENT: 96022 TEST: 02 TIME: 11:36:07 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX Fibrosis Hyperplasia Liver: Centrilobular Degeneration Fibrosis Liver: Hepatocyte Glandular Structures Hypertrophy Multinucleated Liver: Oval Cell Hyperplasia Liver: Portal Fibrosis Lung Hemorrhage Infiltration Cellular Histiocyte Inflammation Metaplasia Lung: Alveolar Epithelium Hyperplasia Metaplasia Bronchiolar Lung: Serosa Fibrosis Lymph Node, Mandibular Ectasia Hemorrhage Hyperplasia Hyperplasia Lymphoid Lymph Node, Mesenteric Ectasia Hemorrhage Hyperplasia Lymph Node: Mediastinal Ectasia Hemorrhage Hyperplasia Pigmentation Lymph Node: Pancreatic Hemorrhage Hyperplasia Hyperplasia Lymphoid Lymph Node: Renal Hyperplasia Mammary Gland Hyperplasia Inflammation Granulomatous Mesentery: Artery Inflammation Chronic Mesentery: Fat Necrosis Nose Inflammation Nose: Glands Hyperplasia Nose: Olfactory Epithelium Metaplasia Nose: Respiratory Epithelium Hyperplasia Nose: Squamous Epithelium Hyperplasia Oral Mucosa: Gingival Hyperplasia Ovary Atrophy Cyst Pancreas Edema Hemorrhage Inflammation Chronic Pancreas: Acinus Atrophy Vacuolization Cytoplasmic Pancreas: Artery Inflammation Chronic Pancreas: Duct Dilatation Pituitary Gland Angiectasis Pituitary Gland: Pars Distalis Hyperplasia Skin Cyst Epithelial Inclusion Spleen Hematopoietic Cell Proliferation Pigmentation Spleen: Lymphoid Follicle Atrophy Spleen: Red Pulp Atrophy Stomach, Forestomach Edema NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 11/15/04 EXPERIMENT: 96022 TEST: 02 TIME: 11:36:07 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX Hyperplasia Mineralization Stomach, Glandular Erosion Hemorrhage Mineralization Thymus Atrophy Thyroid Gland: C-Cell Hyperplasia Thyroid Gland: Follicular Cell Hyperplasia Hypertrophy Urinary Bladder Inflammation Urinary Bladder: Transitional Epithelium Hyperplasia Uterus Adenomyosis Hemorrhage Inflammation Inflammation Chronic Metaplasia Uterus: Endometrium Hyperplasia Cystic =============================================================== Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 42/53 (79%) 35/51 (69%) 39/53 (74%) 25/53 (47%) 4/53 (8%) 6/65 (9%) | |POLY-3 RATE (b) | 42/48.03 35/42.89 39/47.84 25/42.51 4/25.64 6/14.36 | |POLY-3 PERCENT (g) | 87.4% 81.6% 81.5% 58.8% 15.6% 41.8% | |TERMINAL (d) | 26/27 (96%) 16/17 (94%) 21/24 (88%) 11/15 (73%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 482 70 63 390 450 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.515N P=0.132 P=0.432 P=0.322N P=0.342N P=0.008 ** | |POLY 3 | P<0.001N** P=0.292N P=0.281N P<0.001N** P<0.001N** P<0.001N** | |POLY 1.5 | P<0.001N** P=0.211N P=0.273N P<0.001N** P<0.001N** P<0.001N** | |POLY 6 | P<0.001N** P=0.401N P=0.311N P<0.001N** P<0.001N** P=0.249N | |LOGISTIC REGRESSION| P<0.001N** P=0.381N P=0.447N P=0.002N** P<0.001N** P=0.007N** | |COCH-ARM / FISHERS | P<0.001N** P=0.156N P=0.324N P<0.001N** P<0.001N** P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 1/51 (2%) 0/53 (0%) 15/53 (28%) 44/53 (83%) 40/65 (62%) | |POLY-3 RATE (b) | 2/42.18 1/33.36 0/37.79 15/39.73 44/45.82 40/41.82 | |POLY-3 PERCENT (g) | 4.7% 3.0% 0.0% 37.8% 96.0% 95.7% | |TERMINAL (d) | 1/27 (4%) 0/17 (0%) 0/24 (0%) 5/15 (33%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 649 443 --- 534 349 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.614N P=0.273N P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.581N P=0.262N P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.560N P=0.253N P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.603N P=0.272N P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.494N P=0.260N P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.515N P=0.248N P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 12/53 (23%) 12/51 (24%) 13/53 (25%) 11/53 (21%) 6/53 (11%) 2/65 (3%) | |POLY-3 RATE (b) | 12/43.80 12/34.17 13/40.71 11/40.47 6/27.37 2/10.85 | |POLY-3 PERCENT (g) | 27.4% 35.1% 31.9% 27.2% 21.9% 18.4% | |TERMINAL (d) | 6/27 (22%) 7/17 (41%) 7/24 (29%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 482 541 408 534 482 336 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.017 * P=0.189 P=0.368 P=0.359 P=0.094 P=0.152 | |POLY 3 | P=0.186N P=0.313 P=0.413 P=0.589N P=0.409N P=0.442N | |POLY 1.5 | P=0.031N* P=0.386 P=0.444 P=0.566N P=0.240N P=0.116N | |POLY 6 | P=0.467N P=0.249 P=0.382 P=0.580 P=0.547 P=0.479 | |LOGISTIC REGRESSION| P=0.044N* P=0.312 P=0.440 P=0.551N P=0.255N P=0.396N | |COCH-ARM / FISHERS | P<0.001N** P=0.549 P=0.500 P=0.500N P=0.098N P<0.001N** | |ORDER RESTRICTED | P=0.540N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 13/53 (25%) 7/51 (14%) 13/53 (25%) 12/53 (23%) 10/53 (19%) 5/65 (8%) | |POLY-3 RATE (b) | 13/44.54 7/34.51 13/40.27 12/39.26 10/28.88 5/13.17 | |POLY-3 PERCENT (g) | 29.2% 20.3% 32.3% 30.6% 34.6% 38.0% | |TERMINAL (d) | 5/27 (19%) 3/17 (18%) 9/24 (38%) 5/15 (33%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 362 436 455 552 267 321 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.391N P=0.444 P=0.295 P=0.005 ** P=0.004 ** | |POLY 3 | P=0.222 P=0.261N P=0.470 P=0.541 P=0.409 P=0.423 | |POLY 1.5 | P=0.490N P=0.210N P=0.515 P=0.587 P=0.578N P=0.368N | |POLY 6 | P=0.048 * P=0.318N P=0.419 P=0.470 P=0.167 P=0.195 | |LOGISTIC REGRESSION| P=0.531N P=0.178N P=0.539 P=0.579N P=0.452N P=0.532N | |COCH-ARM / FISHERS | P=0.014N* P=0.125N P=0.589N P=0.500N P=0.319N P=0.011N* | |ORDER RESTRICTED | P=0.487 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 45/53 (85%) 40/51 (78%) 47/53 (89%) 44/53 (83%) 45/53 (85%) 27/65 (42%) | |POLY-3 RATE (b) | 45/48.89 40/44.19 47/48.81 44/47.04 45/46.85 27/31.15 | |POLY-3 PERCENT (g) | 92.1% 90.5% 96.3% 93.5% 96.1% 86.7% | |TERMINAL (d) | 26/27 (96%) 15/17 (88%) 24/24 (100%) 14/15 (93%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 328 399 390 337 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.067 P=0.148 P=0.017 * P<0.001 ** P<0.001 ** | |POLY 3 | P=0.480N P=0.549N P=0.278 P=0.555 P=0.305 P=0.303N | |POLY 1.5 | P=0.011N* P=0.522N P=0.290 P=0.541 P=0.393 P=0.006N** | |POLY 6 | P=0.219 P=0.495N P=0.294 P=0.604 P=0.268 P=0.635 | |LOGISTIC REGRESSION| P=0.308 P=0.480 P=0.167 P=0.422 P=0.057 P=0.527 | |COCH-ARM / FISHERS | P<0.001N** P=0.274N P=0.388 P=0.500N P=0.607N P<0.001N** | |ORDER RESTRICTED | P=0.129N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 0/51 (0%) 2/53 (4%) 4/53 (8%) 1/53 (2%) 4/65 (6%) | |POLY-3 RATE (b) | 1/42.24 0/32.58 2/39.10 4/38.53 1/24.86 4/13.13 | |POLY-3 PERCENT (g) | 2.4% 0.0% 5.1% 10.4% 4.0% 30.5% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 628 --- 426 548 313 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.003 ** P=0.571N P=0.457 P=0.139 P=0.649 P=0.077 | |POLY 3 | P=0.037 * P=0.551N P=0.473 P=0.151 P=0.630 P=0.028 * | |POLY 1.5 | P=0.062 P=0.537N P=0.483 P=0.159 P=0.693 P=0.063 | |POLY 6 | P=0.014 * P=0.566N P=0.463 P=0.137 P=0.533 P=0.016 * | |LOGISTIC REGRESSION| P=0.486N P=0.512N P=0.571 P=0.202 P=0.607N P=0.627N | |COCH-ARM / FISHERS | P=0.172 P=0.510N P=0.500 P=0.181 P=0.752N P=0.252 | |ORDER RESTRICTED | P=0.005 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 14/53 (26%) 16/51 (31%) 13/53 (25%) 24/53 (45%) 27/53 (51%) 12/65 (18%) | |POLY-3 RATE (b) | 14/44.09 16/36.76 13/41.07 24/41.43 27/36.88 12/18.81 | |POLY-3 PERCENT (g) | 31.8% 43.5% 31.7% 57.9% 73.2% 63.8% | |TERMINAL (d) | 6/27 (22%) 7/17 (41%) 7/24 (29%) 10/15 (67%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 564 70 443 539 313 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.092 P=0.516 P=0.002 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.191 P=0.589N P=0.010 * P<0.001 ** P=0.034 * | |POLY 1.5 | P=0.003 ** P=0.243 P=0.555N P=0.014 * P<0.001 ** P=0.223 | |POLY 6 | P<0.001 ** P=0.149 P=0.560 P=0.005 ** P<0.001 ** P=0.006 ** | |LOGISTIC REGRESSION| P=0.007 ** P=0.246 P=0.560N P=0.011 * P<0.001 ** P=0.266 | |COCH-ARM / FISHERS | P=0.294N P=0.366 P=0.500N P=0.034 * P=0.008 ** P=0.208N | |ORDER RESTRICTED | P=0.011 * (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 13/53 (25%) 4/51 (8%) 9/53 (17%) 12/53 (23%) 2/53 (4%) 0/64 (0%) | |POLY-3 RATE (b) | 13/42.77 4/32.97 9/38.63 12/38.98 2/24.72 0/9.22 | |POLY-3 PERCENT (g) | 30.4% 12.1% 23.3% 30.8% 8.1% 0.0% | |TERMINAL (d) | 10/27 (37%) 3/17 (18%) 7/24 (29%) 4/15 (27%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 628 616 567 552 525 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.123 P=0.112N P=0.353N P=0.220 P=0.363 P=0.999N | |POLY 3 | P=0.079N P=0.051N P=0.317N P=0.581 P=0.039N* P=0.166N | |POLY 1.5 | P=0.007N** P=0.038N* P=0.285N P=0.576N P=0.011N* P=0.015N* | |POLY 6 | P=0.383N P=0.070N P=0.353N P=0.532 P=0.164N P=0.440N | |LOGISTIC REGRESSION| P=0.187N P=0.072N P=0.358N P=0.491 P=0.231N P=0.612N | |COCH-ARM / FISHERS | P<0.001N** P=0.020N* P=0.237N P=0.500N P=0.002N** P<0.001N** | |ORDER RESTRICTED | P=0.186N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Blood Vessel: Aorta, Adventitia | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/52 (0%) 0/53 (0%) 1/53 (2%) 2/66 (3%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.04 0/36.73 1/24.55 2/11.08 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 4.1% 18.1% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 530 294 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.409 P=0.123 | |POLY 3 | P=0.022 * (e) (e) (e) P=0.400 P=0.095 | |POLY 1.5 | P=0.014 * (e) (e) (e) P=0.443 P=0.136 | |POLY 6 | P=0.038 * (e) (e) (e) P=0.343 P=0.077 | |LOGISTIC REGRESSION| P=0.093 (e) (e) (e) P=0.589 P=0.609 | |COCH-ARM / FISHERS | P=0.020 * (e) (e) (e) P=0.500 P=0.306 | |ORDER RESTRICTED | P=0.004 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Bone Marrow | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 0/53 (0%) 2/53 (4%) 12/66 (18%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 0/36.73 2/25.71 12/20.74 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 7.8% 57.9% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 313 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.231 P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.149 P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.184 P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.110 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.495 P=0.387 | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.248 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 37/53 (70%) 41/51 (80%) 36/53 (68%) 48/53 (91%) 47/53 (89%) 49/66 (74%) | |POLY-3 RATE (b) | 37/51.61 41/49.07 36/50.24 48/52.21 47/48.90 49/50.11 | |POLY-3 PERCENT (g) | 71.7% 83.6% 71.7% 91.9% 96.1% 97.8% | |TERMINAL (d) | 14/27 (52%) 10/17 (59%) 12/24 (50%) 13/15 (87%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 70 63 41 166 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.022 * P=0.371 P=0.002 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.112 P=0.586N P=0.005 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.121 P=0.560N P=0.006 ** P<0.001 ** P=0.002 ** | |POLY 6 | P<0.001 ** P=0.113 P=0.576 P=0.005 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P=0.503 P=0.338 P=0.360N P=0.021 * P=0.069 P=0.298 | |COCH-ARM / FISHERS | P=0.328 P=0.154 P=0.500N P=0.007 ** P=0.015 * P=0.369 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Brain | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 1/51 (2%) 1/53 (2%) 4/53 (8%) 5/53 (9%) 14/66 (21%) | |POLY-3 RATE (b) | 0/41.89 1/33.49 1/37.79 4/38.75 5/28.06 14/22.64 | |POLY-3 PERCENT (g) | 0.0% 3.0% 2.7% 10.3% 17.8% 61.8% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 1/24 (4%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 328 726 (T) 78 313 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.488 P=0.477 P=0.047 * P=0.026 * P<0.001 ** | |POLY 3 | P<0.001 ** P=0.456 P=0.479 P=0.050 P=0.009 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.467 P=0.487 P=0.054 P=0.016 * P<0.001 ** | |POLY 6 | P<0.001 ** P=0.444 P=0.472 P=0.044 * P=0.004 ** P<0.001 ** | |LOGISTIC REGRESSION| P=0.044 * P=0.724 P=0.477 P=0.103 P=0.160 P=0.402 | |COCH-ARM / FISHERS | P<0.001 ** P=0.490 P=0.500 P=0.059 P=0.028 * P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Brain | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 2/53 (4%) 1/53 (2%) 0/66 (0%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 2/38.16 1/24.47 0/9.33 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.2% 4.1% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 78 565 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.360 (e) (e) P=0.220 P=0.379 (e) | |POLY 3 | P=0.121 (e) (e) P=0.216 P=0.399 (e) | |POLY 1.5 | P=0.294 (e) (e) P=0.225 P=0.443 (e) | |POLY 6 | P=0.032 * (e) (e) P=0.203 P=0.343 (e) | |LOGISTIC REGRESSION| P=0.319N (e) (e) P=0.416 P=0.546 (e) | |COCH-ARM / FISHERS | P=0.603N (e) (e) P=0.248 P=0.500 (e) | |ORDER RESTRICTED | P=0.534 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Brain | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 2/53 (4%) 1/53 (2%) 0/66 (0%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 2/38.16 1/24.47 0/9.33 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.2% 4.1% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 78 565 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.360 (e) (e) P=0.220 P=0.379 (e) | |POLY 3 | P=0.121 (e) (e) P=0.216 P=0.399 (e) | |POLY 1.5 | P=0.294 (e) (e) P=0.225 P=0.443 (e) | |POLY 6 | P=0.032 * (e) (e) P=0.203 P=0.343 (e) | |LOGISTIC REGRESSION| P=0.319N (e) (e) P=0.416 P=0.546 (e) | |COCH-ARM / FISHERS | P=0.603N (e) (e) P=0.248 P=0.500 (e) | |ORDER RESTRICTED | P=0.534 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 49/53 (92%) 44/51 (86%) 46/51 (90%) 34/52 (65%) 21/52 (40%) 31/66 (47%) | |POLY-3 RATE (b) | 49/52.29 44/48.11 46/49.70 34/45.57 21/35.74 31/35.89 | |POLY-3 PERCENT (g) | 93.7% 91.5% 92.6% 74.6% 58.8% 86.4% | |TERMINAL (d) | 24/27 (89%) 16/17 (94%) 22/24 (92%) 10/15 (67%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 70 63 390 267 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.078 P=0.403 P=0.534N P=0.014 * P<0.001 ** | |POLY 3 | P<0.001N** P=0.479N P=0.569N P=0.005N** P<0.001N** P=0.160N | |POLY 1.5 | P<0.001N** P=0.390N P=0.518N P=0.002N** P<0.001N** P<0.001N** | |POLY 6 | P=0.083N P=0.570N P=0.657N P=0.015N* P<0.001N** P=0.532 | |LOGISTIC REGRESSION| P<0.001N** P=0.272N P=0.454N P<0.001N** P<0.001N** P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.241N P=0.475N P<0.001N** P<0.001N** P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Clitoral Gland: Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 40/53 (75%) 41/51 (80%) 43/51 (84%) 45/52 (87%) 48/52 (92%) 61/66 (92%) | |POLY-3 RATE (b) | 40/50.23 41/46.05 43/48.26 45/49.78 48/49.06 61/61.31 | |POLY-3 PERCENT (g) | 79.6% 89.0% 89.1% 90.4% 97.9% 99.5% | |TERMINAL (d) | 20/27 (74%) 17/17 (100%) 21/24 (88%) 13/15 (87%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 313 78 399 41 166 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.019 * P=0.156 P=0.008 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.145 P=0.144 P=0.096 P=0.002 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.210 P=0.147 P=0.110 P=0.004 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.079 P=0.139 P=0.073 P=0.002 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.268 P=0.158 P=0.117 P=0.010 * P=0.017 * | |COCH-ARM / FISHERS | P=0.004 ** P=0.357 P=0.190 P=0.116 P=0.018 * P=0.010 * | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Esophagus: Muscularis | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 0/51 (0%) 2/53 (4%) 3/53 (6%) 3/53 (6%) 2/66 (3%) | |POLY-3 RATE (b) | 3/42.85 0/32.58 2/38.52 3/37.73 3/26.07 2/10.61 | |POLY-3 PERCENT (g) | 7.0% 0.0% 5.2% 8.0% 11.5% 18.9% | |TERMINAL (d) | 1/27 (4%) 0/17 (0%) 1/24 (4%) 2/15 (13%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 534 --- 471 78 373 254 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.005 ** P=0.198N P=0.562N P=0.503 P=0.291 P=0.066 | |POLY 3 | P=0.094 P=0.175N P=0.549N P=0.603 P=0.424 P=0.347 | |POLY 1.5 | P=0.186 P=0.157N P=0.530N P=0.628 P=0.532 P=0.556 | |POLY 6 | P=0.049 * P=0.195N P=0.568N P=0.561 P=0.285 P=0.234 | |LOGISTIC REGRESSION| P=0.469N P=0.125N P=0.477N P=0.592N P=0.510N P=0.783 | |COCH-ARM / FISHERS | P=0.538 P=0.129N P=0.500N P=0.661N P=0.661N P=0.397N | |ORDER RESTRICTED | P=0.245 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Eye | | Cataract | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 3/51 (6%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 0/66 (0%) | |POLY-3 RATE (b) | 1/42.21 3/33.49 0/37.79 0/36.73 0/23.94 0/9.33 | |POLY-3 PERCENT (g) | 2.4% 9.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 2/17 (12%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 639 328 --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.267N P=0.199 P=0.541N P=0.541N P=0.713N P=1.000N | |POLY 3 | P=0.164N P=0.227 P=0.522N P=0.528N P=0.605N P=0.697N | |POLY 1.5 | P=0.142N P=0.247 P=0.514N P=0.518N P=0.559N P=0.626N | |POLY 6 | P=0.162N P=0.206 P=0.531N P=0.544N P=0.664N P=0.735N | |LOGISTIC REGRESSION| P=0.064N P=0.306 P=0.499N P=0.502N P=0.593N P=0.905N | |COCH-ARM / FISHERS | P=0.074N P=0.294 P=0.500N P=0.500N P=0.500N P=0.445N | |ORDER RESTRICTED | P=0.499N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Eye: Retina | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 3/51 (6%) 0/53 (0%) 1/53 (2%) 0/53 (0%) 1/66 (2%) | |POLY-3 RATE (b) | 1/42.21 3/32.89 0/37.79 1/36.73 0/23.94 1/9.73 | |POLY-3 PERCENT (g) | 2.4% 9.1% 0.0% 2.7% 0.0% 10.3% | |TERMINAL (d) | 0/27 (0%) 2/17 (12%) 0/24 (0%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 639 642 --- 726 (T) --- 611 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.054 P=0.180 P=0.541N P=0.671 P=0.713N P=0.016 * | |POLY 3 | P=0.438N P=0.222 P=0.522N P=0.729 P=0.605N P=0.442 | |POLY 1.5 | P=0.414N P=0.243 P=0.514N P=0.741 P=0.559N P=0.580 | |POLY 6 | P=0.443N P=0.202 P=0.531N P=0.709 P=0.664N P=0.358 | |LOGISTIC REGRESSION| P=0.371 P=0.216 P=0.499N P=0.734 P=0.593N P=0.457 | |COCH-ARM / FISHERS | P=0.263N P=0.294 P=0.500N P=0.752N P=0.500N P=0.694N | |ORDER RESTRICTED | P=0.405 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Harderian Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 24/53 (45%) 7/51 (14%) 20/53 (38%) 13/53 (25%) 7/53 (13%) 9/66 (14%) | |POLY-3 RATE (b) | 24/45.26 7/34.66 20/40.69 13/38.18 7/27.04 9/16.65 | |POLY-3 PERCENT (g) | 53.0% 20.2% 49.2% 34.1% 25.9% 54.1% | |TERMINAL (d) | 15/27 (56%) 1/17 (6%) 13/24 (54%) 7/15 (47%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 313 541 455 567 523 217 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.023N* P=0.479N P=0.356N P=0.082 P<0.001 ** | |POLY 3 | P=0.216N P=0.002N** P=0.441N P=0.056N P=0.020N* P=0.571 | |POLY 1.5 | P=0.045N* P<0.001N** P=0.378N P=0.039N* P=0.003N** P=0.111N | |POLY 6 | P=0.489 P=0.003N** P=0.510N P=0.100N P=0.155N P=0.194 | |LOGISTIC REGRESSION| P=0.484N P=0.002N** P=0.415N P=0.054N P=0.030N* P=0.329N | |COCH-ARM / FISHERS | P<0.001N** P<0.001N** P=0.277N P=0.020N* P<0.001N** P<0.001N** | |ORDER RESTRICTED | P=0.266N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 20/53 (38%) 13/51 (25%) 17/53 (32%) 34/53 (64%) 14/53 (26%) 19/65 (29%) | |POLY-3 RATE (b) | 20/45.03 13/36.13 17/42.28 34/44.99 14/30.44 19/24.56 | |POLY-3 PERCENT (g) | 44.4% 36.0% 40.2% 75.6% 46.0% 77.4% | |TERMINAL (d) | 11/27 (41%) 3/17 (18%) 7/24 (29%) 10/15 (67%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 534 525 408 537 447 237 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.531N P=0.526N P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P=0.006 ** P=0.292N P=0.427N P<0.001 ** P=0.540 P=0.009 ** | |POLY 1.5 | P=0.124 P=0.236N P=0.395N P<0.001 ** P=0.402N P=0.125 | |POLY 6 | P<0.001 ** P=0.335N P=0.456N P<0.001 ** P=0.244 P<0.001 ** | |LOGISTIC REGRESSION| P=0.038 * P=0.266N P=0.406N P<0.001 ** P=0.566 P=0.117 | |COCH-ARM / FISHERS | P=0.108N P=0.129N P=0.342N P=0.006 ** P=0.149N P=0.217N | |ORDER RESTRICTED | P=0.003 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Heart: Coronary Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 1/51 (2%) 0/53 (0%) 7/53 (13%) 10/53 (19%) 9/65 (14%) | |POLY-3 RATE (b) | 1/41.89 1/32.58 0/37.79 7/37.65 10/29.16 9/16.16 | |POLY-3 PERCENT (g) | 2.4% 3.1% 0.0% 18.6% 34.3% 55.7% | |TERMINAL (d) | 1/27 (4%) 1/17 (6%) 0/24 (0%) 3/15 (20%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 726 (T) --- 567 450 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.656 P=0.523N P=0.006 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.702 P=0.521N P=0.019 * P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.719 P=0.513N P=0.023 * P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.685 P=0.528N P=0.015 * P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.656 (e) P=0.015 * P=0.005 ** P=0.007 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.743 P=0.500N P=0.030 * P=0.004 ** P=0.019 * | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Heart: Epicardium | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 1/51 (2%) 0/53 (0%) 6/53 (11%) 13/53 (25%) 6/65 (9%) | |POLY-3 RATE (b) | 1/42.60 1/33.49 0/37.79 6/38.00 13/30.80 6/13.78 | |POLY-3 PERCENT (g) | 2.4% 3.0% 0.0% 15.8% 42.2% 43.5% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 482 328 --- 619 313 362 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.732 P=0.525N P=0.028 * P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.705 P=0.524N P=0.038 * P<0.001 ** P=0.003 ** | |POLY 1.5 | P<0.001 ** P=0.721 P=0.515N P=0.044 * P<0.001 ** P=0.009 ** | |POLY 6 | P<0.001 ** P=0.688 P=0.533N P=0.032 * P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.608N P=0.431N P=0.054 P=0.003 ** P=0.087 | |COCH-ARM / FISHERS | P=0.002 ** P=0.743 P=0.500N P=0.056 P<0.001 ** P=0.096 | |ORDER RESTRICTED | P=0.002 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Heart: Myocardium | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 3/65 (5%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 0/36.73 0/23.94 3/12.08 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 24.8% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.084 | |POLY 3 | P=0.029 * (e) (e) (e) (e) P=0.030 * | |POLY 1.5 | P=0.009 ** (e) (e) (e) (e) P=0.051 | |POLY 6 | P=0.063 (e) (e) (e) (e) P=0.022 * | |LOGISTIC REGRESSION| P=0.074 (e) (e) (e) (e) P=0.655 | |COCH-ARM / FISHERS | P=0.004 ** (e) (e) (e) (e) P=0.164 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Heart: Myocardium | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 0/36.73 0/23.94 2/11.19 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 17.9% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.012 * (e) (e) (e) (e) P=0.229 | |POLY 3 | P=0.101 (e) (e) (e) (e) P=0.094 | |POLY 1.5 | P=0.042 * (e) (e) (e) (e) P=0.135 | |POLY 6 | P=0.193 (e) (e) (e) (e) P=0.076 | |LOGISTIC REGRESSION| P=0.151 (e) (e) (e) (e) P=0.890 | |COCH-ARM / FISHERS | P=0.019 * (e) (e) (e) (e) P=0.301 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Intestine Large, Cecum | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 0/36.73 0/23.71 2/11.19 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 17.9% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 254 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.012 * (e) (e) (e) (e) P=0.229 | |POLY 3 | P=0.103 (e) (e) (e) (e) P=0.094 | |POLY 1.5 | P=0.042 * (e) (e) (e) (e) P=0.135 | |POLY 6 | P=0.194 (e) (e) (e) (e) P=0.076 | |LOGISTIC REGRESSION| P=0.151 (e) (e) (e) (e) P=0.865 | |COCH-ARM / FISHERS | P=0.019 * (e) (e) (e) (e) P=0.301 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 14 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Intestine Large, Cecum | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 0/53 (0%) 0/52 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 0/36.73 0/23.71 2/11.20 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 17.9% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.014 * (e) (e) (e) (e) P=0.243 | |POLY 3 | P=0.102 (e) (e) (e) (e) P=0.094 | |POLY 1.5 | P=0.042 * (e) (e) (e) (e) P=0.135 | |POLY 6 | P=0.194 (e) (e) (e) (e) P=0.076 | |LOGISTIC REGRESSION| P=0.151 (e) (e) (e) (e) P=0.887 | |COCH-ARM / FISHERS | P=0.019 * (e) (e) (e) (e) P=0.301 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Intestine Large, Cecum: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 2/53 (4%) 0/52 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 2/37.26 0/23.71 0/9.28 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.4% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 567 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.505 (e) (e) P=0.165 (e) (e) | |POLY 3 | P=0.448 (e) (e) P=0.211 (e) (e) | |POLY 1.5 | P=0.641 (e) (e) P=0.220 (e) (e) | |POLY 6 | P=0.182 (e) (e) P=0.198 (e) (e) | |LOGISTIC REGRESSION| P=0.730N (e) (e) P=0.229 (e) (e) | |COCH-ARM / FISHERS | P=0.442N (e) (e) P=0.248 (e) (e) | |ORDER RESTRICTED | P=0.589 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 15 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Intestine Large, Colon | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 1/51 (2%) 0/53 (0%) 0/53 (0%) 0/52 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 2/41.97 1/33.04 0/37.79 0/36.73 0/23.71 2/11.13 | |POLY-3 PERCENT (g) | 4.8% 3.0% 0.0% 0.0% 0.0% 18.0% | |TERMINAL (d) | 1/27 (4%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 707 594 --- --- --- 236 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.038 * P=0.635N P=0.269N P=0.356N P=0.962N P=0.175 | |POLY 3 | P=0.590 P=0.582N P=0.261N P=0.268N P=0.379N P=0.283 | |POLY 1.5 | P=0.483 P=0.561N P=0.252N P=0.256N P=0.313N P=0.444 | |POLY 6 | P=0.505N P=0.603N P=0.270N P=0.287N P=0.480N P=0.197 | |LOGISTIC REGRESSION| P=0.537 P=0.580N P=0.269N P=0.317N P=0.802N P=0.807N | |COCH-ARM / FISHERS | P=0.443 P=0.515N P=0.248N P=0.248N P=0.252N P=0.610N | |ORDER RESTRICTED | P=0.036 * (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Intestine Large, Rectum | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/52 (6%) 2/51 (4%) 2/53 (4%) 2/53 (4%) 1/52 (2%) 0/66 (0%) | |POLY-3 RATE (b) | 3/41.84 2/33.62 2/38.04 2/37.00 1/24.57 0/9.33 | |POLY-3 PERCENT (g) | 7.2% 6.0% 5.3% 5.4% 4.1% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/17 (0%) 1/24 (4%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 567 541 659 687 373 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.618 P=0.657N P=0.559N P=0.667N P=0.702 P=0.987N | |POLY 3 | P=0.357N P=0.599N P=0.543N P=0.556N P=0.508N P=0.482N | |POLY 1.5 | P=0.205N P=0.571N P=0.524N P=0.532N P=0.413N P=0.300N | |POLY 6 | P=0.504N P=0.625N P=0.564N P=0.593N P=0.639N P=0.604N | |LOGISTIC REGRESSION| P=0.109N P=0.516N P=0.529N P=0.546N P=0.273N P=0.613N | |COCH-ARM / FISHERS | P=0.043N* P=0.509N P=0.491N P=0.491N P=0.309N P=0.083N | |ORDER RESTRICTED | P=0.548N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 16 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Intestine Large, Rectum: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/52 (0%) 1/51 (2%) 1/53 (2%) 3/53 (6%) 1/52 (2%) 0/66 (0%) | |POLY-3 RATE (b) | 0/41.24 1/32.58 1/37.79 3/37.69 1/24.26 0/9.33 | |POLY-3 PERCENT (g) | 0.0% 3.1% 2.7% 8.0% 4.1% 0.0% | |TERMINAL (d) | 0/27 (0%) 1/17 (6%) 1/24 (4%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 726 (T) 726 (T) 567 555 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.109 P=0.408 P=0.477 P=0.079 P=0.386 (e) | |POLY 3 | P=0.279 P=0.453 P=0.483 P=0.103 P=0.400 (e) | |POLY 1.5 | P=0.528 P=0.467 P=0.491 P=0.109 P=0.444 (e) | |POLY 6 | P=0.089 P=0.439 P=0.474 P=0.093 P=0.344 (e) | |LOGISTIC REGRESSION| P=0.569 P=0.408 P=0.477 P=0.122 P=0.560 (e) | |COCH-ARM / FISHERS | P=0.270N P=0.495 P=0.505 P=0.125 P=0.500 (e) | |ORDER RESTRICTED | P=0.547 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Kidney | | Calculus Micro Observation Only | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/53 (11%) 6/51 (12%) 6/53 (11%) 0/53 (0%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 6/42.65 6/32.84 6/39.15 0/36.73 0/23.94 0/9.28 | |POLY-3 PERCENT (g) | 14.1% 18.3% 15.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/27 (15%) 5/17 (29%) 3/24 (13%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 586 659 443 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.066N P=0.313 P=0.530 P=0.055N P=0.508N P=0.985N | |POLY 3 | P=0.005N** P=0.430 P=0.560 P=0.024N* P=0.082N P=0.343N | |POLY 1.5 | P=0.002N** P=0.484 P=0.583 P=0.021N* P=0.040N* P=0.128N | |POLY 6 | P=0.008N** P=0.375 P=0.538 P=0.032N* P=0.193N P=0.532N | |LOGISTIC REGRESSION| P=0.008N** P=0.382 P=0.575 P=0.027N* P=0.129N P=0.561N | |COCH-ARM / FISHERS | P<0.001N** P=0.592 P=0.620N P=0.013N* P=0.013N* P=0.007N** | |ORDER RESTRICTED | P=0.334N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 17 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Kidney | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/51 (4%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 0/41.89 2/33.36 0/37.79 0/36.73 0/23.94 0/9.28 | |POLY-3 PERCENT (g) | 0.0% 6.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 1/17 (6%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 443 --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.443N P=0.173 (e) (e) (e) (e) | |POLY 3 | P=0.365N P=0.190 (e) (e) (e) (e) | |POLY 1.5 | P=0.329N P=0.201 (e) (e) (e) (e) | |POLY 6 | P=0.362N P=0.178 (e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.189N P=0.248 (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.208N P=0.238 (e) (e) (e) (e) | |ORDER RESTRICTED | P=0.607N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/51 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 1/65 (2%) | |POLY-3 RATE (b) | 2/41.89 0/32.58 0/37.79 0/36.73 0/23.94 1/10.26 | |POLY-3 PERCENT (g) | 4.8% 0.0% 0.0% 0.0% 0.0% 9.8% | |TERMINAL (d) | 2/27 (7%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) --- --- --- --- 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.192 P=0.344N P=0.264N P=0.374N P=1.000N P=0.534 | |POLY 3 | P=0.532N P=0.296N P=0.260N P=0.267N P=0.377N P=0.535 | |POLY 1.5 | P=0.618N P=0.280N P=0.252N P=0.256N P=0.310N P=0.705 | |POLY 6 | P=0.383N P=0.314N P=0.269N P=0.286N P=0.478N P=0.417 | |LOGISTIC REGRESSION| P=0.633N (e) (e) (e) (e) P=0.732N | |COCH-ARM / FISHERS | P=0.607N P=0.257N P=0.248N P=0.248N P=0.248N P=0.423N | |ORDER RESTRICTED | P=0.191 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 18 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Kidney | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 1/51 (2%) 4/53 (8%) 3/53 (6%) 0/53 (0%) 1/65 (2%) | |POLY-3 RATE (b) | 0/41.89 1/32.58 4/38.07 3/37.44 0/23.94 1/10.26 | |POLY-3 PERCENT (g) | 0.0% 3.1% 10.5% 8.0% 0.0% 9.8% | |TERMINAL (d) | 0/27 (0%) 1/17 (6%) 3/24 (13%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 726 (T) 651 594 --- 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.087 P=0.408 P=0.049 * P=0.077 (e) P=0.534 | |POLY 3 | P=0.568 P=0.450 P=0.048 * P=0.099 (e) P=0.307 | |POLY 1.5 | P=0.452N P=0.464 P=0.053 P=0.106 (e) P=0.378 | |POLY 6 | P=0.335 P=0.437 P=0.044 * P=0.090 (e) P=0.268 | |LOGISTIC REGRESSION| P=0.569N P=0.408 P=0.045 * P=0.107 (e) P=0.996 | |COCH-ARM / FISHERS | P=0.189N P=0.490 P=0.059 P=0.121 (e) P=0.551 | |ORDER RESTRICTED | P=0.373 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 46/53 (87%) 34/51 (67%) 38/53 (72%) 44/53 (83%) 34/53 (64%) 37/65 (57%) | |POLY-3 RATE (b) | 46/51.13 34/44.52 38/48.48 44/50.44 34/44.31 37/39.76 | |POLY-3 PERCENT (g) | 90.0% 76.4% 78.4% 87.2% 76.7% 93.1% | |TERMINAL (d) | 23/27 (85%) 10/17 (59%) 19/24 (79%) 14/15 (93%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 313 275 63 41 166 217 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.424 P=0.402N P=0.048 * P<0.001 ** P<0.001 ** | |POLY 3 | P=0.282 P=0.055N P=0.080N P=0.449N P=0.046N* P=0.434 | |POLY 1.5 | P=0.329N P=0.037N* P=0.057N P=0.398N P=0.015N* P=0.219N | |POLY 6 | P=0.059 P=0.076N P=0.124N P=0.557N P=0.206N P=0.127 | |LOGISTIC REGRESSION| P=0.048N* P=0.033N* P=0.055N P=0.397N P=0.004N** P=0.551N | |COCH-ARM / FISHERS | P<0.001N** P=0.013N* P=0.046N* P=0.393N P=0.006N** P<0.001N** | |ORDER RESTRICTED | P=0.093 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 19 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 41/53 (77%) 37/51 (73%) 37/53 (70%) 48/53 (91%) 50/53 (94%) 43/65 (66%) | |POLY-3 RATE (b) | 41/49.70 37/43.32 37/46.04 48/49.44 50/50.38 43/44.50 | |POLY-3 PERCENT (g) | 82.5% 85.4% 80.4% 97.1% 99.3% 96.6% | |TERMINAL (d) | 24/27 (89%) 14/17 (82%) 21/24 (88%) 15/15 (100%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 328 63 41 267 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.077 P=0.512 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.457 P=0.498N P=0.008 ** P<0.001 ** P=0.013 * | |POLY 1.5 | P=0.003 ** P=0.520 P=0.394N P=0.013 * P=0.002 ** P=0.144 | |POLY 6 | P<0.001 ** P=0.466 P=0.593N P=0.008 ** P=0.003 ** P=0.006 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.552 P=0.326N P=0.025 * P=0.003 ** P=0.133 | |COCH-ARM / FISHERS | P=0.321N P=0.367N P=0.255N P=0.055 P=0.012 * P=0.128N | |ORDER RESTRICTED | P=0.002 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Kidney: Pelvis | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 6/51 (12%) 1/53 (2%) 6/53 (11%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 4/42.25 6/34.63 1/37.79 6/38.27 0/23.94 0/9.28 | |POLY-3 PERCENT (g) | 9.5% 17.3% 2.7% 15.7% 0.0% 0.0% | |TERMINAL (d) | 2/27 (7%) 0/17 (0%) 1/24 (4%) 2/15 (13%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 672 525 726 (T) 567 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.452N P=0.181 P=0.228N P=0.176 P=0.724N P=1.000 | |POLY 3 | P=0.154N P=0.250 P=0.213N P=0.306 P=0.171N P=0.426N | |POLY 1.5 | P=0.048N* P=0.275 P=0.200N P=0.327 P=0.110N P=0.226N | |POLY 6 | P=0.412N P=0.231 P=0.228N P=0.276 P=0.294N P=0.574N | |LOGISTIC REGRESSION| P=0.041N* P=0.275 P=0.223N P=0.306 P=0.356N P=0.876N | |COCH-ARM / FISHERS | P=0.003N** P=0.346 P=0.181N P=0.371 P=0.059N P=0.038N* | |ORDER RESTRICTED | P=0.415N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/51 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 2/42.10 0/32.58 0/37.79 0/36.73 0/23.94 0/9.28 | |POLY-3 PERCENT (g) | 4.8% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 672 --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.608N P=0.339N P=0.275N P=0.348N P=0.804N P=1.000N | |POLY 3 | P=0.234N P=0.298N P=0.262N P=0.268N P=0.378N P=0.564N | |POLY 1.5 | P=0.239N P=0.280N P=0.252N P=0.257N P=0.310N P=0.424N | |POLY 6 | P=0.189N P=0.317N P=0.272N P=0.288N P=0.480N P=0.651N | |LOGISTIC REGRESSION| P=0.441N P=0.307N P=0.266N P=0.284N P=0.587N P=0.966N | |COCH-ARM / FISHERS | P=0.188N P=0.257N P=0.248N P=0.248N P=0.248N P=0.200N | |ORDER RESTRICTED | P=0.411N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Kidney: Transitional Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 6/51 (12%) 6/53 (11%) 16/53 (30%) 1/53 (2%) 0/65 (0%) | |POLY-3 RATE (b) | 4/42.25 6/34.63 6/38.96 16/40.69 1/24.51 0/9.28 | |POLY-3 PERCENT (g) | 9.5% 17.3% 15.4% 39.3% 4.1% 0.0% | |TERMINAL (d) | 2/27 (7%) 0/17 (0%) 3/24 (13%) 5/15 (33%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 672 525 443 541 548 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.202 P=0.181 P=0.295 P<0.001 ** P=0.560 P=1.000N | |POLY 3 | P=0.530N P=0.250 P=0.317 P<0.001 ** P=0.381N P=0.426N | |POLY 1.5 | P=0.093N P=0.275 P=0.336 P<0.001 ** P=0.281N P=0.226N | |POLY 6 | P=0.060 P=0.231 P=0.299 P<0.001 ** P=0.536N P=0.574N | |LOGISTIC REGRESSION| P=0.065N P=0.275 P=0.317 P=0.002 ** P=0.483N P=0.876N | |COCH-ARM / FISHERS | P<0.001N** P=0.346 P=0.371 P=0.003 ** P=0.181N P=0.038N* | |ORDER RESTRICTED | P=0.327N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 21 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 1/51 (2%) 2/53 (4%) 1/53 (2%) 3/53 (6%) 2/65 (3%) | |POLY-3 RATE (b) | 0/41.89 1/32.58 2/37.79 1/37.16 3/25.16 2/10.57 | |POLY-3 PERCENT (g) | 0.0% 3.1% 5.3% 2.7% 11.9% 18.9% | |TERMINAL (d) | 0/27 (0%) 1/17 (6%) 2/24 (8%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 726 (T) 726 (T) 604 523 243 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.408 P=0.212 P=0.468 P=0.011 * P=0.033 * | |POLY 3 | P=0.021 * P=0.450 P=0.214 P=0.476 P=0.054 P=0.092 | |POLY 1.5 | P=0.046 * P=0.464 P=0.223 P=0.484 P=0.077 P=0.133 | |POLY 6 | P=0.013 * P=0.437 P=0.206 P=0.463 P=0.034 * P=0.075 | |LOGISTIC REGRESSION| P=0.022 * P=0.408 P=0.212 P=0.515 P=0.086 P=0.300 | |COCH-ARM / FISHERS | P=0.220 P=0.490 P=0.248 P=0.500 P=0.121 P=0.301 | |ORDER RESTRICTED | P=0.079 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 27/53 (51%) 16/51 (31%) 10/53 (19%) 8/53 (15%) 4/53 (8%) 0/65 (0%) | |POLY-3 RATE (b) | 27/45.63 16/36.90 10/38.79 8/39.71 4/26.06 0/9.28 | |POLY-3 PERCENT (g) | 59.2% 43.4% 25.8% 20.2% 15.4% 0.0% | |TERMINAL (d) | 16/27 (59%) 4/17 (24%) 7/24 (29%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 534 364 608 367 496 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.163N P=0.385N P=0.005N** P=0.015N* P=0.582 P=0.681N | |POLY 3 | P<0.001N** P=0.106N P<0.001N** P<0.001N** P<0.001N** P=0.025N* | |POLY 1.5 | P<0.001N** P=0.076N P<0.001N** P<0.001N** P<0.001N** P<0.001N** | |POLY 6 | P<0.001N** P=0.135N P=0.002N** P<0.001N** P=0.013N* P=0.321N | |LOGISTIC REGRESSION| P<0.001N** P=0.114N P<0.001N** P<0.001N** P<0.001N** P=0.029N* | |COCH-ARM / FISHERS | P<0.001N** P=0.034N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** | |ORDER RESTRICTED | P=0.020N* (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 22 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Cholangiofibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 2/51 (4%) 3/53 (6%) 21/53 (40%) 42/53 (79%) 29/65 (45%) | |POLY-3 RATE (b) | 1/41.89 2/32.58 3/38.59 21/40.03 42/45.21 29/31.95 | |POLY-3 PERCENT (g) | 2.4% 6.1% 7.8% 52.5% 92.9% 90.8% | |TERMINAL (d) | 1/27 (4%) 2/17 (12%) 2/24 (8%) 11/15 (73%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 726 (T) 426 548 267 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.339 P=0.275 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.413 P=0.275 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.437 P=0.286 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.390 P=0.265 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.339 P=0.296 P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.485 P=0.309 P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/53 (9%) 1/51 (2%) 0/53 (0%) 1/53 (2%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 5/42.17 1/32.58 0/37.79 1/36.73 0/23.94 0/9.28 | |POLY-3 PERCENT (g) | 11.9% 3.1% 0.0% 2.7% 0.0% 0.0% | |TERMINAL (d) | 4/27 (15%) 1/17 (6%) 0/24 (0%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 651 726 (T) --- 726 (T) --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.449N P=0.230N P=0.045N* P=0.253N P=0.790N P=1.000N | |POLY 3 | P=0.072N P=0.171N P=0.040N* P=0.135N P=0.117N P=0.379N | |POLY 1.5 | P=0.056N P=0.150N P=0.036N* P=0.122N P=0.066N P=0.169N | |POLY 6 | P=0.080N P=0.196N P=0.044N* P=0.158N P=0.233N P=0.550N | |LOGISTIC REGRESSION| P=0.274N P=0.202N P=0.046N* P=0.187N P=0.377N P=0.931N | |COCH-ARM / FISHERS | P=0.026N* P=0.112N P=0.028N* P=0.103N P=0.028N* P=0.016N* | |ORDER RESTRICTED | P=0.270N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 23 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/53 (19%) 21/51 (41%) 23/53 (43%) 15/53 (28%) 6/53 (11%) 10/65 (15%) | |POLY-3 RATE (b) | 10/43.62 21/39.54 23/45.27 15/43.64 6/28.39 10/18.34 | |POLY-3 PERCENT (g) | 22.9% 53.1% 50.8% 34.4% 21.1% 54.5% | |TERMINAL (d) | 6/27 (22%) 5/17 (29%) 8/24 (33%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 534 347 408 367 267 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002 ** P=0.002 ** P=0.005 ** P=0.070 P=0.118 P<0.001 ** | |POLY 3 | P=0.282N P=0.003 ** P=0.004 ** P=0.168 P=0.543N P=0.033 * | |POLY 1.5 | P=0.057N P=0.004 ** P=0.004 ** P=0.165 P=0.374N P=0.176 | |POLY 6 | P=0.366 P=0.003 ** P=0.005 ** P=0.167 P=0.432 P=0.007 ** | |LOGISTIC REGRESSION| P<0.001N** P=0.006 ** P=0.006 ** P=0.213 P=0.120N P=0.333N | |COCH-ARM / FISHERS | P<0.001N** P=0.011 * P=0.006 ** P=0.180 P=0.208N P=0.398N | |ORDER RESTRICTED | P=0.039 * (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Fatty Change Diffuse | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 14/51 (27%) 27/53 (51%) 45/53 (85%) 49/53 (92%) 56/65 (86%) | |POLY-3 RATE (b) | 3/42.21 14/36.10 27/43.56 45/47.56 49/50.59 56/57.00 | |POLY-3 PERCENT (g) | 7.1% 38.8% 62.0% 94.6% 96.9% 98.3% | |TERMINAL (d) | 2/27 (7%) 6/17 (35%) 14/24 (58%) 15/15 (100%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 639 275 408 390 267 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 24 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Fatty Change Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/53 (19%) 10/51 (20%) 6/53 (11%) 1/53 (2%) 10/53 (19%) 6/65 (9%) | |POLY-3 RATE (b) | 10/43.19 10/35.36 6/38.55 1/36.81 10/28.59 6/13.82 | |POLY-3 PERCENT (g) | 23.2% 28.3% 15.6% 2.7% 35.0% 43.4% | |TERMINAL (d) | 5/27 (19%) 5/17 (29%) 4/24 (17%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 586 498 572 707 383 329 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.239 P=0.312N P=0.037N* P<0.001 ** P<0.001 ** | |POLY 3 | P=0.109 P=0.398 P=0.279N P=0.008N** P=0.207 P=0.199 | |POLY 1.5 | P=0.252 P=0.445 P=0.250N P=0.007N** P=0.365 P=0.522 | |POLY 6 | P=0.049 * P=0.355 P=0.313N P=0.013N* P=0.074 P=0.080 | |LOGISTIC REGRESSION| P=0.106 P=0.416 P=0.279N P=0.011N* P=0.258 P=0.228 | |COCH-ARM / FISHERS | P=0.238N P=0.560 P=0.208N P=0.004N** P=0.598N P=0.106N | |ORDER RESTRICTED | P=0.109 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 27/53 (51%) 27/51 (53%) 30/53 (57%) 32/53 (60%) 22/53 (42%) 11/65 (17%) | |POLY-3 RATE (b) | 27/48.61 27/41.24 30/45.25 32/43.72 22/33.87 11/17.99 | |POLY-3 PERCENT (g) | 55.6% 65.5% 66.3% 73.2% 65.0% 61.1% | |TERMINAL (d) | 11/27 (41%) 9/17 (53%) 14/24 (58%) 13/15 (87%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 364 443 41 267 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.097 P=0.198 P=0.014 * P<0.001 ** P<0.001 ** | |POLY 3 | P=0.355 P=0.224 P=0.189 P=0.050 P=0.257 P=0.456 | |POLY 1.5 | P=0.075N P=0.277 P=0.231 P=0.094 P=0.546 P=0.142N | |POLY 6 | P=0.020 * P=0.197 P=0.160 P=0.019 * P=0.058 P=0.122 | |LOGISTIC REGRESSION| P=0.015N* P=0.436 P=0.335 P=0.182 P=0.444N P=0.014N* | |COCH-ARM / FISHERS | P<0.001N** P=0.497 P=0.349 P=0.217 P=0.218N P<0.001N** | |ORDER RESTRICTED | P=0.399 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 25 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 2/51 (4%) 0/53 (0%) 2/53 (4%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 2/41.89 2/33.21 0/37.79 2/37.47 0/23.94 0/9.28 | |POLY-3 PERCENT (g) | 4.8% 6.0% 0.0% 5.3% 0.0% 0.0% | |TERMINAL (d) | 2/27 (7%) 1/17 (6%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 525 --- 555 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.576N P=0.540 P=0.264N P=0.543 P=1.000N P=1.000N | |POLY 3 | P=0.295N P=0.608 P=0.260N P=0.654 P=0.377N P=0.563N | |POLY 1.5 | P=0.191N P=0.631 P=0.252N P=0.667 P=0.310N P=0.423N | |POLY 6 | P=0.429N P=0.586 P=0.269N P=0.632 P=0.478N P=0.650N | |LOGISTIC REGRESSION| P=0.185N P=0.613 (e) P=0.661 (e) (e) | |COCH-ARM / FISHERS | P=0.066N P=0.676 P=0.248N P=0.691N P=0.248N P=0.200N | |ORDER RESTRICTED | P=0.565N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 10/53 (19%) 45/53 (85%) 50/53 (94%) 61/65 (94%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 10/39.24 45/47.09 50/50.87 61/61.04 | |POLY-3 PERCENT (g) | 0.0% 0.0% 25.5% 95.6% 98.3% 99.9% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 7/24 (29%) 15/15 (100%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 474 480 267 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P<0.001 ** 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 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P<0.001 ** 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 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 26 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 49/53 (92%) 47/51 (92%) 50/53 (94%) 52/53 (98%) 51/53 (96%) 64/65 (98%) | |POLY-3 RATE (b) | 49/51.05 47/49.76 50/51.37 52/53.00 51/51.92 64/64.15 | |POLY-3 PERCENT (g) | 96.0% 94.5% 97.3% 98.1% 98.2% 99.8% | |TERMINAL (d) | 26/27 (96%) 15/17 (88%) 24/24 (100%) 14/15 (93%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 313 70 399 41 166 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.030 * P=0.190 P=0.007 ** P<0.001 ** P<0.001 ** | |POLY 3 | P=0.050 P=0.546N P=0.578 P=0.473 P=0.455 P=0.171 | |POLY 1.5 | P=0.056 P=0.569N P=0.504 P=0.345 P=0.427 P=0.137 | |POLY 6 | P=0.053 P=0.516N P=0.649 P=0.619 P=0.466 P=0.265 | |LOGISTIC REGRESSION| P=0.020 * P=0.583 P=0.351 P=0.133 P=0.176 P=0.054 | |COCH-ARM / FISHERS | P=0.061 P=0.620N P=0.500 P=0.181 P=0.339 P=0.125 | |ORDER RESTRICTED | P=0.056 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 0/53 (0%) 4/53 (8%) 4/65 (6%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 0/36.73 4/26.18 4/11.99 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 15.3% 33.4% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 447 338 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.016 * P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.021 * P=0.009 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.034 * P=0.018 * | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.011 * P=0.006 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.096 P=0.014 * | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.059 P=0.088 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 27 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 38/53 (72%) 28/51 (55%) 32/53 (60%) 16/53 (30%) 2/53 (4%) 3/65 (5%) | |POLY-3 RATE (b) | 38/45.68 28/38.34 32/44.02 16/38.41 2/24.80 3/11.13 | |POLY-3 PERCENT (g) | 83.2% 73.0% 72.7% 41.7% 8.1% 27.0% | |TERMINAL (d) | 26/27 (96%) 15/17 (88%) 20/24 (83%) 10/15 (67%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 534 443 408 534 482 429 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.368N P=0.319 P=0.452N P=0.035N* P=0.388N P=0.005 ** | |POLY 3 | P<0.001N** P=0.161N P=0.140N P<0.001N** P<0.001N** P<0.001N** | |POLY 1.5 | P<0.001N** P=0.127N P=0.146N P<0.001N** P<0.001N** P<0.001N** | |POLY 6 | P<0.001N** P=0.181N P=0.135N P<0.001N** P<0.001N** P=0.254N | |LOGISTIC REGRESSION| P<0.001N** P=0.419N P=0.346N P<0.001N** P<0.001N** P=0.587N | |COCH-ARM / FISHERS | P<0.001N** P=0.057N P=0.153N P<0.001N** P<0.001N** P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 13/51 (25%) 6/53 (11%) 26/53 (49%) 17/53 (32%) 27/65 (42%) | |POLY-3 RATE (b) | 3/42.94 13/38.42 6/40.55 26/46.15 17/33.43 27/31.21 | |POLY-3 PERCENT (g) | 7.0% 33.8% 14.8% 56.3% 50.9% 86.5% | |TERMINAL (d) | 0/27 (0%) 1/17 (6%) 0/24 (0%) 4/15 (27%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 564 347 408 78 313 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.002 ** P=0.192 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.002 ** P=0.212 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.002 ** P=0.223 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.002 ** P=0.204 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P=0.003 ** P=0.010 * P=0.291 P<0.001 ** P=0.003 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.005 ** P=0.244 P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 28 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/53 (9%) 18/51 (35%) 38/53 (72%) 52/53 (98%) 53/53 (100%) 60/65 (92%) | |POLY-3 RATE (b) | 5/43.23 18/37.02 38/46.33 52/52.00 53/53.00 60/60.56 | |POLY-3 PERCENT (g) | 11.6% 48.6% 82.0% 100.0% 100.0% 99.1% | |TERMINAL (d) | 2/27 (7%) 8/17 (47%) 20/24 (83%) 15/15 (100%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 534 328 408 78 166 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Toxic Hepatopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 8/51 (16%) 32/53 (60%) 51/53 (96%) 52/53 (98%) 64/65 (98%) | |POLY-3 RATE (b) | 0/41.89 8/34.02 32/44.65 51/51.00 52/52.01 64/64.00 | |POLY-3 PERCENT (g) | 0.0% 23.5% 71.7% 100.0% 100.0% 100.0% | |TERMINAL (d) | 0/27 (0%) 4/17 (24%) 18/24 (75%) 15/15 (100%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 484 408 261 267 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 29 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver: Bile Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 3/51 (6%) 3/53 (6%) 14/53 (26%) 25/53 (47%) 14/65 (22%) | |POLY-3 RATE (b) | 4/42.10 3/33.78 3/37.79 14/37.69 25/34.09 14/19.17 | |POLY-3 PERCENT (g) | 9.5% 8.9% 7.9% 37.1% 73.4% 73.0% | |TERMINAL (d) | 3/27 (11%) 0/17 (0%) 3/24 (13%) 8/15 (53%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 672 525 726 (T) 636 447 289 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.600 P=0.571N P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.619N P=0.559N P=0.002 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.590N P=0.537N P=0.004 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.643N P=0.583N P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.608N P=0.581N P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.522N P=0.500N P=0.009 ** P<0.001 ** P=0.030 * | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver: Bile Duct | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/53 (11%) 2/51 (4%) 3/53 (6%) 10/53 (19%) 3/53 (6%) 4/65 (6%) | |POLY-3 RATE (b) | 6/42.12 2/32.58 3/38.68 10/39.53 3/25.25 4/12.37 | |POLY-3 PERCENT (g) | 14.2% 6.1% 7.8% 25.3% 11.9% 32.3% | |TERMINAL (d) | 5/27 (19%) 2/17 (12%) 1/24 (4%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 665 726 (T) 586 537 482 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.322N P=0.320N P=0.063 P=0.050 P=0.004 ** | |POLY 3 | P=0.132 P=0.230N P=0.284N P=0.161 P=0.535N P=0.229 | |POLY 1.5 | P=0.334 P=0.200N P=0.269N P=0.172 P=0.396N P=0.489 | |POLY 6 | P=0.030 * P=0.264N P=0.295N P=0.147 P=0.544 P=0.115 | |LOGISTIC REGRESSION| P=0.172 P=0.285N P=0.299N P=0.148 P=0.576 P=0.362 | |COCH-ARM / FISHERS | P=0.251N P=0.148N P=0.244N P=0.208 P=0.244N P=0.251N | |ORDER RESTRICTED | P=0.141 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 30 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/53 (9%) 5/51 (10%) 7/53 (13%) 46/53 (87%) 52/53 (98%) 60/65 (92%) | |POLY-3 RATE (b) | 5/42.04 5/32.90 7/38.20 46/48.29 52/52.01 60/60.13 | |POLY-3 PERCENT (g) | 11.9% 15.2% 18.3% 95.3% 100.0% 99.8% | |TERMINAL (d) | 4/27 (15%) 4/17 (24%) 6/24 (25%) 14/15 (93%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 687 639 608 367 267 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.339 P=0.290 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.470 P=0.310 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.514 P=0.336 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.427 P=0.287 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.387 P=0.273 P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.605 P=0.380 P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver: Centrilobular | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 3/51 (6%) 8/53 (15%) 8/53 (15%) 3/53 (6%) 8/65 (12%) | |POLY-3 RATE (b) | 2/42.71 3/34.67 8/41.87 8/39.66 3/26.01 8/16.92 | |POLY-3 PERCENT (g) | 4.7% 8.7% 19.1% 20.2% 11.5% 47.3% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 564 436 399 367 313 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.384 P=0.040 * P=0.030 * P=0.243 P=0.006 ** | |POLY 3 | P=0.017 * P=0.406 P=0.040 * P=0.032 * P=0.291 P<0.001 ** | |POLY 1.5 | P=0.063 P=0.429 P=0.042 * P=0.036 * P=0.381 P=0.006 ** | |POLY 6 | P=0.002 ** P=0.383 P=0.040 * P=0.027 * P=0.187 P<0.001 ** | |LOGISTIC REGRESSION| P=0.171N P=0.623 P=0.072 P=0.056 P=0.652N P=0.493N | |COCH-ARM / FISHERS | P=0.340 P=0.482 P=0.046 * P=0.046 * P=0.500 P=0.091 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 31 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver: Centrilobular | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 7/53 (13%) 36/53 (68%) 52/53 (98%) 57/65 (88%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 7/40.39 36/46.63 52/52.01 57/59.02 | |POLY-3 PERCENT (g) | 0.0% 0.0% 17.3% 77.2% 100.0% 96.6% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 3/24 (13%) 8/15 (53%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 408 367 267 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.008 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.006 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.007 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.006 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.012 * P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.006 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Glandular Structures | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 1/53 (2%) 5/53 (9%) 25/65 (38%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 1/37.09 5/26.22 25/31.26 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.7% 19.1% 80.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 628 450 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.462 P=0.002 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.476 P=0.008 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.484 P=0.014 * P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.462 P=0.003 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.504 P=0.027 * P=0.007 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.500 P=0.028 * P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 32 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 16/51 (31%) 22/53 (42%) 47/53 (89%) 52/53 (98%) 65/65 (100%) | |POLY-3 RATE (b) | 0/41.89 16/37.84 22/43.78 47/48.93 52/52.01 65/65.00 | |POLY-3 PERCENT (g) | 0.0% 42.3% 50.3% 96.1% 100.0% 100.0% | |TERMINAL (d) | 0/27 (0%) 4/17 (24%) 9/24 (38%) 14/15 (93%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 400 443 367 267 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Multinucleated | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 9/51 (18%) 21/53 (40%) 48/53 (91%) 52/53 (98%) 48/65 (74%) | |POLY-3 RATE (b) | 0/41.89 9/33.70 21/42.85 48/50.29 52/52.80 48/50.32 | |POLY-3 PERCENT (g) | 0.0% 26.7% 49.0% 95.4% 98.5% 95.4% | |TERMINAL (d) | 0/27 (0%) 6/17 (35%) 10/24 (42%) 14/15 (93%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 484 408 261 166 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 33 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver: Oval Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 4/51 (8%) 23/53 (43%) 49/53 (92%) 52/53 (98%) 62/65 (95%) | |POLY-3 RATE (b) | 4/41.89 4/33.76 23/41.82 49/49.34 52/52.01 62/62.03 | |POLY-3 PERCENT (g) | 9.6% 11.9% 55.0% 99.3% 100.0% 100.0% | |TERMINAL (d) | 4/27 (15%) 2/17 (12%) 14/24 (58%) 15/15 (100%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 374 455 367 267 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.412 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.521 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.552 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.491 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.525 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.620 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver: Portal | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 2/53 (4%) 37/53 (70%) 52/53 (98%) 58/65 (89%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 2/38.51 37/45.40 52/52.01 58/58.27 | |POLY-3 PERCENT (g) | 0.0% 0.0% 5.2% 81.5% 100.0% 99.5% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 1/24 (4%) 10/15 (67%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 474 480 267 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.216 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.218 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.225 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.212 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.253 P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.248 P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 34 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver: Serosa | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/51 (4%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 0/41.89 2/33.29 0/37.79 0/36.73 0/23.94 0/9.28 | |POLY-3 PERCENT (g) | 0.0% 6.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 525 --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.499N P=0.169 (e) (e) (e) (e) | |POLY 3 | P=0.365N P=0.189 (e) (e) (e) (e) | |POLY 1.5 | P=0.329N P=0.201 (e) (e) (e) (e) | |POLY 6 | P=0.361N P=0.179 (e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.238N P=0.228 (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.208N P=0.238 (e) (e) (e) (e) | |ORDER RESTRICTED | P=0.607N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lung | | Congestion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 2/53 (4%) 0/53 (0%) 0/66 (0%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 2/38.58 0/23.94 0/9.33 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.2% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 41 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.516N (e) (e) P=0.238 (e) (e) | |POLY 3 | P=0.439 (e) (e) P=0.219 (e) (e) | |POLY 1.5 | P=0.641 (e) (e) P=0.227 (e) (e) | |POLY 6 | P=0.177 (e) (e) P=0.205 (e) (e) | |LOGISTIC REGRESSION| P=0.164N (e) (e) P=0.558 (e) (e) | |COCH-ARM / FISHERS | P=0.438N (e) (e) P=0.248 (e) (e) | |ORDER RESTRICTED | P=0.594 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 35 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 1/53 (2%) 2/53 (4%) 4/66 (6%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 1/37.73 2/25.26 4/12.86 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.7% 7.9% 31.1% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 41 397 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.500 P=0.142 P=0.016 * | |POLY 3 | P<0.001 ** (e) (e) P=0.479 P=0.146 P=0.009 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.488 P=0.182 P=0.019 * | |POLY 6 | P<0.001 ** (e) (e) P=0.465 P=0.109 P=0.006 ** | |LOGISTIC REGRESSION| P=0.129 (e) (e) (e) P=0.371 P=0.397 | |COCH-ARM / FISHERS | P=0.003 ** (e) (e) P=0.500 P=0.248 P=0.091 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 40/53 (75%) 33/51 (65%) 46/53 (87%) 48/53 (91%) 46/53 (87%) 33/66 (50%) | |POLY-3 RATE (b) | 40/49.03 33/40.13 46/48.47 48/49.70 46/48.95 33/37.16 | |POLY-3 PERCENT (g) | 81.6% 82.2% 94.9% 96.6% 94.0% 88.8% | |TERMINAL (d) | 21/27 (78%) 15/17 (88%) 24/24 (100%) 15/15 (100%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 362 374 408 261 267 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.174 P=0.060 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P=0.134 P=0.584 P=0.027 * P=0.011 * P=0.040 * P=0.245 | |POLY 1.5 | P=0.450N P=0.469N P=0.042 * P=0.011 * P=0.062 P=0.456N | |POLY 6 | P=0.019 * P=0.426 P=0.019 * P=0.009 ** P=0.019 * P=0.064 | |LOGISTIC REGRESSION| P=0.090 P=0.542N P=0.037 * P=0.008 ** P=0.035 * P=0.519 | |COCH-ARM / FISHERS | P<0.001N** P=0.162N P=0.107 P=0.034 * P=0.107 P=0.004N** | |ORDER RESTRICTED | P=0.019 * (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 36 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lung | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/53 (9%) 9/51 (18%) 7/53 (13%) 3/53 (6%) 2/53 (4%) 2/66 (3%) | |POLY-3 RATE (b) | 5/43.02 9/35.07 7/38.67 3/38.32 2/25.16 2/11.03 | |POLY-3 PERCENT (g) | 11.6% 25.7% 18.1% 7.8% 8.0% 18.1% | |TERMINAL (d) | 3/27 (11%) 3/17 (18%) 5/24 (21%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 534 70 523 539 504 243 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.215 P=0.062 P=0.297 P=0.512N P=0.502 P=0.162 | |POLY 3 | P=0.164N P=0.093 P=0.304 P=0.421N P=0.474N P=0.481 | |POLY 1.5 | P=0.076N P=0.116 P=0.332 P=0.399N P=0.350N P=0.545N | |POLY 6 | P=0.269N P=0.077 P=0.277 P=0.456N P=0.646 P=0.315 | |LOGISTIC REGRESSION| P=0.021N* P=0.163 P=0.327 P=0.335N P=0.275N P=0.471N | |COCH-ARM / FISHERS | P=0.005N** P=0.174 P=0.380 P=0.358N P=0.219N P=0.140N | |ORDER RESTRICTED | P=0.579N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lung | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 1/51 (2%) 2/53 (4%) 14/53 (26%) 16/53 (30%) 7/66 (11%) | |POLY-3 RATE (b) | 0/41.89 1/32.58 2/38.20 14/37.93 16/31.82 7/14.88 | |POLY-3 PERCENT (g) | 0.0% 3.1% 5.2% 36.9% 50.3% 47.1% | |TERMINAL (d) | 0/27 (0%) 1/17 (6%) 1/24 (4%) 10/15 (67%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 726 (T) 608 567 313 289 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.408 P=0.207 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.450 P=0.217 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.464 P=0.224 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.437 P=0.210 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.408 P=0.224 P<0.001 ** P<0.001 ** P=0.019 * | |COCH-ARM / FISHERS | P=0.007 ** P=0.490 P=0.248 P<0.001 ** P<0.001 ** P=0.014 * | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 37 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 18/53 (34%) 10/51 (20%) 2/53 (4%) 1/53 (2%) 1/53 (2%) 4/66 (6%) | |POLY-3 RATE (b) | 18/43.48 10/33.86 2/37.79 1/36.73 1/24.56 4/12.41 | |POLY-3 PERCENT (g) | 41.4% 29.5% 5.3% 2.7% 4.1% 32.2% | |TERMINAL (d) | 13/27 (48%) 7/17 (41%) 2/24 (8%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 534 443 726 (T) 726 (T) 525 303 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.037 * P=0.394N P<0.001N** P<0.001N** P=0.487N P=0.002 ** | |POLY 3 | P=0.003N** P=0.197N P<0.001N** P<0.001N** P<0.001N** P=0.426N | |POLY 1.5 | P=0.002N** P=0.147N P<0.001N** P<0.001N** P<0.001N** P=0.064N | |POLY 6 | P=0.003N** P=0.265N P<0.001N** P<0.001N** P=0.021N* P=0.408 | |LOGISTIC REGRESSION| P=0.204N P=0.244N P<0.001N** P<0.001N** P=0.012N* P=0.586 | |COCH-ARM / FISHERS | P<0.001N** P=0.076N P<0.001N** P<0.001N** P<0.001N** P<0.001N** | |ORDER RESTRICTED | P=0.033N* (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Metaplasia Bronchiolar | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 14/51 (27%) 39/53 (74%) 46/53 (87%) 35/53 (66%) 8/66 (12%) | |POLY-3 RATE (b) | 1/41.89 14/35.34 39/46.42 46/47.90 35/41.87 8/16.09 | |POLY-3 PERCENT (g) | 2.4% 39.6% 84.0% 96.0% 83.6% 49.7% | |TERMINAL (d) | 1/27 (4%) 7/17 (41%) 21/24 (88%) 15/15 (100%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 498 408 367 267 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P=0.002 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P=0.030 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P=0.066 | |COCH-ARM / FISHERS | P=0.011N* P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P=0.035 * | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 38 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lung: Serosa | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 0/51 (0%) 0/53 (0%) 1/53 (2%) 16/53 (30%) 8/66 (12%) | |POLY-3 RATE (b) | 3/42.18 0/32.58 0/37.79 1/36.96 16/32.54 8/15.93 | |POLY-3 PERCENT (g) | 7.1% 0.0% 0.0% 2.7% 49.2% 50.2% | |TERMINAL (d) | 2/27 (7%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 649 --- --- 667 349 294 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.208N P=0.148N P=0.460N P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.171N P=0.139N P=0.353N P<0.001 ** P=0.003 ** | |POLY 1.5 | P<0.001 ** P=0.155N P=0.131N P=0.336N P<0.001 ** P=0.014 * | |POLY 6 | P<0.001 ** P=0.189N P=0.147N P=0.382N P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.180N P=0.144N P=0.370N P<0.001 ** P=0.084 | |COCH-ARM / FISHERS | P<0.001 ** P=0.129N P=0.121N P=0.309N P<0.001 ** P=0.188 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 2/51 (4%) 3/53 (6%) 4/52 (8%) 4/52 (8%) 1/66 (2%) | |POLY-3 RATE (b) | 3/42.29 2/33.39 3/37.79 4/36.92 4/25.87 1/10.25 | |POLY-3 PERCENT (g) | 7.1% 6.0% 7.9% 10.8% 15.5% 9.8% | |TERMINAL (d) | 1/27 (4%) 0/17 (0%) 3/24 (13%) 2/15 (13%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 639 567 726 (T) 602 383 313 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.666N P=0.597 P=0.290 P=0.029 * P=0.427 | |POLY 3 | P=0.145 P=0.606N P=0.610 P=0.426 P=0.254 P=0.594 | |POLY 1.5 | P=0.364 P=0.579N P=0.630 P=0.448 P=0.355 P=0.565N | |POLY 6 | P=0.048 * P=0.631N P=0.588 P=0.390 P=0.146 P=0.452 | |LOGISTIC REGRESSION| P=0.325 P=0.575N P=0.596 P=0.410 P=0.395 P=0.723N | |COCH-ARM / FISHERS | P=0.221N P=0.518N P=0.661N P=0.489 P=0.489 P=0.232N | |ORDER RESTRICTED | P=0.589 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 39 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 1/53 (2%) 0/52 (0%) 2/52 (4%) 7/66 (11%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 1/37.79 0/36.34 2/25.70 7/15.76 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.7% 0.0% 7.8% 44.4% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 1/24 (4%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 726 (T) --- 313 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.477 (e) P=0.231 P=0.004 ** | |POLY 3 | P<0.001 ** (e) P=0.479 (e) P=0.148 P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.487 (e) P=0.183 P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.472 (e) P=0.109 P<0.001 ** | |LOGISTIC REGRESSION| P=0.027 * (e) P=0.477 (e) P=0.377 P=0.363 | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 (e) P=0.243 P=0.014 * | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 45/53 (85%) 35/51 (69%) 34/53 (64%) 27/52 (52%) 22/52 (42%) 20/66 (30%) | |POLY-3 RATE (b) | 45/51.67 35/41.98 34/46.81 27/43.88 22/36.54 20/26.79 | |POLY-3 PERCENT (g) | 87.1% 83.4% 72.6% 61.5% 60.2% 74.7% | |TERMINAL (d) | 24/27 (89%) 15/17 (88%) 17/24 (71%) 7/15 (47%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 70 408 261 337 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.288 P=0.226N P=0.265N P=0.006 ** P<0.001 ** | |POLY 3 | P=0.010N* P=0.409N P=0.049N* P=0.002N** P<0.001N** P=0.122N | |POLY 1.5 | P<0.001N** P=0.227N P=0.032N* P<0.001N** P<0.001N** P<0.001N** | |POLY 6 | P=0.158N P=0.579N P=0.073N P=0.004N** P=0.026N* P=0.546 | |LOGISTIC REGRESSION| P<0.001N** P=0.114N P=0.016N* P<0.001N** P<0.001N** P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.041N* P=0.012N* P<0.001N** P<0.001N** P<0.001N** | |ORDER RESTRICTED | P=0.019N* (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 40 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 1/51 (2%) 3/53 (6%) 0/52 (0%) 2/52 (4%) 1/66 (2%) | |POLY-3 RATE (b) | 0/41.89 1/32.58 3/38.56 0/36.34 2/24.19 1/10.31 | |POLY-3 PERCENT (g) | 0.0% 3.1% 7.8% 0.0% 8.3% 9.7% | |TERMINAL (d) | 0/27 (0%) 1/17 (6%) 2/24 (8%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 726 (T) 443 --- 674 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.007 ** P=0.408 P=0.108 (e) P=0.002 ** P=0.538 | |POLY 3 | P=0.195 P=0.450 P=0.104 (e) P=0.140 P=0.308 | |POLY 1.5 | P=0.290 P=0.464 P=0.109 (e) P=0.177 P=0.380 | |POLY 6 | P=0.150 P=0.437 P=0.099 (e) P=0.102 P=0.268 | |LOGISTIC REGRESSION| P=0.360 P=0.408 P=0.122 (e) P=0.016 * (e) | |COCH-ARM / FISHERS | P=0.576 P=0.490 P=0.121 (e) P=0.243 P=0.555 | |ORDER RESTRICTED | P=0.320 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 1/51 (2%) 0/53 (0%) 2/53 (4%) 1/52 (2%) 2/65 (3%) | |POLY-3 RATE (b) | 1/41.89 1/32.58 0/37.79 2/37.58 1/24.16 2/11.14 | |POLY-3 PERCENT (g) | 2.4% 3.1% 0.0% 5.3% 4.1% 18.0% | |TERMINAL (d) | 1/27 (4%) 1/17 (6%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 726 (T) --- 567 530 245 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.003 ** P=0.656 P=0.523N P=0.400 P=0.402 P=0.183 | |POLY 3 | P=0.138 P=0.702 P=0.521N P=0.462 P=0.626 P=0.193 | |POLY 1.5 | P=0.175 P=0.719 P=0.513N P=0.475 P=0.688 P=0.298 | |POLY 6 | P=0.105 P=0.685 P=0.528N P=0.442 P=0.533 P=0.142 | |LOGISTIC REGRESSION| P=0.352 P=0.656 (e) P=0.493 P=0.726 P=0.813 | |COCH-ARM / FISHERS | P=0.330 P=0.743 P=0.500N P=0.500 P=0.748 P=0.577 | |ORDER RESTRICTED | P=0.078 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 41 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/51 (4%) 2/53 (4%) 2/53 (4%) 4/52 (8%) 14/65 (22%) | |POLY-3 RATE (b) | 0/41.89 2/32.67 2/38.31 2/37.59 4/26.33 14/22.13 | |POLY-3 PERCENT (g) | 0.0% 6.1% 5.2% 5.3% 15.2% 63.3% | |TERMINAL (d) | 0/27 (0%) 1/17 (6%) 1/24 (4%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 705 567 537 313 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.149 P=0.214 P=0.220 P=0.022 * P<0.001 ** | |POLY 3 | P<0.001 ** P=0.186 P=0.217 P=0.213 P=0.021 * P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.199 P=0.224 P=0.221 P=0.034 * P<0.001 ** | |POLY 6 | P<0.001 ** P=0.174 P=0.211 P=0.201 P=0.011 * P<0.001 ** | |LOGISTIC REGRESSION| P=0.004 ** P=0.157 P=0.233 P=0.254 P=0.188 P=0.136 | |COCH-ARM / FISHERS | P<0.001 ** P=0.238 P=0.248 P=0.248 P=0.057 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 0/51 (0%) 1/53 (2%) 6/53 (11%) 5/52 (10%) 0/65 (0%) | |POLY-3 RATE (b) | 3/42.49 0/32.58 1/38.20 6/38.25 5/26.76 0/9.28 | |POLY-3 PERCENT (g) | 7.1% 0.0% 2.6% 15.7% 18.7% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 639 --- 608 565 337 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002 ** P=0.201N P=0.371N P=0.137 P=0.048 * P=1.000N | |POLY 3 | P=0.016 * P=0.173N P=0.344N P=0.190 P=0.147 P=0.486N | |POLY 1.5 | P=0.137 P=0.156N P=0.329N P=0.207 P=0.223 P=0.307N | |POLY 6 | P<0.001 ** P=0.192N P=0.359N P=0.166 P=0.076 P=0.606N | |LOGISTIC REGRESSION| P=0.464 P=0.156N P=0.315N P=0.209 P=0.458 P=0.661N | |COCH-ARM / FISHERS | P=0.332N P=0.129N P=0.309N P=0.244 P=0.347 P=0.088N | |ORDER RESTRICTED | P=0.451 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 42 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/28 (25%) 7/16 (44%) 7/16 (44%) 7/25 (28%) 7/20 (35%) 27/45 (60%) | |POLY-3 RATE (b) | 7/23.39 7/13.62 7/13.19 7/18.37 7/13.66 27/29.76 | |POLY-3 PERCENT (g) | 29.9% 51.4% 53.1% 38.1% 51.3% 90.7% | |TERMINAL (d) | 2/12 (17%) 1/4 (25%) 3/7 (43%) 0/5 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 275 443 534 313 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.279 P=0.402 P=0.369 P=0.021 * P<0.001 ** | |POLY 3 | P<0.001 ** P=0.166 P=0.147 P=0.411 P=0.172 P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.169 P=0.145 P=0.460 P=0.238 P<0.001 ** | |POLY 6 | P<0.001 ** P=0.164 P=0.153 P=0.347 P=0.101 P<0.001 ** | |LOGISTIC REGRESSION| P=0.104 P=0.215 P=0.181 P=0.532 P=0.468 P=0.140 | |COCH-ARM / FISHERS | P=0.004 ** P=0.171 P=0.171 P=0.525 P=0.332 P=0.003 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/28 (7%) 2/16 (13%) 4/16 (25%) 15/25 (60%) 7/20 (35%) 25/45 (56%) | |POLY-3 RATE (b) | 2/21.96 2/10.73 4/11.85 15/21.55 7/14.28 25/28.50 | |POLY-3 PERCENT (g) | 9.1% 18.6% 33.8% 69.6% 49.0% 87.7% | |TERMINAL (d) | 0/12 (0%) 1/4 (25%) 2/7 (29%) 2/5 (40%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 586 651 567 261 313 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.497 P=0.215 P<0.001 ** P=0.008 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.419 P=0.090 P<0.001 ** P=0.006 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.445 P=0.095 P<0.001 ** P=0.010 * P<0.001 ** | |POLY 6 | P<0.001 ** P=0.385 P=0.087 P<0.001 ** P=0.002 ** P<0.001 ** | |LOGISTIC REGRESSION| P=0.017 * P=0.450 P=0.103 P<0.001 ** P=0.060 P=0.042 * | |COCH-ARM / FISHERS | P<0.001 ** P=0.463 P=0.116 P<0.001 ** P=0.020 * P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 43 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 3/16 (19%) 0/16 (0%) 3/25 (12%) 2/20 (10%) 2/45 (4%) | |POLY-3 RATE (b) | 0/21.26 3/11.72 0/10.91 3/17.31 2/10.58 2/7.29 | |POLY-3 PERCENT (g) | 0.0% 25.6% 0.0% 17.3% 18.9% 27.4% | |TERMINAL (d) | 0/12 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 525 --- 570 555 611 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.075 (e) P=0.101 P=0.064 P<0.001 ** | |POLY 3 | P=0.102 P=0.028 * (e) P=0.077 P=0.105 P=0.108 | |POLY 1.5 | P=0.232 P=0.030 * (e) P=0.085 P=0.128 P=0.165 | |POLY 6 | P=0.046 * P=0.027 * (e) P=0.065 P=0.080 P=0.083 | |LOGISTIC REGRESSION| P=0.165 P=0.044 * (e) P=0.102 P=0.150 P=0.004 ** | |COCH-ARM / FISHERS | P=0.451N P=0.042 * (e) P=0.098 P=0.168 P=0.377 | |ORDER RESTRICTED | P=0.086 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 0/16 (0%) 2/16 (13%) 0/25 (0%) 0/20 (0%) 0/45 (0%) | |POLY-3 RATE (b) | 0/21.26 0/10.45 2/11.58 0/16.09 0/9.74 0/6.56 | |POLY-3 PERCENT (g) | 0.0% 0.0% 17.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/4 (0%) 1/7 (14%) 0/5 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 504 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.629N (e) P=0.171 (e) (e) (e) | |POLY 3 | P=0.452N (e) P=0.108 (e) (e) (e) | |POLY 1.5 | P=0.349N (e) P=0.110 (e) (e) (e) | |POLY 6 | P=0.545N (e) P=0.106 (e) (e) (e) | |LOGISTIC REGRESSION| P=0.273N (e) P=0.124 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.188N (e) P=0.127 (e) (e) (e) | |ORDER RESTRICTED | P=0.551N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 44 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 0/16 (0%) 0/16 (0%) 0/25 (0%) 0/20 (0%) 2/45 (4%) | |POLY-3 RATE (b) | 0/21.26 0/10.45 0/10.91 0/16.09 0/9.74 2/8.07 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 24.8% | |TERMINAL (d) | 0/12 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 289 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.036 * | |POLY 3 | P=0.120 (e) (e) (e) (e) P=0.114 | |POLY 1.5 | P=0.068 (e) (e) (e) (e) P=0.171 | |POLY 6 | P=0.169 (e) (e) (e) (e) P=0.087 | |LOGISTIC REGRESSION| P=0.102 (e) (e) (e) (e) P=0.394 | |COCH-ARM / FISHERS | P=0.053 (e) (e) (e) (e) P=0.377 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lymph Node: Pancreatic | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 0/16 (0%) 0/16 (0%) 0/25 (0%) 1/20 (5%) 4/45 (9%) | |POLY-3 RATE (b) | 0/21.26 0/10.45 0/10.91 0/16.09 1/10.50 4/10.12 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 9.5% 39.5% | |TERMINAL (d) | 0/12 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 450 243 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.470 P=0.020 * | |POLY 3 | P=0.003 ** (e) (e) (e) P=0.365 P=0.013 * | |POLY 1.5 | P=0.002 ** (e) (e) (e) P=0.396 P=0.031 * | |POLY 6 | P=0.002 ** (e) (e) (e) P=0.323 P=0.007 ** | |LOGISTIC REGRESSION| P=0.095 (e) (e) (e) P=0.515 P=0.412 | |COCH-ARM / FISHERS | P=0.007 ** (e) (e) (e) P=0.417 P=0.137 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 45 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lymph Node: Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 0/16 (0%) 0/16 (0%) 1/25 (4%) 4/20 (20%) 3/45 (7%) | |POLY-3 RATE (b) | 0/21.26 0/10.45 0/10.91 1/16.37 4/11.19 3/8.86 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.1% 35.7% 33.9% | |TERMINAL (d) | 0/12 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 651 450 342 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.476 P<0.001 ** P=0.004 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.448 P=0.007 ** P=0.038 * | |POLY 1.5 | P<0.001 ** (e) (e) P=0.463 P=0.011 * P=0.070 | |POLY 6 | P<0.001 ** (e) (e) P=0.423 P=0.003 ** P=0.025 * | |LOGISTIC REGRESSION| P=0.002 ** (e) (e) P=0.462 P=0.016 * P=0.158 | |COCH-ARM / FISHERS | P=0.040 * (e) (e) P=0.472 P=0.025 * P=0.228 | |ORDER RESTRICTED | P=0.005 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lymph Node: Pancreatic | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 0/16 (0%) 0/16 (0%) 2/25 (8%) 0/20 (0%) 1/45 (2%) | |POLY-3 RATE (b) | 0/21.26 0/10.45 0/10.91 2/16.57 0/9.74 1/7.49 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 12.1% 0.0% 13.4% | |TERMINAL (d) | 0/12 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 662 --- 289 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.046 * (e) (e) P=0.179 (e) P=0.457 | |POLY 3 | P=0.283 (e) (e) P=0.180 (e) P=0.342 | |POLY 1.5 | P=0.365 (e) (e) P=0.194 (e) P=0.427 | |POLY 6 | P=0.170 (e) (e) P=0.158 (e) P=0.291 | |LOGISTIC REGRESSION| P=0.505 (e) (e) P=0.179 (e) P=0.934 | |COCH-ARM / FISHERS | P=0.536 (e) (e) P=0.218 (e) P=0.616 | |ORDER RESTRICTED | P=0.143 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 46 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lymph Node: Renal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 0/16 (0%) 0/16 (0%) 0/25 (0%) 2/20 (10%) 2/45 (4%) | |POLY-3 RATE (b) | 0/21.26 0/10.45 0/10.91 0/16.09 2/10.45 2/7.54 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 19.1% 26.5% | |TERMINAL (d) | 0/12 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 623 545 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.064 P<0.001 ** | |POLY 3 | P=0.005 ** (e) (e) (e) P=0.103 P=0.110 | |POLY 1.5 | P=0.009 ** (e) (e) (e) P=0.127 P=0.166 | |POLY 6 | P=0.004 ** (e) (e) (e) P=0.078 P=0.085 | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.115 P=0.028 * | |COCH-ARM / FISHERS | P=0.057 (e) (e) (e) P=0.168 P=0.377 | |ORDER RESTRICTED | P=0.010 * (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Mammary Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 2/51 (4%) 2/53 (4%) 2/53 (4%) 0/53 (0%) 0/66 (0%) | |POLY-3 RATE (b) | 1/42.21 2/33.25 2/38.83 2/36.89 0/23.94 0/9.33 | |POLY-3 PERCENT (g) | 2.4% 6.0% 5.2% 5.4% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 639 541 523 686 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.473N P=0.376 P=0.440 P=0.368 P=0.713N P=1.000N | |POLY 3 | P=0.320N P=0.418 P=0.471 P=0.453 P=0.605N P=0.697N | |POLY 1.5 | P=0.189N P=0.439 P=0.481 P=0.470 P=0.559N P=0.626N | |POLY 6 | P=0.505N P=0.397 P=0.462 P=0.426 P=0.664N P=0.735N | |LOGISTIC REGRESSION| P=0.103N P=0.479 P=0.537 P=0.449 P=0.593N P=0.905N | |COCH-ARM / FISHERS | P=0.052N P=0.485 P=0.500 P=0.500 P=0.500N P=0.445N | |ORDER RESTRICTED | P=0.621N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 47 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 26/53 (49%) 17/51 (33%) 13/53 (25%) 6/53 (11%) 6/53 (11%) 0/66 (0%) | |POLY-3 RATE (b) | 26/46.93 17/39.21 13/40.87 6/37.78 6/25.83 0/9.33 | |POLY-3 PERCENT (g) | 55.4% 43.4% 31.8% 15.9% 23.2% 0.0% | |TERMINAL (d) | 14/27 (52%) 5/17 (29%) 5/24 (21%) 2/15 (13%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 313 328 455 604 474 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.201N P=0.480N P=0.048N* P=0.005N** P=0.288 P=0.399N | |POLY 3 | P<0.001N** P=0.179N P=0.018N* P<0.001N** P=0.008N** P=0.038N* | |POLY 1.5 | P<0.001N** P=0.144N P=0.012N* P<0.001N** P<0.001N** P<0.001N** | |POLY 6 | P=0.005N** P=0.216N P=0.027N* P<0.001N** P=0.127N P=0.344N | |LOGISTIC REGRESSION| P<0.001N** P=0.100N P=0.011N* P<0.001N** P=0.004N** P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.076N P=0.008N** P<0.001N** P<0.001N** P<0.001N** | |ORDER RESTRICTED | P=0.033N* (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Mammary Gland | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 2/51 (4%) 1/53 (2%) 0/53 (0%) 0/53 (0%) 0/66 (0%) | |POLY-3 RATE (b) | 3/42.81 2/33.79 1/38.31 0/36.73 0/23.94 0/9.33 | |POLY-3 PERCENT (g) | 7.0% 5.9% 2.6% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 555 525 567 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.146N P=0.650N P=0.363N P=0.182N P=0.422N P=0.958N | |POLY 3 | P=0.078N P=0.606N P=0.346N P=0.148N P=0.256N P=0.486N | |POLY 1.5 | P=0.066N P=0.579N P=0.330N P=0.137N P=0.185N P=0.306N | |POLY 6 | P=0.078N P=0.633N P=0.362N P=0.168N P=0.377N P=0.606N | |LOGISTIC REGRESSION| P=0.017N* P=0.473N P=0.286N P=0.117N P=0.149N P=0.377N | |COCH-ARM / FISHERS | P=0.030N* P=0.518N P=0.309N P=0.121N P=0.121N P=0.086N | |ORDER RESTRICTED | P=0.470N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 48 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Mesentery: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 1/35 (3%) 1/45 (2%) 9/49 (18%) 9/52 (17%) 3/63 (5%) | |POLY-3 RATE (b) | 0/41.89 1/24.05 1/31.46 9/36.50 9/28.19 3/11.22 | |POLY-3 PERCENT (g) | 0.0% 4.2% 3.2% 24.7% 31.9% 26.7% | |TERMINAL (d) | 0/27 (0%) 1/13 (8%) 1/20 (5%) 4/15 (27%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 726 (T) 726 (T) 537 450 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.354 P=0.440 P<0.001 ** P<0.001 ** P=0.005 ** | |POLY 3 | P<0.001 ** P=0.391 P=0.443 P<0.001 ** P<0.001 ** P=0.028 * | |POLY 1.5 | P<0.001 ** P=0.399 P=0.452 P<0.001 ** P<0.001 ** P=0.047 * | |POLY 6 | P<0.001 ** P=0.383 P=0.435 P<0.001 ** P<0.001 ** P=0.020 * | |LOGISTIC REGRESSION| P=0.002 ** P=0.354 P=0.440 P<0.001 ** P=0.003 ** P=0.113 | |COCH-ARM / FISHERS | P=0.163 P=0.398 P=0.459 P<0.001 ** P<0.001 ** P=0.157 | |ORDER RESTRICTED | P=0.042 * (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 0/35 (0%) 0/45 (0%) 3/49 (6%) 0/52 (0%) 3/63 (5%) | |POLY-3 RATE (b) | 1/41.89 0/24.05 0/31.46 3/35.26 0/23.55 3/11.49 | |POLY-3 PERCENT (g) | 2.4% 0.0% 0.0% 8.5% 0.0% 26.1% | |TERMINAL (d) | 1/27 (4%) 0/13 (0%) 0/20 (0%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) --- --- 651 --- 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.646N P=0.560N P=0.189 P=1.000N P=0.009 ** | |POLY 3 | P=0.105 P=0.609N P=0.557N P=0.245 P=0.607N P=0.072 | |POLY 1.5 | P=0.122 P=0.601N P=0.548N P=0.256 P=0.562N P=0.132 | |POLY 6 | P=0.061 P=0.616N P=0.564N P=0.226 P=0.664N P=0.048 * | |LOGISTIC REGRESSION| P=0.092 (e) (e) P=0.227 (e) P=0.313 | |COCH-ARM / FISHERS | P=0.197 P=0.602N P=0.541N P=0.280 P=0.505N P=0.377 | |ORDER RESTRICTED | P=0.005 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 49 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 17/53 (32%) 15/51 (29%) 16/53 (30%) 10/53 (19%) 22/53 (42%) 11/66 (17%) | |POLY-3 RATE (b) | 17/45.19 15/37.47 16/42.04 10/39.05 22/34.45 11/17.92 | |POLY-3 PERCENT (g) | 37.6% 40.0% 38.1% 25.6% 63.9% 61.4% | |TERMINAL (d) | 10/27 (37%) 3/17 (18%) 6/24 (25%) 5/15 (33%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 364 408 541 337 226 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.298 P=0.501 P=0.431N P<0.001 ** P<0.001 ** | |POLY 3 | P=0.004 ** P=0.501 P=0.572 P=0.168N P=0.013 * P=0.113 | |POLY 1.5 | P=0.062 P=0.553 P=0.573N P=0.138N P=0.050 P=0.476 | |POLY 6 | P<0.001 ** P=0.470 P=0.554 P=0.224N P=0.002 ** P=0.028 * | |LOGISTIC REGRESSION| P=0.157 P=0.548N P=0.527N P=0.118N P=0.077 P=0.487 | |COCH-ARM / FISHERS | P=0.133N P=0.468N P=0.500N P=0.090N P=0.210 P=0.040N* | |ORDER RESTRICTED | P=0.078 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Nose: Glands | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 0/53 (0%) 2/53 (4%) 0/66 (0%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 0/36.73 2/24.74 0/9.33 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 8.1% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 582 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.003 ** (e) (e) (e) P=0.066 (e) | |POLY 3 | P=0.016 * (e) (e) (e) P=0.144 (e) | |POLY 1.5 | P=0.056 (e) (e) (e) P=0.180 (e) | |POLY 6 | P=0.007 ** (e) (e) (e) P=0.107 (e) | |LOGISTIC REGRESSION| P=0.092 (e) (e) (e) P=0.177 (e) | |COCH-ARM / FISHERS | P=0.281 (e) (e) (e) P=0.248 (e) | |ORDER RESTRICTED | P=0.313 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 50 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/51 (4%) 1/53 (2%) 3/53 (6%) 8/53 (15%) 1/66 (2%) | |POLY-3 RATE (b) | 0/41.89 2/33.18 1/37.79 3/37.26 8/27.67 1/10.02 | |POLY-3 PERCENT (g) | 0.0% 6.0% 2.7% 8.1% 28.9% 10.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 1/24 (4%) 2/15 (13%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 639 726 (T) 567 397 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.169 P=0.477 P=0.058 P<0.001 ** P=0.150 | |POLY 3 | P<0.001 ** P=0.189 P=0.479 P=0.098 P<0.001 ** P=0.306 | |POLY 1.5 | P=0.002 ** P=0.200 P=0.487 P=0.105 P<0.001 ** P=0.377 | |POLY 6 | P<0.001 ** P=0.179 P=0.472 P=0.088 P<0.001 ** P=0.268 | |LOGISTIC REGRESSION| P=0.007 ** P=0.207 P=0.477 P=0.101 P=0.003 ** P=0.549 | |COCH-ARM / FISHERS | P=0.212 P=0.238 P=0.500 P=0.121 P=0.003 ** P=0.555 | |ORDER RESTRICTED | P=0.091 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/53 (15%) 11/51 (22%) 5/53 (9%) 8/53 (15%) 16/53 (30%) 9/66 (14%) | |POLY-3 RATE (b) | 8/43.10 11/36.20 5/38.28 8/38.81 16/31.73 9/16.16 | |POLY-3 PERCENT (g) | 18.6% 30.4% 13.1% 20.6% 50.4% 55.7% | |TERMINAL (d) | 5/27 (19%) 2/17 (12%) 3/24 (13%) 4/15 (27%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 564 374 608 541 397 289 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.095 P=0.368N P=0.284 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.165 P=0.355N P=0.518 P=0.003 ** P=0.020 * | |POLY 1.5 | P=0.003 ** P=0.191 P=0.324N P=0.548 P=0.010 * P=0.110 | |POLY 6 | P<0.001 ** P=0.152 P=0.387N P=0.468 P<0.001 ** P=0.005 ** | |LOGISTIC REGRESSION| P=0.005 ** P=0.206 P=0.347N P=0.544 P=0.013 * P=0.050 | |COCH-ARM / FISHERS | P=0.351 P=0.274 P=0.278N P=0.607N P=0.052 P=0.512N | |ORDER RESTRICTED | P=0.015 * (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 51 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Nose: Squamous Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 1/53 (2%) 0/53 (0%) 2/53 (4%) 1/66 (2%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 1/38.31 0/36.73 2/24.99 1/9.90 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.6% 0.0% 8.0% 10.1% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 567 --- 565 545 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.476 (e) P=0.113 P=0.032 * | |POLY 3 | P=0.034 * (e) P=0.482 (e) P=0.145 P=0.305 | |POLY 1.5 | P=0.056 (e) P=0.488 (e) P=0.181 P=0.376 | |POLY 6 | P=0.029 * (e) P=0.477 (e) P=0.108 P=0.267 | |LOGISTIC REGRESSION| P=0.104 (e) P=0.531 (e) P=0.261 P=0.382 | |COCH-ARM / FISHERS | P=0.184 (e) P=0.500 (e) P=0.248 P=0.555 | |ORDER RESTRICTED | P=0.196 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Oral Mucosa: Gingival | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/53 (21%) 10/51 (20%) 20/53 (38%) 24/53 (45%) 27/53 (51%) 18/66 (27%) | |POLY-3 RATE (b) | 11/43.10 10/37.28 20/44.05 24/42.02 27/37.13 18/22.91 | |POLY-3 PERCENT (g) | 25.5% 26.8% 45.4% 57.1% 72.7% 78.6% | |TERMINAL (d) | 7/27 (26%) 2/17 (12%) 9/24 (38%) 10/15 (67%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 582 70 408 480 397 222 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.345 P=0.026 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.549 P=0.038 * P=0.002 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.578 P=0.038 * P=0.002 ** P<0.001 ** P=0.003 ** | |POLY 6 | P<0.001 ** P=0.528 P=0.039 * P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.539N P=0.038 * P=0.002 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P=0.219 P=0.540N P=0.043 * P=0.006 ** P<0.001 ** P=0.273 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 52 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Ovary | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 46/53 (87%) 34/51 (67%) 43/53 (81%) 42/53 (79%) 7/53 (13%) 9/65 (14%) | |POLY-3 RATE (b) | 46/50.65 34/42.80 43/49.57 42/48.77 7/27.77 9/17.30 | |POLY-3 PERCENT (g) | 90.8% 79.4% 86.8% 86.1% 25.2% 52.0% | |TERMINAL (d) | 25/27 (93%) 13/17 (77%) 21/24 (88%) 13/15 (87%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 275 399 367 337 217 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.075 P=0.393 P=0.414 P=0.071 P=0.408N P=0.014 * | |POLY 3 | P<0.001N** P=0.081N P=0.361N P=0.326N P<0.001N** P<0.001N** | |POLY 1.5 | P<0.001N** P=0.046N* P=0.350N P=0.335N P<0.001N** P<0.001N** | |POLY 6 | P<0.001N** P=0.140N P=0.390N P=0.332N P<0.001N** P=0.257N | |LOGISTIC REGRESSION| P<0.001N** P=0.052N P=0.375N P=0.345N P<0.001N** P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.013N* P=0.299N P=0.219N P<0.001N** P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 19/53 (36%) 12/51 (24%) 15/53 (28%) 19/53 (36%) 8/53 (15%) 13/65 (20%) | |POLY-3 RATE (b) | 19/44.54 12/34.68 15/39.84 19/42.00 8/27.70 13/19.19 | |POLY-3 PERCENT (g) | 42.7% 34.6% 37.7% 45.2% 28.9% 67.7% | |TERMINAL (d) | 13/27 (48%) 4/17 (24%) 10/24 (42%) 5/15 (33%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 313 594 455 534 523 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.511N P=0.423N P=0.131 P=0.020 * P<0.001 ** | |POLY 3 | P=0.269 P=0.307N P=0.401N P=0.490 P=0.178N P=0.082 | |POLY 1.5 | P=0.438N P=0.243N P=0.351N P=0.501 P=0.064N P=0.429 | |POLY 6 | P=0.055 P=0.353N P=0.445N P=0.485 P=0.458N P=0.017 * | |LOGISTIC REGRESSION| P=0.148 P=0.287N P=0.371N P=0.486 P=0.154N P=0.199 | |COCH-ARM / FISHERS | P=0.019N* P=0.123N P=0.266N P=0.580N P=0.012N* P=0.043N* | |ORDER RESTRICTED | P=0.045 * (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 53 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Ovary | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 3/53 (6%) 3/53 (6%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 3/38.45 3/38.25 0/23.94 0/9.28 | |POLY-3 PERCENT (g) | 0.0% 0.0% 7.8% 7.8% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 2/24 (8%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 504 548 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.637 (e) P=0.103 P=0.105 (e) (e) | |POLY 3 | P=0.596 (e) P=0.103 P=0.102 (e) (e) | |POLY 1.5 | P=0.396N (e) P=0.109 P=0.108 (e) (e) | |POLY 6 | P=0.278 (e) P=0.098 P=0.095 (e) (e) | |LOGISTIC REGRESSION| P=0.196N (e) P=0.115 P=0.141 (e) (e) | |COCH-ARM / FISHERS | P=0.128N (e) P=0.121 P=0.121 (e) (e) | |ORDER RESTRICTED | P=0.555 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Ovary | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 1/51 (2%) 3/53 (6%) 3/53 (6%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 0/41.89 1/32.58 3/38.30 3/38.09 0/23.94 0/9.28 | |POLY-3 PERCENT (g) | 0.0% 3.1% 7.8% 7.9% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 1/17 (6%) 2/24 (8%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 726 (T) 572 539 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.620 P=0.408 P=0.101 P=0.101 (e) (e) | |POLY 3 | P=0.533N P=0.450 P=0.103 P=0.102 (e) (e) | |POLY 1.5 | P=0.311N P=0.464 P=0.108 P=0.107 (e) (e) | |POLY 6 | P=0.370 P=0.437 P=0.098 P=0.094 (e) (e) | |LOGISTIC REGRESSION| P=0.242N P=0.408 P=0.106 P=0.135 (e) (e) | |COCH-ARM / FISHERS | P=0.085N P=0.490 P=0.121 P=0.121 (e) (e) | |ORDER RESTRICTED | P=0.578 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 54 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Pancreas | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 1/53 (2%) 0/53 (0%) 4/53 (8%) 19/65 (29%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 1/38.13 0/36.73 4/25.96 19/26.29 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.6% 0.0% 15.4% 72.3% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 632 --- 383 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.466 (e) P=0.006 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.481 (e) P=0.021 * P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.488 (e) P=0.034 * P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.475 (e) P=0.011 * P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.504 (e) P=0.092 P=0.029 * | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 (e) P=0.059 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Pancreas | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 0/36.73 0/23.94 2/11.15 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 17.9% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 294 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.007 ** (e) (e) (e) (e) P=0.183 | |POLY 3 | P=0.102 (e) (e) (e) (e) P=0.094 | |POLY 1.5 | P=0.043 * (e) (e) (e) (e) P=0.135 | |POLY 6 | P=0.194 (e) (e) (e) (e) P=0.076 | |LOGISTIC REGRESSION| P=0.144 (e) (e) (e) (e) P=0.782 | |COCH-ARM / FISHERS | P=0.019 * (e) (e) (e) (e) P=0.301 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 55 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Pancreas | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 5/51 (10%) 4/53 (8%) 3/53 (6%) 2/53 (4%) 6/65 (9%) | |POLY-3 RATE (b) | 1/42.38 5/33.91 4/38.31 3/37.11 2/24.78 6/14.33 | |POLY-3 PERCENT (g) | 2.4% 14.8% 10.4% 8.1% 8.1% 41.9% | |TERMINAL (d) | 0/27 (0%) 3/17 (18%) 3/24 (13%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 582 484 567 667 555 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.045 * P=0.144 P=0.193 P=0.203 P<0.001 ** | |POLY 3 | P=0.065 P=0.057 P=0.148 P=0.259 P=0.326 P=0.003 ** | |POLY 1.5 | P=0.109 P=0.067 P=0.159 P=0.275 P=0.400 P=0.010 * | |POLY 6 | P=0.026 * P=0.049 * P=0.138 P=0.234 P=0.239 P<0.001 ** | |LOGISTIC REGRESSION| P=0.146 P=0.085 P=0.162 P=0.275 P=0.499 P=0.278 | |COCH-ARM / FISHERS | P=0.320 P=0.094 P=0.181 P=0.309 P=0.500 P=0.096 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 5/51 (10%) 3/53 (6%) 5/53 (9%) 9/53 (17%) 8/65 (12%) | |POLY-3 RATE (b) | 1/41.89 5/33.91 3/37.79 5/37.54 9/29.33 8/16.01 | |POLY-3 PERCENT (g) | 2.4% 14.8% 7.9% 13.3% 30.7% 50.0% | |TERMINAL (d) | 1/27 (4%) 3/17 (18%) 3/24 (13%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 484 726 (T) 628 349 222 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.039 * P=0.262 P=0.038 * P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.059 P=0.268 P=0.077 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.068 P=0.282 P=0.085 P=0.002 ** P=0.002 ** | |POLY 6 | P<0.001 ** P=0.051 P=0.255 P=0.066 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P=0.009 ** P=0.070 P=0.262 P=0.066 P=0.028 * P=0.099 | |COCH-ARM / FISHERS | P=0.027 * P=0.094 P=0.309 P=0.103 P=0.008 ** P=0.033 * | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 56 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Pancreas: Acinus | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/51 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 2/42.36 0/32.58 0/37.79 0/36.73 0/23.94 0/9.28 | |POLY-3 PERCENT (g) | 4.7% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 639 --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.521N P=0.327N P=0.282N P=0.310N P=0.647N P=1.000N | |POLY 3 | P=0.233N P=0.299N P=0.263N P=0.270N P=0.379N P=0.565N | |POLY 1.5 | P=0.238N P=0.281N P=0.253N P=0.258N P=0.311N P=0.424N | |POLY 6 | P=0.187N P=0.320N P=0.274N P=0.291N P=0.483N P=0.651N | |LOGISTIC REGRESSION| P=0.307N P=0.274N P=0.247N P=0.252N P=0.378N P=0.773N | |COCH-ARM / FISHERS | P=0.188N P=0.257N P=0.248N P=0.248N P=0.248N P=0.200N | |ORDER RESTRICTED | P=0.414N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Pancreas: Acinus | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 1/51 (2%) 8/53 (15%) 39/53 (74%) 49/53 (92%) 43/65 (66%) | |POLY-3 RATE (b) | 0/41.89 1/32.58 8/38.89 39/44.58 49/49.61 43/44.52 | |POLY-3 PERCENT (g) | 0.0% 3.1% 20.6% 87.5% 98.8% 96.6% | |TERMINAL (d) | 0/27 (0%) 1/17 (6%) 4/24 (17%) 15/15 (100%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 726 (T) 572 534 267 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.408 P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.450 P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.464 P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.437 P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.408 P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.490 P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 57 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Pancreas: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/51 (4%) 2/53 (4%) 21/53 (40%) 14/53 (26%) 4/65 (6%) | |POLY-3 RATE (b) | 0/41.89 2/32.58 2/37.79 21/39.86 14/31.26 4/12.01 | |POLY-3 PERCENT (g) | 0.0% 6.1% 5.3% 52.7% 44.8% 33.3% | |TERMINAL (d) | 0/27 (0%) 2/17 (12%) 2/24 (8%) 7/15 (47%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 726 (T) 726 (T) 567 447 329 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.143 P=0.212 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.185 P=0.214 P<0.001 ** P<0.001 ** P=0.009 ** | |POLY 1.5 | P<0.001 ** P=0.199 P=0.223 P<0.001 ** P<0.001 ** P=0.018 * | |POLY 6 | P<0.001 ** P=0.173 P=0.206 P<0.001 ** P<0.001 ** P=0.006 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.143 P=0.212 P<0.001 ** P<0.001 ** P=0.016 * | |COCH-ARM / FISHERS | P=0.206 P=0.238 P=0.248 P<0.001 ** P<0.001 ** P=0.088 | |ORDER RESTRICTED | P=0.007 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Pancreas: Duct | | Dilatation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 1/53 (2%) 3/53 (6%) 0/65 (0%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 1/36.73 3/25.31 0/9.28 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.7% 11.9% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 726 (T) 447 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.383 P=0.021 * (e) | |POLY 3 | P=0.004 ** (e) (e) P=0.474 P=0.055 (e) | |POLY 1.5 | P=0.028 * (e) (e) P=0.483 P=0.077 (e) | |POLY 6 | P<0.001 ** (e) (e) P=0.459 P=0.034 * (e) | |LOGISTIC REGRESSION| P=0.060 (e) (e) P=0.383 P=0.117 (e) | |COCH-ARM / FISHERS | P=0.283 (e) (e) P=0.500 P=0.121 (e) | |ORDER RESTRICTED | P=0.290 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 58 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Pituitary Gland | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 23/53 (43%) 13/51 (25%) 19/52 (37%) 7/53 (13%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 23/44.91 13/34.62 19/40.23 7/38.05 0/23.94 0/9.27 | |POLY-3 PERCENT (g) | 51.2% 37.6% 47.2% 18.4% 0.0% 0.0% | |TERMINAL (d) | 15/27 (56%) 6/17 (35%) 13/24 (54%) 3/15 (20%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 564 611 548 537 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.012N* P=0.364N P=0.491N P=0.030N* P=0.099N P=0.778N | |POLY 3 | P<0.001N** P=0.156N P=0.439N P<0.001N** P<0.001N** P=0.050N | |POLY 1.5 | P<0.001N** P=0.105N P=0.382N P<0.001N** P<0.001N** P<0.001N** | |POLY 6 | P<0.001N** P=0.219N P=0.507N P=0.003N** P=0.002N** P=0.356N | |LOGISTIC REGRESSION| P<0.001N** P=0.171N P=0.443N P=0.002N** P<0.001N** P=0.067N | |COCH-ARM / FISHERS | P<0.001N** P=0.043N* P=0.302N P<0.001N** P<0.001N** P<0.001N** | |ORDER RESTRICTED | P=0.041N* (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Pituitary Gland | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 1/51 (2%) 0/52 (0%) 5/53 (9%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 2/41.89 1/32.58 0/37.62 5/37.69 0/23.94 0/9.27 | |POLY-3 PERCENT (g) | 4.8% 3.1% 0.0% 13.3% 0.0% 0.0% | |TERMINAL (d) | 2/27 (7%) 1/17 (6%) 0/24 (0%) 2/15 (13%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 726 (T) --- 594 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.291 P=0.661N P=0.264N P=0.084 P=1.000N P=1.000N | |POLY 3 | P=0.590N P=0.586N P=0.261N P=0.173 P=0.377N P=0.563N | |POLY 1.5 | P=0.330N P=0.563N P=0.254N P=0.187 P=0.310N P=0.423N | |POLY 6 | P=0.261 P=0.610N P=0.269N P=0.153 P=0.478N P=0.650N | |LOGISTIC REGRESSION| P=0.649N P=0.661N (e) P=0.155 (e) (e) | |COCH-ARM / FISHERS | P=0.080N P=0.515N P=0.252N P=0.219 P=0.248N P=0.200N | |ORDER RESTRICTED | P=0.599N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 59 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/53 (21%) 14/51 (27%) 19/52 (37%) 18/53 (34%) 4/53 (8%) 1/65 (2%) | |POLY-3 RATE (b) | 11/43.08 14/34.98 19/41.75 18/39.76 4/25.18 1/10.02 | |POLY-3 PERCENT (g) | 25.5% 40.0% 45.5% 45.3% 15.9% 10.0% | |TERMINAL (d) | 6/27 (22%) 7/17 (41%) 8/24 (33%) 7/15 (47%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 564 525 471 390 520 456 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.033 * P=0.059 P=0.041 * P=0.007 ** P=0.043 * P=0.289 | |POLY 3 | P=0.087N P=0.127 P=0.040 * P=0.043 * P=0.275N P=0.338N | |POLY 1.5 | P=0.002N** P=0.167 P=0.043 * P=0.057 P=0.136N P=0.074N | |POLY 6 | P=0.476 P=0.098 P=0.040 * P=0.027 * P=0.545N P=0.597 | |LOGISTIC REGRESSION| P=0.041N* P=0.105 P=0.036 * P=0.037 * P=0.572N P=0.625N | |COCH-ARM / FISHERS | P<0.001N** P=0.285 P=0.057 P=0.095 P=0.046N* P<0.001N** | |ORDER RESTRICTED | P=0.238N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Skin | | Cyst Epithelial Inclusion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 1/51 (2%) 0/53 (0%) 2/53 (4%) 1/53 (2%) 0/66 (0%) | |POLY-3 RATE (b) | 0/41.89 1/32.58 0/37.79 2/36.73 1/24.34 0/9.33 | |POLY-3 PERCENT (g) | 0.0% 3.1% 0.0% 5.4% 4.1% 0.0% | |TERMINAL (d) | 0/27 (0%) 1/17 (6%) 0/24 (0%) 2/15 (13%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 726 (T) --- 726 (T) 611 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.015 * P=0.408 (e) P=0.120 P=0.313 (e) | |POLY 3 | P=0.238 P=0.450 (e) P=0.209 P=0.398 (e) | |POLY 1.5 | P=0.443 P=0.464 (e) P=0.219 P=0.442 (e) | |POLY 6 | P=0.089 P=0.437 (e) P=0.193 P=0.342 (e) | |LOGISTIC REGRESSION| P=0.151 P=0.408 (e) P=0.120 P=0.471 (e) | |COCH-ARM / FISHERS | P=0.423N P=0.490 (e) P=0.248 P=0.500 (e) | |ORDER RESTRICTED | P=0.572 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 60 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 49/53 (92%) 44/51 (86%) 49/53 (92%) 52/53 (98%) 50/53 (94%) 43/65 (66%) | |POLY-3 RATE (b) | 49/51.71 44/45.96 49/50.62 52/52.55 50/50.38 43/45.37 | |POLY-3 PERCENT (g) | 94.8% 95.7% 96.8% 99.0% 99.3% 94.8% | |TERMINAL (d) | 26/27 (96%) 17/17 (100%) 23/24 (96%) 15/15 (100%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 70 408 41 267 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.060 P=0.235 P=0.006 ** P<0.001 ** P<0.001 ** | |POLY 3 | P=0.479 P=0.621 P=0.491 P=0.217 P=0.185 P=0.730 | |POLY 1.5 | P=0.101N P=0.592N P=0.485 P=0.196 P=0.239 P=0.144N | |POLY 6 | P=0.150 P=0.510 P=0.553 P=0.267 P=0.215 P=0.396 | |LOGISTIC REGRESSION| P=0.226N P=0.474N P=0.527 P=0.167 P=0.195 P=0.337N | |COCH-ARM / FISHERS | P<0.001N** P=0.241N P=0.642N P=0.181 P=0.500 P<0.001N** | |ORDER RESTRICTED | P=0.229 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Spleen | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 52/53 (98%) 50/51 (98%) 52/53 (98%) 50/53 (94%) 50/53 (94%) 59/65 (91%) | |POLY-3 RATE (b) | 52/53.00 50/50.86 52/52.23 50/51.80 50/51.92 59/59.63 | |POLY-3 PERCENT (g) | 98.1% 98.3% 99.6% 96.5% 96.3% 99.0% | |TERMINAL (d) | 26/27 (96%) 17/17 (100%) 24/24 (100%) 15/15 (100%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 70 63 41 166 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.025 * P=0.231 P=0.032 * P<0.001 ** P<0.001 ** | |POLY 3 | P=0.564N P=0.752 P=0.591 P=0.547N P=0.513N P=0.693 | |POLY 1.5 | P=0.265N P=0.761 P=0.668 P=0.422N P=0.406N P=0.619N | |POLY 6 | P=0.455 P=0.734 P=0.524 P=0.748N P=0.698N P=0.517 | |LOGISTIC REGRESSION| P=0.047N* P=0.684N P=0.740 P=0.301N P=0.109N P=0.397N | |COCH-ARM / FISHERS | P=0.014N* P=0.743N P=0.752N P=0.309N P=0.309N P=0.096N | |ORDER RESTRICTED | P=0.490N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 61 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 5/51 (10%) 2/53 (4%) 5/53 (9%) 3/53 (6%) 9/65 (14%) | |POLY-3 RATE (b) | 4/43.27 5/35.74 2/39.13 5/38.68 3/26.31 9/17.28 | |POLY-3 PERCENT (g) | 9.3% 14.0% 5.1% 12.9% 11.4% 52.1% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 564 275 399 390 313 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.332 P=0.406N P=0.378 P=0.461 P<0.001 ** | |POLY 3 | P=0.009 ** P=0.381 P=0.384N P=0.429 P=0.545 P=0.002 ** | |POLY 1.5 | P=0.022 * P=0.411 P=0.365N P=0.455 P=0.643N P=0.015 * | |POLY 6 | P=0.002 ** P=0.348 P=0.406N P=0.387 P=0.376 P<0.001 ** | |LOGISTIC REGRESSION| P=0.399N P=0.642 P=0.279N P=0.539 P=0.288N P=0.682 | |COCH-ARM / FISHERS | P=0.119 P=0.475 P=0.339N P=0.500 P=0.500N P=0.216 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Spleen: Red Pulp | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 0/53 (0%) 1/53 (2%) 2/65 (3%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 0/36.73 1/24.80 2/11.23 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 4.0% 17.8% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 373 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.009 ** (e) (e) (e) P=0.492 P=0.269 | |POLY 3 | P=0.021 * (e) (e) (e) P=0.401 P=0.094 | |POLY 1.5 | P=0.014 * (e) (e) (e) P=0.445 P=0.136 | |POLY 6 | P=0.037 * (e) (e) (e) P=0.345 P=0.076 | |LOGISTIC REGRESSION| P=0.195 (e) (e) (e) P=0.712 P=0.945 | |COCH-ARM / FISHERS | P=0.019 * (e) (e) (e) P=0.500 P=0.301 | |ORDER RESTRICTED | P=0.004 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 62 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Stomach, Forestomach | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 2/53 (4%) 1/53 (2%) 0/65 (0%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 2/37.16 1/24.14 0/9.25 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.4% 4.1% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 653 672 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.013 * (e) (e) P=0.182 P=0.196 (e) | |POLY 3 | P=0.120 (e) (e) P=0.211 P=0.397 (e) | |POLY 1.5 | P=0.292 (e) (e) P=0.220 P=0.442 (e) | |POLY 6 | P=0.031 * (e) (e) P=0.198 P=0.340 (e) | |LOGISTIC REGRESSION| P=0.188 (e) (e) P=0.215 P=0.303 (e) | |COCH-ARM / FISHERS | P=0.607N (e) (e) P=0.248 P=0.500 (e) | |ORDER RESTRICTED | P=0.530 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 1/51 (2%) 3/53 (6%) 11/53 (21%) 4/53 (8%) 9/65 (14%) | |POLY-3 RATE (b) | 4/41.89 1/32.86 3/38.97 11/39.95 4/26.09 9/16.84 | |POLY-3 PERCENT (g) | 9.6% 3.0% 7.7% 27.5% 15.3% 53.4% | |TERMINAL (d) | 4/27 (15%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 651 548 552 349 217 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.332N P=0.562N P=0.014 * P=0.006 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.260N P=0.540N P=0.031 * P=0.375 P=0.002 ** | |POLY 1.5 | P=0.005 ** P=0.237N P=0.527N P=0.034 * P=0.497 P=0.015 * | |POLY 6 | P<0.001 ** P=0.282N P=0.548N P=0.029 * P=0.225 P<0.001 ** | |LOGISTIC REGRESSION| P=0.047 * P=0.299N P=0.541N P=0.031 * P=0.515 P=0.198 | |COCH-ARM / FISHERS | P=0.095 P=0.194N P=0.500N P=0.046 * P=0.642N P=0.216 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 63 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/51 (0%) 2/53 (4%) 4/53 (8%) 0/53 (0%) 1/65 (2%) | |POLY-3 RATE (b) | 2/41.89 0/32.58 2/38.88 4/37.44 0/23.94 1/9.95 | |POLY-3 PERCENT (g) | 4.8% 0.0% 5.1% 10.7% 0.0% 10.1% | |TERMINAL (d) | 2/27 (7%) 0/17 (0%) 0/24 (0%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) --- 548 651 --- 482 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.056 P=0.344N P=0.650 P=0.177 P=1.000N P=0.186 | |POLY 3 | P=0.548 P=0.296N P=0.668 P=0.285 P=0.377N P=0.529 | |POLY 1.5 | P=0.471N P=0.280N P=0.676 P=0.302 P=0.310N P=0.699 | |POLY 6 | P=0.313 P=0.314N P=0.661 P=0.260 P=0.478N P=0.415 | |LOGISTIC REGRESSION| P=0.597 (e) P=0.696 P=0.248 (e) P=0.554 | |COCH-ARM / FISHERS | P=0.204N P=0.257N P=0.691N P=0.339 P=0.248N P=0.423N | |ORDER RESTRICTED | P=0.500 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Stomach, Forestomach | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 1/53 (2%) 0/53 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 1/37.60 0/23.94 2/11.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.7% 0.0% 18.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 367 --- 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.027 * (e) (e) P=0.500 (e) P=0.205 | |POLY 3 | P=0.102 (e) (e) P=0.478 (e) P=0.094 | |POLY 1.5 | P=0.075 (e) (e) P=0.486 (e) P=0.135 | |POLY 6 | P=0.114 (e) (e) P=0.465 (e) P=0.076 | |LOGISTIC REGRESSION| P=0.358 (e) (e) P=0.661 (e) P=0.817 | |COCH-ARM / FISHERS | P=0.070 (e) (e) P=0.500 (e) P=0.301 | |ORDER RESTRICTED | P=0.004 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 64 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/51 (0%) 1/53 (2%) 1/53 (2%) 0/53 (0%) 1/65 (2%) | |POLY-3 RATE (b) | 2/41.89 0/32.58 1/38.31 1/37.01 0/23.94 1/9.95 | |POLY-3 PERCENT (g) | 4.8% 0.0% 2.6% 2.7% 0.0% 10.1% | |TERMINAL (d) | 2/27 (7%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) --- 567 653 --- 482 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.099 P=0.344N P=0.541N P=0.648N P=1.000N P=0.186 | |POLY 3 | P=0.524N P=0.296N P=0.531N P=0.543N P=0.377N P=0.529 | |POLY 1.5 | P=0.511N P=0.280N P=0.520N P=0.528N P=0.310N P=0.699 | |POLY 6 | P=0.522N P=0.314N P=0.541N P=0.567N P=0.478N P=0.415 | |LOGISTIC REGRESSION| P=0.549 (e) P=0.525N P=0.583N (e) P=0.554 | |COCH-ARM / FISHERS | P=0.389N P=0.257N P=0.500N P=0.500N P=0.248N P=0.423N | |ORDER RESTRICTED | P=0.367 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Stomach, Forestomach: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 2/53 (4%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 2/37.24 0/23.94 0/9.25 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.4% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 602 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.519 (e) (e) P=0.181 (e) (e) | |POLY 3 | P=0.446 (e) (e) P=0.211 (e) (e) | |POLY 1.5 | P=0.641 (e) (e) P=0.220 (e) (e) | |POLY 6 | P=0.180 (e) (e) P=0.198 (e) (e) | |LOGISTIC REGRESSION| P=0.715 (e) (e) P=0.225 (e) (e) | |COCH-ARM / FISHERS | P=0.441N (e) (e) P=0.248 (e) (e) | |ORDER RESTRICTED | P=0.590 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 65 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Stomach, Glandular | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 1/51 (2%) 0/53 (0%) 0/53 (0%) 1/53 (2%) 2/65 (3%) | |POLY-3 RATE (b) | 0/41.89 1/33.46 0/37.79 0/36.73 1/24.70 2/10.92 | |POLY-3 PERCENT (g) | 0.0% 3.0% 0.0% 0.0% 4.1% 18.3% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 364 --- --- 447 237 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.012 * P=0.483 (e) (e) P=0.475 P=0.094 | |POLY 3 | P=0.074 P=0.455 (e) (e) P=0.401 P=0.093 | |POLY 1.5 | P=0.058 P=0.467 (e) (e) P=0.444 P=0.134 | |POLY 6 | P=0.103 P=0.444 (e) (e) P=0.344 P=0.076 | |LOGISTIC REGRESSION| P=0.354 P=0.690 (e) (e) P=0.663 P=0.580 | |COCH-ARM / FISHERS | P=0.083 P=0.490 (e) (e) P=0.500 P=0.301 | |ORDER RESTRICTED | P=0.011 * (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Stomach, Glandular | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 0/53 (0%) 1/53 (2%) 3/65 (5%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 0/36.73 1/24.70 3/12.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 4.1% 24.7% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 447 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.475 P=0.129 | |POLY 3 | P=0.007 ** (e) (e) (e) P=0.401 P=0.030 * | |POLY 1.5 | P=0.003 ** (e) (e) (e) P=0.444 P=0.051 | |POLY 6 | P=0.014 * (e) (e) (e) P=0.344 P=0.022 * | |LOGISTIC REGRESSION| P=0.101 (e) (e) (e) P=0.663 P=0.814 | |COCH-ARM / FISHERS | P=0.004 ** (e) (e) (e) P=0.500 P=0.164 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 66 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Stomach, Glandular | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 12/53 (23%) 6/51 (12%) 6/53 (11%) 1/53 (2%) 6/53 (11%) 5/65 (8%) | |POLY-3 RATE (b) | 12/45.97 6/34.71 6/41.20 1/36.81 6/26.38 5/13.58 | |POLY-3 PERCENT (g) | 26.1% 17.3% 14.6% 2.7% 22.7% 36.8% | |TERMINAL (d) | 3/27 (11%) 2/17 (12%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 313 443 443 707 447 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** P=0.313N P=0.180N P=0.010N* P=0.250 P=0.053 | |POLY 3 | P=0.463 P=0.252N P=0.142N P=0.004N** P=0.486N P=0.378 | |POLY 1.5 | P=0.471N P=0.199N P=0.124N P=0.002N** P=0.279N P=0.434N | |POLY 6 | P=0.343 P=0.315N P=0.164N P=0.007N** P=0.441 P=0.170 | |LOGISTIC REGRESSION| P=0.094N P=0.090N P=0.055N P<0.001N** P=0.113N P=0.033N* | |COCH-ARM / FISHERS | P=0.102N P=0.113N P=0.098N P<0.001N** P=0.098N P=0.021N* | |ORDER RESTRICTED | P=0.174 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 40/53 (75%) 44/51 (86%) 44/51 (86%) 49/51 (96%) 50/51 (98%) 57/59 (97%) | |POLY-3 RATE (b) | 40/48.92 44/46.56 44/48.76 49/49.00 50/50.68 57/57.15 | |POLY-3 PERCENT (g) | 81.8% 94.5% 90.3% 100.0% 98.7% 99.7% | |TERMINAL (d) | 23/27 (85%) 17/17 (100%) 18/22 (82%) 15/15 (100%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 275 399 261 166 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.003 ** P=0.079 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.036 * P=0.162 P<0.001 ** P=0.002 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.037 * P=0.121 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.047 * P=0.248 P=0.002 ** P=0.004 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.029 * P=0.086 P<0.001 ** P<0.001 ** P=0.002 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.125 P=0.125 P=0.003 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 67 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Thymus | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 2/51 (4%) 0/51 (0%) 0/51 (0%) 0/59 (0%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 2/37.17 0/35.75 0/22.78 0/8.50 | |POLY-3 PERCENT (g) | 0.0% 0.0% 5.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/22 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 399 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.430N (e) P=0.234 (e) (e) (e) | |POLY 3 | P=0.472N (e) P=0.211 (e) (e) (e) | |POLY 1.5 | P=0.405N (e) P=0.217 (e) (e) (e) | |POLY 6 | P=0.532N (e) P=0.204 (e) (e) (e) | |LOGISTIC REGRESSION| P=0.145N (e) P=0.300 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.264N (e) P=0.238 (e) (e) (e) | |ORDER RESTRICTED | P=0.689 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/53 (13%) 11/51 (22%) 13/53 (25%) 10/52 (19%) 15/52 (29%) 3/66 (5%) | |POLY-3 RATE (b) | 7/43.53 11/34.81 13/40.75 10/39.26 15/31.04 3/11.81 | |POLY-3 PERCENT (g) | 16.1% 31.6% 31.9% 25.5% 48.3% 25.4% | |TERMINAL (d) | 3/27 (11%) 6/17 (35%) 6/24 (25%) 3/15 (20%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 555 534 455 548 373 321 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.051 P=0.073 P=0.120 P<0.001 ** P=0.034 * | |POLY 3 | P=0.016 * P=0.086 P=0.070 P=0.215 P=0.002 ** P=0.415 | |POLY 1.5 | P=0.213 P=0.113 P=0.082 P=0.235 P=0.009 ** P=0.528N | |POLY 6 | P<0.001 ** P=0.066 P=0.060 P=0.183 P<0.001 ** P=0.237 | |LOGISTIC REGRESSION| P=0.420 P=0.110 P=0.092 P=0.261 P=0.027 * P=0.512N | |COCH-ARM / FISHERS | P=0.032N* P=0.193 P=0.107 P=0.284 P=0.041 * P=0.087N | |ORDER RESTRICTED | P=0.211 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 68 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 0/52 (0%) 2/52 (4%) 1/66 (2%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 0/36.44 2/24.73 1/9.99 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 8.1% 10.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- 582 504 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.066 P=0.128 | |POLY 3 | P=0.009 ** (e) (e) (e) P=0.143 P=0.306 | |POLY 1.5 | P=0.016 * (e) (e) (e) P=0.179 P=0.377 | |POLY 6 | P=0.009 ** (e) (e) (e) P=0.106 P=0.268 | |LOGISTIC REGRESSION| P=0.016 * (e) (e) (e) P=0.180 P=0.511 | |COCH-ARM / FISHERS | P=0.072 (e) (e) (e) P=0.243 P=0.555 | |ORDER RESTRICTED | P=0.135 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 22/53 (42%) 35/51 (69%) 34/53 (64%) 38/52 (73%) 44/52 (85%) 37/66 (56%) | |POLY-3 RATE (b) | 22/47.33 35/45.44 34/48.44 38/49.28 44/47.20 37/40.35 | |POLY-3 PERCENT (g) | 46.5% 77.0% 70.2% 77.1% 93.2% 91.7% | |TERMINAL (d) | 9/27 (33%) 11/17 (65%) 14/24 (58%) 11/15 (73%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 70 399 41 267 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P=0.017 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.002 ** P=0.011 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P=0.302 P=0.009 ** P=0.022 * P=0.002 ** P<0.001 ** P=0.137 | |COCH-ARM / FISHERS | P=0.301 P=0.005 ** P=0.016 * P<0.001 ** P<0.001 ** P=0.082 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 69 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Tooth: Peridontal Tissue | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 29/29 (100%) 26/26 (100%) 33/33 (100%) 34/34 (100%) 29/29 (100%) 25/25 (100%) | |POLY-3 RATE (b) | 29/29.00 26/26.00 33/33.00 34/34.00 29/29.00 25/25.00 | |POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% | |TERMINAL (d) | 16/16 (100%) 8/8 (100%) 20/20 (100%) 10/10 (100%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 534 70 408 480 313 245 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Urinary Bladder | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/53 (15%) 3/51 (6%) 2/53 (4%) 4/53 (8%) 1/52 (2%) 0/66 (0%) | |POLY-3 RATE (b) | 8/43.36 3/33.27 2/37.79 4/37.84 1/24.28 0/9.33 | |POLY-3 PERCENT (g) | 18.5% 9.0% 5.3% 10.6% 4.1% 0.0% | |TERMINAL (d) | 3/27 (11%) 0/17 (0%) 2/24 (8%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 362 616 726 (T) 567 548 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.535N P=0.279N P=0.078N P=0.405N P=0.629N P=0.642N | |POLY 3 | P=0.100N P=0.203N P=0.070N P=0.246N P=0.112N P=0.283N | |POLY 1.5 | P=0.037N* P=0.170N P=0.060N P=0.222N P=0.052N P=0.073N | |POLY 6 | P=0.203N P=0.237N P=0.083N P=0.287N P=0.262N P=0.503N | |LOGISTIC REGRESSION| P=0.049N* P=0.160N P=0.060N P=0.203N P=0.052N P=0.136N | |COCH-ARM / FISHERS | P=0.003N** P=0.113N P=0.046N* P=0.179N P=0.017N* P<0.001N** | |ORDER RESTRICTED | P=0.267N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 70 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Urinary Bladder: Transitional Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 2/51 (4%) 0/53 (0%) 4/53 (8%) 1/52 (2%) 0/66 (0%) | |POLY-3 RATE (b) | 4/42.40 2/33.22 0/37.79 4/37.31 1/24.28 0/9.33 | |POLY-3 PERCENT (g) | 9.4% 6.0% 0.0% 10.7% 4.1% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/17 (0%) 0/24 (0%) 2/15 (13%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 672 616 --- 636 548 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.323 P=0.528N P=0.089N P=0.408 P=0.590 P=1.000 | |POLY 3 | P=0.463N P=0.454N P=0.076N P=0.572 P=0.386N P=0.426N | |POLY 1.5 | P=0.252N P=0.422N P=0.070N P=0.597 P=0.287N P=0.224N | |POLY 6 | P=0.465 P=0.486N P=0.083N P=0.529 P=0.540N P=0.574N | |LOGISTIC REGRESSION| P=0.378N P=0.442N P=0.078N P=0.549 P=0.425N P=0.765N | |COCH-ARM / FISHERS | P=0.046N* P=0.358N P=0.059N P=0.642N P=0.187N P=0.037N* | |ORDER RESTRICTED | P=0.466N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Uterus | | Adenomyosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 1/51 (2%) 0/53 (0%) 3/53 (6%) 0/53 (0%) 1/66 (2%) | |POLY-3 RATE (b) | 0/41.89 1/32.84 0/37.79 3/37.12 0/23.94 1/10.14 | |POLY-3 PERCENT (g) | 0.0% 3.1% 0.0% 8.1% 0.0% 9.9% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 659 --- 663 --- 415 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.015 * P=0.431 (e) P=0.059 (e) P=0.308 | |POLY 3 | P=0.302 P=0.452 (e) P=0.098 (e) P=0.307 | |POLY 1.5 | P=0.426 P=0.464 (e) P=0.105 (e) P=0.378 | |POLY 6 | P=0.145 P=0.440 (e) P=0.088 (e) P=0.268 | |LOGISTIC REGRESSION| P=0.299 P=0.466 (e) P=0.088 (e) P=0.744 | |COCH-ARM / FISHERS | P=0.551N P=0.490 (e) P=0.121 (e) P=0.555 | |ORDER RESTRICTED | P=0.243 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 71 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Uterus | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 2/53 (4%) 0/53 (0%) 1/66 (2%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 2/37.11 0/23.94 1/10.02 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.4% 0.0% 10.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 619 --- 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.006 ** (e) (e) P=0.159 (e) P=0.150 | |POLY 3 | P=0.226 (e) (e) P=0.211 (e) P=0.306 | |POLY 1.5 | P=0.284 (e) (e) P=0.220 (e) P=0.377 | |POLY 6 | P=0.130 (e) (e) P=0.197 (e) P=0.268 | |LOGISTIC REGRESSION| P=0.164 (e) (e) P=0.213 (e) P=0.549 | |COCH-ARM / FISHERS | P=0.397 (e) (e) P=0.248 (e) P=0.555 | |ORDER RESTRICTED | P=0.136 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Uterus | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 3/51 (6%) 5/53 (9%) 7/53 (13%) 0/53 (0%) 2/66 (3%) | |POLY-3 RATE (b) | 4/41.89 3/32.77 5/39.35 7/38.64 0/23.94 2/10.47 | |POLY-3 PERCENT (g) | 9.6% 9.2% 12.7% 18.1% 0.0% 19.1% | |TERMINAL (d) | 4/27 (15%) 1/17 (6%) 2/24 (8%) 2/15 (13%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 700 523 539 --- 415 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.020 * P=0.575 P=0.422 P=0.089 P=1.000N P=0.006 ** | |POLY 3 | P=0.385N P=0.632N P=0.460 P=0.212 P=0.169N P=0.415 | |POLY 1.5 | P=0.197N P=0.597N P=0.473 P=0.227 P=0.109N P=0.653N | |POLY 6 | P=0.440 P=0.644 P=0.454 P=0.191 P=0.289N P=0.274 | |LOGISTIC REGRESSION| P=0.500N P=0.604 P=0.455 P=0.202 (e) P=0.119 | |COCH-ARM / FISHERS | P=0.029N* P=0.522N P=0.500 P=0.263 P=0.059N P=0.242N | |ORDER RESTRICTED | P=0.520 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 72 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Uterus | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 5/51 (10%) 2/53 (4%) 5/53 (9%) 0/53 (0%) 0/66 (0%) | |POLY-3 RATE (b) | 2/42.77 5/34.59 2/38.44 5/38.80 0/23.94 0/9.33 | |POLY-3 PERCENT (g) | 4.7% 14.5% 5.2% 12.9% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 2/17 (12%) 0/24 (0%) 1/15 (7%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 362 374 558 552 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.272N P=0.122 P=0.668 P=0.140 P=0.512N P=0.642N | |POLY 3 | P=0.248N P=0.138 P=0.656 P=0.177 P=0.382N P=0.565N | |POLY 1.5 | P=0.092N P=0.156 P=0.669 P=0.188 P=0.313N P=0.424N | |POLY 6 | P=0.542N P=0.122 P=0.645 P=0.160 P=0.483N P=0.651N | |LOGISTIC REGRESSION| P=0.005N** P=0.272 P=0.657N P=0.263 P=0.145N P=0.191N | |COCH-ARM / FISHERS | P=0.008N** P=0.203 P=0.691N P=0.219 P=0.248N P=0.196N | |ORDER RESTRICTED | P=0.520N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Uterus | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 23/53 (43%) 24/51 (47%) 28/53 (53%) 24/53 (45%) 0/53 (0%) 0/66 (0%) | |POLY-3 RATE (b) | 23/44.48 24/38.40 28/45.95 24/43.93 0/23.94 0/9.33 | |POLY-3 PERCENT (g) | 51.7% 62.5% 60.9% 54.6% 0.0% 0.0% | |TERMINAL (d) | 16/27 (59%) 12/17 (71%) 13/24 (54%) 7/15 (47%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 555 364 399 367 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.026N* P=0.043 * P=0.114 P=0.064 P=0.124N P=0.848N | |POLY 3 | P<0.001N** P=0.210 P=0.242 P=0.474 P<0.001N** P=0.046N* | |POLY 1.5 | P<0.001N** P=0.269 P=0.227 P=0.467 P<0.001N** P<0.001N** | |POLY 6 | P=0.003N** P=0.155 P=0.263 P=0.464 P=0.002N** P=0.350N | |LOGISTIC REGRESSION| P<0.001N** P=0.172 P=0.165 P=0.383 P<0.001N** P=0.120N | |COCH-ARM / FISHERS | P<0.001N** P=0.429 P=0.218 P=0.500 P<0.001N** P<0.001N** | |ORDER RESTRICTED | P=0.031N* (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 73 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 32/53 (60%) 23/51 (45%) 25/53 (47%) 30/53 (57%) 7/53 (13%) 8/66 (12%) | |POLY-3 RATE (b) | 32/46.96 23/36.64 25/45.63 30/43.41 7/26.36 8/15.68 | |POLY-3 PERCENT (g) | 68.2% 62.8% 54.8% 69.1% 26.6% 51.0% | |TERMINAL (d) | 21/27 (78%) 12/17 (71%) 11/24 (46%) 12/15 (80%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 347 399 390 523 243 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.431 P=0.331N P=0.059 P=0.187 P=0.003 ** | |POLY 3 | P=0.005N** P=0.382N P=0.123N P=0.555 P<0.001N** P=0.217N | |POLY 1.5 | P<0.001N** P=0.260N P=0.131N P=0.587N P<0.001N** P=0.003N** | |POLY 6 | P=0.224N P=0.503N P=0.102N P=0.522 P=0.020N* P=0.462 | |LOGISTIC REGRESSION| P<0.001N** P=0.302N P=0.141N P=0.568 P<0.001N** P=0.077N | |COCH-ARM / FISHERS | P<0.001N** P=0.086N P=0.121N P=0.422N P<0.001N** P<0.001N** | |ORDER RESTRICTED | P=0.050N (e) (e) (e) (e) (e) | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Number of tumor-bearing animals / Poly-3 number (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates For all tests a negative trend is indicated by N (e) Value of Statistic cannot be computed. (g) Poly-3 adjusted lifetime tumor incidence. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).