TDMS Study 96022-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 05/06/04 EXPERIMENT: 96022 TEST: 02 TIME: 10:07:11 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX ------------------------------------------------------------------------------------------------------------------------------------ FINAL #1 RATS CTRL. VS. HIGH REASONS FOR REMOVAL: 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 0 NG / 0 UG INCLUDE 006 4000 NG/500 UG NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 05/06/04 EXPERIMENT: 96022 TEST: 02 TIME: 10:07:11 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 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 Infarct Mineralization Nephropathy Kidney: Pelvis Inflammation Kidney: Renal Tubule Hyperplasia Kidney: Transitional Epithelium Hyperplasia Liver Angiectasis Basophilic Focus Cholangiofibrosis Clear Cell Focus Eosinophilic Focus Fatty Change Diffuse Fatty Change Focal Hematopoietic Cell Proliferation Hepatodiaphragmatic Nodule Hyperplasia Inflammation Metaplasia Mixed Cell Focus Necrosis Pigmentation Toxic Hepatopathy NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 05/06/04 EXPERIMENT: 96022 TEST: 02 TIME: 10:07:11 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX Liver: Bile Duct Cyst 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 Lymph Node, Mesenteric Ectasia Hemorrhage Hyperplasia Lymph Node: Mediastinal Ectasia Hemorrhage Hyperplasia Pigmentation Lymph Node: Pancreatic Hemorrhage Hyperplasia Lymph Node: Renal Hyperplasia Mammary Gland Hyperplasia Inflammation Granulomatous Mesentery: Artery Inflammation Chronic Mesentery: Fat Necrosis Nose Inflammation Nose: Respiratory Epithelium Hyperplasia Oral Mucosa: Gingival Hyperplasia Ovary Atrophy Cyst Pancreas Edema Hemorrhage Inflammation Chronic Pancreas: Acinus Atrophy Hyperplasia Vacuolization Cytoplasmic Pancreas: Artery Inflammation Chronic Pituitary Gland Angiectasis Vacuolization Cytoplasmic Pituitary Gland: Pars Distalis Hyperplasia Spleen Hematopoietic Cell Proliferation Pigmentation Spleen: Lymphoid Follicle Atrophy Spleen: Red Pulp Atrophy Stomach, Forestomach Hyperplasia Inflammation Mineralization Ulcer Stomach, Glandular Erosion NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 05/06/04 EXPERIMENT: 96022 TEST: 02 TIME: 10:07:11 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX Hemorrhage Mineralization Thymus Atrophy Thyroid Gland: C-Cell Hyperplasia Thyroid Gland: Follicular Cell Hypertrophy Urinary Bladder Inflammation Urinary Bladder: Transitional Epithelium Hyperplasia Uterus Inflammation Inflammation Chronic Metaplasia Uterus: Endometrium Hyperplasia Cystic =============================================================== Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 42/53 (79%) 6/65 (9%) | |POLY-3 RATE (b) | 42/48.03 6/14.36 | |POLY-3 PERCENT (g) | 87.4% 41.8% | |TERMINAL (d) | 26/27 (96%) 0/0 (0%) | |FIRST INCIDENCE | 482 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.008 ** | |POLY 3 | P=0.007N** | |POLY 1.5 | P<0.001N** | |POLY 6 | P=0.881N | |LOGISTIC REGRESSION| P=0.007N** | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 40/65 (62%) | |POLY-3 RATE (b) | 2/42.18 40/41.82 | |POLY-3 PERCENT (g) | 4.7% 95.7% | |TERMINAL (d) | 1/27 (4%) 0/0 (0%) | |FIRST INCIDENCE | 649 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 12/53 (23%) 2/65 (3%) | |POLY-3 RATE (b) | 12/43.80 2/10.85 | |POLY-3 PERCENT (g) | 27.4% 18.4% | |TERMINAL (d) | 6/27 (22%) 0/0 (0%) | |FIRST INCIDENCE | 482 336 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.152 | |POLY 3 | P=0.716N | |POLY 1.5 | P=0.166N | |POLY 6 | P=0.973 | |LOGISTIC REGRESSION| P=0.396N | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 13/53 (25%) 5/65 (8%) | |POLY-3 RATE (b) | 13/44.54 5/13.17 | |POLY-3 PERCENT (g) | 29.2% 38.0% | |TERMINAL (d) | 5/27 (19%) 0/0 (0%) | |FIRST INCIDENCE | 362 321 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** | |POLY 3 | P=0.626 | |POLY 1.5 | P=0.438N | |POLY 6 | P=0.580 | |LOGISTIC REGRESSION| P=0.532N | |COCH-ARM / FISHERS | P=0.011N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 45/53 (85%) 27/65 (42%) | |POLY-3 RATE (b) | 45/48.89 27/31.15 | |POLY-3 PERCENT (g) | 92.1% 86.7% | |TERMINAL (d) | 26/27 (96%) 0/0 (0%) | |FIRST INCIDENCE | 275 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.377N | |POLY 1.5 | P=0.008N** | |POLY 6 | P=0.757 | |LOGISTIC REGRESSION| P=0.527 | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 4/65 (6%) | |POLY-3 RATE (b) | 1/42.24 4/13.13 | |POLY-3 PERCENT (g) | 2.4% 30.5% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | 628 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.077 | |POLY 3 | P=0.132 | |POLY 1.5 | P=0.105 | |POLY 6 | P=0.352 | |LOGISTIC REGRESSION| P=0.627N | |COCH-ARM / FISHERS | P=0.252 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 14/53 (26%) 12/65 (18%) | |POLY-3 RATE (b) | 14/44.09 12/18.81 | |POLY-3 PERCENT (g) | 31.8% 63.8% | |TERMINAL (d) | 6/27 (22%) 0/0 (0%) | |FIRST INCIDENCE | 564 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.059 | |POLY 1.5 | P=0.257 | |POLY 6 | P=0.020 * | |LOGISTIC REGRESSION| P=0.266 | |COCH-ARM / FISHERS | P=0.208N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 13/53 (25%) 0/64 (0%) | |POLY-3 RATE (b) | 13/42.77 0/9.22 | |POLY-3 PERCENT (g) | 30.4% 0.0% | |TERMINAL (d) | 10/27 (37%) 0/0 (0%) | |FIRST INCIDENCE | 628 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.999N | |POLY 3 | P=0.470N | |POLY 1.5 | P=0.028N* | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.612N | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Blood Vessel: Aorta, Adventitia | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/66 (3%) | |POLY-3 RATE (b) | 0/41.89 2/11.08 | |POLY-3 PERCENT (g) | 0.0% 18.1% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 294 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.123 | |POLY 3 | P=0.582 | |POLY 1.5 | P=0.271 | |POLY 6 | P=0.995 | |LOGISTIC REGRESSION| P=0.609 | |COCH-ARM / FISHERS | P=0.306 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Bone Marrow | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 12/66 (18%) | |POLY-3 RATE (b) | 0/41.89 12/20.74 | |POLY-3 PERCENT (g) | 0.0% 57.9% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.387 | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 37/53 (70%) 49/66 (74%) | |POLY-3 RATE (b) | 37/51.61 49/50.11 | |POLY-3 PERCENT (g) | 71.7% 97.8% | |TERMINAL (d) | 14/27 (52%) 0/0 (0%) | |FIRST INCIDENCE | 275 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P=0.002 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.298 | |COCH-ARM / FISHERS | P=0.369 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Brain | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 14/66 (21%) | |POLY-3 RATE (b) | 0/41.89 14/22.64 | |POLY-3 PERCENT (g) | 0.0% 61.8% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.402 | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 49/53 (92%) 31/66 (47%) | |POLY-3 RATE (b) | 49/52.29 31/35.89 | |POLY-3 PERCENT (g) | 93.7% 86.4% | |TERMINAL (d) | 24/27 (89%) 0/0 (0%) | |FIRST INCIDENCE | 275 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.199N | |POLY 1.5 | P<0.001N** | |POLY 6 | P=0.626 | |LOGISTIC REGRESSION| P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Clitoral Gland: Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 40/53 (75%) 61/66 (92%) | |POLY-3 RATE (b) | 40/50.23 61/61.31 | |POLY-3 PERCENT (g) | 79.6% 99.5% | |TERMINAL (d) | 20/27 (74%) 0/0 (0%) | |FIRST INCIDENCE | 313 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.017 * | |COCH-ARM / FISHERS | P=0.010 * | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Esophagus: Muscularis | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 2/66 (3%) | |POLY-3 RATE (b) | 3/42.85 2/10.61 | |POLY-3 PERCENT (g) | 7.0% 18.9% | |TERMINAL (d) | 1/27 (4%) 0/0 (0%) | |FIRST INCIDENCE | 534 254 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.066 | |POLY 3 | P=0.751 | |POLY 1.5 | P=0.682 | |POLY 6 | P=0.989 | |LOGISTIC REGRESSION| P=0.783 | |COCH-ARM / FISHERS | P=0.397N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Harderian Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 24/53 (45%) 9/66 (14%) | |POLY-3 RATE (b) | 24/45.26 9/16.65 | |POLY-3 PERCENT (g) | 53.0% 54.1% | |TERMINAL (d) | 15/27 (56%) 0/0 (0%) | |FIRST INCIDENCE | 313 217 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.701 | |POLY 1.5 | P=0.137N | |POLY 6 | P=0.416 | |LOGISTIC REGRESSION| P=0.329N | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 20/53 (38%) 19/65 (29%) | |POLY-3 RATE (b) | 20/45.03 19/24.56 | |POLY-3 PERCENT (g) | 44.4% 77.4% | |TERMINAL (d) | 11/27 (41%) 0/0 (0%) | |FIRST INCIDENCE | 534 237 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.014 * | |POLY 1.5 | P=0.140 | |POLY 6 | P=0.002 ** | |LOGISTIC REGRESSION| P=0.117 | |COCH-ARM / FISHERS | P=0.217N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Heart: Coronary Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 9/65 (14%) | |POLY-3 RATE (b) | 1/41.89 9/16.16 | |POLY-3 PERCENT (g) | 2.4% 55.7% | |TERMINAL (d) | 1/27 (4%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.007 ** | |COCH-ARM / FISHERS | P=0.019 * | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Heart: Epicardium | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 6/65 (9%) | |POLY-3 RATE (b) | 1/42.60 6/13.78 | |POLY-3 PERCENT (g) | 2.4% 43.5% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | 482 362 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.017 * | |POLY 1.5 | P=0.018 * | |POLY 6 | P=0.036 * | |LOGISTIC REGRESSION| P=0.087 | |COCH-ARM / FISHERS | P=0.096 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Heart: Myocardium | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 3/65 (5%) | |POLY-3 RATE (b) | 0/41.89 3/12.08 | |POLY-3 PERCENT (g) | 0.0% 24.8% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.084 | |POLY 3 | P=0.221 | |POLY 1.5 | P=0.104 | |POLY 6 | P=0.737 | |LOGISTIC REGRESSION| P=0.655 | |COCH-ARM / FISHERS | P=0.164 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Heart: Myocardium | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 0/41.89 2/11.19 | |POLY-3 PERCENT (g) | 0.0% 17.9% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.229 | |POLY 3 | P=0.569 | |POLY 1.5 | P=0.268 | |POLY 6 | P=0.995 | |LOGISTIC REGRESSION| P=0.890 | |COCH-ARM / FISHERS | P=0.301 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Intestine Large, Cecum | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 0/41.89 2/11.19 | |POLY-3 PERCENT (g) | 0.0% 17.9% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 254 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.229 | |POLY 3 | P=0.570 | |POLY 1.5 | P=0.269 | |POLY 6 | P=0.994 | |LOGISTIC REGRESSION| P=0.865 | |COCH-ARM / FISHERS | P=0.301 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Intestine Large, Cecum | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 0/41.89 2/11.20 | |POLY-3 PERCENT (g) | 0.0% 17.9% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.243 | |POLY 3 | P=0.569 | |POLY 1.5 | P=0.268 | |POLY 6 | P=0.994 | |LOGISTIC REGRESSION| P=0.887 | |COCH-ARM / FISHERS | P=0.301 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Intestine Large, Colon | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 2/65 (3%) | |POLY-3 RATE (b) | 2/41.97 2/11.13 | |POLY-3 PERCENT (g) | 4.8% 18.0% | |TERMINAL (d) | 1/27 (4%) 0/0 (0%) | |FIRST INCIDENCE | 707 236 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.175 | |POLY 3 | P=0.691 | |POLY 1.5 | P=0.582 | |POLY 6 | P=0.978 | |LOGISTIC REGRESSION| P=0.807N | |COCH-ARM / FISHERS | P=0.610N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Intestine Large, Rectum | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/52 (6%) 0/66 (0%) | |POLY-3 RATE (b) | 3/41.84 0/9.33 | |POLY-3 PERCENT (g) | 7.2% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/0 (0%) | |FIRST INCIDENCE | 567 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.987N | |POLY 3 | P=0.935N | |POLY 1.5 | P=0.469N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.613N | |COCH-ARM / FISHERS | P=0.083N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Kidney | | Calculus Micro Observation Only | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/53 (11%) 0/65 (0%) | |POLY-3 RATE (b) | 6/42.65 0/9.28 | |POLY-3 PERCENT (g) | 14.1% 0.0% | |TERMINAL (d) | 4/27 (15%) 0/0 (0%) | |FIRST INCIDENCE | 586 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.985N | |POLY 3 | P=0.778N | |POLY 1.5 | P=0.214N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.561N | |COCH-ARM / FISHERS | P=0.007N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 1/65 (2%) | |POLY-3 RATE (b) | 2/41.89 1/10.26 | |POLY-3 PERCENT (g) | 4.8% 9.8% | |TERMINAL (d) | 2/27 (7%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.534 | |POLY 3 | P=0.926 | |POLY 1.5 | P=0.831 | |POLY 6 | P=1.000 | |LOGISTIC REGRESSION| P=0.732N | |COCH-ARM / FISHERS | P=0.423N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 46/53 (87%) 37/65 (57%) | |POLY-3 RATE (b) | 46/51.13 37/39.76 | |POLY-3 PERCENT (g) | 90.0% 93.1% | |TERMINAL (d) | 23/27 (85%) 0/0 (0%) | |FIRST INCIDENCE | 313 217 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.467 | |POLY 1.5 | P=0.230N | |POLY 6 | P=0.153 | |LOGISTIC REGRESSION| P=0.551N | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 41/53 (77%) 43/65 (66%) | |POLY-3 RATE (b) | 41/49.70 43/44.50 | |POLY-3 PERCENT (g) | 82.5% 96.6% | |TERMINAL (d) | 24/27 (89%) 0/0 (0%) | |FIRST INCIDENCE | 275 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.014 * | |POLY 1.5 | P=0.146 | |POLY 6 | P=0.007 ** | |LOGISTIC REGRESSION| P=0.133 | |COCH-ARM / FISHERS | P=0.128N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Kidney: Pelvis | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 0/65 (0%) | |POLY-3 RATE (b) | 4/42.25 0/9.28 | |POLY-3 PERCENT (g) | 9.5% 0.0% | |TERMINAL (d) | 2/27 (7%) 0/0 (0%) | |FIRST INCIDENCE | 672 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=1.000 | |POLY 3 | P=0.883N | |POLY 1.5 | P=0.364N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.876N | |COCH-ARM / FISHERS | P=0.038N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/65 (0%) | |POLY-3 RATE (b) | 2/42.10 0/9.28 | |POLY-3 PERCENT (g) | 4.8% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/0 (0%) | |FIRST INCIDENCE | 672 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=1.000N | |POLY 3 | P=0.980N | |POLY 1.5 | P=0.642N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.966N | |COCH-ARM / FISHERS | P=0.200N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Kidney: Transitional Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 0/65 (0%) | |POLY-3 RATE (b) | 4/42.25 0/9.28 | |POLY-3 PERCENT (g) | 9.5% 0.0% | |TERMINAL (d) | 2/27 (7%) 0/0 (0%) | |FIRST INCIDENCE | 672 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=1.000N | |POLY 3 | P=0.883N | |POLY 1.5 | P=0.364N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.876N | |COCH-ARM / FISHERS | P=0.038N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 0/41.89 2/10.57 | |POLY-3 PERCENT (g) | 0.0% 18.9% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 243 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.033 * | |POLY 3 | P=0.613 | |POLY 1.5 | P=0.274 | |POLY 6 | P=0.999 | |LOGISTIC REGRESSION| P=0.300 | |COCH-ARM / FISHERS | P=0.301 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 27/53 (51%) 0/65 (0%) | |POLY-3 RATE (b) | 27/45.63 0/9.28 | |POLY-3 PERCENT (g) | 59.2% 0.0% | |TERMINAL (d) | 16/27 (59%) 0/0 (0%) | |FIRST INCIDENCE | 534 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.681N | |POLY 3 | P=0.140N | |POLY 1.5 | P<0.001N** | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.029N* | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver | | Cholangiofibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 29/65 (45%) | |POLY-3 RATE (b) | 1/41.89 29/31.95 | |POLY-3 PERCENT (g) | 2.4% 90.8% | |TERMINAL (d) | 1/27 (4%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/53 (9%) 0/65 (0%) | |POLY-3 RATE (b) | 5/42.17 0/9.28 | |POLY-3 PERCENT (g) | 11.9% 0.0% | |TERMINAL (d) | 4/27 (15%) 0/0 (0%) | |FIRST INCIDENCE | 651 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=1.000N | |POLY 3 | P=0.826N | |POLY 1.5 | P=0.277N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.931N | |COCH-ARM / FISHERS | P=0.016N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/53 (19%) 10/65 (15%) | |POLY-3 RATE (b) | 10/43.62 10/18.34 | |POLY-3 PERCENT (g) | 22.9% 54.5% | |TERMINAL (d) | 6/27 (22%) 0/0 (0%) | |FIRST INCIDENCE | 534 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.060 | |POLY 1.5 | P=0.206 | |POLY 6 | P=0.024 * | |LOGISTIC REGRESSION| P=0.333N | |COCH-ARM / FISHERS | P=0.398N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver | | Fatty Change Diffuse | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 56/65 (86%) | |POLY-3 RATE (b) | 3/42.21 56/57.00 | |POLY-3 PERCENT (g) | 7.1% 98.3% | |TERMINAL (d) | 2/27 (7%) 0/0 (0%) | |FIRST INCIDENCE | 639 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver | | Fatty Change Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/53 (19%) 6/65 (9%) | |POLY-3 RATE (b) | 10/43.19 6/13.82 | |POLY-3 PERCENT (g) | 23.2% 43.4% | |TERMINAL (d) | 5/27 (19%) 0/0 (0%) | |FIRST INCIDENCE | 586 329 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.356 | |POLY 1.5 | P=0.590 | |POLY 6 | P=0.309 | |LOGISTIC REGRESSION| P=0.228 | |COCH-ARM / FISHERS | P=0.106N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 27/53 (51%) 11/65 (17%) | |POLY-3 RATE (b) | 27/48.61 11/17.99 | |POLY-3 PERCENT (g) | 55.6% 61.1% | |TERMINAL (d) | 11/27 (41%) 0/0 (0%) | |FIRST INCIDENCE | 275 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.587 | |POLY 1.5 | P=0.173N | |POLY 6 | P=0.278 | |LOGISTIC REGRESSION| P=0.014N* | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/65 (0%) | |POLY-3 RATE (b) | 2/41.89 0/9.28 | |POLY-3 PERCENT (g) | 4.8% 0.0% | |TERMINAL (d) | 2/27 (7%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=1.000N | |POLY 3 | P=0.979N | |POLY 1.5 | P=0.641N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| (e) | |COCH-ARM / FISHERS | P=0.200N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 61/65 (94%) | |POLY-3 RATE (b) | 0/41.89 61/61.04 | |POLY-3 PERCENT (g) | 0.0% 99.9% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 49/53 (92%) 64/65 (98%) | |POLY-3 RATE (b) | 49/51.05 64/64.15 | |POLY-3 PERCENT (g) | 96.0% 99.8% | |TERMINAL (d) | 26/27 (96%) 0/0 (0%) | |FIRST INCIDENCE | 313 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.149 | |POLY 1.5 | P=0.121 | |POLY 6 | P=0.231 | |LOGISTIC REGRESSION| P=0.054 | |COCH-ARM / FISHERS | P=0.125 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 4/65 (6%) | |POLY-3 RATE (b) | 0/41.89 4/11.99 | |POLY-3 PERCENT (g) | 0.0% 33.4% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 338 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.083 | |POLY 1.5 | P=0.040 * | |POLY 6 | P=0.350 | |LOGISTIC REGRESSION| P=0.014 * | |COCH-ARM / FISHERS | P=0.088 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 38/53 (72%) 3/65 (5%) | |POLY-3 RATE (b) | 38/45.68 3/11.13 | |POLY-3 PERCENT (g) | 83.2% 27.0% | |TERMINAL (d) | 26/27 (96%) 0/0 (0%) | |FIRST INCIDENCE | 534 429 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.005 ** | |POLY 3 | P=0.019N* | |POLY 1.5 | P<0.001N** | |POLY 6 | P=0.994N | |LOGISTIC REGRESSION| P=0.587N | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 27/65 (42%) | |POLY-3 RATE (b) | 3/42.94 27/31.21 | |POLY-3 PERCENT (g) | 7.0% 86.5% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | 564 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/53 (9%) 60/65 (92%) | |POLY-3 RATE (b) | 5/43.23 60/60.56 | |POLY-3 PERCENT (g) | 11.6% 99.1% | |TERMINAL (d) | 2/27 (7%) 0/0 (0%) | |FIRST INCIDENCE | 534 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver | | Toxic Hepatopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 64/65 (98%) | |POLY-3 RATE (b) | 0/41.89 64/64.00 | |POLY-3 PERCENT (g) | 0.0% 100.0% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver: Bile Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 14/65 (22%) | |POLY-3 RATE (b) | 4/42.10 14/19.17 | |POLY-3 PERCENT (g) | 9.5% 73.0% | |TERMINAL (d) | 3/27 (11%) 0/0 (0%) | |FIRST INCIDENCE | 672 289 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P=0.030 * | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver: Bile Duct | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/53 (11%) 4/65 (6%) | |POLY-3 RATE (b) | 6/42.12 4/12.37 | |POLY-3 PERCENT (g) | 14.2% 32.3% | |TERMINAL (d) | 5/27 (19%) 0/0 (0%) | |FIRST INCIDENCE | 665 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** | |POLY 3 | P=0.457 | |POLY 1.5 | P=0.575 | |POLY 6 | P=0.582 | |LOGISTIC REGRESSION| P=0.362 | |COCH-ARM / FISHERS | P=0.251N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/53 (9%) 60/65 (92%) | |POLY-3 RATE (b) | 5/42.04 60/60.13 | |POLY-3 PERCENT (g) | 11.9% 99.8% | |TERMINAL (d) | 4/27 (15%) 0/0 (0%) | |FIRST INCIDENCE | 687 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver: Centrilobular | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 8/65 (12%) | |POLY-3 RATE (b) | 2/42.71 8/16.92 | |POLY-3 PERCENT (g) | 4.7% 47.3% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | 564 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.006 ** | |POLY 3 | P=0.004 ** | |POLY 1.5 | P=0.009 ** | |POLY 6 | P=0.003 ** | |LOGISTIC REGRESSION| P=0.493N | |COCH-ARM / FISHERS | P=0.091 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver: Centrilobular | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 57/65 (88%) | |POLY-3 RATE (b) | 0/41.89 57/59.02 | |POLY-3 PERCENT (g) | 0.0% 96.6% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Glandular Structures | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 25/65 (38%) | |POLY-3 RATE (b) | 0/41.89 25/31.26 | |POLY-3 PERCENT (g) | 0.0% 80.0% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.007 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 65/65 (100%) | |POLY-3 RATE (b) | 0/41.89 65/65.00 | |POLY-3 PERCENT (g) | 0.0% 100.0% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Multinucleated | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 48/65 (74%) | |POLY-3 RATE (b) | 0/41.89 48/50.32 | |POLY-3 PERCENT (g) | 0.0% 95.4% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver: Oval Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 62/65 (95%) | |POLY-3 RATE (b) | 4/41.89 62/62.03 | |POLY-3 PERCENT (g) | 9.6% 100.0% | |TERMINAL (d) | 4/27 (15%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Liver: Portal | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 58/65 (89%) | |POLY-3 RATE (b) | 0/41.89 58/58.27 | |POLY-3 PERCENT (g) | 0.0% 99.5% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 4/66 (6%) | |POLY-3 RATE (b) | 0/41.89 4/12.86 | |POLY-3 PERCENT (g) | 0.0% 31.1% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.016 * | |POLY 3 | P=0.074 | |POLY 1.5 | P=0.040 * | |POLY 6 | P=0.293 | |LOGISTIC REGRESSION| P=0.397 | |COCH-ARM / FISHERS | P=0.091 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 40/53 (75%) 33/66 (50%) | |POLY-3 RATE (b) | 40/49.03 33/37.16 | |POLY-3 PERCENT (g) | 81.6% 88.8% | |TERMINAL (d) | 21/27 (78%) 0/0 (0%) | |FIRST INCIDENCE | 362 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.268 | |POLY 1.5 | P=0.469N | |POLY 6 | P=0.078 | |LOGISTIC REGRESSION| P=0.519 | |COCH-ARM / FISHERS | P=0.004N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lung | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/53 (9%) 2/66 (3%) | |POLY-3 RATE (b) | 5/43.02 2/11.03 | |POLY-3 PERCENT (g) | 11.6% 18.1% | |TERMINAL (d) | 3/27 (11%) 0/0 (0%) | |FIRST INCIDENCE | 534 243 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.162 | |POLY 3 | P=0.798 | |POLY 1.5 | P=0.653N | |POLY 6 | P=0.972 | |LOGISTIC REGRESSION| P=0.471N | |COCH-ARM / FISHERS | P=0.140N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lung | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 7/66 (11%) | |POLY-3 RATE (b) | 0/41.89 7/14.88 | |POLY-3 PERCENT (g) | 0.0% 47.1% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 289 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P=0.002 ** | |POLY 6 | P=0.003 ** | |LOGISTIC REGRESSION| P=0.019 * | |COCH-ARM / FISHERS | P=0.014 * | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 18/53 (34%) 4/66 (6%) | |POLY-3 RATE (b) | 18/43.48 4/12.41 | |POLY-3 PERCENT (g) | 41.4% 32.2% | |TERMINAL (d) | 13/27 (48%) 0/0 (0%) | |FIRST INCIDENCE | 534 303 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002 ** | |POLY 3 | P=0.637N | |POLY 1.5 | P=0.089N | |POLY 6 | P=0.841 | |LOGISTIC REGRESSION| P=0.586 | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Metaplasia Bronchiolar | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 8/66 (12%) | |POLY-3 RATE (b) | 1/41.89 8/16.09 | |POLY-3 PERCENT (g) | 2.4% 49.7% | |TERMINAL (d) | 1/27 (4%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P=0.003 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.066 | |COCH-ARM / FISHERS | P=0.035 * | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lung: Serosa | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 8/66 (12%) | |POLY-3 RATE (b) | 3/42.18 8/15.93 | |POLY-3 PERCENT (g) | 7.1% 50.2% | |TERMINAL (d) | 2/27 (7%) 0/0 (0%) | |FIRST INCIDENCE | 649 294 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.009 ** | |POLY 1.5 | P=0.021 * | |POLY 6 | P=0.007 ** | |LOGISTIC REGRESSION| P=0.084 | |COCH-ARM / FISHERS | P=0.188 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 1/66 (2%) | |POLY-3 RATE (b) | 3/42.29 1/10.25 | |POLY-3 PERCENT (g) | 7.1% 9.8% | |TERMINAL (d) | 1/27 (4%) 0/0 (0%) | |FIRST INCIDENCE | 639 313 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.427 | |POLY 3 | P=0.927 | |POLY 1.5 | P=0.703N | |POLY 6 | P=1.000 | |LOGISTIC REGRESSION| P=0.723N | |COCH-ARM / FISHERS | P=0.232N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 7/66 (11%) | |POLY-3 RATE (b) | 0/41.89 7/15.76 | |POLY-3 PERCENT (g) | 0.0% 44.4% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P=0.002 ** | |POLY 6 | P=0.002 ** | |LOGISTIC REGRESSION| P=0.363 | |COCH-ARM / FISHERS | P=0.014 * | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 45/53 (85%) 20/66 (30%) | |POLY-3 RATE (b) | 45/51.67 20/26.79 | |POLY-3 PERCENT (g) | 87.1% 74.7% | |TERMINAL (d) | 24/27 (89%) 0/0 (0%) | |FIRST INCIDENCE | 275 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.179N | |POLY 1.5 | P<0.001N** | |POLY 6 | P=0.705 | |LOGISTIC REGRESSION| P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 2/65 (3%) | |POLY-3 RATE (b) | 1/41.89 2/11.14 | |POLY-3 PERCENT (g) | 2.4% 18.0% | |TERMINAL (d) | 1/27 (4%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 245 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.183 | |POLY 3 | P=0.640 | |POLY 1.5 | P=0.448 | |POLY 6 | P=0.986 | |LOGISTIC REGRESSION| P=0.813 | |COCH-ARM / FISHERS | P=0.577 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 14/65 (22%) | |POLY-3 RATE (b) | 0/41.89 14/22.13 | |POLY-3 PERCENT (g) | 0.0% 63.3% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.136 | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 0/65 (0%) | |POLY-3 RATE (b) | 3/42.49 0/9.28 | |POLY-3 PERCENT (g) | 7.1% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/0 (0%) | |FIRST INCIDENCE | 639 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=1.000N | |POLY 3 | P=0.939N | |POLY 1.5 | P=0.484N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.661N | |COCH-ARM / FISHERS | P=0.088N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/28 (25%) 27/45 (60%) | |POLY-3 RATE (b) | 7/23.39 27/29.76 | |POLY-3 PERCENT (g) | 29.9% 90.7% | |TERMINAL (d) | 2/12 (17%) 0/0 (0%) | |FIRST INCIDENCE | 275 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.140 | |COCH-ARM / FISHERS | P=0.003 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/28 (7%) 25/45 (56%) | |POLY-3 RATE (b) | 2/21.96 25/28.50 | |POLY-3 PERCENT (g) | 9.1% 87.7% | |TERMINAL (d) | 0/12 (0%) 0/0 (0%) | |FIRST INCIDENCE | 586 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.042 * | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 2/45 (4%) | |POLY-3 RATE (b) | 0/21.26 2/7.29 | |POLY-3 PERCENT (g) | 0.0% 27.4% | |TERMINAL (d) | 0/12 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 611 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.474 | |POLY 1.5 | P=0.249 | |POLY 6 | P=0.948 | |LOGISTIC REGRESSION| P=0.004 ** | |COCH-ARM / FISHERS | P=0.377 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 2/45 (4%) | |POLY-3 RATE (b) | 0/21.26 2/8.07 | |POLY-3 PERCENT (g) | 0.0% 24.8% | |TERMINAL (d) | 0/12 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 289 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.036 * | |POLY 3 | P=0.416 | |POLY 1.5 | P=0.244 | |POLY 6 | P=0.854 | |LOGISTIC REGRESSION| P=0.394 | |COCH-ARM / FISHERS | P=0.377 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lymph Node: Pancreatic | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 4/45 (9%) | |POLY-3 RATE (b) | 0/21.26 4/10.12 | |POLY-3 PERCENT (g) | 0.0% 39.5% | |TERMINAL (d) | 0/12 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 243 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.020 * | |POLY 3 | P=0.042 * | |POLY 1.5 | P=0.041 * | |POLY 6 | P=0.075 | |LOGISTIC REGRESSION| P=0.412 | |COCH-ARM / FISHERS | P=0.137 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lymph Node: Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 3/45 (7%) | |POLY-3 RATE (b) | 0/21.26 3/8.86 | |POLY-3 PERCENT (g) | 0.0% 33.9% | |TERMINAL (d) | 0/12 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 342 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** | |POLY 3 | P=0.146 | |POLY 1.5 | P=0.101 | |POLY 6 | P=0.335 | |LOGISTIC REGRESSION| P=0.158 | |COCH-ARM / FISHERS | P=0.228 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Lymph Node: Renal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 2/45 (4%) | |POLY-3 RATE (b) | 0/21.26 2/7.54 | |POLY-3 PERCENT (g) | 0.0% 26.5% | |TERMINAL (d) | 0/12 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 545 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.454 | |POLY 1.5 | P=0.247 | |POLY 6 | P=0.911 | |LOGISTIC REGRESSION| P=0.028 * | |COCH-ARM / FISHERS | P=0.377 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 26/53 (49%) 0/66 (0%) | |POLY-3 RATE (b) | 26/46.93 0/9.33 | |POLY-3 PERCENT (g) | 55.4% 0.0% | |TERMINAL (d) | 14/27 (52%) 0/0 (0%) | |FIRST INCIDENCE | 313 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.399N | |POLY 3 | P=0.187N | |POLY 1.5 | P<0.001N** | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Mammary Gland | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 0/66 (0%) | |POLY-3 RATE (b) | 3/42.81 0/9.33 | |POLY-3 PERCENT (g) | 7.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/0 (0%) | |FIRST INCIDENCE | 555 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.958N | |POLY 3 | P=0.940N | |POLY 1.5 | P=0.482N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.377N | |COCH-ARM / FISHERS | P=0.086N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Mesentery: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 3/63 (5%) | |POLY-3 RATE (b) | 0/41.89 3/11.22 | |POLY-3 PERCENT (g) | 0.0% 26.7% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.005 ** | |POLY 3 | P=0.245 | |POLY 1.5 | P=0.105 | |POLY 6 | P=0.801 | |LOGISTIC REGRESSION| P=0.113 | |COCH-ARM / FISHERS | P=0.157 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 3/63 (5%) | |POLY-3 RATE (b) | 1/41.89 3/11.49 | |POLY-3 PERCENT (g) | 2.4% 26.1% | |TERMINAL (d) | 1/27 (4%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.009 ** | |POLY 3 | P=0.332 | |POLY 1.5 | P=0.223 | |POLY 6 | P=0.762 | |LOGISTIC REGRESSION| P=0.313 | |COCH-ARM / FISHERS | P=0.377 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 17/53 (32%) 11/66 (17%) | |POLY-3 RATE (b) | 17/45.19 11/17.92 | |POLY-3 PERCENT (g) | 37.6% 61.4% | |TERMINAL (d) | 10/27 (37%) 0/0 (0%) | |FIRST INCIDENCE | 275 226 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.181 | |POLY 1.5 | P=0.525 | |POLY 6 | P=0.077 | |LOGISTIC REGRESSION| P=0.487 | |COCH-ARM / FISHERS | P=0.040N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/53 (15%) 9/66 (14%) | |POLY-3 RATE (b) | 8/43.10 9/16.16 | |POLY-3 PERCENT (g) | 18.6% 55.7% | |TERMINAL (d) | 5/27 (19%) 0/0 (0%) | |FIRST INCIDENCE | 564 289 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.046 * | |POLY 1.5 | P=0.140 | |POLY 6 | P=0.026 * | |LOGISTIC REGRESSION| P=0.050 | |COCH-ARM / FISHERS | P=0.512N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Oral Mucosa: Gingival | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/53 (21%) 18/66 (27%) | |POLY-3 RATE (b) | 11/43.10 18/22.91 | |POLY-3 PERCENT (g) | 25.5% 78.6% | |TERMINAL (d) | 7/27 (26%) 0/0 (0%) | |FIRST INCIDENCE | 582 222 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P=0.003 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P=0.273 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Ovary | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 46/53 (87%) 9/65 (14%) | |POLY-3 RATE (b) | 46/50.65 9/17.30 | |POLY-3 PERCENT (g) | 90.8% 52.0% | |TERMINAL (d) | 25/27 (93%) 0/0 (0%) | |FIRST INCIDENCE | 275 217 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.014 * | |POLY 3 | P=0.003N** | |POLY 1.5 | P<0.001N** | |POLY 6 | P=0.755N | |LOGISTIC REGRESSION| P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 19/53 (36%) 13/65 (20%) | |POLY-3 RATE (b) | 19/44.54 13/19.19 | |POLY-3 PERCENT (g) | 42.7% 67.7% | |TERMINAL (d) | 13/27 (48%) 0/0 (0%) | |FIRST INCIDENCE | 313 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.128 | |POLY 1.5 | P=0.472 | |POLY 6 | P=0.042 * | |LOGISTIC REGRESSION| P=0.199 | |COCH-ARM / FISHERS | P=0.043N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Pancreas | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 19/65 (29%) | |POLY-3 RATE (b) | 0/41.89 19/26.29 | |POLY-3 PERCENT (g) | 0.0% 72.3% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.029 * | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Pancreas | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 0/41.89 2/11.15 | |POLY-3 PERCENT (g) | 0.0% 17.9% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 294 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.183 | |POLY 3 | P=0.572 | |POLY 1.5 | P=0.269 | |POLY 6 | P=0.995 | |LOGISTIC REGRESSION| P=0.782 | |COCH-ARM / FISHERS | P=0.301 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Pancreas | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 6/65 (9%) | |POLY-3 RATE (b) | 1/42.38 6/14.33 | |POLY-3 PERCENT (g) | 2.4% 41.9% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | 582 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.016 * | |POLY 1.5 | P=0.018 * | |POLY 6 | P=0.032 * | |LOGISTIC REGRESSION| P=0.278 | |COCH-ARM / FISHERS | P=0.096 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 8/65 (12%) | |POLY-3 RATE (b) | 1/41.89 8/16.01 | |POLY-3 PERCENT (g) | 2.4% 50.0% | |TERMINAL (d) | 1/27 (4%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 222 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P=0.003 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.099 | |COCH-ARM / FISHERS | P=0.033 * | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Pancreas: Acinus | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/65 (0%) | |POLY-3 RATE (b) | 2/42.36 0/9.28 | |POLY-3 PERCENT (g) | 4.7% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | 639 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=1.000N | |POLY 3 | P=0.981N | |POLY 1.5 | P=0.644N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.773N | |COCH-ARM / FISHERS | P=0.200N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Pancreas: Acinus | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 43/65 (66%) | |POLY-3 RATE (b) | 0/41.89 43/44.52 | |POLY-3 PERCENT (g) | 0.0% 96.6% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Pancreas: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 4/65 (6%) | |POLY-3 RATE (b) | 0/41.89 4/12.01 | |POLY-3 PERCENT (g) | 0.0% 33.3% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 329 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.083 | |POLY 1.5 | P=0.040 * | |POLY 6 | P=0.348 | |LOGISTIC REGRESSION| P=0.016 * | |COCH-ARM / FISHERS | P=0.088 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Pituitary Gland | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 23/53 (43%) 0/65 (0%) | |POLY-3 RATE (b) | 23/44.91 0/9.27 | |POLY-3 PERCENT (g) | 51.2% 0.0% | |TERMINAL (d) | 15/27 (56%) 0/0 (0%) | |FIRST INCIDENCE | 564 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.778N | |POLY 3 | P=0.215N | |POLY 1.5 | P<0.001N** | |POLY 6 | P=0.999N | |LOGISTIC REGRESSION| P=0.067N | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Pituitary Gland | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/65 (0%) | |POLY-3 RATE (b) | 2/41.89 0/9.27 | |POLY-3 PERCENT (g) | 4.8% 0.0% | |TERMINAL (d) | 2/27 (7%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=1.000N | |POLY 3 | P=0.979N | |POLY 1.5 | P=0.641N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| (e) | |COCH-ARM / FISHERS | P=0.200N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/53 (21%) 1/65 (2%) | |POLY-3 RATE (b) | 11/43.08 1/10.02 | |POLY-3 PERCENT (g) | 25.5% 10.0% | |TERMINAL (d) | 6/27 (22%) 0/0 (0%) | |FIRST INCIDENCE | 564 456 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.289 | |POLY 3 | P=0.657N | |POLY 1.5 | P=0.116N | |POLY 6 | P=0.998 | |LOGISTIC REGRESSION| P=0.625N | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 49/53 (92%) 43/65 (66%) | |POLY-3 RATE (b) | 49/51.71 43/45.37 | |POLY-3 PERCENT (g) | 94.8% 94.8% | |TERMINAL (d) | 26/27 (96%) 0/0 (0%) | |FIRST INCIDENCE | 275 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.747 | |POLY 1.5 | P=0.148N | |POLY 6 | P=0.430 | |LOGISTIC REGRESSION| P=0.337N | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Spleen | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 52/53 (98%) 59/65 (91%) | |POLY-3 RATE (b) | 52/53.00 59/59.63 | |POLY-3 PERCENT (g) | 98.1% 99.0% | |TERMINAL (d) | 26/27 (96%) 0/0 (0%) | |FIRST INCIDENCE | 275 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.671 | |POLY 1.5 | P=0.597N | |POLY 6 | P=0.493 | |LOGISTIC REGRESSION| P=0.397N | |COCH-ARM / FISHERS | P=0.096N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 9/65 (14%) | |POLY-3 RATE (b) | 4/43.27 9/17.28 | |POLY-3 PERCENT (g) | 9.3% 52.1% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | 564 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.007 ** | |POLY 1.5 | P=0.021 * | |POLY 6 | P=0.004 ** | |LOGISTIC REGRESSION| P=0.682 | |COCH-ARM / FISHERS | P=0.216 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Spleen: Red Pulp | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 0/41.89 2/11.23 | |POLY-3 PERCENT (g) | 0.0% 17.8% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.269 | |POLY 3 | P=0.567 | |POLY 1.5 | P=0.268 | |POLY 6 | P=0.994 | |LOGISTIC REGRESSION| P=0.945 | |COCH-ARM / FISHERS | P=0.301 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 9/65 (14%) | |POLY-3 RATE (b) | 4/41.89 9/16.84 | |POLY-3 PERCENT (g) | 9.6% 53.4% | |TERMINAL (d) | 4/27 (15%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 217 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.006 ** | |POLY 1.5 | P=0.021 * | |POLY 6 | P=0.004 ** | |LOGISTIC REGRESSION| P=0.198 | |COCH-ARM / FISHERS | P=0.216 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 1/65 (2%) | |POLY-3 RATE (b) | 2/41.89 1/9.95 | |POLY-3 PERCENT (g) | 4.8% 10.1% | |TERMINAL (d) | 2/27 (7%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 482 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.186 | |POLY 3 | P=0.932 | |POLY 1.5 | P=0.832 | |POLY 6 | P=1.000 | |LOGISTIC REGRESSION| P=0.554 | |COCH-ARM / FISHERS | P=0.423N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Stomach, Forestomach | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 0/41.89 2/11.13 | |POLY-3 PERCENT (g) | 0.0% 18.0% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.205 | |POLY 3 | P=0.573 | |POLY 1.5 | P=0.270 | |POLY 6 | P=0.995 | |LOGISTIC REGRESSION| P=0.817 | |COCH-ARM / FISHERS | P=0.301 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 1/65 (2%) | |POLY-3 RATE (b) | 2/41.89 1/9.95 | |POLY-3 PERCENT (g) | 4.8% 10.1% | |TERMINAL (d) | 2/27 (7%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 482 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.186 | |POLY 3 | P=0.932 | |POLY 1.5 | P=0.832 | |POLY 6 | P=1.000 | |LOGISTIC REGRESSION| P=0.554 | |COCH-ARM / FISHERS | P=0.423N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Stomach, Glandular | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 0/41.89 2/10.92 | |POLY-3 PERCENT (g) | 0.0% 18.3% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 237 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.094 | |POLY 3 | P=0.588 | |POLY 1.5 | P=0.272 | |POLY 6 | P=0.996 | |LOGISTIC REGRESSION| P=0.580 | |COCH-ARM / FISHERS | P=0.301 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Stomach, Glandular | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 3/65 (5%) | |POLY-3 RATE (b) | 0/41.89 3/12.13 | |POLY-3 PERCENT (g) | 0.0% 24.7% | |TERMINAL (d) | 0/27 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.129 | |POLY 3 | P=0.220 | |POLY 1.5 | P=0.104 | |POLY 6 | P=0.736 | |LOGISTIC REGRESSION| P=0.814 | |COCH-ARM / FISHERS | P=0.164 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Stomach, Glandular | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 12/53 (23%) 5/65 (8%) | |POLY-3 RATE (b) | 12/45.97 5/13.58 | |POLY-3 PERCENT (g) | 26.1% 36.8% | |TERMINAL (d) | 3/27 (11%) 0/0 (0%) | |FIRST INCIDENCE | 313 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.053 | |POLY 3 | P=0.582 | |POLY 1.5 | P=0.508N | |POLY 6 | P=0.555 | |LOGISTIC REGRESSION| P=0.033N* | |COCH-ARM / FISHERS | P=0.021N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 40/53 (75%) 57/59 (97%) | |POLY-3 RATE (b) | 40/48.92 57/57.15 | |POLY-3 PERCENT (g) | 81.8% 99.7% | |TERMINAL (d) | 23/27 (85%) 0/0 (0%) | |FIRST INCIDENCE | 275 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.002 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/53 (13%) 3/66 (5%) | |POLY-3 RATE (b) | 7/43.53 3/11.81 | |POLY-3 PERCENT (g) | 16.1% 25.4% | |TERMINAL (d) | 3/27 (11%) 0/0 (0%) | |FIRST INCIDENCE | 555 321 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.034 * | |POLY 3 | P=0.689 | |POLY 1.5 | P=0.619N | |POLY 6 | P=0.843 | |LOGISTIC REGRESSION| P=0.512N | |COCH-ARM / FISHERS | P=0.087N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 22/53 (42%) 37/66 (56%) | |POLY-3 RATE (b) | 22/47.33 37/40.35 | |POLY-3 PERCENT (g) | 46.5% 91.7% | |TERMINAL (d) | 9/27 (33%) 0/0 (0%) | |FIRST INCIDENCE | 275 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.137 | |COCH-ARM / FISHERS | P=0.082 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Tooth: Peridontal Tissue | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 29/29 (100%) 25/25 (100%) | |POLY-3 RATE (b) | 29/29.00 25/25.00 | |POLY-3 PERCENT (g) | 100.0% 100.0% | |TERMINAL (d) | 16/16 (100%) 0/0 (0%) | |FIRST INCIDENCE | 534 245 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) | |POLY 3 | (e) | |POLY 1.5 | (e) | |POLY 6 | (e) | |LOGISTIC REGRESSION| (e) | |COCH-ARM / FISHERS | (e) | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Urinary Bladder | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/53 (15%) 0/66 (0%) | |POLY-3 RATE (b) | 8/43.36 0/9.33 | |POLY-3 PERCENT (g) | 18.5% 0.0% | |TERMINAL (d) | 3/27 (11%) 0/0 (0%) | |FIRST INCIDENCE | 362 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.642N | |POLY 3 | P=0.688N | |POLY 1.5 | P=0.126N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.136N | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Urinary Bladder: Transitional Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 0/66 (0%) | |POLY-3 RATE (b) | 4/42.40 0/9.33 | |POLY-3 PERCENT (g) | 9.4% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/0 (0%) | |FIRST INCIDENCE | 672 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=1.000 | |POLY 3 | P=0.884N | |POLY 1.5 | P=0.361N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.765N | |COCH-ARM / FISHERS | P=0.037N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Uterus | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 2/66 (3%) | |POLY-3 RATE (b) | 4/41.89 2/10.47 | |POLY-3 PERCENT (g) | 9.6% 19.1% | |TERMINAL (d) | 4/27 (15%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 415 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.006 ** | |POLY 3 | P=0.777 | |POLY 1.5 | P=0.758N | |POLY 6 | P=0.983 | |LOGISTIC REGRESSION| P=0.119 | |COCH-ARM / FISHERS | P=0.242N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Uterus | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/66 (0%) | |POLY-3 RATE (b) | 2/42.77 0/9.33 | |POLY-3 PERCENT (g) | 4.7% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/0 (0%) | |FIRST INCIDENCE | 362 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.642N | |POLY 3 | P=0.982N | |POLY 1.5 | P=0.645N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.191N | |COCH-ARM / FISHERS | P=0.196N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 05/06/04 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 / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Uterus | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 23/53 (43%) 0/66 (0%) | |POLY-3 RATE (b) | 23/44.48 0/9.33 | |POLY-3 PERCENT (g) | 51.7% 0.0% | |TERMINAL (d) | 16/27 (59%) 0/0 (0%) | |FIRST INCIDENCE | 555 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.848N | |POLY 3 | P=0.203N | |POLY 1.5 | P<0.001N** | |POLY 6 | P=0.999N | |LOGISTIC REGRESSION| P=0.120N | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 4000 NG/ | | | 0 UG 500 UG | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 32/53 (60%) 8/66 (12%) | |POLY-3 RATE (b) | 32/46.96 8/15.68 | |POLY-3 PERCENT (g) | 68.2% 51.0% | |TERMINAL (d) | 21/27 (78%) 0/0 (0%) | |FIRST INCIDENCE | 275 243 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.003 ** | |POLY 3 | P=0.367N | |POLY 1.5 | P=0.004N** | |POLY 6 | P=0.791 | |LOGISTIC REGRESSION| P=0.077N | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (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).