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: 06/10/04 EXPERIMENT: 96022 TEST: 02 TIME: 10:02:55 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 Inflammation Necrosis Vacuolization Cytoplasmic Adrenal Medulla Hyperplasia Blood Vessel: Aorta, Adventitia Hemorrhage 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: Artery Inflammation Chronic Kidney Mineralization Nephropathy Liver Angiectasis Basophilic Focus Cholangiofibrosis Eosinophilic Focus Fatty Change Diffuse Fatty Change Focal Hematopoietic Cell Proliferation Hyperplasia Inflammation Metaplasia Mixed Cell Focus Necrosis Pigmentation Toxic Hepatopathy Liver: Bile Duct Cyst Fibrosis Hyperplasia Liver: Centrilobular Degeneration Fibrosis NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 06/10/04 EXPERIMENT: 96022 TEST: 02 TIME: 10:02:55 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX Liver: Hepatocyte Glandular Structures Hypertrophy Multinucleated Liver: Oval Cell Hyperplasia Liver: Portal Fibrosis Lung Hemorrhage Infiltration Cellular Histiocyte Inflammation Inflammation Granulomatous Keratin Cyst 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 Hemorrhage Hyperplasia Mammary Gland Hyperplasia Mesentery: Artery Inflammation Chronic Mesentery: Fat Necrosis Nose Inflammation Nose: Olfactory Epithelium Metaplasia Nose: Respiratory Epithelium Hyperplasia Oral Mucosa: Gingival Hyperplasia Ovary Atrophy Cyst Pancreas Edema Hemorrhage Inflammation Chronic Pancreas: Acinus Atrophy Vacuolization Cytoplasmic Pancreas: Artery Inflammation Chronic Pituitary Gland Angiectasis Cyst Cytoplasmic Alteration 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 Hemorrhage Mineralization NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 06/10/04 EXPERIMENT: 96022 TEST: 02 TIME: 10:02:55 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX Thymus Atrophy Thyroid Gland Infiltration Cellular Lymphoid Thyroid Gland: C-Cell Hyperplasia Thyroid Gland: Follicular Cell Hypertrophy Uterus Inflammation Metaplasia Uterus: Endometrium Hyperplasia Cystic =============================================================== Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 21/50 (42%) 6/65 (9%) | |POLY-3 RATE (b) | 21/28.18 6/14.36 | |POLY-3 PERCENT (g) | 74.5% 41.8% | |TERMINAL (d) | 9/10 (90%) 0/0 (0%) | |FIRST INCIDENCE | 232 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.485 | |POLY 3 | P=0.048N* | |POLY 1.5 | P<0.001N** | |POLY 6 | P=0.754N | |LOGISTIC REGRESSION| P=0.012N* | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 12/50 (24%) 40/65 (62%) | |POLY-3 RATE (b) | 12/30.21 40/41.82 | |POLY-3 PERCENT (g) | 39.7% 95.7% | |TERMINAL (d) | 1/10 (10%) 0/0 (0%) | |FIRST INCIDENCE | 226 203 | |-------------------| | |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: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 9/50 (18%) 2/65 (3%) | |POLY-3 RATE (b) | 9/22.95 2/10.85 | |POLY-3 PERCENT (g) | 39.2% 18.4% | |TERMINAL (d) | 4/10 (40%) 0/0 (0%) | |FIRST INCIDENCE | 504 336 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.338 | |POLY 3 | P=0.339N | |POLY 1.5 | P=0.053N | |POLY 6 | P=0.924N | |LOGISTIC REGRESSION| P=0.478N | |COCH-ARM / FISHERS | P=0.008N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/50 (20%) 5/65 (8%) | |POLY-3 RATE (b) | 10/25.67 5/13.17 | |POLY-3 PERCENT (g) | 39.0% 38.0% | |TERMINAL (d) | 4/10 (40%) 0/0 (0%) | |FIRST INCIDENCE | 258 321 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.334 | |POLY 3 | P=0.697N | |POLY 1.5 | P=0.260N | |POLY 6 | P=0.537 | |LOGISTIC REGRESSION| P=0.258N | |COCH-ARM / FISHERS | P=0.048N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 29/50 (58%) 27/65 (42%) | |POLY-3 RATE (b) | 29/31.75 27/31.15 | |POLY-3 PERCENT (g) | 91.3% 86.7% | |TERMINAL (d) | 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 230 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.390N | |POLY 1.5 | P=0.121N | |POLY 6 | P=0.824 | |LOGISTIC REGRESSION| P=0.465 | |COCH-ARM / FISHERS | P=0.059N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/65 (0%) | |POLY-3 RATE (b) | 2/22.11 0/9.28 | |POLY-3 PERCENT (g) | 9.1% 0.0% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 279 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.443N | |POLY 3 | P=0.737N | |POLY 1.5 | P=0.356N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.250N | |COCH-ARM / FISHERS | P=0.187N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 4/65 (6%) | |POLY-3 RATE (b) | 2/22.01 4/13.13 | |POLY-3 PERCENT (g) | 9.1% 30.5% | |TERMINAL (d) | 1/10 (10%) 0/0 (0%) | |FIRST INCIDENCE | 267 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.274 | |POLY 3 | P=0.190 | |POLY 1.5 | P=0.286 | |POLY 6 | P=0.159 | |LOGISTIC REGRESSION| P=0.603 | |COCH-ARM / FISHERS | P=0.471 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 16/50 (32%) 12/65 (18%) | |POLY-3 RATE (b) | 16/26.74 12/18.81 | |POLY-3 PERCENT (g) | 59.9% 63.8% | |TERMINAL (d) | 5/10 (50%) 0/0 (0%) | |FIRST INCIDENCE | 201 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.006 ** | |POLY 3 | P=0.558 | |POLY 1.5 | P=0.316N | |POLY 6 | P=0.216 | |LOGISTIC REGRESSION| P=0.572N | |COCH-ARM / FISHERS | P=0.073N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/49 (16%) 0/64 (0%) | |POLY-3 RATE (b) | 8/23.03 0/9.22 | |POLY-3 PERCENT (g) | 34.7% 0.0% | |TERMINAL (d) | 3/9 (33%) 0/0 (0%) | |FIRST INCIDENCE | 226 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.247N | |POLY 3 | P=0.188N | |POLY 1.5 | P=0.012N* | |POLY 6 | P=0.979N | |LOGISTIC REGRESSION| P=0.026N* | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Blood Vessel: Aorta, Adventitia | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 1/66 (2%) | |POLY-3 RATE (b) | 2/22.98 1/10.26 | |POLY-3 PERCENT (g) | 8.7% 9.8% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 240 294 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.412N | |POLY 3 | P=0.848 | |POLY 1.5 | P=0.631N | |POLY 6 | P=0.976 | |LOGISTIC REGRESSION| P=0.264N | |COCH-ARM / FISHERS | P=0.396N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Blood Vessel: Aorta, Adventitia | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 2/66 (3%) | |POLY-3 RATE (b) | 2/22.99 2/11.08 | |POLY-3 PERCENT (g) | 8.7% 18.1% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 240 294 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.654N | |POLY 3 | P=0.592 | |POLY 1.5 | P=0.645 | |POLY 6 | P=0.745 | |LOGISTIC REGRESSION| P=0.452N | |COCH-ARM / FISHERS | P=0.580N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Bone Marrow | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/50 (8%) 12/66 (18%) | |POLY-3 RATE (b) | 4/24.94 12/20.74 | |POLY-3 PERCENT (g) | 16.0% 57.9% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 201 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.102 | |POLY 3 | P=0.002 ** | |POLY 1.5 | P=0.016 * | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.275 | |COCH-ARM / FISHERS | P=0.095 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 40/50 (80%) 49/66 (74%) | |POLY-3 RATE (b) | 40/46.05 49/50.11 | |POLY-3 PERCENT (g) | 86.9% 97.8% | |TERMINAL (d) | 5/10 (50%) 0/0 (0%) | |FIRST INCIDENCE | 209 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.032 * | |POLY 1.5 | P=0.179 | |POLY 6 | P=0.014 * | |LOGISTIC REGRESSION| P=0.432N | |COCH-ARM / FISHERS | P=0.309N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Brain | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/50 (16%) 14/66 (21%) | |POLY-3 RATE (b) | 8/28.75 14/22.64 | |POLY-3 PERCENT (g) | 27.8% 61.8% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 201 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.307 | |POLY 3 | P=0.011 * | |POLY 1.5 | P=0.070 | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.547N | |COCH-ARM / FISHERS | P=0.322 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 30/50 (60%) 31/66 (47%) | |POLY-3 RATE (b) | 30/33.33 31/35.89 | |POLY-3 PERCENT (g) | 90.0% 86.4% | |TERMINAL (d) | 9/10 (90%) 0/0 (0%) | |FIRST INCIDENCE | 226 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.435N | |POLY 1.5 | P=0.144N | |POLY 6 | P=0.592 | |LOGISTIC REGRESSION| P=0.517N | |COCH-ARM / FISHERS | P=0.114N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Clitoral Gland: Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 40/50 (80%) 61/66 (92%) | |POLY-3 RATE (b) | 40/43.50 61/61.31 | |POLY-3 PERCENT (g) | 92.0% 99.5% | |TERMINAL (d) | 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 226 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.019 * | |POLY 1.5 | P=0.013 * | |POLY 6 | P=0.053 | |LOGISTIC REGRESSION| P=0.023 * | |COCH-ARM / FISHERS | P=0.045 * | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Esophagus: Muscularis | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/66 (3%) | |POLY-3 RATE (b) | 0/21.06 2/10.61 | |POLY-3 PERCENT (g) | 0.0% 18.9% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 254 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.055 | |POLY 3 | P=0.277 | |POLY 1.5 | P=0.227 | |POLY 6 | P=0.642 | |LOGISTIC REGRESSION| P=0.221 | |COCH-ARM / FISHERS | P=0.322 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Harderian Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 12/50 (24%) 9/66 (14%) | |POLY-3 RATE (b) | 12/26.40 9/16.65 | |POLY-3 PERCENT (g) | 45.5% 54.1% | |TERMINAL (d) | 5/10 (50%) 0/0 (0%) | |FIRST INCIDENCE | 209 217 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.121 | |POLY 3 | P=0.459 | |POLY 1.5 | P=0.452N | |POLY 6 | P=0.184 | |LOGISTIC REGRESSION| P=0.322N | |COCH-ARM / FISHERS | P=0.117N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 15/50 (30%) 19/65 (29%) | |POLY-3 RATE (b) | 15/28.08 19/24.56 | |POLY-3 PERCENT (g) | 53.4% 77.4% | |TERMINAL (d) | 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 209 237 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.042 * | |POLY 1.5 | P=0.211 | |POLY 6 | P=0.007 ** | |LOGISTIC REGRESSION| P=0.254 | |COCH-ARM / FISHERS | P=0.545N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Heart: Coronary Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/50 (12%) 9/65 (14%) | |POLY-3 RATE (b) | 6/24.90 9/16.16 | |POLY-3 PERCENT (g) | 24.1% 55.7% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 273 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.015 * | |POLY 3 | P=0.054 | |POLY 1.5 | P=0.185 | |POLY 6 | P=0.015 * | |LOGISTIC REGRESSION| P=0.333 | |COCH-ARM / FISHERS | P=0.499 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Heart: Epicardium | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 6/65 (9%) | |POLY-3 RATE (b) | 1/21.78 6/13.78 | |POLY-3 PERCENT (g) | 4.6% 43.5% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 474 362 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.005 ** | |POLY 3 | P=0.014 * | |POLY 1.5 | P=0.035 * | |POLY 6 | P=0.007 ** | |LOGISTIC REGRESSION| P=0.050 | |COCH-ARM / FISHERS | P=0.110 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Heart: Myocardium | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 3/65 (5%) | |POLY-3 RATE (b) | 1/22.01 3/12.08 | |POLY-3 PERCENT (g) | 4.5% 24.8% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 258 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.393 | |POLY 3 | P=0.219 | |POLY 1.5 | P=0.264 | |POLY 6 | P=0.284 | |LOGISTIC REGRESSION| P=0.550 | |COCH-ARM / FISHERS | P=0.414 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Heart: Myocardium | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 0/21.06 2/11.19 | |POLY-3 PERCENT (g) | 0.0% 17.9% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.297 | |POLY 3 | P=0.263 | |POLY 1.5 | P=0.227 | |POLY 6 | P=0.556 | |LOGISTIC REGRESSION| P=0.403 | |COCH-ARM / FISHERS | P=0.317 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Intestine Large, Cecum | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/65 (3%) | |POLY-3 RATE (b) | 1/22.03 2/11.19 | |POLY-3 PERCENT (g) | 4.5% 17.9% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 232 254 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.596 | |POLY 3 | P=0.453 | |POLY 1.5 | P=0.466 | |POLY 6 | P=0.667 | |LOGISTIC REGRESSION| P=0.735N | |COCH-ARM / FISHERS | P=0.598 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Intestine Large, Cecum | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/65 (3%) | |POLY-3 RATE (b) | 1/22.03 2/11.20 | |POLY-3 PERCENT (g) | 4.5% 17.9% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 232 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.600 | |POLY 3 | P=0.453 | |POLY 1.5 | P=0.466 | |POLY 6 | P=0.667 | |LOGISTIC REGRESSION| P=0.732N | |COCH-ARM / FISHERS | P=0.598 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Intestine Large, Colon | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/65 (3%) | |POLY-3 RATE (b) | 1/21.06 2/11.13 | |POLY-3 PERCENT (g) | 4.8% 18.0% | |TERMINAL (d) | 1/10 (10%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 236 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.254 | |POLY 3 | P=0.449 | |POLY 1.5 | P=0.469 | |POLY 6 | P=0.638 | |LOGISTIC REGRESSION| P=0.528 | |COCH-ARM / FISHERS | P=0.598 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 14 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Intestine Large, Rectum: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/50 (8%) 0/66 (0%) | |POLY-3 RATE (b) | 4/21.71 0/9.33 | |POLY-3 PERCENT (g) | 18.4% 0.0% | |TERMINAL (d) | 2/10 (20%) 0/0 (0%) | |FIRST INCIDENCE | 607 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.901N | |POLY 3 | P=0.443N | |POLY 1.5 | P=0.112N | |POLY 6 | P=0.994N | |LOGISTIC REGRESSION| P=0.604N | |COCH-ARM / FISHERS | P=0.032N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 32/50 (64%) 37/65 (57%) | |POLY-3 RATE (b) | 32/39.76 37/39.76 | |POLY-3 PERCENT (g) | 80.5% 93.1% | |TERMINAL (d) | 7/10 (70%) 0/0 (0%) | |FIRST INCIDENCE | 201 217 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.050 | |POLY 1.5 | P=0.266 | |POLY 6 | P=0.016 * | |LOGISTIC REGRESSION| P=0.484N | |COCH-ARM / FISHERS | P=0.283N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 15 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 34/50 (68%) 43/65 (66%) | |POLY-3 RATE (b) | 34/34.66 43/44.50 | |POLY-3 PERCENT (g) | 98.1% 96.6% | |TERMINAL (d) | 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 209 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.742N | |POLY 1.5 | P=0.456N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.123 | |COCH-ARM / FISHERS | P=0.498N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/50 (8%) 2/65 (3%) | |POLY-3 RATE (b) | 4/21.49 2/10.57 | |POLY-3 PERCENT (g) | 18.6% 18.9% | |TERMINAL (d) | 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 601 243 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.107 | |POLY 3 | P=0.776 | |POLY 1.5 | P=0.459N | |POLY 6 | P=0.822 | |LOGISTIC REGRESSION| P=0.493 | |COCH-ARM / FISHERS | P=0.225N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 16 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/50 (10%) 0/65 (0%) | |POLY-3 RATE (b) | 5/21.73 0/9.28 | |POLY-3 PERCENT (g) | 23.0% 0.0% | |TERMINAL (d) | 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 601 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.916N | |POLY 3 | P=0.346N | |POLY 1.5 | P=0.065N | |POLY 6 | P=0.988N | |LOGISTIC REGRESSION| P=0.599N | |COCH-ARM / FISHERS | P=0.014N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Cholangiofibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 27/50 (54%) 29/65 (45%) | |POLY-3 RATE (b) | 27/33.72 29/31.95 | |POLY-3 PERCENT (g) | 80.1% 90.8% | |TERMINAL (d) | 8/10 (80%) 0/0 (0%) | |FIRST INCIDENCE | 201 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.133 | |POLY 1.5 | P=0.483 | |POLY 6 | P=0.043 * | |LOGISTIC REGRESSION| P=0.328 | |COCH-ARM / FISHERS | P=0.209N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 17 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 15/50 (30%) 10/65 (15%) | |POLY-3 RATE (b) | 15/28.06 10/18.34 | |POLY-3 PERCENT (g) | 53.5% 54.5% | |TERMINAL (d) | 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 209 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.186 | |POLY 3 | P=0.642 | |POLY 1.5 | P=0.243N | |POLY 6 | P=0.276 | |LOGISTIC REGRESSION| P=0.114N | |COCH-ARM / FISHERS | P=0.049N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Fatty Change Diffuse | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 35/50 (70%) 56/65 (86%) | |POLY-3 RATE (b) | 35/43.37 56/57.00 | |POLY-3 PERCENT (g) | 80.7% 98.3% | |TERMINAL (d) | 7/10 (70%) 0/0 (0%) | |FIRST INCIDENCE | 201 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=0.106 | |COCH-ARM / FISHERS | P=0.030 * | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 18 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Fatty Change Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 14/50 (28%) 6/65 (9%) | |POLY-3 RATE (b) | 14/24.02 6/13.82 | |POLY-3 PERCENT (g) | 58.3% 43.4% | |TERMINAL (d) | 7/10 (70%) 0/0 (0%) | |FIRST INCIDENCE | 282 329 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.034 * | |POLY 3 | P=0.354N | |POLY 1.5 | P=0.057N | |POLY 6 | P=0.770 | |LOGISTIC REGRESSION| P=0.627 | |COCH-ARM / FISHERS | P=0.009N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 22/50 (44%) 11/65 (17%) | |POLY-3 RATE (b) | 22/29.47 11/17.99 | |POLY-3 PERCENT (g) | 74.6% 61.1% | |TERMINAL (d) | 8/10 (80%) 0/0 (0%) | |FIRST INCIDENCE | 209 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.071 | |POLY 3 | P=0.281N | |POLY 1.5 | P=0.015N* | |POLY 6 | P=0.656 | |LOGISTIC REGRESSION| P=0.080N | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 19 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 34/50 (68%) 61/65 (94%) | |POLY-3 RATE (b) | 34/44.64 61/61.04 | |POLY-3 PERCENT (g) | 76.2% 99.9% | |TERMINAL (d) | 4/10 (40%) 0/0 (0%) | |FIRST INCIDENCE | 201 203 | |-------------------| | |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=0.008 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 48/50 (96%) 64/65 (98%) | |POLY-3 RATE (b) | 48/48.82 64/64.15 | |POLY-3 PERCENT (g) | 98.3% 99.8% | |TERMINAL (d) | 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 201 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.532 | |POLY 1.5 | P=0.464 | |POLY 6 | P=0.667 | |LOGISTIC REGRESSION| P=0.490 | |COCH-ARM / FISHERS | P=0.402 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 4/65 (6%) | |POLY-3 RATE (b) | 2/22.97 4/11.99 | |POLY-3 PERCENT (g) | 8.7% 33.4% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 232 338 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.130 | |POLY 3 | P=0.177 | |POLY 1.5 | P=0.261 | |POLY 6 | P=0.174 | |LOGISTIC REGRESSION| P=0.451 | |COCH-ARM / FISHERS | P=0.471 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 20/50 (40%) 3/65 (5%) | |POLY-3 RATE (b) | 20/26.46 3/11.13 | |POLY-3 PERCENT (g) | 75.6% 27.0% | |TERMINAL (d) | 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 282 429 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.523 | |POLY 3 | P=0.016N* | |POLY 1.5 | P<0.001N** | |POLY 6 | P=0.903N | |LOGISTIC REGRESSION| P=0.046N* | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 21 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/50 (12%) 27/65 (42%) | |POLY-3 RATE (b) | 6/25.40 27/31.21 | |POLY-3 PERCENT (g) | 23.6% 86.5% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 201 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 | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 50/50 (100%) 60/65 (92%) | |POLY-3 RATE (b) | 50/50.00 60/60.56 | |POLY-3 PERCENT (g) | 100.0% 99.1% | |TERMINAL (d) | 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 201 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.890N | |POLY 1.5 | P=0.293N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.109N | |COCH-ARM / FISHERS | P=0.054N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 22 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver | | Toxic Hepatopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 50/50 (100%) 64/65 (98%) | |POLY-3 RATE (b) | 50/50.00 64/64.00 | |POLY-3 PERCENT (g) | 100.0% 100.0% | |TERMINAL (d) | 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 201 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=1.000N | |POLY 1.5 | P=1.000N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| (e) | |COCH-ARM / FISHERS | P=0.565N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver: Bile Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 21/50 (42%) 14/65 (22%) | |POLY-3 RATE (b) | 21/25.42 14/19.17 | |POLY-3 PERCENT (g) | 82.6% 73.0% | |TERMINAL (d) | 9/10 (90%) 0/0 (0%) | |FIRST INCIDENCE | 474 289 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.325N | |POLY 1.5 | P=0.050N | |POLY 6 | P=0.780 | |LOGISTIC REGRESSION| P=0.091 | |COCH-ARM / FISHERS | P=0.016N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 23 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver: Bile Duct | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 12/50 (24%) 4/65 (6%) | |POLY-3 RATE (b) | 12/24.42 4/12.37 | |POLY-3 PERCENT (g) | 49.2% 32.3% | |TERMINAL (d) | 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 383 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.159 | |POLY 3 | P=0.369N | |POLY 1.5 | P=0.050N | |POLY 6 | P=0.800 | |LOGISTIC REGRESSION| P=0.346N | |COCH-ARM / FISHERS | P=0.007N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 37/50 (74%) 60/65 (92%) | |POLY-3 RATE (b) | 37/44.10 60/60.13 | |POLY-3 PERCENT (g) | 83.9% 99.8% | |TERMINAL (d) | 5/10 (50%) 0/0 (0%) | |FIRST INCIDENCE | 209 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P=0.002 ** | |LOGISTIC REGRESSION| P=0.013 * | |COCH-ARM / FISHERS | P=0.008 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 24 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver: Centrilobular | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/50 (12%) 8/65 (12%) | |POLY-3 RATE (b) | 6/25.86 8/16.92 | |POLY-3 PERCENT (g) | 23.2% 47.3% | |TERMINAL (d) | 1/10 (10%) 0/0 (0%) | |FIRST INCIDENCE | 201 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.462 | |POLY 3 | P=0.119 | |POLY 1.5 | P=0.291 | |POLY 6 | P=0.040 * | |LOGISTIC REGRESSION| P=0.345N | |COCH-ARM / FISHERS | P=0.628N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver: Centrilobular | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 43/50 (86%) 57/65 (88%) | |POLY-3 RATE (b) | 43/50.00 57/59.02 | |POLY-3 PERCENT (g) | 86.0% 96.6% | |TERMINAL (d) | 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 201 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.034 * | |POLY 1.5 | P=0.103 | |POLY 6 | P=0.010 * | |LOGISTIC REGRESSION| P=0.070N | |COCH-ARM / FISHERS | P=0.501 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 25 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Glandular Structures | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 9/50 (18%) 25/65 (38%) | |POLY-3 RATE (b) | 9/29.71 25/31.26 | |POLY-3 PERCENT (g) | 30.3% 80.0% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 226 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.005 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.129 | |COCH-ARM / FISHERS | P=0.014 * | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 36/50 (72%) 65/65 (100%) | |POLY-3 RATE (b) | 36/45.73 65/65.00 | |POLY-3 PERCENT (g) | 78.7% 100.0% | |TERMINAL (d) | 5/10 (50%) 0/0 (0%) | |FIRST INCIDENCE | 201 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=0.005 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 26 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Multinucleated | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 38/50 (76%) 48/65 (74%) | |POLY-3 RATE (b) | 38/44.81 48/50.32 | |POLY-3 PERCENT (g) | 84.8% 95.4% | |TERMINAL (d) | 5/10 (50%) 0/0 (0%) | |FIRST INCIDENCE | 201 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.046 * | |POLY 1.5 | P=0.194 | |POLY 6 | P=0.014 * | |LOGISTIC REGRESSION| P=0.356N | |COCH-ARM / FISHERS | P=0.483N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver: Oval Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 43/50 (86%) 62/65 (95%) | |POLY-3 RATE (b) | 43/48.43 62/62.03 | |POLY-3 PERCENT (g) | 88.8% 100.0% | |TERMINAL (d) | 5/10 (50%) 0/0 (0%) | |FIRST INCIDENCE | 201 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.008 ** | |POLY 1.5 | P=0.006 ** | |POLY 6 | P=0.010 * | |LOGISTIC REGRESSION| P=0.183 | |COCH-ARM / FISHERS | P=0.076 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 27 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Liver: Portal | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 42/50 (84%) 58/65 (89%) | |POLY-3 RATE (b) | 42/48.26 58/58.27 | |POLY-3 PERCENT (g) | 87.0% 99.5% | |TERMINAL (d) | 5/10 (50%) 0/0 (0%) | |FIRST INCIDENCE | 201 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.005 ** | |POLY 1.5 | P=0.010 * | |POLY 6 | P=0.007 ** | |LOGISTIC REGRESSION| P=0.443 | |COCH-ARM / FISHERS | P=0.291 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 4/66 (6%) | |POLY-3 RATE (b) | 3/23.69 4/12.86 | |POLY-3 PERCENT (g) | 12.7% 31.1% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 226 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.440 | |POLY 3 | P=0.285 | |POLY 1.5 | P=0.419 | |POLY 6 | P=0.247 | |LOGISTIC REGRESSION| P=0.524N | |COCH-ARM / FISHERS | P=0.651N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 28 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 24/50 (48%) 33/66 (50%) | |POLY-3 RATE (b) | 24/32.50 33/37.16 | |POLY-3 PERCENT (g) | 73.8% 88.8% | |TERMINAL (d) | 6/10 (60%) 0/0 (0%) | |FIRST INCIDENCE | 226 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.054 | |POLY 1.5 | P=0.181 | |POLY 6 | P=0.016 * | |LOGISTIC REGRESSION| P=0.134 | |COCH-ARM / FISHERS | P=0.490 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lung | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/50 (12%) 2/66 (3%) | |POLY-3 RATE (b) | 6/23.16 2/11.03 | |POLY-3 PERCENT (g) | 25.9% 18.1% | |TERMINAL (d) | 2/10 (20%) 0/0 (0%) | |FIRST INCIDENCE | 267 243 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.601 | |POLY 3 | P=0.610N | |POLY 1.5 | P=0.226N | |POLY 6 | P=0.873 | |LOGISTIC REGRESSION| P=0.282N | |COCH-ARM / FISHERS | P=0.065N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 29 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lung | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/50 (8%) 0/66 (0%) | |POLY-3 RATE (b) | 4/22.05 0/9.33 | |POLY-3 PERCENT (g) | 18.1% 0.0% | |TERMINAL (d) | 2/10 (20%) 0/0 (0%) | |FIRST INCIDENCE | 561 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.793N | |POLY 3 | P=0.455N | |POLY 1.5 | P=0.115N | |POLY 6 | P=0.995N | |LOGISTIC REGRESSION| P=0.396N | |COCH-ARM / FISHERS | P=0.032N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lung | | Keratin Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 9/50 (18%) 0/66 (0%) | |POLY-3 RATE (b) | 9/23.33 0/9.33 | |POLY-3 PERCENT (g) | 38.6% 0.0% | |TERMINAL (d) | 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 525 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.664N | |POLY 3 | P=0.145N | |POLY 1.5 | P=0.006N** | |POLY 6 | P=0.977N | |LOGISTIC REGRESSION| P=0.110N | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 30 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lung | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/50 (16%) 7/66 (11%) | |POLY-3 RATE (b) | 8/22.72 7/14.88 | |POLY-3 PERCENT (g) | 35.2% 47.1% | |TERMINAL (d) | 4/10 (40%) 0/0 (0%) | |FIRST INCIDENCE | 541 289 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.006 ** | |POLY 3 | P=0.399 | |POLY 1.5 | P=0.599N | |POLY 6 | P=0.184 | |LOGISTIC REGRESSION| P=0.251 | |COCH-ARM / FISHERS | P=0.280N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/50 (10%) 4/66 (6%) | |POLY-3 RATE (b) | 5/22.02 4/12.41 | |POLY-3 PERCENT (g) | 22.7% 32.2% | |TERMINAL (d) | 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 383 303 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.054 | |POLY 3 | P=0.514 | |POLY 1.5 | P=0.622N | |POLY 6 | P=0.396 | |LOGISTIC REGRESSION| P=0.377 | |COCH-ARM / FISHERS | P=0.329N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 31 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Metaplasia Bronchiolar | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 15/50 (30%) 8/66 (12%) | |POLY-3 RATE (b) | 15/27.99 8/16.09 | |POLY-3 PERCENT (g) | 53.6% 49.7% | |TERMINAL (d) | 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 226 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.194 | |POLY 3 | P=0.597N | |POLY 1.5 | P=0.137N | |POLY 6 | P=0.430 | |LOGISTIC REGRESSION| P=0.160N | |COCH-ARM / FISHERS | P=0.016N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lung: Serosa | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 8/66 (12%) | |POLY-3 RATE (b) | 1/22.01 8/15.93 | |POLY-3 PERCENT (g) | 4.5% 50.2% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 273 294 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.006 ** | |POLY 3 | P=0.002 ** | |POLY 1.5 | P=0.008 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.050 | |COCH-ARM / FISHERS | P=0.043 * | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 32 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/49 (22%) 1/66 (2%) | |POLY-3 RATE (b) | 11/24.51 1/10.25 | |POLY-3 PERCENT (g) | 44.9% 9.8% | |TERMINAL (d) | 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 247 313 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.513N | |POLY 3 | P=0.160N | |POLY 1.5 | P=0.006N** | |POLY 6 | P=0.935N | |LOGISTIC REGRESSION| P=0.041N* | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/49 (8%) 7/66 (11%) | |POLY-3 RATE (b) | 4/24.84 7/15.76 | |POLY-3 PERCENT (g) | 16.1% 44.4% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 230 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.365 | |POLY 3 | P=0.076 | |POLY 1.5 | P=0.188 | |POLY 6 | P=0.031 * | |LOGISTIC REGRESSION| P=0.540N | |COCH-ARM / FISHERS | P=0.458 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 33 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 28/49 (57%) 20/66 (30%) | |POLY-3 RATE (b) | 28/32.76 20/26.79 | |POLY-3 PERCENT (g) | 85.5% 74.7% | |TERMINAL (d) | 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 209 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.038 * | |POLY 3 | P=0.176N | |POLY 1.5 | P=0.022N* | |POLY 6 | P=0.770N | |LOGISTIC REGRESSION| P=0.058N | |COCH-ARM / FISHERS | P=0.003N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/65 (3%) | |POLY-3 RATE (b) | 1/21.31 2/11.14 | |POLY-3 PERCENT (g) | 4.7% 18.0% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 659 245 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.268 | |POLY 3 | P=0.450 | |POLY 1.5 | P=0.468 | |POLY 6 | P=0.651 | |LOGISTIC REGRESSION| P=0.575 | |COCH-ARM / FISHERS | P=0.598 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 34 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/50 (20%) 14/65 (22%) | |POLY-3 RATE (b) | 10/28.48 14/22.13 | |POLY-3 PERCENT (g) | 35.1% 63.3% | |TERMINAL (d) | 1/10 (10%) 0/0 (0%) | |FIRST INCIDENCE | 226 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.176 | |POLY 3 | P=0.037 * | |POLY 1.5 | P=0.164 | |POLY 6 | P=0.006 ** | |LOGISTIC REGRESSION| P=0.373N | |COCH-ARM / FISHERS | P=0.514 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/65 (0%) | |POLY-3 RATE (b) | 2/22.10 0/9.28 | |POLY-3 PERCENT (g) | 9.1% 0.0% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 541 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.753N | |POLY 3 | P=0.736N | |POLY 1.5 | P=0.352N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.388N | |COCH-ARM / FISHERS | P=0.187N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 35 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/22 (14%) 27/45 (60%) | |POLY-3 RATE (b) | 3/10.39 27/29.76 | |POLY-3 PERCENT (g) | 28.9% 90.7% | |TERMINAL (d) | 0/2 (0%) 0/0 (0%) | |FIRST INCIDENCE | 254 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 | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/22 (50%) 25/45 (56%) | |POLY-3 RATE (b) | 11/16.43 25/28.50 | |POLY-3 PERCENT (g) | 67.0% 87.7% | |TERMINAL (d) | 0/2 (0%) 0/0 (0%) | |FIRST INCIDENCE | 226 174 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.034 * | |POLY 1.5 | P=0.126 | |POLY 6 | P=0.009 ** | |LOGISTIC REGRESSION| P=0.473N | |COCH-ARM / FISHERS | P=0.433 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 36 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/22 (18%) 2/45 (4%) | |POLY-3 RATE (b) | 4/10.38 2/7.29 | |POLY-3 PERCENT (g) | 38.5% 27.4% | |TERMINAL (d) | 0/2 (0%) 0/0 (0%) | |FIRST INCIDENCE | 594 611 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.039 * | |POLY 3 | P=0.590N | |POLY 1.5 | P=0.212N | |POLY 6 | P=0.866 | |LOGISTIC REGRESSION| P=0.529 | |COCH-ARM / FISHERS | P=0.085N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/22 (0%) 2/45 (4%) | |POLY-3 RATE (b) | 0/8.85 2/8.07 | |POLY-3 PERCENT (g) | 0.0% 24.8% | |TERMINAL (d) | 0/2 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 289 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.087 | |POLY 3 | P=0.219 | |POLY 1.5 | P=0.240 | |POLY 6 | P=0.236 | |LOGISTIC REGRESSION| P=0.346 | |COCH-ARM / FISHERS | P=0.448 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 37 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lymph Node: Pancreatic | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/22 (14%) 4/45 (9%) | |POLY-3 RATE (b) | 3/11.01 4/10.12 | |POLY-3 PERCENT (g) | 27.3% 39.5% | |TERMINAL (d) | 0/2 (0%) 0/0 (0%) | |FIRST INCIDENCE | 230 243 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.375 | |POLY 3 | P=0.457 | |POLY 1.5 | P=0.621 | |POLY 6 | P=0.326 | |LOGISTIC REGRESSION| P=0.329N | |COCH-ARM / FISHERS | P=0.417N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lymph Node: Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/22 (14%) 3/45 (7%) | |POLY-3 RATE (b) | 3/11.01 3/8.86 | |POLY-3 PERCENT (g) | 27.3% 33.9% | |TERMINAL (d) | 0/2 (0%) 0/0 (0%) | |FIRST INCIDENCE | 230 342 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.354 | |POLY 3 | P=0.612 | |POLY 1.5 | P=0.567N | |POLY 6 | P=0.526 | |LOGISTIC REGRESSION| P=0.363N | |COCH-ARM / FISHERS | P=0.304N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 38 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lymph Node: Renal | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/22 (9%) 0/45 (0%) | |POLY-3 RATE (b) | 2/9.18 0/6.56 | |POLY-3 PERCENT (g) | 21.8% 0.0% | |TERMINAL (d) | 1/2 (50%) 0/0 (0%) | |FIRST INCIDENCE | 636 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.970N | |POLY 3 | P=0.414N | |POLY 1.5 | P=0.151N | |POLY 6 | P=0.952N | |LOGISTIC REGRESSION| P=0.808N | |COCH-ARM / FISHERS | P=0.104N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Lymph Node: Renal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/22 (14%) 2/45 (4%) | |POLY-3 RATE (b) | 3/9.93 2/7.54 | |POLY-3 PERCENT (g) | 30.2% 26.5% | |TERMINAL (d) | 0/2 (0%) 0/0 (0%) | |FIRST INCIDENCE | 601 545 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.030 * | |POLY 3 | P=0.699N | |POLY 1.5 | P=0.371N | |POLY 6 | P=0.780 | |LOGISTIC REGRESSION| P=0.479 | |COCH-ARM / FISHERS | P=0.195N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 39 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/50 (22%) 0/66 (0%) | |POLY-3 RATE (b) | 11/23.96 0/9.33 | |POLY-3 PERCENT (g) | 45.9% 0.0% | |TERMINAL (d) | 4/10 (40%) 0/0 (0%) | |FIRST INCIDENCE | 282 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.276N | |POLY 3 | P=0.087N | |POLY 1.5 | P=0.002N** | |POLY 6 | P=0.973N | |LOGISTIC REGRESSION| P=0.032N* | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Mesentery: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/43 (16%) 3/63 (5%) | |POLY-3 RATE (b) | 7/21.52 3/11.22 | |POLY-3 PERCENT (g) | 32.5% 26.7% | |TERMINAL (d) | 1/9 (11%) 0/0 (0%) | |FIRST INCIDENCE | 451 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.270 | |POLY 3 | P=0.631N | |POLY 1.5 | P=0.207N | |POLY 6 | P=0.746 | |LOGISTIC REGRESSION| P=0.383N | |COCH-ARM / FISHERS | P=0.050N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 40 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/43 (0%) 3/63 (5%) | |POLY-3 RATE (b) | 0/18.60 3/11.49 | |POLY-3 PERCENT (g) | 0.0% 26.1% | |TERMINAL (d) | 0/9 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.036 * | |POLY 3 | P=0.096 | |POLY 1.5 | P=0.108 | |POLY 6 | P=0.157 | |LOGISTIC REGRESSION| P=0.175 | |COCH-ARM / FISHERS | P=0.206 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/50 (22%) 11/66 (17%) | |POLY-3 RATE (b) | 11/25.60 11/17.92 | |POLY-3 PERCENT (g) | 43.0% 61.4% | |TERMINAL (d) | 1/10 (10%) 0/0 (0%) | |FIRST INCIDENCE | 209 226 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002 ** | |POLY 3 | P=0.203 | |POLY 1.5 | P=0.511 | |POLY 6 | P=0.059 | |LOGISTIC REGRESSION| P=0.318 | |COCH-ARM / FISHERS | P=0.312N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 41 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/50 (10%) 1/66 (2%) | |POLY-3 RATE (b) | 5/22.14 1/10.02 | |POLY-3 PERCENT (g) | 22.6% 10.0% | |TERMINAL (d) | 1/10 (10%) 0/0 (0%) | |FIRST INCIDENCE | 593 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.448 | |POLY 3 | P=0.544N | |POLY 1.5 | P=0.176N | |POLY 6 | P=0.975 | |LOGISTIC REGRESSION| P=0.680N | |COCH-ARM / FISHERS | P=0.052N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/50 (20%) 9/66 (14%) | |POLY-3 RATE (b) | 10/24.54 9/16.16 | |POLY-3 PERCENT (g) | 40.7% 55.7% | |TERMINAL (d) | 1/10 (10%) 0/0 (0%) | |FIRST INCIDENCE | 474 289 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002 ** | |POLY 3 | P=0.307 | |POLY 1.5 | P=0.623 | |POLY 6 | P=0.114 | |LOGISTIC REGRESSION| P=0.230 | |COCH-ARM / FISHERS | P=0.252N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 42 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Oral Mucosa: Gingival | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 18/50 (36%) 18/66 (27%) | |POLY-3 RATE (b) | 18/29.52 18/22.91 | |POLY-3 PERCENT (g) | 61.0% 78.6% | |TERMINAL (d) | 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 209 222 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.131 | |POLY 1.5 | P=0.506 | |POLY 6 | P=0.024 * | |LOGISTIC REGRESSION| P=0.301 | |COCH-ARM / FISHERS | P=0.211N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Ovary | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 15/50 (30%) 9/65 (14%) | |POLY-3 RATE (b) | 15/27.64 9/17.30 | |POLY-3 PERCENT (g) | 54.3% 52.0% | |TERMINAL (d) | 6/10 (60%) 0/0 (0%) | |FIRST INCIDENCE | 226 217 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.328 | |POLY 3 | P=0.623N | |POLY 1.5 | P=0.198N | |POLY 6 | P=0.408 | |LOGISTIC REGRESSION| P=0.110N | |COCH-ARM / FISHERS | P=0.030N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 43 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/50 (14%) 13/65 (20%) | |POLY-3 RATE (b) | 7/22.45 13/19.19 | |POLY-3 PERCENT (g) | 31.2% 67.7% | |TERMINAL (d) | 2/10 (20%) 0/0 (0%) | |FIRST INCIDENCE | 525 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.012 * | |POLY 1.5 | P=0.070 | |POLY 6 | P=0.002 ** | |LOGISTIC REGRESSION| P=0.008 ** | |COCH-ARM / FISHERS | P=0.278 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Pancreas | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 12/50 (24%) 19/65 (29%) | |POLY-3 RATE (b) | 12/31.74 19/26.29 | |POLY-3 PERCENT (g) | 37.8% 72.3% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 226 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.127 | |POLY 3 | P=0.005 ** | |POLY 1.5 | P=0.046 * | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.418N | |COCH-ARM / FISHERS | P=0.341 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 44 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Pancreas | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/65 (3%) | |POLY-3 RATE (b) | 1/22.01 2/11.15 | |POLY-3 PERCENT (g) | 4.5% 17.9% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 258 294 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.587 | |POLY 3 | P=0.453 | |POLY 1.5 | P=0.465 | |POLY 6 | P=0.668 | |LOGISTIC REGRESSION| P=0.719 | |COCH-ARM / FISHERS | P=0.598 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Pancreas | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/50 (10%) 6/65 (9%) | |POLY-3 RATE (b) | 5/22.51 6/14.33 | |POLY-3 PERCENT (g) | 22.2% 41.9% | |TERMINAL (d) | 2/10 (20%) 0/0 (0%) | |FIRST INCIDENCE | 541 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.023 * | |POLY 3 | P=0.231 | |POLY 1.5 | P=0.428 | |POLY 6 | P=0.115 | |LOGISTIC REGRESSION| P=0.336 | |COCH-ARM / FISHERS | P=0.567N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 45 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/50 (16%) 8/65 (12%) | |POLY-3 RATE (b) | 8/24.21 8/16.01 | |POLY-3 PERCENT (g) | 33.0% 50.0% | |TERMINAL (d) | 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 258 222 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.044 * | |POLY 3 | P=0.264 | |POLY 1.5 | P=0.526 | |POLY 6 | P=0.103 | |LOGISTIC REGRESSION| P=0.564 | |COCH-ARM / FISHERS | P=0.381N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Pancreas: Acinus | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 41/50 (82%) 43/65 (66%) | |POLY-3 RATE (b) | 41/41.99 43/44.52 | |POLY-3 PERCENT (g) | 97.7% 96.6% | |TERMINAL (d) | 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 209 203 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.754N | |POLY 1.5 | P=0.217N | |POLY 6 | P=1.000 | |LOGISTIC REGRESSION| P=0.268N | |COCH-ARM / FISHERS | P=0.045N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 46 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Pancreas: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/50 (20%) 4/65 (6%) | |POLY-3 RATE (b) | 10/24.82 4/12.01 | |POLY-3 PERCENT (g) | 40.3% 33.3% | |TERMINAL (d) | 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 401 329 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.197 | |POLY 3 | P=0.596N | |POLY 1.5 | P=0.156N | |POLY 6 | P=0.692 | |LOGISTIC REGRESSION| P=0.438N | |COCH-ARM / FISHERS | P=0.025N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Pituitary Gland | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 0/65 (0%) | |POLY-3 RATE (b) | 3/21.06 0/9.27 | |POLY-3 PERCENT (g) | 14.3% 0.0% | |TERMINAL (d) | 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=1.000N | |POLY 3 | P=0.547N | |POLY 1.5 | P=0.194N | |POLY 6 | P=0.997N | |LOGISTIC REGRESSION| (e) | |COCH-ARM / FISHERS | P=0.079N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 47 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Pituitary Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 0/65 (0%) | |POLY-3 RATE (b) | 3/23.88 0/9.27 | |POLY-3 PERCENT (g) | 12.6% 0.0% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 258 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.084N | |POLY 3 | P=0.639N | |POLY 1.5 | P=0.231N | |POLY 6 | P=0.999N | |LOGISTIC REGRESSION| P=0.034N* | |COCH-ARM / FISHERS | P=0.079N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Pituitary Gland | | Cytoplasmic Alteration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/65 (0%) | |POLY-3 RATE (b) | 2/22.03 0/9.27 | |POLY-3 PERCENT (g) | 9.1% 0.0% | |TERMINAL (d) | 1/10 (10%) 0/0 (0%) | |FIRST INCIDENCE | 226 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.459N | |POLY 3 | P=0.735N | |POLY 1.5 | P=0.357N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.234N | |COCH-ARM / FISHERS | P=0.187N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 48 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/50 (16%) 1/65 (2%) | |POLY-3 RATE (b) | 8/22.16 1/10.02 | |POLY-3 PERCENT (g) | 36.1% 10.0% | |TERMINAL (d) | 5/10 (50%) 0/0 (0%) | |FIRST INCIDENCE | 601 456 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.516 | |POLY 3 | P=0.271N | |POLY 1.5 | P=0.036N* | |POLY 6 | P=0.936N | |LOGISTIC REGRESSION| P=0.626N | |COCH-ARM / FISHERS | P=0.005N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 45/50 (90%) 43/65 (66%) | |POLY-3 RATE (b) | 45/46.08 43/45.37 | |POLY-3 PERCENT (g) | 97.7% 94.8% | |TERMINAL (d) | 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 209 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002 ** | |POLY 3 | P=0.395N | |POLY 1.5 | P=0.032N* | |POLY 6 | P=0.809 | |LOGISTIC REGRESSION| P=0.022N* | |COCH-ARM / FISHERS | P=0.002N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 49 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Spleen | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 41/50 (82%) 59/65 (91%) | |POLY-3 RATE (b) | 41/43.06 59/59.63 | |POLY-3 PERCENT (g) | 95.2% 99.0% | |TERMINAL (d) | 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 201 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.153 | |POLY 1.5 | P=0.119 | |POLY 6 | P=0.393 | |LOGISTIC REGRESSION| P=0.065 | |COCH-ARM / FISHERS | P=0.135 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/50 (8%) 9/65 (14%) | |POLY-3 RATE (b) | 4/23.68 9/17.28 | |POLY-3 PERCENT (g) | 16.9% 52.1% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 201 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.040 * | |POLY 3 | P=0.021 * | |POLY 1.5 | P=0.076 | |POLY 6 | P=0.005 ** | |LOGISTIC REGRESSION| P=0.367 | |COCH-ARM / FISHERS | P=0.249 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 50 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Spleen: Red Pulp | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 0/21.06 2/11.23 | |POLY-3 PERCENT (g) | 0.0% 17.8% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.289 | |POLY 3 | P=0.263 | |POLY 1.5 | P=0.227 | |POLY 6 | P=0.555 | |LOGISTIC REGRESSION| P=0.427 | |COCH-ARM / FISHERS | P=0.317 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 9/65 (14%) | |POLY-3 RATE (b) | 2/22.11 9/16.84 | |POLY-3 PERCENT (g) | 9.1% 53.4% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 474 217 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** | |POLY 3 | P=0.003 ** | |POLY 1.5 | P=0.015 * | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.071 | |COCH-ARM / FISHERS | P=0.069 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 51 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 1/65 (2%) | |POLY-3 RATE (b) | 2/21.77 1/9.95 | |POLY-3 PERCENT (g) | 9.2% 10.1% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 593 482 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.399 | |POLY 3 | P=0.846 | |POLY 1.5 | P=0.622N | |POLY 6 | P=0.973 | |LOGISTIC REGRESSION| P=0.751 | |COCH-ARM / FISHERS | P=0.402N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Stomach, Forestomach | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/65 (3%) | |POLY-3 RATE (b) | 1/21.78 2/11.13 | |POLY-3 PERCENT (g) | 4.6% 18.0% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 474 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.465 | |POLY 3 | P=0.452 | |POLY 1.5 | P=0.466 | |POLY 6 | P=0.665 | |LOGISTIC REGRESSION| P=0.669 | |COCH-ARM / FISHERS | P=0.598 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 52 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 1/65 (2%) | |POLY-3 RATE (b) | 2/21.61 1/9.95 | |POLY-3 PERCENT (g) | 9.3% 10.1% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 593 482 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.399 | |POLY 3 | P=0.846 | |POLY 1.5 | P=0.621N | |POLY 6 | P=0.971 | |LOGISTIC REGRESSION| P=0.715 | |COCH-ARM / FISHERS | P=0.402N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Stomach, Glandular | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/65 (3%) | |POLY-3 RATE (b) | 0/21.06 2/10.92 | |POLY-3 PERCENT (g) | 0.0% 18.3% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 237 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.163 | |POLY 3 | P=0.268 | |POLY 1.5 | P=0.226 | |POLY 6 | P=0.570 | |LOGISTIC REGRESSION| P=0.329 | |COCH-ARM / FISHERS | P=0.317 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 53 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Stomach, Glandular | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 3/65 (5%) | |POLY-3 RATE (b) | 0/21.06 3/12.13 | |POLY-3 PERCENT (g) | 0.0% 24.7% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.180 | |POLY 3 | P=0.094 | |POLY 1.5 | P=0.103 | |POLY 6 | P=0.160 | |LOGISTIC REGRESSION| P=0.269 | |COCH-ARM / FISHERS | P=0.177 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Stomach, Glandular | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 5/65 (8%) | |POLY-3 RATE (b) | 1/21.72 5/13.58 | |POLY-3 PERCENT (g) | 4.6% 36.8% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 504 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.048 * | |POLY 3 | P=0.039 * | |POLY 1.5 | P=0.074 | |POLY 6 | P=0.027 * | |LOGISTIC REGRESSION| P=0.191 | |COCH-ARM / FISHERS | P=0.176 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 54 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 45/46 (98%) 57/59 (97%) | |POLY-3 RATE (b) | 45/45.07 57/57.15 | |POLY-3 PERCENT (g) | 99.8% 99.7% | |TERMINAL (d) | 10/10 (100%) 0/0 (0%) | |FIRST INCIDENCE | 201 91 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=1.000N | |POLY 1.5 | P=0.960N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.725 | |COCH-ARM / FISHERS | P=0.593N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Thyroid Gland | | Infiltration Cellular Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/49 (4%) 0/66 (0%) | |POLY-3 RATE (b) | 2/21.97 0/9.33 | |POLY-3 PERCENT (g) | 9.1% 0.0% | |TERMINAL (d) | 0/9 (0%) 0/0 (0%) | |FIRST INCIDENCE | 226 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.186N | |POLY 3 | P=0.734N | |POLY 1.5 | P=0.348N | |POLY 6 | P=1.000N | |LOGISTIC REGRESSION| P=0.095N | |COCH-ARM / FISHERS | P=0.179N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 55 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/49 (12%) 3/66 (5%) | |POLY-3 RATE (b) | 6/21.98 3/11.81 | |POLY-3 PERCENT (g) | 27.3% 25.4% | |TERMINAL (d) | 2/9 (22%) 0/0 (0%) | |FIRST INCIDENCE | 258 321 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.328 | |POLY 3 | P=0.701N | |POLY 1.5 | P=0.334N | |POLY 6 | P=0.687 | |LOGISTIC REGRESSION| P=0.489N | |COCH-ARM / FISHERS | P=0.122N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 29/49 (59%) 37/66 (56%) | |POLY-3 RATE (b) | 29/35.78 37/40.35 | |POLY-3 PERCENT (g) | 81.1% 91.7% | |TERMINAL (d) | 6/9 (67%) 0/0 (0%) | |FIRST INCIDENCE | 209 51 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.100 | |POLY 1.5 | P=0.328 | |POLY 6 | P=0.033 * | |LOGISTIC REGRESSION| P=0.393 | |COCH-ARM / FISHERS | P=0.443N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 56 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Tooth: Peridontal Tissue | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 23/23 (100%) 25/25 (100%) | |POLY-3 RATE (b) | 23/23.00 25/25.00 | |POLY-3 PERCENT (g) | 100.0% 100.0% | |TERMINAL (d) | 7/7 (100%) 0/0 (0%) | |FIRST INCIDENCE | 209 245 | |-------------------| | |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) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Uterus | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/50 (8%) 2/66 (3%) | |POLY-3 RATE (b) | 4/22.63 2/10.47 | |POLY-3 PERCENT (g) | 17.7% 19.1% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) | |FIRST INCIDENCE | 541 415 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.167 | |POLY 3 | P=0.767 | |POLY 1.5 | P=0.475N | |POLY 6 | P=0.843 | |LOGISTIC REGRESSION| P=0.641 | |COCH-ARM / FISHERS | P=0.219N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 06/10/04 EXPERIMENT: 96022 TEST: 02 Page 57 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Uterus | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/50 (16%) 0/66 (0%) | |POLY-3 RATE (b) | 8/23.38 0/9.33 | |POLY-3 PERCENT (g) | 34.2% 0.0% | |TERMINAL (d) | 3/10 (30%) 0/0 (0%) | |FIRST INCIDENCE | 494 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.506N | |POLY 3 | P=0.194N | |POLY 1.5 | P=0.012N* | |POLY 6 | P=0.982N | |LOGISTIC REGRESSION| P=0.097N | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 4000 NG/ 4000 NG/ | | | 500UG ST 500 UG | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 17/50 (34%) 8/66 (12%) | |POLY-3 RATE (b) | 17/24.95 8/15.68 | |POLY-3 PERCENT (g) | 68.2% 51.0% | |TERMINAL (d) | 8/10 (80%) 0/0 (0%) | |FIRST INCIDENCE | 273 243 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.022 * | |POLY 3 | P=0.241N | |POLY 1.5 | P=0.026N* | |POLY 6 | P=0.798 | |LOGISTIC REGRESSION| P=0.490N | |COCH-ARM / FISHERS | P=0.005N** | |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).