NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 11/15/04 EXPERIMENT: 96022 TEST: 02 TIME: 11:34:59 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX ------------------------------------------------------------------------------------------------------------------------------------ CONTROL + STOP STUDY FINAL #1; REVISION #1 RATS REASONS FOR REMOVAL: 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 0 NG TEQ/KG INCLUDE 007 360 NG TEQKG ST NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 11/15/04 EXPERIMENT: 96022 TEST: 02 TIME: 11:34:59 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 Intestine Large, Colon Parasite Metazoan Intestine Large, Rectum Parasite Metazoan Intestine Large, Rectum: Artery Inflammation Chronic Kidney Calculus Micro Observation Only Infarct Mineralization Nephropathy Kidney: Pelvis Inflammation Kidney: Renal Tubule Hyperplasia Kidney: Transitional Epithelium Hyperplasia Liver Angiectasis Basophilic Focus Cholangiofibrosis Clear Cell Focus Eosinophilic Focus Fatty Change Diffuse Fatty Change Focal Hematopoietic Cell Proliferation Hepatodiaphragmatic Nodule Hyperplasia Inflammation Metaplasia Mixed Cell Focus Necrosis Pigmentation Toxic Hepatopathy Liver: Bile Duct Cyst Fibrosis NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 11/15/04 EXPERIMENT: 96022 TEST: 02 TIME: 11:34:59 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX Hyperplasia Liver: Centrilobular Degeneration Fibrosis 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 Hemorrhage Hyperplasia Lymph Node: Mediastinal Ectasia Hemorrhage Hyperplasia Lymph Node: Pancreatic Hemorrhage Hyperplasia Lymph Node: Renal Hemorrhage Hyperplasia Mammary Gland Hyperplasia Inflammation Granulomatous Mesentery: Artery Inflammation Chronic Nose Inflammation Nose: Olfactory Epithelium Metaplasia Nose: Respiratory Epithelium Hyperplasia Oral Mucosa: Gingival Hyperplasia Ovary Atrophy Cyst Pancreas Edema Inflammation Chronic Pancreas: Acinus Atrophy Hyperplasia Vacuolization Cytoplasmic Pancreas: Artery Inflammation Chronic Pituitary Gland Angiectasis Cyst Cytoplasmic Alteration Vacuolization Cytoplasmic Pituitary Gland: Pars Distalis Hyperplasia Spleen Hematopoietic Cell Proliferation Pigmentation Spleen: Lymphoid Follicle Atrophy Stomach, Forestomach Hyperplasia Inflammation Ulcer Stomach, Glandular Mineralization Thymus Atrophy Thyroid Gland Infiltration Cellular Lymphoid NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 11/15/04 EXPERIMENT: 96022 TEST: 02 TIME: 11:34:59 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX Thyroid Gland: C-Cell Hyperplasia Thyroid Gland: Follicular Cell Hypertrophy Urinary Bladder Inflammation Urinary Bladder: Transitional Epithelium Hyperplasia Uterus Inflammation Inflammation Chronic Metaplasia Uterus: Endometrium Hyperplasia Cystic =============================================================== Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Adrenal Cortex | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 42/53 (79%) 21/50 (42%) | |POLY-3 RATE (b) | 42/48.03 21/28.18 | |POLY-3 PERCENT (g) | 87.4% 74.5% | |TERMINAL (d) | 26/27 (96%) 9/10 (90%) | |FIRST INCIDENCE | 482 232 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.190 | |POLY 3 | P=0.134N | |POLY 1.5 | P=0.017N* | |POLY 6 | P=0.364N | |LOGISTIC REGRESSION| P=0.169N | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Adrenal Cortex | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 12/50 (24%) | |POLY-3 RATE (b) | 2/42.18 12/30.21 | |POLY-3 PERCENT (g) | 4.7% 39.7% | |TERMINAL (d) | 1/27 (4%) 1/10 (10%) | |FIRST INCIDENCE | 649 226 | |-------------------| | |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=0.102 | |COCH-ARM / FISHERS | P=0.003 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 12/53 (23%) 9/50 (18%) | |POLY-3 RATE (b) | 12/43.80 9/22.95 | |POLY-3 PERCENT (g) | 27.4% 39.2% | |TERMINAL (d) | 6/27 (22%) 4/10 (40%) | |FIRST INCIDENCE | 482 504 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.098 | |POLY 3 | P=0.303 | |POLY 1.5 | P=0.438 | |POLY 6 | P=0.236 | |LOGISTIC REGRESSION| P=0.233 | |COCH-ARM / FISHERS | P=0.368N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 13/53 (25%) 10/50 (20%) | |POLY-3 RATE (b) | 13/44.54 10/25.67 | |POLY-3 PERCENT (g) | 29.2% 39.0% | |TERMINAL (d) | 5/27 (19%) 4/10 (40%) | |FIRST INCIDENCE | 362 258 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.109 | |POLY 3 | P=0.331 | |POLY 1.5 | P=0.454 | |POLY 6 | P=0.259 | |LOGISTIC REGRESSION| P=0.582 | |COCH-ARM / FISHERS | P=0.377N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 45/53 (85%) 29/50 (58%) | |POLY-3 RATE (b) | 45/48.89 29/31.75 | |POLY-3 PERCENT (g) | 92.1% 91.3% | |TERMINAL (d) | 26/27 (96%) 10/10 (100%) | |FIRST INCIDENCE | 275 230 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.009 ** | |POLY 3 | P=0.700N | |POLY 1.5 | P=0.243N | |POLY 6 | P=0.725 | |LOGISTIC REGRESSION| P=0.452 | |COCH-ARM / FISHERS | P=0.002N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Adrenal Cortex | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/41.89 2/22.11 | |POLY-3 PERCENT (g) | 0.0% 9.1% | |TERMINAL (d) | 0/27 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- 279 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.110 | |POLY 3 | P=0.230 | |POLY 1.5 | P=0.216 | |POLY 6 | P=0.247 | |LOGISTIC REGRESSION| P=0.288 | |COCH-ARM / FISHERS | P=0.233 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Adrenal Cortex | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 1/42.24 2/22.01 | |POLY-3 PERCENT (g) | 2.4% 9.1% | |TERMINAL (d) | 0/27 (0%) 1/10 (10%) | |FIRST INCIDENCE | 628 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.253 | |POLY 3 | P=0.417 | |POLY 1.5 | P=0.422 | |POLY 6 | P=0.425 | |LOGISTIC REGRESSION| P=0.536 | |COCH-ARM / FISHERS | P=0.478 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Adrenal Cortex | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 14/53 (26%) 16/50 (32%) | |POLY-3 RATE (b) | 14/44.09 16/26.74 | |POLY-3 PERCENT (g) | 31.8% 59.9% | |TERMINAL (d) | 6/27 (22%) 5/10 (50%) | |FIRST INCIDENCE | 564 201 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.003 ** | |POLY 3 | P=0.024 * | |POLY 1.5 | P=0.059 | |POLY 6 | P=0.015 * | |LOGISTIC REGRESSION| P=0.033 * | |COCH-ARM / FISHERS | P=0.342 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 13/53 (25%) 8/49 (16%) | |POLY-3 RATE (b) | 13/42.77 8/23.03 | |POLY-3 PERCENT (g) | 30.4% 34.7% | |TERMINAL (d) | 10/27 (37%) 3/9 (33%) | |FIRST INCIDENCE | 628 226 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.180 | |POLY 3 | P=0.523 | |POLY 1.5 | P=0.621N | |POLY 6 | P=0.452 | |LOGISTIC REGRESSION| P=0.448 | |COCH-ARM / FISHERS | P=0.219N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Blood Vessel: Aorta, Adventitia | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/41.89 2/22.98 | |POLY-3 PERCENT (g) | 0.0% 8.7% | |TERMINAL (d) | 0/27 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- 240 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.185 | |POLY 3 | P=0.225 | |POLY 1.5 | P=0.215 | |POLY 6 | P=0.239 | |LOGISTIC REGRESSION| P=0.898 | |COCH-ARM / FISHERS | P=0.233 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Blood Vessel: Aorta, Adventitia | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/41.89 2/22.99 | |POLY-3 PERCENT (g) | 0.0% 8.7% | |TERMINAL (d) | 0/27 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- 240 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.193 | |POLY 3 | P=0.225 | |POLY 1.5 | P=0.215 | |POLY 6 | P=0.239 | |LOGISTIC REGRESSION| P=0.951 | |COCH-ARM / FISHERS | P=0.233 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Bone Marrow | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 4/50 (8%) | |POLY-3 RATE (b) | 0/41.89 4/24.94 | |POLY-3 PERCENT (g) | 0.0% 16.0% | |TERMINAL (d) | 0/27 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- 201 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.051 | |POLY 3 | P=0.031 * | |POLY 1.5 | P=0.035 * | |POLY 6 | P=0.029 * | |LOGISTIC REGRESSION| (e) | |COCH-ARM / FISHERS | P=0.052 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 37/53 (70%) 40/50 (80%) | |POLY-3 RATE (b) | 37/51.61 40/46.05 | |POLY-3 PERCENT (g) | 71.7% 86.9% | |TERMINAL (d) | 14/27 (52%) 5/10 (50%) | |FIRST INCIDENCE | 275 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.054 | |POLY 1.5 | P=0.061 | |POLY 6 | P=0.062 | |LOGISTIC REGRESSION| P=0.555 | |COCH-ARM / FISHERS | P=0.168 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Brain | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 8/50 (16%) | |POLY-3 RATE (b) | 0/41.89 8/28.75 | |POLY-3 PERCENT (g) | 0.0% 27.8% | |TERMINAL (d) | 0/27 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- 201 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.583 | |COCH-ARM / FISHERS | P=0.002 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 49/53 (92%) 30/50 (60%) | |POLY-3 RATE (b) | 49/52.29 30/33.33 | |POLY-3 PERCENT (g) | 93.7% 90.0% | |TERMINAL (d) | 24/27 (89%) 9/10 (90%) | |FIRST INCIDENCE | 275 226 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.037 * | |POLY 3 | P=0.468N | |POLY 1.5 | P=0.076N | |POLY 6 | P=0.741N | |LOGISTIC REGRESSION| P=0.100N | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Clitoral Gland: Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 40/53 (75%) 40/50 (80%) | |POLY-3 RATE (b) | 40/50.23 40/43.50 | |POLY-3 PERCENT (g) | 79.6% 92.0% | |TERMINAL (d) | 20/27 (74%) 10/10 (100%) | |FIRST INCIDENCE | 313 226 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.070 | |POLY 1.5 | P=0.125 | |POLY 6 | P=0.039 * | |LOGISTIC REGRESSION| P=0.310 | |COCH-ARM / FISHERS | P=0.377 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Esophagus: Muscularis | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 0/50 (0%) | |POLY-3 RATE (b) | 3/42.85 0/21.06 | |POLY-3 PERCENT (g) | 7.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/10 (0%) | |FIRST INCIDENCE | 534 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.317N | |POLY 3 | P=0.430N | |POLY 1.5 | P=0.311N | |POLY 6 | P=0.533N | |LOGISTIC REGRESSION| P=0.180N | |COCH-ARM / FISHERS | P=0.132N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Harderian Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 24/53 (45%) 12/50 (24%) | |POLY-3 RATE (b) | 24/45.26 12/26.40 | |POLY-3 PERCENT (g) | 53.0% 45.5% | |TERMINAL (d) | 15/27 (56%) 5/10 (50%) | |FIRST INCIDENCE | 313 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.387 | |POLY 3 | P=0.396N | |POLY 1.5 | P=0.210N | |POLY 6 | P=0.545N | |LOGISTIC REGRESSION| P=0.183N | |COCH-ARM / FISHERS | P=0.019N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 20/53 (38%) 15/50 (30%) | |POLY-3 RATE (b) | 20/45.03 15/28.08 | |POLY-3 PERCENT (g) | 44.4% 53.4% | |TERMINAL (d) | 11/27 (41%) 3/10 (30%) | |FIRST INCIDENCE | 534 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.065 | |POLY 3 | P=0.338 | |POLY 1.5 | P=0.489 | |POLY 6 | P=0.273 | |LOGISTIC REGRESSION| P=0.523 | |COCH-ARM / FISHERS | P=0.268N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Heart: Coronary Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 6/50 (12%) | |POLY-3 RATE (b) | 1/41.89 6/24.90 | |POLY-3 PERCENT (g) | 2.4% 24.1% | |TERMINAL (d) | 1/27 (4%) 0/10 (0%) | |FIRST INCIDENCE | 726 (T) 273 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.005 ** | |POLY 3 | P=0.015 * | |POLY 1.5 | P=0.020 * | |POLY 6 | P=0.013 * | |LOGISTIC REGRESSION| P=0.071 | |COCH-ARM / FISHERS | P=0.048 * | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Intestine Large, Colon | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 2/41.97 1/21.06 | |POLY-3 PERCENT (g) | 4.8% 4.8% | |TERMINAL (d) | 1/27 (4%) 1/10 (10%) | |FIRST INCIDENCE | 707 726 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.652 | |POLY 3 | P=0.820N | |POLY 1.5 | P=0.739N | |POLY 6 | P=0.825 | |LOGISTIC REGRESSION| P=0.674 | |COCH-ARM / FISHERS | P=0.522N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Intestine Large, Rectum | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/52 (6%) 1/50 (2%) | |POLY-3 RATE (b) | 3/41.84 1/22.02 | |POLY-3 PERCENT (g) | 7.2% 4.5% | |TERMINAL (d) | 1/27 (4%) 0/10 (0%) | |FIRST INCIDENCE | 567 254 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.594N | |POLY 3 | P=0.656N | |POLY 1.5 | P=0.550N | |POLY 6 | P=0.733N | |LOGISTIC REGRESSION| P=0.287N | |COCH-ARM / FISHERS | P=0.324N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Intestine Large, Rectum: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/52 (0%) 4/50 (8%) | |POLY-3 RATE (b) | 0/41.24 4/21.71 | |POLY-3 PERCENT (g) | 0.0% 18.4% | |TERMINAL (d) | 0/27 (0%) 2/10 (20%) | |FIRST INCIDENCE | --- 607 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** | |POLY 3 | P=0.030 * | |POLY 1.5 | P=0.033 * | |POLY 6 | P=0.030 * | |LOGISTIC REGRESSION| P=0.007 ** | |COCH-ARM / FISHERS | P=0.054 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Kidney | | Calculus Micro Observation Only | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/53 (11%) 0/50 (0%) | |POLY-3 RATE (b) | 6/42.65 0/21.06 | |POLY-3 PERCENT (g) | 14.1% 0.0% | |TERMINAL (d) | 4/27 (15%) 0/10 (0%) | |FIRST INCIDENCE | 586 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.132N | |POLY 3 | P=0.169N | |POLY 1.5 | P=0.094N | |POLY 6 | P=0.249N | |LOGISTIC REGRESSION| P=0.093N | |COCH-ARM / FISHERS | P=0.016N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 2/41.89 0/21.06 | |POLY-3 PERCENT (g) | 4.8% 0.0% | |TERMINAL (d) | 2/27 (7%) 0/10 (0%) | |FIRST INCIDENCE | 726 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.474N | |POLY 3 | P=0.579N | |POLY 1.5 | P=0.464N | |POLY 6 | P=0.667N | |LOGISTIC REGRESSION| (e) | |COCH-ARM / FISHERS | P=0.262N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 46/53 (87%) 32/50 (64%) | |POLY-3 RATE (b) | 46/51.13 32/39.76 | |POLY-3 PERCENT (g) | 90.0% 80.5% | |TERMINAL (d) | 23/27 (85%) 7/10 (70%) | |FIRST INCIDENCE | 313 201 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.020 * | |POLY 3 | P=0.157N | |POLY 1.5 | P=0.065N | |POLY 6 | P=0.283N | |LOGISTIC REGRESSION| P=0.021N* | |COCH-ARM / FISHERS | P=0.006N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 14 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 41/53 (77%) 34/50 (68%) | |POLY-3 RATE (b) | 41/49.70 34/34.66 | |POLY-3 PERCENT (g) | 82.5% 98.1% | |TERMINAL (d) | 24/27 (89%) 10/10 (100%) | |FIRST INCIDENCE | 275 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.021 * | |POLY 1.5 | P=0.112 | |POLY 6 | P=0.020 * | |LOGISTIC REGRESSION| P=0.045 * | |COCH-ARM / FISHERS | P=0.199N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Kidney: Pelvis | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 0/50 (0%) | |POLY-3 RATE (b) | 4/42.25 0/21.06 | |POLY-3 PERCENT (g) | 9.5% 0.0% | |TERMINAL (d) | 2/27 (7%) 0/10 (0%) | |FIRST INCIDENCE | 672 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.255N | |POLY 3 | P=0.306N | |POLY 1.5 | P=0.205N | |POLY 6 | P=0.400N | |LOGISTIC REGRESSION| P=0.211N | |COCH-ARM / FISHERS | P=0.066N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 15 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 2/42.10 0/21.06 | |POLY-3 PERCENT (g) | 4.8% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/10 (0%) | |FIRST INCIDENCE | 672 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.477N | |POLY 3 | P=0.582N | |POLY 1.5 | P=0.465N | |POLY 6 | P=0.673N | |LOGISTIC REGRESSION| P=0.430N | |COCH-ARM / FISHERS | P=0.262N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Kidney: Transitional Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 0/50 (0%) | |POLY-3 RATE (b) | 4/42.25 0/21.06 | |POLY-3 PERCENT (g) | 9.5% 0.0% | |TERMINAL (d) | 2/27 (7%) 0/10 (0%) | |FIRST INCIDENCE | 672 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.255N | |POLY 3 | P=0.306N | |POLY 1.5 | P=0.205N | |POLY 6 | P=0.400N | |LOGISTIC REGRESSION| P=0.211N | |COCH-ARM / FISHERS | P=0.066N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 16 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 4/50 (8%) | |POLY-3 RATE (b) | 0/41.89 4/21.49 | |POLY-3 PERCENT (g) | 0.0% 18.6% | |TERMINAL (d) | 0/27 (0%) 3/10 (30%) | |FIRST INCIDENCE | --- 601 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** | |POLY 3 | P=0.029 * | |POLY 1.5 | P=0.032 * | |POLY 6 | P=0.029 * | |LOGISTIC REGRESSION| P=0.005 ** | |COCH-ARM / FISHERS | P=0.052 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 27/53 (51%) 5/50 (10%) | |POLY-3 RATE (b) | 27/45.63 5/21.73 | |POLY-3 PERCENT (g) | 59.2% 23.0% | |TERMINAL (d) | 16/27 (59%) 3/10 (30%) | |FIRST INCIDENCE | 534 601 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.053N | |POLY 3 | P=0.013N* | |POLY 1.5 | P<0.001N** | |POLY 6 | P=0.051N | |LOGISTIC REGRESSION| P=0.006N** | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 17 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver | | Cholangiofibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 27/50 (54%) | |POLY-3 RATE (b) | 1/41.89 27/33.72 | |POLY-3 PERCENT (g) | 2.4% 80.1% | |TERMINAL (d) | 1/27 (4%) 8/10 (80%) | |FIRST INCIDENCE | 726 (T) 201 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/53 (9%) 1/50 (2%) | |POLY-3 RATE (b) | 5/42.17 1/21.06 | |POLY-3 PERCENT (g) | 11.9% 4.8% | |TERMINAL (d) | 4/27 (15%) 1/10 (10%) | |FIRST INCIDENCE | 651 726 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.448N | |POLY 3 | P=0.442N | |POLY 1.5 | P=0.317N | |POLY 6 | P=0.542N | |LOGISTIC REGRESSION| P=0.416N | |COCH-ARM / FISHERS | P=0.116N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 18 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/53 (19%) 15/50 (30%) | |POLY-3 RATE (b) | 10/43.62 15/28.06 | |POLY-3 PERCENT (g) | 22.9% 53.5% | |TERMINAL (d) | 6/27 (22%) 3/10 (30%) | |FIRST INCIDENCE | 534 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.010 * | |POLY 1.5 | P=0.021 * | |POLY 6 | P=0.007 ** | |LOGISTIC REGRESSION| P=0.040 * | |COCH-ARM / FISHERS | P=0.138 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver | | Fatty Change Diffuse | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 35/50 (70%) | |POLY-3 RATE (b) | 3/42.21 35/43.37 | |POLY-3 PERCENT (g) | 7.1% 80.7% | |TERMINAL (d) | 2/27 (7%) 7/10 (70%) | |FIRST INCIDENCE | 639 201 | |-------------------| | |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: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 19 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver | | Fatty Change Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/53 (19%) 14/50 (28%) | |POLY-3 RATE (b) | 10/43.19 14/24.02 | |POLY-3 PERCENT (g) | 23.2% 58.3% | |TERMINAL (d) | 5/27 (19%) 7/10 (70%) | |FIRST INCIDENCE | 586 282 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.007 ** | |POLY 1.5 | P=0.022 * | |POLY 6 | P=0.003 ** | |LOGISTIC REGRESSION| P=0.003 ** | |COCH-ARM / FISHERS | P=0.194 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 27/53 (51%) 22/50 (44%) | |POLY-3 RATE (b) | 27/48.61 22/29.47 | |POLY-3 PERCENT (g) | 55.6% 74.6% | |TERMINAL (d) | 11/27 (41%) 8/10 (80%) | |FIRST INCIDENCE | 275 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.010 * | |POLY 3 | P=0.087 | |POLY 1.5 | P=0.221 | |POLY 6 | P=0.047 * | |LOGISTIC REGRESSION| P=0.348 | |COCH-ARM / FISHERS | P=0.306N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 2/41.89 1/21.15 | |POLY-3 PERCENT (g) | 4.8% 4.7% | |TERMINAL (d) | 2/27 (7%) 0/10 (0%) | |FIRST INCIDENCE | 726 (T) 703 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.660 | |POLY 3 | P=0.818N | |POLY 1.5 | P=0.737N | |POLY 6 | P=0.825 | |LOGISTIC REGRESSION| P=0.675 | |COCH-ARM / FISHERS | P=0.522N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 34/50 (68%) | |POLY-3 RATE (b) | 0/41.89 34/44.64 | |POLY-3 PERCENT (g) | 0.0% 76.2% | |TERMINAL (d) | 0/27 (0%) 4/10 (40%) | |FIRST INCIDENCE | --- 201 | |-------------------| | |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: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 21 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 49/53 (92%) 48/50 (96%) | |POLY-3 RATE (b) | 49/51.05 48/48.82 | |POLY-3 PERCENT (g) | 96.0% 98.3% | |TERMINAL (d) | 26/27 (96%) 10/10 (100%) | |FIRST INCIDENCE | 313 201 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.460 | |POLY 1.5 | P=0.408 | |POLY 6 | P=0.541 | |LOGISTIC REGRESSION| P=0.208 | |COCH-ARM / FISHERS | P=0.367 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/41.89 2/22.97 | |POLY-3 PERCENT (g) | 0.0% 8.7% | |TERMINAL (d) | 0/27 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- 232 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.179 | |POLY 3 | P=0.225 | |POLY 1.5 | P=0.215 | |POLY 6 | P=0.239 | |LOGISTIC REGRESSION| P=0.882 | |COCH-ARM / FISHERS | P=0.233 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 22 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 38/53 (72%) 20/50 (40%) | |POLY-3 RATE (b) | 38/45.68 20/26.46 | |POLY-3 PERCENT (g) | 83.2% 75.6% | |TERMINAL (d) | 26/27 (96%) 10/10 (100%) | |FIRST INCIDENCE | 534 282 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.082 | |POLY 3 | P=0.349N | |POLY 1.5 | P=0.095N | |POLY 6 | P=0.599N | |LOGISTIC REGRESSION| P=0.536 | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 6/50 (12%) | |POLY-3 RATE (b) | 3/42.94 6/25.40 | |POLY-3 PERCENT (g) | 7.0% 23.6% | |TERMINAL (d) | 0/27 (0%) 0/10 (0%) | |FIRST INCIDENCE | 564 201 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.051 | |POLY 3 | P=0.083 | |POLY 1.5 | P=0.108 | |POLY 6 | P=0.071 | |LOGISTIC REGRESSION| P=0.499 | |COCH-ARM / FISHERS | P=0.216 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 23 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/53 (9%) 50/50 (100%) | |POLY-3 RATE (b) | 5/43.23 50/50.00 | |POLY-3 PERCENT (g) | 11.6% 100.0% | |TERMINAL (d) | 2/27 (7%) 10/10 (100%) | |FIRST INCIDENCE | 534 201 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver | | Toxic Hepatopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 50/50 (100%) | |POLY-3 RATE (b) | 0/41.89 50/50.00 | |POLY-3 PERCENT (g) | 0.0% 100.0% | |TERMINAL (d) | 0/27 (0%) 10/10 (100%) | |FIRST INCIDENCE | --- 201 | |-------------------| | |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: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 24 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver: Bile Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 21/50 (42%) | |POLY-3 RATE (b) | 4/42.10 21/25.42 | |POLY-3 PERCENT (g) | 9.5% 82.6% | |TERMINAL (d) | 3/27 (11%) 9/10 (90%) | |FIRST INCIDENCE | 672 474 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver: Bile Duct | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/53 (11%) 12/50 (24%) | |POLY-3 RATE (b) | 6/42.12 12/24.42 | |POLY-3 PERCENT (g) | 14.2% 49.2% | |TERMINAL (d) | 5/27 (19%) 3/10 (30%) | |FIRST INCIDENCE | 665 383 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.004 ** | |POLY 1.5 | P=0.009 ** | |POLY 6 | P=0.003 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P=0.075 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 25 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/53 (9%) 37/50 (74%) | |POLY-3 RATE (b) | 5/42.04 37/44.10 | |POLY-3 PERCENT (g) | 11.9% 83.9% | |TERMINAL (d) | 4/27 (15%) 5/10 (50%) | |FIRST INCIDENCE | 687 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver: Centrilobular | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 6/50 (12%) | |POLY-3 RATE (b) | 2/42.71 6/25.86 | |POLY-3 PERCENT (g) | 4.7% 23.2% | |TERMINAL (d) | 0/27 (0%) 1/10 (10%) | |FIRST INCIDENCE | 564 201 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.036 * | |POLY 3 | P=0.042 * | |POLY 1.5 | P=0.056 | |POLY 6 | P=0.034 * | |LOGISTIC REGRESSION| P=0.609 | |COCH-ARM / FISHERS | P=0.117 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 26 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver: Centrilobular | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 43/50 (86%) | |POLY-3 RATE (b) | 0/41.89 43/50.00 | |POLY-3 PERCENT (g) | 0.0% 86.0% | |TERMINAL (d) | 0/27 (0%) 3/10 (30%) | |FIRST INCIDENCE | --- 201 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver: Hepatocyte | | Glandular Structures | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 9/50 (18%) | |POLY-3 RATE (b) | 0/41.89 9/29.71 | |POLY-3 PERCENT (g) | 0.0% 30.3% | |TERMINAL (d) | 0/27 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- 226 | |-------------------| | |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=0.563 | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 27 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver: Hepatocyte | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 36/50 (72%) | |POLY-3 RATE (b) | 0/41.89 36/45.73 | |POLY-3 PERCENT (g) | 0.0% 78.7% | |TERMINAL (d) | 0/27 (0%) 5/10 (50%) | |FIRST INCIDENCE | --- 201 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver: Hepatocyte | | Multinucleated | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 38/50 (76%) | |POLY-3 RATE (b) | 0/41.89 38/44.81 | |POLY-3 PERCENT (g) | 0.0% 84.8% | |TERMINAL (d) | 0/27 (0%) 5/10 (50%) | |FIRST INCIDENCE | --- 201 | |-------------------| | |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: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 28 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver: Oval Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 43/50 (86%) | |POLY-3 RATE (b) | 4/41.89 43/48.43 | |POLY-3 PERCENT (g) | 9.6% 88.8% | |TERMINAL (d) | 4/27 (15%) 5/10 (50%) | |FIRST INCIDENCE | 726 (T) 201 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Liver: Portal | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 42/50 (84%) | |POLY-3 RATE (b) | 0/41.89 42/48.26 | |POLY-3 PERCENT (g) | 0.0% 87.0% | |TERMINAL (d) | 0/27 (0%) 5/10 (50%) | |FIRST INCIDENCE | --- 201 | |-------------------| | |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: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 29 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 3/50 (6%) | |POLY-3 RATE (b) | 0/41.89 3/23.69 | |POLY-3 PERCENT (g) | 0.0% 12.7% | |TERMINAL (d) | 0/27 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- 226 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.063 | |POLY 3 | P=0.083 | |POLY 1.5 | P=0.085 | |POLY 6 | P=0.084 | |LOGISTIC REGRESSION| P=0.467 | |COCH-ARM / FISHERS | P=0.111 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 40/53 (75%) 24/50 (48%) | |POLY-3 RATE (b) | 40/49.03 24/32.50 | |POLY-3 PERCENT (g) | 81.6% 73.8% | |TERMINAL (d) | 21/27 (78%) 6/10 (60%) | |FIRST INCIDENCE | 362 226 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.078 | |POLY 3 | P=0.312N | |POLY 1.5 | P=0.131N | |POLY 6 | P=0.420N | |LOGISTIC REGRESSION| P=0.190N | |COCH-ARM / FISHERS | P=0.004N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 30 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lung | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/53 (9%) 6/50 (12%) | |POLY-3 RATE (b) | 5/43.02 6/23.16 | |POLY-3 PERCENT (g) | 11.6% 25.9% | |TERMINAL (d) | 3/27 (11%) 2/10 (20%) | |FIRST INCIDENCE | 534 267 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.071 | |POLY 3 | P=0.185 | |POLY 1.5 | P=0.244 | |POLY 6 | P=0.156 | |LOGISTIC REGRESSION| P=0.248 | |COCH-ARM / FISHERS | P=0.459 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lung | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 4/50 (8%) | |POLY-3 RATE (b) | 0/41.89 4/22.05 | |POLY-3 PERCENT (g) | 0.0% 18.1% | |TERMINAL (d) | 0/27 (0%) 2/10 (20%) | |FIRST INCIDENCE | --- 561 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.006 ** | |POLY 3 | P=0.029 * | |POLY 1.5 | P=0.032 * | |POLY 6 | P=0.029 * | |LOGISTIC REGRESSION| P=0.011 * | |COCH-ARM / FISHERS | P=0.052 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 31 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lung | | Keratin Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 9/50 (18%) | |POLY-3 RATE (b) | 0/41.89 9/23.33 | |POLY-3 PERCENT (g) | 0.0% 38.6% | |TERMINAL (d) | 0/27 (0%) 3/10 (30%) | |FIRST INCIDENCE | --- 525 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lung | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 8/50 (16%) | |POLY-3 RATE (b) | 0/41.89 8/22.72 | |POLY-3 PERCENT (g) | 0.0% 35.2% | |TERMINAL (d) | 0/27 (0%) 4/10 (40%) | |FIRST INCIDENCE | --- 541 | |-------------------| | |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=0.002 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 32 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 18/53 (34%) 5/50 (10%) | |POLY-3 RATE (b) | 18/43.48 5/22.02 | |POLY-3 PERCENT (g) | 41.4% 22.7% | |TERMINAL (d) | 13/27 (48%) 3/10 (30%) | |FIRST INCIDENCE | 534 383 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.311N | |POLY 3 | P=0.161N | |POLY 1.5 | P=0.062N | |POLY 6 | P=0.282N | |LOGISTIC REGRESSION| P=0.156N | |COCH-ARM / FISHERS | P=0.003N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Metaplasia Bronchiolar | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 15/50 (30%) | |POLY-3 RATE (b) | 1/41.89 15/27.99 | |POLY-3 PERCENT (g) | 2.4% 53.6% | |TERMINAL (d) | 1/27 (4%) 3/10 (30%) | |FIRST INCIDENCE | 726 (T) 226 | |-------------------| | |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: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 33 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lung: Serosa | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 1/50 (2%) | |POLY-3 RATE (b) | 3/42.18 1/22.01 | |POLY-3 PERCENT (g) | 7.1% 4.5% | |TERMINAL (d) | 2/27 (7%) 0/10 (0%) | |FIRST INCIDENCE | 649 273 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.622N | |POLY 3 | P=0.660N | |POLY 1.5 | P=0.557N | |POLY 6 | P=0.731N | |LOGISTIC REGRESSION| P=0.366N | |COCH-ARM / FISHERS | P=0.331N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 11/49 (22%) | |POLY-3 RATE (b) | 3/42.29 11/24.51 | |POLY-3 PERCENT (g) | 7.1% 44.9% | |TERMINAL (d) | 1/27 (4%) 3/10 (30%) | |FIRST INCIDENCE | 639 247 | |-------------------| | |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=0.014 * | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 34 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 4/49 (8%) | |POLY-3 RATE (b) | 0/41.89 4/24.84 | |POLY-3 PERCENT (g) | 0.0% 16.1% | |TERMINAL (d) | 0/27 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- 230 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.035 * | |POLY 3 | P=0.030 * | |POLY 1.5 | P=0.034 * | |POLY 6 | P=0.028 * | |LOGISTIC REGRESSION| P=0.677 | |COCH-ARM / FISHERS | P=0.050 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 45/53 (85%) 28/49 (57%) | |POLY-3 RATE (b) | 45/51.67 28/32.76 | |POLY-3 PERCENT (g) | 87.1% 85.5% | |TERMINAL (d) | 24/27 (89%) 10/10 (100%) | |FIRST INCIDENCE | 275 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.039 * | |POLY 3 | P=0.597N | |POLY 1.5 | P=0.192N | |POLY 6 | P=0.492 | |LOGISTIC REGRESSION| P=0.096N | |COCH-ARM / FISHERS | P=0.002N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 35 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 10/50 (20%) | |POLY-3 RATE (b) | 0/41.89 10/28.48 | |POLY-3 PERCENT (g) | 0.0% 35.1% | |TERMINAL (d) | 0/27 (0%) 1/10 (10%) | |FIRST INCIDENCE | --- 226 | |-------------------| | |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=0.030 * | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 2/50 (4%) | |POLY-3 RATE (b) | 3/42.49 2/22.10 | |POLY-3 PERCENT (g) | 7.1% 9.1% | |TERMINAL (d) | 1/27 (4%) 0/10 (0%) | |FIRST INCIDENCE | 639 541 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.491 | |POLY 3 | P=0.672 | |POLY 1.5 | P=0.703 | |POLY 6 | P=0.659 | |LOGISTIC REGRESSION| P=0.695 | |COCH-ARM / FISHERS | P=0.528N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 36 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/28 (25%) 3/22 (14%) | |POLY-3 RATE (b) | 7/23.39 3/10.39 | |POLY-3 PERCENT (g) | 29.9% 28.9% | |TERMINAL (d) | 2/12 (17%) 0/2 (0%) | |FIRST INCIDENCE | 275 254 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.599 | |POLY 3 | P=0.719N | |POLY 1.5 | P=0.566N | |POLY 6 | P=0.702 | |LOGISTIC REGRESSION| P=0.287N | |COCH-ARM / FISHERS | P=0.263N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/28 (7%) 11/22 (50%) | |POLY-3 RATE (b) | 2/21.96 11/16.43 | |POLY-3 PERCENT (g) | 9.1% 67.0% | |TERMINAL (d) | 0/12 (0%) 0/2 (0%) | |FIRST INCIDENCE | 586 226 | |-------------------| | |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=0.010 * | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 37 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 4/22 (18%) | |POLY-3 RATE (b) | 0/21.26 4/10.38 | |POLY-3 PERCENT (g) | 0.0% 38.5% | |TERMINAL (d) | 0/12 (0%) 0/2 (0%) | |FIRST INCIDENCE | --- 594 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.006 ** | |POLY 3 | P=0.015 * | |POLY 1.5 | P=0.018 * | |POLY 6 | P=0.013 * | |LOGISTIC REGRESSION| P=0.008 ** | |COCH-ARM / FISHERS | P=0.032 * | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lymph Node: Pancreatic | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 3/22 (14%) | |POLY-3 RATE (b) | 0/21.26 3/11.01 | |POLY-3 PERCENT (g) | 0.0% 27.3% | |TERMINAL (d) | 0/12 (0%) 0/2 (0%) | |FIRST INCIDENCE | --- 230 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.048 * | |POLY 3 | P=0.061 | |POLY 1.5 | P=0.065 | |POLY 6 | P=0.061 | |LOGISTIC REGRESSION| P=0.241 | |COCH-ARM / FISHERS | P=0.079 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 38 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lymph Node: Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 3/22 (14%) | |POLY-3 RATE (b) | 0/21.26 3/11.01 | |POLY-3 PERCENT (g) | 0.0% 27.3% | |TERMINAL (d) | 0/12 (0%) 0/2 (0%) | |FIRST INCIDENCE | --- 230 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.048 * | |POLY 3 | P=0.061 | |POLY 1.5 | P=0.065 | |POLY 6 | P=0.061 | |LOGISTIC REGRESSION| P=0.241 | |COCH-ARM / FISHERS | P=0.079 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lymph Node: Renal | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 2/22 (9%) | |POLY-3 RATE (b) | 0/21.26 2/9.18 | |POLY-3 PERCENT (g) | 0.0% 21.8% | |TERMINAL (d) | 0/12 (0%) 1/2 (50%) | |FIRST INCIDENCE | --- 636 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.033 * | |POLY 3 | P=0.225 | |POLY 1.5 | P=0.200 | |POLY 6 | P=0.285 | |LOGISTIC REGRESSION| P=0.039 * | |COCH-ARM / FISHERS | P=0.189 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 39 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Lymph Node: Renal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/28 (0%) 3/22 (14%) | |POLY-3 RATE (b) | 0/21.26 3/9.93 | |POLY-3 PERCENT (g) | 0.0% 30.2% | |TERMINAL (d) | 0/12 (0%) 0/2 (0%) | |FIRST INCIDENCE | --- 601 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.020 * | |POLY 3 | P=0.062 | |POLY 1.5 | P=0.063 | |POLY 6 | P=0.064 | |LOGISTIC REGRESSION| P=0.025 * | |COCH-ARM / FISHERS | P=0.079 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 26/53 (49%) 11/50 (22%) | |POLY-3 RATE (b) | 26/46.93 11/23.96 | |POLY-3 PERCENT (g) | 55.4% 45.9% | |TERMINAL (d) | 14/27 (52%) 4/10 (40%) | |FIRST INCIDENCE | 313 282 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.531 | |POLY 3 | P=0.369N | |POLY 1.5 | P=0.144N | |POLY 6 | P=0.559N | |LOGISTIC REGRESSION| P=0.161N | |COCH-ARM / FISHERS | P=0.004N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 40 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Mammary Gland | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 1/50 (2%) | |POLY-3 RATE (b) | 3/42.81 1/21.06 | |POLY-3 PERCENT (g) | 7.0% 4.8% | |TERMINAL (d) | 1/27 (4%) 1/10 (10%) | |FIRST INCIDENCE | 555 726 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.654N | |POLY 3 | P=0.693N | |POLY 1.5 | P=0.578N | |POLY 6 | P=0.774N | |LOGISTIC REGRESSION| P=0.524N | |COCH-ARM / FISHERS | P=0.331N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Mesentery: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 7/43 (16%) | |POLY-3 RATE (b) | 0/41.89 7/21.52 | |POLY-3 PERCENT (g) | 0.0% 32.5% | |TERMINAL (d) | 0/27 (0%) 1/9 (11%) | |FIRST INCIDENCE | --- 451 | |-------------------| | |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=0.003 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 41 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 17/53 (32%) 11/50 (22%) | |POLY-3 RATE (b) | 17/45.19 11/25.60 | |POLY-3 PERCENT (g) | 37.6% 43.0% | |TERMINAL (d) | 10/27 (37%) 1/10 (10%) | |FIRST INCIDENCE | 275 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.184 | |POLY 3 | P=0.473 | |POLY 1.5 | P=0.614 | |POLY 6 | P=0.420 | |LOGISTIC REGRESSION| P=0.549N | |COCH-ARM / FISHERS | P=0.177N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 5/50 (10%) | |POLY-3 RATE (b) | 0/41.89 5/22.14 | |POLY-3 PERCENT (g) | 0.0% 22.6% | |TERMINAL (d) | 0/27 (0%) 1/10 (10%) | |FIRST INCIDENCE | --- 593 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002 ** | |POLY 3 | P=0.010 * | |POLY 1.5 | P=0.012 * | |POLY 6 | P=0.009 ** | |LOGISTIC REGRESSION| P=0.003 ** | |COCH-ARM / FISHERS | P=0.024 * | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 42 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/53 (15%) 10/50 (20%) | |POLY-3 RATE (b) | 8/43.10 10/24.54 | |POLY-3 PERCENT (g) | 18.6% 40.7% | |TERMINAL (d) | 5/27 (19%) 1/10 (10%) | |FIRST INCIDENCE | 564 474 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.014 * | |POLY 3 | P=0.066 | |POLY 1.5 | P=0.107 | |POLY 6 | P=0.054 | |LOGISTIC REGRESSION| P=0.055 | |COCH-ARM / FISHERS | P=0.346 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Oral Mucosa: Gingival | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/53 (21%) 18/50 (36%) | |POLY-3 RATE (b) | 11/43.10 18/29.52 | |POLY-3 PERCENT (g) | 25.5% 61.0% | |TERMINAL (d) | 7/27 (26%) 3/10 (30%) | |FIRST INCIDENCE | 582 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.002 ** | |POLY 1.5 | P=0.005 ** | |POLY 6 | P=0.002 ** | |LOGISTIC REGRESSION| P=0.006 ** | |COCH-ARM / FISHERS | P=0.067 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 43 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Ovary | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 46/53 (87%) 15/50 (30%) | |POLY-3 RATE (b) | 46/50.65 15/27.64 | |POLY-3 PERCENT (g) | 90.8% 54.3% | |TERMINAL (d) | 25/27 (93%) 6/10 (60%) | |FIRST INCIDENCE | 275 226 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.173N | |POLY 3 | P<0.001N** | |POLY 1.5 | P<0.001N** | |POLY 6 | P=0.003N** | |LOGISTIC REGRESSION| P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 19/53 (36%) 7/50 (14%) | |POLY-3 RATE (b) | 19/44.54 7/22.45 | |POLY-3 PERCENT (g) | 42.7% 31.2% | |TERMINAL (d) | 13/27 (48%) 2/10 (20%) | |FIRST INCIDENCE | 313 525 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.532N | |POLY 3 | P=0.327N | |POLY 1.5 | P=0.156N | |POLY 6 | P=0.455N | |LOGISTIC REGRESSION| P=0.241N | |COCH-ARM / FISHERS | P=0.009N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 44 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Pancreas | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 12/50 (24%) | |POLY-3 RATE (b) | 0/41.89 12/31.74 | |POLY-3 PERCENT (g) | 0.0% 37.8% | |TERMINAL (d) | 0/27 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- 226 | |-------------------| | |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=0.081 | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Pancreas | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 5/50 (10%) | |POLY-3 RATE (b) | 1/42.38 5/22.51 | |POLY-3 PERCENT (g) | 2.4% 22.2% | |TERMINAL (d) | 0/27 (0%) 2/10 (20%) | |FIRST INCIDENCE | 582 541 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.008 ** | |POLY 3 | P=0.034 * | |POLY 1.5 | P=0.042 * | |POLY 6 | P=0.031 * | |LOGISTIC REGRESSION| P=0.024 * | |COCH-ARM / FISHERS | P=0.090 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 45 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 8/50 (16%) | |POLY-3 RATE (b) | 1/41.89 8/24.21 | |POLY-3 PERCENT (g) | 2.4% 33.0% | |TERMINAL (d) | 1/27 (4%) 3/10 (30%) | |FIRST INCIDENCE | 726 (T) 258 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.002 ** | |POLY 1.5 | P=0.003 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.004 ** | |COCH-ARM / FISHERS | P=0.012 * | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Pancreas: Acinus | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 2/42.36 0/21.06 | |POLY-3 PERCENT (g) | 4.7% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/10 (0%) | |FIRST INCIDENCE | 639 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.473N | |POLY 3 | P=0.586N | |POLY 1.5 | P=0.467N | |POLY 6 | P=0.681N | |LOGISTIC REGRESSION| P=0.371N | |COCH-ARM / FISHERS | P=0.262N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 46 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Pancreas: Acinus | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 41/50 (82%) | |POLY-3 RATE (b) | 0/41.89 41/41.99 | |POLY-3 PERCENT (g) | 0.0% 97.7% | |TERMINAL (d) | 0/27 (0%) 10/10 (100%) | |FIRST INCIDENCE | --- 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Pancreas: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 10/50 (20%) | |POLY-3 RATE (b) | 0/41.89 10/24.82 | |POLY-3 PERCENT (g) | 0.0% 40.3% | |TERMINAL (d) | 0/27 (0%) 3/10 (30%) | |FIRST INCIDENCE | --- 401 | |-------------------| | |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: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 47 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Pituitary Gland | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 23/53 (43%) 3/50 (6%) | |POLY-3 RATE (b) | 23/44.91 3/21.06 | |POLY-3 PERCENT (g) | 51.2% 14.3% | |TERMINAL (d) | 15/27 (56%) 3/10 (30%) | |FIRST INCIDENCE | 564 726 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.024N* | |POLY 3 | P=0.012N* | |POLY 1.5 | P<0.001N** | |POLY 6 | P=0.048N* | |LOGISTIC REGRESSION| P=0.005N** | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Pituitary Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 3/50 (6%) | |POLY-3 RATE (b) | 1/42.21 3/23.88 | |POLY-3 PERCENT (g) | 2.4% 12.6% | |TERMINAL (d) | 0/27 (0%) 0/10 (0%) | |FIRST INCIDENCE | 639 258 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.135 | |POLY 3 | P=0.204 | |POLY 1.5 | P=0.218 | |POLY 6 | P=0.198 | |LOGISTIC REGRESSION| P=0.758N | |COCH-ARM / FISHERS | P=0.287 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 48 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Pituitary Gland | | Cytoplasmic Alteration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/41.89 2/22.03 | |POLY-3 PERCENT (g) | 0.0% 9.1% | |TERMINAL (d) | 0/27 (0%) 1/10 (10%) | |FIRST INCIDENCE | --- 226 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.129 | |POLY 3 | P=0.230 | |POLY 1.5 | P=0.216 | |POLY 6 | P=0.249 | |LOGISTIC REGRESSION| P=0.308 | |COCH-ARM / FISHERS | P=0.233 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Pituitary Gland | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 2/41.89 0/21.06 | |POLY-3 PERCENT (g) | 4.8% 0.0% | |TERMINAL (d) | 2/27 (7%) 0/10 (0%) | |FIRST INCIDENCE | 726 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.474N | |POLY 3 | P=0.579N | |POLY 1.5 | P=0.464N | |POLY 6 | P=0.667N | |LOGISTIC REGRESSION| (e) | |COCH-ARM / FISHERS | P=0.262N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 49 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/53 (21%) 8/50 (16%) | |POLY-3 RATE (b) | 11/43.08 8/22.16 | |POLY-3 PERCENT (g) | 25.5% 36.1% | |TERMINAL (d) | 6/27 (22%) 5/10 (50%) | |FIRST INCIDENCE | 564 601 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.107 | |POLY 3 | P=0.345 | |POLY 1.5 | P=0.480 | |POLY 6 | P=0.271 | |LOGISTIC REGRESSION| P=0.185 | |COCH-ARM / FISHERS | P=0.357N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 49/53 (92%) 45/50 (90%) | |POLY-3 RATE (b) | 49/51.71 45/46.08 | |POLY-3 PERCENT (g) | 94.8% 97.7% | |TERMINAL (d) | 26/27 (96%) 10/10 (100%) | |FIRST INCIDENCE | 275 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.417 | |POLY 1.5 | P=0.467 | |POLY 6 | P=0.499 | |LOGISTIC REGRESSION| P=0.465 | |COCH-ARM / FISHERS | P=0.463N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 50 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Spleen | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 52/53 (98%) 41/50 (82%) | |POLY-3 RATE (b) | 52/53.00 41/43.06 | |POLY-3 PERCENT (g) | 98.1% 95.2% | |TERMINAL (d) | 26/27 (96%) 10/10 (100%) | |FIRST INCIDENCE | 275 201 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P=0.427N | |POLY 1.5 | P=0.119N | |POLY 6 | P=0.817N | |LOGISTIC REGRESSION| P=0.070N | |COCH-ARM / FISHERS | P=0.006N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 4/50 (8%) | |POLY-3 RATE (b) | 4/43.27 4/23.68 | |POLY-3 PERCENT (g) | 9.3% 16.9% | |TERMINAL (d) | 0/27 (0%) 0/10 (0%) | |FIRST INCIDENCE | 564 201 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.272 | |POLY 3 | P=0.381 | |POLY 1.5 | P=0.439 | |POLY 6 | P=0.348 | |LOGISTIC REGRESSION| P=0.550N | |COCH-ARM / FISHERS | P=0.609 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 51 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 2/50 (4%) | |POLY-3 RATE (b) | 4/41.89 2/22.11 | |POLY-3 PERCENT (g) | 9.6% 9.1% | |TERMINAL (d) | 4/27 (15%) 0/10 (0%) | |FIRST INCIDENCE | 726 (T) 474 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.584 | |POLY 3 | P=0.720N | |POLY 1.5 | P=0.623N | |POLY 6 | P=0.743 | |LOGISTIC REGRESSION| P=0.654N | |COCH-ARM / FISHERS | P=0.367N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 2/50 (4%) | |POLY-3 RATE (b) | 2/41.89 2/21.77 | |POLY-3 PERCENT (g) | 4.8% 9.2% | |TERMINAL (d) | 2/27 (7%) 0/10 (0%) | |FIRST INCIDENCE | 726 (T) 593 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.358 | |POLY 3 | P=0.562 | |POLY 1.5 | P=0.583 | |POLY 6 | P=0.557 | |LOGISTIC REGRESSION| P=0.431 | |COCH-ARM / FISHERS | P=0.669 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 52 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 2/50 (4%) | |POLY-3 RATE (b) | 2/41.89 2/21.61 | |POLY-3 PERCENT (g) | 4.8% 9.3% | |TERMINAL (d) | 2/27 (7%) 0/10 (0%) | |FIRST INCIDENCE | 726 (T) 593 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.350 | |POLY 3 | P=0.562 | |POLY 1.5 | P=0.582 | |POLY 6 | P=0.557 | |LOGISTIC REGRESSION| P=0.405 | |COCH-ARM / FISHERS | P=0.669 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Stomach, Glandular | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 12/53 (23%) 1/50 (2%) | |POLY-3 RATE (b) | 12/45.97 1/21.72 | |POLY-3 PERCENT (g) | 26.1% 4.6% | |TERMINAL (d) | 3/27 (11%) 0/10 (0%) | |FIRST INCIDENCE | 313 504 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.073N | |POLY 3 | P=0.083N | |POLY 1.5 | P=0.030N* | |POLY 6 | P=0.157N | |LOGISTIC REGRESSION| P=0.003N** | |COCH-ARM / FISHERS | P<0.001N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 53 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 40/53 (75%) 45/46 (98%) | |POLY-3 RATE (b) | 40/48.92 45/45.07 | |POLY-3 PERCENT (g) | 81.8% 99.8% | |TERMINAL (d) | 23/27 (85%) 10/10 (100%) | |FIRST INCIDENCE | 275 201 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P<0.001 ** | |POLY 6 | P=0.004 ** | |LOGISTIC REGRESSION| P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Thyroid Gland | | Infiltration Cellular Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 2/49 (4%) | |POLY-3 RATE (b) | 0/41.89 2/21.97 | |POLY-3 PERCENT (g) | 0.0% 9.1% | |TERMINAL (d) | 0/27 (0%) 0/9 (0%) | |FIRST INCIDENCE | --- 226 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.182 | |POLY 3 | P=0.228 | |POLY 1.5 | P=0.214 | |POLY 6 | P=0.246 | |LOGISTIC REGRESSION| P=0.890 | |COCH-ARM / FISHERS | P=0.228 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 54 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/53 (13%) 6/49 (12%) | |POLY-3 RATE (b) | 7/43.53 6/21.98 | |POLY-3 PERCENT (g) | 16.1% 27.3% | |TERMINAL (d) | 3/27 (11%) 2/9 (22%) | |FIRST INCIDENCE | 555 258 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.143 | |POLY 3 | P=0.308 | |POLY 1.5 | P=0.401 | |POLY 6 | P=0.258 | |LOGISTIC REGRESSION| P=0.373 | |COCH-ARM / FISHERS | P=0.561N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 22/53 (42%) 29/49 (59%) | |POLY-3 RATE (b) | 22/47.33 29/35.78 | |POLY-3 PERCENT (g) | 46.5% 81.1% | |TERMINAL (d) | 9/27 (33%) 6/9 (67%) | |FIRST INCIDENCE | 275 209 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** | |POLY 3 | P<0.001 ** | |POLY 1.5 | P=0.002 ** | |POLY 6 | P<0.001 ** | |LOGISTIC REGRESSION| P=0.039 * | |COCH-ARM / FISHERS | P=0.056 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 55 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Tooth: Peridontal Tissue | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 29/29 (100%) 23/23 (100%) | |POLY-3 RATE (b) | 29/29.00 23/23.00 | |POLY-3 PERCENT (g) | 100.0% 100.0% | |TERMINAL (d) | 16/16 (100%) 7/7 (100%) | |FIRST INCIDENCE | 534 209 | |-------------------| | |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 | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Urinary Bladder | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/53 (15%) 1/50 (2%) | |POLY-3 RATE (b) | 8/43.36 1/21.51 | |POLY-3 PERCENT (g) | 18.5% 4.7% | |TERMINAL (d) | 3/27 (11%) 0/10 (0%) | |FIRST INCIDENCE | 362 594 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.210N | |POLY 3 | P=0.210N | |POLY 1.5 | P=0.118N | |POLY 6 | P=0.296N | |LOGISTIC REGRESSION| P=0.081N | |COCH-ARM / FISHERS | P=0.019N* | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 56 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Urinary Bladder: Transitional Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 0/50 (0%) | |POLY-3 RATE (b) | 4/42.40 0/21.06 | |POLY-3 PERCENT (g) | 9.4% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/10 (0%) | |FIRST INCIDENCE | 672 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.255N | |POLY 3 | P=0.309N | |POLY 1.5 | P=0.206N | |POLY 6 | P=0.405N | |LOGISTIC REGRESSION| P=0.196N | |COCH-ARM / FISHERS | P=0.066N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Uterus | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 4/50 (8%) | |POLY-3 RATE (b) | 4/41.89 4/22.63 | |POLY-3 PERCENT (g) | 9.6% 17.7% | |TERMINAL (d) | 4/27 (15%) 0/10 (0%) | |FIRST INCIDENCE | 726 (T) 541 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.177 | |POLY 3 | P=0.376 | |POLY 1.5 | P=0.430 | |POLY 6 | P=0.354 | |LOGISTIC REGRESSION| P=0.278 | |COCH-ARM / FISHERS | P=0.609 | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 57 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Uterus | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 2/42.77 1/21.74 | |POLY-3 PERCENT (g) | 4.7% 4.6% | |TERMINAL (d) | 1/27 (4%) 0/10 (0%) | |FIRST INCIDENCE | 362 494 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.726 | |POLY 3 | P=0.815N | |POLY 1.5 | P=0.737N | |POLY 6 | P=0.824 | |LOGISTIC REGRESSION| P=0.434N | |COCH-ARM / FISHERS | P=0.522N | |ORDER RESTRICTED | (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Uterus | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 23/53 (43%) 8/50 (16%) | |POLY-3 RATE (b) | 23/44.48 8/23.38 | |POLY-3 PERCENT (g) | 51.7% 34.2% | |TERMINAL (d) | 16/27 (59%) 3/10 (30%) | |FIRST INCIDENCE | 555 494 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.457N | |POLY 3 | P=0.176N | |POLY 1.5 | P=0.065N | |POLY 6 | P=0.276N | |LOGISTIC REGRESSION| P=0.176N | |COCH-ARM / FISHERS | P=0.002N** | |ORDER RESTRICTED | (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 58 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 360 NG | | | TEQ/KG TEQKG ST | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 32/53 (60%) 17/50 (34%) | |POLY-3 RATE (b) | 32/46.96 17/24.95 | |POLY-3 PERCENT (g) | 68.2% 68.2% | |TERMINAL (d) | 21/27 (78%) 8/10 (80%) | |FIRST INCIDENCE | 275 273 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.156 | |POLY 3 | P=0.661 | |POLY 1.5 | P=0.307N | |POLY 6 | P=0.497 | |LOGISTIC REGRESSION| P=0.525N | |COCH-ARM / FISHERS | P=0.006N** | |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).