TDMS Study 96020-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) DATE: 05/24/04 EXPERIMENT: 96020 TEST: 01 TIME: 11:04:59 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96020 PATHOLOGIST: SELLS, DONALD CAS: TEFBINARYMIX SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF TEF EVALUATION (BINARY MIXTURE; PCB 126 =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Adrenal Cortex Angiectasis Hyperplasia Bone Marrow Hyperplasia Eye: Retina Atrophy Heart Cardiomyopathy Kidney Mineralization Pigmentation Kidney: Pelvis Dilatation Inflammation Liver Basophilic Focus Cholangiofibrosis Clear Cell Focus Eosinophilic Focus Fatty Change Diffuse Fatty Change Focal Hematopoietic Cell Proliferation Pigmentation Toxic Hepatopathy Liver: Bile Duct Fibrosis Hyperplasia Liver: Hepatocyte Hypertrophy Liver: Oval Cell Hyperplasia Liver: Portal Fibrosis Lung Infiltration Cellular Histiocyte Lung: Alveolar Epithelium Metaplasia Bronchiolar Mammary Gland Hyperplasia Ovary Atrophy Inflammation Chronic Oviduct Cyst Inflammation Chronic Pancreas: Acinus Vacuolization Cytoplasmic Pituitary Gland Angiectasis Skin Inflammation Stomach, Forestomach Inflammation Stomach, Glandular Erosion Thymus Atrophy Thyroid Gland: Follicular Cell Hypertrophy Uterus Inflammation Metaplasia Uterus: Endometrium Hyperplasia Cystic =============================================================== Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 28/49 (57%) 23/52 (44%) 7/51 (14%) | |POLY-3 RATE (b) | 28/41.28 23/42.61 7/41.65 | |POLY-3 PERCENT (g) | 67.8% 54.0% 16.8% | |TERMINAL (d) | 22/28 (79%) 11/24 (46%) 4/27 (15%) | |FIRST INCIDENCE | 491 499 463 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.424N P<0.001N** | |POLY 3 | P<0.001N** P=0.128N P<0.001N** | |POLY 1.5 | P<0.001N** P=0.151N P<0.001N** | |POLY 6 | P<0.001N** P=0.088N P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.239N P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.136N P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/49 (4%) 3/52 (6%) 5/51 (10%) | |POLY-3 RATE (b) | 2/38.87 3/37.99 5/40.32 | |POLY-3 PERCENT (g) | 5.2% 7.9% 12.4% | |TERMINAL (d) | 2/28 (7%) 2/24 (8%) 3/27 (11%) | |FIRST INCIDENCE | 729 (T) 539 647 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.219 P=0.442 P=0.210 | |POLY 3 | P=0.214 P=0.489 P=0.229 | |POLY 1.5 | P=0.210 P=0.498 P=0.229 | |POLY 6 | P=0.218 P=0.485 P=0.231 | |LOGISTIC REGRESSION| P=0.221 P=0.484 P=0.224 | |COCH-ARM / FISHERS | P=0.205 P=0.528 P=0.235 | |ORDER RESTRICTED | P=0.168 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 14/49 (29%) 14/52 (27%) 18/51 (35%) | |POLY-3 RATE (b) | 14/42.18 14/39.87 18/43.61 | |POLY-3 PERCENT (g) | 33.2% 35.1% 41.3% | |TERMINAL (d) | 8/28 (29%) 7/24 (29%) 11/27 (41%) | |FIRST INCIDENCE | 484 505 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.264 P=0.462 P=0.257 | |POLY 3 | P=0.261 P=0.520 P=0.288 | |POLY 1.5 | P=0.250 P=0.556 P=0.291 | |POLY 6 | P=0.266 P=0.501 P=0.285 | |LOGISTIC REGRESSION| P=0.234 P=0.572N P=0.309 | |COCH-ARM / FISHERS | P=0.222 P=0.515N P=0.307 | |ORDER RESTRICTED | P=0.291 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 17/49 (35%) 25/52 (48%) 21/51 (41%) | |POLY-3 RATE (b) | 17/40.68 25/42.59 21/42.72 | |POLY-3 PERCENT (g) | 41.8% 58.7% 49.2% | |TERMINAL (d) | 13/28 (46%) 14/24 (58%) 14/27 (52%) | |FIRST INCIDENCE | 491 254 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.542N P=0.037 * P=0.245 | |POLY 3 | P=0.560N P=0.083 P=0.320 | |POLY 1.5 | P=0.569N P=0.088 P=0.314 | |POLY 6 | P=0.553N P=0.087 P=0.330 | |LOGISTIC REGRESSION| P=0.540N P=0.071 P=0.301 | |COCH-ARM / FISHERS | P=0.553 P=0.123 P=0.322 | |ORDER RESTRICTED | P=0.172 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 42/49 (86%) 41/52 (79%) 40/51 (78%) | |POLY-3 RATE (b) | 42/46.24 41/44.30 40/47.73 | |POLY-3 PERCENT (g) | 90.8% 92.6% 83.8% | |TERMINAL (d) | 26/28 (93%) 24/24 (100%) 24/27 (89%) | |FIRST INCIDENCE | 441 479 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.340N P=0.314 P=0.489N | |POLY 3 | P=0.106N P=0.540 P=0.221N | |POLY 1.5 | P=0.173N P=0.628N P=0.244N | |POLY 6 | P=0.064N P=0.471 P=0.190N | |LOGISTIC REGRESSION| P=0.240N P=0.617N P=0.272N | |COCH-ARM / FISHERS | P=0.345N P=0.261N P=0.247N | |ORDER RESTRICTED | P=0.115N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/49 (6%) 0/52 (0%) 2/51 (4%) | |POLY-3 RATE (b) | 3/39.68 0/37.39 2/41.77 | |POLY-3 PERCENT (g) | 7.6% 0.0% 4.8% | |TERMINAL (d) | 1/28 (4%) 0/24 (0%) 0/27 (0%) | |FIRST INCIDENCE | 612 --- 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.604 P=0.151N P=0.509N | |POLY 3 | P=0.646 P=0.129N P=0.477N | |POLY 1.5 | P=0.634 P=0.123N P=0.478N | |POLY 6 | P=0.655 P=0.135N P=0.479N | |LOGISTIC REGRESSION| P=0.562 P=0.112N P=0.367N | |COCH-ARM / FISHERS | P=0.603 P=0.111N P=0.481N | |ORDER RESTRICTED | P=0.172N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Adrenal Cortex | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 15/49 (31%) 10/52 (19%) 13/51 (25%) | |POLY-3 RATE (b) | 15/42.24 10/40.66 13/40.68 | |POLY-3 PERCENT (g) | 35.5% 24.6% 32.0% | |TERMINAL (d) | 7/28 (25%) 3/24 (13%) 10/27 (37%) | |FIRST INCIDENCE | 478 330 636 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.558N P=0.278N P=0.442N | |POLY 3 | P=0.537 P=0.196N P=0.456N | |POLY 1.5 | P=0.556 P=0.179N P=0.421N | |POLY 6 | P=0.506 P=0.213N P=0.499N | |LOGISTIC REGRESSION| P=0.565N P=0.130N P=0.375N | |COCH-ARM / FISHERS | P=0.569 P=0.137N P=0.364N | |ORDER RESTRICTED | P=0.321N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/49 (16%) 13/52 (25%) 6/49 (12%) | |POLY-3 RATE (b) | 8/39.28 13/39.45 6/39.40 | |POLY-3 PERCENT (g) | 20.4% 33.0% 15.2% | |TERMINAL (d) | 7/28 (25%) 9/24 (38%) 5/26 (19%) | |FIRST INCIDENCE | 612 479 596 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.145N P=0.090 P=0.438N | |POLY 3 | P=0.136N P=0.153 P=0.381N | |POLY 1.5 | P=0.142N P=0.162 P=0.384N | |POLY 6 | P=0.134N P=0.150 P=0.381N | |LOGISTIC REGRESSION| P=0.131N P=0.135 P=0.385N | |COCH-ARM / FISHERS | P=0.162N P=0.204 P=0.387N | |ORDER RESTRICTED | P=0.150N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 38/50 (76%) 48/53 (91%) 39/51 (76%) | |POLY-3 RATE (b) | 38/48.54 48/53.00 39/48.89 | |POLY-3 PERCENT (g) | 78.3% 90.6% 79.8% | |TERMINAL (d) | 19/28 (68%) 19/24 (79%) 19/27 (70%) | |FIRST INCIDENCE | 441 96 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.264N P=0.043 * P=0.470 | |POLY 3 | P=0.327N P=0.070 P=0.528 | |POLY 1.5 | P=0.288N P=0.056 P=0.544 | |POLY 6 | P=0.371N P=0.092 P=0.514 | |LOGISTIC REGRESSION| P=0.269N P=0.069 P=0.581 | |COCH-ARM / FISHERS | P=0.236N P=0.042 * P=0.570 | |ORDER RESTRICTED | P=0.237 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 38/49 (78%) 40/53 (75%) 40/50 (80%) | |POLY-3 RATE (b) | 38/45.36 40/48.52 40/45.91 | |POLY-3 PERCENT (g) | 83.8% 82.4% 87.1% | |TERMINAL (d) | 25/28 (89%) 17/24 (71%) 24/27 (89%) | |FIRST INCIDENCE | 441 254 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.540N P=0.220 P=0.382 | |POLY 3 | P=0.346 P=0.543N P=0.431 | |POLY 1.5 | P=0.373 P=0.590N P=0.428 | |POLY 6 | P=0.321 P=0.433N P=0.471 | |LOGISTIC REGRESSION| P=0.450 P=0.558 P=0.428 | |COCH-ARM / FISHERS | P=0.392 P=0.495N P=0.479 | |ORDER RESTRICTED | P=0.390 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Clitoral Gland: Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 41/49 (84%) 43/53 (81%) 41/50 (82%) | |POLY-3 RATE (b) | 41/46.10 43/48.31 41/47.73 | |POLY-3 PERCENT (g) | 88.9% 89.0% 85.9% | |TERMINAL (d) | 25/28 (89%) 21/24 (88%) 22/27 (82%) | |FIRST INCIDENCE | 462 254 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.399N P=0.201 P=0.520 | |POLY 3 | P=0.385N P=0.638 P=0.443N | |POLY 1.5 | P=0.428N P=0.624N P=0.473N | |POLY 6 | P=0.342N P=0.641 P=0.414N | |LOGISTIC REGRESSION| P=0.500N P=0.524 P=0.546N | |COCH-ARM / FISHERS | P=0.557N P=0.471N P=0.518N | |ORDER RESTRICTED | P=0.424N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Esophagus: Muscularis | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 3/53 (6%) 0/50 (0%) | |POLY-3 RATE (b) | 0/39.59 3/39.07 0/39.67 | |POLY-3 PERCENT (g) | 0.0% 7.7% 0.0% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 0/27 (0%) | |FIRST INCIDENCE | --- 499 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.304N P=0.116 (e) | |POLY 3 | P=0.312N P=0.115 (e) | |POLY 1.5 | P=0.314N P=0.117 (e) | |POLY 6 | P=0.309N P=0.117 (e) | |LOGISTIC REGRESSION| P=0.341N P=0.171 (e) | |COCH-ARM / FISHERS | P=0.313N P=0.132 (e) | |ORDER RESTRICTED | P=0.189N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Eye: Anterior Chamber, Ciliary Body, Cornea | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 1/52 (2%) 0/51 (0%) | |POLY-3 RATE (b) | 2/40.02 1/37.28 0/39.98 | |POLY-3 PERCENT (g) | 5.0% 2.7% 0.0% | |TERMINAL (d) | 1/28 (4%) 0/24 (0%) 0/27 (0%) | |FIRST INCIDENCE | 603 580 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.243N P=0.536N P=0.252N | |POLY 3 | P=0.230N P=0.525N P=0.237N | |POLY 1.5 | P=0.233N P=0.517N P=0.236N | |POLY 6 | P=0.229N P=0.528N P=0.237N | |LOGISTIC REGRESSION| P=0.248N P=0.485N P=0.234N | |COCH-ARM / FISHERS | P=0.246N P=0.485N P=0.243N | |ORDER RESTRICTED | P=0.103N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Eye: Retina | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/52 (4%) 5/51 (10%) | |POLY-3 RATE (b) | 0/39.59 2/36.79 5/40.52 | |POLY-3 PERCENT (g) | 0.0% 5.4% 12.3% | |TERMINAL (d) | 0/28 (0%) 2/24 (8%) 3/27 (11%) | |FIRST INCIDENCE | --- 729 (T) 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.040 * P=0.204 P=0.036 * | |POLY 3 | P=0.032 * P=0.221 P=0.032 * | |POLY 1.5 | P=0.032 * P=0.226 P=0.031 * | |POLY 6 | P=0.033 * P=0.218 P=0.032 * | |LOGISTIC REGRESSION| P=0.037 * P=0.204 P=0.034 * | |COCH-ARM / FISHERS | P=0.032 * P=0.257 P=0.030 * | |ORDER RESTRICTED | P=0.011 * (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Harderian Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 15/49 (31%) 14/52 (27%) 17/51 (33%) | |POLY-3 RATE (b) | 15/39.74 14/39.15 17/40.73 | |POLY-3 PERCENT (g) | 37.8% 35.8% 41.7% | |TERMINAL (d) | 13/28 (46%) 10/24 (42%) 14/27 (52%) | |FIRST INCIDENCE | 491 330 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.378 P=0.511 P=0.373 | |POLY 3 | P=0.369 P=0.521N P=0.444 | |POLY 1.5 | P=0.369 P=0.509N P=0.447 | |POLY 6 | P=0.368 P=0.518N P=0.447 | |LOGISTIC REGRESSION| P=0.410 P=0.567N P=0.445 | |COCH-ARM / FISHERS | P=0.352 P=0.425N P=0.469 | |ORDER RESTRICTED | P=0.433 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 18/50 (36%) 26/53 (49%) 25/50 (50%) | |POLY-3 RATE (b) | 18/40.91 26/41.49 25/41.97 | |POLY-3 PERCENT (g) | 44.0% 62.7% 59.6% | |TERMINAL (d) | 13/28 (46%) 17/24 (71%) 17/27 (63%) | |FIRST INCIDENCE | 625 96 463 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.338 P=0.030 * P=0.106 | |POLY 3 | P=0.263 P=0.059 P=0.105 | |POLY 1.5 | P=0.245 P=0.071 P=0.103 | |POLY 6 | P=0.284 P=0.053 P=0.110 | |LOGISTIC REGRESSION| P=0.303 P=0.046 * P=0.101 | |COCH-ARM / FISHERS | P=0.223 P=0.127 P=0.113 | |ORDER RESTRICTED | P=0.065 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Intestine Large, Rectum | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 1/53 (2%) 2/51 (4%) | |POLY-3 RATE (b) | 1/39.59 1/37.45 2/40.67 | |POLY-3 PERCENT (g) | 2.5% 2.7% 4.9% | |TERMINAL (d) | 1/28 (4%) 0/24 (0%) 1/27 (4%) | |FIRST INCIDENCE | 729 (T) 715 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.430 P=0.735 P=0.489 | |POLY 3 | P=0.437 P=0.749 P=0.509 | |POLY 1.5 | P=0.431 P=0.754 P=0.507 | |POLY 6 | P=0.443 P=0.746 P=0.514 | |LOGISTIC REGRESSION| P=0.427 P=0.745 P=0.510 | |COCH-ARM / FISHERS | P=0.419 P=0.738N P=0.508 | |ORDER RESTRICTED | P=0.379 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Intestine Large, Rectum: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 0/53 (0%) 2/51 (4%) | |POLY-3 RATE (b) | 1/39.59 0/37.40 2/40.01 | |POLY-3 PERCENT (g) | 2.5% 0.0% 5.0% | |TERMINAL (d) | 1/28 (4%) 0/24 (0%) 1/27 (4%) | |FIRST INCIDENCE | 729 (T) --- 720 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.291 P=0.531N P=0.492 | |POLY 3 | P=0.289 P=0.511N P=0.504 | |POLY 1.5 | P=0.285 P=0.506N P=0.503 | |POLY 6 | P=0.292 P=0.515N P=0.506 | |LOGISTIC REGRESSION| P=0.291 (e) P=0.505 | |COCH-ARM / FISHERS | P=0.274 P=0.485N P=0.508 | |ORDER RESTRICTED | P=0.201 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Intestine Small, Jejunum | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/52 (4%) 0/51 (0%) | |POLY-3 RATE (b) | 0/39.59 2/38.30 0/39.98 | |POLY-3 PERCENT (g) | 0.0% 5.2% 0.0% | |TERMINAL (d) | 0/28 (0%) 1/24 (4%) 0/27 (0%) | |FIRST INCIDENCE | --- 330 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.428N P=0.221 (e) | |POLY 3 | P=0.436N P=0.229 (e) | |POLY 1.5 | P=0.436N P=0.233 (e) | |POLY 6 | P=0.435N P=0.227 (e) | |LOGISTIC REGRESSION| P=0.455N P=0.323 (e) | |COCH-ARM / FISHERS | P=0.432N P=0.257 (e) | |ORDER RESTRICTED | P=0.255N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Kidney | | Accumulation, Hyaline Droplet | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/48 (0%) 1/52 (2%) 2/51 (4%) | |POLY-3 RATE (b) | 0/38.21 1/38.39 2/40.75 | |POLY-3 PERCENT (g) | 0.0% 2.6% 4.9% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 0/27 (0%) | |FIRST INCIDENCE | --- 142 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.264 P=0.508 P=0.251 | |POLY 3 | P=0.257 P=0.501 P=0.251 | |POLY 1.5 | P=0.255 P=0.505 P=0.250 | |POLY 6 | P=0.260 P=0.497 P=0.253 | |LOGISTIC REGRESSION| P=0.193 (e) P=0.260 | |COCH-ARM / FISHERS | P=0.254 P=0.520 P=0.263 | |ORDER RESTRICTED | P=0.113 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Kidney | | Calculus Micro Observation Only | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/48 (13%) 4/52 (8%) 6/51 (12%) | |POLY-3 RATE (b) | 6/39.79 4/39.34 6/41.82 | |POLY-3 PERCENT (g) | 15.1% 10.2% 14.4% | |TERMINAL (d) | 2/28 (7%) 0/24 (0%) 3/27 (11%) | |FIRST INCIDENCE | 491 499 462 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.498 P=0.420N P=0.599 | |POLY 3 | P=0.524 P=0.375N P=0.587N | |POLY 1.5 | P=0.516 P=0.362N P=0.584N | |POLY 6 | P=0.524 P=0.387N P=0.594N | |LOGISTIC REGRESSION| P=0.477 P=0.277N P=0.563N | |COCH-ARM / FISHERS | P=0.494 P=0.320N P=0.576N | |ORDER RESTRICTED | P=0.483N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Kidney | | Hydronephrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/48 (0%) 0/52 (0%) 2/51 (4%) | |POLY-3 RATE (b) | 0/38.21 0/37.39 2/40.51 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.9% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 0/27 (0%) | |FIRST INCIDENCE | --- --- 647 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.111 (e) P=0.250 | |POLY 3 | P=0.105 (e) P=0.250 | |POLY 1.5 | P=0.104 (e) P=0.249 | |POLY 6 | P=0.107 (e) P=0.251 | |LOGISTIC REGRESSION| P=0.104 (e) P=0.251 | |COCH-ARM / FISHERS | P=0.103 (e) P=0.263 | |ORDER RESTRICTED | P=0.059 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/48 (0%) 0/52 (0%) 2/51 (4%) | |POLY-3 RATE (b) | 0/38.21 0/37.39 2/40.21 | |POLY-3 PERCENT (g) | 0.0% 0.0% 5.0% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 1/27 (4%) | |FIRST INCIDENCE | --- --- 668 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.112 (e) P=0.243 | |POLY 3 | P=0.104 (e) P=0.248 | |POLY 1.5 | P=0.103 (e) P=0.248 | |POLY 6 | P=0.105 (e) P=0.248 | |LOGISTIC REGRESSION| P=0.108 (e) P=0.247 | |COCH-ARM / FISHERS | P=0.103 (e) P=0.263 | |ORDER RESTRICTED | P=0.058 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Kidney | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/48 (13%) 5/52 (10%) 3/51 (6%) | |POLY-3 RATE (b) | 6/38.87 5/37.96 3/39.98 | |POLY-3 PERCENT (g) | 15.4% 13.2% 7.5% | |TERMINAL (d) | 4/28 (14%) 4/24 (17%) 3/27 (11%) | |FIRST INCIDENCE | 633 552 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.217N P=0.590N P=0.257N | |POLY 3 | P=0.205N P=0.517N P=0.225N | |POLY 1.5 | P=0.209N P=0.497N P=0.221N | |POLY 6 | P=0.206N P=0.538N P=0.232N | |LOGISTIC REGRESSION| P=0.201N P=0.519N P=0.219N | |COCH-ARM / FISHERS | P=0.221N P=0.443N P=0.214N | |ORDER RESTRICTED | P=0.190N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 39/48 (81%) 42/52 (81%) 33/51 (65%) | |POLY-3 RATE (b) | 39/47.30 42/48.93 33/46.82 | |POLY-3 PERCENT (g) | 82.5% 85.8% 70.5% | |TERMINAL (d) | 22/28 (79%) 19/24 (79%) 19/27 (70%) | |FIRST INCIDENCE | 441 254 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.094N P=0.187 P=0.253N | |POLY 3 | P=0.041N* P=0.428 P=0.119N | |POLY 1.5 | P=0.027N* P=0.473 P=0.085N | |POLY 6 | P=0.070N P=0.400 P=0.174N | |LOGISTIC REGRESSION| P=0.023N* P=0.564N P=0.049N* | |COCH-ARM / FISHERS | P=0.022N* P=0.577N P=0.052N | |ORDER RESTRICTED | P=0.056N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 30/48 (63%) 34/52 (65%) 34/51 (67%) | |POLY-3 RATE (b) | 30/41.51 34/43.59 34/43.74 | |POLY-3 PERCENT (g) | 72.3% 78.0% 77.7% | |TERMINAL (d) | 23/28 (82%) 23/24 (96%) 24/27 (89%) | |FIRST INCIDENCE | 478 142 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.454 P=0.074 P=0.213 | |POLY 3 | P=0.432 P=0.344 P=0.356 | |POLY 1.5 | P=0.427 P=0.378 P=0.368 | |POLY 6 | P=0.444 P=0.319 P=0.353 | |LOGISTIC REGRESSION| P=0.514 P=0.265 P=0.367 | |COCH-ARM / FISHERS | P=0.433 P=0.463 P=0.412 | |ORDER RESTRICTED | P=0.344 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 14 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Kidney | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/48 (4%) 7/52 (13%) 17/51 (33%) | |POLY-3 RATE (b) | 2/38.62 7/38.16 17/42.67 | |POLY-3 PERCENT (g) | 5.2% 18.3% 39.8% | |TERMINAL (d) | 1/28 (4%) 6/24 (25%) 10/27 (37%) | |FIRST INCIDENCE | 612 451 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.052 P<0.001 ** | |POLY 3 | P<0.001 ** P=0.072 P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.080 P<0.001 ** | |POLY 6 | P<0.001 ** P=0.066 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.077 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.100 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Kidney: Pelvis | | Dilatation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/48 (8%) 2/52 (4%) 0/51 (0%) | |POLY-3 RATE (b) | 4/39.17 2/37.83 0/39.98 | |POLY-3 PERCENT (g) | 10.2% 5.3% 0.0% | |TERMINAL (d) | 2/28 (7%) 0/24 (0%) 0/27 (0%) | |FIRST INCIDENCE | 478 618 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.080N P=0.390N P=0.069N | |POLY 3 | P=0.067N P=0.352N P=0.057N | |POLY 1.5 | P=0.069N P=0.338N P=0.056N | |POLY 6 | P=0.066N P=0.365N P=0.058N | |LOGISTIC REGRESSION| P=0.076N P=0.312N P=0.054N | |COCH-ARM / FISHERS | P=0.077N P=0.301N P=0.052N | |ORDER RESTRICTED | P=0.024N* (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 15 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Kidney: Pelvis | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/48 (2%) 3/52 (6%) 8/51 (16%) | |POLY-3 RATE (b) | 1/38.73 3/38.07 8/40.77 | |POLY-3 PERCENT (g) | 2.6% 7.9% 19.6% | |TERMINAL (d) | 0/28 (0%) 2/24 (8%) 6/27 (22%) | |FIRST INCIDENCE | 569 499 556 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.015 * P=0.278 P=0.019 * | |POLY 3 | P=0.011 * P=0.298 P=0.018 * | |POLY 1.5 | P=0.011 * P=0.308 P=0.019 * | |POLY 6 | P=0.011 * P=0.289 P=0.017 * | |LOGISTIC REGRESSION| P=0.014 * P=0.344 P=0.021 * | |COCH-ARM / FISHERS | P=0.012 * P=0.340 P=0.019 * | |ORDER RESTRICTED | P=0.006 ** (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/48 (0%) 2/52 (4%) 0/51 (0%) | |POLY-3 RATE (b) | 0/38.21 2/37.67 0/39.98 | |POLY-3 PERCENT (g) | 0.0% 5.3% 0.0% | |TERMINAL (d) | 0/28 (0%) 1/24 (4%) 0/27 (0%) | |FIRST INCIDENCE | --- 654 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.425N P=0.223 (e) | |POLY 3 | P=0.432N P=0.233 (e) | |POLY 1.5 | P=0.431N P=0.239 (e) | |POLY 6 | P=0.434N P=0.229 (e) | |LOGISTIC REGRESSION| P=0.419N P=0.233 (e) | |COCH-ARM / FISHERS | P=0.426N P=0.268 (e) | |ORDER RESTRICTED | P=0.253N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 16 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Kidney: Transitional Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/48 (13%) 11/52 (21%) 9/51 (18%) | |POLY-3 RATE (b) | 6/39.39 11/39.29 9/40.65 | |POLY-3 PERCENT (g) | 15.2% 28.0% 22.1% | |TERMINAL (d) | 3/28 (11%) 7/24 (29%) 7/27 (26%) | |FIRST INCIDENCE | 569 539 601 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.537 P=0.101 P=0.279 | |POLY 3 | P=0.516 P=0.132 P=0.306 | |POLY 1.5 | P=0.520 P=0.145 P=0.315 | |POLY 6 | P=0.505 P=0.122 P=0.294 | |LOGISTIC REGRESSION| P=0.548 P=0.146 P=0.320 | |COCH-ARM / FISHERS | P=0.520 P=0.189 P=0.334 | |ORDER RESTRICTED | P=0.195 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/52 (4%) 3/51 (6%) | |POLY-3 RATE (b) | 1/39.59 2/37.66 3/40.43 | |POLY-3 PERCENT (g) | 2.5% 5.3% 7.4% | |TERMINAL (d) | 1/28 (4%) 1/24 (4%) 2/27 (7%) | |FIRST INCIDENCE | 729 (T) 659 596 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.330 P=0.461 P=0.296 | |POLY 3 | P=0.324 P=0.482 P=0.312 | |POLY 1.5 | P=0.319 P=0.490 P=0.310 | |POLY 6 | P=0.329 P=0.479 P=0.316 | |LOGISTIC REGRESSION| P=0.329 P=0.475 P=0.308 | |COCH-ARM / FISHERS | P=0.313 P=0.515 P=0.316 | |ORDER RESTRICTED | P=0.219 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 17 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/50 (10%) 3/52 (6%) 18/51 (35%) | |POLY-3 RATE (b) | 5/39.94 3/37.45 18/42.98 | |POLY-3 PERCENT (g) | 12.5% 8.0% 41.9% | |TERMINAL (d) | 3/28 (11%) 2/24 (8%) 9/27 (33%) | |FIRST INCIDENCE | 664 715 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.427N P=0.004 ** | |POLY 3 | P<0.001 ** P=0.391N P=0.002 ** | |POLY 1.5 | P<0.001 ** P=0.376N P=0.002 ** | |POLY 6 | P<0.001 ** P=0.404N P=0.003 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.398N P=0.002 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.336N P=0.002 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Cholangiofibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/50 (10%) 7/52 (13%) 13/51 (25%) | |POLY-3 RATE (b) | 5/39.94 7/37.86 13/41.27 | |POLY-3 PERCENT (g) | 12.5% 18.5% 31.5% | |TERMINAL (d) | 3/28 (11%) 5/24 (21%) 10/27 (37%) | |FIRST INCIDENCE | 664 612 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.032 * P=0.293 P=0.033 * | |POLY 3 | P=0.026 * P=0.339 P=0.033 * | |POLY 1.5 | P=0.025 * P=0.356 P=0.033 * | |POLY 6 | P=0.027 * P=0.327 P=0.033 * | |LOGISTIC REGRESSION| P=0.029 * P=0.324 P=0.034 * | |COCH-ARM / FISHERS | P=0.025 * P=0.408 P=0.037 * | |ORDER RESTRICTED | P=0.019 * (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 18 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/50 (10%) 3/52 (6%) 11/51 (22%) | |POLY-3 RATE (b) | 5/39.59 3/37.39 11/41.02 | |POLY-3 PERCENT (g) | 12.6% 8.0% 26.8% | |TERMINAL (d) | 5/28 (18%) 3/24 (13%) 9/27 (33%) | |FIRST INCIDENCE | 729 (T) 729 (T) 463 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.017 * P=0.442N P=0.070 | |POLY 3 | P=0.019 * P=0.387N P=0.090 | |POLY 1.5 | P=0.018 * P=0.374N P=0.089 | |POLY 6 | P=0.021 * P=0.395N P=0.094 | |LOGISTIC REGRESSION| P=0.019 * P=0.442N P=0.086 | |COCH-ARM / FISHERS | P=0.017 * P=0.336N P=0.093 | |ORDER RESTRICTED | P=0.025 * (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 27/50 (54%) 40/52 (77%) 45/51 (88%) | |POLY-3 RATE (b) | 27/46.61 40/47.53 45/47.97 | |POLY-3 PERCENT (g) | 57.9% 84.2% 93.8% | |TERMINAL (d) | 11/28 (39%) 18/24 (75%) 26/27 (96%) | |FIRST INCIDENCE | 441 330 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.049 * P=0.016 * P=0.005 ** | |POLY 3 | P<0.001 ** P=0.003 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.003 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.003 ** P<0.001 ** | |LOGISTIC REGRESSION| P=0.002 ** P=0.011 * P<0.001 ** | |COCH-ARM / FISHERS | P=0.002 ** P=0.013 * P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 19 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Fatty Change Diffuse | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 28/50 (56%) 31/52 (60%) 47/51 (92%) | |POLY-3 RATE (b) | 28/45.86 31/45.69 47/49.08 | |POLY-3 PERCENT (g) | 61.1% 67.8% 95.8% | |TERMINAL (d) | 15/28 (54%) 15/24 (63%) 27/27 (100%) | |FIRST INCIDENCE | 441 254 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.003 ** P=0.219 P=0.002 ** | |POLY 3 | P<0.001 ** P=0.317 P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.339 P<0.001 ** | |POLY 6 | P<0.001 ** P=0.307 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.427 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.433 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Fatty Change Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/50 (8%) 1/52 (2%) 11/51 (22%) | |POLY-3 RATE (b) | 4/40.12 1/37.83 11/41.62 | |POLY-3 PERCENT (g) | 10.0% 2.6% 26.4% | |TERMINAL (d) | 3/28 (11%) 0/24 (0%) 7/27 (26%) | |FIRST INCIDENCE | 567 603 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.003 ** P=0.225N P=0.045 * | |POLY 3 | P=0.002 ** P=0.195N P=0.048 * | |POLY 1.5 | P=0.002 ** P=0.189N P=0.047 * | |POLY 6 | P=0.003 ** P=0.199N P=0.050 | |LOGISTIC REGRESSION| P=0.003 ** P=0.185N P=0.048 * | |COCH-ARM / FISHERS | P=0.002 ** P=0.169N P=0.050 | |ORDER RESTRICTED | P=0.003 ** (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 18/50 (36%) 19/52 (37%) 29/51 (57%) | |POLY-3 RATE (b) | 18/44.86 19/44.94 29/46.24 | |POLY-3 PERCENT (g) | 40.1% 42.3% 62.7% | |TERMINAL (d) | 9/28 (32%) 6/24 (25%) 16/27 (59%) | |FIRST INCIDENCE | 441 142 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.040 * P=0.396 P=0.042 * | |POLY 3 | P=0.011 * P=0.503 P=0.021 * | |POLY 1.5 | P=0.010 * P=0.513 P=0.021 * | |POLY 6 | P=0.012 * P=0.513 P=0.023 * | |LOGISTIC REGRESSION| P=0.009 ** P=0.453N P=0.030 * | |COCH-ARM / FISHERS | P=0.012 * P=0.559 P=0.028 * | |ORDER RESTRICTED | P=0.017 * (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 20/50 (40%) 24/52 (46%) 21/51 (41%) | |POLY-3 RATE (b) | 20/40.25 24/39.96 21/41.77 | |POLY-3 PERCENT (g) | 49.7% 60.1% 50.3% | |TERMINAL (d) | 18/28 (64%) 16/24 (67%) 15/27 (56%) | |FIRST INCIDENCE | 633 552 602 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.426N P=0.103 P=0.451 | |POLY 3 | P=0.404N P=0.227 P=0.569 | |POLY 1.5 | P=0.440N P=0.241 P=0.541 | |POLY 6 | P=0.357N P=0.247 P=0.569N | |LOGISTIC REGRESSION| P=0.392N P=0.144 P=0.528 | |COCH-ARM / FISHERS | P=0.490N P=0.335 P=0.533 | |ORDER RESTRICTED | P=0.413 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 21 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 47/50 (94%) 48/52 (92%) 46/51 (90%) | |POLY-3 RATE (b) | 47/48.90 48/50.71 46/49.21 | |POLY-3 PERCENT (g) | 96.1% 94.7% 93.5% | |TERMINAL (d) | 27/28 (96%) 23/24 (96%) 26/27 (96%) | |FIRST INCIDENCE | 441 254 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.353N P=0.230 P=0.554N | |POLY 3 | P=0.444N P=0.557N P=0.443N | |POLY 1.5 | P=0.415N P=0.591N P=0.435N | |POLY 6 | P=0.480N P=0.513N P=0.452N | |LOGISTIC REGRESSION| P=0.328N P=0.623N P=0.410N | |COCH-ARM / FISHERS | P=0.363N P=0.522N P=0.369N | |ORDER RESTRICTED | P=0.367N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 27/50 (54%) 26/52 (50%) 27/51 (53%) | |POLY-3 RATE (b) | 27/41.19 26/38.98 27/43.00 | |POLY-3 PERCENT (g) | 65.6% 66.7% 62.8% | |TERMINAL (d) | 24/28 (86%) 23/24 (96%) 21/27 (78%) | |FIRST INCIDENCE | 462 499 463 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.539N P=0.302 P=0.525 | |POLY 3 | P=0.425N P=0.556 P=0.484N | |POLY 1.5 | P=0.504N P=0.580N P=0.524N | |POLY 6 | P=0.311N P=0.523 P=0.409N | |LOGISTIC REGRESSION| P=0.498N P=0.503 P=0.559N | |COCH-ARM / FISHERS | P=0.530 P=0.418N P=0.537N | |ORDER RESTRICTED | P=0.491N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 22 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/50 (12%) 4/52 (8%) 7/51 (14%) | |POLY-3 RATE (b) | 6/41.80 4/38.13 7/42.46 | |POLY-3 PERCENT (g) | 14.4% 10.5% 16.5% | |TERMINAL (d) | 1/28 (4%) 2/24 (8%) 2/27 (7%) | |FIRST INCIDENCE | 484 552 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.368 P=0.433N P=0.494 | |POLY 3 | P=0.382 P=0.428N P=0.512 | |POLY 1.5 | P=0.367 P=0.403N P=0.511 | |POLY 6 | P=0.395 P=0.452N P=0.513 | |LOGISTIC REGRESSION| P=0.324 P=0.336N P=0.551 | |COCH-ARM / FISHERS | P=0.337 P=0.346N P=0.515 | |ORDER RESTRICTED | P=0.404 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 50/50 (100%) 50/52 (96%) 44/51 (86%) | |POLY-3 RATE (b) | 50/50.00 50/50.05 44/48.31 | |POLY-3 PERCENT (g) | 100.0% 99.9% 91.1% | |TERMINAL (d) | 28/28 (100%) 24/24 (100%) 27/27 (100%) | |FIRST INCIDENCE | 441 310 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.119N P=0.264 P=0.259N | |POLY 3 | P<0.001N** P=1.000N P=0.024N* | |POLY 1.5 | P<0.001N** P=0.999N P=0.016N* | |POLY 6 | P=0.004N** P=1.000N P=0.048N* | |LOGISTIC REGRESSION| P<0.001N** (e) P=0.012N* | |COCH-ARM / FISHERS | P=0.005N** P=0.257N P=0.007N** | |ORDER RESTRICTED | P<0.001N** (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 23 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Toxic Hepatopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 44/50 (88%) 48/52 (92%) 48/51 (94%) | |POLY-3 RATE (b) | 44/46.21 48/48.25 48/49.68 | |POLY-3 PERCENT (g) | 95.2% 99.5% 96.6% | |TERMINAL (d) | 28/28 (100%) 24/24 (100%) 27/27 (100%) | |FIRST INCIDENCE | 462 330 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.506 P=0.097 P=0.262 | |POLY 3 | P=0.660N P=0.146 P=0.586 | |POLY 1.5 | P=0.564 P=0.132 P=0.352 | |POLY 6 | P=0.442N P=0.573 P=0.706N | |LOGISTIC REGRESSION| P=0.353 P=0.013 * P=0.132 | |COCH-ARM / FISHERS | P=0.284 P=0.346 P=0.234 | |ORDER RESTRICTED | P=0.193 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver: Bile Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/50 (8%) 5/52 (10%) 6/51 (12%) | |POLY-3 RATE (b) | 4/39.59 5/37.44 6/40.36 | |POLY-3 PERCENT (g) | 10.1% 13.4% 14.9% | |TERMINAL (d) | 4/28 (14%) 4/24 (17%) 5/27 (19%) | |FIRST INCIDENCE | 729 (T) 719 622 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.398 P=0.405 P=0.346 | |POLY 3 | P=0.400 P=0.464 P=0.380 | |POLY 1.5 | P=0.391 P=0.479 P=0.377 | |POLY 6 | P=0.412 P=0.455 P=0.386 | |LOGISTIC REGRESSION| P=0.411 P=0.435 P=0.376 | |COCH-ARM / FISHERS | P=0.376 P=0.525 P=0.383 | |ORDER RESTRICTED | P=0.356 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 24 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver: Bile Duct | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 4/52 (8%) 5/51 (10%) | |POLY-3 RATE (b) | 0/39.59 4/38.64 5/41.42 | |POLY-3 PERCENT (g) | 0.0% 10.4% 12.1% | |TERMINAL (d) | 0/28 (0%) 1/24 (4%) 1/27 (4%) | |FIRST INCIDENCE | --- 506 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.139 P=0.055 P=0.038 * | |POLY 3 | P=0.119 P=0.056 P=0.034 * | |POLY 1.5 | P=0.114 P=0.058 P=0.033 * | |POLY 6 | P=0.127 P=0.056 P=0.036 * | |LOGISTIC REGRESSION| P=0.111 P=0.069 P=0.036 * | |COCH-ARM / FISHERS | P=0.114 P=0.064 P=0.030 * | |ORDER RESTRICTED | P=0.024 * (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 20/50 (40%) 29/52 (56%) 40/51 (78%) | |POLY-3 RATE (b) | 20/41.49 29/42.15 40/45.51 | |POLY-3 PERCENT (g) | 48.2% 68.8% 87.9% | |TERMINAL (d) | 14/28 (50%) 17/24 (71%) 26/27 (96%) | |FIRST INCIDENCE | 484 505 462 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002 ** P=0.025 * P<0.001 ** | |POLY 3 | P<0.001 ** P=0.036 * P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.040 * P<0.001 ** | |POLY 6 | P<0.001 ** P=0.041 * P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.024 * P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.081 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 25 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver: Centrilobular | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/50 (12%) 4/52 (8%) 2/51 (4%) | |POLY-3 RATE (b) | 6/41.72 4/38.67 2/41.55 | |POLY-3 PERCENT (g) | 14.4% 10.3% 4.8% | |TERMINAL (d) | 2/28 (7%) 1/24 (4%) 0/27 (0%) | |FIRST INCIDENCE | 478 552 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.159N P=0.427N P=0.150N | |POLY 3 | P=0.135N P=0.417N P=0.132N | |POLY 1.5 | P=0.140N P=0.398N P=0.131N | |POLY 6 | P=0.135N P=0.430N P=0.135N | |LOGISTIC REGRESSION| P=0.168N P=0.307N P=0.086N | |COCH-ARM / FISHERS | P=0.155N P=0.346N P=0.128N | |ORDER RESTRICTED | P=0.092N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 22/50 (44%) 33/52 (63%) 47/51 (92%) | |POLY-3 RATE (b) | 22/45.91 33/47.28 47/48.94 | |POLY-3 PERCENT (g) | 47.9% 69.8% 96.0% | |TERMINAL (d) | 8/28 (29%) 14/24 (58%) 27/27 (100%) | |FIRST INCIDENCE | 441 254 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.032 * P<0.001 ** | |POLY 3 | P<0.001 ** P=0.022 * P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.024 * P<0.001 ** | |POLY 6 | P<0.001 ** P=0.021 * P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.056 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.038 * P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 26 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Multinucleated | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 42/50 (84%) 46/52 (88%) 44/51 (86%) | |POLY-3 RATE (b) | 42/46.55 46/47.78 44/47.16 | |POLY-3 PERCENT (g) | 90.2% 96.3% 93.3% | |TERMINAL (d) | 27/28 (96%) 23/24 (96%) 27/27 (100%) | |FIRST INCIDENCE | 441 310 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.466N P=0.105 P=0.368 | |POLY 3 | P=0.625 P=0.182 P=0.422 | |POLY 1.5 | P=0.611 P=0.173 P=0.414 | |POLY 6 | P=0.639 P=0.306 P=0.487 | |LOGISTIC REGRESSION| P=0.520N P=0.090 P=0.405 | |COCH-ARM / FISHERS | P=0.579 P=0.357 P=0.483 | |ORDER RESTRICTED | P=0.201 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver: Oval Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 33/50 (66%) 39/52 (75%) 43/51 (84%) | |POLY-3 RATE (b) | 33/43.22 39/43.48 43/46.51 | |POLY-3 PERCENT (g) | 76.4% 89.7% 92.5% | |TERMINAL (d) | 23/28 (82%) 22/24 (92%) 27/27 (100%) | |FIRST INCIDENCE | 484 499 462 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.147 P=0.053 P=0.040 * | |POLY 3 | P=0.050 P=0.056 P=0.016 * | |POLY 1.5 | P=0.040 * P=0.077 P=0.015 * | |POLY 6 | P=0.078 P=0.072 P=0.026 * | |LOGISTIC REGRESSION| P=0.041 * P=0.029 * P=0.010 * | |COCH-ARM / FISHERS | P=0.042 * P=0.218 P=0.028 * | |ORDER RESTRICTED | P=0.005 ** (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 27 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver: Portal | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 7/52 (13%) 10/51 (20%) | |POLY-3 RATE (b) | 3/39.90 7/37.83 10/41.29 | |POLY-3 PERCENT (g) | 7.5% 18.5% 24.2% | |TERMINAL (d) | 2/28 (7%) 6/24 (25%) 7/27 (26%) | |FIRST INCIDENCE | 643 603 490 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.075 P=0.108 P=0.037 * | |POLY 3 | P=0.070 P=0.132 P=0.037 * | |POLY 1.5 | P=0.067 P=0.143 P=0.037 * | |POLY 6 | P=0.073 P=0.125 P=0.038 * | |LOGISTIC REGRESSION| P=0.074 P=0.127 P=0.038 * | |COCH-ARM / FISHERS | P=0.065 P=0.176 P=0.039 * | |ORDER RESTRICTED | P=0.025 * (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 49/50 (98%) 46/53 (87%) 40/50 (80%) | |POLY-3 RATE (b) | 49/49.59 46/46.97 40/45.90 | |POLY-3 PERCENT (g) | 98.8% 97.9% 87.1% | |TERMINAL (d) | 28/28 (100%) 24/24 (100%) 25/27 (93%) | |FIRST INCIDENCE | 441 254 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.065N P=0.427 P=0.126N | |POLY 3 | P<0.001N** P=0.764N P=0.015N* | |POLY 1.5 | P=0.002N** P=0.348N P=0.009N** | |POLY 6 | P=0.002N** P=0.990 P=0.030N* | |LOGISTIC REGRESSION| P=0.002N** P=0.361N P=0.005N** | |COCH-ARM / FISHERS | P=0.020N* P=0.036N* P=0.004N** | |ORDER RESTRICTED | P<0.001N** (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 28 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Lung | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 4/53 (8%) 2/50 (4%) | |POLY-3 RATE (b) | 2/39.59 4/38.58 2/40.50 | |POLY-3 PERCENT (g) | 5.1% 10.4% 4.9% | |TERMINAL (d) | 2/28 (7%) 2/24 (8%) 0/27 (0%) | |FIRST INCIDENCE | 729 (T) 330 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.444N P=0.291 P=0.692 | |POLY 3 | P=0.452N P=0.324 P=0.687N | |POLY 1.5 | P=0.463N P=0.331 P=0.692N | |POLY 6 | P=0.438N P=0.322 P=0.678N | |LOGISTIC REGRESSION| P=0.483N P=0.349 P=0.695 | |COCH-ARM / FISHERS | P=0.480N P=0.367 P=0.691N | |ORDER RESTRICTED | P=0.425N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Lung | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 2/53 (4%) 6/50 (12%) | |POLY-3 RATE (b) | 3/40.28 2/37.40 6/40.41 | |POLY-3 PERCENT (g) | 7.5% 5.4% 14.9% | |TERMINAL (d) | 2/28 (7%) 2/24 (8%) 3/27 (11%) | |FIRST INCIDENCE | 491 729 (T) 632 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.131 P=0.558N P=0.242 | |POLY 3 | P=0.122 P=0.534N P=0.241 | |POLY 1.5 | P=0.116 P=0.519N P=0.238 | |POLY 6 | P=0.130 P=0.545N P=0.248 | |LOGISTIC REGRESSION| P=0.122 P=0.517N P=0.241 | |COCH-ARM / FISHERS | P=0.105 P=0.472N P=0.243 | |ORDER RESTRICTED | P=0.128 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 29 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/50 (10%) 5/53 (9%) 8/50 (16%) | |POLY-3 RATE (b) | 5/39.59 5/38.38 8/41.69 | |POLY-3 PERCENT (g) | 12.6% 13.0% 19.2% | |TERMINAL (d) | 5/28 (18%) 2/24 (8%) 4/27 (15%) | |FIRST INCIDENCE | 729 (T) 505 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.238 P=0.555 P=0.265 | |POLY 3 | P=0.246 P=0.612 P=0.307 | |POLY 1.5 | P=0.227 P=0.620 P=0.291 | |POLY 6 | P=0.267 P=0.615 P=0.328 | |LOGISTIC REGRESSION| P=0.213 P=0.592 P=0.274 | |COCH-ARM / FISHERS | P=0.193 P=0.592N P=0.277 | |ORDER RESTRICTED | P=0.277 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Metaplasia Bronchiolar | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 39/50 (78%) 34/53 (64%) 30/50 (60%) | |POLY-3 RATE (b) | 39/45.77 34/41.55 30/42.62 | |POLY-3 PERCENT (g) | 85.2% 81.8% 70.4% | |TERMINAL (d) | 25/28 (89%) 23/24 (96%) 22/27 (82%) | |FIRST INCIDENCE | 478 505 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.060N P=0.540N P=0.090N | |POLY 3 | P=0.038N* P=0.437N P=0.057N | |POLY 1.5 | P=0.049N* P=0.295N P=0.050N | |POLY 6 | P=0.034N* P=0.595N P=0.070N | |LOGISTIC REGRESSION| P=0.024N* P=0.295N P=0.030N* | |COCH-ARM / FISHERS | P=0.104N P=0.092N P=0.041N* | |ORDER RESTRICTED | P=0.033N* (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 30 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/49 (0%) 3/50 (6%) 2/49 (4%) | |POLY-3 RATE (b) | 0/39.12 3/35.88 2/38.99 | |POLY-3 PERCENT (g) | 0.0% 8.4% 5.1% | |TERMINAL (d) | 0/28 (0%) 2/24 (8%) 2/27 (7%) | |FIRST INCIDENCE | --- 603 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.523 P=0.099 P=0.230 | |POLY 3 | P=0.507 P=0.103 P=0.236 | |POLY 1.5 | P=0.506 P=0.106 P=0.235 | |POLY 6 | P=0.511 P=0.102 P=0.237 | |LOGISTIC REGRESSION| P=0.535 P=0.105 P=0.230 | |COCH-ARM / FISHERS | P=0.512 P=0.125 P=0.247 | |ORDER RESTRICTED | P=0.096 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 33/49 (67%) 36/50 (72%) 32/49 (65%) | |POLY-3 RATE (b) | 33/44.17 36/42.27 32/44.54 | |POLY-3 PERCENT (g) | 74.7% 85.2% 71.9% | |TERMINAL (d) | 22/28 (79%) 23/24 (96%) 20/27 (74%) | |FIRST INCIDENCE | 441 363 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.292N P=0.133 P=0.546N | |POLY 3 | P=0.214N P=0.151 P=0.473N | |POLY 1.5 | P=0.250N P=0.178 P=0.489N | |POLY 6 | P=0.185N P=0.153 P=0.445N | |LOGISTIC REGRESSION| P=0.279N P=0.145 P=0.517N | |COCH-ARM / FISHERS | P=0.372N P=0.388 P=0.500N | |ORDER RESTRICTED | P=0.227N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 31 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/49 (0%) 2/50 (4%) 2/49 (4%) | |POLY-3 RATE (b) | 0/39.12 2/36.99 2/39.96 | |POLY-3 PERCENT (g) | 0.0% 5.4% 5.0% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 1/27 (4%) | |FIRST INCIDENCE | --- 363 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.400 P=0.238 P=0.238 | |POLY 3 | P=0.396 P=0.224 P=0.241 | |POLY 1.5 | P=0.393 P=0.226 P=0.240 | |POLY 6 | P=0.400 P=0.225 P=0.243 | |LOGISTIC REGRESSION| P=0.281 P=0.415 P=0.320 | |COCH-ARM / FISHERS | P=0.388 P=0.253 P=0.247 | |ORDER RESTRICTED | P=0.138 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/49 (2%) 1/52 (2%) 2/49 (4%) | |POLY-3 RATE (b) | 1/38.87 1/38.06 2/38.45 | |POLY-3 PERCENT (g) | 2.6% 2.6% 5.2% | |TERMINAL (d) | 1/28 (4%) 0/24 (0%) 2/27 (7%) | |FIRST INCIDENCE | 729 (T) 506 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.434 P=0.741 P=0.487 | |POLY 3 | P=0.418 P=0.757 P=0.496 | |POLY 1.5 | P=0.416 P=0.760 P=0.496 | |POLY 6 | P=0.420 P=0.755 P=0.498 | |LOGISTIC REGRESSION| P=0.418 P=0.738N P=0.487 | |COCH-ARM / FISHERS | P=0.411 P=0.737N P=0.500 | |ORDER RESTRICTED | P=0.363 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 32 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/2 (0%) 0/7 (0%) 2/5 (40%) | |POLY-3 RATE (b) | 0/1.26 0/3.75 2/4.56 | |POLY-3 PERCENT (g) | 0.0% 0.0% 43.9% | |TERMINAL (d) | 0/1 (0%) 0/2 (0%) 2/4 (50%) | |FIRST INCIDENCE | --- --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.282 (e) P=0.581 | |POLY 3 | P=0.175 (e) P=0.547 | |POLY 1.5 | P=0.135 (e) P=0.513 | |POLY 6 | P=0.224 (e) P=0.572 | |LOGISTIC REGRESSION| (e) (e) P=0.581 | |COCH-ARM / FISHERS | P=0.103 (e) P=0.476 | |ORDER RESTRICTED | P=0.308 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/2 (0%) 1/7 (14%) 2/5 (40%) | |POLY-3 RATE (b) | 0/1.26 1/4.66 2/4.56 | |POLY-3 PERCENT (g) | 0.0% 21.5% 43.9% | |TERMINAL (d) | 0/1 (0%) 0/2 (0%) 2/4 (50%) | |FIRST INCIDENCE | --- 330 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.466 P=0.492 P=0.581 | |POLY 3 | P=0.392 P=0.757 P=0.547 | |POLY 1.5 | P=0.342 P=0.751 P=0.513 | |POLY 6 | P=0.446 P=0.755 P=0.572 | |LOGISTIC REGRESSION| P=0.177 (e) P=0.581 | |COCH-ARM / FISHERS | P=0.269 P=0.778 P=0.476 | |ORDER RESTRICTED | P=0.371 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 33 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Lymph Node: Renal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/2 (0%) 2/7 (29%) 0/5 (0%) | |POLY-3 RATE (b) | 0/1.26 2/4.81 0/4.56 | |POLY-3 PERCENT (g) | 0.0% 41.6% 0.0% | |TERMINAL (d) | 0/1 (0%) 0/2 (0%) 0/4 (0%) | |FIRST INCIDENCE | --- 506 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.424N P=0.225 (e) | |POLY 3 | P=0.282N P=0.568 (e) | |POLY 1.5 | P=0.318N P=0.553 (e) | |POLY 6 | P=0.256N P=0.581 (e) | |LOGISTIC REGRESSION| P=0.509N P=0.547 (e) | |COCH-ARM / FISHERS | P=0.381N P=0.583 (e) | |ORDER RESTRICTED | P=0.394N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Mammary Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 3/53 (6%) 2/51 (4%) | |POLY-3 RATE (b) | 2/40.31 3/38.06 2/40.45 | |POLY-3 PERCENT (g) | 5.0% 7.9% 4.9% | |TERMINAL (d) | 1/28 (4%) 2/24 (8%) 1/27 (4%) | |FIRST INCIDENCE | 478 506 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.541N P=0.452 P=0.689 | |POLY 3 | P=0.549N P=0.474 P=0.693N | |POLY 1.5 | P=0.553N P=0.485 P=0.693N | |POLY 6 | P=0.545N P=0.467 P=0.692N | |LOGISTIC REGRESSION| P=0.565N P=0.533 P=0.679N | |COCH-ARM / FISHERS | P=0.564N P=0.528 P=0.684N | |ORDER RESTRICTED | P=0.528N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 34 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 14/50 (28%) 22/53 (42%) 15/51 (29%) | |POLY-3 RATE (b) | 14/42.77 22/41.66 15/42.12 | |POLY-3 PERCENT (g) | 32.7% 52.8% 35.6% | |TERMINAL (d) | 7/28 (25%) 11/24 (46%) 10/27 (37%) | |FIRST INCIDENCE | 462 499 463 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.298N P=0.053 P=0.480 | |POLY 3 | P=0.334N P=0.044 * P=0.479 | |POLY 1.5 | P=0.327N P=0.053 P=0.493 | |POLY 6 | P=0.353N P=0.042 * P=0.463 | |LOGISTIC REGRESSION| P=0.300N P=0.066 P=0.517 | |COCH-ARM / FISHERS | P=0.337N P=0.109 P=0.525 | |ORDER RESTRICTED | P=0.185 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Mammary Gland | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 3/53 (6%) 0/51 (0%) | |POLY-3 RATE (b) | 2/40.28 3/37.73 0/39.98 | |POLY-3 PERCENT (g) | 5.0% 8.0% 0.0% | |TERMINAL (d) | 1/28 (4%) 1/24 (4%) 0/27 (0%) | |FIRST INCIDENCE | 491 650 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.135N P=0.460 P=0.246N | |POLY 3 | P=0.130N P=0.470 P=0.238N | |POLY 1.5 | P=0.131N P=0.483 P=0.237N | |POLY 6 | P=0.129N P=0.463 P=0.239N | |LOGISTIC REGRESSION| P=0.132N P=0.499 P=0.218N | |COCH-ARM / FISHERS | P=0.135N P=0.528 P=0.243N | |ORDER RESTRICTED | P=0.100N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 35 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Mesentery: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/31 (3%) 2/47 (4%) 1/47 (2%) | |POLY-3 RATE (b) | 1/23.96 2/33.24 1/36.01 | |POLY-3 PERCENT (g) | 4.2% 6.0% 2.8% | |TERMINAL (d) | 1/17 (6%) 2/21 (10%) 0/23 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 720 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.513N P=0.575 P=0.727N | |POLY 3 | P=0.483N P=0.615 P=0.668N | |POLY 1.5 | P=0.487N P=0.621 P=0.668N | |POLY 6 | P=0.482N P=0.612 P=0.669N | |LOGISTIC REGRESSION| P=0.490N P=0.575 P=0.678N | |COCH-ARM / FISHERS | P=0.498N P=0.654 P=0.640N | |ORDER RESTRICTED | P=0.453N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 17/50 (34%) 13/53 (25%) 15/51 (29%) | |POLY-3 RATE (b) | 17/43.73 13/40.22 15/41.65 | |POLY-3 PERCENT (g) | 38.9% 32.3% 36.0% | |TERMINAL (d) | 9/28 (32%) 5/24 (21%) 10/27 (37%) | |FIRST INCIDENCE | 441 539 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.505N P=0.389N P=0.451N | |POLY 3 | P=0.561N P=0.344N P=0.480N | |POLY 1.5 | P=0.548N P=0.309N P=0.450N | |POLY 6 | P=0.567 P=0.357N P=0.509N | |LOGISTIC REGRESSION| P=0.528N P=0.239N P=0.396N | |COCH-ARM / FISHERS | P=0.561N P=0.200N P=0.389N | |ORDER RESTRICTED | P=0.438N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 36 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/50 (10%) 6/53 (11%) 5/51 (10%) | |POLY-3 RATE (b) | 5/41.00 6/38.67 5/41.38 | |POLY-3 PERCENT (g) | 12.2% 15.5% 12.1% | |TERMINAL (d) | 3/28 (11%) 1/24 (4%) 2/27 (7%) | |FIRST INCIDENCE | 478 603 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.520N P=0.444 P=0.613 | |POLY 3 | P=0.517N P=0.458 P=0.626N | |POLY 1.5 | P=0.525N P=0.474 P=0.626N | |POLY 6 | P=0.509N P=0.457 P=0.621N | |LOGISTIC REGRESSION| P=0.543N P=0.515 P=0.605N | |COCH-ARM / FISHERS | P=0.546N P=0.541 P=0.617N | |ORDER RESTRICTED | P=0.549N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 14/50 (28%) 11/53 (21%) 12/51 (24%) | |POLY-3 RATE (b) | 14/43.24 11/40.12 12/41.65 | |POLY-3 PERCENT (g) | 32.4% 27.4% 28.8% | |TERMINAL (d) | 7/28 (25%) 3/24 (13%) 7/27 (26%) | |FIRST INCIDENCE | 441 539 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.470N P=0.441N P=0.442N | |POLY 3 | P=0.504N P=0.399N P=0.452N | |POLY 1.5 | P=0.497N P=0.369N P=0.431N | |POLY 6 | P=0.521N P=0.412N P=0.473N | |LOGISTIC REGRESSION| P=0.495N P=0.290N P=0.390N | |COCH-ARM / FISHERS | P=0.515N P=0.265N P=0.387N | |ORDER RESTRICTED | P=0.452N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 37 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Oral Mucosa: Gingival | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 21/28 (75%) 22/30 (73%) 29/41 (71%) | |POLY-3 RATE (b) | 21/26.86 22/27.81 29/38.96 | |POLY-3 PERCENT (g) | 78.2% 79.1% 74.4% | |TERMINAL (d) | 10/15 (67%) 12/15 (80%) 17/24 (71%) | |FIRST INCIDENCE | 491 451 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.515 P=0.445 P=0.453 | |POLY 3 | P=0.404N P=0.600 P=0.477N | |POLY 1.5 | P=0.413N P=0.620N P=0.463N | |POLY 6 | P=0.409N P=0.549 P=0.509N | |LOGISTIC REGRESSION| P=0.436N P=0.565N P=0.456N | |COCH-ARM / FISHERS | P=0.436N P=0.562N P=0.457N | |ORDER RESTRICTED | P=0.464N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Ovary | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 46/48 (96%) 43/52 (83%) 36/50 (72%) | |POLY-3 RATE (b) | 46/47.26 43/48.11 36/46.64 | |POLY-3 PERCENT (g) | 97.4% 89.4% 77.2% | |TERMINAL (d) | 27/28 (96%) 22/24 (92%) 21/27 (78%) | |FIRST INCIDENCE | 441 254 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.051N P=0.448 P=0.098N | |POLY 3 | P=0.002N** P=0.095N P=0.002N** | |POLY 1.5 | P=0.002N** P=0.064N P<0.001N** | |POLY 6 | P=0.003N** P=0.181N P=0.004N** | |LOGISTIC REGRESSION| P=0.005N** P=0.069N P=0.002N** | |COCH-ARM / FISHERS | P=0.006N** P=0.035N* P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 38 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 16/48 (33%) 14/52 (27%) 19/50 (38%) | |POLY-3 RATE (b) | 16/41.13 14/39.03 19/42.91 | |POLY-3 PERCENT (g) | 38.9% 35.9% 44.3% | |TERMINAL (d) | 10/28 (36%) 11/24 (46%) 12/27 (44%) | |FIRST INCIDENCE | 484 330 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.266 P=0.574N P=0.321 | |POLY 3 | P=0.292 P=0.480N P=0.389 | |POLY 1.5 | P=0.264 P=0.422N P=0.385 | |POLY 6 | P=0.325 P=0.551N P=0.392 | |LOGISTIC REGRESSION| P=0.240 P=0.405N P=0.385 | |COCH-ARM / FISHERS | P=0.223 P=0.315N P=0.393 | |ORDER RESTRICTED | P=0.350 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Ovary | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/48 (0%) 0/52 (0%) 4/50 (8%) | |POLY-3 RATE (b) | 0/38.21 0/37.39 4/39.49 | |POLY-3 PERCENT (g) | 0.0% 0.0% 10.1% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 3/27 (11%) | |FIRST INCIDENCE | --- --- 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.012 * (e) P=0.063 | |POLY 3 | P=0.009 ** (e) P=0.063 | |POLY 1.5 | P=0.009 ** (e) P=0.064 | |POLY 6 | P=0.009 ** (e) P=0.063 | |LOGISTIC REGRESSION| P=0.010 * (e) P=0.065 | |COCH-ARM / FISHERS | P=0.010 * (e) P=0.064 | |ORDER RESTRICTED | P=0.008 ** (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 39 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Oviduct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/1 (0%) 2/2 (100%) 0/3 (0%) | |POLY-3 RATE (b) | 0/1.00 2/2.00 0/2.94 | |POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% | |TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/2 (0%) | |FIRST INCIDENCE | --- 539 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.422N P=0.236 (e) | |POLY 3 | P<0.001N** P=0.333 (e) | |POLY 1.5 | P<0.001N** P=0.333 (e) | |POLY 6 | P<0.001N** P=0.333 (e) | |LOGISTIC REGRESSION| (e) (e) (e) | |COCH-ARM / FISHERS | P=0.211N P=0.333 (e) | |ORDER RESTRICTED | P=0.095N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Oviduct | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/1 (0%) 0/2 (0%) 3/3 (100%) | |POLY-3 RATE (b) | 0/1.00 0/1.14 3/3.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 100.0% | |TERMINAL (d) | 0/1 (0%) 0/0 (0%) 2/2 (100%) | |FIRST INCIDENCE | --- --- 714 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.104 (e) P=0.166 | |POLY 3 | P<0.001 ** (e) P=0.250 | |POLY 1.5 | P<0.001 ** (e) P=0.250 | |POLY 6 | P<0.001 ** (e) P=0.250 | |LOGISTIC REGRESSION| P=0.165 (e) (e) | |COCH-ARM / FISHERS | P=0.049 * (e) P=0.250 | |ORDER RESTRICTED | P=0.011 * (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 40 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Pancreas | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/49 (10%) 1/52 (2%) 5/49 (10%) | |POLY-3 RATE (b) | 5/40.27 1/37.39 5/38.46 | |POLY-3 PERCENT (g) | 12.4% 2.7% 13.0% | |TERMINAL (d) | 2/28 (7%) 1/24 (4%) 4/27 (15%) | |FIRST INCIDENCE | 491 729 (T) 668 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.340 P=0.136N P=0.613 | |POLY 3 | P=0.324 P=0.118N P=0.602 | |POLY 1.5 | P=0.319 P=0.108N P=0.611 | |POLY 6 | P=0.329 P=0.128N P=0.593 | |LOGISTIC REGRESSION| P=0.316 P=0.096N P=0.623 | |COCH-ARM / FISHERS | P=0.303 P=0.089N P=0.630N | |ORDER RESTRICTED | P=0.287 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/49 (8%) 1/52 (2%) 5/49 (10%) | |POLY-3 RATE (b) | 4/40.03 1/37.39 5/38.23 | |POLY-3 PERCENT (g) | 10.0% 2.7% 13.1% | |TERMINAL (d) | 2/28 (7%) 1/24 (4%) 5/27 (19%) | |FIRST INCIDENCE | 491 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.240 P=0.222N P=0.477 | |POLY 3 | P=0.226 P=0.199N P=0.471 | |POLY 1.5 | P=0.223 P=0.187N P=0.480 | |POLY 6 | P=0.226 P=0.210N P=0.460 | |LOGISTIC REGRESSION| P=0.226 P=0.170N P=0.490 | |COCH-ARM / FISHERS | P=0.214 P=0.163N P=0.500 | |ORDER RESTRICTED | P=0.201 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 41 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Pancreas: Acinus | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/49 (6%) 7/52 (13%) 44/49 (90%) | |POLY-3 RATE (b) | 3/39.04 7/38.39 44/45.45 | |POLY-3 PERCENT (g) | 7.7% 18.2% 96.8% | |TERMINAL (d) | 2/28 (7%) 5/24 (21%) 27/27 (100%) | |FIRST INCIDENCE | 701 552 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.114 P<0.001 ** | |POLY 3 | P<0.001 ** P=0.146 P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.154 P<0.001 ** | |POLY 6 | P<0.001 ** P=0.142 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.139 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.185 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Pancreas: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/49 (8%) 2/52 (4%) 3/49 (6%) | |POLY-3 RATE (b) | 4/39.04 2/38.06 3/38.67 | |POLY-3 PERCENT (g) | 10.3% 5.3% 7.8% | |TERMINAL (d) | 3/28 (11%) 1/24 (4%) 2/27 (7%) | |FIRST INCIDENCE | 701 506 601 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.597N P=0.394N P=0.513N | |POLY 3 | P=0.609N P=0.348N P=0.505N | |POLY 1.5 | P=0.616N P=0.339N P=0.506N | |POLY 6 | P=0.601N P=0.353N P=0.502N | |LOGISTIC REGRESSION| P=0.620N P=0.350N P=0.510N | |COCH-ARM / FISHERS | P=0.633N P=0.311N P=0.500N | |ORDER RESTRICTED | P=0.370N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 42 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Pituitary Gland | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 14/50 (28%) 17/52 (33%) 7/51 (14%) | |POLY-3 RATE (b) | 14/41.76 17/39.38 7/40.52 | |POLY-3 PERCENT (g) | 33.5% 43.2% 17.3% | |TERMINAL (d) | 8/28 (29%) 9/24 (38%) 5/27 (19%) | |FIRST INCIDENCE | 491 506 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.023N* P=0.224 P=0.085N | |POLY 3 | P=0.017N* P=0.249 P=0.071N | |POLY 1.5 | P=0.017N* P=0.272 P=0.068N | |POLY 6 | P=0.018N* P=0.244 P=0.077N | |LOGISTIC REGRESSION| P=0.015N* P=0.258 P=0.064N | |COCH-ARM / FISHERS | P=0.022N* P=0.383 P=0.063N | |ORDER RESTRICTED | P=0.022N* (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Pituitary Gland | | Cytoplasmic Alteration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 0/52 (0%) 2/51 (4%) | |POLY-3 RATE (b) | 1/40.20 0/36.79 2/39.98 | |POLY-3 PERCENT (g) | 2.5% 0.0% 5.0% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 2/27 (7%) | |FIRST INCIDENCE | 534 --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.288 P=0.510N P=0.494 | |POLY 3 | P=0.289 P=0.518N P=0.498 | |POLY 1.5 | P=0.286 P=0.512N P=0.500 | |POLY 6 | P=0.290 P=0.522N P=0.496 | |LOGISTIC REGRESSION| P=0.282 P=0.417N P=0.506 | |COCH-ARM / FISHERS | P=0.276 P=0.490N P=0.508 | |ORDER RESTRICTED | P=0.199 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 43 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Pituitary Gland | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 1/52 (2%) 2/51 (4%) | |POLY-3 RATE (b) | 0/39.59 1/36.79 2/40.04 | |POLY-3 PERCENT (g) | 0.0% 2.7% 5.0% | |TERMINAL (d) | 0/28 (0%) 1/24 (4%) 1/27 (4%) | |FIRST INCIDENCE | --- 729 (T) 714 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.262 P=0.469 P=0.240 | |POLY 3 | P=0.247 P=0.485 P=0.239 | |POLY 1.5 | P=0.247 P=0.490 P=0.239 | |POLY 6 | P=0.249 P=0.483 P=0.240 | |LOGISTIC REGRESSION| P=0.262 P=0.469 P=0.240 | |COCH-ARM / FISHERS | P=0.248 P=0.510 P=0.252 | |ORDER RESTRICTED | P=0.105 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 17/50 (34%) 20/52 (38%) 21/51 (41%) | |POLY-3 RATE (b) | 17/42.72 20/40.07 21/42.87 | |POLY-3 PERCENT (g) | 39.8% 49.9% 49.0% | |TERMINAL (d) | 11/28 (39%) 11/24 (46%) 15/27 (56%) | |FIRST INCIDENCE | 484 505 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.376 P=0.215 P=0.245 | |POLY 3 | P=0.354 P=0.236 P=0.256 | |POLY 1.5 | P=0.355 P=0.263 P=0.268 | |POLY 6 | P=0.337 P=0.235 P=0.242 | |LOGISTIC REGRESSION| P=0.376 P=0.271 P=0.282 | |COCH-ARM / FISHERS | P=0.328 P=0.397 P=0.295 | |ORDER RESTRICTED | P=0.243 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 44 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Skin | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 0/53 (0%) 2/51 (4%) | |POLY-3 RATE (b) | 0/39.59 0/37.40 2/41.69 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 0/27 (0%) | |FIRST INCIDENCE | --- --- 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.102 (e) P=0.240 | |POLY 3 | P=0.105 (e) P=0.248 | |POLY 1.5 | P=0.103 (e) P=0.246 | |POLY 6 | P=0.107 (e) P=0.251 | |LOGISTIC REGRESSION| P=0.028 * (e) P=0.564 | |COCH-ARM / FISHERS | P=0.098 (e) P=0.252 | |ORDER RESTRICTED | P=0.059 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 41/49 (84%) 47/52 (90%) 45/49 (92%) | |POLY-3 RATE (b) | 41/45.57 47/50.21 45/46.44 | |POLY-3 PERCENT (g) | 90.0% 93.6% 96.9% | |TERMINAL (d) | 28/28 (100%) 24/24 (100%) 27/27 (100%) | |FIRST INCIDENCE | 441 142 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.547N P=0.053 P=0.246 | |POLY 3 | P=0.158 P=0.371 P=0.117 | |POLY 1.5 | P=0.174 P=0.284 P=0.120 | |POLY 6 | P=0.171 P=0.596 P=0.160 | |LOGISTIC REGRESSION| P=0.282 P=0.166 P=0.109 | |COCH-ARM / FISHERS | P=0.257 P=0.239 P=0.178 | |ORDER RESTRICTED | P=0.071 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 45 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Spleen | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 48/49 (98%) 51/52 (98%) 49/49 (100%) | |POLY-3 RATE (b) | 48/48.68 51/51.01 49/49.00 | |POLY-3 PERCENT (g) | 98.6% 100.0% 100.0% | |TERMINAL (d) | 28/28 (100%) 24/24 (100%) 27/27 (100%) | |FIRST INCIDENCE | 441 254 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.421N P=0.144 P=0.445 | |POLY 3 | P=0.765 P=0.679 P=0.682 | |POLY 1.5 | P=0.654 P=0.615 P=0.585 | |POLY 6 | P=0.927 P=0.876 P=0.879 | |LOGISTIC REGRESSION| P=0.441 P=0.494 P=0.496 | |COCH-ARM / FISHERS | P=0.397 P=0.737 P=0.500 | |ORDER RESTRICTED | P=0.151 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/49 (10%) 4/52 (8%) 2/49 (4%) | |POLY-3 RATE (b) | 5/40.77 4/38.83 2/39.64 | |POLY-3 PERCENT (g) | 12.3% 10.3% 5.1% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 0/27 (0%) | |FIRST INCIDENCE | 567 310 233 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.205N P=0.546N P=0.225N | |POLY 3 | P=0.205N P=0.531N P=0.226N | |POLY 1.5 | P=0.207N P=0.509N P=0.221N | |POLY 6 | P=0.206N P=0.555N P=0.235N | |LOGISTIC REGRESSION| P=0.238N P=0.400N P=0.153N | |COCH-ARM / FISHERS | P=0.220N P=0.462N P=0.218N | |ORDER RESTRICTED | P=0.180N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 46 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/52 (4%) 2/51 (4%) | |POLY-3 RATE (b) | 0/39.59 2/37.84 2/40.33 | |POLY-3 PERCENT (g) | 0.0% 5.3% 5.0% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 1/27 (4%) | |FIRST INCIDENCE | --- 612 632 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.406 P=0.213 P=0.236 | |POLY 3 | P=0.392 P=0.227 P=0.241 | |POLY 1.5 | P=0.390 P=0.231 P=0.240 | |POLY 6 | P=0.396 P=0.225 P=0.243 | |LOGISTIC REGRESSION| P=0.400 P=0.234 P=0.240 | |COCH-ARM / FISHERS | P=0.393 P=0.257 P=0.252 | |ORDER RESTRICTED | P=0.139 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/50 (12%) 7/52 (13%) 9/51 (18%) | |POLY-3 RATE (b) | 6/41.04 7/39.86 9/41.81 | |POLY-3 PERCENT (g) | 14.6% 17.6% 21.5% | |TERMINAL (d) | 3/28 (11%) 1/24 (4%) 5/27 (19%) | |FIRST INCIDENCE | 491 479 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.309 P=0.428 P=0.277 | |POLY 3 | P=0.294 P=0.477 P=0.297 | |POLY 1.5 | P=0.289 P=0.486 P=0.295 | |POLY 6 | P=0.301 P=0.478 P=0.303 | |LOGISTIC REGRESSION| P=0.277 P=0.549 P=0.301 | |COCH-ARM / FISHERS | P=0.277 P=0.531 P=0.303 | |ORDER RESTRICTED | P=0.281 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 47 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 1/52 (2%) 6/51 (12%) | |POLY-3 RATE (b) | 0/39.59 1/37.47 6/41.36 | |POLY-3 PERCENT (g) | 0.0% 2.7% 14.5% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 3/27 (11%) | |FIRST INCIDENCE | --- 710 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.006 ** P=0.493 P=0.018 * | |POLY 3 | P=0.004 ** P=0.489 P=0.017 * | |POLY 1.5 | P=0.004 ** P=0.494 P=0.016 * | |POLY 6 | P=0.004 ** P=0.486 P=0.018 * | |LOGISTIC REGRESSION| P=0.004 ** P=0.485 P=0.019 * | |COCH-ARM / FISHERS | P=0.004 ** P=0.510 P=0.014 * | |ORDER RESTRICTED | P=0.003 ** (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/52 (4%) 1/51 (2%) | |POLY-3 RATE (b) | 1/40.00 2/37.86 1/40.67 | |POLY-3 PERCENT (g) | 2.5% 5.3% 2.5% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 0/27 (0%) | |FIRST INCIDENCE | 612 618 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.565N P=0.467 P=0.752 | |POLY 3 | P=0.566N P=0.481 P=0.757N | |POLY 1.5 | P=0.570N P=0.489 P=0.758N | |POLY 6 | P=0.564N P=0.476 P=0.757N | |LOGISTIC REGRESSION| P=0.590N P=0.511 P=0.721N | |COCH-ARM / FISHERS | P=0.578N P=0.515 P=0.748N | |ORDER RESTRICTED | P=0.493N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 48 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Stomach, Forestomach: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 0/52 (0%) 2/51 (4%) | |POLY-3 RATE (b) | 0/39.59 0/37.39 2/40.01 | |POLY-3 PERCENT (g) | 0.0% 0.0% 5.0% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 1/27 (4%) | |FIRST INCIDENCE | --- --- 720 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.110 (e) P=0.236 | |POLY 3 | P=0.101 (e) P=0.239 | |POLY 1.5 | P=0.100 (e) P=0.239 | |POLY 6 | P=0.102 (e) P=0.240 | |LOGISTIC REGRESSION| P=0.108 (e) P=0.239 | |COCH-ARM / FISHERS | P=0.100 (e) P=0.252 | |ORDER RESTRICTED | P=0.053 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Stomach, Glandular | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 1/52 (2%) 0/51 (0%) | |POLY-3 RATE (b) | 3/41.18 1/37.39 0/39.98 | |POLY-3 PERCENT (g) | 7.3% 2.7% 0.0% | |TERMINAL (d) | 0/28 (0%) 1/24 (4%) 0/27 (0%) | |FIRST INCIDENCE | 478 729 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.160N P=0.343N P=0.125N | |POLY 3 | P=0.144N P=0.340N P=0.123N | |POLY 1.5 | P=0.148N P=0.325N P=0.121N | |POLY 6 | P=0.141N P=0.355N P=0.126N | |LOGISTIC REGRESSION| P=0.166N P=0.244N P=0.083N | |COCH-ARM / FISHERS | P=0.160N P=0.294N P=0.118N | |ORDER RESTRICTED | P=0.042N* (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 49 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 48/48 (100%) 42/50 (84%) 45/47 (96%) | |POLY-3 RATE (b) | 48/48.00 42/43.09 45/45.28 | |POLY-3 PERCENT (g) | 100.0% 97.5% 99.4% | |TERMINAL (d) | 28/28 (100%) 24/24 (100%) 26/26 (100%) | |FIRST INCIDENCE | 441 479 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.493N P=0.512N P=0.494N | |POLY 3 | P=0.885 P=0.398N P=0.998N | |POLY 1.5 | P=0.675 P=0.064N P=0.717N | |POLY 6 | P=0.999 P=0.990N P=1.000N | |LOGISTIC REGRESSION| P=0.683 P=0.100N P=0.526N | |COCH-ARM / FISHERS | P=0.369 P=0.003N** P=0.242N | |ORDER RESTRICTED | P=0.113N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Thymus | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/48 (0%) 3/50 (6%) 0/47 (0%) | |POLY-3 RATE (b) | 0/38.21 3/38.30 0/37.46 | |POLY-3 PERCENT (g) | 0.0% 7.8% 0.0% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- 96 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.307N P=0.125 (e) | |POLY 3 | P=0.315N P=0.118 (e) | |POLY 1.5 | P=0.316N P=0.119 (e) | |POLY 6 | P=0.314N P=0.118 (e) | |LOGISTIC REGRESSION| P=0.481N P=0.640 (e) | |COCH-ARM / FISHERS | P=0.316N P=0.129 (e) | |ORDER RESTRICTED | P=0.192 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 50 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 16/49 (33%) 12/52 (23%) 17/50 (34%) | |POLY-3 RATE (b) | 16/42.03 12/38.36 17/42.66 | |POLY-3 PERCENT (g) | 38.1% 31.3% 39.9% | |TERMINAL (d) | 10/28 (36%) 7/24 (29%) 12/27 (44%) | |FIRST INCIDENCE | 491 552 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.349 P=0.383N P=0.467 | |POLY 3 | P=0.378 P=0.341N P=0.522 | |POLY 1.5 | P=0.355 P=0.302N P=0.520 | |POLY 6 | P=0.391 P=0.368N P=0.523 | |LOGISTIC REGRESSION| P=0.334 P=0.286N P=0.523 | |COCH-ARM / FISHERS | P=0.293 P=0.197N P=0.528 | |ORDER RESTRICTED | P=0.423 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 28/49 (57%) 35/52 (67%) 44/50 (88%) | |POLY-3 RATE (b) | 28/43.27 35/45.78 44/47.40 | |POLY-3 PERCENT (g) | 64.7% 76.5% 92.8% | |TERMINAL (d) | 20/28 (71%) 20/24 (83%) 27/27 (100%) | |FIRST INCIDENCE | 441 142 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.015 * P=0.045 * P=0.003 ** | |POLY 3 | P<0.001 ** P=0.146 P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.148 P<0.001 ** | |POLY 6 | P<0.001 ** P=0.157 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.137 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.198 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 51 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Tooth: Peridontal Tissue | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 25/25 (100%) 35/35 (100%) 42/42 (100%) | |POLY-3 RATE (b) | 25/25.00 35/35.00 42/42.00 | |POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% | |TERMINAL (d) | 17/17 (100%) 17/17 (100%) 25/25 (100%) | |FIRST INCIDENCE | 491 254 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) | |POLY 3 | (e) (e) (e) | |POLY 1.5 | (e) (e) (e) | |POLY 6 | (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Urinary Bladder | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/49 (6%) 7/52 (13%) 8/50 (16%) | |POLY-3 RATE (b) | 3/39.40 7/39.03 8/39.25 | |POLY-3 PERCENT (g) | 7.6% 17.9% 20.4% | |TERMINAL (d) | 2/28 (7%) 4/24 (17%) 7/27 (26%) | |FIRST INCIDENCE | 569 499 668 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.215 P=0.123 P=0.093 | |POLY 3 | P=0.174 P=0.149 P=0.093 | |POLY 1.5 | P=0.178 P=0.156 P=0.097 | |POLY 6 | P=0.169 P=0.147 P=0.089 | |LOGISTIC REGRESSION| P=0.198 P=0.165 P=0.097 | |COCH-ARM / FISHERS | P=0.184 P=0.185 P=0.106 | |ORDER RESTRICTED | P=0.076 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 52 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Uterus | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 10/52 (19%) 8/50 (16%) | |POLY-3 RATE (b) | 2/39.59 10/39.56 8/39.90 | |POLY-3 PERCENT (g) | 5.1% 25.3% 20.1% | |TERMINAL (d) | 2/28 (7%) 6/24 (25%) 5/27 (19%) | |FIRST INCIDENCE | 729 (T) 506 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.318 P=0.009 ** P=0.047 * | |POLY 3 | P=0.270 P=0.012 * P=0.044 * | |POLY 1.5 | P=0.265 P=0.012 * P=0.043 * | |POLY 6 | P=0.281 P=0.012 * P=0.045 * | |LOGISTIC REGRESSION| P=0.284 P=0.013 * P=0.044 * | |COCH-ARM / FISHERS | P=0.268 P=0.017 * P=0.046 * | |ORDER RESTRICTED | P=0.020 * (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Uterus | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/50 (8%) 7/52 (13%) 8/50 (16%) | |POLY-3 RATE (b) | 4/40.12 7/39.10 8/39.83 | |POLY-3 PERCENT (g) | 10.0% 17.9% 20.1% | |TERMINAL (d) | 3/28 (11%) 2/24 (8%) 6/27 (22%) | |FIRST INCIDENCE | 567 310 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.283 P=0.219 P=0.170 | |POLY 3 | P=0.242 P=0.242 P=0.168 | |POLY 1.5 | P=0.239 P=0.251 P=0.170 | |POLY 6 | P=0.245 P=0.241 P=0.170 | |LOGISTIC REGRESSION| P=0.250 P=0.264 P=0.169 | |COCH-ARM / FISHERS | P=0.238 P=0.286 P=0.178 | |ORDER RESTRICTED | P=0.146 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 53 Statistical Analysis of Non-neoplastic Lesions in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Uterus | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 27/50 (54%) 36/52 (69%) 34/50 (68%) | |POLY-3 RATE (b) | 27/43.83 36/44.30 34/45.44 | |POLY-3 PERCENT (g) | 61.6% 81.3% 74.8% | |TERMINAL (d) | 18/28 (64%) 21/24 (88%) 20/27 (74%) | |FIRST INCIDENCE | 441 310 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.406 P=0.022 * P=0.129 | |POLY 3 | P=0.351 P=0.024 * P=0.120 | |POLY 1.5 | P=0.298 P=0.035 * P=0.107 | |POLY 6 | P=0.422 P=0.017 * P=0.141 | |LOGISTIC REGRESSION| P=0.279 P=0.032 * P=0.094 | |COCH-ARM / FISHERS | P=0.249 P=0.084 P=0.109 | |ORDER RESTRICTED | P=0.039 * (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 25/50 (50%) 18/52 (35%) 15/50 (30%) | |POLY-3 RATE (b) | 25/44.81 18/41.18 15/41.92 | |POLY-3 PERCENT (g) | 55.8% 43.7% 35.8% | |TERMINAL (d) | 16/28 (57%) 13/24 (54%) 8/27 (30%) | |FIRST INCIDENCE | 441 142 409 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.072N P=0.249N P=0.058N | |POLY 3 | P=0.067N P=0.174N P=0.043N* | |POLY 1.5 | P=0.074N P=0.135N P=0.040N* | |POLY 6 | P=0.058N P=0.226N P=0.045N* | |LOGISTIC REGRESSION| P=0.082N P=0.091N P=0.034N* | |COCH-ARM / FISHERS | P=0.085N P=0.085N P=0.033N* | |ORDER RESTRICTED | P=0.033N* (e) (e) | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Number of tumor-bearing animals / Poly-3 number (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates For all tests a negative trend is indicated by N (e) Value of Statistic cannot be computed. (g) Poly-3 adjusted lifetime tumor incidence. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).