TDMS Study 96020-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) DATE: 03/03/04 EXPERIMENT: 96020 TEST: 01 TIME: 09:55:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96020 PATHOLOGIST: SELLS, DONALD CAS: TEFBINARYMIX ------------------------------------------------------------------------------------------------------------------------------------ FINAL #1 REASONS FOR REMOVAL: 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 0 NG / 0 UG INCLUDE 002 10 NG / 10 UG INCLUDE 003 100 NG /100 UG INCLUDE 005 300 NG /300 UG INCLUDE 007 1000 NG/1000 UG NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) DATE: 03/03/04 EXPERIMENT: 96020 TEST: 01 TIME: 09:55:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96020 PATHOLOGIST: SELLS, DONALD CAS: TEFBINARYMIX Rats(SPRAGUE-DAWLEY) ----------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED. --------------- Adrenal Cortex Adrenal Medulla Brain Clitoral/Preputial Gland Heart Islets, Pancreatic Kidney Liver Lung Ovary Pancreas Parathyroid Gland Pituitary Gland Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) DATE: 03/03/04 EXPERIMENT: 96020 TEST: 01 TIME: 09:55:48 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 ----- ---------- Liver Cholangiocarcinoma Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Hepatocholangioma Lung Cystic Keratinizing Epithelioma Mammary Gland Carcinoma Carcinoma or Adenoma Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) Squamous Cell Carcinoma Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma Oral Mucosa Squamous Cell Carcinoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Thyroid Gland: C-Cell Adenoma Carcinoma Carcinoma or Adenoma Uterus Sarcoma Stromal or Polyp Stromal All Organs Benign Tumors Malignant Tumors =============================================================== Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 1 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 3/52 (6%) 1/53 (2%) 4/52 (8%) 1/52 (2%) 1/51 (2%) | |POLY-3 RATE (b) | 3/37.43 1/37.40 4/39.19 1/37.39 1/37.18 | |POLY-3 PERCENT (g) | 8.0% 2.7% 10.2% 2.7% 2.7% | |TERMINAL (d) | 2/21 (10%) 1/21 (5%) 2/22 (9%) 1/24 (4%) 0/24 (0%) | |FIRST INCIDENCE | 664 729 (T) 636 729 (T) 314 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.239N P=0.311N P=0.511 P=0.279N P=0.302N | |POLY 3 | P=0.255N P=0.304N P=0.525 P=0.304N P=0.306N | |POLY 1.5 | P=0.261N P=0.305N P=0.515 P=0.306N P=0.312N | |POLY 6 | P=0.250N P=0.301N P=0.535 P=0.300N P=0.299N | |LOGISTIC REGRESSION| P=0.269N P=0.295N P=0.533 P=0.291N P=0.309N | |COCH-ARM / FISHERS | P=0.266N P=0.302N P=0.500 P=0.309N P=0.316N | |ORDER RESTRICTED | P=0.262N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Intestine Small: Duodenum | | Leiomyoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/53 (0%) 2/53 (4%) 0/53 (0%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 0/39.03 2/37.47 0/36.47 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.3% 0.0% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 1/24 (4%) 0/24 (0%) | |FIRST INCIDENCE | --- --- --- 710 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.737 (e) (e) P=0.263 (e) | |POLY 3 | P=0.706 (e) (e) P=0.232 (e) | |POLY 1.5 | P=0.706 (e) (e) P=0.232 (e) | |POLY 6 | P=0.708 (e) (e) P=0.234 (e) | |LOGISTIC REGRESSION| P=0.724 (e) (e) P=0.240 (e) | |COCH-ARM / FISHERS | P=0.724 (e) (e) P=0.248 (e) | |ORDER RESTRICTED | P=0.213 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 2 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Leiomyoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/53 (0%) 2/53 (4%) 0/53 (0%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 0/39.03 2/37.47 0/36.47 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.3% 0.0% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 1/24 (4%) 0/24 (0%) | |FIRST INCIDENCE | --- --- --- 710 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.737 (e) (e) P=0.263 (e) | |POLY 3 | P=0.706 (e) (e) P=0.232 (e) | |POLY 1.5 | P=0.706 (e) (e) P=0.232 (e) | |POLY 6 | P=0.708 (e) (e) P=0.234 (e) | |LOGISTIC REGRESSION| P=0.724 (e) (e) P=0.240 (e) | |COCH-ARM / FISHERS | P=0.724 (e) (e) P=0.248 (e) | |ORDER RESTRICTED | P=0.213 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Cholangiocarcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 1/52 (2%) 9/52 (17%) 30/51 (59%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 1/38.82 9/38.00 30/39.75 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.6% 23.7% 75.5% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 1/22 (5%) 7/24 (29%) 20/24 (83%) | |FIRST INCIDENCE | --- --- 729 (T) 603 479 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.500 P=0.003 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.503 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.501 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.506 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.500 P=0.002 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.495 P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 3 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 3/52 (6%) 5/52 (10%) 27/51 (53%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 3/39.16 5/37.57 27/39.88 | |POLY-3 PERCENT (g) | 0.0% 0.0% 7.7% 13.3% 67.7% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 1/22 (5%) 4/24 (17%) 18/24 (75%) | |FIRST INCIDENCE | --- --- 654 684 479 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.134 P=0.040 * P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.122 P=0.028 * P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.120 P=0.028 * P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.125 P=0.028 * P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.124 P=0.032 * P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.118 P=0.027 * P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/52 (0%) 0/52 (0%) 2/51 (4%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 0/38.82 0/37.39 2/36.26 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 5.5% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 2/24 (8%) | |FIRST INCIDENCE | --- --- --- --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.025 * (e) (e) (e) P=0.257 | |POLY 3 | P=0.017 * (e) (e) (e) P=0.225 | |POLY 1.5 | P=0.017 * (e) (e) (e) P=0.224 | |POLY 6 | P=0.017 * (e) (e) (e) P=0.227 | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.257 | |COCH-ARM / FISHERS | P=0.018 * (e) (e) (e) P=0.238 | |ORDER RESTRICTED | P=0.014 * (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 4 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 3/52 (6%) 5/52 (10%) 27/51 (53%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 3/39.16 5/37.57 27/39.88 | |POLY-3 PERCENT (g) | 0.0% 0.0% 7.7% 13.3% 67.7% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 1/22 (5%) 4/24 (17%) 18/24 (75%) | |FIRST INCIDENCE | --- --- 654 684 479 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.134 P=0.040 * P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.122 P=0.028 * P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.120 P=0.028 * P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.125 P=0.028 * P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.124 P=0.032 * P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.118 P=0.027 * P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 3/52 (6%) 5/52 (10%) 27/51 (53%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 3/39.16 5/37.57 27/39.88 | |POLY-3 PERCENT (g) | 0.0% 0.0% 7.7% 13.3% 67.7% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 1/22 (5%) 4/24 (17%) 18/24 (75%) | |FIRST INCIDENCE | --- --- 654 684 479 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.134 P=0.040 * P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.122 P=0.028 * P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.120 P=0.028 * P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.125 P=0.028 * P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.124 P=0.032 * P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.118 P=0.027 * P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 5 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Liver | | Hepatocholangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/52 (0%) 2/52 (4%) 6/51 (12%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 0/38.82 2/37.39 6/36.26 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.4% 16.6% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 2/24 (8%) 6/24 (25%) | |FIRST INCIDENCE | --- --- --- 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.257 P=0.020 * | |POLY 3 | P<0.001 ** (e) (e) P=0.232 P=0.012 * | |POLY 1.5 | P<0.001 ** (e) (e) P=0.231 P=0.012 * | |POLY 6 | P<0.001 ** (e) (e) P=0.233 P=0.012 * | |LOGISTIC REGRESSION| (e) (e) (e) P=0.257 P=0.020 * | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.243 P=0.012 * | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Lung | | Cystic Keratinizing Epithelioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/52 (0%) 1/53 (2%) 11/52 (21%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 0/38.82 1/37.40 11/37.46 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.7% 29.4% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 1/24 (4%) 7/24 (29%) | |FIRST INCIDENCE | --- --- --- 729 (T) 606 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.517 P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.496 P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.495 P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.498 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.517 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.500 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 6 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 2/53 (4%) 1/53 (2%) 0/53 (0%) 0/53 (0%) 0/53 (0%) | |POLY-3 RATE (b) | 2/38.18 1/37.40 0/39.03 0/37.40 0/36.47 | |POLY-3 PERCENT (g) | 5.2% 2.7% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/22 (9%) 1/21 (5%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.208N P=0.516N P=0.237N P=0.218N P=0.218N | |POLY 3 | P=0.230N P=0.507N P=0.232N P=0.241N P=0.247N | |POLY 1.5 | P=0.229N P=0.507N P=0.234N P=0.242N P=0.248N | |POLY 6 | P=0.230N P=0.505N P=0.229N P=0.238N P=0.244N | |LOGISTIC REGRESSION| P=0.208N P=0.516N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.226N P=0.500N P=0.248N P=0.248N P=0.248N | |ORDER RESTRICTED | P=0.052N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 8/53 (15%) 4/53 (8%) 3/53 (6%) 2/53 (4%) 0/53 (0%) | |POLY-3 RATE (b) | 8/39.17 4/38.30 3/39.78 2/38.16 0/36.47 | |POLY-3 PERCENT (g) | 20.4% 10.4% 7.5% 5.2% 0.0% | |TERMINAL (d) | 6/22 (27%) 3/21 (14%) 2/22 (9%) 1/24 (4%) 0/24 (0%) | |FIRST INCIDENCE | 449 337 461 451 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.007N** P=0.196N P=0.096N P=0.039N* P=0.004N** | |POLY 3 | P=0.010N* P=0.182N P=0.089N P=0.046N* P=0.005N** | |POLY 1.5 | P=0.010N* P=0.184N P=0.093N P=0.048N* P=0.005N** | |POLY 6 | P=0.010N* P=0.179N P=0.086N P=0.044N* P=0.004N** | |LOGISTIC REGRESSION| P=0.010N* P=0.186N P=0.095N P=0.051N P=0.006N** | |COCH-ARM / FISHERS | P=0.010N* P=0.179N P=0.101N P=0.046N* P=0.003N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 7 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 10/53 (19%) 5/53 (9%) 3/53 (6%) 2/53 (4%) 0/53 (0%) | |POLY-3 RATE (b) | 10/39.17 5/38.30 3/39.78 2/38.16 0/36.47 | |POLY-3 PERCENT (g) | 25.5% 13.1% 7.5% 5.2% 0.0% | |TERMINAL (d) | 8/22 (36%) 4/21 (19%) 2/22 (9%) 1/24 (4%) 0/24 (0%) | |FIRST INCIDENCE | 449 337 461 451 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002N** P=0.143N P=0.033N* P=0.011N* P<0.001N** | |POLY 3 | P=0.003N** P=0.132N P=0.029N* P=0.013N* P<0.001N** | |POLY 1.5 | P=0.003N** P=0.135N P=0.031N* P=0.014N* P<0.001N** | |POLY 6 | P=0.003N** P=0.127N P=0.026N* P=0.012N* P<0.001N** | |LOGISTIC REGRESSION| P=0.004N** P=0.138N P=0.033N* P=0.016N* P<0.001N** | |COCH-ARM / FISHERS | P=0.004N** P=0.132N P=0.036N* P=0.014N* P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 40/53 (75%) 39/53 (74%) 40/53 (75%) 34/53 (64%) 12/53 (23%) | |POLY-3 RATE (b) | 40/48.11 39/45.83 40/47.48 34/46.23 12/38.26 | |POLY-3 PERCENT (g) | 83.1% 85.1% 84.2% 73.5% 31.4% | |TERMINAL (d) | 16/22 (73%) 17/21 (81%) 17/22 (77%) 15/24 (63%) 7/24 (29%) | |FIRST INCIDENCE | 345 296 254 254 479 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.553 P=0.522N P=0.209N P<0.001N** | |POLY 3 | P<0.001N** P=0.510 P=0.555 P=0.178N P<0.001N** | |POLY 1.5 | P<0.001N** P=0.566 P=0.584 P=0.166N P<0.001N** | |POLY 6 | P<0.001N** P=0.456 P=0.508 P=0.204N P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.570N P=0.564N P=0.165N P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.500N P=0.589N P=0.145N P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 8 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 40/53 (75%) 39/53 (74%) 40/53 (75%) 34/53 (64%) 12/53 (23%) | |POLY-3 RATE (b) | 40/48.11 39/45.83 40/47.48 34/46.23 12/38.26 | |POLY-3 PERCENT (g) | 83.1% 85.1% 84.2% 73.5% 31.4% | |TERMINAL (d) | 16/22 (73%) 17/21 (81%) 17/22 (77%) 15/24 (63%) 7/24 (29%) | |FIRST INCIDENCE | 345 296 254 254 479 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.553 P=0.522N P=0.209N P<0.001N** | |POLY 3 | P<0.001N** P=0.510 P=0.555 P=0.178N P<0.001N** | |POLY 1.5 | P<0.001N** P=0.566 P=0.584 P=0.166N P<0.001N** | |POLY 6 | P<0.001N** P=0.456 P=0.508 P=0.204N P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.570N P=0.564N P=0.165N P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.500N P=0.589N P=0.145N P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 42/53 (79%) 41/53 (77%) 42/53 (79%) 35/53 (66%) 12/53 (23%) | |POLY-3 RATE (b) | 42/48.88 41/46.73 42/48.23 35/47.00 12/38.26 | |POLY-3 PERCENT (g) | 85.9% 87.7% 87.1% 74.5% 31.4% | |TERMINAL (d) | 17/22 (77%) 18/21 (86%) 18/22 (82%) 15/24 (63%) 7/24 (29%) | |FIRST INCIDENCE | 345 296 254 254 479 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.547 P=0.519N P=0.174N P<0.001N** | |POLY 3 | P<0.001N** P=0.518 P=0.555 P=0.114N P<0.001N** | |POLY 1.5 | P<0.001N** P=0.581 P=0.587 P=0.106N P<0.001N** | |POLY 6 | P<0.001N** P=0.449 P=0.504 P=0.132N P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.569N P=0.571N P=0.109N P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.500N P=0.594N P=0.095N P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 9 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 2/53 (4%) 5/53 (9%) 9/53 (17%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 2/40.06 5/38.73 9/39.63 | |POLY-3 PERCENT (g) | 0.0% 0.0% 5.0% 12.9% 22.7% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 1/24 (4%) 0/24 (0%) | |FIRST INCIDENCE | --- --- 491 479 563 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.242 P=0.043 * P=0.003 ** | |POLY 3 | P<0.001 ** (e) P=0.247 P=0.031 * P=0.002 ** | |POLY 1.5 | P<0.001 ** (e) P=0.243 P=0.030 * P=0.002 ** | |POLY 6 | P<0.001 ** (e) P=0.252 P=0.033 * P=0.003 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.232 P=0.032 * P=0.002 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.248 P=0.028 * P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 2/53 (4%) 5/53 (9%) 9/53 (17%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 2/40.06 5/38.73 9/39.63 | |POLY-3 PERCENT (g) | 0.0% 0.0% 5.0% 12.9% 22.7% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 1/24 (4%) 0/24 (0%) | |FIRST INCIDENCE | --- --- 491 479 563 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.242 P=0.043 * P=0.003 ** | |POLY 3 | P<0.001 ** (e) P=0.247 P=0.031 * P=0.002 ** | |POLY 1.5 | P<0.001 ** (e) P=0.243 P=0.030 * P=0.002 ** | |POLY 6 | P<0.001 ** (e) P=0.252 P=0.033 * P=0.003 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.232 P=0.032 * P=0.002 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.248 P=0.028 * P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 10 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 2/53 (4%) 5/53 (9%) 9/53 (17%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 2/40.06 5/38.73 9/39.63 | |POLY-3 PERCENT (g) | 0.0% 0.0% 5.0% 12.9% 22.7% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 1/24 (4%) 0/24 (0%) | |FIRST INCIDENCE | --- --- 491 479 563 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.242 P=0.043 * P=0.003 ** | |POLY 3 | P<0.001 ** (e) P=0.247 P=0.031 * P=0.002 ** | |POLY 1.5 | P<0.001 ** (e) P=0.243 P=0.030 * P=0.002 ** | |POLY 6 | P<0.001 ** (e) P=0.252 P=0.033 * P=0.003 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.232 P=0.032 * P=0.002 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.248 P=0.028 * P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 0/53 (0%) 0/52 (0%) 2/52 (4%) 0/49 (0%) | |POLY-3 RATE (b) | 1/38.18 0/37.40 0/38.82 2/37.39 0/35.41 | |POLY-3 PERCENT (g) | 2.6% 0.0% 0.0% 5.4% 0.0% | |TERMINAL (d) | 1/22 (5%) 0/21 (0%) 0/22 (0%) 2/24 (8%) 0/24 (0%) | |FIRST INCIDENCE | 729 (T) --- --- 729 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.535N P=0.509N P=0.500N P=0.531 P=0.483N | |POLY 3 | P=0.585N P=0.504N P=0.497N P=0.493 P=0.515N | |POLY 1.5 | P=0.588N P=0.504N P=0.499N P=0.491 P=0.518N | |POLY 6 | P=0.579N P=0.503N P=0.494N P=0.496 P=0.510N | |LOGISTIC REGRESSION| P=0.535N (e) (e) P=0.531 (e) | |COCH-ARM / FISHERS | P=0.585N P=0.500N P=0.505N P=0.493 P=0.520N | |ORDER RESTRICTED | P=0.325N (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 11 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 1/53 (2%) 1/52 (2%) 3/52 (6%) 1/50 (2%) | |POLY-3 RATE (b) | 0/38.18 1/37.52 1/38.82 3/37.39 1/36.09 | |POLY-3 PERCENT (g) | 0.0% 2.7% 2.6% 8.0% 2.8% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 1/22 (5%) 3/24 (13%) 0/24 (0%) | |FIRST INCIDENCE | --- 698 729 (T) 729 (T) 654 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.536 P=0.492 P=0.500 P=0.135 P=0.468 | |POLY 3 | P=0.494 P=0.496 P=0.503 P=0.114 P=0.489 | |POLY 1.5 | P=0.486 P=0.496 P=0.501 P=0.114 P=0.485 | |POLY 6 | P=0.506 P=0.499 P=0.506 P=0.115 P=0.494 | |LOGISTIC REGRESSION| P=0.500 P=0.497 P=0.500 P=0.135 P=0.486 | |COCH-ARM / FISHERS | P=0.494 P=0.500 P=0.495 P=0.118 P=0.485 | |ORDER RESTRICTED | P=0.150 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Pancreas | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 1/53 (2%) 1/52 (2%) 4/52 (8%) 2/50 (4%) | |POLY-3 RATE (b) | 0/38.18 1/37.52 1/38.82 4/37.39 2/36.09 | |POLY-3 PERCENT (g) | 0.0% 2.7% 2.6% 10.7% 5.5% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 1/22 (5%) 4/24 (17%) 1/24 (4%) | |FIRST INCIDENCE | --- 698 729 (T) 729 (T) 654 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.277 P=0.492 P=0.500 P=0.072 P=0.231 | |POLY 3 | P=0.226 P=0.496 P=0.503 P=0.056 P=0.224 | |POLY 1.5 | P=0.221 P=0.496 P=0.501 P=0.057 P=0.221 | |POLY 6 | P=0.236 P=0.499 P=0.506 P=0.057 P=0.229 | |LOGISTIC REGRESSION| P=0.236 P=0.497 P=0.500 P=0.072 P=0.224 | |COCH-ARM / FISHERS | P=0.229 P=0.500 P=0.495 P=0.057 P=0.233 | |ORDER RESTRICTED | P=0.060 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 12 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 22/53 (42%) 21/53 (40%) 17/53 (32%) 17/52 (33%) 1/52 (2%) | |POLY-3 RATE (b) | 22/41.64 21/40.38 17/41.12 17/38.83 1/36.33 | |POLY-3 PERCENT (g) | 52.8% 52.0% 41.3% 43.8% 2.8% | |TERMINAL (d) | 13/22 (59%) 10/21 (48%) 11/22 (50%) 12/24 (50%) 0/24 (0%) | |FIRST INCIDENCE | 418 563 499 506 714 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.541N P=0.212N P=0.168N P<0.001N** | |POLY 3 | P<0.001N** P=0.560N P=0.195N P=0.271N P<0.001N** | |POLY 1.5 | P<0.001N** P=0.558N P=0.199N P=0.268N P<0.001N** | |POLY 6 | P<0.001N** P=0.528N P=0.195N P=0.268N P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.536N P=0.175N P=0.243N P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.500N P=0.210N P=0.232N P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 23/53 (43%) 22/53 (42%) 17/53 (32%) 17/52 (33%) 1/52 (2%) | |POLY-3 RATE (b) | 23/41.70 22/40.38 17/41.12 17/38.83 1/36.33 | |POLY-3 PERCENT (g) | 55.2% 54.5% 41.3% 43.8% 2.8% | |TERMINAL (d) | 13/22 (59%) 11/21 (52%) 11/22 (50%) 12/24 (50%) 0/24 (0%) | |FIRST INCIDENCE | 418 563 499 506 714 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.543N P=0.162N P=0.126N P<0.001N** | |POLY 3 | P<0.001N** P=0.567N P=0.139N P=0.203N P<0.001N** | |POLY 1.5 | P<0.001N** P=0.562N P=0.145N P=0.203N P<0.001N** | |POLY 6 | P<0.001N** P=0.536N P=0.138N P=0.199N P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.537N P=0.126N P=0.182N P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.500N P=0.158N P=0.177N P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 13 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 2/53 (4%) 0/52 (0%) 0/52 (0%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 2/39.87 0/36.79 0/36.27 | |POLY-3 PERCENT (g) | 0.0% 0.0% 5.0% 0.0% 0.0% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- --- 461 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.479N (e) P=0.262 (e) (e) | |POLY 3 | P=0.489N (e) P=0.246 (e) (e) | |POLY 1.5 | P=0.493N (e) P=0.243 (e) (e) | |POLY 6 | P=0.485N (e) P=0.250 (e) (e) | |LOGISTIC REGRESSION| P=0.484N (e) P=0.234 (e) (e) | |COCH-ARM / FISHERS | P=0.494N (e) P=0.248 (e) (e) | |ORDER RESTRICTED | P=0.398 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/53 (0%) 2/53 (4%) 0/53 (0%) 0/53 (0%) 1/53 (2%) | |POLY-3 RATE (b) | 0/38.18 2/37.83 0/39.03 0/37.40 1/37.45 | |POLY-3 PERCENT (g) | 0.0% 5.3% 0.0% 0.0% 2.7% | |TERMINAL (d) | 0/22 (0%) 1/21 (5%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- 603 --- --- 181 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.604 P=0.235 (e) (e) P=0.492 | |POLY 3 | P=0.599 P=0.234 (e) (e) P=0.496 | |POLY 1.5 | P=0.598 P=0.233 (e) (e) P=0.495 | |POLY 6 | P=0.603 P=0.237 (e) (e) P=0.499 | |LOGISTIC REGRESSION| P=0.651 P=0.234 (e) (e) P=0.694 | |COCH-ARM / FISHERS | P=0.607 P=0.248 (e) (e) P=0.500 | |ORDER RESTRICTED | P=0.303 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 14 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor | | (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/53 (0%) 2/53 (4%) 1/53 (2%) 0/53 (0%) 1/53 (2%) | |POLY-3 RATE (b) | 0/38.18 2/37.83 1/39.86 0/37.40 1/37.45 | |POLY-3 PERCENT (g) | 0.0% 5.3% 2.5% 0.0% 2.7% | |TERMINAL (d) | 0/22 (0%) 1/21 (5%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- 603 407 --- 181 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.679 P=0.235 P=0.504 (e) P=0.492 | |POLY 3 | P=0.677 P=0.234 P=0.509 (e) P=0.496 | |POLY 1.5 | P=0.676 P=0.233 P=0.505 (e) P=0.495 | |POLY 6 | P=0.680 P=0.237 P=0.511 (e) P=0.499 | |LOGISTIC REGRESSION| P=0.607N P=0.234 P=0.485 (e) P=0.694 | |COCH-ARM / FISHERS | P=0.677N P=0.248 P=0.500 (e) P=0.500 | |ORDER RESTRICTED | P=0.365 (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 2/53 (4%) 1/53 (2%) 3/53 (6%) 1/53 (2%) 0/53 (0%) | |POLY-3 RATE (b) | 2/38.47 1/37.40 3/39.33 1/37.66 0/36.47 | |POLY-3 PERCENT (g) | 5.2% 2.7% 7.6% 2.7% 0.0% | |TERMINAL (d) | 0/22 (0%) 1/21 (5%) 1/22 (5%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | 664 729 (T) 664 659 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.153N P=0.513N P=0.507 P=0.509N P=0.250N | |POLY 3 | P=0.157N P=0.510N P=0.510 P=0.507N P=0.248N | |POLY 1.5 | P=0.158N P=0.509N P=0.506 P=0.508N P=0.248N | |POLY 6 | P=0.156N P=0.510N P=0.514 P=0.504N P=0.248N | |LOGISTIC REGRESSION| P=0.156N P=0.505N P=0.512 P=0.506N P=0.246N | |COCH-ARM / FISHERS | P=0.150N P=0.500N P=0.500 P=0.500N P=0.248N | |ORDER RESTRICTED | P=0.196N (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 15 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 2/53 (4%) 3/53 (6%) 4/53 (8%) 1/53 (2%) 1/53 (2%) | |POLY-3 RATE (b) | 2/38.47 3/38.36 4/39.33 1/37.66 1/37.44 | |POLY-3 PERCENT (g) | 5.2% 7.8% 10.2% 2.7% 2.7% | |TERMINAL (d) | 0/22 (0%) 1/21 (5%) 2/22 (9%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | 664 407 664 659 206 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.204N P=0.483 P=0.346 P=0.509N P=0.517N | |POLY 3 | P=0.208N P=0.499 P=0.346 P=0.507N P=0.509N | |POLY 1.5 | P=0.209N P=0.496 P=0.343 P=0.508N P=0.511N | |POLY 6 | P=0.206N P=0.504 P=0.348 P=0.504N P=0.508N | |LOGISTIC REGRESSION| P=0.203N P=0.496 P=0.349 P=0.506N P=0.458N | |COCH-ARM / FISHERS | P=0.201N P=0.500 P=0.339 P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.294N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/53 (0%) 2/53 (4%) 1/53 (2%) 0/53 (0%) 1/53 (2%) | |POLY-3 RATE (b) | 0/38.18 2/38.36 1/39.03 0/37.40 1/37.44 | |POLY-3 PERCENT (g) | 0.0% 5.2% 2.6% 0.0% 2.7% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 1/22 (5%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- 407 729 (T) --- 206 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.671N P=0.231 P=0.500 (e) P=0.488 | |POLY 3 | P=0.679 P=0.237 P=0.504 (e) P=0.496 | |POLY 1.5 | P=0.677 P=0.235 P=0.503 (e) P=0.494 | |POLY 6 | P=0.679N P=0.241 P=0.506 (e) P=0.499 | |LOGISTIC REGRESSION| P=0.625N P=0.247 P=0.500 (e) P=0.678 | |COCH-ARM / FISHERS | P=0.677N P=0.248 P=0.500 (e) P=0.500 | |ORDER RESTRICTED | P=0.365 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 16 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 10/53 (19%) 14/53 (26%) 16/51 (31%) 15/52 (29%) 7/52 (13%) | |POLY-3 RATE (b) | 10/39.40 14/39.56 16/39.94 15/38.93 7/37.39 | |POLY-3 PERCENT (g) | 25.4% 35.4% 40.1% 38.5% 18.7% | |TERMINAL (d) | 7/22 (32%) 8/21 (38%) 11/22 (50%) 10/24 (42%) 4/24 (17%) | |FIRST INCIDENCE | 426 499 603 499 485 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.047N* P=0.224 P=0.129 P=0.225 P=0.268N | |POLY 3 | P=0.077N P=0.231 P=0.118 P=0.151 P=0.333N | |POLY 1.5 | P=0.083N P=0.224 P=0.115 P=0.146 P=0.343N | |POLY 6 | P=0.070N P=0.252 P=0.121 P=0.170 P=0.318N | |LOGISTIC REGRESSION| P=0.079N P=0.220 P=0.132 P=0.146 P=0.335N | |COCH-ARM / FISHERS | P=0.070N P=0.243 P=0.106 P=0.166 P=0.314N | |ORDER RESTRICTED | P=0.094N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 0/53 (0%) 1/51 (2%) 1/52 (2%) 0/52 (0%) | |POLY-3 RATE (b) | 4/39.21 0/37.40 1/38.82 1/36.79 0/36.27 | |POLY-3 PERCENT (g) | 10.2% 0.0% 2.6% 2.7% 0.0% | |TERMINAL (d) | 2/22 (9%) 0/21 (0%) 1/22 (5%) 1/24 (4%) 0/24 (0%) | |FIRST INCIDENCE | 426 --- 729 (T) 729 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.140N P=0.070N P=0.182N P=0.169N P=0.063N | |POLY 3 | P=0.152N P=0.065N P=0.180N P=0.196N P=0.069N | |POLY 1.5 | P=0.154N P=0.065N P=0.182N P=0.196N P=0.070N | |POLY 6 | P=0.150N P=0.065N P=0.179N P=0.195N P=0.069N | |LOGISTIC REGRESSION| P=0.157N P=0.064N P=0.184N P=0.190N P=0.067N | |COCH-ARM / FISHERS | P=0.152N P=0.059N P=0.194N P=0.187N P=0.061N | |ORDER RESTRICTED | P=0.008N** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 17 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 13/53 (25%) 14/53 (26%) 17/51 (33%) 16/52 (31%) 7/52 (13%) | |POLY-3 RATE (b) | 13/39.63 14/39.56 17/39.94 16/38.93 7/37.39 | |POLY-3 PERCENT (g) | 32.8% 35.4% 42.6% 41.1% 18.7% | |TERMINAL (d) | 9/22 (41%) 8/21 (38%) 12/22 (55%) 11/24 (46%) 4/24 (17%) | |FIRST INCIDENCE | 426 499 603 499 485 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.021N* P=0.470 P=0.259 P=0.400 P=0.091N | |POLY 3 | P=0.036N* P=0.498 P=0.246 P=0.294 P=0.121N | |POLY 1.5 | P=0.040N* P=0.484 P=0.241 P=0.284 P=0.128N | |POLY 6 | P=0.033N* P=0.530 P=0.251 P=0.323 P=0.111N | |LOGISTIC REGRESSION| P=0.038N* P=0.477 P=0.271 P=0.283 P=0.125N | |COCH-ARM / FISHERS | P=0.035N* P=0.500 P=0.219 P=0.310 P=0.116N | |ORDER RESTRICTED | P=0.050N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 8/53 (15%) 7/53 (13%) 7/53 (13%) 6/53 (11%) 3/53 (6%) | |POLY-3 RATE (b) | 8/38.61 7/38.70 7/39.39 6/37.45 3/36.71 | |POLY-3 PERCENT (g) | 20.7% 18.1% 17.8% 16.0% 8.2% | |TERMINAL (d) | 5/22 (23%) 4/21 (19%) 5/22 (23%) 5/24 (21%) 2/24 (8%) | |FIRST INCIDENCE | 640 534 659 715 665 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.056N P=0.520N P=0.490N P=0.330N P=0.088N | |POLY 3 | P=0.087N P=0.498N P=0.483N P=0.407N P=0.109N | |POLY 1.5 | P=0.088N P=0.507N P=0.489N P=0.407N P=0.112N | |POLY 6 | P=0.086N P=0.481N P=0.477N P=0.405N P=0.105N | |LOGISTIC REGRESSION| P=0.079N P=0.514N P=0.470N P=0.368N P=0.103N | |COCH-ARM / FISHERS | P=0.075N P=0.500N P=0.500N P=0.388N P=0.101N | |ORDER RESTRICTED | P=0.111N (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 18 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 8/53 (15%) 7/53 (13%) 8/53 (15%) 6/53 (11%) 3/53 (6%) | |POLY-3 RATE (b) | 8/38.61 7/38.70 8/40.14 6/37.45 3/36.71 | |POLY-3 PERCENT (g) | 20.7% 18.1% 19.9% 16.0% 8.2% | |TERMINAL (d) | 5/22 (23%) 4/21 (19%) 5/22 (23%) 5/24 (21%) 2/24 (8%) | |FIRST INCIDENCE | 640 534 458 715 665 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.049N* P=0.520N P=0.591N P=0.330N P=0.088N | |POLY 3 | P=0.078N P=0.498N P=0.577N P=0.407N P=0.109N | |POLY 1.5 | P=0.077N P=0.507N P=0.588N P=0.407N P=0.112N | |POLY 6 | P=0.077N P=0.481N P=0.566N P=0.405N P=0.105N | |LOGISTIC REGRESSION| P=0.071N P=0.514N P=0.587N P=0.368N P=0.103N | |COCH-ARM / FISHERS | P=0.065N P=0.500N P=0.607N P=0.388N P=0.101N | |ORDER RESTRICTED | P=0.115N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Uterus | | Schwannoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 0/53 (0%) 2/53 (4%) 0/53 (0%) | |POLY-3 RATE (b) | 0/38.18 0/37.40 0/39.03 2/38.71 0/36.47 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.2% 0.0% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- --- --- 479 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.726 (e) (e) P=0.245 (e) | |POLY 3 | P=0.705 (e) (e) P=0.239 (e) | |POLY 1.5 | P=0.705 (e) (e) P=0.236 (e) | |POLY 6 | P=0.706 (e) (e) P=0.246 (e) | |LOGISTIC REGRESSION| P=0.733N (e) (e) P=0.257 (e) | |COCH-ARM / FISHERS | P=0.724 (e) (e) P=0.248 (e) | |ORDER RESTRICTED | P=0.220 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 19 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |Uterus | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 1/53 (2%) 1/53 (2%) 1/53 (2%) 4/53 (8%) 0/53 (0%) | |POLY-3 RATE (b) | 1/38.18 1/37.40 1/39.03 4/37.49 0/36.47 | |POLY-3 PERCENT (g) | 2.6% 2.7% 2.6% 10.7% 0.0% | |TERMINAL (d) | 1/22 (5%) 1/21 (5%) 1/22 (5%) 2/24 (8%) 0/24 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 715 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.344N P=0.753 P=0.763 P=0.211 P=0.483N | |POLY 3 | P=0.397N P=0.757 P=0.757N P=0.171 P=0.509N | |POLY 1.5 | P=0.397N P=0.756 P=0.758N P=0.171 P=0.510N | |POLY 6 | P=0.394N P=0.759 P=0.755N P=0.173 P=0.507N | |LOGISTIC REGRESSION| P=0.361N P=0.753 P=0.763 P=0.187 (e) | |COCH-ARM / FISHERS | P=0.374N P=0.752N P=0.752N P=0.181 P=0.500N | |ORDER RESTRICTED | P=0.249N (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/53 (0%) 1/53 (2%) 2/53 (4%) 2/53 (4%) 2/53 (4%) | |POLY-3 RATE (b) | 0/38.18 1/38.27 2/39.13 2/37.81 2/36.47 | |POLY-3 PERCENT (g) | 0.0% 2.6% 5.1% 5.3% 5.5% | |TERMINAL (d) | 0/22 (0%) 0/21 (0%) 1/22 (5%) 1/24 (4%) 2/24 (8%) | |FIRST INCIDENCE | --- 367 705 612 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.328 P=0.488 P=0.252 P=0.240 P=0.257 | |POLY 3 | P=0.287 P=0.500 P=0.242 P=0.234 P=0.226 | |POLY 1.5 | P=0.288 P=0.499 P=0.240 P=0.233 P=0.226 | |POLY 6 | P=0.288 P=0.503 P=0.244 P=0.238 P=0.228 | |LOGISTIC REGRESSION| P=0.297 P=0.530 P=0.245 P=0.233 P=0.257 | |COCH-ARM / FISHERS | P=0.310 P=0.500 P=0.248 P=0.248 P=0.248 | |ORDER RESTRICTED | P=0.176 (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 20 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 49/53 (92%) 43/53 (81%) 48/53 (91%) 46/53 (87%) 36/53 (68%) | |POLY-3 RATE (b) | 49/49.76 43/46.09 48/49.33 46/47.73 36/42.50 | |POLY-3 PERCENT (g) | 98.5% 93.3% 97.3% 96.4% 84.7% | |TERMINAL (d) | 22/22 (100%) 20/21 (95%) 22/22 (100%) 23/24 (96%) 22/24 (92%) | |FIRST INCIDENCE | 345 296 254 254 314 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.021N* P=0.302N P=0.463N P=0.313N P=0.024N* | |POLY 3 | P<0.001N** P=0.157N P=0.684N P=0.494N P=0.005N** | |POLY 1.5 | P<0.001N** P=0.102N P=0.550N P=0.416N P=0.002N** | |POLY 6 | P=0.004N** P=0.242N P=0.965N P=0.515N P=0.018N* | |LOGISTIC REGRESSION| P<0.001N** P=0.099N P=0.450N P=0.411N P=0.002N** | |COCH-ARM / FISHERS | P<0.001N** P=0.075N P=0.500N P=0.263N P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 14/53 (26%) 18/53 (34%) 14/53 (26%) 23/53 (43%) 37/53 (70%) | |POLY-3 RATE (b) | 14/40.90 18/43.06 14/41.95 23/42.72 37/44.23 | |POLY-3 PERCENT (g) | 34.2% 41.8% 33.4% 53.8% 83.7% | |TERMINAL (d) | 9/22 (41%) 8/21 (38%) 7/22 (32%) 11/24 (46%) 21/24 (88%) | |FIRST INCIDENCE | 377 167 458 142 169 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.238 P=0.560N P=0.094 P<0.001 ** | |POLY 3 | P<0.001 ** P=0.308 P=0.560N P=0.049 * P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.284 P=0.574N P=0.044 * P<0.001 ** | |POLY 6 | P<0.001 ** P=0.350 P=0.538N P=0.065 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.261 P=0.576N P=0.045 * P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.263 P=0.587N P=0.051 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) | |=================================================================================================================================| Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 21 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ | | | 0 UG 10 UG 100 UG 300 UG 1000 UG | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 51/53 (96%) 49/53 (92%) 50/53 (94%) 50/53 (94%) 46/53 (87%) | |POLY-3 RATE (b) | 51/51.39 49/50.84 50/50.78 50/50.20 46/48.11 | |POLY-3 PERCENT (g) | 99.2% 96.4% 98.5% 99.6% 95.6% | |TERMINAL (d) | 22/22 (100%) 20/21 (95%) 22/22 (100%) 24/24 (100%) 23/24 (96%) | |FIRST INCIDENCE | 345 167 254 142 169 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.218N P=0.525N P=0.459N P=0.421N P=0.258N | |POLY 3 | P=0.252N P=0.359N P=0.798N P=0.973 P=0.254N | |POLY 1.5 | P=0.140N P=0.327N P=0.635N P=0.894N P=0.154N | |POLY 6 | P=0.424N P=0.377N P=0.985N P=1.000 P=0.415N | |LOGISTIC REGRESSION| P=0.158N P=0.408N P=0.479N P=0.710 P=0.174N | |COCH-ARM / FISHERS | P=0.054N P=0.339N P=0.500N P=0.500N P=0.080N | |ORDER RESTRICTED | P=0.091N (e) (e) (e) (e) | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Number of tumor-bearing animals / Poly-3 number (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates For all tests a negative trend is indicated by N (e) Value of Statistic cannot be computed. (g) Poly-3 adjusted lifetime tumor incidence. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).