NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 11/15/04 EXPERIMENT: 96022 TEST: 02 TIME: 11:37:26 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX ------------------------------------------------------------------------------------------------------------------------------------ CONTROL + TREATED GRPS. FINAL #1; REVISION #1 RATS REASONS FOR REMOVAL: 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 0 NG TEQ/KG INCLUDE 002 7 NG TEQ/KG INCLUDE 003 22 NG TEQ/KG INCLUDE 004 72 NG TEQ/KG INCLUDE 005 216 NG TEQ/KG INCLUDE 006 360 NG TEQ/KG NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 11/15/04 EXPERIMENT: 96022 TEST: 02 TIME: 11:37:26 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX 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 Pituitary Gland Thymus Thyroid Gland NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118) DATE: 11/15/04 EXPERIMENT: 96022 TEST: 02 TIME: 11:37:26 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96022 PATHOLOGIST: MISSING CAS: TEFPCBMIX SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF TEF EVALUATION (PCB MIXTURE;PCB 126/P =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Liver Cholangiocarcinoma Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Cystic Keratinizing Epithelioma Mammary Gland Carcinoma Carcinoma or Adenoma Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Thyroid Gland: C-Cell Adenoma Carcinoma Carcinoma or Adenoma Thyroid Gland: Follicular Cell Adenoma Carcinoma or Adenoma Uterus Polyp Stromal All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 1 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 3/51 (6%) 2/53 (4%) 0/53 (0%) 1/53 (2%) 0/64 (0%) | |POLY-3 RATE (b) | 3/41.89 3/32.84 2/37.79 0/36.73 1/24.57 0/9.22 | |POLY-3 PERCENT (g) | 7.2% 9.1% 5.3% 0.0% 4.1% 0.0% | |TERMINAL (d) | 3/27 (11%) 2/17 (12%) 2/24 (8%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 659 726 (T) --- 520 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.618 P=0.447 P=0.555N P=0.240N P=0.433 P=1.000N | |POLY 3 | P=0.187N P=0.546 P=0.547N P=0.143N P=0.508N P=0.484N | |POLY 1.5 | P=0.126N P=0.578 P=0.530N P=0.134N P=0.415N P=0.307N | |POLY 6 | P=0.214N P=0.515 P=0.564N P=0.159N P=0.637N P=0.605N | |LOGISTIC REGRESSION| P=0.401N P=0.481 P=0.555N (e) P=0.663N (e) | |COCH-ARM / FISHERS | P=0.034N* P=0.642 P=0.500N P=0.121N P=0.309N P=0.090N | |ORDER RESTRICTED | P=0.496N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 3/53 (6%) 3/51 (6%) 3/53 (6%) 0/53 (0%) 1/53 (2%) 0/64 (0%) | |POLY-3 RATE (b) | 3/41.89 3/32.84 3/38.61 0/36.73 1/24.57 0/9.22 | |POLY-3 PERCENT (g) | 7.2% 9.1% 7.8% 0.0% 4.1% 0.0% | |TERMINAL (d) | 3/27 (11%) 2/17 (12%) 2/24 (8%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 659 408 --- 520 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.608N P=0.447 P=0.619 P=0.240N P=0.433 P=1.000N | |POLY 3 | P=0.165N P=0.546 P=0.625 P=0.143N P=0.508N P=0.484N | |POLY 1.5 | P=0.104N P=0.578 P=0.639 P=0.134N P=0.415N P=0.307N | |POLY 6 | P=0.202N P=0.515 P=0.611 P=0.159N P=0.637N P=0.605N | |LOGISTIC REGRESSION| P=0.158N P=0.481 P=0.630 (e) P=0.663N (e) | |COCH-ARM / FISHERS | P=0.025N* P=0.642 P=0.661N P=0.121N P=0.309N P=0.090N | |ORDER RESTRICTED | P=0.512N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 2 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 0/51 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 2/42.25 0/32.58 0/37.79 0/36.73 0/23.94 0/9.28 | |POLY-3 PERCENT (g) | 4.7% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 649 --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.543N P=0.336N P=0.277N P=0.304N P=0.692N P=1.000 | |POLY 3 | P=0.233N P=0.299N P=0.262N P=0.269N P=0.379N P=0.564N | |POLY 1.5 | P=0.238N P=0.281N P=0.253N P=0.257N P=0.311N P=0.424N | |POLY 6 | P=0.188N P=0.318N P=0.273N P=0.290N P=0.482N P=0.651N | |LOGISTIC REGRESSION| P=0.354N P=0.288N P=0.255N P=0.262N P=0.447N P=0.862N | |COCH-ARM / FISHERS | P=0.188N P=0.257N P=0.248N P=0.248N P=0.248N P=0.200N | |ORDER RESTRICTED | P=0.413N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Cholangiocarcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 5/53 (9%) 19/53 (36%) 28/53 (53%) 12/65 (18%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 5/37.79 19/39.63 28/35.01 12/17.32 | |POLY-3 PERCENT (g) | 0.0% 0.0% 13.2% 47.9% 80.0% 69.3% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 5/24 (21%) 6/15 (40%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 726 (T) 567 450 294 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.022 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.022 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.025 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.019 * P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.022 * P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.028 * P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 3 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 1/51 (2%) 0/53 (0%) 4/53 (8%) 17/53 (32%) 5/65 (8%) | |POLY-3 RATE (b) | 2/41.89 1/32.84 0/37.79 4/37.67 17/30.45 5/13.19 | |POLY-3 PERCENT (g) | 4.8% 3.1% 0.0% 10.6% 55.8% 37.9% | |TERMINAL (d) | 2/27 (7%) 0/17 (0%) 0/24 (0%) 2/15 (13%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 659 --- 541 474 245 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.645N P=0.264N P=0.164 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.584N P=0.260N P=0.288 P<0.001 ** P=0.021 * | |POLY 1.5 | P<0.001 ** P=0.562N P=0.252N P=0.304 P<0.001 ** P=0.061 | |POLY 6 | P<0.001 ** P=0.604N P=0.269N P=0.262 P<0.001 ** P=0.010 * | |LOGISTIC REGRESSION| P<0.001 ** P=0.616N (e) P=0.279 P<0.001 ** P=0.187 | |COCH-ARM / FISHERS | P<0.001 ** P=0.515N P=0.248N P=0.339 P<0.001 ** P=0.312 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 1/51 (2%) 0/53 (0%) 4/53 (8%) 17/53 (32%) 5/65 (8%) | |POLY-3 RATE (b) | 2/41.89 1/32.84 0/37.79 4/37.67 17/30.45 5/13.19 | |POLY-3 PERCENT (g) | 4.8% 3.1% 0.0% 10.6% 55.8% 37.9% | |TERMINAL (d) | 2/27 (7%) 0/17 (0%) 0/24 (0%) 2/15 (13%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 659 --- 541 474 245 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.645N P=0.264N P=0.164 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.584N P=0.260N P=0.288 P<0.001 ** P=0.021 * | |POLY 1.5 | P<0.001 ** P=0.562N P=0.252N P=0.304 P<0.001 ** P=0.061 | |POLY 6 | P<0.001 ** P=0.604N P=0.269N P=0.262 P<0.001 ** P=0.010 * | |LOGISTIC REGRESSION| P<0.001 ** P=0.616N (e) P=0.279 P<0.001 ** P=0.187 | |COCH-ARM / FISHERS | P<0.001 ** P=0.515N P=0.248N P=0.339 P<0.001 ** P=0.312 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 4 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/53 (4%) 1/51 (2%) 0/53 (0%) 4/53 (8%) 17/53 (32%) 5/65 (8%) | |POLY-3 RATE (b) | 2/41.89 1/32.84 0/37.79 4/37.67 17/30.45 5/13.19 | |POLY-3 PERCENT (g) | 4.8% 3.1% 0.0% 10.6% 55.8% 37.9% | |TERMINAL (d) | 2/27 (7%) 0/17 (0%) 0/24 (0%) 2/15 (13%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 659 --- 541 474 245 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.645N P=0.264N P=0.164 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.584N P=0.260N P=0.288 P<0.001 ** P=0.021 * | |POLY 1.5 | P<0.001 ** P=0.562N P=0.252N P=0.304 P<0.001 ** P=0.061 | |POLY 6 | P<0.001 ** P=0.604N P=0.269N P=0.262 P<0.001 ** P=0.010 * | |LOGISTIC REGRESSION| P<0.001 ** P=0.616N (e) P=0.279 P<0.001 ** P=0.187 | |COCH-ARM / FISHERS | P<0.001 ** P=0.515N P=0.248N P=0.339 P<0.001 ** P=0.312 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Lung | | Cystic Keratinizing Epithelioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 0/53 (0%) 20/53 (38%) 49/53 (92%) 41/66 (62%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 0/37.79 20/38.88 49/50.16 41/42.28 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 51.4% 97.7% 97.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 0/24 (0%) 9/15 (60%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 594 267 260 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 5 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # # | |----------- | | |OVERALL (a) | 2/53 (4%) 1/51 (2%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 0/66 (0%) | |POLY-3 RATE (b) | 2/42.41 1/33.21 0/37.79 0/36.73 0/23.94 0/9.33 | |POLY-3 PERCENT (g) | 4.7% 3.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 567 525 --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.318N P=0.614N P=0.266N P=0.318N P=0.638N P=0.987N | |POLY 3 | P=0.176N P=0.584N P=0.263N P=0.270N P=0.380N P=0.564N | |POLY 1.5 | P=0.170N P=0.562N P=0.253N P=0.258N P=0.311N P=0.423N | |POLY 6 | P=0.153N P=0.606N P=0.274N P=0.291N P=0.482N P=0.650N | |LOGISTIC REGRESSION| P=0.105N P=0.494N P=0.239N P=0.241N P=0.320N P=0.671N | |COCH-ARM / FISHERS | P=0.112N P=0.515N P=0.248N P=0.248N P=0.248N P=0.196N | |ORDER RESTRICTED | P=0.492N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # # | |----------- | | |OVERALL (a) | 5/53 (9%) 1/51 (2%) 4/53 (8%) 0/53 (0%) 0/53 (0%) 0/66 (0%) | |POLY-3 RATE (b) | 5/42.77 1/33.53 4/39.16 0/36.73 0/23.94 0/9.33 | |POLY-3 PERCENT (g) | 11.7% 3.0% 10.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/27 (15%) 0/17 (0%) 2/24 (8%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 362 275 426 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.096N P=0.197N P=0.555N P=0.087N P=0.512N P=0.642N | |POLY 3 | P=0.030N* P=0.167N P=0.556N P=0.045N* P=0.120N P=0.382N | |POLY 1.5 | P=0.021N* P=0.147N P=0.536N P=0.040N* P=0.068N P=0.170N | |POLY 6 | P=0.037N* P=0.188N P=0.572N P=0.054N P=0.238N P=0.551N | |LOGISTIC REGRESSION| P=0.003N** P=0.080N P=0.489N P=0.036N* P=0.065N P=0.255N | |COCH-ARM / FISHERS | P=0.007N** P=0.112N P=0.500N P=0.028N* P=0.028N* P=0.016N* | |ORDER RESTRICTED | P=0.352N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 6 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # # | |----------- | | |OVERALL (a) | 6/53 (11%) 2/51 (4%) 4/53 (8%) 0/53 (0%) 0/53 (0%) 0/66 (0%) | |POLY-3 RATE (b) | 6/43.29 2/34.15 4/39.16 0/36.73 0/23.94 0/9.33 | |POLY-3 PERCENT (g) | 13.9% 5.9% 10.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/27 (15%) 0/17 (0%) 2/24 (8%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 362 275 426 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.056N P=0.264N P=0.430N P=0.052N P=0.322N P=0.598N | |POLY 3 | P=0.016N* P=0.222N P=0.433N P=0.025N* P=0.085N P=0.346N | |POLY 1.5 | P=0.011N* P=0.196N P=0.411N P=0.022N* P=0.042N* P=0.129N | |POLY 6 | P=0.020N* P=0.249N P=0.455N P=0.033N* P=0.197N P=0.533N | |LOGISTIC REGRESSION| P<0.001N** P=0.093N P=0.349N P=0.017N* P=0.025N* P=0.106N | |COCH-ARM / FISHERS | P=0.003N** P=0.148N P=0.371N P=0.013N* P=0.013N* P=0.007N** | |ORDER RESTRICTED | P=0.313N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # # | |----------- | | |OVERALL (a) | 42/53 (79%) 38/51 (75%) 36/53 (68%) 17/53 (32%) 4/53 (8%) 6/66 (9%) | |POLY-3 RATE (b) | 42/51.89 38/44.64 36/47.82 17/40.43 4/26.10 6/14.37 | |POLY-3 PERCENT (g) | 81.0% 85.1% 75.3% 42.0% 15.3% 41.8% | |TERMINAL (d) | 19/27 (70%) 13/17 (77%) 16/24 (67%) 7/15 (47%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 347 426 261 479 222 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.206N P=0.107 P=0.493N P=0.019N* P=0.082N P=0.115 | |POLY 3 | P<0.001N** P=0.389 P=0.324N P<0.001N** P<0.001N** P=0.016N* | |POLY 1.5 | P<0.001N** P=0.480 P=0.257N P<0.001N** P<0.001N** P<0.001N** | |POLY 6 | P<0.001N** P=0.339 P=0.398N P<0.001N** P<0.001N** P=0.454N | |LOGISTIC REGRESSION| P<0.001N** P=0.497N P=0.133N P<0.001N** P<0.001N** P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.367N P=0.135N P<0.001N** P<0.001N** P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 7 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # # | |----------- | | |OVERALL (a) | 42/53 (79%) 39/51 (76%) 36/53 (68%) 17/53 (32%) 4/53 (8%) 6/66 (9%) | |POLY-3 RATE (b) | 42/51.89 39/45.26 36/47.82 17/40.43 4/26.10 6/14.37 | |POLY-3 PERCENT (g) | 81.0% 86.2% 75.3% 42.0% 15.3% 41.8% | |TERMINAL (d) | 19/27 (70%) 13/17 (77%) 16/24 (67%) 7/15 (47%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 347 426 261 479 222 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.188N P=0.083 P=0.493N P=0.019N* P=0.082N P=0.115 | |POLY 3 | P<0.001N** P=0.334 P=0.324N P<0.001N** P<0.001N** P=0.016N* | |POLY 1.5 | P<0.001N** P=0.402 P=0.257N P<0.001N** P<0.001N** P<0.001N** | |POLY 6 | P<0.001N** P=0.307 P=0.398N P<0.001N** P<0.001N** P=0.454N | |LOGISTIC REGRESSION| P<0.001N** P=0.581N P=0.133N P<0.001N** P<0.001N** P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.458N P=0.135N P<0.001N** P<0.001N** P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # # | |----------- | | |OVERALL (a) | 42/53 (79%) 40/51 (78%) 37/53 (70%) 17/53 (32%) 4/53 (8%) 6/66 (9%) | |POLY-3 RATE (b) | 42/51.89 40/46.21 37/48.39 17/40.43 4/26.10 6/14.37 | |POLY-3 PERCENT (g) | 81.0% 86.6% 76.5% 42.0% 15.3% 41.8% | |TERMINAL (d) | 19/27 (70%) 13/17 (77%) 16/24 (67%) 7/15 (47%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 275 426 261 479 222 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.149N P=0.065 P=0.550N P=0.019N* P=0.082N P=0.115 | |POLY 3 | P<0.001N** P=0.312 P=0.377N P<0.001N** P<0.001N** P=0.016N* | |POLY 1.5 | P<0.001N** P=0.362 P=0.318N P<0.001N** P<0.001N** P<0.001N** | |POLY 6 | P<0.001N** P=0.291 P=0.435N P<0.001N** P<0.001N** P=0.454N | |LOGISTIC REGRESSION| P<0.001N** P=0.573 P=0.178N P<0.001N** P<0.001N** P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.555N P=0.186N P<0.001N** P<0.001N** P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 8 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # # | |----------- | | |OVERALL (a) | 1/53 (2%) 1/51 (2%) 2/53 (4%) 4/53 (8%) 0/53 (0%) 1/66 (2%) | |POLY-3 RATE (b) | 1/42.04 1/32.86 2/38.20 4/37.76 0/23.94 1/10.03 | |POLY-3 PERCENT (g) | 2.4% 3.0% 5.2% 10.6% 0.0% 10.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 1/24 (4%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 687 651 608 594 --- 482 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.063 P=0.674 P=0.445 P=0.105 P=0.970N P=0.186 | |POLY 3 | P=0.511 P=0.703 P=0.467 P=0.146 P=0.605N P=0.447 | |POLY 1.5 | P=0.495N P=0.719 P=0.479 P=0.157 P=0.559N P=0.583 | |POLY 6 | P=0.267 P=0.687 P=0.455 P=0.131 P=0.663N P=0.363 | |LOGISTIC REGRESSION| P=0.587 P=0.720 P=0.474 P=0.158 P=0.760N P=0.663 | |COCH-ARM / FISHERS | P=0.205N P=0.743 P=0.500 P=0.181 P=0.500N P=0.694N | |ORDER RESTRICTED | P=0.487 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # # | |----------- | | |OVERALL (a) | 1/53 (2%) 1/51 (2%) 2/53 (4%) 4/53 (8%) 0/53 (0%) 1/66 (2%) | |POLY-3 RATE (b) | 1/42.04 1/32.86 2/38.20 4/37.76 0/23.94 1/10.03 | |POLY-3 PERCENT (g) | 2.4% 3.0% 5.2% 10.6% 0.0% 10.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 1/24 (4%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 687 651 608 594 --- 482 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.063 P=0.674 P=0.445 P=0.105 P=0.970N P=0.186 | |POLY 3 | P=0.511 P=0.703 P=0.467 P=0.146 P=0.605N P=0.447 | |POLY 1.5 | P=0.495N P=0.719 P=0.479 P=0.157 P=0.559N P=0.583 | |POLY 6 | P=0.267 P=0.687 P=0.455 P=0.131 P=0.663N P=0.363 | |LOGISTIC REGRESSION| P=0.587 P=0.720 P=0.474 P=0.158 P=0.760N P=0.663 | |COCH-ARM / FISHERS | P=0.205N P=0.743 P=0.500 P=0.181 P=0.500N P=0.694N | |ORDER RESTRICTED | P=0.487 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 9 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # # | |----------- | | |OVERALL (a) | 1/53 (2%) 1/51 (2%) 2/53 (4%) 4/53 (8%) 0/53 (0%) 1/66 (2%) | |POLY-3 RATE (b) | 1/42.04 1/32.86 2/38.20 4/37.76 0/23.94 1/10.03 | |POLY-3 PERCENT (g) | 2.4% 3.0% 5.2% 10.6% 0.0% 10.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 1/24 (4%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 687 651 608 594 --- 482 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.063 P=0.674 P=0.445 P=0.105 P=0.970N P=0.186 | |POLY 3 | P=0.511 P=0.703 P=0.467 P=0.146 P=0.605N P=0.447 | |POLY 1.5 | P=0.495N P=0.719 P=0.479 P=0.157 P=0.559N P=0.583 | |POLY 6 | P=0.267 P=0.687 P=0.455 P=0.131 P=0.663N P=0.363 | |LOGISTIC REGRESSION| P=0.587 P=0.720 P=0.474 P=0.158 P=0.760N P=0.663 | |COCH-ARM / FISHERS | P=0.205N P=0.743 P=0.500 P=0.181 P=0.500N P=0.694N | |ORDER RESTRICTED | P=0.487 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Pancreas | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 2/53 (4%) 0/53 (0%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 2/38.31 0/36.73 0/23.94 0/9.28 | |POLY-3 PERCENT (g) | 0.0% 0.0% 5.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 1/24 (4%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 567 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.702N (e) P=0.214 (e) (e) (e) | |POLY 3 | P=0.467N (e) P=0.217 (e) (e) (e) | |POLY 1.5 | P=0.396N (e) P=0.224 (e) (e) (e) | |POLY 6 | P=0.523N (e) P=0.211 (e) (e) (e) | |LOGISTIC REGRESSION| P=0.399N (e) P=0.233 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.253N (e) P=0.248 (e) (e) (e) | |ORDER RESTRICTED | P=0.682 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 10 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 30/53 (57%) 11/51 (22%) 16/52 (31%) 10/53 (19%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 30/44.61 11/34.16 16/40.06 10/38.64 0/23.94 0/9.27 | |POLY-3 PERCENT (g) | 67.3% 32.2% 39.9% 25.9% 0.0% 0.0% | |TERMINAL (d) | 21/27 (78%) 6/17 (35%) 10/24 (42%) 4/15 (27%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 582 541 548 537 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.018N* P=0.026N* P=0.029N* P=0.020N* P=0.125N P=0.840N | |POLY 3 | P<0.001N** P<0.001N** P=0.007N** P<0.001N** P<0.001N** P=0.008N** | |POLY 1.5 | P<0.001N** P<0.001N** P=0.006N** P<0.001N** P<0.001N** P<0.001N** | |POLY 6 | P<0.001N** P=0.002N** P=0.008N** P<0.001N** P<0.001N** P=0.260N | |LOGISTIC REGRESSION| P<0.001N** P=0.003N** P=0.015N* P<0.001N** P<0.001N** P=0.172N | |COCH-ARM / FISHERS | P<0.001N** P<0.001N** P=0.007N** P<0.001N** P<0.001N** P<0.001N** | |ORDER RESTRICTED | P=0.008N** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 30/53 (57%) 11/51 (22%) 17/52 (33%) 10/53 (19%) 0/53 (0%) 0/65 (0%) | |POLY-3 RATE (b) | 30/44.61 11/34.16 17/40.57 10/38.64 0/23.94 0/9.27 | |POLY-3 PERCENT (g) | 67.3% 32.2% 41.9% 25.9% 0.0% 0.0% | |TERMINAL (d) | 21/27 (78%) 6/17 (35%) 10/24 (42%) 4/15 (27%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 582 541 548 537 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.016N* P=0.026N* P=0.049N* P=0.020N* P=0.125N P=0.840N | |POLY 3 | P<0.001N** P<0.001N** P=0.011N* P<0.001N** P<0.001N** P=0.008N** | |POLY 1.5 | P<0.001N** P<0.001N** P=0.011N* P<0.001N** P<0.001N** P<0.001N** | |POLY 6 | P<0.001N** P=0.002N** P=0.012N* P<0.001N** P<0.001N** P=0.260N | |LOGISTIC REGRESSION| P<0.001N** P=0.003N** P=0.025N* P<0.001N** P<0.001N** P=0.172N | |COCH-ARM / FISHERS | P<0.001N** P<0.001N** P=0.011N* P<0.001N** P<0.001N** P<0.001N** | |ORDER RESTRICTED | P=0.008N** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 11 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |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) | 2/53 (4%) 0/51 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 0/66 (0%) | |POLY-3 RATE (b) | 2/41.89 0/32.58 0/37.79 0/36.73 0/23.94 0/9.33 | |POLY-3 PERCENT (g) | 4.8% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/27 (7%) 0/17 (0%) 0/24 (0%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.802N P=0.344N P=0.264N P=0.374N P=1.000N P=1.000N | |POLY 3 | P=0.234N P=0.296N P=0.260N P=0.267N P=0.377N P=0.562N | |POLY 1.5 | P=0.238N P=0.280N P=0.252N P=0.256N P=0.310N P=0.421N | |POLY 6 | P=0.189N P=0.314N P=0.269N P=0.286N P=0.478N P=0.650N | |LOGISTIC REGRESSION| P=0.802N (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.186N P=0.257N P=0.248N P=0.248N P=0.248N P=0.196N | |ORDER RESTRICTED | P=0.408N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # # | |----------- | | |OVERALL (a) | 1/53 (2%) 1/51 (2%) 1/53 (2%) 3/53 (6%) 0/53 (0%) 0/66 (0%) | |POLY-3 RATE (b) | 1/41.89 1/32.90 1/37.88 3/36.99 0/23.94 0/9.33 | |POLY-3 PERCENT (g) | 2.4% 3.0% 2.6% 8.1% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/17 (0%) 0/24 (0%) 2/15 (13%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 639 703 659 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.479 P=0.668 P=0.735 P=0.152 P=1.000N P=1.000N | |POLY 3 | P=0.531N P=0.705 P=0.738 P=0.261 P=0.604N P=0.696N | |POLY 1.5 | P=0.329N P=0.720 P=0.747 P=0.276 P=0.559N P=0.625N | |POLY 6 | P=0.415 P=0.690 P=0.730 P=0.238 P=0.662N P=0.735N | |LOGISTIC REGRESSION| P=0.646N P=0.708 P=0.730 P=0.204 (e) (e) | |COCH-ARM / FISHERS | P=0.105N P=0.743 P=0.752N P=0.309 P=0.500N P=0.445N | |ORDER RESTRICTED | P=0.635N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 12 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # # | |----------- | | |OVERALL (a) | 1/53 (2%) 1/51 (2%) 2/53 (4%) 3/53 (6%) 0/53 (0%) 0/66 (0%) | |POLY-3 RATE (b) | 1/41.89 1/32.90 2/37.88 3/36.99 0/23.94 0/9.33 | |POLY-3 PERCENT (g) | 2.4% 3.0% 5.3% 8.1% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/17 (0%) 1/24 (4%) 2/15 (13%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) 639 703 659 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.477 P=0.668 P=0.460 P=0.152 P=1.000N P=1.000N | |POLY 3 | P=0.467N P=0.705 P=0.465 P=0.261 P=0.604N P=0.696N | |POLY 1.5 | P=0.271N P=0.720 P=0.478 P=0.276 P=0.559N P=0.625N | |POLY 6 | P=0.460 P=0.690 P=0.453 P=0.238 P=0.662N P=0.735N | |LOGISTIC REGRESSION| P=0.631N P=0.708 P=0.449 P=0.204 (e) (e) | |COCH-ARM / FISHERS | P=0.075N P=0.743 P=0.500 P=0.309 P=0.500N P=0.445N | |ORDER RESTRICTED | P=0.618N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 9/53 (17%) 5/51 (10%) 8/53 (15%) 8/52 (15%) 4/52 (8%) 1/66 (2%) | |POLY-3 RATE (b) | 9/43.64 5/34.06 8/38.66 8/37.23 4/24.72 1/9.65 | |POLY-3 PERCENT (g) | 20.6% 14.7% 20.7% 21.5% 16.2% 10.4% | |TERMINAL (d) | 4/27 (15%) 1/17 (6%) 5/24 (21%) 5/15 (33%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 548 611 632 619 639 636 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002 ** P=0.468N P=0.588 P=0.344 P=0.069 P=0.183 | |POLY 3 | P=0.420N P=0.353N P=0.605 P=0.571 P=0.452N P=0.429N | |POLY 1.5 | P=0.126N P=0.307N P=0.569N P=0.599N P=0.275N P=0.135N | |POLY 6 | P=0.327 P=0.396N P=0.567 P=0.500 P=0.523 P=0.547 | |LOGISTIC REGRESSION| P=0.484 P=0.292N P=0.582N P=0.587 P=0.614N P=0.586N | |COCH-ARM / FISHERS | P=0.002N** P=0.217N P=0.500N P=0.517N P=0.125N P=0.003N** | |ORDER RESTRICTED | P=0.589N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 13 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 4/53 (8%) 2/51 (4%) 2/53 (4%) 0/52 (0%) 0/52 (0%) 0/66 (0%) | |POLY-3 RATE (b) | 4/42.04 2/32.58 2/37.79 0/36.44 0/23.93 0/9.33 | |POLY-3 PERCENT (g) | 9.5% 6.1% 5.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/27 (11%) 2/17 (12%) 2/24 (8%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 688 726 (T) 726 (T) --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.290N P=0.554N P=0.391N P=0.152N P=0.965N P=1.000N | |POLY 3 | P=0.044N* P=0.460N P=0.387N P=0.080N P=0.169N P=0.425N | |POLY 1.5 | P=0.035N* P=0.425N P=0.368N P=0.074N P=0.110N P=0.223N | |POLY 6 | P=0.045N* P=0.496N P=0.407N P=0.092N P=0.290N P=0.573N | |LOGISTIC REGRESSION| P=0.204N P=0.530N P=0.403N P=0.112N P=0.572N P=0.994N | |COCH-ARM / FISHERS | P=0.014N* P=0.358N P=0.339N P=0.061N P=0.061N P=0.037N* | |ORDER RESTRICTED | P=0.401N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 13/53 (25%) 7/51 (14%) 9/53 (17%) 8/52 (15%) 4/52 (8%) 1/66 (2%) | |POLY-3 RATE (b) | 13/43.79 7/34.06 9/38.66 8/37.23 4/24.72 1/9.65 | |POLY-3 PERCENT (g) | 29.7% 20.6% 23.3% 21.5% 16.2% 10.4% | |TERMINAL (d) | 7/27 (26%) 3/17 (18%) 6/24 (25%) 5/15 (33%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 548 611 632 619 639 636 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.008 ** P=0.407N P=0.357N P=0.557N P=0.081 P=0.183 | |POLY 3 | P=0.141N P=0.256N P=0.341N P=0.277N P=0.181N P=0.298N | |POLY 1.5 | P=0.024N* P=0.208N P=0.298N P=0.237N P=0.069N P=0.043N* | |POLY 6 | P=0.396N P=0.305N P=0.387N P=0.350N P=0.461N P=0.594N | |LOGISTIC REGRESSION| P=0.485N P=0.242N P=0.331N P=0.282N P=0.424N P=0.570N | |COCH-ARM / FISHERS | P<0.001N** P=0.125N P=0.237N P=0.177N P=0.018N* P<0.001N** | |ORDER RESTRICTED | P=0.385N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 14 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/53 (0%) 0/51 (0%) 2/53 (4%) 0/52 (0%) 2/52 (4%) 1/66 (2%) | |POLY-3 RATE (b) | 0/41.89 0/32.58 2/38.13 0/36.44 2/24.61 1/10.09 | |POLY-3 PERCENT (g) | 0.0% 0.0% 5.3% 0.0% 8.1% 9.9% | |TERMINAL (d) | 0/27 (0%) 0/17 (0%) 1/24 (4%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 632 --- 565 452 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.209 (e) P=0.028 * P=0.261 | |POLY 3 | P=0.072 (e) P=0.216 (e) P=0.143 P=0.307 | |POLY 1.5 | P=0.117 (e) P=0.224 (e) P=0.179 P=0.377 | |POLY 6 | P=0.056 (e) P=0.210 (e) P=0.105 P=0.268 | |LOGISTIC REGRESSION| P=0.071 (e) P=0.218 (e) P=0.147 P=0.656 | |COCH-ARM / FISHERS | P=0.316 (e) P=0.248 (e) P=0.243 P=0.555 | |ORDER RESTRICTED | P=0.244 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/53 (2%) 0/51 (0%) 2/53 (4%) 0/52 (0%) 3/52 (6%) 1/66 (2%) | |POLY-3 RATE (b) | 1/41.89 0/32.58 2/38.13 0/36.44 3/25.10 1/10.09 | |POLY-3 PERCENT (g) | 2.4% 0.0% 5.3% 0.0% 12.0% 9.9% | |TERMINAL (d) | 1/27 (4%) 0/17 (0%) 1/24 (4%) 0/15 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 726 (T) --- 632 --- 565 452 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.592N P=0.453 P=0.617N P=0.007 ** P=0.261 | |POLY 3 | P=0.053 P=0.550N P=0.467 P=0.528N P=0.156 P=0.448 | |POLY 1.5 | P=0.107 P=0.536N P=0.479 P=0.519N P=0.212 P=0.584 | |POLY 6 | P=0.038 * P=0.563N P=0.457 P=0.542N P=0.098 P=0.364 | |LOGISTIC REGRESSION| P=0.052 (e) P=0.458 (e) P=0.137 P=0.643 | |COCH-ARM / FISHERS | P=0.373 P=0.510N P=0.500 P=0.505N P=0.302 P=0.694N | |ORDER RESTRICTED | P=0.314 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 15 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # # | |----------- | | |OVERALL (a) | 11/53 (21%) 6/51 (12%) 7/53 (13%) 8/53 (15%) 7/53 (13%) 3/66 (5%) | |POLY-3 RATE (b) | 11/44.47 6/33.44 7/39.93 8/37.87 7/26.50 3/11.76 | |POLY-3 PERCENT (g) | 24.7% 17.9% 17.5% 21.1% 26.4% 25.5% | |TERMINAL (d) | 4/27 (15%) 4/17 (24%) 3/24 (13%) 5/15 (33%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 534 534 399 555 530 300 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.439N P=0.337N P=0.534 P=0.027 * P=0.040 * | |POLY 3 | P=0.347 P=0.331N P=0.294N P=0.450N P=0.548 P=0.588 | |POLY 1.5 | P=0.408N P=0.267N P=0.263N P=0.393N P=0.456N P=0.250N | |POLY 6 | P=0.128 P=0.408N P=0.331N P=0.545N P=0.282 P=0.333 | |LOGISTIC REGRESSION| P=0.521 P=0.256N P=0.222N P=0.379N P=0.580N P=0.264N | |COCH-ARM / FISHERS | P=0.019N* P=0.165N P=0.219N P=0.307N P=0.219N P=0.007N** | |ORDER RESTRICTED | P=0.687 (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # # | |----------- | | |OVERALL (a) | 53/53 (100%) 43/51 (84%) 47/53 (89%) 40/53 (75%) 51/53 (96%) 45/66 (68%) | |POLY-3 RATE (b) | 53/53.00 43/45.66 47/50.14 40/45.86 51/51.18 45/45.91 | |POLY-3 PERCENT (g) | 100.0% 94.2% 93.7% 87.2% 99.7% 98.0% | |TERMINAL (d) | 27/27 (100%) 15/17 (88%) 22/24 (92%) 13/15 (87%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 347 399 261 267 222 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.187 P=0.542 P=0.346 P<0.001 ** P<0.001 ** | |POLY 3 | P=0.136 P=0.099N P=0.074N P=0.003N** P=1.000N P=0.542N | |POLY 1.5 | P=0.564 P=0.038N* P=0.045N* P<0.001N** P=0.872N P<0.001N** | |POLY 6 | P=0.090 P=0.169N P=0.134N P=0.017N* P=1.000N P=1.000N | |LOGISTIC REGRESSION| P=0.033 * P=0.028N* P=0.029N* P<0.001N** P=0.525N P=0.352N | |COCH-ARM / FISHERS | P<0.001N** P=0.002N** P=0.013N* P<0.001N** P=0.248N P<0.001N** | |ORDER RESTRICTED | P=0.091N (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 11/15/04 EXPERIMENT: 96022 TEST: 02 Page 16 Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (PCB MIXTURE;PCB 126/P Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # # | |----------- | | |OVERALL (a) | 16/53 (30%) 13/51 (25%) 18/53 (34%) 22/53 (42%) 28/53 (53%) 14/66 (21%) | |POLY-3 RATE (b) | 16/44.14 13/38.29 18/41.74 22/40.90 28/35.01 14/18.92 | |POLY-3 PERCENT (g) | 36.3% 34.0% 43.1% 53.8% 80.0% 74.0% | |TERMINAL (d) | 10/27 (37%) 3/17 (18%) 11/24 (46%) 6/15 (40%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 362 275 408 567 450 294 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.408 P=0.276 P=0.013 * P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.505N P=0.330 P=0.071 P<0.001 ** P=0.014 * | |POLY 1.5 | P<0.001 ** P=0.473N P=0.358 P=0.089 P<0.001 ** P=0.151 | |POLY 6 | P<0.001 ** P=0.528N P=0.307 P=0.057 P<0.001 ** P=0.002 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.397N P=0.343 P=0.069 P<0.001 ** P=0.002 ** | |COCH-ARM / FISHERS | P=0.353N P=0.377N P=0.418 P=0.156 P=0.015 * P=0.182N | |ORDER RESTRICTED | P=0.005 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 NG 7 NG 22 NG 72 NG 216 NG 360 NG | | | TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG TEQ/KG | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # # | |----------- | | |OVERALL (a) | 53/53 (100%) 47/51 (92%) 51/53 (96%) 42/53 (79%) 51/53 (96%) 45/66 (68%) | |POLY-3 RATE (b) | 53/53.00 47/48.14 51/52.00 42/46.43 51/51.18 45/45.91 | |POLY-3 PERCENT (g) | 100.0% 97.6% 98.1% 90.5% 99.7% 98.0% | |TERMINAL (d) | 27/27 (100%) 16/17 (94%) 23/24 (96%) 13/15 (87%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 275 275 399 261 267 222 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.071 P=0.321 P=0.246 P<0.001 ** P<0.001 ** | |POLY 3 | P=0.472 P=0.424N P=0.496N P=0.013N* P=1.000N P=0.542N | |POLY 1.5 | P=0.098N P=0.319N P=0.486N P=0.004N** P=0.872N P<0.001N** | |POLY 6 | P=0.263 P=0.473N P=0.496N P=0.062N P=1.000N P=1.000N | |LOGISTIC REGRESSION| P=0.370 P=0.229N P=0.341N P=0.002N** P=0.525N P=0.352N | |COCH-ARM / FISHERS | P<0.001N** P=0.054N P=0.248N P<0.001N** P=0.248N P<0.001N** | |ORDER RESTRICTED | P=0.114N (e) (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).