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: 05/24/04 EXPERIMENT: 96020 TEST: 01 TIME: 09:55:00 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96020 PATHOLOGIST: SELLS, DONALD CAS: TEFBINARYMIX Rats(SD) ----------------------------- 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: 05/24/04 EXPERIMENT: 96020 TEST: 01 TIME: 09:55:00 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 or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Pancreas Carcinoma or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 1 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/49 (2%) 1/52 (2%) 2/49 (4%) | |POLY-3 RATE (b) | 1/39.18 1/37.39 2/39.42 | |POLY-3 PERCENT (g) | 2.6% 2.7% 5.1% | |TERMINAL (d) | 0/28 (0%) 1/24 (4%) 1/26 (4%) | |FIRST INCIDENCE | 643 729 (T) 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.437 P=0.740 P=0.503 | |POLY 3 | P=0.428 P=0.751 P=0.502 | |POLY 1.5 | P=0.423 P=0.757 P=0.501 | |POLY 6 | P=0.430 P=0.745 P=0.502 | |LOGISTIC REGRESSION| P=0.421 P=0.757 P=0.500 | |COCH-ARM / FISHERS | P=0.411 P=0.737N P=0.500 | |ORDER RESTRICTED | P=0.370 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Intestine Small: Duodenum | | Leiomyoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 0/50 (0%) 2/53 (4%) 0/51 (0%) | |POLY-3 RATE (b) | 0/39.59 2/37.47 0/39.98 | |POLY-3 PERCENT (g) | 0.0% 5.3% 0.0% | |TERMINAL (d) | 0/28 (0%) 1/24 (4%) 0/27 (0%) | |FIRST INCIDENCE | --- 710 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.419N P=0.219 (e) | |POLY 3 | P=0.439N P=0.225 (e) | |POLY 1.5 | P=0.439N P=0.230 (e) | |POLY 6 | P=0.439N P=0.221 (e) | |LOGISTIC REGRESSION| P=0.419N P=0.218 (e) | |COCH-ARM / FISHERS | P=0.434N P=0.262 (e) | |ORDER RESTRICTED | P=0.252N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 2 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Leiomyoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 0/50 (0%) 2/53 (4%) 0/51 (0%) | |POLY-3 RATE (b) | 0/39.59 2/37.47 0/39.98 | |POLY-3 PERCENT (g) | 0.0% 5.3% 0.0% | |TERMINAL (d) | 0/28 (0%) 1/24 (4%) 0/27 (0%) | |FIRST INCIDENCE | --- 710 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.419N P=0.219 (e) | |POLY 3 | P=0.439N P=0.225 (e) | |POLY 1.5 | P=0.439N P=0.230 (e) | |POLY 6 | P=0.439N P=0.221 (e) | |LOGISTIC REGRESSION| P=0.419N P=0.218 (e) | |COCH-ARM / FISHERS | P=0.434N P=0.262 (e) | |ORDER RESTRICTED | P=0.252N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Cholangiocarcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 7/50 (14%) 9/52 (17%) 25/51 (49%) | |POLY-3 RATE (b) | 7/40.58 9/38.00 25/42.00 | |POLY-3 PERCENT (g) | 17.3% 23.7% 59.5% | |TERMINAL (d) | 4/28 (14%) 7/24 (29%) 18/27 (67%) | |FIRST INCIDENCE | 603 603 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.292 P<0.001 ** | |POLY 3 | P<0.001 ** P=0.334 P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.359 P<0.001 ** | |POLY 6 | P<0.001 ** P=0.313 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.335 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.427 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 3 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 5/52 (10%) 21/51 (41%) | |POLY-3 RATE (b) | 2/39.59 5/37.57 21/42.31 | |POLY-3 PERCENT (g) | 5.1% 13.3% 49.6% | |TERMINAL (d) | 2/28 (7%) 4/24 (17%) 14/27 (52%) | |FIRST INCIDENCE | 729 (T) 684 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.162 P<0.001 ** | |POLY 3 | P<0.001 ** P=0.193 P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.202 P<0.001 ** | |POLY 6 | P<0.001 ** P=0.187 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.179 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.235 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 5/52 (10%) 21/51 (41%) | |POLY-3 RATE (b) | 2/39.59 5/37.57 21/42.31 | |POLY-3 PERCENT (g) | 5.1% 13.3% 49.6% | |TERMINAL (d) | 2/28 (7%) 4/24 (17%) 14/27 (52%) | |FIRST INCIDENCE | 729 (T) 684 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.162 P<0.001 ** | |POLY 3 | P<0.001 ** P=0.193 P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.202 P<0.001 ** | |POLY 6 | P<0.001 ** P=0.187 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.179 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.235 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 4 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 5/52 (10%) 21/51 (41%) | |POLY-3 RATE (b) | 2/39.59 5/37.57 21/42.31 | |POLY-3 PERCENT (g) | 5.1% 13.3% 49.6% | |TERMINAL (d) | 2/28 (7%) 4/24 (17%) 14/27 (52%) | |FIRST INCIDENCE | 729 (T) 684 491 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.162 P<0.001 ** | |POLY 3 | P<0.001 ** P=0.193 P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.202 P<0.001 ** | |POLY 6 | P<0.001 ** P=0.187 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.179 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.235 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Liver | | Hepatocholangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/52 (4%) 2/51 (4%) | |POLY-3 RATE (b) | 0/39.59 2/37.39 2/39.98 | |POLY-3 PERCENT (g) | 0.0% 5.4% 5.0% | |TERMINAL (d) | 0/28 (0%) 2/24 (8%) 2/27 (7%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.403 P=0.204 P=0.230 | |POLY 3 | P=0.388 P=0.224 P=0.239 | |POLY 1.5 | P=0.388 P=0.230 P=0.239 | |POLY 6 | P=0.389 P=0.220 P=0.239 | |LOGISTIC REGRESSION| (e) P=0.204 P=0.230 | |COCH-ARM / FISHERS | P=0.393 P=0.257 P=0.252 | |ORDER RESTRICTED | P=0.137 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 5 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Lung | | Cystic Keratinizing Epithelioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 1/53 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 1/39.96 1/37.40 2/39.67 | |POLY-3 PERCENT (g) | 2.5% 2.7% 5.0% | |TERMINAL (d) | 0/28 (0%) 1/24 (4%) 2/27 (7%) | |FIRST INCIDENCE | 625 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.434 P=0.727 P=0.488 | |POLY 3 | P=0.425 P=0.746 P=0.497 | |POLY 1.5 | P=0.421 P=0.753 P=0.497 | |POLY 6 | P=0.428 P=0.741 P=0.498 | |LOGISTIC REGRESSION| P=0.436 P=0.757 P=0.501 | |COCH-ARM / FISHERS | P=0.411 P=0.738N P=0.500 | |ORDER RESTRICTED | P=0.365 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 1/50 (2%) 2/53 (4%) 4/51 (8%) | |POLY-3 RATE (b) | 1/40.28 2/38.16 4/41.34 | |POLY-3 PERCENT (g) | 2.5% 5.2% 9.7% | |TERMINAL (d) | 0/28 (0%) 1/24 (4%) 1/27 (4%) | |FIRST INCIDENCE | 494 451 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.176 P=0.480 P=0.185 | |POLY 3 | P=0.167 P=0.481 P=0.185 | |POLY 1.5 | P=0.163 P=0.489 P=0.183 | |POLY 6 | P=0.174 P=0.476 P=0.191 | |LOGISTIC REGRESSION| P=0.137 P=0.616 P=0.204 | |COCH-ARM / FISHERS | P=0.156 P=0.522 P=0.187 | |ORDER RESTRICTED | P=0.110 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 6 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 2/50 (4%) 2/53 (4%) 5/51 (10%) | |POLY-3 RATE (b) | 2/40.65 2/38.16 5/41.34 | |POLY-3 PERCENT (g) | 4.9% 5.2% 12.1% | |TERMINAL (d) | 0/28 (0%) 1/24 (4%) 2/27 (7%) | |FIRST INCIDENCE | 494 451 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.154 P=0.663 P=0.220 | |POLY 3 | P=0.145 P=0.672 P=0.221 | |POLY 1.5 | P=0.141 P=0.682 P=0.220 | |POLY 6 | P=0.151 P=0.664 P=0.225 | |LOGISTIC REGRESSION| P=0.121 P=0.605N P=0.238 | |COCH-ARM / FISHERS | P=0.132 P=0.669N P=0.226 | |ORDER RESTRICTED | P=0.146 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 29/50 (58%) 34/53 (64%) 29/51 (57%) | |POLY-3 RATE (b) | 29/45.97 34/46.23 29/45.69 | |POLY-3 PERCENT (g) | 63.1% 73.5% 63.5% | |TERMINAL (d) | 16/28 (57%) 15/24 (63%) 16/27 (59%) | |FIRST INCIDENCE | 441 254 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.328N P=0.137 P=0.533 | |POLY 3 | P=0.377N P=0.188 P=0.573 | |POLY 1.5 | P=0.369N P=0.201 P=0.583 | |POLY 6 | P=0.393N P=0.199 P=0.569 | |LOGISTIC REGRESSION| P=0.354N P=0.266 P=0.539N | |COCH-ARM / FISHERS | P=0.381N P=0.331 P=0.534N | |ORDER RESTRICTED | P=0.389 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 7 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 29/50 (58%) 34/53 (64%) 30/51 (59%) | |POLY-3 RATE (b) | 29/45.97 34/46.23 30/45.69 | |POLY-3 PERCENT (g) | 63.1% 73.5% 65.7% | |TERMINAL (d) | 16/28 (57%) 15/24 (63%) 17/27 (63%) | |FIRST INCIDENCE | 441 254 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.393N P=0.137 P=0.468 | |POLY 3 | P=0.480N P=0.188 P=0.484 | |POLY 1.5 | P=0.468N P=0.201 P=0.498 | |POLY 6 | P=0.501N P=0.199 P=0.476 | |LOGISTIC REGRESSION| P=0.441N P=0.266 P=0.540 | |COCH-ARM / FISHERS | P=0.472N P=0.331 P=0.547 | |ORDER RESTRICTED | P=0.337 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 30/50 (60%) 35/53 (66%) 31/51 (61%) | |POLY-3 RATE (b) | 30/46.65 35/47.00 31/46.13 | |POLY-3 PERCENT (g) | 64.3% 74.5% 67.2% | |TERMINAL (d) | 16/28 (57%) 15/24 (63%) 17/27 (63%) | |FIRST INCIDENCE | 441 254 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.395N P=0.142 P=0.467 | |POLY 3 | P=0.501N P=0.192 P=0.469 | |POLY 1.5 | P=0.483N P=0.204 P=0.487 | |POLY 6 | P=0.521N P=0.202 P=0.462 | |LOGISTIC REGRESSION| P=0.453N P=0.300 P=0.548 | |COCH-ARM / FISHERS | P=0.472N P=0.333 P=0.549 | |ORDER RESTRICTED | P=0.332 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 8 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 3/50 (6%) 5/53 (9%) 6/51 (12%) | |POLY-3 RATE (b) | 3/40.73 5/38.73 6/41.64 | |POLY-3 PERCENT (g) | 7.4% 12.9% 14.4% | |TERMINAL (d) | 1/28 (4%) 1/24 (4%) 2/27 (7%) | |FIRST INCIDENCE | 484 479 490 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.320 P=0.317 P=0.241 | |POLY 3 | P=0.308 P=0.327 P=0.251 | |POLY 1.5 | P=0.301 P=0.340 P=0.248 | |POLY 6 | P=0.320 P=0.321 P=0.257 | |LOGISTIC REGRESSION| P=0.281 P=0.402 P=0.264 | |COCH-ARM / FISHERS | P=0.287 P=0.391 P=0.254 | |ORDER RESTRICTED | P=0.215 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 3/50 (6%) 5/53 (9%) 6/51 (12%) | |POLY-3 RATE (b) | 3/40.73 5/38.73 6/41.64 | |POLY-3 PERCENT (g) | 7.4% 12.9% 14.4% | |TERMINAL (d) | 1/28 (4%) 1/24 (4%) 2/27 (7%) | |FIRST INCIDENCE | 484 479 490 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.320 P=0.317 P=0.241 | |POLY 3 | P=0.308 P=0.327 P=0.251 | |POLY 1.5 | P=0.301 P=0.340 P=0.248 | |POLY 6 | P=0.320 P=0.321 P=0.257 | |LOGISTIC REGRESSION| P=0.281 P=0.402 P=0.264 | |COCH-ARM / FISHERS | P=0.287 P=0.391 P=0.254 | |ORDER RESTRICTED | P=0.215 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 9 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 3/50 (6%) 5/53 (9%) 6/51 (12%) | |POLY-3 RATE (b) | 3/40.73 5/38.73 6/41.64 | |POLY-3 PERCENT (g) | 7.4% 12.9% 14.4% | |TERMINAL (d) | 1/28 (4%) 1/24 (4%) 2/27 (7%) | |FIRST INCIDENCE | 484 479 490 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.320 P=0.317 P=0.241 | |POLY 3 | P=0.308 P=0.327 P=0.251 | |POLY 1.5 | P=0.301 P=0.340 P=0.248 | |POLY 6 | P=0.320 P=0.321 P=0.257 | |LOGISTIC REGRESSION| P=0.281 P=0.402 P=0.264 | |COCH-ARM / FISHERS | P=0.287 P=0.391 P=0.254 | |ORDER RESTRICTED | P=0.215 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/48 (0%) 2/52 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/38.21 2/37.39 0/39.01 | |POLY-3 PERCENT (g) | 0.0% 5.4% 0.0% | |TERMINAL (d) | 0/28 (0%) 2/24 (8%) 0/27 (0%) | |FIRST INCIDENCE | --- 729 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.425N P=0.204 (e) | |POLY 3 | P=0.439N P=0.232 (e) | |POLY 1.5 | P=0.437N P=0.238 (e) | |POLY 6 | P=0.441N P=0.226 (e) | |LOGISTIC REGRESSION| (e) P=0.204 (e) | |COCH-ARM / FISHERS | P=0.431N P=0.268 (e) | |ORDER RESTRICTED | P=0.255N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 10 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/49 (0%) 3/52 (6%) 1/49 (2%) | |POLY-3 RATE (b) | 0/38.93 3/37.39 1/38.23 | |POLY-3 PERCENT (g) | 0.0% 8.0% 2.6% | |TERMINAL (d) | 0/28 (0%) 3/24 (13%) 1/27 (4%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.597N P=0.094 P=0.493 | |POLY 3 | P=0.626N P=0.111 P=0.496 | |POLY 1.5 | P=0.625N P=0.116 P=0.497 | |POLY 6 | P=0.627N P=0.107 P=0.496 | |LOGISTIC REGRESSION| (e) P=0.094 P=0.493 | |COCH-ARM / FISHERS | P=0.619N P=0.133 P=0.500 | |ORDER RESTRICTED | P=0.138 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Pancreas | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/49 (0%) 4/52 (8%) 2/49 (4%) | |POLY-3 RATE (b) | 0/38.93 4/37.39 2/38.23 | |POLY-3 PERCENT (g) | 0.0% 10.7% 5.2% | |TERMINAL (d) | 0/28 (0%) 4/24 (17%) 2/27 (7%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.631 P=0.044 * P=0.230 | |POLY 3 | P=0.595 P=0.054 P=0.232 | |POLY 1.5 | P=0.597 P=0.058 P=0.233 | |POLY 6 | P=0.594 P=0.051 P=0.232 | |LOGISTIC REGRESSION| (e) P=0.044 * P=0.230 | |COCH-ARM / FISHERS | P=0.606 P=0.066 P=0.247 | |ORDER RESTRICTED | P=0.077 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 11 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 19/50 (38%) 17/52 (33%) 9/51 (18%) | |POLY-3 RATE (b) | 19/42.40 17/38.83 9/40.52 | |POLY-3 PERCENT (g) | 44.8% 43.8% 22.2% | |TERMINAL (d) | 11/28 (39%) 12/24 (50%) 7/27 (26%) | |FIRST INCIDENCE | 491 506 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.016N* P=0.564 P=0.032N* | |POLY 3 | P=0.011N* P=0.553N P=0.022N* | |POLY 1.5 | P=0.012N* P=0.504N P=0.020N* | |POLY 6 | P=0.013N* P=0.587 P=0.027N* | |LOGISTIC REGRESSION| P=0.010N* P=0.519N P=0.019N* | |COCH-ARM / FISHERS | P=0.017N* P=0.362N P=0.019N* | |ORDER RESTRICTED | P=0.017N* (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 20/50 (40%) 17/52 (33%) 9/51 (18%) | |POLY-3 RATE (b) | 20/42.40 17/38.83 9/40.52 | |POLY-3 PERCENT (g) | 47.2% 43.8% 22.2% | |TERMINAL (d) | 12/28 (43%) 12/24 (50%) 7/27 (26%) | |FIRST INCIDENCE | 491 506 588 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.012N* P=0.520N P=0.021N* | |POLY 3 | P=0.007N** P=0.466N P=0.012N* | |POLY 1.5 | P=0.008N** P=0.420N P=0.011N* | |POLY 6 | P=0.008N** P=0.512N P=0.015N* | |LOGISTIC REGRESSION| P=0.007N** P=0.438N P=0.011N* | |COCH-ARM / FISHERS | P=0.013N* P=0.287N P=0.011N* | |ORDER RESTRICTED | P=0.009N** (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 12 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 2/50 (4%) 1/53 (2%) 1/51 (2%) | |POLY-3 RATE (b) | 2/39.99 1/37.66 1/39.98 | |POLY-3 PERCENT (g) | 5.0% 2.7% 2.5% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 1/27 (4%) | |FIRST INCIDENCE | 664 659 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.530N P=0.524N P=0.501N | |POLY 3 | P=0.527N P=0.521N P=0.500N | |POLY 1.5 | P=0.532N P=0.512N P=0.499N | |POLY 6 | P=0.524N P=0.528N P=0.502N | |LOGISTIC REGRESSION| P=0.537N P=0.506N P=0.496N | |COCH-ARM / FISHERS | P=0.551N P=0.478N P=0.492N | |ORDER RESTRICTED | P=0.368N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 3/50 (6%) 1/53 (2%) 1/51 (2%) | |POLY-3 RATE (b) | 3/40.68 1/37.66 1/39.98 | |POLY-3 PERCENT (g) | 7.4% 2.7% 2.5% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 1/27 (4%) | |FIRST INCIDENCE | 491 659 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.391N P=0.329N P=0.311N | |POLY 3 | P=0.376N P=0.333N P=0.311N | |POLY 1.5 | P=0.382N P=0.321N P=0.307N | |POLY 6 | P=0.374N P=0.343N P=0.315N | |LOGISTIC REGRESSION| P=0.404N P=0.268N P=0.293N | |COCH-ARM / FISHERS | P=0.405N P=0.287N P=0.301N | |ORDER RESTRICTED | P=0.189N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 13 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 6/49 (12%) 15/52 (29%) 8/50 (16%) | |POLY-3 RATE (b) | 6/39.12 15/38.93 8/39.67 | |POLY-3 PERCENT (g) | 15.3% 38.5% 20.2% | |TERMINAL (d) | 6/28 (21%) 10/24 (42%) 8/27 (30%) | |FIRST INCIDENCE | 729 (T) 499 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.313N P=0.010 * P=0.350 | |POLY 3 | P=0.340N P=0.016 * P=0.395 | |POLY 1.5 | P=0.345N P=0.018 * P=0.395 | |POLY 6 | P=0.339N P=0.017 * P=0.396 | |LOGISTIC REGRESSION| P=0.298N P=0.014 * P=0.350 | |COCH-ARM / FISHERS | P=0.360N P=0.034 * P=0.403 | |ORDER RESTRICTED | P=0.093 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 7/49 (14%) 16/52 (31%) 8/50 (16%) | |POLY-3 RATE (b) | 7/39.12 16/38.93 8/39.67 | |POLY-3 PERCENT (g) | 17.9% 41.1% 20.2% | |TERMINAL (d) | 7/28 (25%) 11/24 (46%) 8/27 (30%) | |FIRST INCIDENCE | 729 (T) 499 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.218N P=0.011 * P=0.467 | |POLY 3 | P=0.238N P=0.019 * P=0.512 | |POLY 1.5 | P=0.245N P=0.021 * P=0.510 | |POLY 6 | P=0.235N P=0.019 * P=0.515 | |LOGISTIC REGRESSION| P=0.204N P=0.015 * P=0.467 | |COCH-ARM / FISHERS | P=0.263N P=0.040 * P=0.517 | |ORDER RESTRICTED | P=0.128 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 14 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 4/50 (8%) 6/53 (11%) 1/51 (2%) | |POLY-3 RATE (b) | 4/39.59 6/37.45 1/39.98 | |POLY-3 PERCENT (g) | 10.1% 16.0% 2.5% | |TERMINAL (d) | 4/28 (14%) 5/24 (21%) 1/27 (4%) | |FIRST INCIDENCE | 729 (T) 715 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.072N P=0.277 P=0.187N | |POLY 3 | P=0.071N P=0.332 P=0.174N | |POLY 1.5 | P=0.074N P=0.349 P=0.175N | |POLY 6 | P=0.068N P=0.322 P=0.172N | |LOGISTIC REGRESSION| P=0.065N P=0.302 P=0.187N | |COCH-ARM / FISHERS | P=0.082N P=0.408 P=0.175N | |ORDER RESTRICTED | P=0.068N (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 4/50 (8%) 6/53 (11%) 1/51 (2%) | |POLY-3 RATE (b) | 4/39.59 6/37.45 1/39.98 | |POLY-3 PERCENT (g) | 10.1% 16.0% 2.5% | |TERMINAL (d) | 4/28 (14%) 5/24 (21%) 1/27 (4%) | |FIRST INCIDENCE | 729 (T) 715 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.072N P=0.277 P=0.187N | |POLY 3 | P=0.071N P=0.332 P=0.174N | |POLY 1.5 | P=0.074N P=0.349 P=0.175N | |POLY 6 | P=0.068N P=0.322 P=0.172N | |LOGISTIC REGRESSION| P=0.065N P=0.302 P=0.187N | |COCH-ARM / FISHERS | P=0.082N P=0.408 P=0.175N | |ORDER RESTRICTED | P=0.068N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 15 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Uterus | | Schwannoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 1/50 (2%) 2/53 (4%) 2/51 (4%) | |POLY-3 RATE (b) | 1/39.83 2/38.71 2/40.62 | |POLY-3 PERCENT (g) | 2.5% 5.2% 4.9% | |TERMINAL (d) | 0/28 (0%) 0/24 (0%) 0/27 (0%) | |FIRST INCIDENCE | 664 479 636 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.557 P=0.487 P=0.507 | |POLY 3 | P=0.549 P=0.490 P=0.507 | |POLY 1.5 | P=0.545 P=0.495 P=0.505 | |POLY 6 | P=0.555 P=0.489 P=0.511 | |LOGISTIC REGRESSION| P=0.518 P=0.612 P=0.510 | |COCH-ARM / FISHERS | P=0.541 P=0.522 P=0.508 | |ORDER RESTRICTED | P=0.391 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |Uterus | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 2/50 (4%) 4/53 (8%) 0/51 (0%) | |POLY-3 RATE (b) | 2/39.94 4/37.49 0/39.98 | |POLY-3 PERCENT (g) | 5.0% 10.7% 0.0% | |TERMINAL (d) | 1/28 (4%) 2/24 (8%) 0/27 (0%) | |FIRST INCIDENCE | 633 715 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.099N P=0.284 P=0.247N | |POLY 3 | P=0.097N P=0.307 P=0.236N | |POLY 1.5 | P=0.098N P=0.320 P=0.236N | |POLY 6 | P=0.096N P=0.297 P=0.237N | |LOGISTIC REGRESSION| P=0.092N P=0.302 P=0.235N | |COCH-ARM / FISHERS | P=0.102N P=0.367 P=0.243N | |ORDER RESTRICTED | P=0.074N (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 16 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 1/50 (2%) 2/53 (4%) 1/51 (2%) | |POLY-3 RATE (b) | 1/40.00 2/37.81 1/39.98 | |POLY-3 PERCENT (g) | 2.5% 5.3% 2.5% | |TERMINAL (d) | 0/28 (0%) 1/24 (4%) 1/27 (4%) | |FIRST INCIDENCE | 612 612 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.571N P=0.451 P=0.750 | |POLY 3 | P=0.574N P=0.480 P=0.761 | |POLY 1.5 | P=0.575N P=0.489 P=0.760N | |POLY 6 | P=0.574N P=0.475 P=0.760 | |LOGISTIC REGRESSION| P=0.572N P=0.509 P=0.759N | |COCH-ARM / FISHERS | P=0.581N P=0.522 P=0.748N | |ORDER RESTRICTED | P=0.498 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 39/50 (78%) 46/53 (87%) 40/51 (78%) | |POLY-3 RATE (b) | 39/46.95 46/47.73 40/45.69 | |POLY-3 PERCENT (g) | 83.1% 96.4% 87.6% | |TERMINAL (d) | 22/28 (79%) 23/24 (96%) 27/27 (100%) | |FIRST INCIDENCE | 441 254 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.304N P=0.059 P=0.448 | |POLY 3 | P=0.516N P=0.023 * P=0.365 | |POLY 1.5 | P=0.414N P=0.032 * P=0.445 | |POLY 6 | P=0.569 P=0.029 * P=0.254 | |LOGISTIC REGRESSION| P=0.249N P=0.033 * P=0.530 | |COCH-ARM / FISHERS | P=0.371N P=0.180 P=0.574 | |ORDER RESTRICTED | P=0.081 (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96020 TEST: 01 Page 17 Statistical Analysis of Primary Tumors in Rats(SD) - TEF EVALUATION (BINARY MIXTURE; PCB 126 Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 16/50 (32%) 23/53 (43%) 35/51 (69%) | |POLY-3 RATE (b) | 16/43.43 23/42.72 35/44.93 | |POLY-3 PERCENT (g) | 36.8% 53.8% 77.9% | |TERMINAL (d) | 8/28 (29%) 11/24 (46%) 20/27 (74%) | |FIRST INCIDENCE | 484 142 490 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** P=0.078 P<0.001 ** | |POLY 3 | P<0.001 ** P=0.079 P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.095 P<0.001 ** | |POLY 6 | P<0.001 ** P=0.071 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.135 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.161 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 300 NG / 300 NG / 300 NG / | | | 100 UG 300 UG 3000 UG | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | |----------- | | |OVERALL (a) | 44/50 (88%) 50/53 (94%) 47/51 (92%) | |POLY-3 RATE (b) | 44/48.33 50/50.20 47/48.02 | |POLY-3 PERCENT (g) | 91.0% 99.6% 97.9% | |TERMINAL (d) | 25/28 (89%) 24/24 (100%) 27/27 (100%) | |FIRST INCIDENCE | 441 142 458 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.466N P=0.075 P=0.331 | |POLY 3 | P=0.301 P=0.041 * P=0.122 | |POLY 1.5 | P=0.388 P=0.050 P=0.175 | |POLY 6 | P=0.242 P=0.058 P=0.104 | |LOGISTIC REGRESSION| P=0.612N P=0.053 P=0.269 | |COCH-ARM / FISHERS | P=0.515 P=0.216 P=0.358 | |ORDER RESTRICTED | P=0.014 * (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).