TDMS Study 05132-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest TETRAFLUOROETHYLENE DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 TIME: 01:31:41 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES85207 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61596B PATHOLOGIST: P. MELLICK CAS: 116-14-3 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest TETRAFLUOROETHYLENE DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 TIME: 01:31:41 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES85207 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61596B PATHOLOGIST: P. MELLICK CAS: 116-14-3 MICE(B6C3F1) ---------------------------- 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 NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Epididymis Gallbladder Heart Islets, Pancreatic Kidney Larynx Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest TETRAFLUOROETHYLENE DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 TIME: 01:31:41 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES85207 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61596B PATHOLOGIST: P. MELLICK CAS: 116-14-3 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF TETRAFLUOROETHYLENE ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Harderian Gland Adenoma Carcinoma or Adenoma Liver Hemangioma Hemangiosarcoma Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Stomach, Forestomach Squamous Cell Carcinoma or Papilloma Squamous Thyroid Gland: Follicular Cell Adenoma Carcinoma or Adenoma All Organs Hemangioma Hemangiosarcoma Hemangiosarcoma or Hemangioma Histiocytic Sarcoma Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest TETRAFLUOROETHYLENE DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 TIME: 01:31:41 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES85207 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61596B PATHOLOGIST: P. MELLICK CAS: 116-14-3 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF TETRAFLUOROETHYLENE ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Harderian Gland Adenoma Carcinoma or Adenoma Liver Hemangioma Hemangiosarcoma Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Skin Sarcoma All Organs Hemangioma Hemangiosarcoma Hemangiosarcoma or Hemangioma Histiocytic Sarcoma Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAFLUOROETHYLENE TERMINAL SACRIFICE AT 96 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 312 PPM 625 PPM 1250 PPM | CONTROL 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/58 (10%) 9/58 (16%) 4/58 (7%) 5/58 (9%) | 3/58 (5%) 3/58 (5%) 0/57 (0%) 8/58 (14%) | |ADJUSTED (b) | 14.1% 37.7% 13.4% 26.1% | 7.2% 39.7% 0.0% 63.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/10 (20%) 0/10 (0%) 1/10 (10%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 2/10 (20%) | |TERMINAL (d) | 4/38 (11%) 2/11 (18%) 0/2 (0%) 0/1 (0%) | 2/36 (6%) 1/4 (25%) 0/6 (0%) 2/4 (50%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 447 456 (I) | 457 (I) 639 --- 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.092 P=0.020 * P=0.220 P=0.086 | P<0.001 ** P=0.090 P=0.341N P<0.001 ** | |INCIDENTAL TUMOR | P=0.264N P=0.294 P=0.352N P=0.594N | P=0.004 ** P=0.483 P=0.341N P=0.028 * | |LOGISTIC REGRESSION | P=0.326N P=0.228 P=0.418N P=0.520N | P=0.017 * P=0.556 P=0.125N P=0.086 | |COCHRAN-ARMITAGE | P=0.280N | P=0.038 * | |FISHER EXACT | P=0.291 P=0.371N P=0.500N | P=0.660N P=0.125N P=0.102 | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 7/58 (12%) 10/58 (17%) 4/58 (7%) 6/58 (10%) | 3/58 (5%) 3/58 (5%) 0/57 (0%) 8/58 (14%) | |ADJUSTED (b) | 16.1% 44.6% 13.4% 28.0% | 7.2% 39.7% 0.0% 63.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/10 (20%) 0/10 (0%) 1/10 (10%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 2/10 (20%) | |TERMINAL (d) | 4/38 (11%) 3/11 (27%) 0/2 (0%) 0/1 (0%) | 2/36 (6%) 1/4 (25%) 0/6 (0%) 2/4 (50%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 447 456 (I) | 457 (I) 639 --- 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.066 P=0.014 * P=0.302 P=0.084 | P<0.001 ** P=0.090 P=0.341N P<0.001 ** | |INCIDENTAL TUMOR | P=0.279N P=0.309 P=0.125N P=0.380N | P=0.004 ** P=0.483 P=0.341N P=0.028 * | |LOGISTIC REGRESSION | P=0.345N P=0.214 P=0.303N P=0.508N | P=0.017 * P=0.556 P=0.125N P=0.086 | |COCHRAN-ARMITAGE | P=0.278N | P=0.038 * | |FISHER EXACT | P=0.300 P=0.264N P=0.500N | P=0.660N P=0.125N P=0.102 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAFLUOROETHYLENE TERMINAL SACRIFICE AT 96 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 312 PPM 625 PPM 1250 PPM | CONTROL 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 10/58 (17%) 5/58 (9%) 2/58 (3%) | 0/58 (0%) 5/58 (9%) 2/57 (4%) 1/57 (2%) | |ADJUSTED (b) | 0.0% 53.2% 60.1% 12.3% | 0.0% 37.1% 13.0% 25.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/38 (0%) 4/11 (36%) 1/2 (50%) 0/1 (0%) | 0/36 (0%) 0/4 (0%) 0/6 (0%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | --- 590 548 599 | --- 541 569 667 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.012 * P<0.001 ** P<0.001 ** P=0.066 | P=0.145 P<0.001 ** P=0.084 P=0.091 | |INCIDENTAL TUMOR | P=0.370N P<0.001 ** P=0.067 P=0.715 | P=0.458N P=0.306 P=0.583 P=0.091 | |LOGISTIC REGRESSION | P=0.289N P<0.001 ** P=0.010 ** P=0.151 | P=0.461 P=0.016 * P=0.184 P=0.091 | |COCHRAN-ARMITAGE | P=0.449N | P=0.508N | |FISHER EXACT | P<0.001 ** P=0.029 * P=0.248 | P=0.029 * P=0.243 P=0.496 | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 21/58 (36%) 27/58 (47%) 40/58 (69%) | 0/58 (0%) 28/58 (48%) 27/57 (47%) 34/57 (60%) | |ADJUSTED (b) | 0.0% 89.3% 95.6% 100.0% | 0.0% 100.0% 95.5% 93.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/38 (0%) 9/11 (82%) 1/2 (50%) 1/1 (100%) | 0/36 (0%) 4/4 (100%) 5/6 (83%) 2/4 (50%) | |FIRST INCIDENCE (DAYS) | --- 522 497 401 | --- 457 (I) 481 468 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAFLUOROETHYLENE TERMINAL SACRIFICE AT 96 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 312 PPM 625 PPM 1250 PPM | CONTROL 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 23/58 (40%) 19/58 (33%) 16/58 (28%) 21/58 (36%) | 15/58 (26%) 19/58 (33%) 23/57 (40%) 17/57 (30%) | |ADJUSTED (b) | 48.0% 84.1% 72.7% 71.7% | 37.2% 89.5% 93.6% 77.7% | |INTERIM SACRIFICE 1 (c)| 6/10 (60%) 2/10 (20%) 4/10 (40%) 1/10 (10%) | 0/10 (0%) 2/10 (20%) 3/10 (30%) 2/10 (20%) | |TERMINAL (d) | 15/38 (39%) 8/11 (73%) 1/2 (50%) 0/1 (0%) | 11/36 (31%) 3/4 (75%) 5/6 (83%) 2/4 (50%) | |FIRST INCIDENCE (DAYS) | 452 456 (I) 456 (I) 401 | 595 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.010 ** P=0.009 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.292 P=0.363 P=0.455N P=0.295N | P=0.146 P=0.165 P=0.026 * P=0.302 | |LOGISTIC REGRESSION | P=0.360 P=0.543N P=0.092N P=0.548N | P=0.071 P=0.068 P=0.005 ** P=0.080 | |COCHRAN-ARMITAGE | P=0.417N | P=0.376 | |FISHER EXACT | P=0.281N P=0.119N P=0.424N | P=0.270 P=0.073 P=0.395 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/58 (22%) 24/58 (41%) 35/58 (60%) 28/58 (48%) | 4/58 (7%) 31/58 (53%) 23/57 (40%) 23/57 (40%) | |ADJUSTED (b) | 27.0% 66.1% 94.4% 100.0% | 10.8% 95.3% 87.9% 74.0% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 4/10 (40%) 2/10 (20%) 2/10 (20%) | 0/10 (0%) 3/10 (30%) 1/10 (10%) 3/10 (30%) | |TERMINAL (d) | 5/38 (13%) 3/11 (27%) 1/2 (50%) 1/1 (100%) | 3/36 (8%) 3/4 (75%) 4/6 (67%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 363 315 | 660 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.263 P=0.287 P=0.270 P=0.593N | P=0.037 * P<0.001 ** P<0.001 ** P=0.003 ** | |LOGISTIC REGRESSION | P=0.004 ** P=0.253 P<0.001 ** P=0.004 ** | P=0.017 * P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.004 ** | P=0.006 ** | |FISHER EXACT | P=0.023 * P<0.001 ** P=0.003 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAFLUOROETHYLENE TERMINAL SACRIFICE AT 96 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 312 PPM 625 PPM 1250 PPM | CONTROL 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 32/58 (55%) 40/58 (69%) 45/58 (78%) 38/58 (66%) | 17/58 (29%) 38/58 (66%) 33/57 (58%) 33/57 (58%) | |ADJUSTED (b) | 61.7% 97.2% 100.0% 100.0% | 42.2% 100.0% 95.9% 89.7% | |INTERIM SACRIFICE 1 (c)| 6/10 (60%) 6/10 (60%) 6/10 (60%) 3/10 (30%) | 0/10 (0%) 5/10 (50%) 4/10 (40%) 5/10 (50%) | |TERMINAL (d) | 19/38 (50%) 10/11 (91%) 2/2 (100%) 1/1 (100%) | 13/36 (36%) 4/4 (100%) 5/6 (83%) 2/4 (50%) | |FIRST INCIDENCE (DAYS) | 452 456 (I) 363 315 | 595 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.363 P=0.080 P=0.241 P=0.335N | P=0.019 * P<0.001 ** P=0.002 ** P=0.007 ** | |LOGISTIC REGRESSION | P=0.095 P=0.033 * P=0.055 P=0.139 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.179 | P=0.014 * | |FISHER EXACT | P=0.090 P=0.009 ** P=0.171 | P<0.001 ** P=0.002 ** P=0.002 ** | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 32/58 (55%) 40/58 (69%) 45/58 (78%) 38/58 (66%) | 17/58 (29%) 38/58 (66%) 33/57 (58%) 33/57 (58%) | |ADJUSTED (b) | 61.7% 97.2% 100.0% 100.0% | 42.2% 100.0% 95.9% 89.7% | |INTERIM SACRIFICE 1 (c)| 6/10 (60%) 6/10 (60%) 6/10 (60%) 3/10 (30%) | 0/10 (0%) 5/10 (50%) 4/10 (40%) 5/10 (50%) | |TERMINAL (d) | 19/38 (50%) 10/11 (91%) 2/2 (100%) 1/1 (100%) | 13/36 (36%) 4/4 (100%) 5/6 (83%) 2/4 (50%) | |FIRST INCIDENCE (DAYS) | 452 456 (I) 363 315 | 595 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.363 P=0.080 P=0.241 P=0.335N | P=0.019 * P<0.001 ** P=0.002 ** P=0.007 ** | |LOGISTIC REGRESSION | P=0.095 P=0.033 * P=0.055 P=0.139 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.179 | P=0.014 * | |FISHER EXACT | P=0.090 P=0.009 ** P=0.171 | P<0.001 ** P=0.002 ** P=0.002 ** | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAFLUOROETHYLENE TERMINAL SACRIFICE AT 96 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 312 PPM 625 PPM 1250 PPM | CONTROL 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/58 (19%) 8/58 (14%) 13/58 (22%) 6/58 (10%) | 6/58 (10%) 1/58 (2%) 7/57 (12%) 3/57 (5%) | |ADJUSTED (b) | 26.0% 41.7% 76.4% 24.6% | 16.7% 1.9% 41.7% 30.2% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 8/38 (21%) 3/11 (27%) 1/2 (50%) 0/1 (0%) | 6/36 (17%) 0/4 (0%) 2/6 (33%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | 456 (I) 522 433 456 (I) | 667 (T) 457 (I) 457 (I) 509 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.007 ** P=0.139 P<0.001 ** P=0.065 | P=0.086 P=0.681N P=0.015 * P=0.162 | |INCIDENTAL TUMOR | P=0.319N P=0.533N P=0.451 P=0.389N | P=0.224 P=0.681N P=0.086 P=0.391 | |LOGISTIC REGRESSION | P=0.419N P=0.572N P=0.225 P=0.327N | P=0.529N P=0.122N P=0.341 P=0.639 | |COCHRAN-ARMITAGE | P=0.184N | P=0.395N | |FISHER EXACT | P=0.308N P=0.410 P=0.147N | P=0.057N P=0.487 P=0.254N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/58 (3%) 5/58 (9%) 3/58 (5%) 2/58 (3%) | 0/58 (0%) 1/58 (2%) 2/57 (4%) 1/57 (2%) | |ADJUSTED (b) | 5.3% 28.4% 51.9% 20.0% | 0.0% 2.5% 14.5% 5.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/38 (5%) 2/11 (18%) 0/2 (0%) 0/1 (0%) | 0/36 (0%) 0/4 (0%) 0/6 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 666 (T) 537 548 606 | --- 541 615 597 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.014 * P=0.015 * P=0.004 ** P=0.043 * | P=0.124 P=0.477 P=0.063 P=0.342 | |INCIDENTAL TUMOR | P=0.538 P=0.108 P=0.386 P=0.730 | P=0.528 P=0.718 P=0.583 P=0.780 | |LOGISTIC REGRESSION | P=0.294 P=0.077 P=0.127 P=0.293 | P=0.287 P=0.540 P=0.132 P=0.468 | |COCHRAN-ARMITAGE | P=0.420N | P=0.361 | |FISHER EXACT | P=0.219 P=0.500 P=0.691N | P=0.500 P=0.243 P=0.496 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAFLUOROETHYLENE TERMINAL SACRIFICE AT 96 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 312 PPM 625 PPM 1250 PPM | CONTROL 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/58 (22%) 13/58 (22%) 16/58 (28%) 8/58 (14%) | 6/58 (10%) 2/58 (3%) 9/57 (16%) 4/57 (7%) | |ADJUSTED (b) | 30.9% 61.8% 88.7% 39.7% | 16.7% 4.3% 50.1% 33.8% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 10/38 (26%) 5/11 (45%) 1/2 (50%) 0/1 (0%) | 6/36 (17%) 0/4 (0%) 2/6 (33%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | 456 (I) 522 433 456 (I) | 667 (T) 457 (I) 457 (I) 509 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.008 ** P<0.001 ** P=0.008 ** | P=0.028 * P=0.529 P=0.002 ** P=0.064 | |INCIDENTAL TUMOR | P=0.366N P=0.298 P=0.278 P=0.452N | P=0.205 P=0.643 P=0.062 P=0.327 | |LOGISTIC REGRESSION | P=0.531N P=0.238 P=0.088 P=0.489N | P=0.438 P=0.209N P=0.137 P=0.480 | |COCHRAN-ARMITAGE | P=0.153N | P=0.530N | |FISHER EXACT | P=0.588N P=0.334 P=0.167N | P=0.136N P=0.278 P=0.382N | |=================================================================================================================================| | | |Mesentery | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/58 (0%) 0/58 (0%) 0/58 (0%) 1/58 (2%) | 0/58 (0%) 2/58 (3%) 0/57 (0%) 0/58 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 3.7% | 0.0% 7.6% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/38 (0%) 0/11 (0%) 0/2 (0%) 0/1 (0%) | 0/36 (0%) 0/4 (0%) 0/6 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 565 | --- 541 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.157 (e) (e) P=0.403 | P=0.569N P=0.158 (e) (e) | |INCIDENTAL TUMOR | P=0.346 (e) (e) P=0.877 | P=0.253N P=0.516 (e) (e) | |LOGISTIC REGRESSION | P=0.185 (e) (e) P=0.512 | P=0.429N P=0.236 (e) (e) | |COCHRAN-ARMITAGE | P=0.198 | P=0.405N | |FISHER EXACT | (e) (e) P=0.500 | P=0.248 (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAFLUOROETHYLENE TERMINAL SACRIFICE AT 96 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 312 PPM 625 PPM 1250 PPM | CONTROL 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/57 (4%) 0/57 (0%) 0/55 (0%) 2/56 (4%) | |ADJUSTED (b) | | 5.1% 0.0% 0.0% 12.3% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 1/36 (3%) 0/4 (0%) 0/6 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | | 603 --- --- 587 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.173 P=0.484N P=0.505N P=0.261 | |INCIDENTAL TUMOR | | P=0.556 P=0.234N P=0.240N P=0.491N | |LOGISTIC REGRESSION | | P=0.353 P=0.302N P=0.333N P=0.559 | |COCHRAN-ARMITAGE | | P=0.493 | |FISHER EXACT | | P=0.248N P=0.257N P=0.684 | |=================================================================================================================================| | | |Ovary | | Luteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/57 (4%) 0/57 (0%) 0/55 (0%) 0/56 (0%) | |ADJUSTED (b) | | 5.6% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 2/36 (6%) 0/4 (0%) 0/6 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | | 667 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.434N P=0.763N P=0.669N P=0.763N | |INCIDENTAL TUMOR | | P=0.434N P=0.763N P=0.669N P=0.763N | |LOGISTIC REGRESSION | | P=0.434N P=0.763N P=0.669N P=0.763N | |COCHRAN-ARMITAGE | | P=0.118N | |FISHER EXACT | | P=0.248N P=0.257N P=0.252N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAFLUOROETHYLENE TERMINAL SACRIFICE AT 96 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 312 PPM 625 PPM 1250 PPM | CONTROL 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/57 (0%) 0/53 (0%) 0/53 (0%) 0/54 (0%) | 4/56 (7%) 5/55 (9%) 2/54 (4%) 6/56 (11%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 10.6% 55.3% 18.2% 53.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/37 (0%) 0/11 (0%) 0/2 (0%) 0/1 (0%) | 3/36 (8%) 2/4 (50%) 0/6 (0%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 617 585 652 565 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.002 ** P=0.018 * P=0.374 P=0.002 ** | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.173 P=0.209 P=0.315N P=0.395 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.053 P=0.222 P=0.645 P=0.079 | |COCHRAN-ARMITAGE | (e) | P=0.353 | |FISHER EXACT | (e) (e) (e) | P=0.488 P=0.357N P=0.371 | |=================================================================================================================================| | | |Skin | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/58 (0%) 0/58 (0%) 0/58 (0%) 0/58 (0%) | 0/58 (0%) 0/58 (0%) 0/57 (0%) 2/58 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 8.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/38 (0%) 0/11 (0%) 0/2 (0%) 0/1 (0%) | 0/36 (0%) 0/4 (0%) 0/6 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- --- 366 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.022 * (e) (e) P=0.136 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.082 (e) (e) P=0.526 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.077 (e) (e) P=0.335 | |COCHRAN-ARMITAGE | (e) | P=0.047 * | |FISHER EXACT | (e) (e) (e) | (e) (e) P=0.248 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAFLUOROETHYLENE TERMINAL SACRIFICE AT 96 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 312 PPM 625 PPM 1250 PPM | CONTROL 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/58 (3%) 0/58 (0%) 0/56 (0%) 0/56 (0%) | 0/58 (0%) 0/58 (0%) 0/56 (0%) 0/57 (0%) | |ADJUSTED (b) | 5.3% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/38 (5%) 0/11 (0%) 0/2 (0%) 0/1 (0%) | 0/36 (0%) 0/4 (0%) 0/6 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 666 (T) --- --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.604N P=0.535N P=0.906N P=0.979N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.604N P=0.535N P=0.906N P=0.979N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.604N P=0.535N P=0.906N P=0.979N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.119N | (e) | |FISHER EXACT | P=0.248N P=0.257N P=0.257N | (e) (e) (e) | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/58 (3%) 1/58 (2%) 1/58 (2%) 2/58 (3%) | 0/58 (0%) 1/58 (2%) 1/57 (2%) 0/58 (0%) | |ADJUSTED (b) | 5.3% 2.9% 2.0% 100.0% | 0.0% 6.3% 7.1% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/38 (5%) 0/11 (0%) 0/2 (0%) 1/1 (100%) | 0/36 (0%) 0/4 (0%) 0/6 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 666 (T) 541 456 (I) 610 | --- 639 636 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.056 P=0.693 P=0.568 P=0.006 ** | P=0.503 P=0.333 P=0.307 (e) | |INCIDENTAL TUMOR | P=0.163 P=0.654N P=0.568 P=0.098 | P=0.403N P=0.744 P=0.727 (e) | |LOGISTIC REGRESSION | P=0.406 P=0.612N P=0.582N P=0.133 | P=0.634 P=0.416 P=0.402 (e) | |COCHRAN-ARMITAGE | P=0.556 | P=0.595N | |FISHER EXACT | P=0.500N P=0.500N P=0.691N | P=0.500 P=0.496 (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAFLUOROETHYLENE TERMINAL SACRIFICE AT 96 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 312 PPM 625 PPM 1250 PPM | CONTROL 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/58 (3%) 1/58 (2%) 1/58 (2%) 1/58 (2%) | 0/58 (0%) 1/58 (2%) 1/57 (2%) 0/58 (0%) | |ADJUSTED (b) | 5.3% 2.9% 2.0% 100.0% | 0.0% 6.3% 7.1% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/38 (5%) 0/11 (0%) 0/2 (0%) 1/1 (100%) | 0/36 (0%) 0/4 (0%) 0/6 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 666 (T) 541 456 (I) 666 (T) | --- 639 636 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.272 P=0.693 P=0.568 P=0.056 | P=0.503 P=0.333 P=0.307 (e) | |INCIDENTAL TUMOR | P=0.318 P=0.654N P=0.568 P=0.056 | P=0.403N P=0.744 P=0.727 (e) | |LOGISTIC REGRESSION | P=0.535N P=0.612N P=0.582N P=0.056 | P=0.634 P=0.416 P=0.402 (e) | |COCHRAN-ARMITAGE | P=0.409N | P=0.595N | |FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.500 P=0.496 (e) | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 3/58 (5%) 0/57 (0%) 0/57 (0%) | 3/58 (5%) 1/58 (2%) 1/56 (2%) 1/56 (2%) | |ADJUSTED (b) | 0.0% 23.3% 0.0% 0.0% | 7.2% 3.7% 5.0% 5.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/38 (0%) 2/11 (18%) 0/2 (0%) 0/1 (0%) | 2/36 (6%) 0/4 (0%) 0/6 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- 637 --- --- | 457 (I) 614 615 597 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.345 P=0.008 ** (e) (e) | P=0.586 P=0.687N P=0.674N P=0.729N | |INCIDENTAL TUMOR | P=0.684N P=0.039 * (e) (e) | P=0.303N P=0.513N P=0.478N P=0.500N | |LOGISTIC REGRESSION | P=0.588 P=0.020 * (e) (e) | P=0.324N P=0.320N P=0.345N P=0.356N | |COCHRAN-ARMITAGE | P=0.316N | P=0.254N | |FISHER EXACT | P=0.122 (e) (e) | P=0.309N P=0.323N P=0.323N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAFLUOROETHYLENE TERMINAL SACRIFICE AT 96 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 312 PPM 625 PPM 1250 PPM | CONTROL 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 4/58 (7%) 0/57 (0%) 0/57 (0%) | 3/58 (5%) 1/58 (2%) 1/56 (2%) 1/56 (2%) | |ADJUSTED (b) | 0.0% 31.8% 0.0% 0.0% | 7.2% 3.7% 5.0% 5.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/38 (0%) 3/11 (27%) 0/2 (0%) 0/1 (0%) | 2/36 (6%) 0/4 (0%) 0/6 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- 637 --- --- | 457 (I) 614 615 597 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.228 P=0.001 ** (e) (e) | P=0.586 P=0.687N P=0.674N P=0.729N | |INCIDENTAL TUMOR | P=0.616 P=0.006 ** (e) (e) | P=0.303N P=0.513N P=0.478N P=0.500N | |LOGISTIC REGRESSION | P=0.477 P=0.004 ** (e) (e) | P=0.324N P=0.320N P=0.345N P=0.356N | |COCHRAN-ARMITAGE | P=0.252N | P=0.254N | |FISHER EXACT | P=0.059 (e) (e) | P=0.309N P=0.323N P=0.323N | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/58 (0%) 11/58 (19%) 6/58 (10%) 3/58 (5%) | 0/58 (0%) 5/58 (9%) 4/57 (7%) 1/58 (2%) | |ADJUSTED (b) | 0.0% 54.7% 61.3% 26.9% | 0.0% 37.1% 33.5% 25.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/38 (0%) 4/11 (36%) 1/2 (50%) 0/1 (0%) | 0/36 (0%) 0/4 (0%) 1/6 (17%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | --- 566 541 599 | --- 541 569 667 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.005 ** P<0.001 ** P<0.001 ** P=0.005 ** | P=0.054 P<0.001 ** P=0.002 ** P=0.091 | |INCIDENTAL TUMOR | P=0.382N P<0.001 ** P=0.062 P=0.598 | P=0.570 P=0.306 P=0.108 P=0.091 | |LOGISTIC REGRESSION | P=0.310N P<0.001 ** P=0.006 ** P=0.040 * | P=0.307 P=0.016 * P=0.015 * P=0.091 | |COCHRAN-ARMITAGE | P=0.562N | P=0.544N | |FISHER EXACT | P<0.001 ** P=0.014 * P=0.122 | P=0.029 * P=0.057 P=0.500 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAFLUOROETHYLENE TERMINAL SACRIFICE AT 96 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 312 PPM 625 PPM 1250 PPM | CONTROL 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/58 (3%) 21/58 (36%) 27/58 (47%) 40/58 (69%) | 0/58 (0%) 28/58 (48%) 27/57 (47%) 34/58 (59%) | |ADJUSTED (b) | 5.3% 89.3% 95.6% 100.0% | 0.0% 100.0% 95.5% 93.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/38 (5%) 9/11 (82%) 1/2 (50%) 1/1 (100%) | 0/36 (0%) 4/4 (100%) 5/6 (83%) 2/4 (50%) | |FIRST INCIDENCE (DAYS) | 666 (T) 522 497 401 | --- 457 (I) 481 468 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/58 (3%) 27/58 (47%) 30/58 (52%) 41/58 (71%) | 0/58 (0%) 32/58 (55%) 28/57 (49%) 35/58 (60%) | |ADJUSTED (b) | 5.3% 95.8% 100.0% 100.0% | 0.0% 100.0% 96.0% 96.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/38 (5%) 10/11 (91%) 2/2 (100%) 1/1 (100%) | 0/36 (0%) 4/4 (100%) 5/6 (83%) 3/4 (75%) | |FIRST INCIDENCE (DAYS) | 666 (T) 522 497 401 | --- 457 (I) 481 468 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAFLUOROETHYLENE TERMINAL SACRIFICE AT 96 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 312 PPM 625 PPM 1250 PPM | CONTROL 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/58 (0%) 12/58 (21%) 7/58 (12%) 8/58 (14%) | 1/58 (2%) 21/58 (36%) 19/57 (33%) 18/58 (31%) | |ADJUSTED (b) | 0.0% 47.8% 34.5% 66.4% | 1.7% 77.4% 51.1% 78.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/38 (0%) 1/11 (9%) 0/2 (0%) 0/1 (0%) | 0/36 (0%) 1/4 (25%) 0/6 (0%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | --- 513 415 456 (I) | 400 429 457 (I) 484 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.562N P=0.016 * P=0.204 P=0.103 | P=0.135 P=0.007 ** P=0.016 * P=0.010 ** | |LOGISTIC REGRESSION | P=0.035 * P<0.001 ** P=0.016 * P=0.002 ** | P=0.037 * P<0.001 ** P=0.003 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.089 | P=0.003 ** | |FISHER EXACT | P<0.001 ** P=0.006 ** P=0.003 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/58 (3%) 1/58 (2%) 0/58 (0%) 1/58 (2%) | 5/58 (9%) 3/58 (5%) 0/57 (0%) 3/58 (5%) | |ADJUSTED (b) | 5.1% 4.8% 0.0% 12.5% | 12.8% 18.0% 0.0% 31.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 1/38 (3%) 0/11 (0%) 0/2 (0%) 0/1 (0%) | 3/36 (8%) 0/4 (0%) 0/6 (0%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | 650 614 --- 623 | 595 530 --- 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.266 P=0.651 P=0.840N P=0.281 | P=0.276 P=0.348 P=0.250N P=0.229 | |INCIDENTAL TUMOR | P=0.346N P=0.393N P=0.338N P=0.561N | P=0.409N P=0.227N P=0.042N* P=0.572N | |LOGISTIC REGRESSION | P=0.602 P=0.689N P=0.618N P=0.667 | P=0.436N P=0.514N P=0.088N P=0.582N | |COCHRAN-ARMITAGE | P=0.367N | P=0.250N | |FISHER EXACT | P=0.500N P=0.248N P=0.500N | P=0.358N P=0.030N* P=0.358N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAFLUOROETHYLENE TERMINAL SACRIFICE AT 96 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 312 PPM 625 PPM 1250 PPM | CONTROL 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 32/58 (55%) 34/58 (59%) 31/58 (53%) 30/58 (52%) | 29/58 (50%) 27/58 (47%) 30/57 (53%) 33/58 (57%) | |ADJUSTED (b) | 65.5% 100.0% 100.0% 100.0% | 65.4% 100.0% 95.4% 100.0% | |INTERIM SACRIFICE 1 (c)| 6/10 (60%) 4/10 (40%) 4/10 (40%) 3/10 (30%) | 2/10 (20%) 3/10 (30%) 4/10 (40%) 4/10 (40%) | |TERMINAL (d) | 22/38 (58%) 11/11 (100%) 2/2 (100%) 1/1 (100%) | 21/36 (58%) 4/4 (100%) 5/6 (83%) 4/4 (100%) | |FIRST INCIDENCE (DAYS) | 452 456 (I) 433 401 | 457 (I) 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.427 P=0.081 P=0.431 P=0.597N | P=0.014 * P=0.331 P=0.210 P=0.082 | |LOGISTIC REGRESSION | P=0.355 P=0.129 P=0.525 P=0.447 | P=0.008 ** P=0.350 P=0.118 P=0.016 * | |COCHRAN-ARMITAGE | P=0.320N | P=0.190 | |FISHER EXACT | P=0.426 P=0.500N P=0.426N | P=0.426N P=0.462 P=0.288 | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 18/58 (31%) 43/58 (74%) 49/58 (84%) 50/58 (86%) | 14/58 (24%) 49/58 (84%) 46/57 (81%) 50/58 (86%) | |ADJUSTED (b) | 36.9% 95.3% 100.0% 100.0% | 32.1% 100.0% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 4/10 (40%) 2/10 (20%) 4/10 (40%) | 0/10 (0%) 3/10 (30%) 1/10 (10%) 4/10 (40%) | |TERMINAL (d) | 8/38 (21%) 9/11 (82%) 2/2 (100%) 1/1 (100%) | 7/36 (19%) 4/4 (100%) 6/6 (100%) 4/4 (100%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 363 315 | 400 429 457 (I) 366 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P=0.025 * P=0.011 * | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAFLUOROETHYLENE TERMINAL SACRIFICE AT 96 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 312 PPM 625 PPM 1250 PPM | CONTROL 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 43/58 (74%) 51/58 (88%) 54/58 (93%) 52/58 (90%) | 36/58 (62%) 53/58 (91%) 50/57 (88%) 52/58 (90%) | |ADJUSTED (b) | 80.8% 100.0% 100.0% 100.0% | 77.9% 100.0% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 6/10 (60%) 7/10 (70%) 6/10 (60%) 6/10 (60%) | 2/10 (20%) 6/10 (60%) 5/10 (50%) 6/10 (60%) | |TERMINAL (d) | 28/38 (74%) 11/11 (100%) 2/2 (100%) 1/1 (100%) | 26/36 (72%) 4/4 (100%) 6/6 (100%) 4/4 (100%) | |FIRST INCIDENCE (DAYS) | 452 456 (I) 363 315 | 400 429 457 (I) 366 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.095 P=0.050 P=0.262 P=0.306 | P<0.001 ** P<0.001 ** P=0.002 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.003 ** P=0.004 ** P=0.003 ** P=0.003 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.020 * | P=0.001 ** | |FISHER EXACT | P=0.048 * P=0.005 ** P=0.026 * | P<0.001 ** P=0.001 ** P<0.001 ** | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 456 Female interim sacrifices(days): 457 (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. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's 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. (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).