TDMS Study 05127-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason BARIUM CHLORIDE DIHYDRATE DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 TIME: 19:05:35 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES55115 ROUTE: DOSED WATER NTP C#: C61074 PATHOLOGIST: A. RUSSFIELD S. EUSTIS CAS: 10326279 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason BARIUM CHLORIDE DIHYDRATE DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 TIME: 19:05:35 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES55115 ROUTE: DOSED WATER NTP C#: C61074 PATHOLOGIST: A. RUSSFIELD S. EUSTIS CAS: 10326279 RATS(FISCHER344) ---------------------------- 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 Gland Bone Marrow Brain Clitoral Gland Epididymis Heart Islets, Pancreatic Kidney 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: Mason BARIUM CHLORIDE DIHYDRATE DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 TIME: 19:05:35 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES55115 ROUTE: DOSED WATER NTP C#: C61074 PATHOLOGIST: A. RUSSFIELD S. EUSTIS CAS: 10326279 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF BARIUM CHLORIDE DIHYDRATE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Mammary Gland Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Skin Fibroma Uterus Polyp Stromal All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 1/60 (2%) 3/59 (5%) 1/59 (2%) 0/60 (0%) | |ADJUSTED (b) | 4.3% 0.0% 0.0% 3.0% | 3.2% 8.3% 2.6% 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) | 0/22 (0%) 0/31 (0%) 0/29 (0%) 1/33 (3%) | 1/31 (3%) 3/36 (8%) 1/38 (3%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 723 --- --- 730 (T) | 737 (T) 737 (T) 737 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.632 P=0.428N P=0.447N P=0.669N | P=0.168N P=0.359 P=0.716N P=0.494N | |INCIDENTAL TUMOR | P=0.515 P=0.628N P=0.576N P=0.700 | P=0.168N P=0.359 P=0.716N P=0.494N | |LOGISTIC REGRESSION | P=0.603 P=0.479N P=0.473N P=0.727N | P=0.168N P=0.359 P=0.716N P=0.494N | |COCHRAN-ARMITAGE | P=0.577 | P=0.176N | |FISHER EXACT | P=0.496N P=0.496N P=0.748N | P=0.303 P=0.748 P=0.500N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/59 (19%) 9/60 (15%) 11/59 (19%) 6/60 (10%) | 2/60 (3%) 4/59 (7%) 2/59 (3%) 1/60 (2%) | |ADJUSTED (b) | 40.2% 27.0% 34.0% 18.2% | 6.5% 10.3% 5.3% 2.4% | |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) | 7/22 (32%) 7/31 (23%) 9/29 (31%) 6/33 (18%) | 2/31 (6%) 3/36 (8%) 2/38 (5%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 691 673 452 (I) 730 (T) | 737 (T) 647 737 (T) 669 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.046N* P=0.180N P=0.347N P=0.033N* | P=0.233N P=0.413 P=0.620N P=0.474N | |INCIDENTAL TUMOR | P=0.104N P=0.346N P=0.493N P=0.098N | P=0.229N P=0.414 P=0.620N P=0.456N | |LOGISTIC REGRESSION | P=0.117N P=0.319N P=0.538N P=0.085N | P=0.227N P=0.401 P=0.620N P=0.473N | |COCHRAN-ARMITAGE | P=0.145N | P=0.241N | |FISHER EXACT | P=0.387N P=0.593N P=0.139N | P=0.332 P=0.684 P=0.500N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/59 (3%) 2/60 (3%) 2/59 (3%) 0/60 (0%) | 0/60 (0%) 0/59 (0%) 0/59 (0%) 1/60 (2%) | |ADJUSTED (b) | 6.7% 5.6% 6.9% 0.0% | 0.0% 0.0% 0.0% 3.1% | |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) | 1/22 (5%) 1/31 (3%) 2/29 (7%) 0/33 (0%) | 0/31 (0%) 0/36 (0%) 0/38 (0%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 605 653 730 (T) --- | --- --- --- 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.124N P=0.638N P=0.618N P=0.200N | P=0.186 (e) (e) P=0.506 | |INCIDENTAL TUMOR | P=0.130N P=0.654N P=0.618N P=0.130N | P=0.186 (e) (e) P=0.506 | |LOGISTIC REGRESSION | P=0.156N P=0.684N P=0.681N P=0.234N | P=0.186 (e) (e) P=0.506 | |COCHRAN-ARMITAGE | P=0.160N | P=0.195 | |FISHER EXACT | P=0.684N P=0.691N P=0.244N | (e) (e) P=0.500 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/59 (22%) 11/60 (18%) 13/59 (22%) 6/60 (10%) | 2/60 (3%) 5/59 (8%) 2/59 (3%) 2/60 (3%) | |ADJUSTED (b) | 45.5% 31.8% 40.6% 18.2% | 6.5% 13.0% 5.3% 5.5% | |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) | 8/22 (36%) 8/31 (26%) 11/29 (38%) 6/33 (18%) | 2/31 (6%) 4/36 (11%) 2/38 (5%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 605 653 452 (I) 730 (T) | 737 (T) 647 737 (T) 669 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.014N* P=0.181N P=0.321N P=0.011N* | P=0.355N P=0.285 P=0.620N P=0.671N | |INCIDENTAL TUMOR | P=0.037N* P=0.336N P=0.455N P=0.028N* | P=0.347N P=0.286 P=0.620N P=0.657N | |LOGISTIC REGRESSION | P=0.048N* P=0.347N P=0.531N P=0.042N* | P=0.344N P=0.277 P=0.620N P=0.665N | |COCHRAN-ARMITAGE | P=0.065N | P=0.362N | |FISHER EXACT | P=0.392N P=0.588N P=0.061N | P=0.213 P=0.684 P=0.691N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 2/60 (3%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 3.0% | 5.3% 0.0% 1.9% 1.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 0/22 (0%) 0/31 (0%) 0/29 (0%) 1/33 (3%) | 0/31 (0%) 0/36 (0%) 0/39 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 730 (T) | 652 --- 458 (I) 458 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.227 (e) (e) P=0.581 | P=0.524N P=0.196N P=0.479N P=0.479N | |INCIDENTAL TUMOR | P=0.227 (e) (e) P=0.581 | P=0.506N P=0.166N P=0.708 P=0.426N | |LOGISTIC REGRESSION | P=0.227 (e) (e) P=0.581 | P=0.554N P=0.238N P=0.508N P=0.533N | |COCHRAN-ARMITAGE | P=0.194 | P=0.527N | |FISHER EXACT | (e) (e) P=0.500 | P=0.248N P=0.500N P=0.500N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 2/59 (3%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 1/59 (2%) 0/60 (0%) 2/57 (4%) | |ADJUSTED (b) | 4.5% 6.7% 6.9% 0.0% | 0.0% 2.8% 0.0% 6.7% | |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) | 1/22 (5%) 2/30 (7%) 2/29 (7%) 0/33 (0%) | 0/31 (0%) 1/36 (3%) 0/39 (0%) 2/30 (7%) | |FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) 730 (T) --- | --- 737 (T) --- 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.201N P=0.608 P=0.597 P=0.419N | P=0.129 P=0.530 (e) P=0.231 | |INCIDENTAL TUMOR | P=0.201N P=0.608 P=0.597 P=0.419N | P=0.129 P=0.530 (e) P=0.231 | |LOGISTIC REGRESSION | P=0.201N P=0.608 P=0.597 P=0.419N | P=0.129 P=0.530 (e) P=0.231 | |COCHRAN-ARMITAGE | P=0.279N | P=0.140 | |FISHER EXACT | P=0.500 P=0.506 P=0.496N | P=0.496 (e) P=0.235 | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 1/59 (2%) 0/60 (0%) 1/60 (2%) | 3/60 (5%) 3/59 (5%) 0/60 (0%) 1/57 (2%) | |ADJUSTED (b) | 2.2% 3.3% 0.0% 3.0% | 9.7% 7.1% 0.0% 3.3% | |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) | 0/22 (0%) 1/30 (3%) 0/29 (0%) 1/33 (3%) | 3/31 (10%) 1/36 (3%) 0/39 (0%) 1/30 (3%) | |FIRST INCIDENCE (DAYS) | 565 730 (T) --- 730 (T) | 737 (T) 647 --- 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.557N P=0.726N P=0.500N P=0.722N | P=0.124N P=0.572N P=0.084N P=0.316N | |INCIDENTAL TUMOR | P=0.501N P=0.679N P=0.500N P=0.634N | P=0.131N P=0.580N P=0.084N P=0.316N | |LOGISTIC REGRESSION | P=0.601N P=0.762N P=0.515N P=0.758N | P=0.126N P=0.609N P=0.084N P=0.316N | |COCHRAN-ARMITAGE | P=0.601N | P=0.134N | |FISHER EXACT | P=0.752N P=0.496N P=0.748N | P=0.652 P=0.122N P=0.329N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/59 (3%) 3/59 (5%) 2/60 (3%) 1/60 (2%) | 3/60 (5%) 4/59 (7%) 0/60 (0%) 3/57 (5%) | |ADJUSTED (b) | 6.6% 10.0% 6.9% 3.0% | 9.7% 9.7% 0.0% 10.0% | |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) | 1/22 (5%) 3/30 (10%) 2/29 (7%) 1/33 (3%) | 3/31 (10%) 2/36 (6%) 0/39 (0%) 3/30 (10%) | |FIRST INCIDENCE (DAYS) | 565 730 (T) 730 (T) 730 (T) | 737 (T) 647 --- 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.207N P=0.612 P=0.618N P=0.412N | P=0.448N P=0.598 P=0.084N P=0.650 | |INCIDENTAL TUMOR | P=0.185N P=0.648 P=0.618N P=0.330N | P=0.447N P=0.592 P=0.084N P=0.650 | |LOGISTIC REGRESSION | P=0.281N P=0.508 P=0.677N P=0.493N | P=0.443N P=0.570 P=0.084N P=0.650 | |COCHRAN-ARMITAGE | P=0.293N | P=0.453N | |FISHER EXACT | P=0.500 P=0.684N P=0.494N | P=0.491 P=0.122N P=0.636 | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/55 (5%) 2/58 (3%) 5/58 (9%) 5/59 (8%) | 0/59 (0%) 1/58 (2%) 1/59 (2%) 1/59 (2%) | |ADJUSTED (b) | 10.9% 5.9% 15.7% 14.0% | 0.0% 2.8% 2.6% 2.8% | |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) | 1/22 (5%) 1/31 (3%) 4/29 (14%) 3/33 (9%) | 0/31 (0%) 1/36 (3%) 1/39 (3%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 708 673 591 633 | --- 737 (T) 737 (T) 707 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.281 P=0.429N P=0.478 P=0.517 | P=0.392 P=0.530 P=0.546 P=0.530 | |INCIDENTAL TUMOR | P=0.192 P=0.639N P=0.412 P=0.291 | P=0.412 P=0.530 P=0.546 P=0.564 | |LOGISTIC REGRESSION | P=0.203 P=0.473N P=0.401 P=0.396 | P=0.398 P=0.530 P=0.546 P=0.509 | |COCHRAN-ARMITAGE | P=0.207 | P=0.395 | |FISHER EXACT | P=0.475N P=0.388 P=0.398 | P=0.496 P=0.500 P=0.500 | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/55 (4%) 0/58 (0%) 2/58 (3%) 0/59 (0%) | 0/59 (0%) 2/58 (3%) 0/59 (0%) 0/59 (0%) | |ADJUSTED (b) | 6.8% 0.0% 6.9% 0.0% | 0.0% 5.6% 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) | 1/22 (5%) 0/31 (0%) 2/29 (7%) 0/33 (0%) | 0/31 (0%) 2/36 (6%) 0/39 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 612 --- 730 (T) --- | --- 737 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.222N P=0.205N P=0.616N P=0.198N | P=0.353N P=0.272 (e) (e) | |INCIDENTAL TUMOR | P=0.184N P=0.135N P=0.590N P=0.106N | P=0.353N P=0.272 (e) (e) | |LOGISTIC REGRESSION | P=0.259N P=0.226N P=0.668N P=0.224N | P=0.353N P=0.272 (e) (e) | |COCHRAN-ARMITAGE | P=0.259N | P=0.352N | |FISHER EXACT | P=0.235N P=0.671N P=0.231N | P=0.244 (e) (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/55 (9%) 2/58 (3%) 6/58 (10%) 5/59 (8%) | 0/59 (0%) 3/58 (5%) 1/59 (2%) 1/59 (2%) | |ADJUSTED (b) | 17.1% 5.9% 19.1% 14.0% | 0.0% 8.3% 2.6% 2.8% | |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) | 2/22 (9%) 1/31 (3%) 5/29 (17%) 3/33 (9%) | 0/31 (0%) 3/36 (8%) 1/39 (3%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 612 673 591 633 | --- 737 (T) 737 (T) 707 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.507 P=0.163N P=0.607N P=0.461N | P=0.613N P=0.148 P=0.546 P=0.530 | |INCIDENTAL TUMOR | P=0.438 P=0.237N P=0.605 P=0.603N | P=0.597N P=0.148 P=0.546 P=0.564 | |LOGISTIC REGRESSION | P=0.406 P=0.195N P=0.554 P=0.590N | P=0.602N P=0.148 P=0.546 P=0.509 | |COCHRAN-ARMITAGE | P=0.409 | P=0.604N | |FISHER EXACT | P=0.198N P=0.538 P=0.583N | P=0.119 P=0.500 P=0.500 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 2/60 (3%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.6% 5.6% 2.6% 3.1% | |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) | 0/22 (0%) 0/31 (0%) 0/29 (0%) 0/33 (0%) | 0/31 (0%) 2/36 (6%) 1/39 (3%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 645 737 (T) 737 (T) 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.510N P=0.556 P=0.729N P=0.746N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.502N P=0.571 P=0.657 P=0.722N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.501N P=0.537 P=0.754N P=0.752N | |COCHRAN-ARMITAGE | (e) | P=0.512N | |FISHER EXACT | (e) (e) (e) | P=0.500 P=0.752N P=0.752N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.3% 5.3% 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) | 0/22 (0%) 0/31 (0%) 0/29 (0%) 0/33 (0%) | 0/31 (0%) 1/36 (3%) 0/39 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 589 713 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.161N P=0.548 P=0.500N P=0.491N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.192N P=0.292 P=0.669N P=0.612N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.165N P=0.515 P=0.505N P=0.518N | |COCHRAN-ARMITAGE | (e) | P=0.168N | |FISHER EXACT | (e) (e) (e) | P=0.500 P=0.500N P=0.500N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 2/60 (3%) 2/60 (3%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.4% 5.3% 2.4% 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) | 0/22 (0%) 0/31 (0%) 0/29 (0%) 0/33 (0%) | 1/31 (3%) 1/36 (3%) 0/39 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 589 713 668 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.113N P=0.641N P=0.455N P=0.231N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.135N P=0.571 P=0.714N P=0.296N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.117N P=0.669N P=0.496N P=0.235N | |COCHRAN-ARMITAGE | (e) | P=0.121N | |FISHER EXACT | (e) (e) (e) | P=0.691N P=0.500N P=0.248N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 3/60 (5%) 1/60 (2%) 0/60 (0%) | 15/60 (25%) 19/60 (32%) 12/60 (20%) 11/60 (18%) | |ADJUSTED (b) | 7.6% 9.7% 3.4% 0.0% | 45.2% 48.4% 29.8% 32.2% | |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) | 1/22 (5%) 3/31 (10%) 1/29 (3%) 0/33 (0%) | 13/31 (42%) 16/36 (44%) 11/39 (28%) 9/32 (28%) | |FIRST INCIDENCE (DAYS) | 703 730 (T) 730 (T) --- | 658 647 520 707 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.059N P=0.632 P=0.416N P=0.187N | P=0.080N P=0.478 P=0.132N P=0.203N | |INCIDENTAL TUMOR | P=0.076N P=0.564 P=0.485N P=0.304N | P=0.074N P=0.496 P=0.185N P=0.173N | |LOGISTIC REGRESSION | P=0.076N P=0.553 P=0.464N P=0.226N | P=0.066N P=0.518 P=0.209N P=0.150N | |COCHRAN-ARMITAGE | P=0.094N | P=0.101N | |FISHER EXACT | P=0.500 P=0.500N P=0.248N | P=0.272 P=0.331N P=0.253N | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 3/60 (5%) 1/60 (2%) 0/60 (0%) | 16/60 (27%) 21/60 (35%) 12/60 (20%) 11/60 (18%) | |ADJUSTED (b) | 7.6% 9.7% 3.4% 0.0% | 46.4% 52.3% 29.8% 32.2% | |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) | 1/22 (5%) 3/31 (10%) 1/29 (3%) 0/33 (0%) | 13/31 (42%) 17/36 (47%) 11/39 (28%) 9/32 (28%) | |FIRST INCIDENCE (DAYS) | 703 730 (T) 730 (T) --- | 589 647 520 707 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.059N P=0.632 P=0.416N P=0.187N | P=0.041N* P=0.415 P=0.094N P=0.149N | |INCIDENTAL TUMOR | P=0.076N P=0.564 P=0.485N P=0.304N | P=0.039N* P=0.346 P=0.155N P=0.138N | |LOGISTIC REGRESSION | P=0.076N P=0.553 P=0.464N P=0.226N | P=0.032N* P=0.418 P=0.164N P=0.109N | |COCHRAN-ARMITAGE | P=0.094N | P=0.054N | |FISHER EXACT | P=0.500 P=0.500N P=0.248N | P=0.215 P=0.259N P=0.191N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 3/60 (5%) 1/60 (2%) 0/60 (0%) | 17/60 (28%) 21/60 (35%) 13/60 (22%) 11/60 (18%) | |ADJUSTED (b) | 7.6% 9.7% 3.4% 0.0% | 49.4% 52.3% 31.5% 32.2% | |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) | 1/22 (5%) 3/31 (10%) 1/29 (3%) 0/33 (0%) | 14/31 (45%) 17/36 (47%) 11/39 (28%) 9/32 (28%) | |FIRST INCIDENCE (DAYS) | 703 730 (T) 730 (T) --- | 589 647 520 707 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.059N P=0.632 P=0.416N P=0.187N | P=0.031N* P=0.502 P=0.094N P=0.104N | |INCIDENTAL TUMOR | P=0.076N P=0.564 P=0.485N P=0.304N | P=0.029N* P=0.436 P=0.187N P=0.095N | |LOGISTIC REGRESSION | P=0.076N P=0.553 P=0.464N P=0.226N | P=0.024N* P=0.515 P=0.167N P=0.071N | |COCHRAN-ARMITAGE | P=0.094N | P=0.042N* | |FISHER EXACT | P=0.500 P=0.500N P=0.248N | P=0.278 P=0.264N P=0.140N | |=================================================================================================================================| | | |Nose | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/58 (3%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 5.7% 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) | 0/22 (0%) 1/29 (3%) 0/29 (0%) 0/33 (0%) | 0/31 (0%) 0/36 (0%) 0/39 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- 580 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.321N P=0.267 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.275N P=0.317 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.351N P=0.231 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.351N | (e) | |FISHER EXACT | P=0.239 (e) (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/55 (5%) 4/58 (7%) 1/59 (2%) 3/60 (5%) | 1/59 (2%) 0/57 (0%) 1/59 (2%) 0/60 (0%) | |ADJUSTED (b) | 13.6% 12.9% 3.4% 9.1% | 3.2% 0.0% 2.6% 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) | 3/22 (14%) 4/31 (13%) 1/29 (3%) 3/33 (9%) | 1/31 (3%) 0/36 (0%) 1/39 (3%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) 730 (T) 730 (T) | 737 (T) --- 737 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.312N P=0.630N P=0.210N P=0.465N | P=0.422N P=0.470N P=0.710N P=0.494N | |INCIDENTAL TUMOR | P=0.312N P=0.630N P=0.210N P=0.465N | P=0.422N P=0.470N P=0.710N P=0.494N | |LOGISTIC REGRESSION | P=0.312N P=0.630N P=0.210N P=0.465N | P=0.422N P=0.470N P=0.710N P=0.494N | |COCHRAN-ARMITAGE | P=0.421N | P=0.419N | |FISHER EXACT | P=0.530 P=0.283N P=0.618N | P=0.509N P=0.752N P=0.496N | |=================================================================================================================================| | | |Pancreas | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/55 (7%) 4/58 (7%) 1/59 (2%) 3/60 (5%) | 1/59 (2%) 0/57 (0%) 1/59 (2%) 0/60 (0%) | |ADJUSTED (b) | 18.2% 12.9% 3.4% 9.1% | 3.2% 0.0% 2.6% 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) | 4/22 (18%) 4/31 (13%) 1/29 (3%) 3/33 (9%) | 1/31 (3%) 0/36 (0%) 1/39 (3%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) 730 (T) 730 (T) | 737 (T) --- 737 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.199N P=0.445N P=0.103N P=0.283N | P=0.422N P=0.470N P=0.710N P=0.494N | |INCIDENTAL TUMOR | P=0.199N P=0.445N P=0.103N P=0.283N | P=0.422N P=0.470N P=0.710N P=0.494N | |LOGISTIC REGRESSION | P=0.199N P=0.445N P=0.103N P=0.283N | P=0.422N P=0.470N P=0.710N P=0.494N | |COCHRAN-ARMITAGE | P=0.297N | P=0.419N | |FISHER EXACT | P=0.612N P=0.161N P=0.451N | P=0.509N P=0.752N P=0.496N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 23/58 (40%) 25/55 (45%) 20/59 (34%) 23/56 (41%) | 30/58 (52%) 26/58 (45%) 30/59 (51%) 26/60 (43%) | |ADJUSTED (b) | 71.6% 56.7% 49.1% 54.0% | 72.5% 61.5% 65.8% 58.9% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 4/10 (40%) 3/10 (30%) 2/10 (20%) | 1/10 (10%) 0/10 (0%) 3/10 (30%) 2/10 (20%) | |TERMINAL (d) | 14/22 (64%) 12/29 (41%) 10/29 (34%) 14/32 (44%) | 20/31 (65%) 20/36 (56%) 23/38 (61%) 15/32 (47%) | |FIRST INCIDENCE (DAYS) | 452 (I) 452 (I) 452 (I) 452 (I) | 458 (I) 647 430 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.183N P=0.443N P=0.128N P=0.202N | P=0.334N P=0.094N P=0.249N P=0.232N | |INCIDENTAL TUMOR | P=0.435N P=0.416 P=0.255N P=0.384N | P=0.266N P=0.294N P=0.568 P=0.254N | |LOGISTIC REGRESSION | P=0.451N P=0.346 P=0.288N P=0.533 | P=0.224N P=0.287N P=0.512N P=0.190N | |COCHRAN-ARMITAGE | P=0.462N | P=0.275N | |FISHER EXACT | P=0.333 P=0.325N P=0.515 | P=0.289N P=0.536N P=0.233N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/58 (2%) 1/55 (2%) 1/59 (2%) 2/56 (4%) | 4/58 (7%) 6/58 (10%) 4/59 (7%) 5/60 (8%) | |ADJUSTED (b) | 4.5% 3.0% 2.1% 5.5% | 12.9% 15.3% 10.5% 14.0% | |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) | 1/22 (5%) 0/29 (0%) 0/29 (0%) 1/32 (3%) | 4/31 (13%) 5/36 (14%) 4/38 (11%) 3/32 (9%) | |FIRST INCIDENCE (DAYS) | 730 (T) 723 528 620 | 737 (T) 428 737 (T) 669 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.402 P=0.688N P=0.730N P=0.583 | P=0.538 P=0.458 P=0.528N P=0.538 | |INCIDENTAL TUMOR | P=0.316 P=0.722 P=0.696N P=0.649 | P=0.552 P=0.456 P=0.528N P=0.559 | |LOGISTIC REGRESSION | P=0.345 P=0.746N P=0.763N P=0.497 | P=0.562N P=0.418 P=0.528N P=0.560 | |COCHRAN-ARMITAGE | P=0.344 | P=0.556 | |FISHER EXACT | P=0.739 P=0.748N P=0.487 | P=0.371 P=0.632N P=0.522 | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 24/58 (41%) 26/55 (47%) 21/59 (36%) 25/56 (45%) | 34/58 (59%) 31/58 (53%) 33/59 (56%) 31/60 (52%) | |ADJUSTED (b) | 75.1% 58.0% 50.1% 57.6% | 82.5% 71.6% 72.7% 67.9% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 4/10 (40%) 3/10 (30%) 2/10 (20%) | 1/10 (10%) 0/10 (0%) 3/10 (30%) 2/10 (20%) | |TERMINAL (d) | 15/22 (68%) 12/29 (41%) 10/29 (34%) 15/32 (47%) | 24/31 (77%) 24/36 (67%) 26/38 (68%) 18/32 (56%) | |FIRST INCIDENCE (DAYS) | 452 (I) 452 (I) 452 (I) 452 (I) | 458 (I) 428 430 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.231N P=0.423N P=0.127N P=0.239N | P=0.365N P=0.100N P=0.155N P=0.271N | |INCIDENTAL TUMOR | P=0.527N P=0.402 P=0.239N P=0.412N | P=0.284N P=0.317N P=0.452N P=0.285N | |LOGISTIC REGRESSION | P=0.535N P=0.344 P=0.290N P=0.453 | P=0.251N P=0.184N P=0.423N P=0.216N | |COCHRAN-ARMITAGE | P=0.526 | P=0.296N | |FISHER EXACT | P=0.330 P=0.325N P=0.435 | P=0.354N P=0.457N P=0.283N | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 4.5% 0.0% 0.0% 6.1% | 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) | 1/22 (5%) 0/31 (0%) 0/29 (0%) 2/33 (6%) | 0/31 (0%) 0/36 (0%) 0/39 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 730 (T) --- --- 730 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.295 P=0.432N P=0.445N P=0.641 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.295 P=0.432N P=0.445N P=0.641 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.295 P=0.432N P=0.445N P=0.641 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.232 | (e) | |FISHER EXACT | P=0.500N P=0.500N P=0.500 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | 4/60 (7%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 3.4% 2.9% | 12.9% 2.8% 0.0% 2.8% | |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) | 0/22 (0%) 0/31 (0%) 1/29 (3%) 0/33 (0%) | 4/31 (13%) 1/36 (3%) 0/39 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 730 (T) 726 | 737 (T) 737 (T) --- 707 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.280 (e) P=0.555 P=0.587 | P=0.103N P=0.136N P=0.038N* P=0.165N | |INCIDENTAL TUMOR | P=0.166 (e) P=0.555 P=0.261 | P=0.108N P=0.136N P=0.038N* P=0.155N | |LOGISTIC REGRESSION | P=0.250 (e) P=0.555 P=0.532 | P=0.101N P=0.136N P=0.038N* P=0.149N | |COCHRAN-ARMITAGE | P=0.225 | P=0.114N | |FISHER EXACT | (e) P=0.500 P=0.500 | P=0.182N P=0.059N P=0.182N | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 3.8% 9.7% 0.0% 0.0% | 0.0% 2.8% 2.6% 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) | 0/22 (0%) 3/31 (10%) 0/29 (0%) 0/33 (0%) | 0/31 (0%) 1/36 (3%) 1/39 (3%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 712 730 (T) --- --- | --- 737 (T) 737 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.090N P=0.424 P=0.459N P=0.446N | P=0.577N P=0.530 P=0.546 (e) | |INCIDENTAL TUMOR | P=0.122N P=0.334 P=0.586N P=0.739N | P=0.577N P=0.530 P=0.546 (e) | |LOGISTIC REGRESSION | P=0.109N P=0.350 P=0.487N P=0.493N | P=0.577N P=0.530 P=0.546 (e) | |COCHRAN-ARMITAGE | P=0.128N | P=0.575N | |FISHER EXACT | P=0.309 P=0.500N P=0.500N | P=0.500 P=0.500 (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.7% 0.0% 0.0% 2.4% | |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) | 0/22 (0%) 0/31 (0%) 0/29 (0%) 0/33 (0%) | 1/31 (3%) 0/36 (0%) 0/39 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 645 --- --- 650 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.479N P=0.204N P=0.209N P=0.474N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.464N P=0.190N P=0.343N P=0.422N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.481N P=0.222N P=0.228N P=0.489N | |COCHRAN-ARMITAGE | (e) | P=0.485N | |FISHER EXACT | (e) (e) (e) | P=0.248N P=0.248N P=0.500N | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 1/60 (2%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 9.1% 0.0% 2.7% 6.1% | 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) | 2/22 (9%) 0/31 (0%) 0/29 (0%) 2/33 (6%) | 0/31 (0%) 0/36 (0%) 0/39 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 730 (T) --- 704 730 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.527 P=0.166N P=0.412N P=0.542N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.458 P=0.166N P=0.485N P=0.542N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.470 P=0.166N P=0.463N P=0.542N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.440 | (e) | |FISHER EXACT | P=0.248N P=0.500N P=0.691N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 3/60 (5%) 1/60 (2%) 2/60 (3%) | 2/60 (3%) 1/60 (2%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 12.6% 9.7% 2.7% 6.1% | 5.7% 2.8% 2.6% 2.4% | |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) | 2/22 (9%) 3/31 (10%) 0/29 (0%) 2/33 (6%) | 1/31 (3%) 1/36 (3%) 1/39 (3%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 712 730 (T) 704 730 (T) | 645 737 (T) 737 (T) 650 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.232N P=0.506N P=0.226N P=0.332N | P=0.411N P=0.444N P=0.441N P=0.474N | |INCIDENTAL TUMOR | P=0.318N P=0.583N P=0.331N P=0.450N | P=0.401N P=0.429N P=0.591N P=0.422N | |LOGISTIC REGRESSION | P=0.292N P=0.583N P=0.273N P=0.423N | P=0.408N P=0.463N P=0.477N P=0.489N | |COCHRAN-ARMITAGE | P=0.334N | P=0.417N | |FISHER EXACT | P=0.660N P=0.309N P=0.500N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 1/60 (2%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 5.7% 1.7% 0.0% | 3.0% 0.0% 3.9% 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) | 0/22 (0%) 0/31 (0%) 0/29 (0%) 0/33 (0%) | 0/31 (0%) 0/36 (0%) 0/39 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- 673 452 (I) --- | 692 --- 310 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.405N P=0.266 P=0.500 (e) | P=0.478N P=0.443N P=0.530 P=0.472N | |INCIDENTAL TUMOR | P=0.588N P=0.102 P=0.500 (e) | P=0.599N P=0.436N P=0.263 P=0.436N | |LOGISTIC REGRESSION | P=0.422N P=0.242 P=0.417 (e) | P=0.512N P=0.486N P=0.492 P=0.490N | |COCHRAN-ARMITAGE | P=0.424N | P=0.485N | |FISHER EXACT | P=0.248 P=0.500 (e) | P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 43/59 (73%) 48/60 (80%) 50/60 (83%) 44/60 (73%) | | |ADJUSTED (b) | 91.1% 95.9% 100.0% 93.3% | | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 4/10 (40%) 4/10 (40%) 7/10 (70%) | | |TERMINAL (d) | 18/22 (82%) 29/31 (94%) 29/29 (100%) 30/33 (91%) | | |FIRST INCIDENCE (DAYS) | 452 (I) 452 (I) 452 (I) 452 (I) | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.085N P=0.349N P=0.468N P=0.092N | | |INCIDENTAL TUMOR | P=0.487N P=0.256 P=0.095 P=0.562N | | |LOGISTIC REGRESSION | P=0.515N P=0.258 P=0.129 P=0.555 | | |COCHRAN-ARMITAGE | P=0.483N | | |FISHER EXACT | P=0.242 P=0.123 P=0.560 | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/59 (8%) 5/58 (9%) 8/60 (13%) 8/60 (13%) | 6/59 (10%) 8/60 (13%) 10/60 (17%) 10/60 (17%) | |ADJUSTED (b) | 13.3% 16.1% 22.1% 24.2% | 16.4% 19.2% 23.7% 27.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 1/22 (5%) 5/31 (16%) 4/29 (14%) 8/33 (24%) | 4/31 (13%) 4/36 (11%) 8/39 (21%) 7/32 (22%) | |FIRST INCIDENCE (DAYS) | 565 730 (T) 453 (I) 730 (T) | 456 (I) 647 458 (I) 458 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.308 P=0.514N P=0.382 P=0.460 | P=0.181 P=0.514 P=0.332 P=0.238 | |INCIDENTAL TUMOR | P=0.238 P=0.564N P=0.287 P=0.429 | P=0.196 P=0.439 P=0.315 P=0.221 | |LOGISTIC REGRESSION | P=0.187 P=0.625N P=0.294 P=0.296 | P=0.192 P=0.452 P=0.236 P=0.238 | |COCHRAN-ARMITAGE | P=0.189 | P=0.183 | |FISHER EXACT | P=0.618 P=0.290 P=0.290 | P=0.402 P=0.221 P=0.221 | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/59 (8%) 6/58 (10%) 8/60 (13%) 9/60 (15%) | 6/59 (10%) 8/60 (13%) 10/60 (17%) 10/60 (17%) | |ADJUSTED (b) | 13.3% 18.7% 22.1% 25.9% | 16.4% 19.2% 23.7% 27.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 1/22 (5%) 5/31 (16%) 4/29 (14%) 8/33 (24%) | 4/31 (13%) 4/36 (11%) 8/39 (21%) 7/32 (22%) | |FIRST INCIDENCE (DAYS) | 565 723 453 (I) 564 | 456 (I) 647 458 (I) 458 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.259 P=0.615N P=0.382 P=0.352 | P=0.181 P=0.514 P=0.332 P=0.238 | |INCIDENTAL TUMOR | P=0.186 P=0.522 P=0.287 P=0.354 | P=0.196 P=0.439 P=0.315 P=0.221 | |LOGISTIC REGRESSION | P=0.147 P=0.508 P=0.294 P=0.208 | P=0.192 P=0.452 P=0.236 P=0.238 | |COCHRAN-ARMITAGE | P=0.150 | P=0.183 | |FISHER EXACT | P=0.488 P=0.290 P=0.207 | P=0.402 P=0.221 P=0.221 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 0/58 (0%) 2/60 (3%) 1/60 (2%) | 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 5.2% 3.0% | 0.0% 0.0% 0.0% 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) | 0/22 (0%) 0/31 (0%) 1/29 (3%) 1/33 (3%) | 0/31 (0%) 0/36 (0%) 0/39 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 453 (I) 730 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.274 (e) P=0.270 P=0.581 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.274 (e) P=0.270 P=0.581 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.238 (e) P=0.228 P=0.581 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.238 | (e) | |FISHER EXACT | (e) P=0.252 P=0.504 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 0/58 (0%) 2/60 (3%) 1/60 (2%) | 1/59 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 4.5% 0.0% 5.2% 3.0% | 3.0% 2.8% 0.0% 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) | 1/22 (5%) 0/31 (0%) 1/29 (3%) 1/33 (3%) | 0/31 (0%) 1/36 (3%) 0/39 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 730 (T) --- 453 (I) 730 (T) | 692 737 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.540 P=0.432N P=0.564 P=0.669N | P=0.217N P=0.711N P=0.467N P=0.472N | |INCIDENTAL TUMOR | P=0.540 P=0.432N P=0.564 P=0.669N | P=0.217N P=0.693N P=0.748N P=0.410N | |LOGISTIC REGRESSION | P=0.481 P=0.432N P=0.502 P=0.669N | P=0.217N P=0.732N P=0.489N P=0.487N | |COCHRAN-ARMITAGE | P=0.481 | P=0.223N | |FISHER EXACT | P=0.504N P=0.506 P=0.748N | P=0.748N P=0.496N P=0.496N | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 15/60 (25%) 8/60 (13%) 11/60 (18%) 16/60 (27%) | |ADJUSTED (b) | | 36.8% 21.5% 26.2% 40.1% | |INTERIM SACRIFICE 1 (c)| | 2/10 (20%) 0/10 (0%) 1/10 (10%) 2/10 (20%) | |TERMINAL (d) | | 8/31 (26%) 7/36 (19%) 9/39 (23%) 10/32 (31%) | |FIRST INCIDENCE (DAYS) | | 456 (I) 707 456 (I) 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.258 P=0.044N* P=0.136N P=0.551 | |INCIDENTAL TUMOR | | P=0.251 P=0.089N P=0.264N P=0.521 | |LOGISTIC REGRESSION | | P=0.265 P=0.063N P=0.234N P=0.529 | |COCHRAN-ARMITAGE | | P=0.250 | |FISHER EXACT | | P=0.082N P=0.253N P=0.500 | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/60 (0%) 2/60 (3%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | | 0.0% 5.6% 2.3% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 0/31 (0%) 2/36 (6%) 0/39 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | | --- 737 (T) 627 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.418N P=0.272 P=0.519 (e) | |INCIDENTAL TUMOR | | P=0.444N P=0.272 P=0.331 (e) | |LOGISTIC REGRESSION | | P=0.417N P=0.272 P=0.497 (e) | |COCHRAN-ARMITAGE | | P=0.424N | |FISHER EXACT | | P=0.248 P=0.500 (e) | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 15/60 (25%) 10/60 (17%) 12/60 (20%) 16/60 (27%) | |ADJUSTED (b) | | 36.8% 26.9% 27.8% 40.1% | |INTERIM SACRIFICE 1 (c)| | 2/10 (20%) 0/10 (0%) 1/10 (10%) 2/10 (20%) | |TERMINAL (d) | | 8/31 (26%) 9/36 (25%) 9/39 (23%) 10/32 (31%) | |FIRST INCIDENCE (DAYS) | | 456 (I) 707 456 (I) 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.317 P=0.105N P=0.191N P=0.551 | |INCIDENTAL TUMOR | | P=0.302 P=0.191N P=0.377N P=0.521 | |LOGISTIC REGRESSION | | P=0.325 P=0.143N P=0.311N P=0.529 | |COCHRAN-ARMITAGE | | P=0.306 | |FISHER EXACT | | P=0.184N P=0.331N P=0.500 | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 1/60 (2%) 2/60 (3%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 4.4% 2.0% 4.6% | 2.2% 0.0% 0.0% 2.3% | |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) | 0/22 (0%) 0/31 (0%) 0/29 (0%) 0/33 (0%) | 0/31 (0%) 0/36 (0%) 0/39 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- 544 520 582 | 575 --- --- 644 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.267 P=0.244 P=0.504 P=0.240 | P=0.578 P=0.496N P=0.509N P=0.747N | |INCIDENTAL TUMOR | P=0.328 P=0.284 P=0.557 P=0.397 | P=0.524 (e) P=0.669N P=0.638 | |LOGISTIC REGRESSION | P=0.272 P=0.226 P=0.467 P=0.239 | P=0.568 P=0.524N P=0.505N P=0.750 | |COCHRAN-ARMITAGE | P=0.264 | P=0.575 | |FISHER EXACT | P=0.248 P=0.500 P=0.248 | P=0.500N P=0.500N P=0.752N | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, | | or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 35/60 (58%) 25/60 (42%) 26/60 (43%) 15/60 (25%) | 15/60 (25%) 13/60 (22%) 9/60 (15%) 9/60 (15%) | |ADJUSTED (b) | 72.7% 56.5% 60.1% 37.0% | 36.5% 30.9% 20.5% 24.2% | |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) | 9/22 (41%) 13/31 (42%) 12/29 (41%) 8/33 (24%) | 7/31 (23%) 8/36 (22%) 5/39 (13%) 5/32 (16%) | |FIRST INCIDENCE (DAYS) | 305 520 590 564 | 359 666 462 493 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001N** P=0.031N* P=0.036N* P<0.001N** | P=0.080N P=0.246N P=0.074N P=0.111N | |INCIDENTAL TUMOR | P=0.003N** P=0.140N P=0.200N P=0.010N** | P=0.075N P=0.559N P=0.237N P=0.154N | |LOGISTIC REGRESSION | P<0.001N** P=0.040N* P=0.056N P<0.001N** | P=0.073N P=0.349N P=0.123N P=0.112N | |COCHRAN-ARMITAGE | P<0.001N** | P=0.082N | |FISHER EXACT | P=0.050N* P=0.072N P<0.001N** | P=0.415N P=0.127N P=0.127N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 52/60 (87%) 57/60 (95%) 56/60 (93%) 52/60 (87%) | 46/60 (77%) 39/60 (65%) 43/60 (72%) 43/60 (72%) | |ADJUSTED (b) | 98.1% 100.0% 100.0% 100.0% | 93.8% 88.6% 85.6% 83.9% | |INTERIM SACRIFICE 1 (c)| 6/10 (60%) 7/10 (70%) 8/10 (80%) 8/10 (80%) | 3/10 (30%) 0/10 (0%) 4/10 (40%) 5/10 (50%) | |TERMINAL (d) | 21/22 (95%) 31/31 (100%) 29/29 (100%) 33/33 (100%)| 28/31 (90%) 31/36 (86%) 32/39 (82%) 24/32 (75%) | |FIRST INCIDENCE (DAYS) | 452 (I) 452 (I) 452 (I) 452 (I) | 456 (I) 647 310 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.046N* P=0.299N P=0.279N P=0.050N* | P=0.449N P=0.013N* P=0.054N P=0.261N | |INCIDENTAL TUMOR | P=0.304N P=0.113 P=0.187 P=0.482N | P=0.468N P=0.017N* P=0.331N P=0.245N | |LOGISTIC REGRESSION | P=0.418N P=0.114 P=0.218 P=0.585 | P=0.394N P=0.010N* P=0.273N P=0.214N | |COCHRAN-ARMITAGE | P=0.369N | P=0.481N | |FISHER EXACT | P=0.102 P=0.181 P=0.605N | P=0.114N P=0.339N P=0.339N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 39/60 (65%) 27/60 (45%) 35/60 (58%) 25/60 (42%) | 27/60 (45%) 27/60 (45%) 16/60 (27%) 22/60 (37%) | |ADJUSTED (b) | 77.9% 60.2% 71.3% 56.4% | 59.0% 57.9% 34.3% 50.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 11/22 (50%) 14/31 (45%) 15/29 (52%) 14/33 (42%) | 13/31 (42%) 17/36 (47%) 9/39 (23%) 11/32 (34%) | |FIRST INCIDENCE (DAYS) | 305 520 453 (I) 564 | 359 428 458 (I) 458 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.017N* P=0.015N* P=0.128N P=0.005N** | P=0.123N P=0.295N P=0.014N* P=0.194N | |INCIDENTAL TUMOR | P=0.081N P=0.042N* P=0.573N P=0.044N* | P=0.086N P=0.552 P=0.112N P=0.212N | |LOGISTIC REGRESSION | P=0.043N* P=0.014N* P=0.284N P=0.010N** | P=0.086N P=0.485N P=0.026N* P=0.190N | |COCHRAN-ARMITAGE | P=0.032N* | P=0.112N | |FISHER EXACT | P=0.022N* P=0.287N P=0.009N** | P=0.573N P=0.028N* P=0.229N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 01 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 56/60 (93%) 57/60 (95%) 59/60 (98%) 57/60 (95%) | 51/60 (85%) 44/60 (73%) 48/60 (80%) 50/60 (83%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 96.2% 89.8% 88.8% 94.3% | |INTERIM SACRIFICE 1 (c)| 6/10 (60%) 7/10 (70%) 9/10 (90%) 9/10 (90%) | 3/10 (30%) 0/10 (0%) 4/10 (40%) 5/10 (50%) | |TERMINAL (d) | 22/22 (100%) 31/31 (100%) 29/29 (100%) 33/33 (100%)| 29/31 (94%) 31/36 (86%) 33/39 (85%) 29/32 (91%) | |FIRST INCIDENCE (DAYS) | 305 452 (I) 452 (I) 452 (I) | 359 428 310 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.110N P=0.136N P=0.235N P=0.079N | P=0.480 P=0.018N* P=0.063N P=0.354N | |INCIDENTAL TUMOR | P=0.380 P=0.500 P=0.157 P=0.533 | P=0.380 P=0.042N* P=0.376N P=0.509N | |LOGISTIC REGRESSION | P=0.261 P=0.647 P=0.253 P=0.435 | P=0.493 P=0.016N* P=0.274N P=0.343N | |COCHRAN-ARMITAGE | P=0.395 | P=0.410 | |FISHER EXACT | P=0.500 P=0.182 P=0.500 | P=0.088N P=0.316N P=0.500N | |=================================================================================================================================| (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): 452 Female interim sacrifices(days): 456 (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).