TDMS Study 05122-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: LITRI NICKEL SULFATE HEXAHYDRATE DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 TIME: 03:19:03 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: Y01-ES-30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C60344 PATHOLOGIST: K. NIKULA CAS: 010101970 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: LITRI NICKEL SULFATE HEXAHYDRATE DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 TIME: 03:19:03 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: Y01-ES-30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C60344 PATHOLOGIST: K. NIKULA CAS: 010101970 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 Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis 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: LITRI NICKEL SULFATE HEXAHYDRATE DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 TIME: 03:19:03 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: Y01-ES-30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C60344 PATHOLOGIST: K. NIKULA CAS: 010101970 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF NICKEL SULFATE HEXAHYDRATE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Lung Alveolar/Bronchiolar Adenoma Skin Fibroma Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma Keratoacanthoma Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Mammary Gland Carcinoma Carcinoma or Adenoma Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/59 (27%) 16/58 (28%) 12/58 (21%) 11/58 (19%) | 2/56 (4%) 4/57 (7%) 2/58 (3%) 3/59 (5%) | |ADJUSTED (b) | 61.2% 62.3% 46.2% 43.3% | 6.6% 15.5% 6.8% 10.3% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/4 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 7/16 (44%) 8/16 (50%) 6/18 (33%) 7/21 (33%) | 1/22 (5%) 1/17 (6%) 1/28 (4%) 3/29 (10%) | |FIRST INCIDENCE (DAYS) | 622 580 471 688 | 584 644 711 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.045N* P=0.523N P=0.185N P=0.088N | P=0.516N P=0.238 P=0.628N P=0.583 | |INCIDENTAL TUMOR | P=0.101N P=0.464N P=0.246N P=0.178N | P=0.463 P=0.362 P=0.681N P=0.483 | |LOGISTIC REGRESSION | P=0.083N P=0.475N P=0.201N P=0.142N | P=0.535 P=0.317 P=0.671N P=0.486 | |COCHRAN-ARMITAGE | P=0.128N | P=0.551 | |FISHER EXACT | P=0.560 P=0.275N P=0.204N | P=0.348 P=0.677N P=0.525 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 3/58 (5%) 2/58 (3%) 1/58 (2%) | 0/56 (0%) 0/57 (0%) 0/58 (0%) 0/59 (0%) | |ADJUSTED (b) | 0.0% 9.7% 8.5% 4.8% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/4 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 1/18 (6%) 1/21 (5%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- 632 651 733 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.601 P=0.150 P=0.253 P=0.554 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.527 P=0.152 P=0.238 P=0.554 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.568 P=0.126 P=0.246 P=0.554 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.557 | (e) | |FISHER EXACT | P=0.119 P=0.244 P=0.496 | (e) (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/59 (27%) 19/58 (33%) 13/58 (22%) 12/58 (21%) | 2/56 (4%) 4/57 (7%) 3/58 (5%) 3/59 (5%) | |ADJUSTED (b) | 61.2% 66.0% 50.7% 47.4% | 6.6% 15.5% 9.6% 10.3% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/4 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 7/16 (44%) 8/16 (50%) 7/18 (39%) 8/21 (38%) | 1/22 (5%) 1/17 (6%) 1/28 (4%) 3/29 (10%) | |FIRST INCIDENCE (DAYS) | 622 580 471 688 | 584 644 700 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.049N* P=0.419 P=0.243N P=0.122N | P=0.524N P=0.238 P=0.584 P=0.583 | |INCIDENTAL TUMOR | P=0.112N P=0.469 P=0.321N P=0.241N | P=0.423 P=0.362 P=0.518 P=0.483 | |LOGISTIC REGRESSION | P=0.091N P=0.442 P=0.270N P=0.167N | P=0.514 P=0.317 P=0.532 P=0.486 | |COCHRAN-ARMITAGE | P=0.140N | P=0.530 | |FISHER EXACT | P=0.321 P=0.354N P=0.275N | P=0.348 P=0.517 P=0.525 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/59 (3%) 0/58 (0%) 3/57 (5%) 3/58 (5%) | 4/56 (7%) 4/57 (7%) 3/57 (5%) 3/59 (5%) | |ADJUSTED (b) | 7.8% 0.0% 9.9% 8.9% | 13.9% 19.7% 9.2% 10.3% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 1/17 (6%) 1/21 (5%) | 1/22 (5%) 3/17 (18%) 2/28 (7%) 3/29 (10%) | |FIRST INCIDENCE (DAYS) | 622 --- 538 460 | 683 596 647 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.266 P=0.231N P=0.513 P=0.543 | P=0.242N P=0.471 P=0.413N P=0.405N | |INCIDENTAL TUMOR | P=0.251 P=0.206N P=0.493 P=0.487 | P=0.359N P=0.558 P=0.444N P=0.546N | |LOGISTIC REGRESSION | P=0.220 P=0.230N P=0.485 P=0.489 | P=0.353N P=0.532 P=0.460N P=0.497N | |COCHRAN-ARMITAGE | P=0.223 | P=0.362N | |FISHER EXACT | P=0.252N P=0.484 P=0.492 | P=0.632N P=0.490N P=0.471N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 3/58 (5%) 1/57 (2%) 1/58 (2%) | 0/56 (0%) 1/57 (2%) 0/57 (0%) 1/59 (2%) | |ADJUSTED (b) | 1.9% 8.0% 3.2% 2.2% | 0.0% 3.4% 0.0% 3.4% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 0/17 (0%) 0/21 (0%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 1/29 (3%) | |FIRST INCIDENCE (DAYS) | 482 607 679 563 | --- 653 --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.447N P=0.333 P=0.750N P=0.756 | P=0.459 P=0.446 (e) P=0.555 | |INCIDENTAL TUMOR | P=0.472N P=0.203 P=0.728 P=0.741 | P=0.404 P=0.443 (e) P=0.555 | |LOGISTIC REGRESSION | P=0.451N P=0.274 P=0.744 P=0.728 | P=0.412 P=0.500 (e) P=0.555 | |COCHRAN-ARMITAGE | P=0.444N | P=0.420 | |FISHER EXACT | P=0.303 P=0.743 P=0.748 | P=0.504 (e) P=0.513 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/59 (5%) 3/58 (5%) 4/57 (7%) 4/58 (7%) | 4/56 (7%) 5/57 (9%) 3/57 (5%) 4/59 (7%) | |ADJUSTED (b) | 9.6% 8.0% 12.8% 10.9% | 13.9% 22.4% 9.2% 13.8% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 1/17 (6%) 1/21 (5%) | 1/22 (5%) 3/17 (18%) 2/28 (7%) 4/29 (14%) | |FIRST INCIDENCE (DAYS) | 482 607 538 460 | 683 596 647 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.418 P=0.632N P=0.518 P=0.534 | P=0.327N P=0.323 P=0.413N P=0.535N | |INCIDENTAL TUMOR | P=0.385 P=0.611 P=0.472 P=0.474 | P=0.472N P=0.395 P=0.444N P=0.625 | |LOGISTIC REGRESSION | P=0.373 P=0.645 P=0.476 P=0.471 | P=0.465N P=0.393 P=0.460N P=0.638N | |COCHRAN-ARMITAGE | P=0.381 | P=0.467N | |FISHER EXACT | P=0.652 P=0.481 P=0.490 | P=0.511 P=0.490N P=0.612N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/57 (4%) 2/56 (4%) 1/57 (2%) 4/58 (7%) | 0/57 (0%) 0/58 (0%) 0/58 (0%) 0/59 (0%) | |ADJUSTED (b) | 6.8% 6.1% 5.9% 14.9% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 1/5 (20%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 1/17 (6%) 2/21 (10%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 657 458 (I) 733 (T) 630 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.266 P=0.666N P=0.477N P=0.384 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.203 P=0.663N P=0.524N P=0.309 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.235 P=0.679 P=0.493N P=0.355 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.237 | (e) | |FISHER EXACT | P=0.684 P=0.500N P=0.348 | (e) (e) (e) | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/57 (4%) 2/56 (4%) 2/57 (4%) 5/58 (9%) | 0/57 (0%) 0/58 (0%) 0/58 (0%) 0/59 (0%) | |ADJUSTED (b) | 6.8% 6.1% 8.4% 17.4% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 1/5 (20%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 1/17 (6%) 2/21 (10%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 657 458 (I) 614 630 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.141 P=0.666N P=0.679N P=0.261 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.107 P=0.663N P=0.689 P=0.209 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.120 P=0.679 P=0.692N P=0.231 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.121 | (e) | |FISHER EXACT | P=0.684 P=0.691N P=0.226 | (e) (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 0/58 (0%) 2/58 (3%) 2/58 (3%) | 0/57 (0%) 0/58 (0%) 0/58 (0%) 0/59 (0%) | |ADJUSTED (b) | 3.2% 0.0% 6.0% 5.2% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 0/18 (0%) 0/21 (0%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 657 --- 471 583 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.244 P=0.488N P=0.519 P=0.508 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.206 P=0.466N P=0.451 P=0.490 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.235 P=0.497N P=0.488 P=0.493 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.238 | (e) | |FISHER EXACT | P=0.504N P=0.494 P=0.494 | (e) (e) (e) | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/59 (3%) 1/58 (2%) 2/58 (3%) 2/58 (3%) | 0/57 (0%) 0/58 (0%) 0/58 (0%) 0/59 (0%) | |ADJUSTED (b) | 5.6% 6.3% 6.0% 5.2% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 1/16 (6%) 0/18 (0%) 0/21 (0%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 610 733 (T) 471 583 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.540 P=0.490N P=0.684N P=0.685N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.508 P=0.464N P=0.662 P=0.692N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.516 P=0.490N P=0.682 P=0.686 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.517 | (e) | |FISHER EXACT | P=0.506N P=0.684 P=0.684 | (e) (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/59 (3%) 1/58 (2%) 2/58 (3%) 2/58 (3%) | 0/57 (0%) 0/58 (0%) 0/58 (0%) 0/59 (0%) | |ADJUSTED (b) | 5.6% 6.3% 6.0% 5.2% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 1/16 (6%) 0/18 (0%) 0/21 (0%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 610 733 (T) 471 583 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.540 P=0.490N P=0.684N P=0.685N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.508 P=0.464N P=0.662 P=0.692N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.516 P=0.490N P=0.682 P=0.686 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.517 | (e) | |FISHER EXACT | P=0.506N P=0.684 P=0.684 | (e) (e) (e) | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/64 (0%) 0/63 (0%) 0/63 (0%) 2/63 (3%) | 0/62 (0%) 0/63 (0%) 0/63 (0%) 1/64 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 9.5% | 0.0% 0.0% 0.0% 3.4% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 0/18 (0%) 2/21 (10%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 1/29 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- 733 (T) | --- --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.068 (e) (e) P=0.299 | P=0.247 (e) (e) P=0.555 | |INCIDENTAL TUMOR | P=0.068 (e) (e) P=0.299 | P=0.247 (e) (e) P=0.555 | |LOGISTIC REGRESSION | P=0.068 (e) (e) P=0.299 | P=0.247 (e) (e) P=0.555 | |COCHRAN-ARMITAGE | P=0.046 * | P=0.201 | |FISHER EXACT | (e) (e) P=0.244 | (e) (e) P=0.508 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/64 (2%) 0/63 (0%) 1/63 (2%) 3/63 (5%) | 0/62 (0%) 0/63 (0%) 0/63 (0%) 1/64 (2%) | |ADJUSTED (b) | 6.3% 0.0% 4.0% 11.8% | 0.0% 0.0% 0.0% 3.4% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/16 (6%) 0/16 (0%) 0/18 (0%) 2/21 (10%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 1/29 (3%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 711 628 | --- --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.137 P=0.500N P=0.722N P=0.396 | P=0.247 (e) (e) P=0.555 | |INCIDENTAL TUMOR | P=0.114 P=0.500N P=0.759 P=0.394 | P=0.247 (e) (e) P=0.555 | |LOGISTIC REGRESSION | P=0.099 P=0.500N P=0.740N P=0.326 | P=0.247 (e) (e) P=0.555 | |COCHRAN-ARMITAGE | P=0.094 | P=0.201 | |FISHER EXACT | P=0.504N P=0.748 P=0.304 | (e) (e) P=0.508 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/64 (2%) 1/63 (2%) 0/63 (0%) 0/63 (0%) | 4/63 (6%) 4/63 (6%) 1/63 (2%) 1/64 (2%) | |ADJUSTED (b) | 6.3% 6.3% 0.0% 0.0% | 13.9% 21.1% 2.5% 3.4% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/16 (6%) 1/16 (6%) 0/18 (0%) 0/21 (0%) | 2/22 (9%) 2/17 (12%) 0/28 (0%) 1/29 (3%) | |FIRST INCIDENCE (DAYS) | 733 (T) 733 (T) --- --- | 643 706 662 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.193N P=0.764 P=0.477N P=0.446N | P=0.044N* P=0.482 P=0.147N P=0.141N | |INCIDENTAL TUMOR | P=0.193N P=0.764 P=0.477N P=0.446N | P=0.083N P=0.555 P=0.175N P=0.240N | |LOGISTIC REGRESSION | P=0.193N P=0.764 P=0.477N P=0.446N | P=0.065N P=0.499 P=0.164N P=0.191N | |COCHRAN-ARMITAGE | P=0.236N | P=0.075N | |FISHER EXACT | P=0.748 P=0.504N P=0.504N | P=0.641N P=0.182N P=0.178N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/64 (2%) 1/63 (2%) 0/63 (0%) 0/63 (0%) | 5/63 (8%) 4/63 (6%) 1/63 (2%) 1/64 (2%) | |ADJUSTED (b) | 6.3% 6.3% 0.0% 0.0% | 16.3% 21.1% 2.5% 3.4% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/16 (6%) 1/16 (6%) 0/18 (0%) 0/21 (0%) | 2/22 (9%) 2/17 (12%) 0/28 (0%) 1/29 (3%) | |FIRST INCIDENCE (DAYS) | 733 (T) 733 (T) --- --- | 643 706 662 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.193N P=0.764 P=0.477N P=0.446N | P=0.023N* P=0.589 P=0.085N P=0.084N | |INCIDENTAL TUMOR | P=0.193N P=0.764 P=0.477N P=0.446N | P=0.048N* P=0.608N P=0.098N P=0.168N | |LOGISTIC REGRESSION | P=0.193N P=0.764 P=0.477N P=0.446N | P=0.036N* P=0.638 P=0.093N P=0.114N | |COCHRAN-ARMITAGE | P=0.236N | P=0.041N* | |FISHER EXACT | P=0.748 P=0.504N P=0.504N | P=0.500N P=0.104N P=0.100N | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/64 (0%) 1/63 (2%) 1/63 (2%) 1/63 (2%) | 17/63 (27%) 18/63 (29%) 10/63 (16%) 9/64 (14%) | |ADJUSTED (b) | 0.0% 3.2% 5.6% 2.4% | 49.0% 44.0% 28.8% 26.8% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 1/18 (6%) 0/21 (0%) | 7/22 (32%) 1/17 (6%) 6/28 (21%) 6/29 (21%) | |FIRST INCIDENCE (DAYS) | --- 679 733 (T) 602 | 542 392 617 538 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.413 P=0.528 P=0.523 P=0.505 | P=0.010N* P=0.262 P=0.045N* P=0.036N* | |INCIDENTAL TUMOR | P=0.383 P=0.534 P=0.523 P=0.529 | P=0.035N* P=0.581 P=0.086N P=0.100N | |LOGISTIC REGRESSION | P=0.387 P=0.510 P=0.523 P=0.497 | P=0.057N P=0.449 P=0.067N P=0.079N | |COCHRAN-ARMITAGE | P=0.383 | P=0.019N* | |FISHER EXACT | P=0.496 P=0.496 P=0.496 | P=0.500 P=0.096N P=0.056N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/64 (0%) 1/63 (2%) 1/63 (2%) 1/63 (2%) | 18/63 (29%) 18/63 (29%) 10/63 (16%) 9/64 (14%) | |ADJUSTED (b) | 0.0% 3.2% 5.6% 2.4% | 50.5% 44.0% 28.8% 26.8% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 1/18 (6%) 0/21 (0%) | 7/22 (32%) 1/17 (6%) 6/28 (21%) 6/29 (21%) | |FIRST INCIDENCE (DAYS) | --- 679 733 (T) 602 | 542 392 617 538 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.413 P=0.528 P=0.523 P=0.505 | P=0.007N** P=0.311 P=0.031N* P=0.025N* | |INCIDENTAL TUMOR | P=0.383 P=0.534 P=0.523 P=0.529 | P=0.024N* P=0.515N P=0.058N P=0.076N | |LOGISTIC REGRESSION | P=0.387 P=0.510 P=0.523 P=0.497 | P=0.042N* P=0.526 P=0.044N* P=0.053N | |COCHRAN-ARMITAGE | P=0.383 | P=0.012N* | |FISHER EXACT | P=0.496 P=0.496 P=0.496 | P=0.578N P=0.066N P=0.037N* | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/64 (2%) 2/63 (3%) 1/63 (2%) 1/63 (2%) | 22/63 (35%) 21/63 (33%) 11/63 (17%) 10/64 (16%) | |ADJUSTED (b) | 6.3% 9.3% 5.6% 2.4% | 59.4% 53.6% 30.7% 30.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/16 (6%) 1/16 (6%) 1/18 (6%) 0/21 (0%) | 9/22 (41%) 3/17 (18%) 6/28 (21%) 7/29 (24%) | |FIRST INCIDENCE (DAYS) | 733 (T) 679 733 (T) 602 | 542 392 617 538 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.466N P=0.516 P=0.737N P=0.728N | P=0.001N** P=0.322 P=0.009N** P=0.006N** | |INCIDENTAL TUMOR | P=0.488N P=0.520 P=0.737N P=0.714N | P=0.005N** P=0.474N P=0.016N* P=0.028N* | |LOGISTIC REGRESSION | P=0.518N P=0.529 P=0.737N P=0.759N | P=0.010N** P=0.568 P=0.012N* P=0.016N* | |COCHRAN-ARMITAGE | P=0.531N | P=0.003N** | |FISHER EXACT | P=0.494 P=0.748 P=0.748 | P=0.500N P=0.021N* P=0.010N* | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Mesentery | | Lipoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/64 (0%) 2/63 (3%) 0/63 (0%) 0/63 (0%) | 0/63 (0%) 0/63 (0%) 1/63 (2%) 0/64 (0%) | |ADJUSTED (b) | 0.0% 5.7% 0.0% 0.0% | 0.0% 0.0% 3.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 0/18 (0%) 0/21 (0%) | 0/22 (0%) 0/17 (0%) 1/28 (4%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- 566 --- --- | --- --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.384N P=0.261 (e) (e) | P=0.736 (e) P=0.548 (e) | |INCIDENTAL TUMOR | P=0.426N P=0.275 (e) (e) | P=0.736 (e) P=0.548 (e) | |LOGISTIC REGRESSION | P=0.396N P=0.238 (e) (e) | P=0.736 (e) P=0.548 (e) | |COCHRAN-ARMITAGE | P=0.397N | P=0.693 | |FISHER EXACT | P=0.244 (e) (e) | (e) P=0.500 (e) | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/64 (3%) 1/63 (2%) 1/63 (2%) 0/63 (0%) | 0/63 (0%) 1/63 (2%) 0/63 (0%) 0/64 (0%) | |ADJUSTED (b) | 7.3% 2.6% 2.8% 0.0% | 0.0% 5.9% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 0/18 (0%) 0/21 (0%) | 0/22 (0%) 1/17 (6%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 577 640 617 --- | --- 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.151N P=0.464N P=0.495N P=0.224N | P=0.500N P=0.449 (e) (e) | |INCIDENTAL TUMOR | P=0.154N P=0.447N P=0.498N P=0.263N | P=0.500N P=0.449 (e) (e) | |LOGISTIC REGRESSION | P=0.155N P=0.494N P=0.500N P=0.236N | P=0.500N P=0.449 (e) (e) | |COCHRAN-ARMITAGE | P=0.157N | P=0.557N | |FISHER EXACT | P=0.506N P=0.506N P=0.252N | P=0.500 (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/64 (0%) 1/63 (2%) 3/63 (5%) 0/63 (0%) | 3/63 (5%) 1/63 (2%) 2/63 (3%) 1/64 (2%) | |ADJUSTED (b) | 0.0% 2.9% 13.4% 0.0% | 6.4% 2.1% 5.1% 2.1% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 1/18 (6%) 0/21 (0%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- 646 697 --- | 536 559 661 480 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.590N P=0.518 P=0.151 (e) | P=0.298N P=0.338N P=0.468N P=0.355N | |INCIDENTAL TUMOR | P=0.565 P=0.534 P=0.112 (e) | P=0.431N P=0.152N P=0.659N P=0.419N | |LOGISTIC REGRESSION | P=0.625N P=0.504 P=0.135 (e) | P=0.448N P=0.297N P=0.623N P=0.280N | |COCHRAN-ARMITAGE | P=0.629 | P=0.278N | |FISHER EXACT | P=0.496 P=0.119 (e) | P=0.309N P=0.500N P=0.304N | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/64 (3%) 2/63 (3%) 4/63 (6%) 0/63 (0%) | 3/63 (5%) 2/63 (3%) 2/63 (3%) 1/64 (2%) | |ADJUSTED (b) | 7.3% 5.3% 15.8% 0.0% | 6.4% 7.9% 5.1% 2.1% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 1/18 (6%) 0/21 (0%) | 0/22 (0%) 1/17 (6%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 577 640 617 --- | 536 559 661 480 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.211N P=0.655N P=0.377 P=0.224N | P=0.232N P=0.552N P=0.468N P=0.355N | |INCIDENTAL TUMOR | P=0.274N P=0.637N P=0.327 P=0.263N | P=0.335N P=0.353N P=0.659N P=0.419N | |LOGISTIC REGRESSION | P=0.231N P=0.688N P=0.348 P=0.236N | P=0.229N P=0.500N P=0.623N P=0.280N | |COCHRAN-ARMITAGE | P=0.238N | P=0.229N | |FISHER EXACT | P=0.685 P=0.332 P=0.252N | P=0.500N P=0.500N P=0.304N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/64 (0%) 0/63 (0%) 3/63 (5%) 0/63 (0%) | 3/63 (5%) 1/63 (2%) 2/63 (3%) 1/64 (2%) | |ADJUSTED (b) | 0.0% 0.0% 13.4% 0.0% | 6.4% 2.1% 5.1% 2.1% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 1/18 (6%) 0/21 (0%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 697 --- | 536 559 661 480 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.586 (e) P=0.151 (e) | P=0.298N P=0.338N P=0.468N P=0.355N | |INCIDENTAL TUMOR | P=0.486 (e) P=0.112 (e) | P=0.431N P=0.152N P=0.659N P=0.419N | |LOGISTIC REGRESSION | P=0.553 (e) P=0.135 (e) | P=0.448N P=0.297N P=0.623N P=0.280N | |COCHRAN-ARMITAGE | P=0.531 | P=0.278N | |FISHER EXACT | (e) P=0.119 (e) | P=0.309N P=0.500N P=0.304N | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/64 (3%) 1/63 (2%) 1/63 (2%) 0/63 (0%) | 0/63 (0%) 1/63 (2%) 0/63 (0%) 0/64 (0%) | |ADJUSTED (b) | 7.3% 2.6% 2.8% 0.0% | 0.0% 5.9% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 0/18 (0%) 0/21 (0%) | 0/22 (0%) 1/17 (6%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 577 640 617 --- | --- 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.151N P=0.464N P=0.495N P=0.224N | P=0.500N P=0.449 (e) (e) | |INCIDENTAL TUMOR | P=0.154N P=0.447N P=0.498N P=0.263N | P=0.500N P=0.449 (e) (e) | |LOGISTIC REGRESSION | P=0.155N P=0.494N P=0.500N P=0.236N | P=0.500N P=0.449 (e) (e) | |COCHRAN-ARMITAGE | P=0.157N | P=0.557N | |FISHER EXACT | P=0.506N P=0.506N P=0.252N | P=0.500 (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/59 (25%) 12/56 (21%) 18/58 (31%) 14/58 (24%) | 22/57 (39%) 24/58 (41%) 24/58 (41%) 22/59 (37%) | |ADJUSTED (b) | 44.5% 42.4% 59.1% 46.2% | 63.6% 72.3% 62.1% 62.3% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 2/5 (40%) 0/5 (0%) 0/5 (0%) 1/5 (20%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 3/16 (19%) 3/15 (20%) 8/18 (44%) 6/21 (29%) | 11/22 (50%) 9/17 (53%) 14/28 (50%) 16/29 (55%) | |FIRST INCIDENCE (DAYS) | 458 (I) 547 432 458 (I) | 621 537 629 538 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.407N P=0.304N P=0.435 P=0.366N | P=0.142N P=0.118 P=0.430N P=0.321N | |INCIDENTAL TUMOR | P=0.481 P=0.371N P=0.334 P=0.552N | P=0.454 P=0.340 P=0.561N P=0.391 | |LOGISTIC REGRESSION | P=0.523 P=0.357N P=0.340 P=0.494N | P=0.522N P=0.228 P=0.565 P=0.471 | |COCHRAN-ARMITAGE | P=0.504 | P=0.442N | |FISHER EXACT | P=0.388N P=0.320 P=0.521N | P=0.455 P=0.455 P=0.518N | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, | | malignant or NOS), or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/64 (0%) 1/63 (2%) 0/63 (0%) 2/63 (3%) | 0/63 (0%) 0/63 (0%) 0/63 (0%) 0/64 (0%) | |ADJUSTED (b) | 0.0% 3.4% 0.0% 6.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 0/18 (0%) 0/21 (0%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- 683 --- 419 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.153 P=0.530 (e) P=0.255 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.099 P=0.534 (e) P=0.166 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.140 P=0.511 (e) P=0.232 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.140 | (e) | |FISHER EXACT | P=0.496 (e) P=0.244 | (e) (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal | | Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/64 (8%) 3/63 (5%) 3/63 (5%) 4/63 (6%) | 1/63 (2%) 0/63 (0%) 0/63 (0%) 0/64 (0%) | |ADJUSTED (b) | 18.7% 13.4% 14.3% 15.0% | 2.1% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 1/5 (20%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/16 (6%) 1/16 (6%) 2/18 (11%) 2/21 (10%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 458 (I) 683 685 419 | 566 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.396N P=0.331N P=0.305N P=0.429N | P=0.323N P=0.513N P=0.488N P=0.536N | |INCIDENTAL TUMOR | P=0.532N P=0.299N P=0.369N P=0.570N | P=0.486N P=0.372N P=0.602N P=0.814N | |LOGISTIC REGRESSION | P=0.479N P=0.333N P=0.343N P=0.496N | P=0.301N P=0.494N P=0.504N P=0.487N | |COCHRAN-ARMITAGE | P=0.492N | P=0.307N | |FISHER EXACT | P=0.368N P=0.368N P=0.510N | P=0.500N P=0.500N P=0.496N | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/64 (0%) 1/63 (2%) 0/63 (0%) 3/63 (5%) | 0/63 (0%) 0/63 (0%) 1/63 (2%) 2/64 (3%) | |ADJUSTED (b) | 0.0% 4.3% 0.0% 10.5% | 0.0% 0.0% 3.6% 5.5% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 0/18 (0%) 1/21 (5%) | 0/22 (0%) 0/17 (0%) 1/28 (4%) 1/29 (3%) | |FIRST INCIDENCE (DAYS) | --- 704 --- 628 | --- --- 729 (T) 480 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.060 P=0.518 (e) P=0.161 | P=0.095 (e) P=0.548 P=0.258 | |INCIDENTAL TUMOR | P=0.034 * P=0.534 (e) P=0.124 | P=0.148 (e) P=0.548 P=0.349 | |LOGISTIC REGRESSION | P=0.045 * P=0.515 (e) P=0.125 | P=0.067 (e) P=0.548 P=0.240 | |COCHRAN-ARMITAGE | P=0.044 * | P=0.071 | |FISHER EXACT | P=0.496 (e) P=0.119 | (e) P=0.500 P=0.252 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/64 (0%) 1/63 (2%) 1/63 (2%) 3/63 (5%) | 1/63 (2%) 0/63 (0%) 1/63 (2%) 2/64 (3%) | |ADJUSTED (b) | 0.0% 4.3% 4.0% 10.5% | 2.8% 0.0% 3.6% 5.5% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 0/18 (0%) 1/21 (5%) | 0/22 (0%) 0/17 (0%) 1/28 (4%) 1/29 (3%) | |FIRST INCIDENCE (DAYS) | --- 704 711 628 | 666 --- 729 (T) 480 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.073 P=0.518 P=0.545 P=0.161 | P=0.296 P=0.589N P=0.731N P=0.513 | |INCIDENTAL TUMOR | P=0.035 * P=0.534 P=0.473 P=0.124 | P=0.330 P=0.557N P=0.727N P=0.545 | |LOGISTIC REGRESSION | P=0.055 P=0.515 P=0.515 P=0.125 | P=0.239 P=0.517N P=0.747N P=0.496 | |COCHRAN-ARMITAGE | P=0.054 | P=0.249 | |FISHER EXACT | P=0.496 P=0.496 P=0.119 | P=0.500N P=0.752N P=0.506 | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/64 (8%) 1/63 (2%) 1/63 (2%) 0/63 (0%) | 0/63 (0%) 0/63 (0%) 0/63 (0%) 0/64 (0%) | |ADJUSTED (b) | 18.7% 4.3% 3.6% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 1/5 (20%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/16 (6%) 0/16 (0%) 0/18 (0%) 0/21 (0%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 458 (I) 704 685 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.014N* P=0.099N P=0.088N P=0.030N* | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.024N* P=0.079N P=0.118N P=0.049N* | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.016N* P=0.097N P=0.101N P=0.033N* | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.017N* | (e) | |FISHER EXACT | P=0.107N P=0.107N P=0.030N* | (e) (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/64 (0%) 0/63 (0%) 2/63 (3%) 2/63 (3%) | 0/63 (0%) 0/63 (0%) 0/63 (0%) 0/64 (0%) | |ADJUSTED (b) | 0.0% 0.0% 11.1% 9.5% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 2/18 (11%) 2/21 (10%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 733 (T) 733 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.129 (e) P=0.263 P=0.299 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.129 (e) P=0.263 P=0.299 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.129 (e) P=0.263 P=0.299 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.084 | (e) | |FISHER EXACT | (e) P=0.244 P=0.244 | (e) (e) (e) | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/64 (8%) 2/63 (3%) 3/63 (5%) 2/63 (3%) | 1/63 (2%) 0/63 (0%) 0/63 (0%) 0/64 (0%) | |ADJUSTED (b) | 18.7% 10.3% 14.3% 9.5% | 2.1% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 1/5 (20%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/16 (6%) 1/16 (6%) 2/18 (11%) 2/21 (10%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 458 (I) 704 685 733 (T) | 566 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.158N P=0.206N P=0.305N P=0.172N | P=0.323N P=0.513N P=0.488N P=0.536N | |INCIDENTAL TUMOR | P=0.220N P=0.180N P=0.369N P=0.233N | P=0.486N P=0.372N P=0.602N P=0.814N | |LOGISTIC REGRESSION | P=0.203N P=0.200N P=0.343N P=0.207N | P=0.301N P=0.494N P=0.504N P=0.487N | |COCHRAN-ARMITAGE | P=0.220N | P=0.307N | |FISHER EXACT | P=0.226N P=0.368N P=0.226N | P=0.500N P=0.500N P=0.496N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/64 (8%) 1/63 (2%) 3/63 (5%) 2/63 (3%) | 0/63 (0%) 0/63 (0%) 0/63 (0%) 0/64 (0%) | |ADJUSTED (b) | 18.7% 4.3% 14.3% 9.5% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 1/5 (20%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/16 (6%) 0/16 (0%) 2/18 (11%) 2/21 (10%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 458 (I) 704 685 733 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.197N P=0.099N P=0.305N P=0.172N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.273N P=0.079N P=0.369N P=0.233N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.244N P=0.097N P=0.343N P=0.207N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.260N | (e) | |FISHER EXACT | P=0.107N P=0.368N P=0.226N | (e) (e) (e) | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 50/59 (85%) 51/58 (88%) 50/58 (86%) 54/58 (93%) | | |ADJUSTED (b) | 100.0% 98.0% 98.0% 98.2% | | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | | |INTERIM SACRIFICE 2 (c)| 5/5 (100%) 5/5 (100%) 5/5 (100%) 4/5 (80%) | | |TERMINAL (d) | 16/16 (100%) 15/16 (94%) 17/18 (94%) 20/21 (95%) | | |FIRST INCIDENCE (DAYS) | 458 (I) 458 (I) 458 (I) 320 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.379N P=0.474N P=0.367N P=0.417N | | |INCIDENTAL TUMOR | P=0.118 P=0.573N P=0.574N P=0.172 | | |LOGISTIC REGRESSION | P=0.109 P=0.581 P=0.610 P=0.146 | | |COCHRAN-ARMITAGE | P=0.117 | | |FISHER EXACT | P=0.409 P=0.515 P=0.126 | | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/58 (14%) 1/58 (2%) 2/56 (4%) 1/57 (2%) | 1/57 (2%) 2/58 (3%) 4/58 (7%) 2/57 (4%) | |ADJUSTED (b) | 37.6% 6.3% 6.8% 4.8% | 2.2% 8.4% 10.6% 6.9% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 4/16 (25%) 1/16 (6%) 0/18 (0%) 1/21 (5%) | 0/22 (0%) 1/17 (6%) 1/28 (4%) 2/29 (7%) | |FIRST INCIDENCE (DAYS) | 577 733 (T) 538 733 (T) | 621 619 648 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.008N** P=0.018N* P=0.036N* P=0.008N** | P=0.476 P=0.419 P=0.224 P=0.547 | |INCIDENTAL TUMOR | P=0.015N* P=0.013N* P=0.060N P=0.014N* | P=0.268 P=0.617 P=0.174 P=0.402 | |LOGISTIC REGRESSION | P=0.013N* P=0.012N* P=0.045N* P=0.012N* | P=0.379 P=0.495 P=0.186 P=0.483 | |COCHRAN-ARMITAGE | P=0.016N* | P=0.384 | |FISHER EXACT | P=0.016N* P=0.053N P=0.017N* | P=0.507 P=0.187 P=0.500 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 1/58 (2%) 0/56 (0%) 2/57 (4%) | 1/57 (2%) 0/58 (0%) 2/58 (3%) 3/57 (5%) | |ADJUSTED (b) | 0.0% 2.7% 0.0% 7.9% | 4.5% 0.0% 7.1% 9.5% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 0/18 (0%) 1/21 (5%) | 1/22 (5%) 0/17 (0%) 2/28 (7%) 2/29 (7%) | |FIRST INCIDENCE (DAYS) | --- 643 --- 671 | 729 (T) --- 729 (T) 661 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.158 P=0.529 (e) P=0.282 | P=0.176 P=0.551N P=0.585 P=0.379 | |INCIDENTAL TUMOR | P=0.138 P=0.529 (e) P=0.226 | P=0.153 P=0.551N P=0.585 P=0.327 | |LOGISTIC REGRESSION | P=0.142 P=0.501 (e) P=0.248 | P=0.127 P=0.551N P=0.585 P=0.300 | |COCHRAN-ARMITAGE | P=0.139 | P=0.100 | |FISHER EXACT | P=0.500 (e) P=0.243 | P=0.496N P=0.507 P=0.309 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/58 (14%) 2/58 (3%) 2/56 (4%) 3/57 (5%) | 2/57 (4%) 2/58 (3%) 6/58 (10%) 5/57 (9%) | |ADJUSTED (b) | 37.6% 8.8% 6.8% 12.5% | 6.7% 8.4% 17.3% 16.2% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 4/16 (25%) 1/16 (6%) 0/18 (0%) 2/21 (10%) | 1/22 (5%) 1/17 (6%) 3/28 (11%) 4/29 (14%) | |FIRST INCIDENCE (DAYS) | 577 643 538 671 | 621 619 648 661 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.062N P=0.046N* P=0.036N* P=0.054N | P=0.206 P=0.604 P=0.200 P=0.292 | |INCIDENTAL TUMOR | P=0.100N P=0.037N* P=0.060N P=0.089N | P=0.087 P=0.630N P=0.163 P=0.178 | |LOGISTIC REGRESSION | P=0.091N P=0.034N* P=0.045N* P=0.077N | P=0.110 P=0.666 P=0.153 P=0.200 | |COCHRAN-ARMITAGE | P=0.104N | P=0.108 | |FISHER EXACT | P=0.047N* P=0.053N P=0.107N | P=0.684N P=0.141 P=0.219 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 0/58 (0%) 1/56 (2%) 1/57 (2%) | 0/57 (0%) 2/58 (3%) 0/58 (0%) 0/57 (0%) | |ADJUSTED (b) | 0.0% 0.0% 4.5% 4.8% | 0.0% 7.7% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 0/18 (0%) 1/21 (5%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 725 733 (T) | --- 627 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.280 (e) P=0.540 P=0.554 | P=0.376N P=0.179 (e) (e) | |INCIDENTAL TUMOR | P=0.219 (e) P=0.459 P=0.554 | P=0.590N P=0.272 (e) (e) | |LOGISTIC REGRESSION | P=0.254 (e) P=0.519 P=0.554 | P=0.397N P=0.230 (e) (e) | |COCHRAN-ARMITAGE | P=0.230 | P=0.395N | |FISHER EXACT | (e) P=0.491 P=0.496 | P=0.252 (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 5/63 (8%) 3/63 (5%) 4/63 (6%) 7/64 (11%) | |ADJUSTED (b) | | 13.9% 13.6% 11.2% 20.3% | |INTERIM SACRIFICE 1 (c)| | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| | 1/5 (20%) 0/5 (0%) 1/5 (20%) 0/5 (0%) | |TERMINAL (d) | | 1/22 (5%) 1/17 (6%) 2/28 (7%) 4/29 (14%) | |FIRST INCIDENCE (DAYS) | | 459 (I) 656 459 (I) 538 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.331 P=0.513N P=0.430N P=0.438 | |INCIDENTAL TUMOR | | P=0.249 P=0.429N P=0.472N P=0.359 | |LOGISTIC REGRESSION | | P=0.207 P=0.386N P=0.497N P=0.354 | |COCHRAN-ARMITAGE | | P=0.228 | |FISHER EXACT | | P=0.359N P=0.500N P=0.393 | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 5/63 (8%) 3/63 (5%) 4/63 (6%) 8/64 (13%) | |ADJUSTED (b) | | 13.9% 13.6% 11.2% 22.9% | |INTERIM SACRIFICE 1 (c)| | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| | 1/5 (20%) 0/5 (0%) 1/5 (20%) 0/5 (0%) | |TERMINAL (d) | | 1/22 (5%) 1/17 (6%) 2/28 (7%) 4/29 (14%) | |FIRST INCIDENCE (DAYS) | | 459 (I) 656 459 (I) 538 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.229 P=0.513N P=0.430N P=0.342 | |INCIDENTAL TUMOR | | P=0.144 P=0.429N P=0.472N P=0.231 | |LOGISTIC REGRESSION | | P=0.123 P=0.386N P=0.497N P=0.252 | |COCHRAN-ARMITAGE | | P=0.140 | |FISHER EXACT | | P=0.359N P=0.500N P=0.290 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/64 (2%) 0/63 (0%) 2/63 (3%) 0/63 (0%) | 0/63 (0%) 0/63 (0%) 1/63 (2%) 0/64 (0%) | |ADJUSTED (b) | 3.7% 0.0% 4.6% 0.0% | 0.0% 0.0% 1.9% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 0/18 (0%) 0/21 (0%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 679 --- 279 --- | --- --- 510 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.455N P=0.472N P=0.518 P=0.493N | P=0.679 (e) P=0.504 (e) | |INCIDENTAL TUMOR | P=0.562N P=0.466N P=0.415 P=0.575N | P=0.676N (e) P=0.318 (e) | |LOGISTIC REGRESSION | P=0.474N P=0.490N P=0.484 P=0.495N | P=0.710 (e) P=0.494 (e) | |COCHRAN-ARMITAGE | P=0.469N | P=0.693 | |FISHER EXACT | P=0.504N P=0.494 P=0.504N | (e) P=0.500 (e) | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 31/64 (48%) 36/63 (57%) 39/63 (62%) 38/63 (60%) | 25/63 (40%) 26/63 (41%) 34/63 (54%) 23/64 (36%) | |ADJUSTED (b) | 81.4% 89.0% 90.3% 82.2% | 62.0% 67.5% 67.1% 54.2% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 1/5 (20%) 0/5 (0%) | 0/5 (0%) 1/5 (20%) 1/5 (20%) 0/5 (0%) | |TERMINAL (d) | 10/16 (63%) 12/16 (75%) 14/18 (78%) 13/21 (62%) | 8/22 (36%) 7/17 (41%) 12/28 (43%) 10/29 (34%) | |FIRST INCIDENCE (DAYS) | 496 539 458 (I) 539 | 503 459 (I) 403 475 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.444 P=0.383 P=0.283 P=0.424 | P=0.191N P=0.179 P=0.312 P=0.308N | |INCIDENTAL TUMOR | P=0.080 P=0.170 P=0.079 P=0.096 | P=0.199 P=0.559 P=0.039 * P=0.289 | |LOGISTIC REGRESSION | P=0.048 * P=0.290 P=0.060 P=0.060 | P=0.258 P=0.547 P=0.050 * P=0.351 | |COCHRAN-ARMITAGE | P=0.116 | P=0.401N | |FISHER EXACT | P=0.211 P=0.089 P=0.122 | P=0.500 P=0.076 P=0.400N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/64 (0%) 2/63 (3%) 0/63 (0%) 0/63 (0%) | 0/63 (0%) 0/63 (0%) 0/63 (0%) 0/64 (0%) | |ADJUSTED (b) | 0.0% 3.9% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/16 (0%) 0/16 (0%) 0/18 (0%) 0/21 (0%) | 0/22 (0%) 0/17 (0%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- 363 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.391N P=0.250 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.461N P=0.255 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.405N P=0.213 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.397N | (e) | |FISHER EXACT | P=0.244 (e) (e) | (e) (e) (e) | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 54/64 (84%) 55/63 (87%) 55/63 (87%) 55/63 (87%) | 36/63 (57%) 42/63 (67%) 36/63 (57%) 36/64 (56%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 82.4% 90.9% 83.0% 87.6% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 5/5 (100%) 5/5 (100%) 5/5 (100%) 4/5 (80%) | 1/5 (20%) 0/5 (0%) 1/5 (20%) 0/5 (0%) | |TERMINAL (d) | 16/16 (100%) 16/16 (100%) 18/18 (100%) 21/21 (100%)| 15/22 (68%) 13/17 (76%) 21/28 (75%) 24/29 (83%) | |FIRST INCIDENCE (DAYS) | 458 (I) 458 (I) 432 320 | 459 (I) 392 459 (I) 480 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.239N P=0.458N P=0.424N P=0.275N | P=0.065N P=0.028 * P=0.230N P=0.283N | |INCIDENTAL TUMOR | P=0.454 P=0.587 P=0.554 P=0.504 | P=0.524N P=0.111 P=0.389N P=0.326 | |LOGISTIC REGRESSION | P=0.323 P=0.522 P=0.466 P=0.422 | P=0.400 P=0.066 P=0.447N P=0.333 | |COCHRAN-ARMITAGE | P=0.390 | P=0.333N | |FISHER EXACT | P=0.414 P=0.414 P=0.414 | P=0.180 P=0.571N P=0.531N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | 0.0MG/M3 0.12MGM3 0.25MGM3 0.5MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 37/64 (58%) 43/63 (68%) 42/63 (67%) 41/63 (65%) | 35/63 (56%) 34/63 (54%) 38/63 (60%) 29/64 (45%) | |ADJUSTED (b) | 88.8% 93.1% 91.0% 86.9% | 73.5% 80.8% 72.5% 64.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 1/5 (20%) 0/5 (0%) | 0/5 (0%) 1/5 (20%) 1/5 (20%) 0/5 (0%) | |TERMINAL (d) | 12/16 (75%) 13/16 (81%) 14/18 (78%) 15/21 (71%) | 10/22 (45%) 10/17 (59%) 14/28 (50%) 13/29 (45%) | |FIRST INCIDENCE (DAYS) | 262 539 279 320 | 503 459 (I) 403 272 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.383N P=0.361 P=0.447 P=0.494N | P=0.065N P=0.210 P=0.432N P=0.152N | |INCIDENTAL TUMOR | P=0.230 P=0.096 P=0.167 P=0.216 | P=0.446 P=0.372N P=0.194 P=0.500 | |LOGISTIC REGRESSION | P=0.291 P=0.204 P=0.212 P=0.275 | P=0.490N P=0.387N P=0.229 P=0.271N | |COCHRAN-ARMITAGE | P=0.305 | P=0.150N | |FISHER EXACT | P=0.150 P=0.199 P=0.255 | P=0.500N P=0.359 P=0.164N | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 58/64 (91%) 57/63 (90%) 57/63 (90%) 55/63 (87%) | 50/63 (79%) 53/63 (84%) 52/63 (83%) 48/64 (75%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 96.1% 98.1% 96.3% 98.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 1/5 (20%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 5/5 (100%) 5/5 (100%) 5/5 (100%) 4/5 (80%) | 1/5 (20%) 1/5 (20%) 2/5 (40%) 0/5 (0%) | |TERMINAL (d) | 16/16 (100%) 16/16 (100%) 18/18 (100%) 21/21 (100%)| 20/22 (91%) 16/17 (94%) 26/28 (93%) 28/29 (97%) | |FIRST INCIDENCE (DAYS) | 262 363 199 (I) 320 | 459 (I) 392 403 272 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.125N P=0.363N P=0.337N P=0.144N | P=0.042N* P=0.045 * P=0.248N P=0.181N | |INCIDENTAL TUMOR | P=0.143N P=0.807 P=0.605N P=0.233N | P=0.520 P=0.261 P=0.449 P=0.386 | |LOGISTIC REGRESSION | P=0.126N P=0.324N P=0.515N P=0.167N | P=0.442 P=0.196 P=0.494 P=0.317 | |COCHRAN-ARMITAGE | P=0.303N | P=0.224N | |FISHER EXACT | P=0.607N P=0.607N P=0.377N | P=0.323 P=0.410 P=0.354N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 05 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SULFATE HEXAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS (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): 199 458 Female interim sacrifices(days): 200 459 (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).