TDMS Study 05107-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: LITRI NICKEL SUBSULFIDE DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 TIME: 22:25:53 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: Y01ES30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C61654 PATHOLOGIST: F. HAHN CAS: 12035722 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: LITRI NICKEL SUBSULFIDE DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 TIME: 22:25:53 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: Y01ES30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C61654 PATHOLOGIST: F. HAHN CAS: 12035722 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 SUBSULFIDE DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 TIME: 22:25:53 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: Y01ES30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C61654 PATHOLOGIST: F. HAHN CAS: 12035722 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF NICKEL SUBSULFIDE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma Malignant Pheochromocytoma: Benign, Complex, Malignant, NOS Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Skin Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma Squamous Cell Papilloma, Papilloma, or Keratoacanthoma Testes Adenoma Thyroid Gland: C-Cell Adenoma All Organs Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Lung Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma All Organs Benign Tumors ==================================================================================================== DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/58 (22%) 30/57 (53%) 37/58 (64%) | 2/58 (3%) 7/56 (13%) 36/58 (62%) | |ADJUSTED (b) | 54.4% 84.5% 88.0% | 7.6% 24.4% 85.5% | |INTERIM SACRIFICE 1 (c)| 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%) 0/3 (0%) 0/5 (0%) | |TERMINAL (d) | 4/13 (31%) 16/21 (76%) 13/18 (72%) | 1/25 (4%) 5/25 (20%) 22/28 (79%) | |FIRST INCIDENCE (DAYS) | 559 455 552 | 721 590 563 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.006 ** P=0.054 P=0.004 ** | P<0.001 ** P=0.087 P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.086 P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.002 ** P<0.001 ** | P<0.001 ** P=0.082 P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** | P=0.073 P<0.001 ** | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 2/57 (4%) 11/58 (19%) | 1/58 (2%) 0/56 (0%) 1/58 (2%) | |ADJUSTED (b) | 0.0% 6.9% 48.6% | 3.1% 0.0% 3.6% | |INTERIM SACRIFICE 1 (c)| 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%) 0/3 (0%) 0/5 (0%) | |TERMINAL (d) | 0/13 (0%) 0/21 (0%) 7/18 (39%) | 0/25 (0%) 0/25 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | --- 601 703 | 677 --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.309 P=0.004 ** | P=0.633 P=0.494N P=0.748N | |INCIDENTAL TUMOR | P<0.001 ** P=0.190 P=0.001 ** | P=0.567 P=0.536N P=0.701 | |LOGISTIC REGRESSION | P<0.001 ** P=0.250 P=0.002 ** | P=0.628 P=0.499N P=0.755N | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.624 | |FISHER EXACT | P=0.243 P<0.001 ** | P=0.509N P=0.752N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/58 (24%) 30/57 (53%) 42/58 (72%) | 3/58 (5%) 7/56 (13%) 36/58 (62%) | |ADJUSTED (b) | 55.4% 84.5% 100.0% | 10.4% 24.4% 85.5% | |INTERIM SACRIFICE 1 (c)| 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%) 0/3 (0%) 0/5 (0%) | |TERMINAL (d) | 4/13 (31%) 16/21 (76%) 18/18 (100%) | 1/25 (4%) 5/25 (20%) 22/28 (79%) | |FIRST INCIDENCE (DAYS) | 553 455 552 | 677 590 563 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.081 P<0.001 ** | P<0.001 ** P=0.170 P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.002 ** P<0.001 ** | P<0.001 ** P=0.159 P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.004 ** P<0.001 ** | P<0.001 ** P=0.164 P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P=0.001 ** P<0.001 ** | P=0.147 P<0.001 ** | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/58 (2%) 2/58 (3%) 0/59 (0%) | 0/57 (0%) 2/57 (4%) 1/57 (2%) | |ADJUSTED (b) | 7.7% 6.4% 0.0% | 0.0% 6.7% 3.6% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/1 (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%) | |TERMINAL (d) | 1/13 (8%) 0/21 (0%) 0/18 (0%) | 0/25 (0%) 1/25 (4%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 733 (T) 599 --- | --- 642 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.261N P=0.636 P=0.435N | P=0.657 P=0.234 P=0.523 | |INCIDENTAL TUMOR | P=0.279N P=0.509 P=0.435N | P=0.689 P=0.292 P=0.523 | |LOGISTIC REGRESSION | P=0.271N P=0.544 P=0.435N | P=0.649 P=0.241 P=0.523 | |COCHRAN-ARMITAGE | P=0.283N | P=0.642 | |FISHER EXACT | P=0.500 P=0.496N | P=0.248 P=0.500 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/58 (3%) 0/58 (0%) 0/59 (0%) | 2/57 (4%) 3/57 (5%) 3/57 (5%) | |ADJUSTED (b) | 5.5% 0.0% 0.0% | 4.0% 9.2% 10.1% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/1 (0%) | 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) | 1/5 (20%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/13 (0%) 0/21 (0%) 0/18 (0%) | 0/25 (0%) 1/25 (4%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 553 --- --- | 459 (I) 620 709 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.278N P=0.221N P=0.218N | P=0.547 P=0.516 P=0.532 | |INCIDENTAL TUMOR | P=0.308N P=0.214N P=0.249N | P=0.498 P=0.570 P=0.503 | |LOGISTIC REGRESSION | P=0.288N P=0.255N P=0.240N | P=0.514 P=0.481 P=0.497 | |COCHRAN-ARMITAGE | P=0.287N | P=0.514 | |FISHER EXACT | P=0.248N P=0.244N | P=0.500 P=0.500 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/58 (5%) 2/58 (3%) 0/59 (0%) | 2/57 (4%) 5/57 (9%) 4/57 (7%) | |ADJUSTED (b) | 12.8% 6.4% 0.0% | 4.0% 15.4% 13.6% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/1 (0%) | 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) | 1/5 (20%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/13 (8%) 0/21 (0%) 0/18 (0%) | 0/25 (0%) 2/25 (8%) 3/28 (11%) | |FIRST INCIDENCE (DAYS) | 553 599 --- | 459 (I) 620 709 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.096N P=0.380N P=0.095N | P=0.509 P=0.231 P=0.376 | |INCIDENTAL TUMOR | P=0.112N P=0.474N P=0.109N | P=0.485 P=0.295 P=0.349 | |LOGISTIC REGRESSION | P=0.105N P=0.483N P=0.114N | P=0.473 P=0.210 P=0.339 | |COCHRAN-ARMITAGE | P=0.107N | P=0.469 | |FISHER EXACT | P=0.500N P=0.119N | P=0.219 P=0.339 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Heart | | Schwannoma NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 0/58 (0%) 0/58 (0%) | 1/58 (2%) 2/58 (3%) 0/58 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 4.0% 4.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 0/13 (0%) 0/21 (0%) 0/18 (0%) | 1/25 (4%) 0/25 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 729 (T) 609 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.285N P=0.499 P=0.477N | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.225N P=0.629 P=0.477N | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.286N P=0.504 P=0.477N | |COCHRAN-ARMITAGE | (e) | P=0.287N | |FISHER EXACT | (e) (e) | P=0.500 P=0.500N | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/58 (3%) 4/58 (7%) 4/58 (7%) | 0/58 (0%) 1/58 (2%) 1/58 (2%) | |ADJUSTED (b) | 9.9% 16.7% 13.3% | 0.0% 4.0% 2.0% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 1/13 (8%) 2/21 (10%) 1/18 (6%) | 0/25 (0%) 1/25 (4%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 572 690 559 | --- 729 (T) 526 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.468 P=0.516 P=0.447 | P=0.548 P=0.500 P=0.517 | |INCIDENTAL TUMOR | P=0.428 P=0.375 P=0.369 | P=0.493 P=0.500 P=0.388 | |LOGISTIC REGRESSION | P=0.430 P=0.416 P=0.358 | P=0.524 P=0.500 P=0.470 | |COCHRAN-ARMITAGE | P=0.400 | P=0.527 | |FISHER EXACT | P=0.340 P=0.340 | P=0.500 P=0.500 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 1/58 (2%) 2/58 (3%) | 1/58 (2%) 1/58 (2%) 0/58 (0%) | |ADJUSTED (b) | 0.0% 2.0% 8.6% | 4.0% 2.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 0/13 (0%) 0/21 (0%) 1/18 (6%) | 1/25 (4%) 0/25 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- 538 650 | 729 (T) 566 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.240 P=0.512 P=0.287 | P=0.363N P=0.748N P=0.477N | |INCIDENTAL TUMOR | P=0.242 P=0.398 P=0.267 | P=0.329N P=0.700N P=0.477N | |LOGISTIC REGRESSION | P=0.225 P=0.446 P=0.266 | P=0.379N P=0.763 P=0.477N | |COCHRAN-ARMITAGE | P=0.223 | P=0.378N | |FISHER EXACT | P=0.500 P=0.248 | P=0.752N P=0.500N | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/58 (3%) 5/58 (9%) 6/58 (10%) | 1/58 (2%) 2/58 (3%) 1/58 (2%) | |ADJUSTED (b) | 9.9% 18.4% 21.0% | 4.0% 6.0% 2.0% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 1/13 (8%) 2/21 (10%) 2/18 (11%) | 1/25 (4%) 1/25 (4%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 572 538 559 | 729 (T) 566 526 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.246 P=0.367 P=0.223 | P=0.558N P=0.512 P=0.738N | |INCIDENTAL TUMOR | P=0.216 P=0.215 P=0.164 | P=0.571N P=0.564 P=0.714 | |LOGISTIC REGRESSION | P=0.208 P=0.258 P=0.155 | P=0.590N P=0.509 P=0.759 | |COCHRAN-ARMITAGE | P=0.190 | P=0.587N | |FISHER EXACT | P=0.219 P=0.136 | P=0.500 P=0.752N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/58 (7%) 1/58 (2%) 3/58 (5%) | 0/58 (0%) 0/58 (0%) 0/59 (0%) | |ADJUSTED (b) | 18.5% 2.2% 14.4% | 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/1 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/13 (8%) 0/21 (0%) 2/18 (11%) | 0/25 (0%) 0/25 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 574 570 703 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.604N P=0.114N P=0.354N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.627 P=0.162N P=0.445N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.634 P=0.170N P=0.432N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.611 | (e) | |FISHER EXACT | P=0.182N P=0.500N | (e) (e) | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/63 (0%) 3/63 (5%) 6/63 (10%) | 2/63 (3%) 5/63 (8%) 5/63 (8%) | |ADJUSTED (b) | 0.0% 10.5% 31.6% | 8.0% 17.8% 16.2% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 0/13 (0%) 0/21 (0%) 5/18 (28%) | 2/25 (8%) 4/25 (16%) 4/28 (14%) | |FIRST INCIDENCE (DAYS) | --- 549 731 | 729 (T) 594 594 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.033 * P=0.190 P=0.039 * | P=0.372 P=0.221 P=0.260 | |INCIDENTAL TUMOR | P=0.030 * P=0.071 P=0.032 * | P=0.403 P=0.246 P=0.291 | |LOGISTIC REGRESSION | P=0.029 * P=0.136 P=0.036 * | P=0.326 P=0.222 P=0.230 | |COCHRAN-ARMITAGE | P=0.023 * | P=0.312 | |FISHER EXACT | P=0.122 P=0.014 * | P=0.220 P=0.220 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/63 (0%) 3/63 (5%) 7/63 (11%) | 0/63 (0%) 0/63 (0%) 4/63 (6%) | |ADJUSTED (b) | 0.0% 10.3% 30.3% | 0.0% 0.0% 12.0% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 0/13 (0%) 1/21 (5%) 4/18 (22%) | 0/25 (0%) 0/25 (0%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | --- 623 621 | --- --- 635 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.015 * P=0.171 P=0.024 * | P=0.012 * (e) P=0.070 | |INCIDENTAL TUMOR | P=0.011 * P=0.164 P=0.016 * | P=0.017 * (e) P=0.112 | |LOGISTIC REGRESSION | P=0.011 * P=0.136 P=0.015 * | P=0.010 ** (e) P=0.067 | |COCHRAN-ARMITAGE | P=0.009 ** | P=0.010 ** | |FISHER EXACT | P=0.122 P=0.007 ** | (e) P=0.060 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/63 (0%) 6/63 (10%) 11/63 (17%) | 2/63 (3%) 5/63 (8%) 9/63 (14%) | |ADJUSTED (b) | 0.0% 19.7% 48.1% | 8.0% 17.8% 27.2% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 0/13 (0%) 1/21 (5%) 7/18 (39%) | 2/25 (8%) 4/25 (16%) 6/28 (21%) | |FIRST INCIDENCE (DAYS) | --- 549 621 | 729 (T) 594 594 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.005 ** P=0.044 * P=0.003 ** | P=0.042 * P=0.221 P=0.038 * | |INCIDENTAL TUMOR | P=0.003 ** P=0.015 * P=0.002 ** | P=0.056 P=0.246 P=0.062 | |LOGISTIC REGRESSION | P=0.003 ** P=0.023 * P=0.002 ** | P=0.030 * P=0.222 P=0.031 * | |COCHRAN-ARMITAGE | P=0.002 ** | P=0.029 * | |FISHER EXACT | P=0.014 * P<0.001 ** | P=0.220 P=0.027 * | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/63 (0%) 0/63 (0%) 0/63 (0%) | 1/63 (2%) 3/63 (5%) 0/63 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 4.0% 9.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 0/13 (0%) 0/21 (0%) 0/18 (0%) | 1/25 (4%) 1/25 (4%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 729 (T) 594 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.207N P=0.321 P=0.477N | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.224N P=0.339 P=0.477N | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.219N P=0.315 P=0.477N | |COCHRAN-ARMITAGE | (e) | P=0.225N | |FISHER EXACT | (e) (e) | P=0.309 P=0.500N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/63 (2%) 0/63 (0%) 0/63 (0%) | 2/63 (3%) 3/63 (5%) 0/63 (0%) | |ADJUSTED (b) | 2.8% 0.0% 0.0% | 6.7% 9.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 0/13 (0%) 0/21 (0%) 0/18 (0%) | 1/25 (4%) 1/25 (4%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 596 --- --- | 665 594 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.539N P=0.469N P=0.489N | P=0.133N P=0.508 P=0.234N | |INCIDENTAL TUMOR | P=0.557N P=0.479N P=0.511N | P=0.163N P=0.517 P=0.299N | |LOGISTIC REGRESSION | P=0.538N P=0.500N P=0.500N | P=0.137N P=0.513 P=0.230N | |COCHRAN-ARMITAGE | P=0.538N | P=0.142N | |FISHER EXACT | P=0.500N P=0.500N | P=0.500 P=0.248N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/63 (0%) 1/63 (2%) 0/63 (0%) | 22/63 (35%) 11/63 (17%) 10/63 (16%) | |ADJUSTED (b) | 0.0% 2.2% 0.0% | 57.8% 34.0% 30.0% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 0/13 (0%) 0/21 (0%) 0/18 (0%) | 11/25 (44%) 6/25 (24%) 6/28 (21%) | |FIRST INCIDENCE (DAYS) | --- 594 --- | 377 594 594 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.670N P=0.539 (e) | P=0.030N* P=0.027N* P=0.010N** | |INCIDENTAL TUMOR | P=0.688N P=0.521 (e) | P=0.032N* P=0.011N* P=0.008N** | |LOGISTIC REGRESSION | P=0.669N P=0.499 (e) | P=0.033N* P=0.015N* P=0.008N** | |COCHRAN-ARMITAGE | P=0.669N | P=0.041N* | |FISHER EXACT | P=0.500 (e) | P=0.021N* P=0.012N* | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/63 (2%) 1/63 (2%) 0/63 (0%) | 23/63 (37%) 11/63 (17%) 10/63 (16%) | |ADJUSTED (b) | 2.8% 2.2% 0.0% | 59.1% 34.0% 30.0% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 0/13 (0%) 0/21 (0%) 0/18 (0%) | 11/25 (44%) 6/25 (24%) 6/28 (21%) | |FIRST INCIDENCE (DAYS) | 596 594 --- | 377 594 594 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.379N P=0.721N P=0.489N | P=0.023N* P=0.019N* P=0.007N** | |INCIDENTAL TUMOR | P=0.400N P=0.740N P=0.511N | P=0.026N* P=0.007N** P=0.005N** | |LOGISTIC REGRESSION | P=0.379N P=0.762 P=0.500N | P=0.024N* P=0.009N** P=0.005N** | |COCHRAN-ARMITAGE | P=0.378N | P=0.031N* | |FISHER EXACT | P=0.752N P=0.500N | P=0.013N* P=0.007N** | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/63 (2%) 1/63 (2%) 0/63 (0%) | 24/63 (38%) 13/63 (21%) 10/63 (16%) | |ADJUSTED (b) | 2.8% 2.2% 0.0% | 62.0% 37.8% 30.0% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 0/13 (0%) 0/21 (0%) 0/18 (0%) | 12/25 (48%) 6/25 (24%) 6/28 (21%) | |FIRST INCIDENCE (DAYS) | 596 594 --- | 377 594 594 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.379N P=0.721N P=0.489N | P=0.012N* P=0.033N* P=0.004N** | |INCIDENTAL TUMOR | P=0.400N P=0.740N P=0.511N | P=0.012N* P=0.013N* P=0.003N** | |LOGISTIC REGRESSION | P=0.379N P=0.762 P=0.500N | P=0.011N* P=0.017N* P=0.003N** | |COCHRAN-ARMITAGE | P=0.378N | P=0.016N* | |FISHER EXACT | P=0.752N P=0.500N | P=0.025N* P=0.004N** | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/63 (2%) 0/63 (0%) 2/63 (3%) | 0/63 (0%) 1/63 (2%) 0/63 (0%) | |ADJUSTED (b) | 7.7% 0.0% 6.9% | 0.0% 2.7% 0.0% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 1/13 (8%) 0/21 (0%) 0/18 (0%) | 0/25 (0%) 0/25 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 621 | --- 640 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.325 P=0.404N P=0.598 | P=0.680N P=0.480 (e) | |INCIDENTAL TUMOR | P=0.300 P=0.404N P=0.523 | P=0.613N P=0.612 (e) | |LOGISTIC REGRESSION | P=0.305 P=0.404N P=0.544 | P=0.668N P=0.503 (e) | |COCHRAN-ARMITAGE | P=0.287 | P=0.669N | |FISHER EXACT | P=0.500N P=0.500 | P=0.500 (e) | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/59 (3%) 0/59 (0%) 0/59 (0%) | |ADJUSTED (b) | | 7.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/1 (0%) 0/1 (0%) 0/1 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | | 1/25 (4%) 0/25 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | | 677 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.281N P=0.236N P=0.227N | |INCIDENTAL TUMOR | | P=0.337N P=0.260N P=0.299N | |LOGISTIC REGRESSION | | P=0.285N P=0.232N P=0.230N | |COCHRAN-ARMITAGE | | P=0.291N | |FISHER EXACT | | P=0.248N P=0.248N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 20/58 (34%) 17/57 (30%) 17/58 (29%) | 24/57 (42%) 31/58 (53%) 17/58 (29%) | |ADJUSTED (b) | 59.9% 54.1% 46.2% | 67.1% 71.0% 44.0% | |INTERIM SACRIFICE 1 (c)| 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%) 1/5 (20%) 2/5 (40%) | |TERMINAL (d) | 4/13 (31%) 9/21 (43%) 4/18 (22%) | 14/25 (56%) 13/25 (52%) 9/28 (32%) | |FIRST INCIDENCE (DAYS) | 521 552 509 | 477 459 (I) 459 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.300N P=0.109N P=0.187N | P=0.024N* P=0.179 P=0.087N | |INCIDENTAL TUMOR | P=0.370N P=0.230N P=0.331N | P=0.027N* P=0.172 P=0.084N | |LOGISTIC REGRESSION | P=0.406N P=0.288N P=0.398N | P=0.019N* P=0.162 P=0.093N | |COCHRAN-ARMITAGE | P=0.383N | P=0.023N* | |FISHER EXACT | P=0.369N P=0.345N | P=0.151 P=0.108N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | 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) | 7/63 (11%) 6/63 (10%) 3/63 (5%) | 0/63 (0%) 0/63 (0%) 1/63 (2%) | |ADJUSTED (b) | 34.0% 24.9% 13.7% | 0.0% 0.0% 2.9% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 3/13 (23%) 4/21 (19%) 2/18 (11%) | 0/25 (0%) 0/25 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 542 638 642 | --- --- 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.100N P=0.245N P=0.084N | P=0.328 (e) P=0.489 | |INCIDENTAL TUMOR | P=0.118N P=0.375N P=0.117N | P=0.214 (e) P=0.362 | |LOGISTIC REGRESSION | P=0.109N P=0.390N P=0.120N | P=0.333 (e) P=0.504 | |COCHRAN-ARMITAGE | P=0.142N | P=0.331 | |FISHER EXACT | P=0.500N P=0.162N | (e) P=0.500 | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/63 (5%) 2/63 (3%) 3/63 (5%) | 0/63 (0%) 0/63 (0%) 0/63 (0%) | |ADJUSTED (b) | 13.2% 6.7% 12.9% | 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%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/13 (0%) 1/21 (5%) 2/18 (11%) | 0/25 (0%) 0/25 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 573 549 527 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.610 P=0.378N P=0.552N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.581 P=0.529N P=0.644N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.580 P=0.469N P=0.629N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.562 | (e) | |FISHER EXACT | P=0.500N P=0.660N | (e) (e) | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | 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) | 4/63 (6%) 2/63 (3%) 3/63 (5%) | 1/63 (2%) 1/63 (2%) 1/63 (2%) | |ADJUSTED (b) | 15.5% 6.7% 12.9% | 2.9% 2.5% 3.6% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 0/13 (0%) 1/21 (5%) 2/18 (11%) | 0/25 (0%) 0/25 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 573 549 527 | 665 622 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.537N P=0.231N P=0.391N | P=0.700N P=0.751 P=0.754N | |INCIDENTAL TUMOR | P=0.572N P=0.353N P=0.487N | P=0.704 P=0.723N P=0.701 | |LOGISTIC REGRESSION | P=0.569N P=0.313N P=0.468N | P=0.709N P=0.759N P=0.755N | |COCHRAN-ARMITAGE | P=0.584N | P=0.713 | |FISHER EXACT | P=0.340N P=0.500N | P=0.752N P=0.752N | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 5/63 (8%) 4/63 (6%) 1/63 (2%) | 0/63 (0%) 0/63 (0%) 1/63 (2%) | |ADJUSTED (b) | 25.8% 16.7% 5.6% | 0.0% 0.0% 2.9% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 2/13 (15%) 3/21 (14%) 1/18 (6%) | 0/25 (0%) 0/25 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 574 638 733 (T) | --- --- 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.067N P=0.287N P=0.059N | P=0.328 (e) P=0.489 | |INCIDENTAL TUMOR | P=0.076N P=0.350N P=0.077N | P=0.214 (e) P=0.362 | |LOGISTIC REGRESSION | P=0.071N P=0.405N P=0.076N | P=0.333 (e) P=0.504 | |COCHRAN-ARMITAGE | P=0.091N | P=0.331 | |FISHER EXACT | P=0.500N P=0.104N | (e) P=0.500 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/63 (3%) 1/63 (2%) 1/63 (2%) | 0/63 (0%) 0/63 (0%) 0/63 (0%) | |ADJUSTED (b) | 9.7% 4.5% 5.6% | 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%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/13 (8%) 0/21 (0%) 1/18 (6%) | 0/25 (0%) 0/25 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 542 727 733 (T) | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.486N P=0.387N P=0.420N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.494N P=0.563N P=0.450N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.497N P=0.467N P=0.470N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.519N | (e) | |FISHER EXACT | P=0.500N P=0.500N | (e) (e) | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 7/63 (11%) 5/63 (8%) 2/63 (3%) | 0/63 (0%) 0/63 (0%) 1/63 (2%) | |ADJUSTED (b) | 34.0% 20.5% 11.1% | 0.0% 0.0% 2.9% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 3/13 (23%) 3/21 (14%) 2/18 (11%) | 0/25 (0%) 0/25 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 542 638 733 (T) | --- --- 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.058N P=0.173N P=0.038N* | P=0.328 (e) P=0.489 | |INCIDENTAL TUMOR | P=0.067N P=0.286N P=0.053N | P=0.214 (e) P=0.362 | |LOGISTIC REGRESSION | P=0.062N P=0.287N P=0.057N | P=0.333 (e) P=0.504 | |COCHRAN-ARMITAGE | P=0.083N | P=0.331 | |FISHER EXACT | P=0.381N P=0.082N | (e) P=0.500 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 7/63 (11%) 5/63 (8%) 2/63 (3%) | 0/63 (0%) 0/63 (0%) 1/63 (2%) | |ADJUSTED (b) | 34.0% 20.5% 11.1% | 0.0% 0.0% 2.9% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 3/13 (23%) 3/21 (14%) 2/18 (11%) | 0/25 (0%) 0/25 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 542 638 733 (T) | --- --- 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.058N P=0.173N P=0.038N* | P=0.328 (e) P=0.489 | |INCIDENTAL TUMOR | P=0.067N P=0.286N P=0.053N | P=0.214 (e) P=0.362 | |LOGISTIC REGRESSION | P=0.062N P=0.287N P=0.057N | P=0.333 (e) P=0.504 | |COCHRAN-ARMITAGE | P=0.083N | P=0.331 | |FISHER EXACT | P=0.381N P=0.082N | (e) P=0.500 | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 43/58 (74%) 46/58 (79%) 37/58 (64%) | | |ADJUSTED (b) | 100.0% 97.8% 91.9% | | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 | | |INTERIM SACRIFICE 2 (c)| 4/5 (80%) 1/5 (20%) 2/5 (40%) | | |TERMINAL (d) | 13/13 (100%) 20/21 (95%) 15/18 (83%) | | |FIRST INCIDENCE (DAYS) | 458 (I) 455 458 (I) | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.050N* P=0.124N P=0.028N* | | |INCIDENTAL TUMOR | P=0.017N* P=0.585 P=0.043N* | | |LOGISTIC REGRESSION | P=0.021N* P=0.560 P=0.059N | | |COCHRAN-ARMITAGE | P=0.063N | | |FISHER EXACT | P=0.330 P=0.158N | | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/57 (7%) 2/58 (3%) 9/58 (16%) | 3/56 (5%) 4/58 (7%) 4/57 (7%) | |ADJUSTED (b) | 18.1% 7.0% 34.9% | 10.6% 12.9% 12.2% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 1/13 (8%) 1/21 (5%) 4/18 (22%) | 2/25 (8%) 2/25 (8%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 594 599 564 | 665 612 635 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.047 * P=0.208N P=0.259 | P=0.546 P=0.502 P=0.520 | |INCIDENTAL TUMOR | P=0.033 * P=0.280N P=0.154 | P=0.541 P=0.514 P=0.569 | |LOGISTIC REGRESSION | P=0.033 * P=0.303N P=0.161 | P=0.526 P=0.517 P=0.519 | |COCHRAN-ARMITAGE | P=0.029 * | P=0.515 | |FISHER EXACT | P=0.331N P=0.126 | P=0.520 P=0.510 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/57 (4%) 1/58 (2%) 0/58 (0%) | 0/56 (0%) 3/58 (5%) 0/57 (0%) | |ADJUSTED (b) | 8.4% 4.8% 0.0% | 0.0% 9.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 0/13 (0%) 1/21 (5%) 0/18 (0%) | 0/25 (0%) 2/25 (8%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 651 733 (T) --- | --- 538 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.198N P=0.411N P=0.200N | P=0.334N P=0.127 (e) | |INCIDENTAL TUMOR | P=0.204N P=0.564N P=0.251N | P=0.363N P=0.099 (e) | |LOGISTIC REGRESSION | P=0.206N P=0.444N P=0.217N | P=0.355N P=0.128 (e) | |COCHRAN-ARMITAGE | P=0.221N | P=0.357N | |FISHER EXACT | P=0.493N P=0.243N | P=0.128 (e) | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/57 (11%) 3/58 (5%) 9/58 (16%) | 3/56 (5%) 7/58 (12%) 4/57 (7%) | |ADJUSTED (b) | 25.0% 11.7% 34.9% | 10.6% 22.1% 12.2% | |INTERIM SACRIFICE 1 (c)| 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%) | |TERMINAL (d) | 1/13 (8%) 2/21 (10%) 4/18 (22%) | 2/25 (8%) 4/25 (16%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 594 599 564 | 665 538 635 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.173 P=0.127N P=0.493 | P=0.482N P=0.168 P=0.520 | |INCIDENTAL TUMOR | P=0.137 P=0.228N P=0.336 | P=0.503N P=0.152 P=0.569 | |LOGISTIC REGRESSION | P=0.136 P=0.196N P=0.367 | P=0.514N P=0.173 P=0.519 | |COCHRAN-ARMITAGE | P=0.119 | P=0.524N | |FISHER EXACT | P=0.236N P=0.303 | P=0.175 P=0.510 | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 2/63 (3%) 1/63 (2%) 3/63 (5%) | |ADJUSTED (b) | | 6.0% 4.0% 6.4% | |INTERIM SACRIFICE 1 (c)| | 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | | 1/25 (4%) 1/25 (4%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | | 500 729 (T) 444 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.369 P=0.495N P=0.521 | |INCIDENTAL TUMOR | | P=0.351 P=0.564N P=0.511 | |LOGISTIC REGRESSION | | P=0.344 P=0.493N P=0.495 | |COCHRAN-ARMITAGE | | P=0.344 | |FISHER EXACT | | P=0.500N P=0.500 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 2/63 (3%) 1/63 (2%) 4/63 (6%) | |ADJUSTED (b) | | 6.0% 4.0% 8.1% | |INTERIM SACRIFICE 1 (c)| | 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/5 (0%) 0/5 (0%) 1/5 (20%) | |TERMINAL (d) | | 1/25 (4%) 1/25 (4%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | | 500 729 (T) 444 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.201 P=0.495N P=0.359 | |INCIDENTAL TUMOR | | P=0.186 P=0.564N P=0.343 | |LOGISTIC REGRESSION | | P=0.179 P=0.493N P=0.329 | |COCHRAN-ARMITAGE | | P=0.181 | |FISHER EXACT | | P=0.500N P=0.340 | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 28/63 (44%) 32/63 (51%) 36/63 (57%) | 19/63 (30%) 18/63 (29%) 22/63 (35%) | |ADJUSTED (b) | 78.9% 71.9% 81.4% | 46.6% 48.3% 50.0% | |INTERIM SACRIFICE 1 (c)| 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%) 0/5 (0%) | |TERMINAL (d) | 7/13 (54%) 9/21 (43%) 11/18 (61%) | 6/25 (24%) 8/25 (32%) 8/28 (29%) | |FIRST INCIDENCE (DAYS) | 539 455 408 | 263 452 501 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.331 P=0.347N P=0.466 | P=0.375 P=0.499N P=0.437 | |INCIDENTAL TUMOR | P=0.125 P=0.252 P=0.122 | P=0.183 P=0.567 P=0.235 | |LOGISTIC REGRESSION | P=0.105 P=0.326 P=0.149 | P=0.288 P=0.469N P=0.373 | |COCHRAN-ARMITAGE | P=0.119 | P=0.277 | |FISHER EXACT | P=0.296 P=0.106 | P=0.500N P=0.352 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 53/63 (84%) 53/63 (84%) 52/63 (83%) | 37/63 (59%) 46/63 (73%) 48/63 (76%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 83.1% 97.8% 94.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 4/5 (80%) 1/5 (20%) 2/5 (40%) | 0/5 (0%) 1/5 (20%) 3/5 (60%) | |TERMINAL (d) | 13/13 (100%) 21/21 (100%) 18/18 (100%) | 18/25 (72%) 24/25 (96%) 25/28 (89%) | |FIRST INCIDENCE (DAYS) | 458 (I) 455 458 (I) | 377 459 (I) 444 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.243N P=0.059N P=0.103N | P=0.254 P=0.131 P=0.150 | |INCIDENTAL TUMOR | P=0.205N P=0.212N P=0.159N | P=0.034 * P=0.063 P=0.024 * | |LOGISTIC REGRESSION | P=0.286N P=0.349N P=0.245N | P=0.046 * P=0.073 P=0.025 * | |COCHRAN-ARMITAGE | P=0.466N | P=0.064 | |FISHER EXACT | P=0.596N P=0.500N | P=0.066 P=0.028 * | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 33/63 (52%) 37/63 (59%) 46/63 (73%) | 25/63 (40%) 31/63 (49%) 29/63 (46%) | |ADJUSTED (b) | 81.3% 78.2% 95.5% | 56.9% 66.8% 62.6% | |INTERIM SACRIFICE 1 (c)| 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%) | 1/5 (20%) 1/5 (20%) 1/5 (20%) | |TERMINAL (d) | 7/13 (54%) 11/21 (52%) 16/18 (89%) | 8/25 (32%) 11/25 (44%) 12/28 (43%) | |FIRST INCIDENCE (DAYS) | 361 455 408 | 263 452 459 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.146 P=0.318N P=0.300 | P=0.526 P=0.247 P=0.408 | |INCIDENTAL TUMOR | P=0.005 ** P=0.178 P=0.006 ** | P=0.344 P=0.170 P=0.219 | |LOGISTIC REGRESSION | P=0.008 ** P=0.337 P=0.017 * | P=0.426 P=0.232 P=0.323 | |COCHRAN-ARMITAGE | P=0.012 * | P=0.416 | |FISHER EXACT | P=0.295 P=0.013 * | P=0.185 P=0.295 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 05 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL SUBSULFIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.15 1.0 | 0.0MG/M3 0.15 1.0 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 56/63 (89%) 53/63 (84%) 56/63 (89%) | 49/63 (78%) 53/63 (84%) 52/63 (83%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 90.7% 98.1% 94.5% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 4/5 (80%) 1/5 (20%) 3/5 (60%) | 1/5 (20%) 2/5 (40%) 4/5 (80%) | |TERMINAL (d) | 13/13 (100%) 21/21 (100%) 18/18 (100%) | 20/25 (80%) 24/25 (96%) 25/28 (89%) | |FIRST INCIDENCE (DAYS) | 361 455 408 | 263 452 444 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.346N P=0.030N* P=0.132N | P=0.449N P=0.371 P=0.550 | |INCIDENTAL TUMOR | P=0.549 P=0.046N* P=0.500N | P=0.293 P=0.133 P=0.212 | |LOGISTIC REGRESSION | P=0.611 P=0.023N* P=0.384N | P=0.429 P=0.334 P=0.354 | |COCHRAN-ARMITAGE | P=0.446 | P=0.417 | |FISHER EXACT | P=0.302N P=0.611N | P=0.248 P=0.328 | |=================================================================================================================================| (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).