TDMS Study 05107-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: LITRI NICKEL SUBSULFIDE DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 TIME: 23:03:08 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: 06 TIME: 23:03:08 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: Y01ES30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C61654 PATHOLOGIST: F. HAHN CAS: 12035722 MICE(B6C3F1) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Epididymis Gallbladder Heart Islets, Pancreatic Kidney Larynx Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: LITRI NICKEL SUBSULFIDE DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 TIME: 23:03:08 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 MICE ------------- ORGAN MORPHOLOGY ------- ------------ Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma All Organs Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Lung Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma ==================================================================================================== DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SUBSULFIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/66 (3%) 0/64 (0%) 1/63 (2%) | 1/63 (2%) 0/63 (0%) 0/65 (0%) | |ADJUSTED (b) | 6.8% 0.0% 2.1% | 2.8% 0.0% 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) | 1/26 (4%) 0/25 (0%) 0/25 (0%) | 1/36 (3%) 0/34 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 679 --- 485 | 733 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.382N P=0.255N P=0.525N | P=0.265N P=0.511N P=0.489N | |INCIDENTAL TUMOR | P=0.313N P=0.244N P=0.435N | P=0.265N P=0.511N P=0.489N | |LOGISTIC REGRESSION | P=0.374N P=0.246N P=0.517N | P=0.265N P=0.511N P=0.489N | |COCHRAN-ARMITAGE | P=0.373N | P=0.266N | |FISHER EXACT | P=0.256N P=0.518N | P=0.500N P=0.492N | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/66 (0%) 0/64 (0%) 1/64 (2%) | 2/63 (3%) 1/65 (2%) 2/65 (3%) | |ADJUSTED (b) | 0.0% 0.0% 2.6% | 5.0% 2.9% 4.2% | |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%) 1/5 (20%) | |TERMINAL (d) | 0/26 (0%) 0/25 (0%) 0/25 (0%) | 1/36 (3%) 1/34 (3%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | --- --- 661 | 680 733 (T) 477 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.288 (e) P=0.522 | P=0.596N P=0.519N P=0.682N | |INCIDENTAL TUMOR | P=0.334 (e) P=0.581 | P=0.592 P=0.503N P=0.663 | |LOGISTIC REGRESSION | P=0.265 (e) P=0.493 | P=0.600N P=0.502N P=0.683N | |COCHRAN-ARMITAGE | P=0.266 | P=0.598N | |FISHER EXACT | (e) P=0.492 | P=0.488N P=0.679N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SUBSULFIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/66 (21%) 11/64 (17%) 15/64 (23%) | 14/63 (22%) 10/65 (15%) 10/65 (15%) | |ADJUSTED (b) | 38.5% 28.3% 42.8% | 32.9% 25.7% 23.8% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 1/5 (20%) 2/5 (40%) 1/5 (20%) | 1/5 (20%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 7/26 (27%) 3/25 (12%) 8/25 (32%) | 9/36 (25%) 7/34 (21%) 7/38 (18%) | |FIRST INCIDENCE (DAYS) | 476 (I) 476 (I) 476 (I) | 477 (I) 520 563 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.453 P=0.380N P=0.492 | P=0.181N P=0.288N P=0.213N | |INCIDENTAL TUMOR | P=0.332 P=0.386N P=0.350 | P=0.217N P=0.247N P=0.287N | |LOGISTIC REGRESSION | P=0.411 P=0.371N P=0.452 | P=0.187N P=0.242N P=0.223N | |COCHRAN-ARMITAGE | P=0.422 | P=0.186N | |FISHER EXACT | P=0.360N P=0.462 | P=0.222N P=0.222N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/66 (17%) 17/64 (27%) 13/64 (20%) | 11/63 (17%) 9/65 (14%) 4/65 (6%) | |ADJUSTED (b) | 26.8% 40.2% 29.4% | 25.0% 21.2% 8.4% | |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%) 1/5 (20%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 3/26 (12%) 5/25 (20%) 1/25 (4%) | 4/36 (11%) 3/34 (9%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 434 415 450 | 603 552 563 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.370 P=0.137 P=0.412 | P=0.043N* P=0.434N P=0.051N | |INCIDENTAL TUMOR | P=0.282 P=0.104 P=0.364 | P=0.030N* P=0.347N P=0.040N* | |LOGISTIC REGRESSION | P=0.187 P=0.124 P=0.212 | P=0.033N* P=0.344N P=0.042N* | |COCHRAN-ARMITAGE | P=0.340 | P=0.035N* | |FISHER EXACT | P=0.123 P=0.378 | P=0.375N P=0.042N* | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SUBSULFIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/66 (17%) 17/64 (27%) 13/64 (20%) | 11/63 (17%) 9/65 (14%) 4/65 (6%) | |ADJUSTED (b) | 26.8% 40.2% 29.4% | 25.0% 21.2% 8.4% | |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%) 1/5 (20%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 3/26 (12%) 5/25 (20%) 1/25 (4%) | 4/36 (11%) 3/34 (9%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 434 415 450 | 603 552 563 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.370 P=0.137 P=0.412 | P=0.043N* P=0.434N P=0.051N | |INCIDENTAL TUMOR | P=0.282 P=0.104 P=0.364 | P=0.030N* P=0.347N P=0.040N* | |LOGISTIC REGRESSION | P=0.187 P=0.124 P=0.212 | P=0.033N* P=0.344N P=0.042N* | |COCHRAN-ARMITAGE | P=0.340 | P=0.035N* | |FISHER EXACT | P=0.123 P=0.378 | P=0.375N P=0.042N* | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 25/66 (38%) 24/64 (38%) 26/64 (41%) | 21/63 (33%) 18/65 (28%) 13/65 (20%) | |ADJUSTED (b) | 57.1% 51.2% 58.7% | 45.7% 41.6% 29.3% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 1/5 (20%) 2/5 (40%) 1/5 (20%) | 1/5 (20%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 10/26 (38%) 6/25 (24%) 9/25 (36%) | 12/36 (33%) 10/34 (29%) 8/38 (21%) | |FIRST INCIDENCE (DAYS) | 434 415 450 | 477 (I) 520 563 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.451 P=0.554 P=0.488 | P=0.063N P=0.408N P=0.073N | |INCIDENTAL TUMOR | P=0.341 P=0.555 P=0.369 | P=0.067N P=0.324N P=0.084N | |LOGISTIC REGRESSION | P=0.232 P=0.562N P=0.269 | P=0.054N P=0.340N P=0.065N | |COCHRAN-ARMITAGE | P=0.409 | P=0.055N | |FISHER EXACT | P=0.554N P=0.444 | P=0.308N P=0.066N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SUBSULFIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 25/66 (38%) 24/64 (38%) 26/64 (41%) | 21/63 (33%) 18/65 (28%) 13/65 (20%) | |ADJUSTED (b) | 57.1% 51.2% 58.7% | 45.7% 41.6% 29.3% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 1/5 (20%) 2/5 (40%) 1/5 (20%) | 1/5 (20%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 10/26 (38%) 6/25 (24%) 9/25 (36%) | 12/36 (33%) 10/34 (29%) 8/38 (21%) | |FIRST INCIDENCE (DAYS) | 434 415 450 | 477 (I) 520 563 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.451 P=0.554 P=0.488 | P=0.063N P=0.408N P=0.073N | |INCIDENTAL TUMOR | P=0.341 P=0.555 P=0.369 | P=0.067N P=0.324N P=0.084N | |LOGISTIC REGRESSION | P=0.232 P=0.562N P=0.269 | P=0.054N P=0.340N P=0.065N | |COCHRAN-ARMITAGE | P=0.409 | P=0.055N | |FISHER EXACT | P=0.554N P=0.444 | P=0.308N P=0.066N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/71 (8%) 3/69 (4%) 2/68 (3%) | 3/68 (4%) 1/69 (1%) 1/70 (1%) | |ADJUSTED (b) | 19.8% 10.8% 7.7% | 7.8% 2.9% 2.6% | |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) | 3/26 (12%) 2/25 (8%) 1/25 (4%) | 2/36 (6%) 1/34 (3%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 641 661 734 | 683 733 (T) 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.097N P=0.269N P=0.144N | P=0.193N P=0.324N P=0.290N | |INCIDENTAL TUMOR | P=0.076N P=0.261N P=0.124N | P=0.212N P=0.314N P=0.331N | |LOGISTIC REGRESSION | P=0.088N P=0.260N P=0.130N | P=0.193N P=0.309N P=0.293N | |COCHRAN-ARMITAGE | P=0.103N | P=0.195N | |FISHER EXACT | P=0.261N P=0.152N | P=0.304N P=0.299N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SUBSULFIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/71 (10%) 2/69 (3%) 4/68 (6%) | 7/68 (10%) 1/69 (1%) 2/70 (3%) | |ADJUSTED (b) | 23.7% 8.0% 14.3% | 18.7% 1.9% 5.3% | |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) | 5/26 (19%) 2/25 (8%) 3/25 (12%) | 6/36 (17%) 0/34 (0%) 2/38 (5%) | |FIRST INCIDENCE (DAYS) | 552 737 (T) 661 | 683 552 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.200N P=0.092N P=0.279N | P=0.033N* P=0.040N* P=0.070N | |INCIDENTAL TUMOR | P=0.196N P=0.092N P=0.278N | P=0.031N* P=0.035N* P=0.081N | |LOGISTIC REGRESSION | P=0.183N P=0.088N P=0.259N | P=0.033N* P=0.033N* P=0.070N | |COCHRAN-ARMITAGE | P=0.209N | P=0.034N* | |FISHER EXACT | P=0.090N P=0.291N | P=0.030N* P=0.076N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/71 (18%) 5/69 (7%) 6/68 (9%) | 9/68 (13%) 2/69 (3%) 3/70 (4%) | |ADJUSTED (b) | 40.7% 18.5% 21.4% | 24.1% 4.8% 7.9% | |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) | 8/26 (31%) 4/25 (16%) 4/25 (16%) | 8/36 (22%) 1/34 (3%) 3/38 (8%) | |FIRST INCIDENCE (DAYS) | 552 661 661 | 683 552 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.045N* P=0.046N* P=0.076N | P=0.026N* P=0.035N* P=0.051N | |INCIDENTAL TUMOR | P=0.033N* P=0.041N* P=0.062N | P=0.024N* P=0.031N* P=0.058N | |LOGISTIC REGRESSION | P=0.034N* P=0.038N* P=0.057N | P=0.027N* P=0.028N* P=0.050N | |COCHRAN-ARMITAGE | P=0.051N | P=0.028N* | |FISHER EXACT | P=0.043N* P=0.083N | P=0.026N* P=0.058N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SUBSULFIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/71 (0%) 0/70 (0%) 0/70 (0%) | 1/68 (1%) 3/70 (4%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 2.8% 8.3% 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) | 0/26 (0%) 0/25 (0%) 0/25 (0%) | 1/36 (3%) 2/34 (6%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 733 (T) 711 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.361N P=0.294 P=0.489N | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.397N P=0.299 P=0.489N | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.365N P=0.297 P=0.489N | |COCHRAN-ARMITAGE | (e) | P=0.369N | |FISHER EXACT | (e) (e) | P=0.321 P=0.493N | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/62 (3%) 0/63 (0%) 1/65 (2%) | |ADJUSTED (b) | | 5.3% 0.0% 1.9% | |INTERIM SACRIFICE 1 (c)| | 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| | 0/4 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | | 1/36 (3%) 0/34 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | | 723 --- 580 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.347N P=0.255N P=0.478N | |INCIDENTAL TUMOR | | P=0.339N P=0.246N P=0.479N | |LOGISTIC REGRESSION | | P=0.351N P=0.243N P=0.486N | |COCHRAN-ARMITAGE | | P=0.348N | |FISHER EXACT | | P=0.244N P=0.482N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SUBSULFIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/63 (0%) 0/63 (0%) 1/60 (2%) | 8/62 (13%) 5/62 (8%) 3/65 (5%) | |ADJUSTED (b) | 0.0% 0.0% 4.3% | 21.0% 13.6% 7.0% | |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%) | 0/4 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/24 (0%) 0/25 (0%) 1/23 (4%) | 7/36 (19%) 3/34 (9%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | --- --- 737 (T) | 536 712 607 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.262 (e) P=0.492 | P=0.066N P=0.309N P=0.089N | |INCIDENTAL TUMOR | P=0.262 (e) P=0.492 | P=0.079N P=0.296N P=0.096N | |LOGISTIC REGRESSION | P=0.262 (e) P=0.492 | P=0.067N P=0.289N P=0.092N | |COCHRAN-ARMITAGE | P=0.262 | P=0.065N | |FISHER EXACT | (e) P=0.488 | P=0.280N P=0.089N | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/71 (1%) 1/70 (1%) 1/70 (1%) | 2/68 (3%) 0/70 (0%) 3/70 (4%) | |ADJUSTED (b) | 1.9% 3.0% 4.0% | 4.7% 0.0% 6.1% | |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) | 0/26 (0%) 0/25 (0%) 1/25 (4%) | 1/36 (3%) 0/34 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 499 661 737 (T) | 598 --- 507 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.632 P=0.748 P=0.741 | P=0.408 P=0.246N P=0.519 | |INCIDENTAL TUMOR | P=0.567N P=0.760 P=0.733N | P=0.433 P=0.226N P=0.543 | |LOGISTIC REGRESSION | P=0.633 P=0.759 P=0.758 | P=0.401 P=0.235N P=0.513 | |COCHRAN-ARMITAGE | P=0.635 | P=0.401 | |FISHER EXACT | P=0.748 P=0.748 | P=0.241N P=0.514 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SUBSULFIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/71 (1%) 0/70 (0%) 0/70 (0%) | 2/68 (3%) 0/70 (0%) 2/70 (3%) | |ADJUSTED (b) | 1.9% 0.0% 0.0% | 4.7% 0.0% 3.7% | |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) | 0/26 (0%) 0/25 (0%) 0/25 (0%) | 1/36 (3%) 0/34 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 499 --- --- | 598 --- 507 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.289N P=0.515N P=0.528N | P=0.611N P=0.246N P=0.682N | |INCIDENTAL TUMOR | P=0.235N P=0.500N P=0.443N | P=0.541N P=0.226N P=0.612N | |LOGISTIC REGRESSION | P=0.267N P=0.493N P=0.498N | P=0.612N P=0.235N P=0.683N | |COCHRAN-ARMITAGE | P=0.272N | P=0.613N | |FISHER EXACT | P=0.504N P=0.504N | P=0.241N P=0.679N | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/71 (1%) 1/70 (1%) 1/70 (1%) | 2/68 (3%) 0/70 (0%) 2/70 (3%) | |ADJUSTED (b) | 1.9% 3.0% 4.0% | 4.7% 0.0% 3.7% | |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) | 0/26 (0%) 0/25 (0%) 1/25 (4%) | 1/36 (3%) 0/34 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 499 661 737 (T) | 598 --- 507 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.632 P=0.748 P=0.741 | P=0.611N P=0.246N P=0.682N | |INCIDENTAL TUMOR | P=0.567N P=0.760 P=0.733N | P=0.541N P=0.226N P=0.612N | |LOGISTIC REGRESSION | P=0.633 P=0.759 P=0.758 | P=0.612N P=0.235N P=0.683N | |COCHRAN-ARMITAGE | P=0.635 | P=0.613N | |FISHER EXACT | P=0.748 P=0.748 | P=0.241N P=0.679N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SUBSULFIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/66 (6%) 1/64 (2%) 1/64 (2%) | 2/63 (3%) 4/65 (6%) 3/65 (5%) | |ADJUSTED (b) | 12.3% 3.6% 4.0% | 5.1% 11.2% 7.9% | |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) | 2/26 (8%) 0/25 (0%) 1/25 (4%) | 1/36 (3%) 3/34 (9%) 3/38 (8%) | |FIRST INCIDENCE (DAYS) | 313 704 737 (T) | 691 711 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.106N P=0.194N P=0.188N | P=0.445 P=0.324 P=0.522 | |INCIDENTAL TUMOR | P=0.076N P=0.169N P=0.149N | P=0.394 P=0.334 P=0.479 | |LOGISTIC REGRESSION | P=0.110N P=0.193N P=0.192N | P=0.437 P=0.330 P=0.517 | |COCHRAN-ARMITAGE | P=0.108N | P=0.432 | |FISHER EXACT | P=0.192N P=0.192N | P=0.355 P=0.515 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/66 (6%) 1/64 (2%) 1/64 (2%) | 3/63 (5%) 4/65 (6%) 3/65 (5%) | |ADJUSTED (b) | 12.3% 3.6% 4.0% | 7.9% 11.2% 7.9% | |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) | 2/26 (8%) 0/25 (0%) 1/25 (4%) | 2/36 (6%) 3/34 (9%) 3/38 (8%) | |FIRST INCIDENCE (DAYS) | 313 704 737 (T) | 691 711 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.106N P=0.194N P=0.188N | P=0.550N P=0.480 P=0.639N | |INCIDENTAL TUMOR | P=0.076N P=0.169N P=0.149N | P=0.561 P=0.491 P=0.649 | |LOGISTIC REGRESSION | P=0.110N P=0.193N P=0.192N | P=0.557N P=0.491 P=0.646N | |COCHRAN-ARMITAGE | P=0.108N | P=0.563N | |FISHER EXACT | P=0.192N P=0.192N | P=0.518 P=0.645N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SUBSULFIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Tooth | | Odontoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/71 (0%) 0/70 (0%) 2/70 (3%) | 0/68 (0%) 0/70 (0%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 0.0% 5.4% | 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) | 0/26 (0%) 0/25 (0%) 1/25 (4%) | 0/36 (0%) 0/34 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 144 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.095 (e) P=0.234 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.100 (e) P=0.267 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.095 (e) P=0.244 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.095 | (e) | |FISHER EXACT | (e) P=0.245 | (e) (e) | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 1/68 (1%) 1/70 (1%) 2/70 (3%) | |ADJUSTED (b) | | 2.8% 2.0% 4.0% | |INTERIM SACRIFICE 1 (c)| | 0/5 (0%) 0/5 (0%) 1/5 (20%) | |INTERIM SACRIFICE 2 (c)| | 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | | 1/36 (3%) 0/34 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | | 733 (T) 623 197 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.390 P=0.759 P=0.513 | |INCIDENTAL TUMOR | | P=0.436 P=0.747N P=0.513 | |LOGISTIC REGRESSION | | P=0.390 P=0.760N P=0.516 | |COCHRAN-ARMITAGE | | P=0.387 | |FISHER EXACT | | P=0.745N P=0.511 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SUBSULFIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/71 (1%) 1/70 (1%) 2/70 (3%) | 2/68 (3%) 0/70 (0%) 1/70 (1%) | |ADJUSTED (b) | 3.8% 3.7% 7.4% | 4.4% 0.0% 2.6% | |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%) | 1/5 (20%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/26 (4%) 0/25 (0%) 1/25 (4%) | 1/36 (3%) 0/34 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 737 (T) 716 713 | 477 (I) --- 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.374 P=0.756 P=0.491 | P=0.353N P=0.246N P=0.487N | |INCIDENTAL TUMOR | P=0.456 P=0.756 P=0.546 | P=0.353N P=0.246N P=0.487N | |LOGISTIC REGRESSION | P=0.388 P=0.757 P=0.510 | P=0.354N P=0.230N P=0.491N | |COCHRAN-ARMITAGE | P=0.374 | P=0.353N | |FISHER EXACT | P=0.748 P=0.495 | P=0.241N P=0.489N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/71 (1%) 3/70 (4%) 2/70 (3%) | 3/68 (4%) 4/70 (6%) 4/70 (6%) | |ADJUSTED (b) | 1.8% 10.9% 6.5% | 7.8% 10.1% 9.4% | |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%) 1/5 (20%) | |TERMINAL (d) | 0/26 (0%) 2/25 (8%) 1/25 (4%) | 2/36 (6%) 2/34 (6%) 3/38 (8%) | |FIRST INCIDENCE (DAYS) | 480 671 661 | 680 623 477 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.390 P=0.291 P=0.493 | P=0.449 P=0.482 P=0.521 | |INCIDENTAL TUMOR | P=0.481 P=0.301 P=0.584 | P=0.434 P=0.510 P=0.487 | |LOGISTIC REGRESSION | P=0.394 P=0.291 P=0.493 | P=0.439 P=0.500 P=0.514 | |COCHRAN-ARMITAGE | P=0.394 | P=0.440 | |FISHER EXACT | P=0.304 P=0.495 | P=0.516 P=0.516 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SUBSULFIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/71 (3%) 4/70 (6%) 4/70 (6%) | 5/68 (7%) 4/70 (6%) 5/70 (7%) | |ADJUSTED (b) | 5.6% 14.2% 13.6% | 12.0% 10.1% 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%) | 1/5 (20%) 0/5 (0%) 1/5 (20%) | |TERMINAL (d) | 1/26 (4%) 2/25 (8%) 2/25 (8%) | 3/36 (8%) 2/34 (6%) 4/38 (11%) | |FIRST INCIDENCE (DAYS) | 480 671 661 | 477 (I) 623 477 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.268 P=0.323 P=0.329 | P=0.541N P=0.520N P=0.605N | |INCIDENTAL TUMOR | P=0.379 P=0.329 P=0.427 | P=0.554N P=0.495N P=0.625 | |LOGISTIC REGRESSION | P=0.274 P=0.317 P=0.332 | P=0.552N P=0.496N P=0.613N | |COCHRAN-ARMITAGE | P=0.270 | P=0.549N | |FISHER EXACT | P=0.334 P=0.334 | P=0.482N P=0.609N | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/71 (0%) 0/70 (0%) 0/70 (0%) | 2/68 (3%) 2/70 (3%) 2/70 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 4.4% 5.1% 3.5% | |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)| 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/26 (0%) 0/25 (0%) 0/25 (0%) | 1/36 (3%) 1/34 (3%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 419 655 445 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.583N P=0.681 P=0.674N | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.591 P=0.675N P=0.697N | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.588N P=0.686N P=0.678N | |COCHRAN-ARMITAGE | (e) | P=0.589N | |FISHER EXACT | (e) (e) | P=0.679N P=0.679N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SUBSULFIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/71 (1%) 1/70 (1%) 0/70 (0%) | 7/68 (10%) 9/70 (13%) 8/70 (11%) | |ADJUSTED (b) | 3.8% 4.0% 0.0% | 17.2% 20.1% 17.6% | |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) | 1/26 (4%) 1/25 (4%) 0/25 (0%) | 5/36 (14%) 3/34 (9%) 4/38 (11%) | |FIRST INCIDENCE (DAYS) | 737 (T) 737 (T) --- | 419 425 445 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.340N P=0.754 P=0.508N | P=0.485 P=0.375 P=0.537 | |INCIDENTAL TUMOR | P=0.340N P=0.754 P=0.508N | P=0.354 P=0.427 P=0.453 | |LOGISTIC REGRESSION | P=0.339N P=0.754 P=0.508N | P=0.468 P=0.405 P=0.521 | |COCHRAN-ARMITAGE | P=0.335N | P=0.471 | |FISHER EXACT | P=0.748 P=0.504N | P=0.420 P=0.524 | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/71 (1%) 1/70 (1%) 0/70 (0%) | 5/68 (7%) 7/70 (10%) 6/70 (9%) | |ADJUSTED (b) | 3.8% 4.0% 0.0% | 13.1% 15.6% 14.6% | |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) | 1/26 (4%) 1/25 (4%) 0/25 (0%) | 4/36 (11%) 2/34 (6%) 4/38 (11%) | |FIRST INCIDENCE (DAYS) | 737 (T) 737 (T) --- | 679 425 653 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.340N P=0.754 P=0.508N | P=0.474 P=0.365 P=0.532 | |INCIDENTAL TUMOR | P=0.340N P=0.754 P=0.508N | P=0.344 P=0.406 P=0.443 | |LOGISTIC REGRESSION | P=0.339N P=0.754 P=0.508N | P=0.458 P=0.387 P=0.522 | |COCHRAN-ARMITAGE | P=0.335N | P=0.461 | |FISHER EXACT | P=0.748 P=0.504N | P=0.403 P=0.520 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SUBSULFIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 28/71 (39%) 17/70 (24%) 20/70 (29%) | 29/68 (43%) 22/70 (31%) 21/70 (30%) | |ADJUSTED (b) | 71.9% 43.2% 53.8% | 65.0% 49.4% 45.5% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 1/5 (20%) | |INTERIM SACRIFICE 2 (c)| 1/5 (20%) 2/5 (40%) 1/5 (20%) | 2/5 (40%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 16/26 (62%) 6/25 (24%) 10/25 (40%) | 21/36 (58%) 13/34 (38%) 14/38 (37%) | |FIRST INCIDENCE (DAYS) | 313 475 144 | 477 (I) 116 197 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.108N P=0.064N P=0.127N | P=0.068N P=0.194N P=0.076N | |INCIDENTAL TUMOR | P=0.083N P=0.043N* P=0.118N | P=0.070N P=0.132N P=0.101N | |LOGISTIC REGRESSION | P=0.091N P=0.043N* P=0.111N | P=0.066N P=0.128N P=0.078N | |COCHRAN-ARMITAGE | P=0.095N | P=0.071N | |FISHER EXACT | P=0.040N* P=0.118N | P=0.117N P=0.086N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 21/71 (30%) 23/70 (33%) 21/70 (30%) | 26/68 (38%) 27/70 (39%) 23/70 (33%) | |ADJUSTED (b) | 49.0% 55.1% 48.8% | 54.7% 51.1% 43.6% | |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%) | 0/5 (0%) 0/5 (0%) 1/5 (20%) | |TERMINAL (d) | 8/26 (31%) 9/25 (36%) 6/25 (24%) | 15/36 (42%) 9/34 (26%) 10/38 (26%) | |FIRST INCIDENCE (DAYS) | 434 415 450 | 419 206 445 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.512 P=0.370 P=0.553 | P=0.295N P=0.455 P=0.317N | |INCIDENTAL TUMOR | P=0.482 P=0.342 P=0.523 | P=0.355N P=0.559N P=0.360N | |LOGISTIC REGRESSION | P=0.352 P=0.369 P=0.380 | P=0.286N P=0.519 P=0.306N | |COCHRAN-ARMITAGE | P=0.514 | P=0.284N | |FISHER EXACT | P=0.406 P=0.551 | P=0.554 P=0.315N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05107 TEST: 06 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SUBSULFIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | 0.0MG/M3 0.6MG/M3 1.2MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 41/71 (58%) 33/70 (47%) 36/70 (51%) | 44/68 (65%) 39/70 (56%) 39/70 (56%) | |ADJUSTED (b) | 84.1% 68.1% 77.0% | 86.0% 70.3% 70.5% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 1/5 (20%) | |INTERIM SACRIFICE 2 (c)| 1/5 (20%) 2/5 (40%) 1/5 (20%) | 2/5 (40%) 0/5 (0%) 1/5 (20%) | |TERMINAL (d) | 19/26 (73%) 11/25 (44%) 15/25 (60%) | 29/36 (81%) 18/34 (53%) 22/38 (58%) | |FIRST INCIDENCE (DAYS) | 313 415 144 | 419 116 197 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.303N P=0.239N P=0.321N | P=0.190N P=0.356N P=0.196N | |INCIDENTAL TUMOR | P=0.215N P=0.154N P=0.276N | P=0.194N P=0.158N P=0.215N | |LOGISTIC REGRESSION | P=0.313N P=0.169N P=0.296N | P=0.156N P=0.205N P=0.170N | |COCHRAN-ARMITAGE | P=0.251N | P=0.163N | |FISHER EXACT | P=0.137N P=0.280N | P=0.183N P=0.183N | |=================================================================================================================================| (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): 196 476 Female interim sacrifices(days): 197 477 (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).