TDMS Study 05122-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: LITRI NICKEL SULFATE HEXAHYDRATE DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 TIME: 04:06:44 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: Y01ES30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C60344 PATHOLOGIST: F. HAHN CAS: 010101970 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: LITRI NICKEL SULFATE HEXAHYDRATE DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 TIME: 04:06:44 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: Y01ES30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C60344 PATHOLOGIST: F. HAHN CAS: 010101970 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 SULFATE HEXAHYDRATE DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 TIME: 04:06:44 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: Y01ES30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C60344 PATHOLOGIST: F. HAHN CAS: 010101970 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF NICKEL SULFATE HEXAHYDRATE ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma All Organs Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Harderian Gland Adenoma Liver Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Skin Fibrosarcoma All Organs Benign Tumors ==================================================================================================== DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SULFATE HEXAHYDRATE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/66 (2%) 2/65 (3%) 3/66 (5%) 1/65 (2%) | 1/65 (2%) 0/63 (0%) 0/65 (0%) 0/65 (0%) | |ADJUSTED (b) | 4.8% 3.9% 11.6% 2.4% | 2.3% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 1/5 (20%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/26 (4%) 0/22 (0%) 1/24 (4%) 0/25 (0%) | 0/34 (0%) 0/39 (0%) 0/45 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 737 (T) 458 (I) 621 601 | 696 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.537N P=0.466 P=0.304 P=0.749N | P=0.308N P=0.500N P=0.487N P=0.509N | |INCIDENTAL TUMOR | P=0.599 P=0.453 P=0.311 P=0.716 | P=0.347N P=0.590N P=0.590N P=0.564N | |LOGISTIC REGRESSION | P=0.581N P=0.512 P=0.299 P=0.762N | P=0.304N P=0.500N P=0.487N P=0.503N | |COCHRAN-ARMITAGE | P=0.581N | P=0.305N | |FISHER EXACT | P=0.494 P=0.310 P=0.748 | P=0.508N P=0.500N P=0.500N | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/71 (0%) 2/71 (3%) 2/72 (3%) 1/72 (1%) | 0/71 (0%) 2/70 (3%) 4/70 (6%) 1/70 (1%) | |ADJUSTED (b) | 0.0% 8.0% 6.0% 3.8% | 0.0% 4.6% 8.3% 1.7% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 1/5 (20%) | |TERMINAL (d) | 0/26 (0%) 1/23 (4%) 1/24 (4%) 0/25 (0%) | 0/34 (0%) 1/39 (3%) 2/45 (4%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | --- 714 538 720 | --- 635 672 459 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.464 P=0.222 P=0.225 P=0.492 | P=0.431 P=0.262 P=0.097 P=0.500 | |INCIDENTAL TUMOR | P=0.559 P=0.298 P=0.281 P=0.638 | P=0.373 P=0.222 P=0.046 * P=0.500 | |LOGISTIC REGRESSION | P=0.482 P=0.226 P=0.237 P=0.505 | P=0.416 P=0.240 P=0.072 P=0.489 | |COCHRAN-ARMITAGE | P=0.475 | P=0.419 | |FISHER EXACT | P=0.248 P=0.252 P=0.503 | P=0.245 P=0.058 P=0.496 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SULFATE HEXAHYDRATE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/66 (0%) 0/65 (0%) 1/62 (2%) 0/63 (0%) | 2/65 (3%) 1/61 (2%) 1/64 (2%) 1/65 (2%) | |ADJUSTED (b) | 0.0% 0.0% 2.9% 0.0% | 5.0% 2.7% 2.2% 2.7% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/26 (0%) 0/22 (0%) 0/23 (0%) 0/25 (0%) | 1/33 (3%) 1/37 (3%) 1/45 (2%) 1/37 (3%) | |FIRST INCIDENCE (DAYS) | --- --- 614 --- | 626 730 (T) 730 (T) 730 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.708 (e) P=0.512 (e) | P=0.384N P=0.476N P=0.422N P=0.486N | |INCIDENTAL TUMOR | P=0.646 (e) P=0.451 (e) | P=0.397N P=0.527N P=0.506N P=0.507N | |LOGISTIC REGRESSION | P=0.687 (e) P=0.488 (e) | P=0.406N P=0.512N P=0.481N P=0.503N | |COCHRAN-ARMITAGE | P=0.688 | P=0.404N | |FISHER EXACT | (e) P=0.484 (e) | P=0.524N P=0.506N P=0.500N | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/66 (2%) 0/67 (0%) 2/68 (3%) 0/65 (0%) | 0/66 (0%) 0/64 (0%) 0/65 (0%) 1/65 (2%) | |ADJUSTED (b) | 3.4% 0.0% 8.3% 0.0% | 0.0% 0.0% 0.0% 2.3% | |INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/1 (0%) 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/26 (0%) 0/23 (0%) 2/24 (8%) 0/25 (0%) | 0/34 (0%) 0/39 (0%) 0/45 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 687 --- 737 (T) --- | --- --- --- 675 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.463N P=0.500N P=0.485 P=0.500N | P=0.194 (e) (e) P=0.500 | |INCIDENTAL TUMOR | P=0.424N P=0.362N P=0.535 P=0.362N | P=0.169 (e) (e) P=0.419 | |LOGISTIC REGRESSION | P=0.452N P=0.507N P=0.496 P=0.498N | P=0.197 (e) (e) P=0.496 | |COCHRAN-ARMITAGE | P=0.465N | P=0.198 | |FISHER EXACT | P=0.496N P=0.511 P=0.504N | (e) (e) P=0.496 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SULFATE HEXAHYDRATE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 20/66 (30%) 8/67 (12%) 19/68 (28%) 10/65 (15%) | 13/66 (20%) 14/64 (22%) 13/65 (20%) 10/65 (15%) | |ADJUSTED (b) | 48.8% 18.8% 49.6% 25.2% | 35.0% 34.7% 26.3% 23.5% | |INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/1 (0%) 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 2/5 (40%) 1/5 (20%) 1/5 (20%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 2/5 (40%) 1/5 (20%) | |TERMINAL (d) | 9/26 (35%) 0/23 (0%) 8/24 (33%) 3/25 (12%) | 11/34 (32%) 13/39 (33%) 10/45 (22%) 6/37 (16%) | |FIRST INCIDENCE (DAYS) | 395 458 (I) 284 404 | 547 635 459 (I) 459 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.102N P=0.024N* P=0.559N P=0.040N* | P=0.190N P=0.529N P=0.324N P=0.269N | |INCIDENTAL TUMOR | P=0.118N P=0.014N* P=0.506N P=0.055N | P=0.232N P=0.577N P=0.405N P=0.339N | |LOGISTIC REGRESSION | P=0.103N P=0.009N** P=0.483N P=0.034N* | P=0.260N P=0.524 P=0.527N P=0.349N | |COCHRAN-ARMITAGE | P=0.107N | P=0.252N | |FISHER EXACT | P=0.008N** P=0.456N P=0.033N* | P=0.464 P=0.569 P=0.338N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/66 (17%) 11/67 (16%) 15/68 (22%) 10/65 (15%) | 7/66 (11%) 14/64 (22%) 5/65 (8%) 11/65 (17%) | |ADJUSTED (b) | 24.3% 31.8% 39.7% 26.9% | 17.4% 27.7% 10.8% 23.6% | |INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/1 (0%) 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 2/26 (8%) 3/23 (13%) 6/24 (25%) 3/25 (12%) | 4/34 (12%) 4/39 (10%) 4/45 (9%) 5/37 (14%) | |FIRST INCIDENCE (DAYS) | 452 552 482 533 | 530 511 681 516 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.461N P=0.499 P=0.235 P=0.478N | P=0.410 P=0.123 P=0.245N P=0.251 | |INCIDENTAL TUMOR | P=0.468N P=0.565N P=0.224 P=0.404N | P=0.325 P=0.032 * P=0.358N P=0.213 | |LOGISTIC REGRESSION | P=0.528N P=0.592 P=0.201 P=0.570N | P=0.324 P=0.039 * P=0.338N P=0.171 | |COCHRAN-ARMITAGE | P=0.508N | P=0.387 | |FISHER EXACT | P=0.577N P=0.285 P=0.515N | P=0.065 P=0.392N P=0.213 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SULFATE HEXAHYDRATE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 29/66 (44%) 19/67 (28%) 30/68 (44%) 19/65 (29%) | 18/66 (27%) 28/64 (44%) 17/65 (26%) 20/65 (31%) | |ADJUSTED (b) | 61.5% 44.6% 67.8% 44.6% | 45.9% 55.5% 34.7% 42.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/1 (0%) 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 2/5 (40%) 1/5 (20%) 1/5 (20%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 2/5 (40%) 1/5 (20%) | |TERMINAL (d) | 11/26 (42%) 3/23 (13%) 12/24 (50%) 6/25 (24%) | 14/34 (41%) 17/39 (44%) 14/45 (31%) 11/37 (30%) | |FIRST INCIDENCE (DAYS) | 395 458 (I) 284 404 | 530 511 459 (I) 459 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.134N P=0.138N P=0.424 P=0.076N | P=0.364N P=0.125 P=0.204N P=0.493 | |INCIDENTAL TUMOR | P=0.123N P=0.050N P=0.482 P=0.056N | P=0.447N P=0.041 * P=0.296N P=0.425 | |LOGISTIC REGRESSION | P=0.133N P=0.052N P=0.534 P=0.058N | P=0.446N P=0.031 * P=0.420N P=0.387 | |COCHRAN-ARMITAGE | P=0.133N | P=0.431N | |FISHER EXACT | P=0.045N* P=0.561 P=0.058N | P=0.037 * P=0.521N P=0.402 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 29/66 (44%) 19/67 (28%) 30/68 (44%) 19/65 (29%) | 18/66 (27%) 28/64 (44%) 17/65 (26%) 20/65 (31%) | |ADJUSTED (b) | 61.5% 44.6% 67.8% 44.6% | 45.9% 55.5% 34.7% 42.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/1 (0%) 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 2/5 (40%) 1/5 (20%) 1/5 (20%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 2/5 (40%) 1/5 (20%) | |TERMINAL (d) | 11/26 (42%) 3/23 (13%) 12/24 (50%) 6/25 (24%) | 14/34 (41%) 17/39 (44%) 14/45 (31%) 11/37 (30%) | |FIRST INCIDENCE (DAYS) | 395 458 (I) 284 404 | 530 511 459 (I) 459 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.134N P=0.138N P=0.424 P=0.076N | P=0.364N P=0.125 P=0.204N P=0.493 | |INCIDENTAL TUMOR | P=0.123N P=0.050N P=0.482 P=0.056N | P=0.447N P=0.041 * P=0.296N P=0.425 | |LOGISTIC REGRESSION | P=0.133N P=0.052N P=0.534 P=0.058N | P=0.446N P=0.031 * P=0.420N P=0.387 | |COCHRAN-ARMITAGE | P=0.133N | P=0.431N | |FISHER EXACT | P=0.045N* P=0.561 P=0.058N | P=0.037 * P=0.521N P=0.402 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SULFATE HEXAHYDRATE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/71 (7%) 5/71 (7%) 3/72 (4%) 5/71 (7%) | 3/71 (4%) 3/70 (4%) 2/70 (3%) 0/70 (0%) | |ADJUSTED (b) | 18.4% 17.2% 9.1% 17.2% | 8.8% 7.2% 4.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 4/26 (15%) 3/23 (13%) 1/24 (4%) 3/25 (12%) | 3/34 (9%) 1/39 (3%) 2/45 (4%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 688 552 552 597 | 730 (T) 711 730 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.525N P=0.574 P=0.384N P=0.615 | P=0.059N P=0.602N P=0.373N P=0.106N | |INCIDENTAL TUMOR | P=0.525N P=0.588 P=0.337N P=0.583N | P=0.076N P=0.661 P=0.373N P=0.106N | |LOGISTIC REGRESSION | P=0.508N P=0.606 P=0.363N P=0.614N | P=0.067N P=0.637N P=0.373N P=0.106N | |COCHRAN-ARMITAGE | P=0.532N | P=0.075N | |FISHER EXACT | P=0.628N P=0.352N P=0.628N | P=0.653 P=0.507N P=0.125N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/71 (13%) 13/71 (18%) 4/72 (6%) 3/71 (4%) | 4/71 (6%) 3/70 (4%) 9/70 (13%) 2/70 (3%) | |ADJUSTED (b) | 29.5% 51.6% 13.0% 9.8% | 10.7% 7.1% 18.9% 4.3% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 6/26 (23%) 11/23 (48%) 2/24 (8%) 2/25 (8%) | 3/34 (9%) 2/39 (5%) 7/45 (16%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 516 687 613 561 | 627 649 656 562 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.012N* P=0.155 P=0.138N P=0.068N | P=0.378N P=0.444N P=0.238 P=0.332N | |INCIDENTAL TUMOR | P=0.009N** P=0.250 P=0.111N P=0.044N* | P=0.452N P=0.491N P=0.151 P=0.394N | |LOGISTIC REGRESSION | P=0.009N** P=0.191 P=0.122N P=0.057N | P=0.417N P=0.489N P=0.155 P=0.349N | |COCHRAN-ARMITAGE | P=0.013N* | P=0.410N | |FISHER EXACT | P=0.244 P=0.117N P=0.064N | P=0.508N P=0.116 P=0.347N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SULFATE HEXAHYDRATE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/71 (18%) 18/71 (25%) 7/72 (10%) 8/71 (11%) | 7/71 (10%) 6/70 (9%) 10/70 (14%) 2/70 (3%) | |ADJUSTED (b) | 43.6% 65.4% 21.2% 26.2% | 19.3% 13.9% 21.1% 4.3% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 10/26 (38%) 14/23 (61%) 3/24 (13%) 5/25 (20%) | 6/34 (18%) 3/39 (8%) 8/45 (18%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 516 552 552 561 | 627 649 656 562 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.040N* P=0.105 P=0.135N P=0.179N | P=0.089N P=0.415N P=0.512 P=0.077N | |INCIDENTAL TUMOR | P=0.033N* P=0.157 P=0.103N P=0.126N | P=0.131N P=0.495N P=0.404 P=0.096N | |LOGISTIC REGRESSION | P=0.028N* P=0.144 P=0.110N P=0.141N | P=0.111N P=0.477N P=0.377 P=0.089N | |COCHRAN-ARMITAGE | P=0.045N* | P=0.112N | |FISHER EXACT | P=0.208 P=0.107N P=0.172N | P=0.511N P=0.292 P=0.086N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/71 (0%) 0/71 (0%) 0/72 (0%) 0/72 (0%) | 2/71 (3%) 1/70 (1%) 0/70 (0%) 1/70 (1%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.9% 2.3% 0.0% 2.7% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/26 (0%) 0/23 (0%) 0/24 (0%) 0/25 (0%) | 2/34 (6%) 0/39 (0%) 0/45 (0%) 1/37 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 730 (T) 687 --- 730 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.352N P=0.466N P=0.179N P=0.470N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.379N P=0.501N P=0.179N P=0.470N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.371N P=0.489N P=0.179N P=0.470N | |COCHRAN-ARMITAGE | (e) | P=0.370N | |FISHER EXACT | (e) (e) (e) | P=0.505N P=0.252N P=0.505N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SULFATE HEXAHYDRATE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/71 (0%) 0/71 (0%) 0/72 (0%) 0/72 (0%) | 2/71 (3%) 2/70 (3%) 0/70 (0%) 1/70 (1%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.9% 4.8% 0.0% 2.7% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/26 (0%) 0/23 (0%) 0/24 (0%) 0/25 (0%) | 2/34 (6%) 1/39 (3%) 0/45 (0%) 1/37 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 730 (T) 687 --- 730 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.278N P=0.654N P=0.179N P=0.470N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.300N P=0.683N P=0.179N P=0.470N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.299N P=0.682N P=0.179N P=0.470N | |COCHRAN-ARMITAGE | (e) | P=0.300N | |FISHER EXACT | (e) (e) (e) | P=0.685 P=0.252N P=0.505N | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/64 (3%) 1/63 (2%) 0/65 (0%) 0/64 (0%) | |ADJUSTED (b) | | 5.8% 2.6% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | | 1/33 (3%) 1/38 (3%) 0/45 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | | 728 730 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.085N P=0.452N P=0.181N P=0.218N | |INCIDENTAL TUMOR | | P=0.106N P=0.514N P=0.259N P=0.270N | |LOGISTIC REGRESSION | | P=0.089N P=0.466N P=0.193N P=0.225N | |COCHRAN-ARMITAGE | | P=0.100N | |FISHER EXACT | | P=0.506N P=0.244N P=0.248N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SULFATE HEXAHYDRATE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 0/57 (0%) 0/63 (0%) 0/62 (0%) | 8/64 (13%) 9/61 (15%) 5/64 (8%) 4/61 (7%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 20.6% 21.8% 11.1% 9.4% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/3 (0%) 0/5 (0%) 0/4 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/4 (0%) | |TERMINAL (d) | 0/25 (0%) 0/22 (0%) 0/24 (0%) 0/24 (0%) | 4/33 (12%) 7/38 (18%) 5/45 (11%) 1/37 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 696 559 730 (T) 601 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.072N P=0.589 P=0.144N P=0.172N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.108N P=0.425 P=0.241N P=0.271N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.086N P=0.497 P=0.189N P=0.186N | |COCHRAN-ARMITAGE | (e) | P=0.102N | |FISHER EXACT | (e) (e) (e) | P=0.457 P=0.280N P=0.206N | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/71 (0%) 0/71 (0%) 0/72 (0%) 0/72 (0%) | 5/71 (7%) 0/70 (0%) 1/70 (1%) 2/70 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 9.3% 0.0% 1.7% 4.3% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/26 (0%) 0/23 (0%) 0/24 (0%) 0/25 (0%) | 0/34 (0%) 0/39 (0%) 0/45 (0%) 1/37 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 384 --- 510 393 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.239N P=0.037N* P=0.096N P=0.233N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.168N P=0.033N* P=0.173N P=0.143N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.202N P=0.037N* P=0.130N P=0.226N | |COCHRAN-ARMITAGE | (e) | P=0.237N | |FISHER EXACT | (e) (e) (e) | P=0.030N* P=0.108N P=0.226N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SULFATE HEXAHYDRATE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/66 (0%) 2/66 (3%) 1/66 (2%) 1/67 (1%) | 1/65 (2%) 1/64 (2%) 2/65 (3%) 1/65 (2%) | |ADJUSTED (b) | 0.0% 8.3% 3.0% 4.8% | 2.9% 2.6% 4.4% 2.7% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/26 (0%) 1/23 (4%) 0/24 (0%) 1/25 (4%) | 1/34 (3%) 1/39 (3%) 2/45 (4%) 1/37 (3%) | |FIRST INCIDENCE (DAYS) | --- 594 627 737 (T) | 730 (T) 730 (T) 730 (T) 730 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.530 P=0.209 P=0.519 P=0.500 | P=0.617 P=0.731N P=0.597 P=0.743N | |INCIDENTAL TUMOR | P=0.460 P=0.200 P=0.451 P=0.492 | P=0.617 P=0.731N P=0.597 P=0.743N | |LOGISTIC REGRESSION | P=0.510 P=0.231 P=0.500 P=0.492 | P=0.617 P=0.731N P=0.597 P=0.743N | |COCHRAN-ARMITAGE | P=0.505 | P=0.592 | |FISHER EXACT | P=0.248 P=0.500 P=0.504 | P=0.748 P=0.500 P=0.752N | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 2/71 (3%) 3/70 (4%) 0/70 (0%) 1/70 (1%) | |ADJUSTED (b) | | 5.9% 6.5% 0.0% 2.7% | |INTERIM SACRIFICE 1 (c)| | 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%) | |TERMINAL (d) | | 2/34 (6%) 1/39 (3%) 0/45 (0%) 1/37 (3%) | |FIRST INCIDENCE (DAYS) | | 730 (T) 614 --- 730 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.229N P=0.545 P=0.179N P=0.470N | |INCIDENTAL TUMOR | | P=0.263N P=0.485 P=0.179N P=0.470N | |LOGISTIC REGRESSION | | P=0.247N P=0.507 P=0.179N P=0.470N | |COCHRAN-ARMITAGE | | P=0.246N | |FISHER EXACT | | P=0.493 P=0.252N P=0.505N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SULFATE HEXAHYDRATE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/71 (3%) 1/71 (1%) 2/72 (3%) 0/72 (0%) | 1/71 (1%) 0/70 (0%) 0/70 (0%) 1/70 (1%) | |ADJUSTED (b) | 6.9% 4.3% 8.3% 0.0% | 2.9% 0.0% 0.0% 2.3% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/26 (0%) 1/23 (4%) 2/24 (8%) 0/25 (0%) | 1/34 (3%) 0/39 (0%) 0/45 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 687 737 (T) 737 (T) --- | 730 (T) --- --- 675 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.202N P=0.514N P=0.687 P=0.236N | P=0.604 P=0.473N P=0.444N P=0.751N | |INCIDENTAL TUMOR | P=0.162N P=0.355N P=0.626N P=0.097N | P=0.560 P=0.473N P=0.444N P=0.726 | |LOGISTIC REGRESSION | P=0.192N P=0.514N P=0.692 P=0.232N | P=0.591 P=0.473N P=0.444N P=0.756 | |COCHRAN-ARMITAGE | P=0.197N | P=0.592 | |FISHER EXACT | P=0.500N P=0.685N P=0.245N | P=0.504N P=0.504N P=0.748 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/71 (3%) 1/71 (1%) 2/72 (3%) 0/72 (0%) | 1/71 (1%) 1/70 (1%) 1/70 (1%) 2/70 (3%) | |ADJUSTED (b) | 6.9% 4.3% 8.3% 0.0% | 2.9% 2.6% 2.2% 5.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/26 (0%) 1/23 (4%) 2/24 (8%) 0/25 (0%) | 1/34 (3%) 1/39 (3%) 1/45 (2%) 1/37 (3%) | |FIRST INCIDENCE (DAYS) | 687 737 (T) 737 (T) --- | 730 (T) 730 (T) 730 (T) 675 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.202N P=0.514N P=0.687 P=0.236N | P=0.364 P=0.731N P=0.698N P=0.520 | |INCIDENTAL TUMOR | P=0.162N P=0.355N P=0.626N P=0.097N | P=0.340 P=0.731N P=0.698N P=0.473 | |LOGISTIC REGRESSION | P=0.192N P=0.514N P=0.692 P=0.232N | P=0.340 P=0.732N P=0.698N P=0.490 | |COCHRAN-ARMITAGE | P=0.197N | P=0.348 | |FISHER EXACT | P=0.500N P=0.685N P=0.245N | P=0.748 P=0.748 P=0.495 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SULFATE HEXAHYDRATE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/71 (1%) 1/71 (1%) 2/72 (3%) 0/72 (0%) | 1/71 (1%) 4/70 (6%) 2/70 (3%) 4/70 (6%) | |ADJUSTED (b) | 3.8% 2.7% 5.9% 0.0% | 2.3% 9.0% 4.0% 8.8% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/26 (4%) 0/23 (0%) 1/24 (4%) 0/25 (0%) | 0/34 (0%) 2/39 (5%) 1/45 (2%) 1/37 (3%) | |FIRST INCIDENCE (DAYS) | 737 (T) 621 485 --- | 670 398 577 571 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.360N P=0.753 P=0.475 P=0.508N | P=0.217 P=0.213 P=0.551 P=0.181 | |INCIDENTAL TUMOR | P=0.356N P=0.719 P=0.535 P=0.508N | P=0.176 P=0.164 P=0.392 P=0.110 | |LOGISTIC REGRESSION | P=0.360N P=0.754 P=0.497 P=0.508N | P=0.212 P=0.180 P=0.506 P=0.089 | |COCHRAN-ARMITAGE | P=0.362N | P=0.214 | |FISHER EXACT | P=0.752N P=0.505 P=0.497N | P=0.179 P=0.495 P=0.179 | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/71 (4%) 2/71 (3%) 5/72 (7%) 0/72 (0%) | 8/71 (11%) 15/70 (21%) 11/70 (16%) 10/70 (14%) | |ADJUSTED (b) | 11.5% 6.1% 17.6% 0.0% | 19.5% 33.6% 21.8% 22.7% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 3/26 (12%) 0/23 (0%) 3/24 (13%) 0/25 (0%) | 3/34 (9%) 10/39 (26%) 7/45 (16%) 5/37 (14%) | |FIRST INCIDENCE (DAYS) | 737 (T) 621 485 --- | 626 398 567 571 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.165N P=0.528N P=0.315 P=0.126N | P=0.514N P=0.146 P=0.495 P=0.429 | |INCIDENTAL TUMOR | P=0.136N P=0.495N P=0.386 P=0.126N | P=0.435 P=0.065 P=0.199 P=0.261 | |LOGISTIC REGRESSION | P=0.152N P=0.519N P=0.349 P=0.126N | P=0.518 P=0.088 P=0.360 P=0.374 | |COCHRAN-ARMITAGE | P=0.159N | P=0.532 | |FISHER EXACT | P=0.500N P=0.367 P=0.120N | P=0.080 P=0.300 P=0.388 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SULFATE HEXAHYDRATE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/71 (3%) 1/71 (1%) 3/72 (4%) 0/72 (0%) | 7/71 (10%) 12/70 (17%) 9/70 (13%) 6/70 (9%) | |ADJUSTED (b) | 7.7% 3.4% 12.0% 0.0% | 17.6% 28.4% 18.3% 15.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 2/26 (8%) 0/23 (0%) 2/24 (8%) 0/25 (0%) | 3/34 (9%) 9/39 (23%) 6/45 (13%) 4/37 (11%) | |FIRST INCIDENCE (DAYS) | 737 (T) 687 728 --- | 626 687 567 596 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.248N P=0.528N P=0.464 P=0.246N | P=0.258N P=0.238 P=0.574 P=0.467N | |INCIDENTAL TUMOR | P=0.203N P=0.450N P=0.513 P=0.246N | P=0.357N P=0.144 P=0.310 P=0.592N | |LOGISTIC REGRESSION | P=0.233N P=0.516N P=0.480 P=0.244N | P=0.305N P=0.175 P=0.453 P=0.523N | |COCHRAN-ARMITAGE | P=0.238N | P=0.298N | |FISHER EXACT | P=0.500N P=0.507 P=0.245N | P=0.154 P=0.384 P=0.511N | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 24/71 (34%) 18/71 (25%) 25/72 (35%) 16/72 (22%) | 27/71 (38%) 35/70 (50%) 24/70 (34%) 18/70 (26%) | |ADJUSTED (b) | 59.4% 43.8% 60.0% 42.4% | 60.9% 71.0% 47.4% 39.8% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 2/5 (40%) 2/5 (40%) 1/5 (20%) 0/5 (0%) | 0/5 (0%) 1/5 (20%) 2/5 (40%) 2/5 (40%) | |TERMINAL (d) | 12/26 (46%) 5/23 (22%) 10/24 (42%) 7/25 (28%) | 17/34 (50%) 25/39 (64%) 19/45 (42%) 11/37 (30%) | |FIRST INCIDENCE (DAYS) | 395 458 (I) 284 404 | 547 459 (I) 459 (I) 459 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.142N P=0.280N P=0.441 P=0.112N | P=0.009N** P=0.278 P=0.088N P=0.059N | |INCIDENTAL TUMOR | P=0.139N P=0.220N P=0.487 P=0.108N | P=0.018N* P=0.095 P=0.255N P=0.108N | |LOGISTIC REGRESSION | P=0.114N P=0.201N P=0.487 P=0.079N | P=0.014N* P=0.109 P=0.234N P=0.079N | |COCHRAN-ARMITAGE | P=0.127N | P=0.017N* | |FISHER EXACT | P=0.179N P=0.524 P=0.087N | P=0.103 P=0.387N P=0.082N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SULFATE HEXAHYDRATE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | 0.0MG/M3 .25MG/M3 0.5MG/M3 1.0MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 20/71 (28%) 22/71 (31%) 25/72 (35%) 13/72 (18%) | 26/71 (37%) 27/70 (39%) 26/70 (37%) 26/70 (37%) | |ADJUSTED (b) | 48.8% 66.8% 64.1% 34.8% | 53.0% 52.3% 47.7% 50.0% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 8/26 (31%) 13/23 (57%) 12/24 (50%) 5/25 (20%) | 12/34 (35%) 15/39 (38%) 17/45 (38%) 12/37 (32%) | |FIRST INCIDENCE (DAYS) | 452 552 482 533 | 384 398 510 393 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.095N P=0.302 P=0.205 P=0.129N | P=0.467N P=0.478N P=0.252N P=0.516N | |INCIDENTAL TUMOR | P=0.057N P=0.439 P=0.227 P=0.044N* | P=0.458 P=0.413 P=0.436 P=0.470 | |LOGISTIC REGRESSION | P=0.064N P=0.365 P=0.213 P=0.101N | P=0.499 P=0.512 P=0.491N P=0.518 | |COCHRAN-ARMITAGE | P=0.081N | P=0.530N | |FISHER EXACT | P=0.427 P=0.254 P=0.108N | P=0.474 P=0.544 P=0.544 | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 40/71 (56%) 38/71 (54%) 42/72 (58%) 27/72 (38%) | 41/71 (58%) 46/70 (66%) 42/70 (60%) 38/70 (54%) | |ADJUSTED (b) | 83.8% 85.0% 82.6% 62.3% | 80.0% 80.6% 72.2% 67.6% | |INTERIM SACRIFICE 1 (c)| 0/5 (0%) 1/5 (20%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 2/5 (40%) 2/5 (40%) 1/5 (20%) 0/5 (0%) | 0/5 (0%) 1/5 (20%) 2/5 (40%) 2/5 (40%) | |TERMINAL (d) | 19/26 (73%) 17/23 (74%) 16/24 (67%) 11/25 (44%) | 24/34 (71%) 28/39 (72%) 29/45 (64%) 19/37 (51%) | |FIRST INCIDENCE (DAYS) | 395 206 (I) 284 404 | 384 398 459 (I) 393 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.033N* P=0.485 P=0.363 P=0.042N* | P=0.203N P=0.511 P=0.157N P=0.318N | |INCIDENTAL TUMOR | P=0.009N** P=0.489N P=0.429 P=0.008N** | P=0.304N P=0.170 P=0.510 P=0.474N | |LOGISTIC REGRESSION | P=0.008N** P=0.519N P=0.399 P=0.013N* | P=0.260N P=0.230 P=0.502N P=0.430N | |COCHRAN-ARMITAGE | P=0.014N* | P=0.250N | |FISHER EXACT | P=0.433N P=0.471 P=0.018N* | P=0.212 P=0.460 P=0.404N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05122 TEST: 06 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL SULFATE HEXAHYDRATE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 206 458 Female interim sacrifices(days): 207 459 (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).