TDMS Study 05085-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus MANGANESE SULFATE DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 TIME: 02:31:46 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-45041 ROUTE: DOSED FEED NTP C#: 61143B PATHOLOGIST: J. TOFT CAS: 7785-87-7 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus MANGANESE SULFATE DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 TIME: 02:31:46 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-45041 ROUTE: DOSED FEED NTP C#: 61143B PATHOLOGIST: J. TOFT CAS: 7785-87-7 RATS(FISCHER344) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Bone Marrow Brain Clitoral Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus MANGANESE SULFATE DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 TIME: 02:31:46 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-45041 ROUTE: DOSED FEED NTP C#: 61143B PATHOLOGIST: J. TOFT CAS: 7785-87-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF MANGANESE SULFATE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Islets, Pancreatic Carcinoma or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Skin: Subcutaneous Tissue Fibrous Histiocytoma Testes Adenoma All Organs Benign Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ All Organs Malignant and Benign Tumors ==================================================================================================== DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/70 (20%) 17/70 (24%) 14/70 (20%) 6/70 (9%) | 1/70 (1%) 0/61 (0%) 4/62 (6%) 1/68 (1%) | |ADJUSTED (b) | 45.7% 52.7% 45.7% 31.8% | 2.7% 0.0% 9.5% 2.8% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 9/25 (36%) 3/17 (18%) 7/22 (32%) 0/7 (0%) | 1/37 (3%) 0/37 (0%) 4/42 (10%) 1/36 (3%) | |FIRST INCIDENCE (DAYS) | 621 613 618 661 | 729 (T) --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.232N P=0.168 P=0.503 P=0.501N | P=0.552 P=0.500N P=0.219 P=0.756 | |INCIDENTAL TUMOR | P=0.002N** P=0.499 P=0.551 P=0.038N* | P=0.552 P=0.500N P=0.219 P=0.756 | |LOGISTIC REGRESSION | P=0.003N** P=0.299 P=0.576 P=0.077N | P=0.552 P=0.500N P=0.219 P=0.756 | |COCHRAN-ARMITAGE | P=0.013N* | P=0.574 | |FISHER EXACT | P=0.342 P=0.584N P=0.045N* | P=0.534N P=0.147 P=0.745 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/70 (20%) 18/70 (26%) 16/70 (23%) 6/70 (9%) | 2/70 (3%) 0/61 (0%) 4/62 (6%) 1/68 (1%) | |ADJUSTED (b) | 45.7% 56.1% 53.0% 31.8% | 5.1% 0.0% 9.5% 2.8% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 9/25 (36%) 4/17 (24%) 9/22 (41%) 0/7 (0%) | 1/37 (3%) 0/37 (0%) 4/42 (10%) 1/36 (3%) | |FIRST INCIDENCE (DAYS) | 621 613 618 661 | 694 --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.246N P=0.118 P=0.333 P=0.501N | P=0.572N P=0.245N P=0.389 P=0.504N | |INCIDENTAL TUMOR | P=0.003N** P=0.391 P=0.361 P=0.038N* | P=0.529N P=0.284N P=0.334 P=0.460N | |LOGISTIC REGRESSION | P=0.003N** P=0.226 P=0.393 P=0.077N | P=0.555N P=0.251N P=0.352 P=0.503N | |COCHRAN-ARMITAGE | P=0.011N* | P=0.548N | |FISHER EXACT | P=0.273 P=0.419 P=0.045N* | P=0.284N P=0.284 P=0.511N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Brain | | Astrocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/70 (3%) 0/69 (0%) 0/70 (0%) 0/70 (0%) | 0/70 (0%) 0/61 (0%) 0/62 (0%) 0/68 (0%) | |ADJUSTED (b) | 6.1% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 1/25 (4%) 0/17 (0%) 0/22 (0%) 0/7 (0%) | 0/37 (0%) 0/37 (0%) 0/42 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | 571 --- --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.306N P=0.282N P=0.262N P=0.371N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.296N P=0.346N P=0.299N P=0.381N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.246N P=0.246N P=0.240N P=0.247N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.242N | (e) | |FISHER EXACT | P=0.252N P=0.248N P=0.248N | (e) (e) (e) | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/70 (3%) 0/69 (0%) 0/70 (0%) 0/70 (0%) | 0/70 (0%) 0/61 (0%) 0/62 (0%) 1/68 (1%) | |ADJUSTED (b) | 6.1% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 2.8% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 1/25 (4%) 0/17 (0%) 0/22 (0%) 0/7 (0%) | 0/37 (0%) 0/37 (0%) 0/42 (0%) 1/36 (3%) | |FIRST INCIDENCE (DAYS) | 571 --- --- --- | --- --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.306N P=0.282N P=0.262N P=0.371N | P=0.205 (e) (e) P=0.495 | |INCIDENTAL TUMOR | P=0.296N P=0.346N P=0.299N P=0.381N | P=0.205 (e) (e) P=0.495 | |LOGISTIC REGRESSION | P=0.246N P=0.246N P=0.240N P=0.247N | P=0.205 (e) (e) P=0.495 | |COCHRAN-ARMITAGE | P=0.242N | P=0.222 | |FISHER EXACT | P=0.252N P=0.248N P=0.248N | (e) (e) P=0.493 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/70 (4%) 2/70 (3%) 2/70 (3%) 0/70 (0%) | 5/69 (7%) 1/60 (2%) 6/58 (10%) 2/67 (3%) | |ADJUSTED (b) | 12.0% 5.8% 6.5% 0.0% | 12.7% 2.7% 14.8% 5.6% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/9 (11%) 1/9 (11%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 3/25 (12%) 0/17 (0%) 1/22 (5%) 0/7 (0%) | 4/37 (11%) 1/37 (3%) 5/39 (13%) 2/36 (6%) | |FIRST INCIDENCE (DAYS) | 729 (T) 437 (I) 437 (I) --- | 599 729 (T) 663 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.214N P=0.619N P=0.556N P=0.411N | P=0.350N P=0.110N P=0.531 P=0.230N | |INCIDENTAL TUMOR | P=0.171N P=0.550N P=0.556N P=0.411N | P=0.377N P=0.120N P=0.424 P=0.313N | |LOGISTIC REGRESSION | P=0.103N P=0.509N P=0.506N P=0.411N | P=0.333N P=0.119N P=0.456 P=0.224N | |COCHRAN-ARMITAGE | P=0.099N | P=0.326N | |FISHER EXACT | P=0.500N P=0.500N P=0.122N | P=0.140N P=0.379 P=0.233N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/70 (3%) 2/70 (3%) 4/70 (6%) 2/70 (3%) | 0/69 (0%) 1/60 (2%) 1/58 (2%) 0/67 (0%) | |ADJUSTED (b) | 4.9% 5.0% 14.9% 9.9% | 0.0% 2.7% 2.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/25 (0%) 0/17 (0%) 2/22 (9%) 0/7 (0%) | 0/37 (0%) 1/37 (3%) 0/39 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | 571 613 659 655 | --- 729 (T) 528 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.499 P=0.666N P=0.322 P=0.646 | P=0.547N P=0.500 P=0.496 (e) | |INCIDENTAL TUMOR | P=0.464N P=0.621 P=0.297 P=0.530N | P=0.543N P=0.500 (e) (e) | |LOGISTIC REGRESSION | P=0.602 P=0.691 P=0.331 P=0.682 | P=0.529N P=0.500 P=0.456 (e) | |COCHRAN-ARMITAGE | P=0.593N | P=0.528N | |FISHER EXACT | P=0.690N P=0.340 P=0.690N | P=0.465 P=0.457 (e) | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/70 (7%) 4/70 (6%) 6/70 (9%) 2/70 (3%) | 5/69 (7%) 2/60 (3%) 7/58 (12%) 2/67 (3%) | |ADJUSTED (b) | 16.3% 10.5% 20.8% 9.9% | 12.7% 5.4% 16.5% 5.6% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/9 (11%) 1/9 (11%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 3/25 (12%) 0/17 (0%) 3/22 (14%) 0/7 (0%) | 4/37 (11%) 2/37 (5%) 5/39 (13%) 2/36 (6%) | |FIRST INCIDENCE (DAYS) | 571 437 (I) 437 (I) 655 | 599 729 (T) 528 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.406N P=0.570N P=0.446 P=0.492N | P=0.294N P=0.226N P=0.409 P=0.230N | |INCIDENTAL TUMOR | P=0.196N P=0.599N P=0.428 P=0.306N | P=0.316N P=0.241N P=0.424 P=0.313N | |LOGISTIC REGRESSION | P=0.206N P=0.510N P=0.491 P=0.249N | P=0.278N P=0.244N P=0.320 P=0.224N | |COCHRAN-ARMITAGE | P=0.192N | P=0.269N | |FISHER EXACT | P=0.500N P=0.500 P=0.221N | P=0.282N P=0.267 P=0.233N | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 3/69 (4%) 4/70 (6%) 3/69 (4%) | 0/70 (0%) 0/60 (0%) 1/61 (2%) 0/68 (0%) | |ADJUSTED (b) | 0.0% 11.5% 15.4% 20.5% | 0.0% 0.0% 2.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/25 (0%) 1/17 (6%) 2/22 (9%) 1/7 (14%) | 0/37 (0%) 0/37 (0%) 1/42 (2%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | --- 613 701 631 | --- --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.100 P=0.102 P=0.062 P=0.053 | P=0.795N (e) P=0.525 (e) | |INCIDENTAL TUMOR | P=0.258 P=0.104 P=0.071 P=0.086 | P=0.795N (e) P=0.525 (e) | |LOGISTIC REGRESSION | P=0.221 P=0.116 P=0.060 P=0.100 | P=0.795N (e) P=0.525 (e) | |COCHRAN-ARMITAGE | P=0.273 | P=0.777N | |FISHER EXACT | P=0.120 P=0.060 P=0.120 | (e) P=0.466 (e) | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 3/69 (4%) 4/70 (6%) 4/69 (6%) | 0/70 (0%) 0/60 (0%) 1/61 (2%) 0/68 (0%) | |ADJUSTED (b) | 0.0% 11.5% 15.4% 23.3% | 0.0% 0.0% 2.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/25 (0%) 1/17 (6%) 2/22 (9%) 1/7 (14%) | 0/37 (0%) 0/37 (0%) 1/42 (2%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | --- 613 701 631 | --- --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.036 * P=0.102 P=0.062 P=0.026 * | P=0.795N (e) P=0.525 (e) | |INCIDENTAL TUMOR | P=0.148 P=0.104 P=0.071 P=0.067 | P=0.795N (e) P=0.525 (e) | |LOGISTIC REGRESSION | P=0.104 P=0.116 P=0.060 P=0.051 | P=0.795N (e) P=0.525 (e) | |COCHRAN-ARMITAGE | P=0.139 | P=0.777N | |FISHER EXACT | P=0.120 P=0.060 P=0.058 | (e) P=0.466 (e) | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/70 (1%) 2/69 (3%) 0/70 (0%) 1/70 (1%) | 0/70 (0%) 0/61 (0%) 1/62 (2%) 0/68 (0%) | |ADJUSTED (b) | 4.0% 9.8% 0.0% 4.2% | 0.0% 0.0% 2.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 1/25 (4%) 1/17 (6%) 0/22 (0%) 0/7 (0%) | 0/37 (0%) 0/37 (0%) 1/42 (2%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 698 --- 687 | --- --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.640 P=0.398 P=0.525N P=0.600 | P=0.795N (e) P=0.525 (e) | |INCIDENTAL TUMOR | P=0.568N P=0.494 P=0.525N P=0.775 | P=0.795N (e) P=0.525 (e) | |LOGISTIC REGRESSION | P=0.616N P=0.472 P=0.525N P=0.720 | P=0.795N (e) P=0.525 (e) | |COCHRAN-ARMITAGE | P=0.549N | P=0.778N | |FISHER EXACT | P=0.495 P=0.500N P=0.752N | (e) P=0.470 (e) | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/70 (1%) 2/69 (3%) 0/70 (0%) 1/70 (1%) | 0/70 (0%) 0/61 (0%) 1/62 (2%) 0/68 (0%) | |ADJUSTED (b) | 4.0% 9.8% 0.0% 4.2% | 0.0% 0.0% 2.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 1/25 (4%) 1/17 (6%) 0/22 (0%) 0/7 (0%) | 0/37 (0%) 0/37 (0%) 1/42 (2%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 698 --- 687 | --- --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.640 P=0.398 P=0.525N P=0.600 | P=0.795N (e) P=0.525 (e) | |INCIDENTAL TUMOR | P=0.568N P=0.494 P=0.525N P=0.775 | P=0.795N (e) P=0.525 (e) | |LOGISTIC REGRESSION | P=0.616N P=0.472 P=0.525N P=0.720 | P=0.795N (e) P=0.525 (e) | |COCHRAN-ARMITAGE | P=0.549N | P=0.778N | |FISHER EXACT | P=0.495 P=0.500N P=0.752N | (e) P=0.470 (e) | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/70 (1%) 3/70 (4%) 0/70 (0%) 0/70 (0%) | 1/70 (1%) 1/61 (2%) 0/62 (0%) 2/68 (3%) | |ADJUSTED (b) | 1.7% 12.5% 0.0% 0.0% | 2.7% 2.7% 0.0% 5.6% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 1/10 (10%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/25 (0%) 1/17 (6%) 0/22 (0%) 0/7 (0%) | 1/37 (3%) 1/37 (3%) 0/42 (0%) 2/36 (6%) | |FIRST INCIDENCE (DAYS) | 437 (I) 666 --- --- | 729 (T) 729 (T) --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.215N P=0.258 P=0.521N P=0.545N | P=0.320 P=0.762 P=0.475N P=0.490 | |INCIDENTAL TUMOR | P=0.126N P=0.390 P=0.521N P=0.545N | P=0.320 P=0.762 P=0.475N P=0.490 | |LOGISTIC REGRESSION | P=0.154N P=0.300 P=0.505N P=0.497N | P=0.320 P=0.762 P=0.475N P=0.490 | |COCHRAN-ARMITAGE | P=0.151N | P=0.345 | |FISHER EXACT | P=0.310 P=0.500N P=0.500N | P=0.716 P=0.530N P=0.489 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/70 (3%) 0/70 (0%) 0/70 (0%) 1/70 (1%) | 0/70 (0%) 0/61 (0%) 0/62 (0%) 0/68 (0%) | |ADJUSTED (b) | 8.0% 0.0% 0.0% 3.7% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 2/25 (8%) 0/17 (0%) 0/22 (0%) 0/7 (0%) | 0/37 (0%) 0/37 (0%) 0/42 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- 673 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.582 P=0.326N P=0.266N P=0.695 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.672 P=0.326N P=0.266N P=0.673N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.694 P=0.326N P=0.266N P=0.584N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.650N | (e) | |FISHER EXACT | P=0.248N P=0.248N P=0.500N | (e) (e) (e) | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/70 (4%) 3/70 (4%) 0/70 (0%) 1/70 (1%) | 1/70 (1%) 1/61 (2%) 0/62 (0%) 2/68 (3%) | |ADJUSTED (b) | 9.5% 12.5% 0.0% 3.7% | 2.7% 2.7% 0.0% 5.6% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 1/10 (10%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 2/25 (8%) 1/17 (6%) 0/22 (0%) 0/7 (0%) | 1/37 (3%) 1/37 (3%) 0/42 (0%) 2/36 (6%) | |FIRST INCIDENCE (DAYS) | 437 (I) 666 --- 673 | 729 (T) 729 (T) --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.353N P=0.555 P=0.145N P=0.573N | P=0.320 P=0.762 P=0.475N P=0.490 | |INCIDENTAL TUMOR | P=0.200N P=0.653N P=0.145N P=0.446N | P=0.320 P=0.762 P=0.475N P=0.490 | |LOGISTIC REGRESSION | P=0.207N P=0.653 P=0.122N P=0.318N | P=0.320 P=0.762 P=0.475N P=0.490 | |COCHRAN-ARMITAGE | P=0.195N | P=0.345 | |FISHER EXACT | P=0.660N P=0.122N P=0.310N | P=0.716 P=0.530N P=0.489 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 0/70 (0%) 1/70 (1%) 2/70 (3%) | 19/70 (27%) 16/61 (26%) 26/62 (42%) 16/68 (24%) | |ADJUSTED (b) | 4.0% 0.0% 3.1% 17.7% | 45.9% 40.9% 57.7% 38.5% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 1/25 (4%) 0/17 (0%) 0/22 (0%) 1/7 (14%) | 15/37 (41%) 14/37 (38%) 23/42 (55%) 11/36 (31%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 684 684 | 624 667 571 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.093 P=0.577N P=0.754 P=0.212 | P=0.390N P=0.352N P=0.246 P=0.358N | |INCIDENTAL TUMOR | P=0.208 P=0.577N P=0.747N P=0.327 | P=0.347N P=0.445N P=0.104 P=0.370N | |LOGISTIC REGRESSION | P=0.185 P=0.577N P=0.761 P=0.398 | P=0.328N P=0.420N P=0.116 P=0.351N | |COCHRAN-ARMITAGE | P=0.232 | P=0.321N | |FISHER EXACT | P=0.500N P=0.752N P=0.500 | P=0.533N P=0.054 P=0.385N | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 0/70 (0%) 1/70 (1%) 2/70 (3%) | 19/70 (27%) 17/61 (28%) 26/62 (42%) 16/68 (24%) | |ADJUSTED (b) | 4.0% 0.0% 3.1% 17.7% | 45.9% 43.5% 57.7% 38.5% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 1/25 (4%) 0/17 (0%) 0/22 (0%) 1/7 (14%) | 15/37 (41%) 15/37 (41%) 23/42 (55%) 11/36 (31%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 684 684 | 624 667 571 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.093 P=0.577N P=0.754 P=0.212 | P=0.355N P=0.430N P=0.246 P=0.358N | |INCIDENTAL TUMOR | P=0.208 P=0.577N P=0.747N P=0.327 | P=0.312N P=0.529N P=0.104 P=0.370N | |LOGISTIC REGRESSION | P=0.185 P=0.577N P=0.761 P=0.398 | P=0.293N P=0.508N P=0.116 P=0.351N | |COCHRAN-ARMITAGE | P=0.232 | P=0.290N | |FISHER EXACT | P=0.500N P=0.752N P=0.500 | P=0.540 P=0.054 P=0.385N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/70 (3%) 0/70 (0%) 0/70 (0%) 0/70 (0%) | 0/70 (0%) 1/61 (2%) 0/62 (0%) 0/68 (0%) | |ADJUSTED (b) | 8.0% 0.0% 0.0% 0.0% | 0.0% 2.7% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 2/25 (8%) 0/17 (0%) 0/22 (0%) 0/7 (0%) | 0/37 (0%) 1/37 (3%) 0/42 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | --- 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.386N P=0.326N P=0.266N P=0.543N | P=0.583N P=0.500 (e) (e) | |INCIDENTAL TUMOR | P=0.386N P=0.326N P=0.266N P=0.543N | P=0.583N P=0.500 (e) (e) | |LOGISTIC REGRESSION | P=0.386N P=0.326N P=0.266N P=0.543N | P=0.583N P=0.500 (e) (e) | |COCHRAN-ARMITAGE | P=0.243N | P=0.570N | |FISHER EXACT | P=0.248N P=0.248N P=0.248N | P=0.466 (e) (e) | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/70 (3%) 0/70 (0%) 1/70 (1%) 0/70 (0%) | 0/70 (0%) 1/61 (2%) 0/62 (0%) 0/68 (0%) | |ADJUSTED (b) | 8.0% 0.0% 4.5% 0.0% | 0.0% 2.7% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 2/25 (8%) 0/17 (0%) 1/22 (5%) 0/7 (0%) | 0/37 (0%) 1/37 (3%) 0/42 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) --- | --- 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.491N P=0.326N P=0.545N P=0.543N | P=0.583N P=0.500 (e) (e) | |INCIDENTAL TUMOR | P=0.491N P=0.326N P=0.545N P=0.543N | P=0.583N P=0.500 (e) (e) | |LOGISTIC REGRESSION | P=0.491N P=0.326N P=0.545N P=0.543N | P=0.583N P=0.500 (e) (e) | |COCHRAN-ARMITAGE | P=0.272N | P=0.570N | |FISHER EXACT | P=0.248N P=0.500N P=0.248N | P=0.466 (e) (e) | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 2/69 (3%) 1/70 (1%) 0/69 (0%) | 0/70 (0%) 0/60 (0%) 0/61 (0%) 0/68 (0%) | |ADJUSTED (b) | 0.0% 8.8% 3.6% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/25 (0%) 1/17 (6%) 0/22 (0%) 0/7 (0%) | 0/37 (0%) 0/37 (0%) 0/42 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | --- 674 703 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.500N P=0.201 P=0.515 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.326N P=0.269 P=0.552 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.413N P=0.229 P=0.498 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.380N | (e) | |FISHER EXACT | P=0.245 P=0.500 (e) | (e) (e) (e) | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/70 (19%) 12/68 (18%) 15/70 (21%) 15/68 (22%) | 23/70 (33%) 17/61 (28%) 19/62 (31%) 22/67 (33%) | |ADJUSTED (b) | 39.0% 46.4% 43.0% 65.5% | 53.1% 42.0% 44.2% 50.1% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 2/10 (20%) | |TERMINAL (d) | 7/25 (28%) 6/17 (35%) 6/22 (27%) 2/7 (29%) | 17/37 (46%) 14/37 (38%) 18/42 (43%) 14/35 (40%) | |FIRST INCIDENCE (DAYS) | 547 613 417 618 | 585 548 684 437 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.027 * P=0.464 P=0.355 P=0.041 * | P=0.339 P=0.188N P=0.154N P=0.552N | |INCIDENTAL TUMOR | P=0.293 P=0.582 P=0.422 P=0.491 | P=0.313 P=0.283N P=0.291N P=0.555 | |LOGISTIC REGRESSION | P=0.331 P=0.563N P=0.398 P=0.283 | P=0.375 P=0.227N P=0.253N P=0.576N | |COCHRAN-ARMITAGE | P=0.305 | P=0.434 | |FISHER EXACT | P=0.532N P=0.416 P=0.383 | P=0.335N P=0.467N P=0.571N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/68 (0%) 1/70 (1%) 0/68 (0%) | 0/70 (0%) 1/61 (2%) 0/62 (0%) 2/67 (3%) | |ADJUSTED (b) | 0.0% 0.0% 2.3% 0.0% | 0.0% 2.7% 0.0% 4.2% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/25 (0%) 0/17 (0%) 0/22 (0%) 0/7 (0%) | 0/37 (0%) 1/37 (3%) 0/42 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 557 --- | --- 729 (T) --- 495 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.782N (e) P=0.487 (e) | P=0.151 P=0.500 (e) P=0.240 | |INCIDENTAL TUMOR | P=0.766N (e) P=0.419 (e) | P=0.064 P=0.500 (e) P=0.128 | |LOGISTIC REGRESSION | P=0.788N (e) P=0.500 (e) | P=0.157 P=0.500 (e) P=0.229 | |COCHRAN-ARMITAGE | P=0.789N | P=0.157 | |FISHER EXACT | (e) P=0.500 (e) | P=0.466 (e) P=0.237 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/70 (19%) 12/68 (18%) 16/70 (23%) 15/68 (22%) | 23/70 (33%) 18/61 (30%) 19/62 (31%) 24/67 (36%) | |ADJUSTED (b) | 39.0% 46.4% 44.3% 65.5% | 53.1% 44.5% 44.2% 52.2% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 2/10 (20%) | |TERMINAL (d) | 7/25 (28%) 6/17 (35%) 6/22 (27%) 2/7 (29%) | 17/37 (46%) 15/37 (41%) 18/42 (43%) 14/35 (40%) | |FIRST INCIDENCE (DAYS) | 547 613 417 618 | 585 548 684 437 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.030 * P=0.464 P=0.284 P=0.041 * | P=0.224 P=0.245N P=0.154N P=0.449 | |INCIDENTAL TUMOR | P=0.299 P=0.582 P=0.323 P=0.491 | P=0.173 P=0.358N P=0.291N P=0.415 | |LOGISTIC REGRESSION | P=0.345 P=0.563N P=0.286 P=0.283 | P=0.205 P=0.296N P=0.253N P=0.349 | |COCHRAN-ARMITAGE | P=0.310 | P=0.307 | |FISHER EXACT | P=0.532N P=0.339 P=0.383 | P=0.412N P=0.467N P=0.426 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/70 (0%) 2/70 (3%) 0/70 (0%) | 1/70 (1%) 0/61 (0%) 0/62 (0%) 0/68 (0%) | |ADJUSTED (b) | 0.0% 0.0% 7.5% 0.0% | 2.7% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/25 (0%) 0/17 (0%) 1/22 (5%) 0/7 (0%) | 1/37 (3%) 0/37 (0%) 0/42 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 684 --- | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.685 (e) P=0.233 (e) | P=0.479N P=0.500N P=0.475N P=0.505N | |INCIDENTAL TUMOR | P=0.716N (e) P=0.253 (e) | P=0.479N P=0.500N P=0.475N P=0.505N | |LOGISTIC REGRESSION | P=0.736N (e) P=0.235 (e) | P=0.479N P=0.500N P=0.475N P=0.505N | |COCHRAN-ARMITAGE | P=0.697N | P=0.470N | |FISHER EXACT | (e) P=0.248 (e) | P=0.534N P=0.530N P=0.507N | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 0/70 (0%) 3/70 (4%) 0/70 (0%) | 2/70 (3%) 0/61 (0%) 0/62 (0%) 0/68 (0%) | |ADJUSTED (b) | 4.0% 0.0% 11.1% 0.0% | 5.4% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 1/25 (4%) 0/17 (0%) 1/22 (5%) 0/7 (0%) | 2/37 (5%) 0/37 (0%) 0/42 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 684 --- | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.659N P=0.577N P=0.291 P=0.752N | P=0.244N P=0.238N P=0.211N P=0.244N | |INCIDENTAL TUMOR | P=0.459N P=0.577N P=0.329 P=0.752N | P=0.244N P=0.238N P=0.211N P=0.244N | |LOGISTIC REGRESSION | P=0.520N P=0.577N P=0.301 P=0.752N | P=0.243N P=0.238N P=0.211N P=0.244N | |COCHRAN-ARMITAGE | P=0.449N | P=0.241N | |FISHER EXACT | P=0.500N P=0.310 P=0.500N | P=0.284N P=0.279N P=0.255N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/70 (4%) 1/70 (1%) 4/70 (6%) 2/70 (3%) | 2/70 (3%) 2/61 (3%) 0/62 (0%) 0/68 (0%) | |ADJUSTED (b) | 10.7% 5.9% 13.6% 18.0% | 5.4% 5.2% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 1/25 (4%) 1/17 (6%) 1/22 (5%) 0/7 (0%) | 2/37 (5%) 1/37 (3%) 0/42 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | 691 729 (T) 635 713 | 729 (T) 718 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.396 P=0.403N P=0.494 P=0.567 | P=0.123N P=0.691N P=0.211N P=0.244N | |INCIDENTAL TUMOR | P=0.448N P=0.241N P=0.531 P=0.239N | P=0.104N P=0.658 P=0.211N P=0.244N | |LOGISTIC REGRESSION | P=0.589 P=0.321N P=0.493 P=0.619N | P=0.118N P=0.683 P=0.211N P=0.244N | |COCHRAN-ARMITAGE | P=0.560N | P=0.122N | |FISHER EXACT | P=0.310N P=0.500 P=0.500N | P=0.637 P=0.279N P=0.255N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 1/70 (1%) 0/70 (0%) 0/70 (0%) | 0/70 (0%) 2/61 (3%) 0/62 (0%) 0/68 (0%) | |ADJUSTED (b) | 2.0% 1.7% 0.0% 0.0% | 0.0% 5.4% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/25 (0%) 0/17 (0%) 0/22 (0%) 0/7 (0%) | 0/37 (0%) 2/37 (5%) 0/42 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | 495 333 --- --- | --- 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.304N P=0.751 P=0.504N P=0.500N | P=0.374N P=0.238 (e) (e) | |INCIDENTAL TUMOR | P=0.278N P=0.716N P=0.305N P=0.500N | P=0.374N P=0.238 (e) (e) | |LOGISTIC REGRESSION | P=0.304N P=0.753N P=0.501N P=0.496N | P=0.373N P=0.238 (e) (e) | |COCHRAN-ARMITAGE | P=0.303N | P=0.365N | |FISHER EXACT | P=0.752N P=0.500N P=0.500N | P=0.215 (e) (e) | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 2/70 (3%) | 0/70 (0%) 0/61 (0%) 0/62 (0%) 0/68 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 2.9% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/25 (0%) 0/17 (0%) 0/22 (0%) 0/7 (0%) | 0/37 (0%) 0/37 (0%) 0/42 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 268 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.043 * (e) (e) P=0.243 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.080 (e) (e) P=0.309 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.024 * (e) (e) P=0.184 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.042 * | (e) | |FISHER EXACT | (e) (e) P=0.248 | (e) (e) (e) | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/70 (3%) 1/70 (1%) 0/70 (0%) 0/70 (0%) | 0/70 (0%) 0/61 (0%) 0/62 (0%) 0/68 (0%) | |ADJUSTED (b) | 6.9% 4.3% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 1/25 (4%) 0/17 (0%) 0/22 (0%) 0/7 (0%) | 0/37 (0%) 0/37 (0%) 0/42 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | 673 711 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.235N P=0.562N P=0.257N P=0.397N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.131N P=0.375N P=0.224N P=0.225N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.186N P=0.512N P=0.240N P=0.270N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.170N | (e) | |FISHER EXACT | P=0.500N P=0.248N P=0.248N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/70 (4%) 2/70 (3%) 1/70 (1%) 1/70 (1%) | 0/70 (0%) 3/61 (5%) 0/62 (0%) 0/68 (0%) | |ADJUSTED (b) | 8.8% 6.0% 2.6% 6.3% | 0.0% 7.7% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 1/25 (4%) 0/17 (0%) 0/22 (0%) 0/7 (0%) | 0/37 (0%) 2/37 (5%) 0/42 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | 495 333 618 713 | --- 667 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.345N P=0.555N P=0.322N P=0.479N | P=0.255N P=0.120 (e) (e) | |INCIDENTAL TUMOR | P=0.187N P=0.369N P=0.247N P=0.219N | P=0.218N P=0.099 (e) (e) | |LOGISTIC REGRESSION | P=0.268N P=0.501N P=0.308N P=0.321N | P=0.253N P=0.110 (e) (e) | |COCHRAN-ARMITAGE | P=0.264N | P=0.252N | |FISHER EXACT | P=0.500N P=0.310N P=0.310N | P=0.098 (e) (e) | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/70 (4%) 2/70 (3%) 0/70 (0%) 0/70 (0%) | 0/70 (0%) 2/61 (3%) 0/62 (0%) 0/68 (0%) | |ADJUSTED (b) | 8.8% 6.0% 0.0% 0.0% | 0.0% 5.4% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 1/25 (4%) 0/17 (0%) 0/22 (0%) 0/7 (0%) | 0/37 (0%) 2/37 (5%) 0/42 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | 495 333 --- --- | --- 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.099N P=0.555N P=0.135N P=0.207N | P=0.374N P=0.238 (e) (e) | |INCIDENTAL TUMOR | P=0.053N P=0.369N P=0.065N P=0.111N | P=0.374N P=0.238 (e) (e) | |LOGISTIC REGRESSION | P=0.073N P=0.501N P=0.123N P=0.126N | P=0.373N P=0.238 (e) (e) | |COCHRAN-ARMITAGE | P=0.073N | P=0.365N | |FISHER EXACT | P=0.500N P=0.122N P=0.122N | P=0.215 (e) (e) | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/70 (0%) 1/70 (1%) 1/70 (1%) | 0/70 (0%) 0/61 (0%) 2/62 (3%) 0/68 (0%) | |ADJUSTED (b) | 0.0% 0.0% 3.3% 10.0% | 0.0% 0.0% 4.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/25 (0%) 0/17 (0%) 0/22 (0%) 0/7 (0%) | 0/37 (0%) 0/37 (0%) 2/42 (5%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 698 726 | --- --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.185 (e) P=0.521 P=0.310 | P=0.708N (e) P=0.267 (e) | |INCIDENTAL TUMOR | P=0.471 (e) P=0.552 P=0.705 | P=0.708N (e) P=0.267 (e) | |LOGISTIC REGRESSION | P=0.252 (e) P=0.497 P=0.360 | P=0.708N (e) P=0.267 (e) | |COCHRAN-ARMITAGE | P=0.303 | P=0.688N | |FISHER EXACT | (e) P=0.500 P=0.500 | (e) P=0.219 (e) | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 48/70 (69%) 44/70 (63%) 42/70 (60%) 43/70 (61%) | | |ADJUSTED (b) | 100.0% 97.7% 100.0% 97.6% | | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 2/9 (22%) 0/9 (0%) 2/8 (25%) | | |TERMINAL (d) | 25/25 (100%) 16/17 (94%) 22/22 (100%) 6/7 (86%) | | |FIRST INCIDENCE (DAYS) | 437 (I) 437 (I) 481 437 (I) | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.005 ** P=0.295 P=0.388N P=0.010 ** | | |INCIDENTAL TUMOR | P=0.348N P=0.318N P=0.078N P=0.337N | | |LOGISTIC REGRESSION | P=0.210N P=0.284N P=0.122N P=0.197N | | |COCHRAN-ARMITAGE | P=0.295N | | |FISHER EXACT | P=0.297N P=0.189N P=0.239N | | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Thymus | | Thymoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/67 (0%) 0/66 (0%) 0/68 (0%) 0/63 (0%) | 2/66 (3%) 0/59 (0%) 1/58 (2%) 1/65 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.9% 0.0% 2.6% 2.9% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/23 (0%) 0/16 (0%) 0/21 (0%) 0/6 (0%) | 2/34 (6%) 0/37 (0%) 1/38 (3%) 1/34 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 729 (T) --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.634N P=0.220N P=0.461N P=0.500N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.634N P=0.220N P=0.461N P=0.500N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.634N P=0.220N P=0.461N P=0.500N | |COCHRAN-ARMITAGE | (e) | P=0.606N | |FISHER EXACT | (e) (e) (e) | P=0.277N P=0.549N P=0.506N | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/70 (9%) 8/67 (12%) 7/70 (10%) 4/69 (6%) | 8/70 (11%) 7/61 (11%) 6/61 (10%) 8/68 (12%) | |ADJUSTED (b) | 19.6% 29.7% 22.4% 12.9% | 19.8% 18.9% 13.9% 21.3% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 4/25 (16%) 3/17 (18%) 3/22 (14%) 0/7 (0%) | 6/37 (16%) 7/37 (19%) 5/42 (12%) 7/36 (19%) | |FIRST INCIDENCE (DAYS) | 495 451 519 631 | 599 729 (T) 663 684 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.507N P=0.250 P=0.447 P=0.583 | P=0.486 P=0.511N P=0.314N P=0.589 | |INCIDENTAL TUMOR | P=0.260N P=0.347 P=0.499 P=0.566N | P=0.443 P=0.561N P=0.435N P=0.446 | |LOGISTIC REGRESSION | P=0.235N P=0.344 P=0.491 P=0.415N | P=0.518 P=0.551N P=0.390N P=0.597 | |COCHRAN-ARMITAGE | P=0.209N | P=0.533 | |FISHER EXACT | P=0.356 P=0.500 P=0.381N | P=0.603 P=0.498N P=0.580 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/67 (0%) 0/70 (0%) 1/69 (1%) | 1/70 (1%) 2/61 (3%) 1/61 (2%) 0/68 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 1.8% | 2.7% 5.4% 2.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 1/8 (13%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/25 (0%) 0/17 (0%) 0/22 (0%) 0/7 (0%) | 1/37 (3%) 2/37 (5%) 1/42 (2%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 437 (I) | 729 (T) 729 (T) 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.187 (e) (e) P=0.455 | P=0.234N P=0.500 P=0.733N P=0.505N | |INCIDENTAL TUMOR | P=0.187 (e) (e) P=0.455 | P=0.234N P=0.500 P=0.733N P=0.505N | |LOGISTIC REGRESSION | P=0.219 (e) (e) P=0.502 | P=0.234N P=0.500 P=0.733N P=0.505N | |COCHRAN-ARMITAGE | P=0.214 | P=0.229N | |FISHER EXACT | (e) (e) P=0.496 | P=0.448 P=0.716 P=0.507N | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/70 (9%) 8/67 (12%) 7/70 (10%) 5/69 (7%) | 9/70 (13%) 9/61 (15%) 7/61 (11%) 8/68 (12%) | |ADJUSTED (b) | 19.6% 29.7% 22.4% 14.4% | 22.4% 24.3% 16.2% 21.3% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 1/8 (13%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 4/25 (16%) 3/17 (18%) 3/22 (14%) 0/7 (0%) | 7/37 (19%) 9/37 (24%) 6/42 (14%) 7/36 (19%) | |FIRST INCIDENCE (DAYS) | 495 451 519 437 (I) | 599 729 (T) 663 684 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.492 P=0.250 P=0.447 P=0.435 | P=0.472N P=0.593 P=0.311N P=0.519N | |INCIDENTAL TUMOR | P=0.402N P=0.347 P=0.499 P=0.558 | P=0.511N P=0.548 P=0.425N P=0.556 | |LOGISTIC REGRESSION | P=0.354N P=0.344 P=0.491 P=0.536N | P=0.434N P=0.548 P=0.392N P=0.511N | |COCHRAN-ARMITAGE | P=0.324N | P=0.422N | |FISHER EXACT | P=0.356 P=0.500 P=0.510N | P=0.474 P=0.512N P=0.526N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/70 (1%) 1/67 (1%) 1/70 (1%) 3/69 (4%) | 0/70 (0%) 0/61 (0%) 0/61 (0%) 1/68 (1%) | |ADJUSTED (b) | 3.0% 3.3% 2.6% 12.7% | 0.0% 0.0% 0.0% 2.8% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/25 (0%) 0/17 (0%) 0/22 (0%) 0/7 (0%) | 0/37 (0%) 0/37 (0%) 0/42 (0%) 1/36 (3%) | |FIRST INCIDENCE (DAYS) | 673 682 621 527 | --- --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.119 P=0.757 P=0.757 P=0.227 | P=0.205 (e) (e) P=0.495 | |INCIDENTAL TUMOR | P=0.322 P=0.600N P=0.748 P=0.583 | P=0.205 (e) (e) P=0.495 | |LOGISTIC REGRESSION | P=0.146 P=0.749 P=0.760 P=0.283 | P=0.205 (e) (e) P=0.495 | |COCHRAN-ARMITAGE | P=0.158 | P=0.222 | |FISHER EXACT | P=0.741 P=0.752N P=0.304 | (e) (e) P=0.493 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 2/67 (3%) 0/70 (0%) 0/69 (0%) | 1/70 (1%) 1/61 (2%) 1/61 (2%) 0/68 (0%) | |ADJUSTED (b) | 0.0% 8.0% 0.0% 0.0% | 2.7% 2.7% 2.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/25 (0%) 0/17 (0%) 0/22 (0%) 0/7 (0%) | 1/37 (3%) 1/37 (3%) 1/42 (2%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | --- 684 --- --- | 729 (T) 729 (T) 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.454N P=0.214 (e) (e) | P=0.327N P=0.762 P=0.733N P=0.505N | |INCIDENTAL TUMOR | P=0.242N P=0.400 (e) (e) | P=0.327N P=0.762 P=0.733N P=0.505N | |LOGISTIC REGRESSION | P=0.393N P=0.223 (e) (e) | P=0.327N P=0.762 P=0.733N P=0.505N | |COCHRAN-ARMITAGE | P=0.369N | P=0.319N | |FISHER EXACT | P=0.237 (e) (e) | P=0.716 P=0.716 P=0.507N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/70 (1%) 3/67 (4%) 1/70 (1%) 3/69 (4%) | 1/70 (1%) 1/61 (2%) 1/61 (2%) 1/68 (1%) | |ADJUSTED (b) | 3.0% 11.0% 2.6% 12.7% | 2.7% 2.7% 2.4% 2.8% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/25 (0%) 0/17 (0%) 0/22 (0%) 0/7 (0%) | 1/37 (3%) 1/37 (3%) 1/42 (2%) 1/36 (3%) | |FIRST INCIDENCE (DAYS) | 673 682 621 527 | 729 (T) 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.253 P=0.285 P=0.757 P=0.227 | P=0.661 P=0.762 P=0.733N P=0.756 | |INCIDENTAL TUMOR | P=0.602 P=0.574 P=0.748 P=0.583 | P=0.661 P=0.762 P=0.733N P=0.756 | |LOGISTIC REGRESSION | P=0.322 P=0.283 P=0.760 P=0.283 | P=0.661 P=0.762 P=0.733N P=0.756 | |COCHRAN-ARMITAGE | P=0.346 | P=0.655N | |FISHER EXACT | P=0.293 P=0.752N P=0.304 | P=0.716 P=0.716 P=0.745 | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 13/70 (19%) 7/61 (11%) 8/62 (13%) 7/68 (10%) | |ADJUSTED (b) | | 34.1% 17.5% 17.3% 18.9% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/9 (0%) 2/8 (25%) 0/10 (0%) | |TERMINAL (d) | | 12/37 (32%) 5/37 (14%) 6/42 (14%) 6/36 (17%) | |FIRST INCIDENCE (DAYS) | | 694 451 437 (I) 715 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.207N P=0.109N P=0.115N P=0.115N | |INCIDENTAL TUMOR | | P=0.165N P=0.074N P=0.131N P=0.095N | |LOGISTIC REGRESSION | | P=0.186N P=0.135N P=0.178N P=0.099N | |COCHRAN-ARMITAGE | | P=0.179N | |FISHER EXACT | | P=0.189N P=0.259N P=0.127N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 13/70 (19%) 8/61 (13%) 8/62 (13%) 7/68 (10%) | |ADJUSTED (b) | | 34.1% 18.9% 17.3% 18.9% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/9 (0%) 2/8 (25%) 0/10 (0%) | |TERMINAL (d) | | 12/37 (32%) 5/37 (14%) 6/42 (14%) 6/36 (17%) | |FIRST INCIDENCE (DAYS) | | 694 396 437 (I) 715 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.178N P=0.170N P=0.115N P=0.115N | |INCIDENTAL TUMOR | | P=0.140N P=0.074N P=0.131N P=0.095N | |LOGISTIC REGRESSION | | P=0.159N P=0.211N P=0.178N P=0.099N | |COCHRAN-ARMITAGE | | P=0.152N | |FISHER EXACT | | P=0.272N P=0.259N P=0.127N | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/70 (3%) 1/70 (1%) 0/70 (0%) 0/70 (0%) | 0/70 (0%) 0/61 (0%) 0/62 (0%) 0/68 (0%) | |ADJUSTED (b) | 4.5% 2.1% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 1/10 (10%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/25 (0%) 0/17 (0%) 0/22 (0%) 0/7 (0%) | 0/37 (0%) 0/37 (0%) 0/42 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | 437 (I) 451 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.182N P=0.510N P=0.255N P=0.268N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.135N P=0.429N P=0.222N P=0.152N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.168N P=0.494N P=0.238N P=0.236N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.170N | (e) | |FISHER EXACT | P=0.500N P=0.248N P=0.248N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/70 (3%) 1/70 (1%) 1/70 (1%) 0/70 (0%) | 0/70 (0%) 0/61 (0%) 0/62 (0%) 0/68 (0%) | |ADJUSTED (b) | 4.5% 2.1% 4.5% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 1/10 (10%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 0/25 (0%) 0/17 (0%) 1/22 (5%) 0/7 (0%) | 0/37 (0%) 0/37 (0%) 0/42 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | 437 (I) 451 729 (T) --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.247N P=0.510N P=0.530N P=0.268N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.195N P=0.429N P=0.497N P=0.152N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.194N P=0.494N P=0.501N P=0.236N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.194N | (e) | |FISHER EXACT | P=0.500N P=0.500N P=0.248N | (e) (e) (e) | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, | | or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 32/70 (46%) 31/70 (44%) 30/70 (43%) 25/70 (36%) | 19/70 (27%) 21/61 (34%) 26/62 (42%) 18/68 (26%) | |ADJUSTED (b) | 79.0% 90.5% 77.1% 93.6% | 42.5% 51.2% 54.1% 43.6% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 17/25 (68%) 14/17 (82%) 14/22 (64%) 6/7 (86%) | 12/37 (32%) 17/37 (46%) 20/42 (48%) 13/36 (36%) | |FIRST INCIDENCE (DAYS) | 526 532 481 498 | 599 609 528 527 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.126 P=0.240 P=0.557 P=0.130 | P=0.400N P=0.398 P=0.244 P=0.527N | |INCIDENTAL TUMOR | P=0.246N P=0.495 P=0.468N P=0.497N | P=0.384N P=0.230 P=0.064 P=0.581N | |LOGISTIC REGRESSION | P=0.058N P=0.535N P=0.527N P=0.091N | P=0.405N P=0.144 P=0.051 P=0.539 | |COCHRAN-ARMITAGE | P=0.116N | P=0.320N | |FISHER EXACT | P=0.500N P=0.432N P=0.151N | P=0.238 P=0.054 P=0.541N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |All Organs | | Mesothelioma Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/70 (3%) 2/70 (3%) 0/70 (0%) 1/70 (1%) | 0/70 (0%) 0/61 (0%) 0/62 (0%) 0/68 (0%) | |ADJUSTED (b) | 5.9% 9.3% 0.0% 14.3% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 1/25 (4%) 0/17 (0%) 0/22 (0%) 1/7 (14%) | 0/37 (0%) 0/37 (0%) 0/42 (0%) 0/36 (0%) | |FIRST INCIDENCE (DAYS) | 456 717 --- 729 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.618N P=0.612 P=0.256N P=0.715 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.388N P=0.599N P=0.149N P=0.717 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.400N P=0.688 P=0.238N P=0.511N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.382N | (e) | |FISHER EXACT | P=0.690N P=0.248N P=0.500N | (e) (e) (e) | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 53/70 (76%) 48/70 (69%) 49/70 (70%) 49/70 (70%) | 40/70 (57%) 36/61 (59%) 45/62 (73%) 38/68 (56%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 88.8% 79.9% 93.7% 80.7% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 4/10 (40%) 3/9 (33%) 1/9 (11%) 2/8 (25%) | 0/10 (0%) 0/9 (0%) 2/8 (25%) 2/10 (20%) | |TERMINAL (d) | 25/25 (100%) 17/17 (100%) 22/22 (100%) 7/7 (100%) | 32/37 (86%) 28/37 (76%) 39/42 (93%) 27/36 (75%) | |FIRST INCIDENCE (DAYS) | 437 (I) 437 (I) 417 437 (I) | 585 451 437 (I) 437 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.003 ** P=0.337 P=0.522N P=0.008 ** | P=0.532 P=0.319N P=0.527 P=0.472N | |INCIDENTAL TUMOR | P=0.408N P=0.198N P=0.113N P=0.297N | P=0.532 P=0.458N P=0.125 P=0.581 | |LOGISTIC REGRESSION | P=0.303N P=0.227N P=0.247N P=0.233N | P=0.489N P=0.478N P=0.105 P=0.500N | |COCHRAN-ARMITAGE | P=0.388N | P=0.399N | |FISHER EXACT | P=0.226N P=0.284N P=0.284N | P=0.485 P=0.047 * P=0.509N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 1500 PPM 5000 PPM 15000 P | 0 PPM 1500 PPM 5000 PPM 15000 | | | PM | PPM | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 39/70 (56%) 38/70 (54%) 34/70 (49%) 31/70 (44%) | 24/70 (34%) 26/61 (43%) 30/62 (48%) 22/68 (32%) | |ADJUSTED (b) | 83.9% 94.7% 83.8% 94.5% | 51.7% 60.1% 61.2% 49.5% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 1/10 (10%) 0/9 (0%) 0/9 (0%) 1/8 (13%) | 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/10 (0%) | |TERMINAL (d) | 18/25 (72%) 15/17 (88%) 16/22 (73%) 6/7 (86%) | 15/37 (41%) 20/37 (54%) 23/42 (55%) 14/36 (39%) | |FIRST INCIDENCE (DAYS) | 269 333 481 268 | 585 396 528 495 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.134 P=0.236 P=0.409N P=0.149 | P=0.337N P=0.396 P=0.333 P=0.460N | |INCIDENTAL TUMOR | P=0.145N P=0.516 P=0.267N P=0.314N | P=0.359N P=0.338 P=0.068 P=0.508N | |LOGISTIC REGRESSION | P=0.082N P=0.566N P=0.246N P=0.130N | P=0.365N P=0.297 P=0.062 P=0.552 | |COCHRAN-ARMITAGE | P=0.088N | P=0.251N | |FISHER EXACT | P=0.500N P=0.249N P=0.118N | P=0.212 P=0.071 P=0.476N | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 55/70 (79%) 50/70 (71%) 50/70 (71%) 54/70 (77%) | 45/70 (64%) 47/61 (77%) 51/62 (82%) 44/68 (65%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 91.8% 95.9% 100.0% 87.9% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 4/10 (40%) 3/9 (33%) 1/9 (11%) 3/8 (38%) | 0/10 (0%) 0/9 (0%) 2/8 (25%) 2/10 (20%) | |TERMINAL (d) | 25/25 (100%) 17/17 (100%) 22/22 (100%) 7/7 (100%) | 33/37 (89%) 35/37 (95%) 42/42 (100%) 30/36 (83%) | |FIRST INCIDENCE (DAYS) | 269 333 417 268 | 585 396 437 (I) 437 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.001 ** P=0.342 P=0.472N P=0.004 ** | P=0.443N P=0.369 P=0.467 P=0.549N | |INCIDENTAL TUMOR | P=0.318 P=0.209N P=0.110N P=0.632 | P=0.497N P=0.249 P=0.009 ** P=0.605 | |LOGISTIC REGRESSION | P=0.339 P=0.243N P=0.129N P=0.566 | P=0.457N P=0.097 P=0.011 * P=0.467 | |COCHRAN-ARMITAGE | P=0.438 | P=0.259N | |FISHER EXACT | P=0.218N P=0.218N P=0.500N | P=0.080 P=0.016 * P=0.550 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 01 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- MANGANESE SULFATE 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): 275 437 Female interim sacrifices(days): 275 437 (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).