TDMS Study 05085-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus MANGANESE SULFATE DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 TIME: 05:11:58 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-45041 ROUTE: DOSED FEED NTP C#: 61143B PATHOLOGIST: R. PERSING 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: 02 TIME: 05:11:58 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-45041 ROUTE: DOSED FEED NTP C#: 61143B PATHOLOGIST: R. PERSING CAS: 7785-87-7 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 Gland Bone Marrow Brain Epididymis Gallbladder 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: 02 TIME: 05:11:58 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-45041 ROUTE: DOSED FEED NTP C#: 61143B PATHOLOGIST: R. PERSING CAS: 7785-87-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF MANGANESE SULFATE ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Gland: Non-medullary, Non-cortical Adenoma Harderian Gland Carcinoma Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Thyroid Gland: Follicular Cell Adenoma All Organs Benign Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Thyroid Gland: Follicular Cell Adenoma ==================================================================================================== DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/69 (0%) 3/60 (5%) 1/61 (2%) 1/68 (1%) | 0/70 (0%) 0/61 (0%) 0/60 (0%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 6.8% 2.2% 2.2% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/45 (0%) 3/44 (7%) 1/46 (2%) 1/45 (2%) | 0/42 (0%) 0/46 (0%) 0/36 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) 729 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.578N P=0.117 P=0.504 P=0.500 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.578N P=0.117 P=0.504 P=0.500 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.578N P=0.117 P=0.504 P=0.500 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.562N | (e) | |FISHER EXACT | P=0.098 P=0.469 P=0.496 | (e) (e) (e) | |=================================================================================================================================| | | |Adrenal Gland: Non-medullary, Non-cortical | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/70 (14%) 5/60 (8%) 7/61 (11%) 14/68 (21%) | 0/70 (0%) 2/61 (3%) 3/62 (5%) 0/70 (0%) | |ADJUSTED (b) | 21.7% 11.4% 15.2% 31.1% | 0.0% 4.3% 7.9% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 10/46 (22%) 5/44 (11%) 7/46 (15%) 14/45 (31%) | 0/42 (0%) 2/46 (4%) 3/38 (8%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 729 (T) | --- 729 (T) 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.042 * P=0.151N P=0.297N P=0.220 | P=0.395N P=0.259 P=0.104 (e) | |INCIDENTAL TUMOR | P=0.042 * P=0.151N P=0.297N P=0.220 | P=0.395N P=0.259 P=0.104 (e) | |LOGISTIC REGRESSION | P=0.042 * P=0.151N P=0.297N P=0.220 | P=0.395N P=0.259 P=0.104 (e) | |COCHRAN-ARMITAGE | P=0.063 | P=0.364N | |FISHER EXACT | P=0.218N P=0.416N P=0.226 | P=0.215 P=0.101 (e) | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |Bone | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/61 (0%) 0/70 (0%) | 0/70 (0%) 0/61 (0%) 1/62 (2%) 2/70 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 2.3% 4.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/46 (0%) 0/44 (0%) 0/46 (0%) 0/46 (0%) | 0/42 (0%) 0/46 (0%) 0/38 (0%) 1/42 (2%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 693 696 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.082 (e) P=0.496 P=0.240 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.105 (e) P=0.638 P=0.295 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.086 (e) P=0.491 P=0.243 | |COCHRAN-ARMITAGE | (e) | P=0.096 | |FISHER EXACT | (e) (e) (e) | (e) P=0.470 P=0.248 | |=================================================================================================================================| | | |Bone Marrow | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 1/60 (2%) 0/61 (0%) 0/69 (0%) | 0/70 (0%) 3/61 (5%) 0/62 (0%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 2.3% 0.0% 0.0% | 0.0% 6.5% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/46 (0%) 1/44 (2%) 0/46 (0%) 0/46 (0%) | 0/42 (0%) 3/46 (7%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | --- 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.573N P=0.491 (e) (e) | P=0.264N P=0.138 (e) (e) | |INCIDENTAL TUMOR | P=0.573N P=0.491 (e) (e) | P=0.264N P=0.138 (e) (e) | |LOGISTIC REGRESSION | P=0.573N P=0.491 (e) (e) | P=0.264N P=0.138 (e) (e) | |COCHRAN-ARMITAGE | P=0.566N | P=0.247N | |FISHER EXACT | P=0.462 (e) (e) | P=0.098 (e) (e) | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/70 (7%) 2/60 (3%) 2/61 (3%) 1/70 (1%) | 2/70 (3%) 3/61 (5%) 2/62 (3%) 0/70 (0%) | |ADJUSTED (b) | 10.2% 4.3% 4.2% 2.2% | 4.8% 6.5% 5.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 1/10 (10%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 4/46 (9%) 1/44 (2%) 1/46 (2%) 1/46 (2%) | 2/42 (5%) 3/46 (7%) 2/38 (5%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | 452 (I) 617 592 729 (T) | 729 (T) 729 (T) 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.125N P=0.234N P=0.227N P=0.106N | P=0.125N P=0.541 P=0.658 P=0.238N | |INCIDENTAL TUMOR | P=0.078N P=0.115N P=0.110N P=0.106N | P=0.125N P=0.541 P=0.658 P=0.238N | |LOGISTIC REGRESSION | P=0.087N P=0.140N P=0.170N P=0.107N | P=0.125N P=0.541 P=0.658 P=0.237N | |COCHRAN-ARMITAGE | P=0.115N | P=0.110N | |FISHER EXACT | P=0.289N P=0.281N P=0.104N | P=0.435 P=0.643 P=0.248N | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 0/60 (0%) 0/61 (0%) 4/70 (6%) | 1/70 (1%) 0/61 (0%) 0/62 (0%) 0/70 (0%) | |ADJUSTED (b) | 2.2% 0.0% 0.0% 8.4% | 2.4% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 1/46 (2%) 0/44 (0%) 0/46 (0%) 3/46 (7%) | 1/42 (2%) 0/46 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- 634 | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.016 * P=0.509N P=0.500N P=0.182 | P=0.480N P=0.482N P=0.520N P=0.500N | |INCIDENTAL TUMOR | P=0.022 * P=0.509N P=0.500N P=0.306 | P=0.480N P=0.482N P=0.520N P=0.500N | |LOGISTIC REGRESSION | P=0.015 * P=0.509N P=0.500N P=0.175 | P=0.480N P=0.482N P=0.520N P=0.500N | |COCHRAN-ARMITAGE | P=0.020 * | P=0.465N | |FISHER EXACT | P=0.538N P=0.534N P=0.183 | P=0.534N P=0.530N P=0.500N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/70 (9%) 2/60 (3%) 2/61 (3%) 5/70 (7%) | 3/70 (4%) 3/61 (5%) 2/62 (3%) 0/70 (0%) | |ADJUSTED (b) | 12.4% 4.3% 4.2% 10.6% | 7.1% 6.5% 5.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 1/10 (10%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 5/46 (11%) 1/44 (2%) 1/46 (2%) 4/46 (9%) | 3/42 (7%) 3/46 (7%) 2/38 (5%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | 452 (I) 617 592 634 | 729 (T) 729 (T) 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.466 P=0.150N P=0.144N P=0.500N | P=0.080N P=0.620N P=0.546N P=0.121N | |INCIDENTAL TUMOR | P=0.570 P=0.067N P=0.063N P=0.371N | P=0.080N P=0.620N P=0.546N P=0.121N | |LOGISTIC REGRESSION | P=0.546 P=0.085N P=0.104N P=0.509N | P=0.080N P=0.620N P=0.546N P=0.121N | |COCHRAN-ARMITAGE | P=0.501 | P=0.070N | |FISHER EXACT | P=0.193N P=0.186N P=0.500N | P=0.592 P=0.558N P=0.122N | |=================================================================================================================================| | | |Intestine Small | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 2/60 (3%) 0/61 (0%) 0/70 (0%) | 0/70 (0%) 0/61 (0%) 0/62 (0%) 1/70 (1%) | |ADJUSTED (b) | 0.0% 4.4% 0.0% 0.0% | 0.0% 0.0% 0.0% 2.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/46 (0%) 1/44 (2%) 0/46 (0%) 0/46 (0%) | 0/42 (0%) 0/46 (0%) 0/38 (0%) 1/42 (2%) | |FIRST INCIDENCE (DAYS) | --- 679 --- --- | --- --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.372N P=0.230 (e) (e) | P=0.211 (e) (e) P=0.500 | |INCIDENTAL TUMOR | P=0.420N P=0.266 (e) (e) | P=0.211 (e) (e) P=0.500 | |LOGISTIC REGRESSION | P=0.369N P=0.228 (e) (e) | P=0.211 (e) (e) P=0.500 | |COCHRAN-ARMITAGE | P=0.358N | P=0.227 | |FISHER EXACT | P=0.211 (e) (e) | (e) (e) P=0.500 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 2/60 (3%) 0/61 (0%) 0/70 (0%) | 0/70 (0%) 0/61 (0%) 0/62 (0%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 4.4% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/46 (0%) 1/44 (2%) 0/46 (0%) 0/46 (0%) | 0/42 (0%) 0/46 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | --- 679 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.372N P=0.230 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.420N P=0.266 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.369N P=0.228 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.358N | (e) | |FISHER EXACT | P=0.211 (e) (e) | (e) (e) (e) | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/60 (0%) 2/60 (3%) 0/69 (0%) | 0/70 (0%) 0/61 (0%) 0/62 (0%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 0.0% 4.3% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/46 (0%) 0/44 (0%) 2/46 (4%) 0/46 (0%) | 0/42 (0%) 0/46 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.693N (e) P=0.239 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.693N (e) P=0.239 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.693N (e) P=0.239 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.682N | (e) | |FISHER EXACT | (e) P=0.211 (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 31/70 (44%) 29/60 (48%) 19/61 (31%) 21/69 (30%) | 12/70 (17%) 14/61 (23%) 8/62 (13%) 12/70 (17%) | |ADJUSTED (b) | 64.3% 64.4% 40.4% 43.5% | 27.8% 29.7% 18.2% 27.9% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) | 0/9 (0%) 0/10 (0%) 2/9 (22%) 0/9 (0%) | |TERMINAL (d) | 29/46 (63%) 28/44 (64%) 18/46 (39%) 19/46 (41%) | 11/42 (26%) 13/46 (28%) 5/38 (13%) 11/42 (26%) | |FIRST INCIDENCE (DAYS) | 276 (I) 708 702 452 (I) | 607 701 452 (I) 726 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.023N* P=0.570 P=0.022N* P=0.044N* | P=0.528N P=0.516 P=0.299N P=0.590N | |INCIDENTAL TUMOR | P=0.028N* P=0.566N P=0.025N* P=0.049N* | P=0.503N P=0.429 P=0.252N P=0.585 | |LOGISTIC REGRESSION | P=0.032N* P=0.483N P=0.018N* P=0.048N* | P=0.486N P=0.505 P=0.262N P=0.567N | |COCHRAN-ARMITAGE | P=0.026N* | P=0.415N | |FISHER EXACT | P=0.388 P=0.086N P=0.065N | P=0.270 P=0.333N P=0.589N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/70 (13%) 12/60 (20%) 8/61 (13%) 6/69 (9%) | 3/70 (4%) 1/61 (2%) 1/62 (2%) 2/70 (3%) | |ADJUSTED (b) | 18.7% 26.1% 16.3% 13.0% | 6.8% 2.2% 2.4% 4.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 7/46 (15%) 10/44 (23%) 6/46 (13%) 6/46 (13%) | 2/42 (5%) 1/46 (2%) 0/38 (0%) 2/42 (5%) | |FIRST INCIDENCE (DAYS) | 466 701 417 729 (T) | 607 729 (T) 702 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.131N P=0.280 P=0.501N P=0.294N | P=0.612N P=0.278N P=0.332N P=0.498N | |INCIDENTAL TUMOR | P=0.135N P=0.230 P=0.545N P=0.310N | P=0.602N P=0.468N P=0.232N P=0.561N | |LOGISTIC REGRESSION | P=0.135N P=0.283 P=0.541N P=0.302N | P=0.599N P=0.295N P=0.321N P=0.490N | |COCHRAN-ARMITAGE | P=0.115N | P=0.573N | |FISHER EXACT | P=0.194 P=0.584 P=0.303N | P=0.363N P=0.357N P=0.500N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 35/70 (50%) 31/60 (52%) 24/61 (39%) 23/69 (33%) | 13/70 (19%) 15/61 (25%) 9/62 (15%) 13/70 (19%) | |ADJUSTED (b) | 71.2% 67.4% 48.8% 47.7% | 30.1% 31.9% 20.2% 30.2% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) | 0/9 (0%) 0/10 (0%) 2/9 (22%) 0/9 (0%) | |TERMINAL (d) | 32/46 (70%) 29/44 (66%) 21/46 (46%) 21/46 (46%) | 12/42 (29%) 14/46 (30%) 5/38 (13%) 12/42 (29%) | |FIRST INCIDENCE (DAYS) | 276 (I) 701 417 452 (I) | 607 701 452 (I) 726 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.014N* P=0.441N P=0.042N* P=0.019N* | P=0.531N P=0.523 P=0.313N P=0.588N | |INCIDENTAL TUMOR | P=0.014N* P=0.478N P=0.041N* P=0.021N* | P=0.497N P=0.439 P=0.238N P=0.583 | |LOGISTIC REGRESSION | P=0.017N* P=0.328N P=0.035N* P=0.021N* | P=0.487N P=0.513 P=0.271N P=0.564N | |COCHRAN-ARMITAGE | P=0.014N* | P=0.412N | |FISHER EXACT | P=0.495 P=0.148N P=0.034N* | P=0.266 P=0.350N P=0.586N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 35/70 (50%) 31/60 (52%) 24/61 (39%) 23/69 (33%) | 13/70 (19%) 15/61 (25%) 9/62 (15%) 13/70 (19%) | |ADJUSTED (b) | 71.2% 67.4% 48.8% 47.7% | 30.1% 31.9% 20.2% 30.2% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) | 0/9 (0%) 0/10 (0%) 2/9 (22%) 0/9 (0%) | |TERMINAL (d) | 32/46 (70%) 29/44 (66%) 21/46 (46%) 21/46 (46%) | 12/42 (29%) 14/46 (30%) 5/38 (13%) 12/42 (29%) | |FIRST INCIDENCE (DAYS) | 276 (I) 701 417 452 (I) | 607 701 452 (I) 726 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.014N* P=0.441N P=0.042N* P=0.019N* | P=0.531N P=0.523 P=0.313N P=0.588N | |INCIDENTAL TUMOR | P=0.014N* P=0.478N P=0.041N* P=0.021N* | P=0.497N P=0.439 P=0.238N P=0.583 | |LOGISTIC REGRESSION | P=0.017N* P=0.328N P=0.035N* P=0.021N* | P=0.487N P=0.513 P=0.271N P=0.564N | |COCHRAN-ARMITAGE | P=0.014N* | P=0.412N | |FISHER EXACT | P=0.495 P=0.148N P=0.034N* | P=0.266 P=0.350N P=0.586N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/70 (11%) 10/60 (17%) 5/61 (8%) 9/69 (13%) | 2/70 (3%) 4/61 (7%) 3/62 (5%) 4/70 (6%) | |ADJUSTED (b) | 16.4% 21.6% 10.9% 20.0% | 4.8% 8.5% 7.9% 9.2% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 7/46 (15%) 8/44 (18%) 5/46 (11%) 9/45 (20%) | 2/42 (5%) 3/46 (7%) 3/38 (8%) 3/42 (7%) | |FIRST INCIDENCE (DAYS) | 276 (I) 647 729 (T) 729 (T) | 729 (T) 720 729 (T) 689 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.536 P=0.286 P=0.360N P=0.476 | P=0.364 P=0.381 P=0.454 P=0.340 | |INCIDENTAL TUMOR | P=0.509 P=0.313 P=0.360N P=0.476 | P=0.395 P=0.396 P=0.454 P=0.377 | |LOGISTIC REGRESSION | P=0.505 P=0.352 P=0.308N P=0.469 | P=0.375 P=0.380 P=0.454 P=0.347 | |COCHRAN-ARMITAGE | P=0.550N | P=0.420 | |FISHER EXACT | P=0.271 P=0.375N P=0.487 | P=0.277 P=0.442 P=0.340 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/70 (7%) 4/60 (7%) 4/61 (7%) 4/69 (6%) | 4/70 (6%) 0/61 (0%) 3/62 (5%) 0/70 (0%) | |ADJUSTED (b) | 10.9% 9.1% 8.7% 8.9% | 9.2% 0.0% 7.9% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 5/46 (11%) 4/44 (9%) 4/46 (9%) 4/45 (9%) | 3/42 (7%) 0/46 (0%) 3/38 (8%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 729 (T) | 620 --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.497N P=0.528N P=0.500N P=0.514N | P=0.132N P=0.054N P=0.550N P=0.064N | |INCIDENTAL TUMOR | P=0.497N P=0.528N P=0.500N P=0.514N | P=0.133N P=0.106N P=0.516N P=0.086N | |LOGISTIC REGRESSION | P=0.497N P=0.528N P=0.500N P=0.514N | P=0.124N P=0.058N P=0.518N P=0.060N | |COCHRAN-ARMITAGE | P=0.458N | P=0.117N | |FISHER EXACT | P=0.597N P=0.587N P=0.509N | P=0.078N P=0.568N P=0.060N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/70 (19%) 13/60 (22%) 9/61 (15%) 12/69 (17%) | 6/70 (9%) 4/61 (7%) 6/62 (10%) 4/70 (6%) | |ADJUSTED (b) | 27.1% 28.1% 19.6% 26.7% | 13.8% 8.5% 15.8% 9.2% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 12/46 (26%) 11/44 (25%) 9/46 (20%) 12/45 (27%) | 5/42 (12%) 3/46 (7%) 6/38 (16%) 3/42 (7%) | |FIRST INCIDENCE (DAYS) | 276 (I) 647 729 (T) 729 (T) | 620 720 729 (T) 689 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.457N P=0.468 P=0.297N P=0.529N | P=0.421N P=0.318N P=0.552 P=0.368N | |INCIDENTAL TUMOR | P=0.481N P=0.496 P=0.297N P=0.529N | P=0.400N P=0.430N P=0.579 P=0.381N | |LOGISTIC REGRESSION | P=0.498N P=0.544 P=0.260N P=0.543N | P=0.403N P=0.327N P=0.597 P=0.355N | |COCHRAN-ARMITAGE | P=0.404N | P=0.358N | |FISHER EXACT | P=0.412 P=0.365N P=0.516N | P=0.462N P=0.531 P=0.372N | |=================================================================================================================================| | | |Ovary | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/70 (0%) 2/61 (3%) 0/62 (0%) 0/70 (0%) | |ADJUSTED (b) | | 0.0% 4.3% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | | 0/42 (0%) 2/46 (4%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | | --- 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.378N P=0.259 (e) (e) | |INCIDENTAL TUMOR | | P=0.378N P=0.259 (e) (e) | |LOGISTIC REGRESSION | | P=0.378N P=0.259 (e) (e) | |COCHRAN-ARMITAGE | | P=0.359N | |FISHER EXACT | | P=0.215 (e) (e) | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/70 (3%) 0/61 (0%) 1/62 (2%) 2/70 (3%) | |ADJUSTED (b) | | 4.8% 0.0% 2.6% 4.8% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | | 2/42 (5%) 0/46 (0%) 1/38 (3%) 2/42 (5%) | |FIRST INCIDENCE (DAYS) | | 729 (T) --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.392 P=0.219N P=0.535N P=0.695 | |INCIDENTAL TUMOR | | P=0.392 P=0.219N P=0.535N P=0.695 | |LOGISTIC REGRESSION | | P=0.392 P=0.219N P=0.535N P=0.695 | |COCHRAN-ARMITAGE | | P=0.428 | |FISHER EXACT | | P=0.284N P=0.546N P=0.690N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/66 (0%) 0/55 (0%) 0/59 (0%) 0/65 (0%) | 2/67 (3%) 3/57 (5%) 6/62 (10%) 5/68 (7%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.1% 6.7% 15.8% 12.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/42 (0%) 0/39 (0%) 0/45 (0%) 0/43 (0%) | 2/39 (5%) 2/42 (5%) 6/38 (16%) 5/40 (13%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 729 (T) 712 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.202 P=0.537 P=0.125 P=0.226 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.213 P=0.553 P=0.125 P=0.226 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.206 P=0.533 P=0.125 P=0.226 | |COCHRAN-ARMITAGE | (e) | P=0.254 | |FISHER EXACT | (e) (e) (e) | P=0.423 P=0.113 P=0.226 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/66 (0%) 0/55 (0%) 0/59 (0%) 0/65 (0%) | 0/67 (0%) 0/57 (0%) 2/62 (3%) 1/68 (1%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 5.3% 2.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/42 (0%) 0/39 (0%) 0/45 (0%) 0/43 (0%) | 0/39 (0%) 0/42 (0%) 2/38 (5%) 0/40 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 729 (T) 473 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.353 (e) P=0.233 P=0.508 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.446 (e) P=0.233 P=0.581 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.372 (e) P=0.233 P=0.492 | |COCHRAN-ARMITAGE | (e) | P=0.375 | |FISHER EXACT | (e) (e) (e) | (e) P=0.229 P=0.504 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/61 (0%) 0/70 (0%) | 2/70 (3%) 0/61 (0%) 0/62 (0%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 4.4% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/46 (0%) 0/44 (0%) 0/46 (0%) 0/46 (0%) | 0/42 (0%) 0/46 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 607 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.247N P=0.223N P=0.250N P=0.237N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.210N P=0.443N P=0.130N P=0.249N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.239N P=0.249N P=0.253N P=0.235N | |COCHRAN-ARMITAGE | (e) | P=0.237N | |FISHER EXACT | (e) (e) (e) | P=0.284N P=0.279N P=0.248N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/61 (0%) 0/70 (0%) | 1/70 (1%) 0/61 (0%) 3/62 (5%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.2% 0.0% 5.9% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/46 (0%) 0/44 (0%) 0/46 (0%) 0/46 (0%) | 0/42 (0%) 0/46 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 696 --- 409 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.449N P=0.483N P=0.304 P=0.500N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.272N P=0.443N P=0.397 P=0.398N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.424N P=0.496N P=0.231 P=0.496N | |COCHRAN-ARMITAGE | (e) | P=0.431N | |FISHER EXACT | (e) (e) (e) | P=0.534N P=0.265 P=0.500N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/61 (0%) 0/70 (0%) | 3/70 (4%) 0/61 (0%) 3/62 (5%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 6.5% 0.0% 5.9% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/46 (0%) 0/44 (0%) 0/46 (0%) 0/46 (0%) | 0/42 (0%) 0/46 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 607 --- 409 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.198N P=0.111N P=0.648 P=0.123N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.085N P=0.157N P=0.487N P=0.085N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.172N P=0.124N P=0.614N P=0.118N | |COCHRAN-ARMITAGE | (e) | P=0.183N | |FISHER EXACT | (e) (e) (e) | P=0.150N P=0.601 P=0.122N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/61 (0%) 0/70 (0%) | 3/70 (4%) 0/61 (0%) 3/62 (5%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 6.5% 0.0% 5.9% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/46 (0%) 0/44 (0%) 0/46 (0%) 0/46 (0%) | 0/42 (0%) 0/46 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 607 --- 409 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.198N P=0.111N P=0.648 P=0.123N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.085N P=0.157N P=0.487N P=0.085N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.172N P=0.124N P=0.614N P=0.118N | |COCHRAN-ARMITAGE | (e) | P=0.183N | |FISHER EXACT | (e) (e) (e) | P=0.150N P=0.601 P=0.122N | |=================================================================================================================================| | | |Spleen | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 2/60 (3%) 0/60 (0%) 0/69 (0%) | 1/70 (1%) 0/61 (0%) 0/62 (0%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 4.5% 0.0% 0.0% | 2.4% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/46 (0%) 2/44 (5%) 0/46 (0%) 0/46 (0%) | 1/42 (2%) 0/46 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.366N P=0.229 (e) (e) | P=0.480N P=0.482N P=0.520N P=0.500N | |INCIDENTAL TUMOR | P=0.366N P=0.229 (e) (e) | P=0.480N P=0.482N P=0.520N P=0.500N | |LOGISTIC REGRESSION | P=0.366N P=0.229 (e) (e) | P=0.480N P=0.482N P=0.520N P=0.500N | |COCHRAN-ARMITAGE | P=0.361N | P=0.465N | |FISHER EXACT | P=0.211 (e) (e) | P=0.534N P=0.530N P=0.500N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 1/60 (2%) 2/60 (3%) 0/69 (0%) | 0/70 (0%) 2/61 (3%) 0/62 (0%) 2/70 (3%) | |ADJUSTED (b) | 0.0% 2.3% 4.3% 0.0% | 0.0% 4.3% 0.0% 4.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/46 (0%) 1/44 (2%) 2/46 (4%) 0/46 (0%) | 0/42 (0%) 2/46 (4%) 0/38 (0%) 1/42 (2%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) --- | --- 729 (T) --- 631 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.510N P=0.491 P=0.239 (e) | P=0.284 P=0.259 (e) P=0.247 | |INCIDENTAL TUMOR | P=0.510N P=0.491 P=0.239 (e) | P=0.264 P=0.259 (e) P=0.166 | |LOGISTIC REGRESSION | P=0.510N P=0.491 P=0.239 (e) | P=0.290 P=0.259 (e) P=0.242 | |COCHRAN-ARMITAGE | P=0.500N | P=0.309 | |FISHER EXACT | P=0.462 P=0.211 (e) | P=0.215 (e) P=0.248 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/61 (0%) 4/69 (6%) | 2/69 (3%) 1/61 (2%) 0/61 (0%) 5/70 (7%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 8.3% | 4.8% 2.2% 0.0% 11.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/46 (0%) 0/44 (0%) 0/46 (0%) 3/46 (7%) | 2/42 (5%) 1/46 (2%) 0/37 (0%) 5/42 (12%) | |FIRST INCIDENCE (DAYS) | --- --- --- 453 (I) | 729 (T) 729 (T) --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.002 ** (e) (e) P=0.065 | P=0.037 * P=0.468N P=0.267N P=0.216 | |INCIDENTAL TUMOR | P=0.002 ** (e) (e) P=0.065 | P=0.037 * P=0.468N P=0.267N P=0.216 | |LOGISTIC REGRESSION | P=0.003 ** (e) (e) P=0.062 | P=0.037 * P=0.468N P=0.267N P=0.216 | |COCHRAN-ARMITAGE | P=0.003 ** | P=0.052 | |FISHER EXACT | (e) (e) P=0.058 | P=0.546N P=0.280N P=0.226 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |Uterus | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/70 (0%) 2/61 (3%) 0/62 (0%) 0/70 (0%) | |ADJUSTED (b) | | 0.0% 4.1% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | | 0/42 (0%) 1/46 (2%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | | --- 679 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.376N P=0.262 (e) (e) | |INCIDENTAL TUMOR | | P=0.337N P=0.282 (e) (e) | |LOGISTIC REGRESSION | | P=0.369N P=0.245 (e) (e) | |COCHRAN-ARMITAGE | | P=0.359N | |FISHER EXACT | | P=0.215 (e) (e) | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 1/70 (1%) 1/61 (2%) 0/62 (0%) 2/70 (3%) | |ADJUSTED (b) | | 2.4% 2.2% 0.0% 4.8% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | | 1/42 (2%) 1/46 (2%) 0/38 (0%) 2/42 (5%) | |FIRST INCIDENCE (DAYS) | | 729 (T) 729 (T) --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.323 P=0.741N P=0.520N P=0.500 | |INCIDENTAL TUMOR | | P=0.323 P=0.741N P=0.520N P=0.500 | |LOGISTIC REGRESSION | | P=0.323 P=0.741N P=0.520N P=0.500 | |COCHRAN-ARMITAGE | | P=0.355 | |FISHER EXACT | | P=0.716 P=0.530N P=0.500 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 1/70 (1%) 2/61 (3%) 0/62 (0%) 2/70 (3%) | |ADJUSTED (b) | | 2.4% 4.3% 0.0% 4.8% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | | 1/42 (2%) 2/46 (4%) 0/38 (0%) 2/42 (5%) | |FIRST INCIDENCE (DAYS) | | 729 (T) 729 (T) --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.453 P=0.532 P=0.520N P=0.500 | |INCIDENTAL TUMOR | | P=0.453 P=0.532 P=0.520N P=0.500 | |LOGISTIC REGRESSION | | P=0.453 P=0.532 P=0.520N P=0.500 | |COCHRAN-ARMITAGE | | P=0.488 | |FISHER EXACT | | P=0.448 P=0.530N P=0.500 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 5/60 (8%) 3/61 (5%) 1/70 (1%) | 2/70 (3%) 4/61 (7%) 0/62 (0%) 3/70 (4%) | |ADJUSTED (b) | 2.2% 11.0% 6.5% 2.2% | 4.8% 8.7% 0.0% 6.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 1/46 (2%) 4/44 (9%) 3/46 (7%) 1/46 (2%) | 2/42 (5%) 4/46 (9%) 0/38 (0%) 2/42 (5%) | |FIRST INCIDENCE (DAYS) | 729 (T) 647 729 (T) 729 (T) | 729 (T) 729 (T) --- 631 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.263N P=0.097 P=0.306 P=0.761 | P=0.541 P=0.380 P=0.261N P=0.506 | |INCIDENTAL TUMOR | P=0.281N P=0.108 P=0.306 P=0.761 | P=0.531 P=0.380 P=0.261N P=0.439 | |LOGISTIC REGRESSION | P=0.270N P=0.096 P=0.306 P=0.761 | P=0.552 P=0.380 P=0.261N P=0.511 | |COCHRAN-ARMITAGE | P=0.245N | P=0.582 | |FISHER EXACT | P=0.073 P=0.260 P=0.752N | P=0.277 P=0.279N P=0.500 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 5/60 (8%) 3/61 (5%) 1/70 (1%) | 3/70 (4%) 4/61 (7%) 0/62 (0%) 3/70 (4%) | |ADJUSTED (b) | 2.2% 11.0% 6.5% 2.2% | 7.1% 8.7% 0.0% 6.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 1/46 (2%) 4/44 (9%) 3/46 (7%) 1/46 (2%) | 3/42 (7%) 4/46 (9%) 0/38 (0%) 2/42 (5%) | |FIRST INCIDENCE (DAYS) | 729 (T) 647 729 (T) 729 (T) | 729 (T) 729 (T) --- 631 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.263N P=0.097 P=0.306 P=0.761 | P=0.564N P=0.550 P=0.139N P=0.657N | |INCIDENTAL TUMOR | P=0.281N P=0.108 P=0.306 P=0.761 | P=0.575N P=0.550 P=0.139N P=0.610 | |LOGISTIC REGRESSION | P=0.270N P=0.096 P=0.306 P=0.761 | P=0.553N P=0.550 P=0.139N P=0.652N | |COCHRAN-ARMITAGE | P=0.245N | P=0.517N | |FISHER EXACT | P=0.073 P=0.260 P=0.752N | P=0.423 P=0.146N P=0.660N | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/70 (7%) 4/60 (7%) 5/61 (8%) 2/70 (3%) | 15/70 (21%) 17/61 (28%) 21/62 (34%) 13/70 (19%) | |ADJUSTED (b) | 10.6% 9.1% 10.9% 4.2% | 32.8% 37.0% 47.4% 28.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 4/46 (9%) 4/44 (9%) 5/46 (11%) 1/46 (2%) | 12/42 (29%) 17/46 (37%) 15/38 (39%) 10/42 (24%) | |FIRST INCIDENCE (DAYS) | 709 729 (T) 729 (T) 645 | 323 729 (T) 554 676 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.183N P=0.530N P=0.628 P=0.225N | P=0.318N P=0.533 P=0.105 P=0.412N | |INCIDENTAL TUMOR | P=0.207N P=0.505N P=0.604 P=0.261N | P=0.278N P=0.367 P=0.164 P=0.393N | |LOGISTIC REGRESSION | P=0.191N P=0.526N P=0.624 P=0.225N | P=0.268N P=0.485 P=0.123 P=0.385N | |COCHRAN-ARMITAGE | P=0.166N | P=0.211N | |FISHER EXACT | P=0.597N P=0.538 P=0.221N | P=0.257 P=0.080 P=0.416N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/70 (7%) 4/60 (7%) 5/61 (8%) 2/70 (3%) | 15/70 (21%) 17/61 (28%) 21/62 (34%) 13/70 (19%) | |ADJUSTED (b) | 10.6% 9.1% 10.9% 4.2% | 32.8% 37.0% 47.4% 28.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 4/46 (9%) 4/44 (9%) 5/46 (11%) 1/46 (2%) | 12/42 (29%) 17/46 (37%) 15/38 (39%) 10/42 (24%) | |FIRST INCIDENCE (DAYS) | 709 729 (T) 729 (T) 645 | 323 729 (T) 554 676 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.183N P=0.530N P=0.628 P=0.225N | P=0.318N P=0.533 P=0.105 P=0.412N | |INCIDENTAL TUMOR | P=0.207N P=0.505N P=0.604 P=0.261N | P=0.278N P=0.367 P=0.164 P=0.393N | |LOGISTIC REGRESSION | P=0.191N P=0.526N P=0.624 P=0.225N | P=0.268N P=0.485 P=0.123 P=0.385N | |COCHRAN-ARMITAGE | P=0.166N | P=0.211N | |FISHER EXACT | P=0.597N P=0.538 P=0.221N | P=0.257 P=0.080 P=0.416N | |=================================================================================================================================| | | |All Organs | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/61 (0%) 0/70 (0%) | 0/70 (0%) 0/61 (0%) 1/62 (2%) 2/70 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 2.3% 4.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/46 (0%) 0/44 (0%) 0/46 (0%) 0/46 (0%) | 0/42 (0%) 0/46 (0%) 0/38 (0%) 1/42 (2%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 693 696 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.082 (e) P=0.496 P=0.240 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.105 (e) P=0.638 P=0.295 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.086 (e) P=0.491 P=0.243 | |COCHRAN-ARMITAGE | (e) | P=0.096 | |FISHER EXACT | (e) (e) (e) | (e) P=0.470 P=0.248 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/61 (0%) 0/70 (0%) | 0/70 (0%) 0/61 (0%) 1/62 (2%) 2/70 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 2.3% 4.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/46 (0%) 0/44 (0%) 0/46 (0%) 0/46 (0%) | 0/42 (0%) 0/46 (0%) 0/38 (0%) 1/42 (2%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 693 696 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.082 (e) P=0.496 P=0.240 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.105 (e) P=0.638 P=0.295 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.086 (e) P=0.491 P=0.243 | |COCHRAN-ARMITAGE | (e) | P=0.096 | |FISHER EXACT | (e) (e) (e) | (e) P=0.470 P=0.248 | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 41/70 (59%) 40/60 (67%) 31/61 (51%) 34/70 (49%) | 21/70 (30%) 24/61 (39%) 18/62 (29%) 25/70 (36%) | |ADJUSTED (b) | 81.7% 81.5% 63.3% 69.2% | 48.7% 49.0% 43.0% 55.4% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 1/1 (100%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 1/10 (10%) 0/10 (0%) 0/9 (0%) 2/10 (20%) | 0/9 (0%) 0/10 (0%) 2/9 (22%) 0/9 (0%) | |TERMINAL (d) | 37/46 (80%) 35/44 (80%) 28/46 (61%) 31/46 (67%) | 20/42 (48%) 21/46 (46%) 15/38 (39%) 22/42 (52%) | |FIRST INCIDENCE (DAYS) | 276 (I) 276 (I) 592 452 (I) | 607 701 452 (I) 473 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.066N P=0.321 P=0.071N P=0.118N | P=0.239 P=0.504 P=0.482N P=0.279 | |INCIDENTAL TUMOR | P=0.069N P=0.455 P=0.051N P=0.131N | P=0.291 P=0.443 P=0.436N P=0.298 | |LOGISTIC REGRESSION | P=0.080N P=0.363 P=0.048N* P=0.131N | P=0.284 P=0.492 P=0.387N P=0.312 | |COCHRAN-ARMITAGE | P=0.052N | P=0.411 | |FISHER EXACT | P=0.221 P=0.238N P=0.155N | P=0.174 P=0.528N P=0.295 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- MANGANESE SULFATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 1500 PPM 5000 PPM 15000 P | 0PPM 1500 PPM 5000 PPM 15000 P | | | PM | PM | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 20/70 (29%) 24/60 (40%) 21/61 (34%) 15/70 (21%) | 23/70 (33%) 23/61 (38%) 26/62 (42%) 21/70 (30%) | |ADJUSTED (b) | 40.8% 50.0% 43.5% 31.2% | 46.8% 48.9% 54.8% 43.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 17/46 (37%) 20/44 (45%) 19/46 (41%) 13/46 (28%) | 16/42 (38%) 22/46 (48%) 17/38 (45%) 15/42 (36%) | |FIRST INCIDENCE (DAYS) | 466 647 417 634 | 323 679 409 447 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.076N P=0.229 P=0.499 P=0.217N | P=0.424N P=0.426N P=0.256 P=0.421N | |INCIDENTAL TUMOR | P=0.079N P=0.204 P=0.451 P=0.179N | P=0.285N P=0.443 P=0.446 P=0.404N | |LOGISTIC REGRESSION | P=0.079N P=0.234 P=0.467 P=0.162N | P=0.329N P=0.489N P=0.280 P=0.385N | |COCHRAN-ARMITAGE | P=0.054N | P=0.268N | |FISHER EXACT | P=0.118 P=0.297 P=0.218N | P=0.346 P=0.185 P=0.428N | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 49/70 (70%) 45/60 (75%) 40/61 (66%) 41/70 (59%) | 37/70 (53%) 37/61 (61%) 39/62 (63%) 36/70 (51%) | |ADJUSTED (b) | 94.1% 90.0% 79.9% 80.3% | 75.4% 74.0% 77.7% 71.9% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 1/1 (100%) 0/1 (0%) 0/9 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 1/10 (10%) 0/10 (0%) 0/9 (0%) 2/10 (20%) | 0/9 (0%) 0/10 (0%) 2/9 (22%) 0/9 (0%) | |TERMINAL (d) | 43/46 (93%) 39/44 (89%) 36/46 (78%) 36/46 (78%) | 30/42 (71%) 33/46 (72%) 27/38 (71%) 28/42 (67%) | |FIRST INCIDENCE (DAYS) | 276 (I) 276 (I) 417 452 (I) | 323 679 409 447 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.055N P=0.553 P=0.079N P=0.072N | P=0.537 P=0.335N P=0.243 P=0.488N | |INCIDENTAL TUMOR | P=0.037N* P=0.552N P=0.040N* P=0.046N* | P=0.342N P=0.581 P=0.455 P=0.446N | |LOGISTIC REGRESSION | P=0.062N P=0.536N P=0.046N* P=0.059N | P=0.425N P=0.386N P=0.322 P=0.424N | |COCHRAN-ARMITAGE | P=0.037N* | P=0.289N | |FISHER EXACT | P=0.331 P=0.361N P=0.108N | P=0.235 P=0.161 P=0.500N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05085 TEST: 02 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 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): 276 452 Female interim sacrifices(days): 276 452 (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).