TDMS Study 05069-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: TSI Mason Research 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER) DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 TIME: 03:22:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-95256 ROUTE: DERMAL,SOLUTION NTP C#: 60902D PATHOLOGIST: DR. VOELKER CAS: 147-47-7 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: TSI Mason Research 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER) DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 TIME: 03:22:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-95256 ROUTE: DERMAL,SOLUTION NTP C#: 60902D PATHOLOGIST: DR. VOELKER CAS: 147-47-7 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 Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland 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: TSI Mason Research 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER) DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 TIME: 03:22:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-95256 ROUTE: DERMAL,SOLUTION NTP C#: 60902D PATHOLOGIST: DR. VOELKER CAS: 147-47-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Skin Sarcoma ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Thyroid Gland: C-Cell Carcinoma or Adenoma Thyroid Gland: Follicular Cell Adenoma Carcinoma or Adenoma All Organs Histiocytic Sarcoma Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 0/59 (0%) 3/59 (5%) 1/59 (2%) | 2/58 (3%) 0/59 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 7.3% 2.7% | 6.1% 0.0% 0.0% 2.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/37 (0%) 3/41 (7%) 1/37 (3%) | 2/33 (6%) 0/39 (0%) 0/40 (0%) 1/40 (3%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) 729 (T) | 736 (T) --- --- 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.180 (e) P=0.130 P=0.490 | P=0.269N P=0.202N P=0.197N P=0.433N | |INCIDENTAL TUMOR | P=0.180 (e) P=0.130 P=0.490 | P=0.269N P=0.202N P=0.197N P=0.433N | |LOGISTIC REGRESSION | P=0.180 (e) P=0.130 P=0.490 | P=0.269N P=0.202N P=0.197N P=0.433N | |COCHRAN-ARMITAGE | P=0.187 | P=0.304N | |FISHER EXACT | (e) P=0.122 P=0.500 | P=0.244N P=0.239N P=0.487N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/57 (2%) 0/58 (0%) 1/59 (2%) 0/59 (0%) | 2/58 (3%) 1/59 (2%) 0/58 (0%) 0/60 (0%) | |ADJUSTED (b) | 2.6% 0.0% 2.4% 0.0% | 5.5% 1.7% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 1/39 (3%) 0/37 (0%) 1/41 (2%) 0/37 (0%) | 1/33 (3%) 0/39 (0%) 0/38 (0%) 0/40 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) --- | 711 455 (I) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.356N P=0.510N P=0.751N P=0.510N | P=0.066N P=0.478N P=0.217N P=0.214N | |INCIDENTAL TUMOR | P=0.356N P=0.510N P=0.751N P=0.510N | P=0.099N P=0.569N P=0.305N P=0.298N | |LOGISTIC REGRESSION | P=0.356N P=0.510N P=0.751N P=0.510N | P=0.068N P=0.495N P=0.234N P=0.223N | |COCHRAN-ARMITAGE | P=0.344N | P=0.069N | |FISHER EXACT | P=0.496N P=0.743N P=0.491N | P=0.494N P=0.248N P=0.239N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Bone Marrow | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/59 (3%) 1/59 (2%) 0/60 (0%) 1/59 (2%) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 4.4% 2.6% 0.0% 2.5% | 2.9% 0.0% 2.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/37 (0%) 0/41 (0%) 0/37 (0%) | 0/34 (0%) 0/40 (0%) 0/40 (0%) 0/40 (0%) | |FIRST INCIDENCE (DAYS) | 592 710 --- 691 | 729 --- 709 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.294N P=0.521N P=0.247N P=0.527N | P=0.335N P=0.473N P=0.735N P=0.473N | |INCIDENTAL TUMOR | P=0.181N P=0.523N P=0.260N P=0.416N | P=0.549N P=0.674N P=0.556 P=0.674N | |LOGISTIC REGRESSION | P=0.279N P=0.506N P=0.236N P=0.500N | P=0.347N P=0.495N P=0.759N P=0.492N | |COCHRAN-ARMITAGE | P=0.280N | P=0.352N | |FISHER EXACT | P=0.500N P=0.244N P=0.500N | P=0.500N P=0.752N P=0.500N | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 5/60 (8%) 3/60 (5%) 1/60 (2%) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 7.1% 12.4% 6.6% 2.7% | 0.0% 2.5% 4.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 2/39 (5%) 3/37 (8%) 1/41 (2%) 1/37 (3%) | 0/34 (0%) 1/40 (3%) 1/40 (3%) 0/40 (0%) | |FIRST INCIDENCE (DAYS) | 592 540 553 729 (T) | --- 736 (T) 726 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.215N P=0.329 P=0.650N P=0.331N | P=0.590 P=0.532 P=0.278 (e) | |INCIDENTAL TUMOR | P=0.153N P=0.444 P=0.623 P=0.382N | P=0.495 P=0.532 P=0.162 (e) | |LOGISTIC REGRESSION | P=0.217N P=0.335 P=0.655 P=0.311N | P=0.567 P=0.532 P=0.248 (e) | |COCHRAN-ARMITAGE | P=0.200N | P=0.553 | |FISHER EXACT | P=0.359 P=0.660N P=0.309N | P=0.500 P=0.248 (e) | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 2.4% 5.0% | 0.0% 0.0% 2.5% 2.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/37 (0%) 1/41 (2%) 1/37 (3%) | 0/34 (0%) 0/40 (0%) 1/40 (3%) 0/40 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) 660 | --- --- 736 (T) 638 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.070 (e) P=0.510 P=0.234 | P=0.219 (e) P=0.532 P=0.504 | |INCIDENTAL TUMOR | P=0.090 (e) P=0.510 P=0.277 | P=0.240 (e) P=0.532 P=0.581 | |LOGISTIC REGRESSION | P=0.070 (e) P=0.510 P=0.234 | P=0.208 (e) P=0.532 P=0.497 | |COCHRAN-ARMITAGE | P=0.071 | P=0.207 | |FISHER EXACT | (e) P=0.500 P=0.248 | (e) P=0.500 P=0.500 | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 5/60 (8%) 4/60 (7%) 3/60 (5%) | 0/60 (0%) 1/60 (2%) 3/60 (5%) 1/60 (2%) | |ADJUSTED (b) | 7.1% 12.4% 8.9% 7.6% | 0.0% 2.5% 7.3% 2.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 2/39 (5%) 3/37 (8%) 2/41 (5%) 2/37 (5%) | 0/34 (0%) 1/40 (3%) 2/40 (5%) 0/40 (0%) | |FIRST INCIDENCE (DAYS) | 592 540 553 660 | --- 736 (T) 726 638 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.540N P=0.329 P=0.514 P=0.636 | P=0.286 P=0.532 P=0.155 P=0.504 | |INCIDENTAL TUMOR | P=0.446N P=0.444 P=0.465 P=0.625 | P=0.243 P=0.532 P=0.089 P=0.581 | |LOGISTIC REGRESSION | P=0.556 P=0.335 P=0.501 P=0.656 | P=0.260 P=0.532 P=0.132 P=0.497 | |COCHRAN-ARMITAGE | P=0.524N | P=0.255 | |FISHER EXACT | P=0.359 P=0.500 P=0.660N | P=0.500 P=0.122 P=0.500 | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 2/60 (3%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 2.6% 5.4% 4.9% 0.0% | 2.6% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 1/39 (3%) 2/37 (5%) 2/41 (5%) 0/37 (0%) | 0/34 (0%) 0/40 (0%) 0/40 (0%) 0/40 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) --- | 714 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.359N P=0.482 P=0.518 P=0.510N | P=0.186N P=0.485N P=0.475N P=0.480N | |INCIDENTAL TUMOR | P=0.359N P=0.482 P=0.517 P=0.510N | P=0.322N P=0.674N P=0.674N P=0.674N | |LOGISTIC REGRESSION | P=0.359N P=0.482 P=0.517 P=0.510N | P=0.197N P=0.498N P=0.498N P=0.496N | |COCHRAN-ARMITAGE | P=0.351N | P=0.199N | |FISHER EXACT | P=0.500 P=0.500 P=0.500N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 4/60 (7%) 2/60 (3%) 1/60 (2%) | 2/60 (3%) 1/59 (2%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 6.8% 10.5% 4.9% 2.7% | 5.9% 2.5% 0.0% 2.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 1/39 (3%) 3/37 (8%) 2/41 (5%) 1/37 (3%) | 2/34 (6%) 1/40 (3%) 0/40 (0%) 1/40 (3%) | |FIRST INCIDENCE (DAYS) | 592 710 729 (T) 729 (T) | 736 (T) 736 (T) --- 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.191N P=0.470 P=0.492N P=0.334N | P=0.241N P=0.443N P=0.203N P=0.443N | |INCIDENTAL TUMOR | P=0.177N P=0.425 P=0.529N P=0.339N | P=0.241N P=0.443N P=0.203N P=0.443N | |LOGISTIC REGRESSION | P=0.184N P=0.471 P=0.500N P=0.309N | P=0.241N P=0.443N P=0.203N P=0.443N | |COCHRAN-ARMITAGE | P=0.180N | P=0.280N | |FISHER EXACT | P=0.500 P=0.500N P=0.309N | P=0.506N P=0.248N P=0.500N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 2.7% 4.8% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 1/37 (3%) 1/41 (2%) 0/37 (0%) | 0/34 (0%) 0/40 (0%) 0/40 (0%) 0/40 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) 669 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.547 P=0.490 P=0.243 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.585 P=0.490 P=0.213 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.550 P=0.490 P=0.238 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.553 | (e) | |FISHER EXACT | P=0.500 P=0.248 (e) | (e) (e) (e) | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 28/60 (47%) 32/60 (53%) 26/60 (43%) 28/60 (47%) | 32/60 (53%) 24/59 (41%) 22/60 (37%) 19/60 (32%) | |ADJUSTED (b) | 59.9% 73.9% 54.6% 64.3% | 70.6% 55.3% 49.7% 44.6% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 2/10 (20%) 1/10 (10%) 2/10 (20%) | 2/10 (20%) 2/9 (22%) 1/9 (11%) 1/10 (10%) | |TERMINAL (d) | 21/39 (54%) 26/37 (70%) 20/41 (49%) 22/37 (59%) | 21/34 (62%) 21/40 (53%) 18/40 (45%) 17/40 (43%) | |FIRST INCIDENCE (DAYS) | 456 (I) 357 385 456 (I) | 455 (I) 455 (I) 455 (I) 455 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.484N P=0.208 P=0.363N P=0.481 | P=0.001N** P=0.031N* P=0.015N* P=0.003N** | |INCIDENTAL TUMOR | P=0.424N P=0.202 P=0.335N P=0.515N | P=0.005N** P=0.096N P=0.077N P=0.009N** | |LOGISTIC REGRESSION | P=0.433N P=0.203 P=0.421N P=0.556 | P=0.005N** P=0.090N P=0.041N* P=0.008N** | |COCHRAN-ARMITAGE | P=0.433N | P=0.009N** | |FISHER EXACT | P=0.292 P=0.427N P=0.573N | P=0.115N P=0.049N* P=0.013N* | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/60 (17%) 9/60 (15%) 5/60 (8%) 14/60 (23%) | 13/60 (22%) 8/59 (14%) 6/60 (10%) 13/60 (22%) | |ADJUSTED (b) | 21.7% 21.0% 11.4% 30.6% | 31.3% 17.5% 13.6% 29.3% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 2/10 (20%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 6/39 (15%) 6/37 (16%) 3/41 (7%) 7/37 (19%) | 7/34 (21%) 5/40 (13%) 4/40 (10%) 9/40 (23%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 618 456 (I) | 567 448 446 603 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.241 P=0.545N P=0.132N P=0.224 | P=0.391N P=0.124N P=0.044N* P=0.459N | |INCIDENTAL TUMOR | P=0.224 P=0.559N P=0.148N P=0.194 | P=0.480 P=0.204N P=0.124N P=0.444 | |LOGISTIC REGRESSION | P=0.267 P=0.505N P=0.134N P=0.251 | P=0.525N P=0.193N P=0.126N P=0.550 | |COCHRAN-ARMITAGE | P=0.253 | P=0.491N | |FISHER EXACT | P=0.500N P=0.135N P=0.247 | P=0.179N P=0.066N P=0.588N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/60 (17%) 10/60 (17%) 7/60 (12%) 14/60 (23%) | 13/60 (22%) 8/59 (14%) 6/60 (10%) 13/60 (22%) | |ADJUSTED (b) | 21.7% 23.6% 15.8% 30.6% | 31.3% 17.5% 13.6% 29.3% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 2/10 (20%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 6/39 (15%) 7/37 (19%) 4/41 (10%) 7/37 (19%) | 7/34 (21%) 5/40 (13%) 4/40 (10%) 9/40 (23%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 618 456 (I) | 567 448 446 603 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.232 P=0.549 P=0.290N P=0.224 | P=0.391N P=0.124N P=0.044N* P=0.459N | |INCIDENTAL TUMOR | P=0.223 P=0.538 P=0.330N P=0.194 | P=0.480 P=0.204N P=0.124N P=0.444 | |LOGISTIC REGRESSION | P=0.253 P=0.588 P=0.299N P=0.251 | P=0.525N P=0.193N P=0.126N P=0.550 | |COCHRAN-ARMITAGE | P=0.243 | P=0.491N | |FISHER EXACT | P=0.596N P=0.301N P=0.247 | P=0.179N P=0.066N P=0.588N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 32/60 (53%) 37/60 (62%) 29/60 (48%) 39/60 (65%) | 35/60 (58%) 29/59 (49%) 28/60 (47%) 26/60 (43%) | |ADJUSTED (b) | 65.7% 79.9% 61.1% 80.9% | 75.6% 62.3% 60.5% 57.4% | |INTERIM SACRIFICE 1 (c)| 5/10 (50%) 4/10 (40%) 1/10 (10%) 2/10 (20%) | 2/10 (20%) 2/9 (22%) 1/9 (11%) 1/10 (10%) | |TERMINAL (d) | 23/39 (59%) 28/37 (76%) 23/41 (56%) 28/37 (76%) | 23/34 (68%) 23/40 (58%) 22/40 (55%) 21/40 (53%) | |FIRST INCIDENCE (DAYS) | 456 (I) 357 385 456 (I) | 455 (I) 448 446 455 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.165 P=0.156 P=0.296N P=0.098 | P=0.015N* P=0.069N P=0.045N* P=0.022N* | |INCIDENTAL TUMOR | P=0.173 P=0.140 P=0.268N P=0.140 | P=0.054N P=0.179N P=0.201N P=0.081N | |LOGISTIC REGRESSION | P=0.188 P=0.162 P=0.348N P=0.120 | P=0.042N* P=0.179N P=0.126N P=0.049N* | |COCHRAN-ARMITAGE | P=0.192 | P=0.055N | |FISHER EXACT | P=0.230 P=0.358N P=0.133 | P=0.206N P=0.136N P=0.072N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 32/60 (53%) 37/60 (62%) 31/60 (52%) 39/60 (65%) | 35/60 (58%) 29/59 (49%) 28/60 (47%) 26/60 (43%) | |ADJUSTED (b) | 65.7% 79.9% 64.2% 80.9% | 75.6% 62.3% 60.5% 57.4% | |INTERIM SACRIFICE 1 (c)| 5/10 (50%) 4/10 (40%) 1/10 (10%) 2/10 (20%) | 2/10 (20%) 2/9 (22%) 1/9 (11%) 1/10 (10%) | |TERMINAL (d) | 23/39 (59%) 28/37 (76%) 24/41 (59%) 28/37 (76%) | 23/34 (68%) 23/40 (58%) 22/40 (55%) 21/40 (53%) | |FIRST INCIDENCE (DAYS) | 456 (I) 357 385 456 (I) | 455 (I) 448 446 455 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.148 P=0.156 P=0.425N P=0.098 | P=0.015N* P=0.069N P=0.045N* P=0.022N* | |INCIDENTAL TUMOR | P=0.158 P=0.140 P=0.412N P=0.140 | P=0.054N P=0.179N P=0.201N P=0.081N | |LOGISTIC REGRESSION | P=0.166 P=0.162 P=0.493N P=0.120 | P=0.042N* P=0.179N P=0.126N P=0.049N* | |COCHRAN-ARMITAGE | P=0.170 | P=0.055N | |FISHER EXACT | P=0.230 P=0.500N P=0.133 | P=0.206N P=0.136N P=0.072N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/60 (20%) 8/60 (13%) 12/60 (20%) 13/60 (22%) | 1/60 (2%) 5/60 (8%) 6/60 (10%) 2/60 (3%) | |ADJUSTED (b) | 28.8% 20.8% 27.2% 28.3% | 2.9% 12.5% 13.9% 4.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 3/10 (30%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 10/39 (26%) 7/37 (19%) 10/41 (24%) 7/37 (19%) | 1/34 (3%) 5/40 (13%) 4/40 (10%) 1/40 (3%) | |FIRST INCIDENCE (DAYS) | 592 626 456 (I) 456 (I) | 736 (T) 736 (T) 504 684 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.341 P=0.276N P=0.548N P=0.453 | P=0.441 P=0.143 P=0.084 P=0.540 | |INCIDENTAL TUMOR | P=0.357 P=0.283N P=0.571N P=0.526 | P=0.367 P=0.143 P=0.073 P=0.441 | |LOGISTIC REGRESSION | P=0.364 P=0.274N P=0.590 P=0.496 | P=0.385 P=0.143 P=0.059 P=0.508 | |COCHRAN-ARMITAGE | P=0.366 | P=0.376 | |FISHER EXACT | P=0.232N P=0.590N P=0.500 | P=0.103 P=0.057 P=0.500 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/60 (12%) 6/60 (10%) 8/60 (13%) 8/60 (13%) | 3/60 (5%) 2/60 (3%) 2/60 (3%) 3/60 (5%) | |ADJUSTED (b) | 17.5% 14.6% 18.8% 21.6% | 8.4% 5.0% 5.0% 6.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 6/39 (15%) 3/37 (8%) 7/41 (17%) 8/37 (22%) | 2/34 (6%) 2/40 (5%) 2/40 (5%) 2/40 (5%) | |FIRST INCIDENCE (DAYS) | 709 588 571 729 (T) | 714 736 (T) 736 (T) 537 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.362 P=0.542N P=0.536 P=0.457 | P=0.508N P=0.434N P=0.430N P=0.601N | |INCIDENTAL TUMOR | P=0.344 P=0.582N P=0.510 P=0.481 | P=0.553N P=0.516N P=0.516N P=0.650 | |LOGISTIC REGRESSION | P=0.372 P=0.545N P=0.498 P=0.479 | P=0.560N P=0.482N P=0.473N P=0.657N | |COCHRAN-ARMITAGE | P=0.386 | P=0.569 | |FISHER EXACT | P=0.500N P=0.500 P=0.500 | P=0.500N P=0.500N P=0.660N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/60 (30%) 13/60 (22%) 17/60 (28%) 20/60 (33%) | 4/60 (7%) 7/60 (12%) 8/60 (13%) 5/60 (8%) | |ADJUSTED (b) | 42.6% 32.2% 39.0% 45.0% | 11.2% 17.5% 18.7% 11.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 3/10 (30%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 15/39 (38%) 10/37 (27%) 15/41 (37%) 14/37 (38%) | 3/34 (9%) 7/40 (18%) 6/40 (15%) 3/40 (8%) | |FIRST INCIDENCE (DAYS) | 592 588 456 (I) 456 (I) | 714 736 (T) 504 537 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.278 P=0.258N P=0.441N P=0.359 | P=0.495 P=0.356 P=0.255 P=0.576 | |INCIDENTAL TUMOR | P=0.297 P=0.280N P=0.472N P=0.434 | P=0.406 P=0.302 P=0.196 P=0.453 | |LOGISTIC REGRESSION | P=0.297 P=0.254N P=0.506N P=0.399 | P=0.415 P=0.300 P=0.181 P=0.510 | |COCHRAN-ARMITAGE | P=0.311 | P=0.402 | |FISHER EXACT | P=0.202N P=0.500N P=0.422 | P=0.264 P=0.181 P=0.500 | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 1/60 (2%) 1/59 (2%) 2/59 (3%) 0/59 (0%) | |ADJUSTED (b) | | 2.9% 1.7% 5.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | | 1/34 (3%) 0/39 (0%) 2/40 (5%) 0/40 (0%) | |FIRST INCIDENCE (DAYS) | | 736 (T) 455 (I) 736 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.362N P=0.745N P=0.557 P=0.468N | |INCIDENTAL TUMOR | | P=0.362N P=0.745N P=0.557 P=0.468N | |LOGISTIC REGRESSION | | P=0.398N P=0.759 P=0.557 P=0.468N | |COCHRAN-ARMITAGE | | P=0.398N | |FISHER EXACT | | P=0.748 P=0.494 P=0.504N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/55 (0%) 0/53 (0%) 0/50 (0%) 0/56 (0%) | 5/52 (10%) 4/57 (7%) 6/56 (11%) 4/54 (7%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 15.5% 10.5% 15.3% 11.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/36 (0%) 0/32 (0%) 0/31 (0%) 0/35 (0%) | 4/30 (13%) 4/38 (11%) 5/38 (13%) 4/35 (11%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 711 736 (T) 735 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.388N P=0.369N P=0.602N P=0.411N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.454N P=0.415N P=0.526 P=0.460N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.418N P=0.409N P=0.619 P=0.452N | |COCHRAN-ARMITAGE | (e) | P=0.457N | |FISHER EXACT | (e) (e) (e) | P=0.442N P=0.553 P=0.476N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/55 (0%) 0/53 (0%) 0/50 (0%) 0/56 (0%) | 5/52 (10%) 5/57 (9%) 6/56 (11%) 4/54 (7%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 15.5% 12.7% 15.3% 11.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/36 (0%) 0/32 (0%) 0/31 (0%) 0/35 (0%) | 4/30 (13%) 4/38 (11%) 5/38 (13%) 4/35 (11%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 711 724 735 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.358N P=0.496N P=0.602N P=0.411N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.455N P=0.597N P=0.526 P=0.460N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.396N P=0.547N P=0.619 P=0.452N | |COCHRAN-ARMITAGE | (e) | P=0.428N | |FISHER EXACT | (e) (e) (e) | P=0.569N P=0.553 P=0.476N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Skin | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | 2/60 (3%) 2/60 (3%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 4.8% | 5.6% 4.7% 4.6% 2.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/37 (0%) 0/41 (0%) 1/37 (3%) | 1/34 (3%) 1/40 (3%) 1/40 (3%) 1/40 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- 581 | 721 659 504 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.056 (e) (e) P=0.227 | P=0.337N P=0.653N P=0.651N P=0.450N | |INCIDENTAL TUMOR | P=0.037 * (e) (e) P=0.161 | P=0.438N P=0.572 P=0.684N P=0.559N | |LOGISTIC REGRESSION | P=0.057 (e) (e) P=0.238 | P=0.371N P=0.692N P=0.693 P=0.484N | |COCHRAN-ARMITAGE | P=0.057 | P=0.373N | |FISHER EXACT | (e) (e) P=0.248 | P=0.691N P=0.691N P=0.500N | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/58 (3%) 2/59 (3%) 0/59 (0%) 1/60 (2%) | 1/60 (2%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 4.5% 5.2% 0.0% 2.5% | 2.9% 2.5% 4.7% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/38 (0%) 1/37 (3%) 0/41 (0%) 0/37 (0%) | 0/34 (0%) 1/40 (3%) 1/40 (3%) 0/40 (0%) | |FIRST INCIDENCE (DAYS) | 612 710 --- 691 | 729 736 (T) 709 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.265N P=0.677 P=0.247N P=0.522N | P=0.360N P=0.727N P=0.545 P=0.473N | |INCIDENTAL TUMOR | P=0.224N P=0.604 P=0.337N P=0.483N | P=0.514N P=0.690 P=0.321 P=0.674N | |LOGISTIC REGRESSION | P=0.274N P=0.684 P=0.233N P=0.489N | P=0.383N P=0.753N P=0.509 P=0.492N | |COCHRAN-ARMITAGE | P=0.247N | P=0.393N | |FISHER EXACT | P=0.684N P=0.244N P=0.487N | P=0.752N P=0.500 P=0.500N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 4.9% 2.7% 0.0% 2.3% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 1/39 (3%) 1/37 (3%) 0/41 (0%) 0/37 (0%) | 0/34 (0%) 0/40 (0%) 0/40 (0%) 0/40 (0%) | |FIRST INCIDENCE (DAYS) | 701 729 (T) --- 660 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.287N P=0.515N P=0.234N P=0.512N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.236N P=0.545N P=0.265N P=0.410N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.284N P=0.521N P=0.238N P=0.506N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.281N | (e) | |FISHER EXACT | P=0.500N P=0.248N P=0.500N | (e) (e) (e) | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 1/60 (2%) 1/60 (2%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 4.9% 2.7% 2.4% 2.3% | 2.9% 0.0% 0.0% 2.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 1/39 (3%) 1/37 (3%) 1/41 (2%) 0/37 (0%) | 1/34 (3%) 0/40 (0%) 0/40 (0%) 1/40 (3%) | |FIRST INCIDENCE (DAYS) | 701 729 (T) 729 (T) 660 | 736 (T) --- --- 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.358N P=0.515N P=0.488N P=0.512N | P=0.622N P=0.468N P=0.468N P=0.725N | |INCIDENTAL TUMOR | P=0.305N P=0.545N P=0.522N P=0.410N | P=0.622N P=0.468N P=0.468N P=0.725N | |LOGISTIC REGRESSION | P=0.356N P=0.521N P=0.500N P=0.506N | P=0.622N P=0.468N P=0.468N P=0.725N | |COCHRAN-ARMITAGE | P=0.351N | P=0.648 | |FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.500N P=0.500N P=0.752N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 1/60 (2%) 1/60 (2%) 3/60 (5%) | | |ADJUSTED (b) | 2.6% 2.4% 2.4% 7.8% | | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | | |TERMINAL (d) | 1/39 (3%) 0/37 (0%) 1/41 (2%) 2/37 (5%) | | |FIRST INCIDENCE (DAYS) | 729 (T) 640 729 (T) 722 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.176 P=0.749 P=0.751N P=0.293 | | |INCIDENTAL TUMOR | P=0.182 P=0.734 P=0.751N P=0.351 | | |LOGISTIC REGRESSION | P=0.179 P=0.758 P=0.751N P=0.297 | | |COCHRAN-ARMITAGE | P=0.182 | | |FISHER EXACT | P=0.748N P=0.748N P=0.316 | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 2/59 (3%) 0/60 (0%) 0/59 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.9% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/38 (0%) 0/37 (0%) 0/41 (0%) 0/37 (0%) | 2/34 (6%) 0/40 (0%) 0/40 (0%) 0/40 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 736 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.046N* P=0.203N P=0.203N P=0.203N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.046N* P=0.203N P=0.203N P=0.203N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.046N* P=0.203N P=0.203N P=0.203N | |COCHRAN-ARMITAGE | (e) | P=0.056N | |FISHER EXACT | (e) (e) (e) | P=0.244N P=0.248N P=0.244N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | 0/59 (0%) 1/60 (2%) 2/59 (3%) 3/60 (5%) | |ADJUSTED (b) | 1.7% 0.0% 4.9% 2.7% | 0.0% 2.5% 4.9% 7.5% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/38 (0%) 0/37 (0%) 2/41 (5%) 1/37 (3%) | 0/34 (0%) 1/40 (3%) 1/40 (3%) 3/40 (8%) | |FIRST INCIDENCE (DAYS) | 456 (I) --- 729 (T) 729 (T) | --- 736 (T) 735 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.484 P=0.500N P=0.518 P=0.757 | P=0.065 P=0.532 P=0.279 P=0.151 | |INCIDENTAL TUMOR | P=0.484 P=0.500N P=0.518 P=0.757 | P=0.050 * P=0.532 P=0.171 P=0.151 | |LOGISTIC REGRESSION | P=0.490 P=0.470N P=0.501 P=0.757 | P=0.062 P=0.532 P=0.272 P=0.151 | |COCHRAN-ARMITAGE | P=0.489 | P=0.054 | |FISHER EXACT | P=0.496N P=0.506 P=0.748N | P=0.504 P=0.248 P=0.125 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/59 (3%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | 0/59 (0%) 1/60 (2%) 2/59 (3%) 3/60 (5%) | |ADJUSTED (b) | 4.3% 0.0% 4.9% 2.7% | 0.0% 2.5% 4.9% 7.5% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 1/38 (3%) 0/37 (0%) 2/41 (5%) 1/37 (3%) | 0/34 (0%) 1/40 (3%) 1/40 (3%) 3/40 (8%) | |FIRST INCIDENCE (DAYS) | 456 (I) --- 729 (T) 729 (T) | --- 736 (T) 735 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.459N P=0.243N P=0.673N P=0.506N | P=0.065 P=0.532 P=0.279 P=0.151 | |INCIDENTAL TUMOR | P=0.459N P=0.243N P=0.673N P=0.506N | P=0.050 * P=0.532 P=0.171 P=0.151 | |LOGISTIC REGRESSION | P=0.452N P=0.223N P=0.688N P=0.496N | P=0.062 P=0.532 P=0.272 P=0.151 | |COCHRAN-ARMITAGE | P=0.453N | P=0.054 | |FISHER EXACT | P=0.244N P=0.684N P=0.494N | P=0.504 P=0.248 P=0.125 | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/60 (0%) 3/60 (5%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | | 0.0% 6.6% 2.5% 2.5% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | | 0/34 (0%) 2/40 (5%) 1/40 (3%) 1/40 (3%) | |FIRST INCIDENCE (DAYS) | | --- 455 (I) 736 (T) 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.496 P=0.143 P=0.532 P=0.532 | |INCIDENTAL TUMOR | | P=0.496 P=0.143 P=0.532 P=0.532 | |LOGISTIC REGRESSION | | P=0.460 P=0.121 P=0.532 P=0.532 | |COCHRAN-ARMITAGE | | P=0.459 | |FISHER EXACT | | P=0.122 P=0.500 P=0.500 | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 3/60 (5%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 5.1% 0.0% 4.9% 2.7% | 0.0% 7.2% 2.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 2/39 (5%) 0/37 (0%) 2/41 (5%) 1/37 (3%) | 0/34 (0%) 2/40 (5%) 1/40 (3%) 0/40 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) 729 (T) | --- 684 736 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.467N P=0.250N P=0.677N P=0.518N | P=0.450N P=0.144 P=0.532 (e) | |INCIDENTAL TUMOR | P=0.467N P=0.250N P=0.677N P=0.518N | P=0.524N P=0.089 P=0.532 (e) | |LOGISTIC REGRESSION | P=0.467N P=0.250N P=0.677N P=0.518N | P=0.477N P=0.122 P=0.532 (e) | |COCHRAN-ARMITAGE | P=0.459N | P=0.485N | |FISHER EXACT | P=0.248N P=0.691N P=0.500N | P=0.122 P=0.500 (e) | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 7/60 (12%) 2/60 (3%) 3/60 (5%) | 4/60 (7%) 3/60 (5%) 3/60 (5%) 2/60 (3%) | |ADJUSTED (b) | 8.8% 17.6% 4.9% 7.8% | 10.1% 7.2% 7.2% 4.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 1/39 (3%) 5/37 (14%) 2/41 (5%) 2/37 (5%) | 2/34 (6%) 2/40 (5%) 2/40 (5%) 1/40 (3%) | |FIRST INCIDENCE (DAYS) | 592 560 729 (T) 691 | 388 684 709 684 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.289N P=0.237 P=0.337N P=0.534N | P=0.214N P=0.439N P=0.435N P=0.293N | |INCIDENTAL TUMOR | P=0.289N P=0.190 P=0.377N P=0.555N | P=0.357N P=0.578N P=0.526N P=0.429N | |LOGISTIC REGRESSION | P=0.272N P=0.180 P=0.336N P=0.504N | P=0.251N P=0.500N P=0.503N P=0.338N | |COCHRAN-ARMITAGE | P=0.269N | P=0.255N | |FISHER EXACT | P=0.264 P=0.340N P=0.500N | P=0.500N P=0.500N P=0.340N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/60 (10%) 7/60 (12%) 4/60 (7%) 4/60 (7%) | 4/60 (7%) 5/60 (8%) 4/60 (7%) 2/60 (3%) | |ADJUSTED (b) | 13.6% 17.6% 9.8% 10.4% | 10.1% 12.0% 9.6% 4.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 3/39 (8%) 5/37 (14%) 4/41 (10%) 3/37 (8%) | 2/34 (6%) 4/40 (10%) 3/40 (8%) 1/40 (3%) | |FIRST INCIDENCE (DAYS) | 592 560 729 (T) 691 | 388 684 709 684 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.256N P=0.456 P=0.358N P=0.411N | P=0.200N P=0.577 P=0.570N P=0.293N | |INCIDENTAL TUMOR | P=0.256N P=0.409 P=0.390N P=0.423N | P=0.324N P=0.453 P=0.634 P=0.429N | |LOGISTIC REGRESSION | P=0.241N P=0.398 P=0.370N P=0.380N | P=0.244N P=0.501 P=0.640 P=0.338N | |COCHRAN-ARMITAGE | P=0.236N | P=0.250N | |FISHER EXACT | P=0.500 P=0.372N P=0.372N | P=0.500 P=0.641N P=0.340N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 4/60 (7%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 2.3% 0.0% 0.0% 2.7% | 10.7% 0.0% 0.0% 2.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/37 (0%) 0/41 (0%) 1/37 (3%) | 3/34 (9%) 0/40 (0%) 0/40 (0%) 0/40 (0%) | |FIRST INCIDENCE (DAYS) | 639 --- --- 729 (T) | 502 --- --- 718 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.645 P=0.514N P=0.500N P=0.752 | P=0.041N* P=0.051N P=0.051N P=0.147N | |INCIDENTAL TUMOR | P=0.589 P=0.536N P=0.536N P=0.679 | P=0.056N P=0.050N P=0.033N* P=0.200N | |LOGISTIC REGRESSION | P=0.648 P=0.498N P=0.502N P=0.761 | P=0.051N P=0.063N P=0.064N P=0.178N | |COCHRAN-ARMITAGE | P=0.648 | P=0.052N | |FISHER EXACT | P=0.500N P=0.500N P=0.752N | P=0.059N P=0.059N P=0.182N | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 5/60 (8%) 2/60 (3%) 3/60 (5%) | 10/60 (17%) 9/60 (15%) 13/60 (22%) 9/60 (15%) | |ADJUSTED (b) | 7.3% 12.4% 4.7% 7.7% | 24.3% 22.5% 29.9% 21.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 2/39 (5%) 3/37 (8%) 1/41 (2%) 2/37 (5%) | 5/34 (15%) 9/40 (23%) 10/40 (25%) 7/40 (18%) | |FIRST INCIDENCE (DAYS) | 679 616 661 686 | 665 736 (T) 490 642 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.469N P=0.330 P=0.489N P=0.639 | P=0.405N P=0.391N P=0.450 P=0.402N | |INCIDENTAL TUMOR | P=0.456N P=0.297 P=0.539N P=0.618N | P=0.475 P=0.596N P=0.206 P=0.573 | |LOGISTIC REGRESSION | P=0.496N P=0.329 P=0.501N P=0.650 | P=0.504N P=0.486N P=0.190 P=0.479N | |COCHRAN-ARMITAGE | P=0.456N | P=0.526N | |FISHER EXACT | P=0.359 P=0.500N P=0.660N | P=0.500N P=0.322 P=0.500N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 40/60 (67%) 35/60 (58%) 37/60 (62%) 39/60 (65%) | 36/60 (60%) 34/60 (57%) 30/60 (50%) 25/60 (42%) | |ADJUSTED (b) | 81.1% 77.3% 75.1% 80.7% | 79.6% 71.7% 63.4% 56.3% | |INTERIM SACRIFICE 1 (c)| 5/10 (50%) 2/10 (20%) 2/10 (20%) 5/10 (50%) | 2/10 (20%) 4/10 (40%) 1/9 (11%) 1/10 (10%) | |TERMINAL (d) | 30/39 (77%) 27/37 (73%) 29/41 (71%) 28/37 (76%) | 25/34 (74%) 27/40 (68%) 23/40 (58%) 21/40 (53%) | |FIRST INCIDENCE (DAYS) | 456 (I) 357 385 456 (I) | 455 (I) 455 (I) 394 455 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.499 P=0.346N P=0.271N P=0.520 | P=0.003N** P=0.165N P=0.057N P=0.007N** | |INCIDENTAL TUMOR | P=0.460N P=0.272N P=0.242N P=0.489N | P=0.012N* P=0.382N P=0.202N P=0.017N* | |LOGISTIC REGRESSION | P=0.481N P=0.318N P=0.337N P=0.514N | P=0.013N* P=0.419N P=0.173N P=0.020N* | |COCHRAN-ARMITAGE | P=0.488N | P=0.020N* | |FISHER EXACT | P=0.225N P=0.352N P=0.500N | P=0.427N P=0.179N P=0.034N* | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 24/60 (40%) 27/60 (45%) 20/60 (33%) 29/60 (48%) | 31/60 (52%) 22/60 (37%) 26/60 (43%) 28/60 (47%) | |ADJUSTED (b) | 48.5% 56.9% 42.5% 60.0% | 63.1% 47.3% 55.0% 56.0% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 3/10 (30%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 14/39 (36%) 17/37 (46%) 14/41 (34%) 18/37 (49%) | 16/34 (47%) 16/40 (40%) 19/40 (48%) 18/40 (45%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 571 456 (I) | 388 448 446 493 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.273 P=0.295 P=0.270N P=0.203 | P=0.220N P=0.041N* P=0.121N P=0.213N | |INCIDENTAL TUMOR | P=0.273 P=0.186 P=0.334N P=0.245 | P=0.473 P=0.148N P=0.365N P=0.550 | |LOGISTIC REGRESSION | P=0.285 P=0.222 P=0.294N P=0.205 | P=0.419N P=0.074N P=0.374N P=0.384N | |COCHRAN-ARMITAGE | P=0.290 | P=0.379N | |FISHER EXACT | P=0.356 P=0.285N P=0.231 | P=0.071N P=0.232N P=0.358N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 07 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_ MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3.6 6.0 10.0 | 0 MG/KG 3.6 6.0 10.0 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 48/60 (80%) 46/60 (77%) 45/60 (75%) 51/60 (85%) | 48/60 (80%) 44/60 (73%) 42/60 (70%) 40/60 (67%) | |ADJUSTED (b) | 88.8% 88.3% 86.4% 92.7% | 94.1% 86.0% 82.2% 78.4% | |INTERIM SACRIFICE 1 (c)| 6/10 (60%) 5/10 (50%) 2/10 (20%) 5/10 (50%) | 2/10 (20%) 4/10 (40%) 1/9 (11%) 1/10 (10%) | |TERMINAL (d) | 33/39 (85%) 31/37 (84%) 34/41 (83%) 33/37 (89%) | 31/34 (91%) 33/40 (83%) 31/40 (78%) 29/40 (73%) | |FIRST INCIDENCE (DAYS) | 456 (I) 357 385 456 (I) | 388 448 394 455 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.276 P=0.550 P=0.272N P=0.244 | P=0.015N* P=0.077N P=0.043N* P=0.024N* | |INCIDENTAL TUMOR | P=0.369 P=0.587 P=0.252N P=0.458 | P=0.044N* P=0.258N P=0.128N P=0.072N | |LOGISTIC REGRESSION | P=0.315 P=0.556N P=0.305N P=0.311 | P=0.034N* P=0.237N P=0.148N P=0.039N* | |COCHRAN-ARMITAGE | P=0.300 | P=0.054N | |FISHER EXACT | P=0.412N P=0.331N P=0.316 | P=0.259N P=0.146N P=0.074N | |=================================================================================================================================| (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): 456 Female interim sacrifices(days): 455 (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).