TDMS Study 05069-08 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: 08 TIME: 04:32:18 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-95256 ROUTE: DERMAL,SOLUTION NTP C#: 60902D PATHOLOGIST: K. MURTHY VOELKER, FRANK 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: 08 TIME: 04:32:18 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-95256 ROUTE: DERMAL,SOLUTION NTP C#: 60902D PATHOLOGIST: K. MURTHY VOELKER, FRANK CAS: 147-47-7 RATS(FISCHER344) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: TSI Mason Research 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER) DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 TIME: 04:32:18 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-95256 ROUTE: DERMAL,SOLUTION NTP C#: 60902D PATHOLOGIST: K. MURTHY VOELKER, FRANK 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 RATS ------------- ORGAN MORPHOLOGY ------- ------------ Islets, Pancreatic Adenoma Kidney: Renal Tubule Adenoma Carcinoma or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Testes Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma: Benign, Complex, Malignant, NOS Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 1/60 (2%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.6% 4.8% 9.1% 3.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 1/21 (5%) 2/22 (9%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 604 736 (T) 736 (T) 708 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.574 P=0.744N P=0.540 P=0.757N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.563 P=0.717 P=0.508 P=0.738 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.550 P=0.762N P=0.509 P=0.761N | |COCHRAN-ARMITAGE | (e) | P=0.545 | |FISHER EXACT | (e) (e) (e) | P=0.752N P=0.500 P=0.752N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/60 (8%) 7/60 (12%) 7/60 (12%) 2/60 (3%) | 4/60 (7%) 1/60 (2%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 34.5% 62.5% 54.3% 34.5% | 14.7% 4.5% 2.5% 4.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 1/2 (50%) 1/4 (25%) 0/1 (0%) | 1/19 (5%) 0/21 (0%) 0/22 (0%) 1/22 (5%) | |FIRST INCIDENCE (DAYS) | 649 568 462 (I) 445 | 581 734 609 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.484N P=0.289 P=0.251 P=0.494N | P=0.084N P=0.186N P=0.172N P=0.172N | |INCIDENTAL TUMOR | P=0.301N P=0.471 P=0.322 P=0.397N | P=0.097N P=0.204N P=0.207N P=0.189N | |LOGISTIC REGRESSION | P=0.265N P=0.396 P=0.341 P=0.297N | P=0.087N P=0.178N P=0.174N P=0.176N | |COCHRAN-ARMITAGE | P=0.195N | P=0.090N | |FISHER EXACT | P=0.381 P=0.381 P=0.219N | P=0.182N P=0.182N P=0.182N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 18.3% 0.0% 0.0% | 3.3% 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%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | --- 653 --- --- | 698 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.580N P=0.228 (e) (e) | P=0.218N P=0.521N P=0.514N P=0.507N | |INCIDENTAL TUMOR | P=0.547N P=0.237 (e) (e) | P=0.230N P=0.500N P=0.513N P=0.541N | |LOGISTIC REGRESSION | P=0.534N P=0.229 (e) (e) | P=0.210N P=0.500N P=0.494N P=0.498N | |COCHRAN-ARMITAGE | P=0.455N | P=0.212N | |FISHER EXACT | P=0.248 (e) (e) | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/60 (8%) 9/60 (15%) 7/60 (12%) 2/60 (3%) | 5/60 (8%) 1/60 (2%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 34.5% 69.4% 54.3% 34.5% | 17.5% 4.5% 2.5% 4.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 1/2 (50%) 1/4 (25%) 0/1 (0%) | 1/19 (5%) 0/21 (0%) 0/22 (0%) 1/22 (5%) | |FIRST INCIDENCE (DAYS) | 649 568 462 (I) 445 | 581 734 609 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.460N P=0.142 P=0.251 P=0.494N | P=0.039N* P=0.115N P=0.104N P=0.103N | |INCIDENTAL TUMOR | P=0.276N P=0.254 P=0.322 P=0.397N | P=0.047N* P=0.117N P=0.123N P=0.117N | |LOGISTIC REGRESSION | P=0.236N P=0.202 P=0.341 P=0.297N | P=0.039N* P=0.102N P=0.099N P=0.100N | |COCHRAN-ARMITAGE | P=0.163N | P=0.041N* | |FISHER EXACT | P=0.197 P=0.381 P=0.219N | P=0.103N P=0.103N P=0.103N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/59 (3%) 3/59 (5%) 1/59 (2%) | 5/59 (8%) 2/56 (4%) 5/55 (9%) 2/59 (3%) | |ADJUSTED (b) | 5.3% 5.0% 18.3% 2.2% | 17.4% 10.0% 22.4% 7.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 1/19 (5%) 2/20 (10%) 4/21 (19%) 1/22 (5%) | |FIRST INCIDENCE (DAYS) | 653 568 575 519 | 461 (I) 736 (T) 730 701 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.442 P=0.501 P=0.259 P=0.719 | P=0.201N P=0.217N P=0.589N P=0.207N | |INCIDENTAL TUMOR | P=0.540 P=0.632 P=0.286 P=0.689 | P=0.235N P=0.221N P=0.610 P=0.248N | |LOGISTIC REGRESSION | P=0.524 P=0.500 P=0.287 P=0.759 | P=0.230N P=0.239N P=0.611 P=0.213N | |COCHRAN-ARMITAGE | P=0.540 | P=0.241N | |FISHER EXACT | P=0.494 P=0.303 P=0.748 | P=0.241N P=0.583 P=0.219N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/59 (2%) 1/59 (2%) 2/59 (3%) | 1/59 (2%) 0/56 (0%) 0/55 (0%) 0/59 (0%) | |ADJUSTED (b) | 0.0% 6.7% 5.9% 21.4% | 3.3% 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%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/20 (0%) 0/21 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | --- 653 653 378 | 698 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.088 P=0.453 P=0.478 P=0.201 | P=0.218N P=0.521N P=0.514N P=0.507N | |INCIDENTAL TUMOR | P=0.089 P=0.500 P=0.455 P=0.173 | P=0.238N P=0.513N P=0.541N P=0.541N | |LOGISTIC REGRESSION | P=0.130 P=0.502 P=0.486 P=0.248 | P=0.213N P=0.511N P=0.507N P=0.498N | |COCHRAN-ARMITAGE | P=0.132 | P=0.215N | |FISHER EXACT | P=0.496 P=0.496 P=0.244 | P=0.513N P=0.518N P=0.500N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/59 (5%) 4/59 (7%) 3/59 (5%) | 6/59 (10%) 2/56 (4%) 5/55 (9%) 2/59 (3%) | |ADJUSTED (b) | 5.3% 11.3% 23.1% 23.1% | 20.2% 10.0% 22.4% 7.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 1/19 (5%) 2/20 (10%) 4/21 (19%) 1/22 (5%) | |FIRST INCIDENCE (DAYS) | 653 568 575 378 | 461 (I) 736 (T) 730 701 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.135 P=0.286 P=0.145 P=0.245 | P=0.123N P=0.142N P=0.466N P=0.133N | |INCIDENTAL TUMOR | P=0.176 P=0.411 P=0.151 P=0.200 | P=0.149N P=0.140N P=0.534N P=0.163N | |LOGISTIC REGRESSION | P=0.208 P=0.309 P=0.163 P=0.312 | P=0.140N P=0.152N P=0.523N P=0.132N | |COCHRAN-ARMITAGE | P=0.219 | P=0.150N | |FISHER EXACT | P=0.303 P=0.177 P=0.303 | P=0.153N P=0.550N P=0.136N | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/60 (10%) 2/60 (3%) 0/59 (0%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 37.8% 8.7% 0.0% 15.4% | 0.0% 0.0% 4.5% 4.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 1/22 (5%) 1/22 (5%) | |FIRST INCIDENCE (DAYS) | 521 563 --- 596 | --- --- 736 (T) 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.232N P=0.208N P=0.041N* P=0.518N | P=0.225 (e) P=0.529 P=0.529 | |INCIDENTAL TUMOR | P=0.145N P=0.156N P=0.043N* P=0.328N | P=0.225 (e) P=0.529 P=0.529 | |LOGISTIC REGRESSION | P=0.136N P=0.124N P=0.022N* P=0.328N | P=0.225 (e) P=0.529 P=0.529 | |COCHRAN-ARMITAGE | P=0.107N | P=0.206 | |FISHER EXACT | P=0.136N P=0.014N* P=0.245N | (e) P=0.500 P=0.500 | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 1/59 (2%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 5.1% 25.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 1/4 (25%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | --- 462 (I) 729 (T) --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.600 P=0.244 P=0.455 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.590N P=0.306 P=0.455 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.543N P=0.207 P=0.455 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.533N | (e) | |FISHER EXACT | P=0.248 P=0.496 (e) | (e) (e) (e) | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/60 (10%) 4/60 (7%) 1/59 (2%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 37.8% 13.3% 25.0% 15.4% | 0.0% 0.0% 4.5% 4.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 1/4 (25%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 1/22 (5%) 1/22 (5%) | |FIRST INCIDENCE (DAYS) | 521 462 (I) 729 (T) 596 | --- --- 736 (T) 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.269N P=0.462N P=0.119N P=0.518N | P=0.225 (e) P=0.529 P=0.529 | |INCIDENTAL TUMOR | P=0.161N P=0.378N P=0.130N P=0.328N | P=0.225 (e) P=0.529 P=0.529 | |LOGISTIC REGRESSION | P=0.139N P=0.354N P=0.073N P=0.328N | P=0.225 (e) P=0.529 P=0.529 | |COCHRAN-ARMITAGE | P=0.111N | P=0.206 | |FISHER EXACT | P=0.372N P=0.060N P=0.245N | (e) P=0.500 P=0.500 | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 7/60 (12%) 10/60 (17%) 8/60 (13%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 20.0% 71.6% 70.8% 38.4% | 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%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/5 (20%) 1/2 (50%) 2/4 (50%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 563 575 601 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.009 ** P=0.003 ** P=0.003 ** | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.005 ** P=0.016 * P=0.006 ** P=0.024 * | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.005 ** P=0.029 * P=0.003 ** P=0.009 ** | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.020 * | (e) | |FISHER EXACT | P=0.031 * P=0.004 ** P=0.016 * | (e) (e) (e) | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 8/60 (13%) 10/60 (17%) 8/60 (13%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 20.0% 73.3% 70.8% 38.4% | 0.0% 0.0% 0.0% 4.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/5 (20%) 1/2 (50%) 2/4 (50%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 1/22 (5%) | |FIRST INCIDENCE (DAYS) | 729 (T) 563 575 601 | --- --- --- 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.001 ** P=0.004 ** P=0.003 ** P=0.003 ** | P=0.209 (e) (e) P=0.529 | |INCIDENTAL TUMOR | P=0.007 ** P=0.008 ** P=0.006 ** P=0.024 * | P=0.210 (e) (e) P=0.529 | |LOGISTIC REGRESSION | P=0.006 ** P=0.016 * P=0.003 ** P=0.009 ** | P=0.210 (e) (e) P=0.529 | |COCHRAN-ARMITAGE | P=0.026 * | P=0.197 | |FISHER EXACT | P=0.016 * P=0.004 ** P=0.016 * | (e) (e) P=0.500 | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 11.4% 0.0% 0.0% | 0.0% 6.7% 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%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | --- 600 --- --- | --- 622 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.534N P=0.207 (e) (e) | P=0.444N P=0.256 (e) (e) | |INCIDENTAL TUMOR | P=0.449N P=0.306 (e) (e) | P=0.470N P=0.185 (e) (e) | |LOGISTIC REGRESSION | P=0.479N P=0.244 (e) (e) | P=0.452N P=0.238 (e) (e) | |COCHRAN-ARMITAGE | P=0.455N | P=0.455N | |FISHER EXACT | P=0.248 (e) (e) | P=0.248 (e) (e) | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 8.3% 0.0% 6.1% 2.4% | 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%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | 679 --- 575 543 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.402 P=0.557N P=0.462 P=0.696 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.505 P=0.500N P=0.598 P=0.689 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.469 P=0.507N P=0.492 P=0.751 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.478 | (e) | |FISHER EXACT | P=0.500N P=0.500 P=0.752N | (e) (e) (e) | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 8.3% 11.4% 6.1% 2.4% | 0.0% 6.7% 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%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | 679 600 575 543 | --- 622 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.493 P=0.433 P=0.462 P=0.696 | P=0.444N P=0.256 (e) (e) | |INCIDENTAL TUMOR | P=0.557N P=0.570 P=0.598 P=0.689 | P=0.470N P=0.185 (e) (e) | |LOGISTIC REGRESSION | P=0.580 P=0.509 P=0.492 P=0.751 | P=0.452N P=0.238 (e) (e) | |COCHRAN-ARMITAGE | P=0.581N | P=0.455N | |FISHER EXACT | P=0.500 P=0.500 P=0.752N | P=0.248 (e) (e) | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 8.3% 11.4% 6.1% 2.4% | 0.0% 6.7% 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%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | 679 600 575 543 | --- 622 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.493 P=0.433 P=0.462 P=0.696 | P=0.444N P=0.256 (e) (e) | |INCIDENTAL TUMOR | P=0.557N P=0.570 P=0.598 P=0.689 | P=0.470N P=0.185 (e) (e) | |LOGISTIC REGRESSION | P=0.580 P=0.509 P=0.492 P=0.751 | P=0.452N P=0.238 (e) (e) | |COCHRAN-ARMITAGE | P=0.581N | P=0.455N | |FISHER EXACT | P=0.500 P=0.500 P=0.752N | P=0.248 (e) (e) | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/59 (0%) 0/60 (0%) | 2/60 (3%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 8.0% 0.0% 4.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 1/19 (5%) 0/21 (0%) 0/22 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 654 --- 727 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.132N P=0.226N P=0.459N P=0.224N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.151N P=0.229N P=0.498N P=0.246N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.139N P=0.237N P=0.489N P=0.235N | |COCHRAN-ARMITAGE | (e) | P=0.142N | |FISHER EXACT | (e) (e) (e) | P=0.248N P=0.500N P=0.248N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/59 (2%) 0/60 (0%) | 2/60 (3%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.8% 0.0% | 8.0% 0.0% 4.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 1/19 (5%) 0/21 (0%) 0/22 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 585 --- | 654 --- 727 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.590 (e) P=0.500 (e) | P=0.132N P=0.226N P=0.459N P=0.224N | |INCIDENTAL TUMOR | P=0.673 (e) P=0.607 (e) | P=0.151N P=0.229N P=0.498N P=0.246N | |LOGISTIC REGRESSION | P=0.599 (e) P=0.497 (e) | P=0.139N P=0.237N P=0.489N P=0.235N | |COCHRAN-ARMITAGE | P=0.598 | P=0.142N | |FISHER EXACT | (e) P=0.496 (e) | P=0.248N P=0.500N P=0.248N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 8.6% 0.0% | 2.1% 0.0% 3.4% 4.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 1/22 (5%) | |FIRST INCIDENCE (DAYS) | --- --- 590 --- | 498 --- 697 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.436 (e) P=0.225 (e) | P=0.552 P=0.513N P=0.752 P=0.749N | |INCIDENTAL TUMOR | P=0.488 (e) P=0.270 (e) | P=0.536 P=0.419N P=0.743N P=0.744N | |LOGISTIC REGRESSION | P=0.467 (e) P=0.233 (e) | P=0.546 P=0.503N P=0.756 P=0.761 | |COCHRAN-ARMITAGE | P=0.485 | P=0.545 | |FISHER EXACT | (e) P=0.248 (e) | P=0.500N P=0.752N P=0.752N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 3/60 (5%) 5/60 (8%) 0/60 (0%) 3/60 (5%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 10.2% 19.5% 0.0% 12.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 1/19 (5%) 3/21 (14%) 0/22 (0%) 2/22 (9%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 500 655 --- 708 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.335N P=0.383 P=0.115N P=0.631N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.369N P=0.413 P=0.106N P=0.660N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.363N P=0.357 P=0.121N P=0.659N | |COCHRAN-ARMITAGE | (e) | P=0.371N | |FISHER EXACT | (e) (e) (e) | P=0.359 P=0.122N P=0.660N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | 4/60 (7%) 5/60 (8%) 1/60 (2%) 4/60 (7%) | |ADJUSTED (b) | 0.0% 0.0% 8.6% 0.0% | 12.0% 19.5% 3.4% 16.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 1/19 (5%) 3/21 (14%) 0/22 (0%) 3/22 (14%) | |FIRST INCIDENCE (DAYS) | --- --- 590 --- | 498 655 697 708 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.436 (e) P=0.225 (e) | P=0.386N P=0.519 P=0.181N P=0.607N | |INCIDENTAL TUMOR | P=0.488 (e) P=0.270 (e) | P=0.426N P=0.583 P=0.151N P=0.632N | |LOGISTIC REGRESSION | P=0.467 (e) P=0.233 (e) | P=0.415N P=0.500 P=0.183N P=0.640N | |COCHRAN-ARMITAGE | P=0.485 | P=0.422N | |FISHER EXACT | (e) P=0.248 (e) | P=0.500 P=0.182N P=0.641N | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | 25/60 (42%) 16/60 (27%) 15/60 (25%) 17/60 (28%) | |ADJUSTED (b) | 0.0% 5.0% 0.0% 5.0% | 72.6% 55.7% 56.7% 50.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 11/19 (58%) 9/21 (43%) 11/22 (50%) 7/22 (32%) | |FIRST INCIDENCE (DAYS) | --- 649 --- 624 | 427 638 691 461 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.262 P=0.455 (e) P=0.419 | P=0.046N* P=0.054N P=0.022N* P=0.078N | |INCIDENTAL TUMOR | P=0.360 P=0.500 (e) P=0.623 | P=0.053N P=0.052N P=0.020N* P=0.084N | |LOGISTIC REGRESSION | P=0.332 P=0.505 (e) P=0.481 | P=0.050N P=0.048N* P=0.023N* P=0.077N | |COCHRAN-ARMITAGE | P=0.362 | P=0.071N | |FISHER EXACT | P=0.500 (e) P=0.500 | P=0.062N P=0.040N* P=0.090N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 1/60 (2%) | 26/60 (43%) 16/60 (27%) 15/60 (25%) 17/60 (28%) | |ADJUSTED (b) | 0.0% 5.0% 8.6% 5.0% | 73.2% 55.7% 56.7% 50.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 11/19 (58%) 9/21 (43%) 11/22 (50%) 7/22 (32%) | |FIRST INCIDENCE (DAYS) | --- 649 590 624 | 427 638 691 461 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.199 P=0.455 P=0.225 P=0.419 | P=0.033N* P=0.040N* P=0.015N* P=0.059N | |INCIDENTAL TUMOR | P=0.285 P=0.500 P=0.270 P=0.623 | P=0.035N* P=0.032N* P=0.012N* P=0.058N | |LOGISTIC REGRESSION | P=0.259 P=0.505 P=0.233 P=0.481 | P=0.034N* P=0.033N* P=0.015N* P=0.054N | |COCHRAN-ARMITAGE | P=0.290 | P=0.049N* | |FISHER EXACT | P=0.500 P=0.248 P=0.500 | P=0.042N* P=0.027N* P=0.064N | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 1/60 (2%) | 29/60 (48%) 20/60 (33%) 15/60 (25%) 20/60 (33%) | |ADJUSTED (b) | 0.0% 5.0% 8.6% 5.0% | 77.8% 65.4% 56.7% 58.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 12/19 (63%) 11/21 (52%) 11/22 (50%) 9/22 (41%) | |FIRST INCIDENCE (DAYS) | --- 649 590 624 | 427 638 691 461 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.199 P=0.455 P=0.225 P=0.419 | P=0.025N* P=0.066N P=0.004N** P=0.063N | |INCIDENTAL TUMOR | P=0.285 P=0.500 P=0.270 P=0.623 | P=0.025N* P=0.044N* P=0.002N** P=0.058N | |LOGISTIC REGRESSION | P=0.259 P=0.505 P=0.233 P=0.481 | P=0.024N* P=0.053N P=0.003N** P=0.056N | |COCHRAN-ARMITAGE | P=0.290 | P=0.038N* | |FISHER EXACT | P=0.500 P=0.248 P=0.500 | P=0.068N P=0.007N** P=0.068N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/58 (52%) 23/60 (38%) 23/60 (38%) 19/58 (33%) | 35/59 (59%) 31/60 (52%) 35/60 (58%) 38/60 (63%) | |ADJUSTED (b) | 75.7% 100.0% 61.9% 100.0% | 85.3% 84.5% 79.6% 81.1% | |INTERIM SACRIFICE 1 (c)| 5/9 (56%) 0/10 (0%) 4/10 (40%) 1/9 (11%) | 5/10 (50%) 3/10 (30%) 4/10 (40%) 5/10 (50%) | |TERMINAL (d) | 1/5 (20%) 2/2 (100%) 0/4 (0%) 1/1 (100%) | 14/19 (74%) 16/21 (76%) 14/22 (64%) 14/22 (64%) | |FIRST INCIDENCE (DAYS) | 428 471 455 445 | 427 461 (I) 457 461 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.333N P=0.285N P=0.262N P=0.346N | P=0.426 P=0.241N P=0.415N P=0.517 | |INCIDENTAL TUMOR | P=0.021N* P=0.143N P=0.100N P=0.030N* | P=0.308 P=0.216N P=0.455N P=0.413 | |LOGISTIC REGRESSION | P=0.029N* P=0.104N P=0.094N P=0.032N* | P=0.305 P=0.239N P=0.498N P=0.411 | |COCHRAN-ARMITAGE | P=0.027N* | P=0.286 | |FISHER EXACT | P=0.101N P=0.101N P=0.030N* | P=0.256N P=0.531N P=0.397 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 1/60 (2%) 0/60 (0%) 0/58 (0%) | 2/59 (3%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 7.7% 0.0% 0.0% | 9.6% 0.0% 9.1% 3.2% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 1/19 (5%) 0/21 (0%) 2/22 (9%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | --- 660 --- --- | 729 --- 736 (T) 685 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.659N P=0.447 (e) (e) | P=0.444N P=0.229N P=0.647N P=0.483N | |INCIDENTAL TUMOR | P=0.637N P=0.510 (e) (e) | P=0.465N P=0.222N P=0.655N P=0.516N | |LOGISTIC REGRESSION | P=0.615N P=0.511 (e) (e) | P=0.462N P=0.229N P=0.665N P=0.487N | |COCHRAN-ARMITAGE | P=0.578N | P=0.469N | |FISHER EXACT | P=0.508 (e) (e) | P=0.244N P=0.684N P=0.494N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/58 (52%) 24/60 (40%) 23/60 (38%) 19/58 (33%) | 37/59 (63%) 31/60 (52%) 37/60 (62%) 39/60 (65%) | |ADJUSTED (b) | 75.7% 100.0% 61.9% 100.0% | 88.8% 84.5% 84.7% 81.7% | |INTERIM SACRIFICE 1 (c)| 5/9 (56%) 0/10 (0%) 4/10 (40%) 1/9 (11%) | 5/10 (50%) 3/10 (30%) 4/10 (40%) 5/10 (50%) | |TERMINAL (d) | 1/5 (20%) 2/2 (100%) 0/4 (0%) 1/1 (100%) | 15/19 (79%) 16/21 (76%) 16/22 (73%) 14/22 (64%) | |FIRST INCIDENCE (DAYS) | 428 471 455 445 | 427 461 (I) 457 461 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.328N P=0.343N P=0.262N P=0.346N | P=0.462 P=0.154N P=0.400N P=0.535N | |INCIDENTAL TUMOR | P=0.020N* P=0.191N P=0.100N P=0.030N* | P=0.341 P=0.115N P=0.437N P=0.482 | |LOGISTIC REGRESSION | P=0.026N* P=0.139N P=0.094N P=0.032N* | P=0.341 P=0.132N P=0.485N P=0.491 | |COCHRAN-ARMITAGE | P=0.024N* | P=0.318 | |FISHER EXACT | P=0.137N P=0.101N P=0.030N* | P=0.151N P=0.529N P=0.472 | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal | | Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 3/60 (5%) 5/60 (8%) 3/60 (5%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 14.3% 14.8% 22.4% 24.6% | 0.0% 3.7% 0.0% 4.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 1/22 (5%) | |FIRST INCIDENCE (DAYS) | 630 598 585 619 | --- 713 --- 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.280 P=0.584 P=0.270 P=0.439 | P=0.367 P=0.500 (e) P=0.529 | |INCIDENTAL TUMOR | P=0.505 P=0.517N P=0.386 P=0.626N | P=0.355 P=0.500 (e) P=0.529 | |LOGISTIC REGRESSION | P=0.411 P=0.649N P=0.335 P=0.573 | P=0.363 P=0.500 (e) P=0.529 | |COCHRAN-ARMITAGE | P=0.494 | P=0.362 | |FISHER EXACT | P=0.660N P=0.359 P=0.660N | P=0.500 (e) P=0.500 | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 1/60 (2%) 1/60 (2%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 6.3% 10.4% 3.1% 2.8% | 3.3% 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%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | 667 640 613 565 | 698 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.543 P=0.419 P=0.722 P=0.686 | P=0.218N P=0.521N P=0.514N P=0.507N | |INCIDENTAL TUMOR | P=0.499N P=0.570 P=0.730N P=0.748N | P=0.230N P=0.500N P=0.513N P=0.541N | |LOGISTIC REGRESSION | P=0.570N P=0.507 P=0.754 P=0.748 | P=0.210N P=0.500N P=0.494N P=0.498N | |COCHRAN-ARMITAGE | P=0.535N | P=0.212N | |FISHER EXACT | P=0.500 P=0.752N P=0.752N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 1/60 (2%) 2/60 (3%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 6.3% 10.4% 3.1% 22.2% | 3.3% 0.0% 0.0% 3.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | 667 640 613 565 | 698 --- --- 708 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.291 P=0.419 P=0.722 P=0.384 | P=0.634 P=0.521N P=0.514N P=0.757 | |INCIDENTAL TUMOR | P=0.421 P=0.570 P=0.730N P=0.470 | P=0.599 P=0.500N P=0.513N P=0.717 | |LOGISTIC REGRESSION | P=0.364 P=0.507 P=0.754 P=0.441 | P=0.641 P=0.500N P=0.494N P=0.761N | |COCHRAN-ARMITAGE | P=0.419 | P=0.638 | |FISHER EXACT | P=0.500 P=0.752N P=0.500 | P=0.500N P=0.500N P=0.752N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 9.2% 2.5% 6.3% 0.0% | 0.0% 3.7% 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%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | 630 598 585 --- | --- 713 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.271N P=0.542N P=0.641 P=0.364N | P=0.590N P=0.500 (e) (e) | |INCIDENTAL TUMOR | P=0.122N P=0.359N P=0.567N P=0.213N | P=0.608N P=0.500 (e) (e) | |LOGISTIC REGRESSION | P=0.209N P=0.490N P=0.687 P=0.276N | P=0.576N P=0.500 (e) (e) | |COCHRAN-ARMITAGE | P=0.195N | P=0.577N | |FISHER EXACT | P=0.500N P=0.691N P=0.248N | P=0.500 (e) (e) | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 2/60 (3%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 5.6% 12.6% 12.8% 24.6% | 0.0% 0.0% 0.0% 4.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 1/22 (5%) | |FIRST INCIDENCE (DAYS) | 656 610 651 619 | --- --- --- 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.100 P=0.429 P=0.424 P=0.173 | P=0.209 (e) (e) P=0.529 | |INCIDENTAL TUMOR | P=0.174 P=0.570 P=0.421 P=0.333 | P=0.210 (e) (e) P=0.529 | |LOGISTIC REGRESSION | P=0.150 P=0.509 P=0.475 P=0.232 | P=0.210 (e) (e) P=0.529 | |COCHRAN-ARMITAGE | P=0.214 | P=0.197 | |FISHER EXACT | P=0.500 P=0.500 P=0.309 | (e) (e) P=0.500 | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 3/60 (5%) 4/60 (7%) 3/60 (5%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 14.3% 14.8% 18.3% 24.6% | 0.0% 3.7% 0.0% 4.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 1/22 (5%) | |FIRST INCIDENCE (DAYS) | 630 598 585 619 | --- 713 --- 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.321 P=0.584 P=0.408 P=0.439 | P=0.367 P=0.500 (e) P=0.529 | |INCIDENTAL TUMOR | P=0.560 P=0.517N P=0.555 P=0.626N | P=0.355 P=0.500 (e) P=0.529 | |LOGISTIC REGRESSION | P=0.451 P=0.649N P=0.480 P=0.573 | P=0.363 P=0.500 (e) P=0.529 | |COCHRAN-ARMITAGE | P=0.528 | P=0.362 | |FISHER EXACT | P=0.660N P=0.500 P=0.660N | P=0.500 (e) P=0.500 | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 3/60 (5%) 4/60 (7%) 3/60 (5%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 14.3% 14.8% 18.3% 24.6% | 0.0% 3.7% 0.0% 4.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 1/22 (5%) | |FIRST INCIDENCE (DAYS) | 630 598 585 619 | --- 713 --- 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.321 P=0.584 P=0.408 P=0.439 | P=0.367 P=0.500 (e) P=0.529 | |INCIDENTAL TUMOR | P=0.560 P=0.517N P=0.555 P=0.626N | P=0.355 P=0.500 (e) P=0.529 | |LOGISTIC REGRESSION | P=0.451 P=0.649N P=0.480 P=0.573 | P=0.363 P=0.500 (e) P=0.529 | |COCHRAN-ARMITAGE | P=0.528 | P=0.362 | |FISHER EXACT | P=0.660N P=0.500 P=0.660N | P=0.500 (e) P=0.500 | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 41/60 (68%) 49/60 (82%) 44/60 (73%) 48/60 (80%) | | |ADJUSTED (b) | 100.0% 100.0% 97.6% 100.0% | | |INTERIM SACRIFICE 1 (c)| 5/10 (50%) 8/10 (80%) 7/10 (70%) 7/10 (70%) | | |TERMINAL (d) | 5/5 (100%) 2/2 (100%) 3/4 (75%) 1/1 (100%) | | |FIRST INCIDENCE (DAYS) | 462 (I) 462 (I) 462 (I) 462 (I) | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.004 ** P=0.064 P=0.190 P=0.004 ** | | |INCIDENTAL TUMOR | P=0.049 * P=0.181 P=0.382 P=0.072 | | |LOGISTIC REGRESSION | P=0.065 P=0.116 P=0.313 P=0.051 | | |COCHRAN-ARMITAGE | P=0.135 | | |FISHER EXACT | P=0.070 P=0.344 P=0.105 | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | 7/59 (12%) 5/60 (8%) 2/58 (3%) 2/59 (3%) | |ADJUSTED (b) | 0.0% 25.0% 0.0% 0.0% | 31.2% 19.5% 9.1% 9.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 5/19 (26%) 3/21 (14%) 2/22 (9%) 2/22 (9%) | |FIRST INCIDENCE (DAYS) | --- 725 --- --- | 568 655 736 (T) 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.729 P=0.455 (e) (e) | P=0.018N* P=0.334N P=0.053N P=0.054N | |INCIDENTAL TUMOR | P=0.643N P=0.500 (e) (e) | P=0.021N* P=0.360N P=0.064N P=0.058N | |LOGISTIC REGRESSION | P=0.711N P=0.453 (e) (e) | P=0.027N* P=0.373N P=0.078N P=0.076N | |COCHRAN-ARMITAGE | P=0.577N | P=0.031N* | |FISHER EXACT | P=0.500 (e) (e) | P=0.369N P=0.085N P=0.081N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | 7/59 (12%) 5/60 (8%) 3/58 (5%) 2/59 (3%) | |ADJUSTED (b) | 0.0% 25.0% 0.0% 0.0% | 31.2% 19.5% 13.6% 9.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 5/19 (26%) 3/21 (14%) 3/22 (14%) 2/22 (9%) | |FIRST INCIDENCE (DAYS) | --- 725 --- --- | 568 655 736 (T) 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.729 P=0.455 (e) (e) | P=0.023N* P=0.334N P=0.108N P=0.054N | |INCIDENTAL TUMOR | P=0.643N P=0.500 (e) (e) | P=0.027N* P=0.360N P=0.126N P=0.058N | |LOGISTIC REGRESSION | P=0.711N P=0.453 (e) (e) | P=0.036N* P=0.373N P=0.154N P=0.076N | |COCHRAN-ARMITAGE | P=0.577N | P=0.041N* | |FISHER EXACT | P=0.500 (e) (e) | P=0.369N P=0.168N P=0.081N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | 1/59 (2%) 2/60 (3%) 0/58 (0%) 1/59 (2%) | |ADJUSTED (b) | 0.0% 6.7% 0.0% 0.0% | 2.9% 6.1% 0.0% 4.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 1/22 (5%) | |FIRST INCIDENCE (DAYS) | --- 653 --- --- | 654 608 --- 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.635N P=0.453 (e) (e) | P=0.469N P=0.515 P=0.483N P=0.744N | |INCIDENTAL TUMOR | P=0.643N P=0.500 (e) (e) | P=0.498N P=0.441 P=0.527N P=0.754 | |LOGISTIC REGRESSION | P=0.612N P=0.504 (e) (e) | P=0.476N P=0.505 P=0.502N P=0.760N | |COCHRAN-ARMITAGE | P=0.577N | P=0.481N | |FISHER EXACT | P=0.500 (e) (e) | P=0.506 P=0.504N P=0.752N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 4/60 (7%) 4/60 (7%) 4/60 (7%) 0/60 (0%) | |ADJUSTED (b) | | 15.2% 10.8% 17.2% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 2/19 (11%) 1/21 (5%) 3/22 (14%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | | 576 461 (I) 730 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.054N P=0.613N P=0.577N P=0.054N | |INCIDENTAL TUMOR | | P=0.061N P=0.621 P=0.617N P=0.062N | |LOGISTIC REGRESSION | | P=0.065N P=0.643 P=0.628N P=0.062N | |COCHRAN-ARMITAGE | | P=0.067N | |FISHER EXACT | | P=0.641N P=0.641N P=0.059N | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 4/60 (7%) 5/60 (8%) 4/60 (7%) 1/60 (2%) | |ADJUSTED (b) | | 15.2% 13.2% 17.2% 1.7% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 2/19 (11%) 1/21 (5%) 3/22 (14%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | | 576 461 (I) 730 336 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.115N P=0.532 P=0.577N P=0.162N | |INCIDENTAL TUMOR | | P=0.138N P=0.479 P=0.617N P=0.179N | |LOGISTIC REGRESSION | | P=0.134N P=0.500 P=0.628N P=0.182N | |COCHRAN-ARMITAGE | | P=0.135N | |FISHER EXACT | | P=0.500 P=0.641N P=0.182N | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 25/60 (42%) 26/60 (43%) 19/60 (32%) 14/60 (23%) | 22/60 (37%) 16/60 (27%) 23/60 (38%) 10/60 (17%) | |ADJUSTED (b) | 93.4% 100.0% 75.3% 63.9% | 64.2% 52.7% 72.4% 32.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 2/10 (20%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/5 (80%) 2/2 (100%) 1/4 (25%) 0/1 (0%) | 9/19 (47%) 8/21 (38%) 14/22 (64%) 4/22 (18%) | |FIRST INCIDENCE (DAYS) | 428 462 (I) 455 487 | 272 557 492 540 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.266N P=0.310 P=0.374N P=0.389N | P=0.018N* P=0.150N P=0.503N P=0.012N* | |INCIDENTAL TUMOR | P=0.020N* P=0.440 P=0.276N P=0.091N | P=0.018N* P=0.188N P=0.472 P=0.011N* | |LOGISTIC REGRESSION | P=0.017N* P=0.575N P=0.181N P=0.040N* | P=0.017N* P=0.153N P=0.540 P=0.010N** | |COCHRAN-ARMITAGE | P=0.011N* | P=0.025N* | |FISHER EXACT | P=0.500 P=0.172N P=0.025N* | P=0.163N P=0.500 P=0.011N* | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 4/60 (7%) 2/60 (3%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 4.2% 12.7% 6.2% 100.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 1/1 (100%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | 462 (I) 554 459 612 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.550 P=0.383 P=0.689 P=0.550 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.454N P=0.363 P=0.608 P=0.613 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.470N P=0.302 P=0.676N P=0.695 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.479N | (e) | |FISHER EXACT | P=0.340 P=0.691N P=0.691N | (e) (e) (e) | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |All Organs | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 4.2% 5.1% 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%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | --- 641 381 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.496 P=0.492 P=0.231 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.612N P=0.623 P=0.203 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.589 P=0.506 P=0.259 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.570 | (e) | |FISHER EXACT | P=0.500 P=0.248 (e) | (e) (e) (e) | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 4.2% 5.1% 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%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 0/4 (0%) 0/1 (0%) | 0/19 (0%) 0/21 (0%) 0/22 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | --- 641 381 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.496 P=0.492 P=0.231 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.612N P=0.623 P=0.203 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.589 P=0.506 P=0.259 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.570 | (e) | |FISHER EXACT | P=0.500 P=0.248 (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 55/60 (92%) 58/60 (97%) 54/60 (90%) 55/60 (92%) | 49/60 (82%) 41/60 (68%) 41/60 (68%) 44/60 (73%) | |ADJUSTED (b) | 100.0% 100.0% 98.1% 100.0% | 95.8% 95.0% 94.9% 87.5% | |INTERIM SACRIFICE 1 (c)| 7/10 (70%) 8/10 (80%) 9/10 (90%) 8/10 (80%) | 6/10 (60%) 4/10 (40%) 4/10 (40%) 6/10 (60%) | |TERMINAL (d) | 5/5 (100%) 2/2 (100%) 3/4 (75%) 1/1 (100%) | 17/19 (89%) 19/21 (90%) 20/22 (91%) 16/22 (73%) | |FIRST INCIDENCE (DAYS) | 428 462 (I) 455 445 | 427 461 (I) 457 461 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.032 * P=0.203 P=0.357 P=0.034 * | P=0.158N P=0.114N P=0.078N P=0.191N | |INCIDENTAL TUMOR | P=0.532 P=0.244 P=0.624N P=0.500 | P=0.155N P=0.067N P=0.039N* P=0.191N | |LOGISTIC REGRESSION | P=0.549N P=0.397 P=0.563N P=0.590 | P=0.153N P=0.054N P=0.045N* P=0.190N | |COCHRAN-ARMITAGE | P=0.421N | P=0.191N | |FISHER EXACT | P=0.219 P=0.500N P=0.628N | P=0.070N P=0.070N P=0.191N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 28/60 (47%) 36/60 (60%) 26/60 (43%) 21/60 (35%) | 30/60 (50%) 26/60 (43%) 29/60 (48%) 18/60 (30%) | |ADJUSTED (b) | 94.3% 100.0% 93.6% 100.0% | 76.4% 72.6% 81.4% 50.8% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/10 (20%) 2/10 (20%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 4/5 (80%) 2/2 (100%) 3/4 (75%) 1/1 (100%) | 11/19 (58%) 12/21 (57%) 16/22 (73%) 7/22 (32%) | |FIRST INCIDENCE (DAYS) | 428 462 (I) 381 378 | 272 485 447 336 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.415 P=0.068 P=0.477 P=0.364 | P=0.022N* P=0.265N P=0.351N P=0.025N* | |INCIDENTAL TUMOR | P=0.113N P=0.091 P=0.545 P=0.343N | P=0.017N* P=0.326N P=0.516N P=0.016N* | |LOGISTIC REGRESSION | P=0.081N P=0.137 P=0.451N P=0.188N | P=0.016N* P=0.278N P=0.456N P=0.018N* | |COCHRAN-ARMITAGE | P=0.050N* | P=0.024N* | |FISHER EXACT | P=0.100 P=0.427N P=0.133N | P=0.292N P=0.500N P=0.020N* | |=================================================================================================================================| DATE: 04/03/96 EXPERIMENT: 05069 TEST: 08 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 36 MG/KG 60 MG/KG 100 | 0 MG/KG 36 MG/KG 60 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 55/60 (92%) 59/60 (98%) 55/60 (92%) 57/60 (95%) | 55/60 (92%) 47/60 (78%) 52/60 (87%) 49/60 (82%) | |ADJUSTED (b) | 100.0% 100.0% 98.1% 100.0% | 98.2% 97.9% 98.1% 90.6% | |INTERIM SACRIFICE 1 (c)| 7/10 (70%) 9/10 (90%) 9/10 (90%) 8/10 (80%) | 6/10 (60%) 4/10 (40%) 5/10 (50%) 6/10 (60%) | |TERMINAL (d) | 5/5 (100%) 2/2 (100%) 3/4 (75%) 1/1 (100%) | 18/19 (95%) 20/21 (95%) 21/22 (95%) 17/22 (77%) | |FIRST INCIDENCE (DAYS) | 428 462 (I) 381 378 | 272 461 (I) 447 336 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.020 * P=0.174 P=0.318 P=0.022 * | P=0.177N P=0.132N P=0.240N P=0.171N | |INCIDENTAL TUMOR | P=0.214 P=0.117 P=0.457 P=0.181 | P=0.136N P=0.026N* P=0.270N P=0.096N | |LOGISTIC REGRESSION | P=0.311 P=0.201 P=0.594 P=0.278 | P=0.108N P=0.022N* P=0.203N P=0.080N | |COCHRAN-ARMITAGE | P=0.409 | P=0.145N | |FISHER EXACT | P=0.103 P=0.628N P=0.359 | P=0.036N* P=0.279N P=0.089N | |=================================================================================================================================| (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): 462 Female interim sacrifices(days): 461 (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).