TDMS Study 05182-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: TSI Mason Research PHENOLPHTHALEIN DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 TIME: 04:07:17 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-05302 ROUTE: DOSED FEED NTP C#: 55798B PATHOLOGIST: A. RUSSFIELD CAS: 77-09-8 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: TSI Mason Research PHENOLPHTHALEIN DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 TIME: 04:07:17 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-05302 ROUTE: DOSED FEED NTP C#: 55798B PATHOLOGIST: A. RUSSFIELD CAS: 77-09-8 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 PHENOLPHTHALEIN DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 TIME: 04:07:17 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-05302 ROUTE: DOSED FEED NTP C#: 55798B PATHOLOGIST: A. RUSSFIELD CAS: 77-09-8 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF PHENOLPHTHALEIN ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Spleen Hemangiosarcoma All Organs Histiocytic Sarcoma Benign Tumors Malignant Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Ovary Sex Cord Stromal Tumor, Benign All Organs Histiocytic Sarcoma Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 3/50 (6%) 0/49 (0%) 0/48 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.5% 8.2% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/40 (3%) 2/33 (6%) 0/35 (0%) 0/35 (0%) | 0/39 (0%) 0/31 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 634 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.168N P=0.255 P=0.527N P=0.527N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.198N P=0.312 P=0.527N P=0.527N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.158N P=0.308 P=0.527N P=0.527N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.156N | (e) | |FISHER EXACT | P=0.316 P=0.500N P=0.505N | (e) (e) (e) | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 3/50 (6%) 2/50 (4%) 1/49 (2%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 7.5% 8.7% 5.6% 2.8% | 5.0% 3.2% 2.9% 3.6% | |TERMINAL (d) | 3/40 (8%) 2/33 (6%) 2/36 (6%) 1/36 (3%) | 1/39 (3%) 1/31 (3%) 1/34 (3%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 729 (T) 714 729 (T) 729 (T) | 730 737 (T) 737 (T) 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.215N P=0.574 P=0.548N P=0.343N | P=0.500N P=0.582N P=0.550N P=0.613N | |INCIDENTAL TUMOR | P=0.196N P=0.641 P=0.548N P=0.343N | P=0.457N P=0.527N P=0.485N P=0.530N | |LOGISTIC REGRESSION | P=0.208N P=0.613 P=0.548N P=0.343N | P=0.493N P=0.584N P=0.555N P=0.603N | |COCHRAN-ARMITAGE | P=0.199N | P=0.409N | |FISHER EXACT | P=0.661N P=0.500N P=0.316N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/49 (2%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 5.6% 2.8% | 5.1% 0.0% 0.0% 3.6% | |TERMINAL (d) | 0/40 (0%) 0/33 (0%) 2/36 (6%) 1/36 (3%) | 2/39 (5%) 0/31 (0%) 0/34 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) 729 (T) | 737 (T) --- --- 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.237 (e) P=0.215 P=0.479 | P=0.533N P=0.290N P=0.269N P=0.615N | |INCIDENTAL TUMOR | P=0.237 (e) P=0.215 P=0.479 | P=0.533N P=0.290N P=0.269N P=0.615N | |LOGISTIC REGRESSION | P=0.237 (e) P=0.215 P=0.479 | P=0.533N P=0.290N P=0.269N P=0.615N | |COCHRAN-ARMITAGE | P=0.241 | P=0.461N | |FISHER EXACT | (e) P=0.247 P=0.495 | P=0.247N P=0.247N P=0.500N | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) 2/49 (4%) | 4/50 (8%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |ADJUSTED (b) | 7.5% 8.7% 11.1% 5.6% | 10.0% 3.2% 2.9% 7.1% | |TERMINAL (d) | 3/40 (8%) 2/33 (6%) 4/36 (11%) 2/36 (6%) | 3/39 (8%) 1/31 (3%) 1/34 (3%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 729 (T) 714 729 (T) 729 (T) | 730 737 (T) 737 (T) 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.451N P=0.574 P=0.442 P=0.548N | P=0.422N P=0.258N P=0.227N P=0.497N | |INCIDENTAL TUMOR | P=0.429N P=0.641 P=0.442 P=0.548N | P=0.388N P=0.224N P=0.189N P=0.436N | |LOGISTIC REGRESSION | P=0.444N P=0.613 P=0.442 P=0.548N | P=0.414N P=0.259N P=0.230N P=0.485N | |COCHRAN-ARMITAGE | P=0.431N | P=0.313N | |FISHER EXACT | P=0.661N P=0.500 P=0.510N | P=0.181N P=0.181N P=0.339N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 5.3% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/33 (0%) 1/36 (3%) 0/36 (0%) | 0/39 (0%) 0/31 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 713 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.583 (e) P=0.217 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.636 (e) P=0.300 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.590 (e) P=0.227 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.591 | (e) | |FISHER EXACT | (e) P=0.247 (e) | (e) (e) (e) | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.5% 5.4% 5.6% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/40 (3%) 0/33 (0%) 2/36 (6%) 0/36 (0%) | 0/39 (0%) 0/31 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 703 729 (T) --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.319N P=0.445 P=0.463 P=0.521N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.253N P=0.638 P=0.463 P=0.521N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.304N P=0.482 P=0.463 P=0.521N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.301N | (e) | |FISHER EXACT | P=0.500 P=0.500 P=0.505N | (e) (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/50 (44%) 12/50 (24%) 8/50 (16%) 10/49 (20%) | 17/50 (34%) 2/50 (4%) 6/50 (12%) 1/50 (2%) | |ADJUSTED (b) | 53.5% 29.3% 19.6% 25.0% | 41.2% 6.5% 17.1% 3.6% | |TERMINAL (d) | 21/40 (53%) 6/33 (18%) 5/36 (14%) 7/36 (19%) | 15/39 (38%) 2/31 (6%) 5/34 (15%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 582 563 495 522 | 597 737 (T) 693 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.017N* P=0.103N P=0.006N** P=0.022N* | P<0.001N** P=0.001N** P=0.022N* P<0.001N** | |INCIDENTAL TUMOR | P=0.009N** P=0.031N* P=0.002N** P=0.015N* | P<0.001N** P<0.001N** P=0.013N* P<0.001N** | |LOGISTIC REGRESSION | P=0.010N** P=0.032N* P=0.003N** P=0.011N* | P<0.001N** P<0.001N** P=0.015N* P<0.001N** | |COCHRAN-ARMITAGE | P=0.010N** | P<0.001N** | |FISHER EXACT | P=0.028N* P=0.002N** P=0.010N* | P<0.001N** P=0.008N** P<0.001N** | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 10/50 (20%) 5/50 (10%) 9/49 (18%) | 6/50 (12%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 19.5% 25.0% 11.8% 22.0% | 14.9% 3.2% 0.0% 3.6% | |TERMINAL (d) | 7/40 (18%) 5/33 (15%) 2/36 (6%) 5/36 (14%) | 5/39 (13%) 1/31 (3%) 0/34 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 727 560 500 639 | 708 737 (T) --- 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.508 P=0.275 P=0.343N P=0.420 | P=0.046N* P=0.106N P=0.028N* P=0.128N | |INCIDENTAL TUMOR | P=0.546N P=0.484 P=0.246N P=0.560 | P=0.038N* P=0.089N P=0.021N* P=0.101N | |LOGISTIC REGRESSION | P=0.533 P=0.385 P=0.273N P=0.474 | P=0.042N* P=0.099N P=0.025N* P=0.111N | |COCHRAN-ARMITAGE | P=0.533 | P=0.025N* | |FISHER EXACT | P=0.398 P=0.277N P=0.482 | P=0.056N P=0.013N* P=0.056N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 27/50 (54%) 20/50 (40%) 11/50 (22%) 16/49 (33%) | 21/50 (42%) 3/50 (6%) 6/50 (12%) 2/50 (4%) | |ADJUSTED (b) | 64.2% 45.3% 25.8% 38.4% | 49.8% 9.7% 17.1% 7.1% | |TERMINAL (d) | 25/40 (63%) 10/33 (30%) 6/36 (17%) 11/36 (31%) | 18/39 (46%) 3/31 (10%) 5/34 (15%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 582 560 495 522 | 597 737 (T) 693 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.033N* P=0.341N P=0.005N** P=0.060N | P<0.001N** P<0.001N** P=0.003N** P<0.001N** | |INCIDENTAL TUMOR | P=0.016N* P=0.088N P=0.001N** P=0.032N* | P<0.001N** P<0.001N** P=0.001N** P<0.001N** | |LOGISTIC REGRESSION | P=0.016N* P=0.123N P=0.001N** P=0.026N* | P<0.001N** P<0.001N** P=0.002N** P<0.001N** | |COCHRAN-ARMITAGE | P=0.016N* | P<0.001N** | |FISHER EXACT | P=0.115N P<0.001N** P=0.026N* | P<0.001N** P<0.001N** P<0.001N** | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 27/50 (54%) 20/50 (40%) 11/50 (22%) 16/49 (33%) | 21/50 (42%) 3/50 (6%) 6/50 (12%) 2/50 (4%) | |ADJUSTED (b) | 64.2% 45.3% 25.8% 38.4% | 49.8% 9.7% 17.1% 7.1% | |TERMINAL (d) | 25/40 (63%) 10/33 (30%) 6/36 (17%) 11/36 (31%) | 18/39 (46%) 3/31 (10%) 5/34 (15%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 582 560 495 522 | 597 737 (T) 693 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.033N* P=0.341N P=0.005N** P=0.060N | P<0.001N** P<0.001N** P=0.003N** P<0.001N** | |INCIDENTAL TUMOR | P=0.016N* P=0.088N P=0.001N** P=0.032N* | P<0.001N** P<0.001N** P=0.001N** P<0.001N** | |LOGISTIC REGRESSION | P=0.016N* P=0.123N P=0.001N** P=0.026N* | P<0.001N** P<0.001N** P=0.002N** P<0.001N** | |COCHRAN-ARMITAGE | P=0.016N* | P<0.001N** | |FISHER EXACT | P=0.115N P<0.001N** P=0.026N* | P<0.001N** P<0.001N** P<0.001N** | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 10/50 (20%) 4/50 (8%) 12/49 (24%) | 3/50 (6%) 1/50 (2%) 5/50 (10%) 6/50 (12%) | |ADJUSTED (b) | 20.0% 27.0% 10.5% 30.6% | 7.2% 3.2% 14.7% 20.7% | |TERMINAL (d) | 8/40 (20%) 7/33 (21%) 3/36 (8%) 9/36 (25%) | 2/39 (5%) 1/31 (3%) 5/34 (15%) 5/28 (18%) | |FIRST INCIDENCE (DAYS) | 729 (T) 602 659 699 | 615 737 (T) 737 (T) 730 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.211 P=0.255 P=0.229N P=0.162 | P=0.032 * P=0.385N P=0.289 P=0.115 | |INCIDENTAL TUMOR | P=0.251 P=0.353 P=0.196N P=0.231 | P=0.045 * P=0.305N P=0.328 P=0.186 | |LOGISTIC REGRESSION | P=0.225 P=0.352 P=0.203N P=0.185 | P=0.041 * P=0.328N P=0.315 P=0.154 | |COCHRAN-ARMITAGE | P=0.226 | P=0.080 | |FISHER EXACT | P=0.398 P=0.178N P=0.212 | P=0.309N P=0.357 P=0.243 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/50 (10%) 4/50 (8%) 5/49 (10%) | 4/50 (8%) 4/50 (8%) 1/50 (2%) 2/50 (4%) | |ADJUSTED (b) | 6.5% 14.2% 11.1% 13.5% | 9.4% 12.3% 2.9% 5.6% | |TERMINAL (d) | 0/40 (0%) 4/33 (12%) 4/36 (11%) 4/36 (11%) | 2/39 (5%) 3/31 (10%) 0/34 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 550 637 729 (T) 720 | 597 663 693 449 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.324 P=0.291 P=0.450 P=0.314 | P=0.276N P=0.514 P=0.231N P=0.459N | |INCIDENTAL TUMOR | P=0.286 P=0.492 P=0.326 P=0.378 | P=0.148N P=0.642 P=0.118N P=0.214N | |LOGISTIC REGRESSION | P=0.335 P=0.361 P=0.505 P=0.349 | P=0.190N P=0.607 P=0.180N P=0.321N | |COCHRAN-ARMITAGE | P=0.337 | P=0.186N | |FISHER EXACT | P=0.357 P=0.500 P=0.346 | P=0.643N P=0.181N P=0.339N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 15/50 (30%) 8/50 (16%) 16/49 (33%) | 6/50 (12%) 5/50 (10%) 6/50 (12%) 8/50 (16%) | |ADJUSTED (b) | 25.2% 39.7% 21.3% 40.9% | 13.8% 15.4% 17.1% 25.7% | |TERMINAL (d) | 8/40 (20%) 11/33 (33%) 7/36 (19%) 13/36 (36%) | 3/39 (8%) 4/31 (13%) 5/34 (15%) 6/28 (21%) | |FIRST INCIDENCE (DAYS) | 550 602 659 699 | 597 663 693 449 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.200 P=0.134 P=0.394N P=0.126 | P=0.133 P=0.597 P=0.522 P=0.198 | |INCIDENTAL TUMOR | P=0.202 P=0.283 P=0.430N P=0.180 | P=0.243 P=0.489N P=0.574N P=0.435 | |LOGISTIC REGRESSION | P=0.215 P=0.236 P=0.318N P=0.160 | P=0.213 P=0.542N P=0.603 P=0.354 | |COCHRAN-ARMITAGE | P=0.217 | P=0.269 | |FISHER EXACT | P=0.247 P=0.306N P=0.168 | P=0.500N P=0.620N P=0.387 | |=================================================================================================================================| | | |Mesentery | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 6.1% 0.0% 0.0% | 0.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 0/40 (0%) 2/33 (6%) 0/36 (0%) 0/36 (0%) | 0/39 (0%) 0/31 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | --- --- 567 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.418N P=0.197 (e) (e) | P=0.688 (e) P=0.491 (e) | |INCIDENTAL TUMOR | P=0.418N P=0.197 (e) (e) | P=0.720N (e) P=0.612 (e) | |LOGISTIC REGRESSION | P=0.418N P=0.195 (e) (e) | P=0.700 (e) P=0.474 (e) | |COCHRAN-ARMITAGE | P=0.409N | P=0.694 | |FISHER EXACT | P=0.247 (e) (e) | (e) P=0.500 (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/50 (0%) 3/49 (6%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | | 0.0% 9.7% 0.0% 2.1% | |TERMINAL (d) | | 0/39 (0%) 3/31 (10%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | | --- 737 (T) --- 449 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.575 P=0.084 (e) P=0.500 | |INCIDENTAL TUMOR | | P=0.613N P=0.084 (e) P=0.814 | |LOGISTIC REGRESSION | | P=0.626N P=0.084 (e) P=0.518 | |COCHRAN-ARMITAGE | | P=0.631N | |FISHER EXACT | | P=0.117 (e) P=0.500 | |=================================================================================================================================| | | |Ovary | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/50 (4%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | | 4.8% 0.0% 0.0% 3.6% | |TERMINAL (d) | | 1/39 (3%) 0/31 (0%) 0/34 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | | 686 --- --- 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.532N P=0.295N P=0.272N P=0.614N | |INCIDENTAL TUMOR | | P=0.469N P=0.265N P=0.209N P=0.530N | |LOGISTIC REGRESSION | | P=0.497N P=0.259N P=0.244N P=0.560N | |COCHRAN-ARMITAGE | | P=0.459N | |FISHER EXACT | | P=0.253N P=0.247N P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |Ovary | | Sex Cord Stromal Tumor, Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/50 (0%) 7/49 (14%) 6/50 (12%) 5/50 (10%) | |ADJUSTED (b) | | 0.0% 21.7% 17.6% 17.9% | |TERMINAL (d) | | 0/39 (0%) 6/31 (19%) 6/34 (18%) 5/28 (18%) | |FIRST INCIDENCE (DAYS) | | --- 668 737 (T) 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.056 P=0.004 ** P=0.011 * P=0.012 * | |INCIDENTAL TUMOR | | P=0.064 P=0.004 ** P=0.011 * P=0.012 * | |LOGISTIC REGRESSION | | P=0.066 P=0.004 ** P=0.011 * P=0.012 * | |COCHRAN-ARMITAGE | | P=0.142 | |FISHER EXACT | | P=0.006 ** P=0.013 * P=0.028 * | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 1/50 (2%) 0/49 (0%) 0/48 (0%) | 3/49 (6%) 2/50 (4%) 1/49 (2%) 0/48 (0%) | |ADJUSTED (b) | 0.0% 3.0% 0.0% 0.0% | 7.9% 6.5% 2.9% 0.0% | |TERMINAL (d) | 0/39 (0%) 1/33 (3%) 0/36 (0%) 0/36 (0%) | 3/38 (8%) 2/31 (6%) 1/34 (3%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | 737 (T) 737 (T) 737 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.572N P=0.467 (e) (e) | P=0.094N P=0.593N P=0.345N P=0.187N | |INCIDENTAL TUMOR | P=0.572N P=0.467 (e) (e) | P=0.094N P=0.593N P=0.345N P=0.187N | |LOGISTIC REGRESSION | P=0.572N P=0.467 (e) (e) | P=0.094N P=0.594N P=0.345N P=0.187N | |COCHRAN-ARMITAGE | P=0.569N | P=0.064N | |FISHER EXACT | P=0.510 (e) (e) | P=0.490N P=0.309N P=0.125N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |Skin | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 2.5% 0.0% 7.4% 0.0% | 0.0% 0.0% 2.9% 3.2% | |TERMINAL (d) | 1/40 (3%) 0/33 (0%) 1/36 (3%) 0/36 (0%) | 0/39 (0%) 0/31 (0%) 1/34 (3%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 515 --- | --- --- 737 (T) 715 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.515N P=0.538N P=0.275 P=0.521N | P=0.196 (e) P=0.473 P=0.444 | |INCIDENTAL TUMOR | P=0.437N P=0.538N P=0.477 P=0.521N | P=0.241 (e) P=0.473 P=0.581 | |LOGISTIC REGRESSION | P=0.496N P=0.538N P=0.307 P=0.521N | P=0.204 (e) P=0.473 P=0.473 | |COCHRAN-ARMITAGE | P=0.506N | P=0.236 | |FISHER EXACT | P=0.500N P=0.309 P=0.505N | (e) P=0.500 P=0.500 | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 5/50 (10%) 1/50 (2%) 1/49 (2%) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 14.0% 2.7% 2.8% | 0.0% 3.2% 5.1% 3.2% | |TERMINAL (d) | 0/40 (0%) 3/33 (9%) 0/36 (0%) 1/36 (3%) | 0/39 (0%) 1/31 (3%) 1/34 (3%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- 703 716 729 (T) | --- 737 (T) 567 715 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.500N P=0.022 * P=0.475 P=0.479 | P=0.310 P=0.454 P=0.220 P=0.444 | |INCIDENTAL TUMOR | P=0.409N P=0.044 * P=0.638 P=0.479 | P=0.403 P=0.454 P=0.283 P=0.581 | |LOGISTIC REGRESSION | P=0.484N P=0.026 * P=0.494 P=0.479 | P=0.359 P=0.454 P=0.236 P=0.473 | |COCHRAN-ARMITAGE | P=0.482N | P=0.366 | |FISHER EXACT | P=0.028 * P=0.500 P=0.495 | P=0.500 P=0.247 P=0.500 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/49 (2%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 3/50 (6%) | |ADJUSTED (b) | 0.0% 0.0% 5.6% 2.8% | 2.6% 6.5% 0.0% 10.7% | |TERMINAL (d) | 0/40 (0%) 0/33 (0%) 2/36 (6%) 1/36 (3%) | 1/39 (3%) 2/31 (6%) 0/34 (0%) 3/28 (11%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) 729 (T) | 737 (T) 737 (T) --- 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.237 (e) P=0.215 P=0.479 | P=0.164 P=0.420 P=0.527N P=0.195 | |INCIDENTAL TUMOR | P=0.237 (e) P=0.215 P=0.479 | P=0.164 P=0.420 P=0.527N P=0.195 | |LOGISTIC REGRESSION | P=0.237 (e) P=0.215 P=0.479 | P=0.164 P=0.420 P=0.527N P=0.195 | |COCHRAN-ARMITAGE | P=0.241 | P=0.242 | |FISHER EXACT | (e) P=0.247 P=0.495 | P=0.500 P=0.500N P=0.309 | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 3/50 (6%) | |ADJUSTED (b) | 0.0% 0.0% 5.6% 0.0% | 2.6% 3.2% 0.0% 10.7% | |TERMINAL (d) | 0/40 (0%) 0/33 (0%) 2/36 (6%) 0/36 (0%) | 1/39 (3%) 1/31 (3%) 0/34 (0%) 3/28 (11%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) --- | 737 (T) 737 (T) --- 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.582 (e) P=0.215 (e) | P=0.105 P=0.710 P=0.527N P=0.195 | |INCIDENTAL TUMOR | P=0.582 (e) P=0.215 (e) | P=0.105 P=0.710 P=0.527N P=0.195 | |LOGISTIC REGRESSION | P=0.582 (e) P=0.215 (e) | P=0.105 P=0.710 P=0.527N P=0.195 | |COCHRAN-ARMITAGE | P=0.591 | P=0.160 | |FISHER EXACT | (e) P=0.247 (e) | P=0.753N P=0.500N P=0.309 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/50 (2%) 2/50 (4%) 0/49 (0%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 2.1% 5.3% 0.0% | 2.6% 6.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/33 (0%) 1/36 (3%) 0/36 (0%) | 1/39 (3%) 1/31 (3%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- 563 713 --- | 737 (T) 663 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.623N P=0.500 P=0.220 (e) | P=0.234N P=0.423 P=0.527N P=0.566N | |INCIDENTAL TUMOR | P=0.642N P=0.638 P=0.303 (e) | P=0.196N P=0.473 P=0.527N P=0.566N | |LOGISTIC REGRESSION | P=0.608N P=0.472 P=0.232 (e) | P=0.204N P=0.467 P=0.527N P=0.566N | |COCHRAN-ARMITAGE | P=0.618N | P=0.188N | |FISHER EXACT | P=0.505 P=0.253 (e) | P=0.500 P=0.500N P=0.500N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 1/50 (2%) 2/50 (4%) 0/49 (0%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.3% 2.1% 5.3% 0.0% | 2.6% 6.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/33 (0%) 1/36 (3%) 0/36 (0%) | 1/39 (3%) 1/31 (3%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 662 563 713 --- | 737 (T) 663 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.379N P=0.750 P=0.474 P=0.514N | P=0.234N P=0.423 P=0.527N P=0.566N | |INCIDENTAL TUMOR | P=0.348N P=0.599N P=0.651 P=0.362N | P=0.196N P=0.473 P=0.527N P=0.566N | |LOGISTIC REGRESSION | P=0.355N P=0.759 P=0.506 P=0.493N | P=0.204N P=0.467 P=0.527N P=0.566N | |COCHRAN-ARMITAGE | P=0.367N | P=0.188N | |FISHER EXACT | P=0.747N P=0.508 P=0.500N | P=0.500 P=0.500N P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 1/50 (2%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | |ADJUSTED (b) | | 2.6% 6.2% 8.8% 3.6% | |TERMINAL (d) | | 1/39 (3%) 1/31 (3%) 3/34 (9%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | | 737 (T) 703 737 (T) 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.521 P=0.419 P=0.257 P=0.686 | |INCIDENTAL TUMOR | | P=0.557 P=0.473 P=0.257 P=0.686 | |LOGISTIC REGRESSION | | P=0.541 P=0.440 P=0.257 P=0.686 | |COCHRAN-ARMITAGE | | P=0.577N | |FISHER EXACT | | P=0.500 P=0.309 P=0.753N | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 4.8% 0.0% 2.2% 3.6% | |TERMINAL (d) | 0/40 (0%) 0/33 (0%) 0/36 (0%) 0/36 (0%) | 1/39 (3%) 0/31 (0%) 0/34 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 686 --- 567 737 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.564N P=0.295N P=0.538N P=0.614N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.461N P=0.239N P=0.406N P=0.530N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.502N P=0.255N P=0.499N P=0.560N | |COCHRAN-ARMITAGE | (e) | P=0.500N | |FISHER EXACT | (e) (e) (e) | P=0.247N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 6/50 (12%) 7/50 (14%) 2/49 (4%) | 0/50 (0%) 1/50 (2%) 4/50 (8%) 1/50 (2%) | |ADJUSTED (b) | 7.3% 16.9% 18.0% 5.6% | 0.0% 3.2% 10.8% 3.2% | |TERMINAL (d) | 2/40 (5%) 4/33 (12%) 5/36 (14%) 2/36 (6%) | 0/39 (0%) 1/31 (3%) 3/34 (9%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 724 703 515 729 (T) | --- 737 (T) 567 715 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.380N P=0.166 P=0.125 P=0.552N | P=0.263 P=0.454 P=0.051 P=0.444 | |INCIDENTAL TUMOR | P=0.287N P=0.285 P=0.244 P=0.477N | P=0.334 P=0.454 P=0.067 P=0.581 | |LOGISTIC REGRESSION | P=0.351N P=0.197 P=0.154 P=0.534N | P=0.312 P=0.454 P=0.062 P=0.473 | |COCHRAN-ARMITAGE | P=0.350N | P=0.337 | |FISHER EXACT | P=0.243 P=0.159 P=0.510N | P=0.500 P=0.059 P=0.500 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 6/50 (12%) 7/50 (14%) 2/49 (4%) | 2/50 (4%) 1/50 (2%) 4/50 (8%) 2/50 (4%) | |ADJUSTED (b) | 7.3% 16.9% 18.0% 5.6% | 4.8% 3.2% 10.8% 6.7% | |TERMINAL (d) | 2/40 (5%) 4/33 (12%) 5/36 (14%) 2/36 (6%) | 1/39 (3%) 1/31 (3%) 3/34 (9%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 724 703 515 729 (T) | 686 737 (T) 567 715 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.380N P=0.166 P=0.125 P=0.552N | P=0.368 P=0.583N P=0.285 P=0.575 | |INCIDENTAL TUMOR | P=0.287N P=0.285 P=0.244 P=0.477N | P=0.466 P=0.527N P=0.369 P=0.687N | |LOGISTIC REGRESSION | P=0.351N P=0.197 P=0.154 P=0.534N | P=0.435 P=0.548N P=0.332 P=0.640 | |COCHRAN-ARMITAGE | P=0.350N | P=0.477 | |FISHER EXACT | P=0.243 P=0.159 P=0.510N | P=0.500N P=0.339 P=0.691N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 11/50 (22%) 12/49 (24%) | 0/50 (0%) 2/50 (4%) 7/50 (14%) 7/50 (14%) | |ADJUSTED (b) | 2.4% 7.9% 28.0% 27.5% | 0.0% 6.5% 17.6% 18.0% | |TERMINAL (d) | 0/40 (0%) 0/33 (0%) 8/36 (22%) 5/36 (14%) | 0/39 (0%) 2/31 (6%) 3/34 (9%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 727 658 665 549 | --- 737 (T) 567 588 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.255 P=0.002 ** P=0.002 ** | P=0.002 ** P=0.189 P=0.007 ** P=0.005 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.582 P=0.005 ** P=0.003 ** | P=0.011 * P=0.189 P=0.015 * P=0.052 | |LOGISTIC REGRESSION | P<0.001 ** P=0.302 P=0.002 ** P=0.001 ** | P=0.009 ** P=0.189 P=0.010 ** P=0.011 * | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.004 ** | |FISHER EXACT | P=0.309 P=0.002 ** P<0.001 ** | P=0.247 P=0.006 ** P=0.006 ** | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 8/50 (16%) 12/50 (24%) 8/49 (16%) | 15/50 (30%) 28/50 (56%) 33/50 (66%) 25/50 (50%) | |ADJUSTED (b) | 14.5% 19.1% 27.2% 22.2% | 34.3% 60.2% 74.6% 65.8% | |TERMINAL (d) | 5/40 (13%) 3/33 (9%) 6/36 (17%) 8/36 (22%) | 11/39 (28%) 13/31 (42%) 23/34 (68%) 16/28 (57%) | |FIRST INCIDENCE (DAYS) | 662 347 423 729 (T) | 156 266 338 447 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.299 P=0.300 P=0.082 P=0.309 | P=0.010 * P=0.003 ** P<0.001 ** P=0.004 ** | |INCIDENTAL TUMOR | P=0.330 P=0.488 P=0.267 P=0.347 | P=0.101 P=0.026 * P<0.001 ** P=0.043 * | |LOGISTIC REGRESSION | P=0.324 P=0.396 P=0.101 P=0.353 | P=0.114 P=0.051 P<0.001 ** P=0.035 * | |COCHRAN-ARMITAGE | P=0.310 | P=0.060 | |FISHER EXACT | P=0.387 P=0.096 P=0.371 | P=0.007 ** P<0.001 ** P=0.033 * | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 29/50 (58%) 24/50 (48%) 18/50 (36%) 19/49 (39%) | 26/50 (52%) 20/50 (40%) 23/50 (46%) 17/50 (34%) | |ADJUSTED (b) | 68.9% 55.0% 43.3% 45.9% | 58.8% 58.7% 61.7% 56.1% | |TERMINAL (d) | 27/40 (68%) 14/33 (42%) 13/36 (36%) 14/36 (39%) | 21/39 (54%) 17/31 (55%) 20/34 (59%) 15/28 (54%) | |FIRST INCIDENCE (DAYS) | 582 563 495 522 | 78 663 479 449 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.058N P=0.521N P=0.066N P=0.095N | P=0.372N P=0.509N P=0.566 P=0.389N | |INCIDENTAL TUMOR | P=0.026N* P=0.203N P=0.019N* P=0.043N* | P=0.204N P=0.346N P=0.451N P=0.202N | |LOGISTIC REGRESSION | P=0.030N* P=0.234N P=0.027N* P=0.043N* | P=0.208N P=0.431N P=0.559N P=0.199N | |COCHRAN-ARMITAGE | P=0.030N* | P=0.067N | |FISHER EXACT | P=0.212N P=0.022N* P=0.043N* | P=0.158N P=0.345N P=0.053N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 19/50 (38%) 29/50 (58%) 35/50 (70%) 29/49 (59%) | 25/50 (50%) 35/50 (70%) 41/50 (82%) 37/50 (74%) | |ADJUSTED (b) | 41.2% 61.3% 71.4% 63.0% | 55.1% 71.4% 85.4% 78.5% | |TERMINAL (d) | 13/40 (33%) 15/33 (45%) 22/36 (61%) 19/36 (53%) | 19/39 (49%) 17/31 (55%) 27/34 (79%) 18/28 (64%) | |FIRST INCIDENCE (DAYS) | 550 347 423 549 | 156 266 338 447 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.057 P=0.021 * P=0.002 ** P=0.030 * | P=0.002 ** P=0.011 * P<0.001 ** P=0.001 ** | |INCIDENTAL TUMOR | P=0.039 * P=0.128 P=0.003 ** P=0.047 * | P=0.041 * P=0.097 P=0.001 ** P=0.056 | |LOGISTIC REGRESSION | P=0.026 * P=0.039 * P=0.001 ** P=0.035 * | P=0.040 * P=0.166 P<0.001 ** P=0.058 | |COCHRAN-ARMITAGE | P=0.031 * | P=0.010 * | |FISHER EXACT | P=0.036 * P=0.001 ** P=0.028 * | P=0.033 * P<0.001 ** P=0.011 * | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 04 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENOLPHTHALEIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 3000 PPM 6000 PPM 12000 | 0 PPM 3000 PPM 6000 PPM 12000 | | | PPM | PPM | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 40/50 (80%) 40/50 (80%) 42/50 (84%) 38/49 (78%) | 40/50 (80%) 40/50 (80%) 47/50 (94%) 43/50 (86%) | |ADJUSTED (b) | 83.3% 81.6% 84.0% 80.8% | 83.3% 81.6% 95.9% 91.4% | |TERMINAL (d) | 32/40 (80%) 24/33 (73%) 28/36 (78%) 27/36 (75%) | 31/39 (79%) 22/31 (71%) 32/34 (94%) 24/28 (86%) | |FIRST INCIDENCE (DAYS) | 550 347 423 522 | 78 266 338 447 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.516 P=0.194 P=0.211 P=0.459 | P=0.014 * P=0.135 P=0.024 * P=0.014 * | |INCIDENTAL TUMOR | P=0.378N P=0.369N P=0.519 P=0.395N | P=0.269 P=0.477N P=0.053 P=0.374 | |LOGISTIC REGRESSION | P=0.461N P=0.590 P=0.392 P=0.502N | P=0.230 P=0.566N P=0.037 * P=0.282 | |COCHRAN-ARMITAGE | P=0.443N | P=0.158 | |FISHER EXACT | P=0.598N P=0.398 P=0.479N | P=0.598N P=0.036 * P=0.298 | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (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).