TDMS Study 05182-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: TSI Mason Research PHENOLPHTHALEIN DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 TIME: 03:25:49 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-05302 ROUTE: DOSED FEED NTP C#: 55798B PATHOLOGIST: VOELKER, FRANK KOVATCH, ROBERT 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: 03 TIME: 03:25:49 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-05302 ROUTE: DOSED FEED NTP C#: 55798B PATHOLOGIST: VOELKER, FRANK KOVATCH, ROBERT CAS: 77-09-8 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 PHENOLPHTHALEIN DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 TIME: 03:25:49 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-05302 ROUTE: DOSED FEED NTP C#: 55798B PATHOLOGIST: VOELKER, FRANK KOVATCH, ROBERT CAS: 77-09-8 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF PHENOLPHTHALEIN ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Kidney: Renal Tubule Adenoma Carcinoma or Adenoma Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Thyroid Gland: C-Cell Adenoma Carcinoma Carcinoma or Adenoma Thyroid Gland: Follicular Cell Adenoma ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Brain Astrocytoma Malignant Oligodendroglioma, Glioma, or Astrocytoma Clitoral/Preputial Gland Adenoma Islets, Pancreatic Carcinoma or Adenoma Mammary Gland Carcinoma or Adenoma Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors ==================================================================================================== DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 1/49 (2%) 2/49 (4%) | |ADJUSTED (b) | 4.8% 0.0% 0.0% 0.0% | 6.7% 2.6% 3.1% 5.3% | |TERMINAL (d) | 1/21 (5%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | 2/30 (7%) 1/38 (3%) 1/32 (3%) 2/38 (5%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | 735 (T) 735 (T) 735 (T) 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.364N P=0.567N P=0.567N P=0.596N | P=0.608N P=0.417N P=0.477N P=0.607N | |INCIDENTAL TUMOR | P=0.364N P=0.567N P=0.567N P=0.596N | P=0.608N P=0.417N P=0.477N P=0.607N | |LOGISTIC REGRESSION | P=0.364N P=0.567N P=0.567N P=0.596N | P=0.608N P=0.417N P=0.477N P=0.607N | |COCHRAN-ARMITAGE | P=0.309N | P=0.545 | |FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.500N P=0.508N P=0.684 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/50 (34%) 34/50 (68%) 34/50 (68%) 34/50 (68%) | 3/50 (6%) 11/50 (22%) 9/50 (18%) 2/49 (4%) | |ADJUSTED (b) | 62.1% 88.6% 93.7% 87.0% | 10.0% 25.8% 23.7% 5.3% | |TERMINAL (d) | 11/21 (52%) 11/15 (73%) 13/15 (87%) 9/13 (69%) | 3/30 (10%) 7/38 (18%) 5/32 (16%) 2/38 (5%) | |FIRST INCIDENCE (DAYS) | 608 485 372 528 | 735 (T) 549 608 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.138N P=0.060 P=0.088 P=0.392N | |INCIDENTAL TUMOR | P=0.007 ** P=0.001 ** P=0.002 ** P=0.002 ** | P=0.262N P=0.033 * P=0.082 P=0.392N | |LOGISTIC REGRESSION | P=0.006 ** P<0.001 ** P<0.001 ** P=0.001 ** | P=0.197N P=0.031 * P=0.074 P=0.392N | |COCHRAN-ARMITAGE | P=0.003 ** | P=0.207N | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P=0.020 * P=0.061 P=0.510N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/49 (0%) | |ADJUSTED (b) | 2.0% 2.5% 2.9% 13.1% | 0.0% 2.6% 2.1% 0.0% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 0/15 (0%) 1/13 (8%) | 0/30 (0%) 1/38 (3%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 330 591 645 717 | --- 735 (T) 568 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.332 P=0.746N P=0.737N P=0.413 | P=0.579N P=0.547 P=0.517 (e) | |INCIDENTAL TUMOR | P=0.202 P=0.575 P=0.682 P=0.276 | P=0.639N P=0.547 P=0.536 (e) | |LOGISTIC REGRESSION | P=0.287 P=0.591 P=0.686 P=0.418 | P=0.587N P=0.547 P=0.412 (e) | |COCHRAN-ARMITAGE | P=0.350 | P=0.595N | |FISHER EXACT | P=0.753N P=0.753N P=0.500 | P=0.500 P=0.500 (e) | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 35/50 (70%) 35/50 (70%) 35/50 (70%) | 3/50 (6%) 12/50 (24%) 10/50 (20%) 2/49 (4%) | |ADJUSTED (b) | 62.9% 88.9% 93.9% 90.3% | 10.0% 28.2% 25.3% 5.3% | |TERMINAL (d) | 11/21 (52%) 11/15 (73%) 13/15 (87%) 10/13 (77%) | 3/30 (10%) 8/38 (21%) 5/32 (16%) 2/38 (5%) | |FIRST INCIDENCE (DAYS) | 330 485 372 528 | 735 (T) 549 568 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.130N P=0.040 * P=0.058 P=0.392N | |INCIDENTAL TUMOR | P=0.004 ** P<0.001 ** P=0.001 ** P<0.001 ** | P=0.254N P=0.021 * P=0.052 P=0.392N | |LOGISTIC REGRESSION | P=0.005 ** P<0.001 ** P<0.001 ** P=0.001 ** | P=0.189N P=0.019 * P=0.041 * P=0.392N | |COCHRAN-ARMITAGE | P=0.003 ** | P=0.195N | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P=0.011 * P=0.036 * P=0.510N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Brain | | Astrocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 4.6% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | 0/30 (0%) 0/38 (0%) 0/32 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- --- 271 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.052 (e) (e) P=0.266 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.217 (e) (e) P=0.547 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.093 (e) (e) P=0.258 | |COCHRAN-ARMITAGE | (e) | P=0.046 * | |FISHER EXACT | (e) (e) (e) | (e) (e) P=0.247 | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 2.6% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 4.6% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | 0/30 (0%) 0/38 (0%) 0/32 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 571 --- --- --- | --- --- --- 271 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.292N P=0.485N P=0.466N P=0.475N | P=0.052 (e) (e) P=0.266 | |INCIDENTAL TUMOR | P=0.325N P=0.425N P=0.519N P=0.500N | P=0.217 (e) (e) P=0.547 | |LOGISTIC REGRESSION | P=0.348N P=0.545N P=0.533N P=0.571N | P=0.093 (e) (e) P=0.258 | |COCHRAN-ARMITAGE | P=0.309N | P=0.046 * | |FISHER EXACT | P=0.500N P=0.500N P=0.500N | (e) (e) P=0.247 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 4/49 (8%) 4/50 (8%) 4/49 (8%) | 10/50 (20%) 7/50 (14%) 4/49 (8%) 7/48 (15%) | |ADJUSTED (b) | 21.9% 13.5% 18.4% 22.9% | 32.2% 17.8% 12.5% 18.9% | |TERMINAL (d) | 4/21 (19%) 0/15 (0%) 1/15 (7%) 2/13 (15%) | 9/30 (30%) 6/38 (16%) 4/32 (13%) 7/37 (19%) | |FIRST INCIDENCE (DAYS) | 671 485 416 585 | 723 705 735 (T) 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.543 P=0.613N P=0.625 P=0.561 | P=0.162N P=0.142N P=0.053N P=0.150N | |INCIDENTAL TUMOR | P=0.462N P=0.504N P=0.468N P=0.581N | P=0.198N P=0.168N P=0.054N P=0.192N | |LOGISTIC REGRESSION | P=0.439N P=0.502N P=0.472N P=0.539N | P=0.176N P=0.157N P=0.044N* P=0.162N | |COCHRAN-ARMITAGE | P=0.458N | P=0.275N | |FISHER EXACT | P=0.513N P=0.500N P=0.513N | P=0.298N P=0.080N P=0.330N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/49 (6%) 2/50 (4%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 1/48 (2%) | |ADJUSTED (b) | 0.0% 15.8% 13.3% 0.0% | 0.0% 0.0% 3.1% 2.7% | |TERMINAL (d) | 0/21 (0%) 2/15 (13%) 2/15 (13%) 0/13 (0%) | 0/30 (0%) 0/38 (0%) 1/32 (3%) 1/37 (3%) | |FIRST INCIDENCE (DAYS) | --- 618 729 (T) --- | --- --- 735 (T) 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.498N P=0.092 P=0.166 (e) | P=0.257 (e) P=0.513 P=0.542 | |INCIDENTAL TUMOR | P=0.523N P=0.099 P=0.166 (e) | P=0.257 (e) P=0.513 P=0.542 | |LOGISTIC REGRESSION | P=0.419N P=0.114 P=0.166 (e) | P=0.257 (e) P=0.513 P=0.542 | |COCHRAN-ARMITAGE | P=0.405N | P=0.225 | |FISHER EXACT | P=0.117 P=0.247 (e) | (e) P=0.495 P=0.490 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 7/49 (14%) 5/50 (10%) 4/49 (8%) | 10/50 (20%) 7/50 (14%) 5/49 (10%) 7/48 (15%) | |ADJUSTED (b) | 21.9% 27.2% 24.2% 22.9% | 32.2% 17.8% 15.6% 18.9% | |TERMINAL (d) | 4/21 (19%) 2/15 (13%) 2/15 (13%) 2/13 (15%) | 9/30 (30%) 6/38 (16%) 5/32 (16%) 7/37 (19%) | |FIRST INCIDENCE (DAYS) | 671 485 416 585 | 723 705 735 (T) 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.491N P=0.263 P=0.466 P=0.561 | P=0.172N P=0.142N P=0.097N P=0.150N | |INCIDENTAL TUMOR | P=0.385N P=0.355 P=0.629N P=0.581N | P=0.209N P=0.168N P=0.099N P=0.192N | |LOGISTIC REGRESSION | P=0.316N P=0.375 P=0.602N P=0.539N | P=0.186N P=0.157N P=0.083N P=0.162N | |COCHRAN-ARMITAGE | P=0.339N | P=0.291N | |FISHER EXACT | P=0.365 P=0.630N P=0.513N | P=0.298N P=0.140N P=0.330N | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 0/50 (0%) 1/48 (2%) | 2/49 (4%) 0/49 (0%) 1/49 (2%) 1/47 (2%) | |ADJUSTED (b) | 13.6% 11.9% 0.0% 2.5% | 6.7% 0.0% 3.1% 2.6% | |TERMINAL (d) | 2/21 (10%) 1/15 (7%) 0/15 (0%) 0/13 (0%) | 2/30 (7%) 0/38 (0%) 1/32 (3%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 727 715 --- 612 | 735 (T) --- 735 (T) 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.242N P=0.644N P=0.186N P=0.425N | P=0.457N P=0.188N P=0.477N P=0.417N | |INCIDENTAL TUMOR | P=0.152N P=0.504N P=0.101N P=0.308N | P=0.457N P=0.188N P=0.477N P=0.417N | |LOGISTIC REGRESSION | P=0.169N P=0.612N P=0.175N P=0.311N | P=0.457N P=0.188N P=0.477N P=0.417N | |COCHRAN-ARMITAGE | P=0.171N | P=0.518N | |FISHER EXACT | P=0.500N P=0.121N P=0.324N | P=0.247N P=0.500N P=0.516N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 2/48 (4%) | 3/49 (6%) 0/49 (0%) 0/49 (0%) 1/47 (2%) | |ADJUSTED (b) | 4.8% 8.3% 3.8% 10.0% | 9.2% 0.0% 0.0% 2.6% | |TERMINAL (d) | 1/21 (5%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | 2/30 (7%) 0/38 (0%) 0/32 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) 638 681 700 | 683 --- --- 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.384 P=0.428 P=0.719 P=0.389 | P=0.222N P=0.091N P=0.111N P=0.238N | |INCIDENTAL TUMOR | P=0.606 P=0.560 P=0.709N P=0.652 | P=0.287N P=0.107N P=0.121N P=0.383N | |LOGISTIC REGRESSION | P=0.447 P=0.496 P=0.760N P=0.462 | P=0.254N P=0.101N P=0.110N P=0.297N | |COCHRAN-ARMITAGE | P=0.431 | P=0.261N | |FISHER EXACT | P=0.500 P=0.753N P=0.485 | P=0.121N P=0.121N P=0.324N | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/50 (8%) 1/50 (2%) 3/48 (6%) | 5/49 (10%) 0/49 (0%) 1/49 (2%) 1/47 (2%) | |ADJUSTED (b) | 18.2% 19.1% 3.8% 12.2% | 15.7% 0.0% 3.1% 2.6% | |TERMINAL (d) | 3/21 (14%) 1/15 (7%) 0/15 (0%) 0/13 (0%) | 4/30 (13%) 0/38 (0%) 1/32 (3%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 727 638 681 612 | 683 --- 735 (T) 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.466N P=0.483 P=0.271N P=0.635 | P=0.069N P=0.019N* P=0.089N P=0.063N | |INCIDENTAL TUMOR | P=0.233N P=0.614N P=0.128N P=0.406N | P=0.089N P=0.023N* P=0.096N P=0.107N | |LOGISTIC REGRESSION | P=0.344N P=0.593 P=0.199N P=0.525N | P=0.084N P=0.022N* P=0.086N P=0.091N | |COCHRAN-ARMITAGE | P=0.361N | P=0.095N | |FISHER EXACT | P=0.643N P=0.181N P=0.523N | P=0.028N* P=0.102N P=0.112N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 4/50 (8%) 2/50 (4%) 6/50 (12%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 20.4% 10.6% 22.4% | 0.0% 0.0% 0.0% 2.6% | |TERMINAL (d) | 0/21 (0%) 2/15 (13%) 1/15 (7%) 1/13 (8%) | 0/30 (0%) 0/38 (0%) 0/32 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | --- 577 692 542 | --- --- --- 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.015 * P=0.040 * P=0.195 P=0.017 * | P=0.217 (e) (e) P=0.547 | |INCIDENTAL TUMOR | P=0.033 * P=0.068 P=0.291 P=0.034 * | P=0.217 (e) (e) P=0.547 | |LOGISTIC REGRESSION | P=0.026 * P=0.060 P=0.233 P=0.018 * | P=0.217 (e) (e) P=0.547 | |COCHRAN-ARMITAGE | P=0.023 * | P=0.197 | |FISHER EXACT | P=0.059 P=0.247 P=0.013 * | (e) (e) P=0.500 | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 4.5% 6.3% 8.1% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | 0/30 (0%) 0/38 (0%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | --- 693 727 652 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.131 P=0.467 P=0.436 P=0.231 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.340 P=0.597 P=0.682 P=0.467 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.156 P=0.496 P=0.446 P=0.245 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.154 | (e) | |FISHER EXACT | P=0.500 P=0.500 P=0.247 | (e) (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 5/50 (10%) 3/50 (6%) 7/50 (14%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 24.0% 16.1% 24.7% | 0.0% 0.0% 0.0% 2.6% | |TERMINAL (d) | 0/21 (0%) 2/15 (13%) 1/15 (7%) 1/13 (8%) | 0/30 (0%) 0/38 (0%) 0/32 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | --- 577 692 542 | --- --- --- 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.011 * P=0.020 * P=0.084 P=0.011 * | P=0.217 (e) (e) P=0.547 | |INCIDENTAL TUMOR | P=0.041 * P=0.044 * P=0.206 P=0.026 * | P=0.217 (e) (e) P=0.547 | |LOGISTIC REGRESSION | P=0.020 * P=0.031 * P=0.106 P=0.009 ** | P=0.217 (e) (e) P=0.547 | |COCHRAN-ARMITAGE | P=0.017 * | P=0.197 | |FISHER EXACT | P=0.028 * P=0.121 P=0.006 ** | (e) (e) P=0.500 | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/49 (2%) | |ADJUSTED (b) | 4.5% 9.4% 0.0% 8.8% | 0.0% 5.0% 3.1% 2.6% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | 0/30 (0%) 1/38 (3%) 1/32 (3%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 727 577 --- 668 | --- 705 735 (T) 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.532 P=0.285 P=0.564N P=0.409 | P=0.551 P=0.291 P=0.513 P=0.547 | |INCIDENTAL TUMOR | P=0.473N P=0.468 P=0.318N P=0.670N | P=0.479 P=0.240 P=0.513 P=0.547 | |LOGISTIC REGRESSION | P=0.571 P=0.307 P=0.554N P=0.495 | P=0.521 P=0.262 P=0.513 P=0.547 | |COCHRAN-ARMITAGE | P=0.562 | P=0.499 | |FISHER EXACT | P=0.309 P=0.500N P=0.500 | P=0.247 P=0.500 P=0.495 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/49 (2%) | |ADJUSTED (b) | 4.5% 9.4% 0.0% 8.8% | 0.0% 7.2% 3.1% 2.6% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | 0/30 (0%) 1/38 (3%) 1/32 (3%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 727 577 --- 668 | --- 679 735 (T) 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.532 P=0.285 P=0.564N P=0.409 | P=0.596N P=0.162 P=0.513 P=0.547 | |INCIDENTAL TUMOR | P=0.473N P=0.468 P=0.318N P=0.670N | P=0.522 P=0.106 P=0.513 P=0.547 | |LOGISTIC REGRESSION | P=0.571 P=0.307 P=0.554N P=0.495 | P=0.602 P=0.126 P=0.513 P=0.547 | |COCHRAN-ARMITAGE | P=0.562 | P=0.592 | |FISHER EXACT | P=0.309 P=0.500N P=0.500 | P=0.121 P=0.500 P=0.495 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/49 (2%) | |ADJUSTED (b) | 4.5% 9.4% 0.0% 8.8% | 0.0% 7.2% 3.1% 2.6% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | 0/30 (0%) 1/38 (3%) 1/32 (3%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 727 577 --- 668 | --- 679 735 (T) 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.532 P=0.285 P=0.564N P=0.409 | P=0.596N P=0.162 P=0.513 P=0.547 | |INCIDENTAL TUMOR | P=0.473N P=0.468 P=0.318N P=0.670N | P=0.522 P=0.106 P=0.513 P=0.547 | |LOGISTIC REGRESSION | P=0.571 P=0.307 P=0.554N P=0.495 | P=0.602 P=0.126 P=0.513 P=0.547 | |COCHRAN-ARMITAGE | P=0.562 | P=0.592 | |FISHER EXACT | P=0.309 P=0.500N P=0.500 | P=0.121 P=0.500 P=0.495 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 2/50 (4%) | |ADJUSTED (b) | 4.8% 6.7% 0.0% 7.7% | 10.0% 7.9% 3.1% 5.3% | |TERMINAL (d) | 1/21 (5%) 1/15 (7%) 0/15 (0%) 1/13 (8%) | 3/30 (10%) 3/38 (8%) 1/32 (3%) 2/38 (5%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- 729 (T) | 735 (T) 735 (T) 735 (T) 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.589 P=0.686 P=0.567N P=0.652 | P=0.276N P=0.550N P=0.281N P=0.392N | |INCIDENTAL TUMOR | P=0.589 P=0.686 P=0.567N P=0.652 | P=0.276N P=0.550N P=0.281N P=0.392N | |LOGISTIC REGRESSION | P=0.589 P=0.686 P=0.567N P=0.652 | P=0.276N P=0.550N P=0.281N P=0.392N | |COCHRAN-ARMITAGE | P=0.614N | P=0.341N | |FISHER EXACT | P=0.753N P=0.500N P=0.753N | P=0.661N P=0.309N P=0.500N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | 3/50 (6%) 4/50 (8%) 1/50 (2%) 2/50 (4%) | |ADJUSTED (b) | 4.8% 13.3% 0.0% 7.7% | 10.0% 10.5% 3.1% 5.3% | |TERMINAL (d) | 1/21 (5%) 2/15 (13%) 0/15 (0%) 1/13 (8%) | 3/30 (10%) 4/38 (11%) 1/32 (3%) 2/38 (5%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- 729 (T) | 735 (T) 735 (T) 735 (T) 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.623N P=0.382 P=0.567N P=0.652 | P=0.225N P=0.629 P=0.281N P=0.392N | |INCIDENTAL TUMOR | P=0.623N P=0.382 P=0.567N P=0.652 | P=0.225N P=0.629 P=0.281N P=0.392N | |LOGISTIC REGRESSION | P=0.623N P=0.382 P=0.567N P=0.652 | P=0.225N P=0.630 P=0.281N P=0.392N | |COCHRAN-ARMITAGE | P=0.495N | P=0.288N | |FISHER EXACT | P=0.500 P=0.500N P=0.753N | P=0.500 P=0.309N P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 4.2% 0.0% 6.7% 0.0% | 5.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 1/15 (7%) 0/13 (0%) | 1/30 (3%) 0/38 (0%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 715 --- 729 (T) --- | 594 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.486N P=0.557N P=0.683 P=0.569N | P=0.112N P=0.207N P=0.226N P=0.219N | |INCIDENTAL TUMOR | P=0.365N P=0.403N P=0.709N P=0.308N | P=0.125N P=0.266N P=0.213N P=0.304N | |LOGISTIC REGRESSION | P=0.450N P=0.524N P=0.737 P=0.524N | P=0.118N P=0.264N P=0.252N P=0.239N | |COCHRAN-ARMITAGE | P=0.409N | P=0.118N | |FISHER EXACT | P=0.500N P=0.753N P=0.500N | P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 8.8% 0.0% 0.0% 6.7% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | 2/30 (7%) 0/38 (0%) 0/32 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 594 --- --- 330 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.461 P=0.093N P=0.112N P=0.612N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.519N P=0.121N P=0.105N P=0.514N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.492 P=0.122N P=0.120N P=0.662N | |COCHRAN-ARMITAGE | (e) | P=0.438 | |FISHER EXACT | (e) (e) (e) | P=0.121N P=0.121N P=0.661N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 4/50 (8%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | |ADJUSTED (b) | 4.2% 0.0% 6.7% 0.0% | 12.0% 0.0% 0.0% 6.7% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 1/15 (7%) 0/13 (0%) | 3/30 (10%) 0/38 (0%) 0/32 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 715 --- 729 (T) --- | 594 --- --- 330 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.486N P=0.557N P=0.683 P=0.569N | P=0.554N P=0.043N* P=0.056N P=0.435N | |INCIDENTAL TUMOR | P=0.365N P=0.403N P=0.709N P=0.308N | P=0.325N P=0.056N P=0.053N P=0.330N | |LOGISTIC REGRESSION | P=0.450N P=0.524N P=0.737 P=0.524N | P=0.542N P=0.058N P=0.059N P=0.500N | |COCHRAN-ARMITAGE | P=0.409N | P=0.584N | |FISHER EXACT | P=0.500N P=0.753N P=0.500N | P=0.059N P=0.059N P=0.500N | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 2/50 (4%) 2/50 (4%) 1/50 (2%) | 30/50 (60%) 25/50 (50%) 17/50 (34%) 24/50 (48%) | |ADJUSTED (b) | 22.8% 10.9% 13.3% 7.7% | 83.2% 60.6% 50.0% 58.4% | |TERMINAL (d) | 3/21 (14%) 1/15 (7%) 2/15 (13%) 1/13 (8%) | 24/30 (80%) 22/38 (58%) 15/32 (47%) 21/38 (55%) | |FIRST INCIDENCE (DAYS) | 534 693 729 (T) 729 (T) | 606 435 729 506 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.092N P=0.231N P=0.235N P=0.131N | P=0.026N* P=0.019N* P=0.002N** P=0.014N* | |INCIDENTAL TUMOR | P=0.049N* P=0.138N P=0.142N P=0.063N | P=0.067N P=0.046N* P=0.002N** P=0.083N | |LOGISTIC REGRESSION | P=0.041N* P=0.138N P=0.120N P=0.054N | P=0.060N P=0.050N* P<0.001N** P=0.075N | |COCHRAN-ARMITAGE | P=0.043N* | P=0.125N | |FISHER EXACT | P=0.134N P=0.134N P=0.056N | P=0.211N P=0.008N** P=0.158N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 7/50 (14%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | 32/50 (64%) 25/50 (50%) 17/50 (34%) 24/50 (48%) | |ADJUSTED (b) | 26.0% 10.9% 20.0% 7.7% | 86.3% 60.6% 50.0% 58.4% | |TERMINAL (d) | 3/21 (14%) 1/15 (7%) 3/15 (20%) 1/13 (8%) | 25/30 (83%) 22/38 (58%) 15/32 (47%) 21/38 (55%) | |FIRST INCIDENCE (DAYS) | 534 693 729 (T) 729 (T) | 594 435 729 506 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.075N P=0.162N P=0.295N P=0.088N | P=0.011N* P=0.007N** P<0.001N** P=0.005N** | |INCIDENTAL TUMOR | P=0.030N* P=0.068N P=0.143N P=0.022N* | P=0.034N* P=0.019N* P<0.001N** P=0.039N* | |LOGISTIC REGRESSION | P=0.030N* P=0.084N P=0.142N P=0.030N* | P=0.047N* P=0.021N* P<0.001N** P=0.033N* | |COCHRAN-ARMITAGE | P=0.030N* | P=0.070N | |FISHER EXACT | P=0.080N P=0.159N P=0.030N* | P=0.113N P=0.002N** P=0.079N | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 7/50 (14%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | 32/50 (64%) 25/50 (50%) 17/50 (34%) 25/50 (50%) | |ADJUSTED (b) | 26.0% 10.9% 20.0% 7.7% | 86.3% 60.6% 50.0% 59.2% | |TERMINAL (d) | 3/21 (14%) 1/15 (7%) 3/15 (20%) 1/13 (8%) | 25/30 (83%) 22/38 (58%) 15/32 (47%) 21/38 (55%) | |FIRST INCIDENCE (DAYS) | 534 693 729 (T) 729 (T) | 594 435 729 330 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.075N P=0.162N P=0.295N P=0.088N | P=0.021N* P=0.007N** P<0.001N** P=0.009N** | |INCIDENTAL TUMOR | P=0.030N* P=0.068N P=0.143N P=0.022N* | P=0.034N* P=0.019N* P<0.001N** P=0.039N* | |LOGISTIC REGRESSION | P=0.030N* P=0.084N P=0.142N P=0.030N* | P=0.043N* P=0.021N* P<0.001N** P=0.073N | |COCHRAN-ARMITAGE | P=0.030N* | P=0.103N | |FISHER EXACT | P=0.080N P=0.159N P=0.030N* | P=0.113N P=0.002N** P=0.113N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.9% 0.0% 0.0% 0.0% | 0.0% 5.1% 0.0% 0.0% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | 0/30 (0%) 1/38 (3%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 601 --- --- --- | --- 717 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.289N P=0.489N P=0.459N P=0.473N | P=0.366N P=0.292 (e) (e) | |INCIDENTAL TUMOR | P=0.325N P=0.425N P=0.519N P=0.500N | P=0.461N P=0.240 (e) (e) | |LOGISTIC REGRESSION | P=0.330N P=0.522N P=0.519N P=0.539N | P=0.384N P=0.271 (e) (e) | |COCHRAN-ARMITAGE | P=0.309N | P=0.394N | |FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.247 (e) (e) | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 3.2% 0.0% | 5.1% 2.6% 0.0% 0.0% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | 0/30 (0%) 1/38 (3%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 664 --- | 370 735 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.704 (e) P=0.520 (e) | P=0.093N P=0.453N P=0.230N P=0.222N | |INCIDENTAL TUMOR | P=0.711N (e) P=0.682 (e) | P=0.120N P=0.661N P=0.336N P=0.362N | |LOGISTIC REGRESSION | P=0.695 (e) P=0.505 (e) | P=0.094N P=0.657N P=0.343N P=0.216N | |COCHRAN-ARMITAGE | P=0.691 | P=0.101N | |FISHER EXACT | (e) P=0.500 (e) | P=0.500N P=0.247N P=0.247N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.9% 0.0% 3.2% 0.0% | 5.1% 7.6% 0.0% 0.0% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | 0/30 (0%) 2/38 (5%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 601 --- 664 --- | 370 717 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.384N P=0.489N P=0.726N P=0.473N | P=0.061N P=0.577 P=0.230N P=0.222N | |INCIDENTAL TUMOR | P=0.337N P=0.425N P=0.677N P=0.500N | P=0.093N P=0.377 P=0.336N P=0.362N | |LOGISTIC REGRESSION | P=0.422N P=0.522N P=0.757 P=0.539N | P=0.070N P=0.408 P=0.343N P=0.216N | |COCHRAN-ARMITAGE | P=0.409N | P=0.071N | |FISHER EXACT | P=0.500N P=0.753N P=0.500N | P=0.500 P=0.247N P=0.247N | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.9% 0.0% 0.0% 0.0% | 0.0% 5.1% 0.0% 0.0% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | 0/30 (0%) 1/38 (3%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 601 --- --- --- | --- 717 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.289N P=0.489N P=0.459N P=0.473N | P=0.366N P=0.292 (e) (e) | |INCIDENTAL TUMOR | P=0.325N P=0.425N P=0.519N P=0.500N | P=0.461N P=0.240 (e) (e) | |LOGISTIC REGRESSION | P=0.330N P=0.522N P=0.519N P=0.539N | P=0.384N P=0.271 (e) (e) | |COCHRAN-ARMITAGE | P=0.309N | P=0.394N | |FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.247 (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | | 0.0% 5.3% 0.0% 0.0% | |TERMINAL (d) | | 0/30 (0%) 2/38 (5%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | | --- 735 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.363N P=0.292 (e) (e) | |INCIDENTAL TUMOR | | P=0.363N P=0.292 (e) (e) | |LOGISTIC REGRESSION | | P=0.363N P=0.292 (e) (e) | |COCHRAN-ARMITAGE | | P=0.394N | |FISHER EXACT | | P=0.247 (e) (e) | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | | 0.0% 5.3% 3.1% 0.0% | |TERMINAL (d) | | 0/30 (0%) 2/38 (5%) 1/32 (3%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | | --- 735 (T) 735 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.413N P=0.292 P=0.513 (e) | |INCIDENTAL TUMOR | | P=0.413N P=0.292 P=0.513 (e) | |LOGISTIC REGRESSION | | P=0.413N P=0.292 P=0.513 (e) | |COCHRAN-ARMITAGE | | P=0.453N | |FISHER EXACT | | P=0.247 P=0.500 (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/47 (2%) | 0/49 (0%) 0/49 (0%) 0/49 (0%) 1/46 (2%) | |ADJUSTED (b) | 4.8% 0.0% 12.5% 7.7% | 0.0% 0.0% 0.0% 2.6% | |TERMINAL (d) | 1/21 (5%) 0/15 (0%) 1/15 (7%) 1/13 (8%) | 0/30 (0%) 0/38 (0%) 0/32 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 727 729 (T) | --- --- --- 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.364 P=0.567N P=0.386 P=0.652 | P=0.217 (e) (e) P=0.547 | |INCIDENTAL TUMOR | P=0.453 P=0.567N P=0.523 P=0.652 | P=0.217 (e) (e) P=0.547 | |LOGISTIC REGRESSION | P=0.365 P=0.567N P=0.388 P=0.652 | P=0.217 (e) (e) P=0.547 | |COCHRAN-ARMITAGE | P=0.476 | P=0.188 | |FISHER EXACT | P=0.500N P=0.500 P=0.737 | (e) (e) P=0.484 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 11/50 (22%) 16/50 (32%) 11/50 (22%) | 35/50 (70%) 32/49 (65%) 29/50 (58%) 25/47 (53%) | |ADJUSTED (b) | 42.9% 50.8% 67.3% 51.3% | 89.5% 77.7% 75.6% 63.9% | |TERMINAL (d) | 6/21 (29%) 6/15 (40%) 8/15 (53%) 5/13 (38%) | 26/30 (87%) 28/37 (76%) 23/32 (72%) 23/37 (62%) | |FIRST INCIDENCE (DAYS) | 407 610 623 542 | 370 571 391 506 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.362 P=0.555 P=0.169 P=0.528 | P=0.002N** P=0.040N* P=0.078N P=0.002N** | |INCIDENTAL TUMOR | P=0.438N P=0.416N P=0.440 P=0.460N | P=0.011N* P=0.114N P=0.105N P=0.022N* | |LOGISTIC REGRESSION | P=0.390N P=0.391N P=0.388 P=0.367N | P=0.032N* P=0.154N P=0.090N P=0.034N* | |COCHRAN-ARMITAGE | P=0.449N | P=0.044N* | |FISHER EXACT | P=0.408N P=0.330 P=0.408N | P=0.388N P=0.149N P=0.067N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 11/50 (22%) 16/50 (32%) 11/50 (22%) | 36/50 (72%) 32/49 (65%) 29/50 (58%) 25/47 (53%) | |ADJUSTED (b) | 42.9% 50.8% 67.3% 51.3% | 89.8% 77.7% 75.6% 63.9% | |TERMINAL (d) | 6/21 (29%) 6/15 (40%) 8/15 (53%) 5/13 (38%) | 26/30 (87%) 28/37 (76%) 23/32 (72%) 23/37 (62%) | |FIRST INCIDENCE (DAYS) | 407 610 623 542 | 370 571 391 506 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.362 P=0.555 P=0.169 P=0.528 | P=0.001N** P=0.027N* P=0.055N P<0.001N** | |INCIDENTAL TUMOR | P=0.438N P=0.416N P=0.440 P=0.460N | P=0.008N** P=0.079N P=0.070N P=0.018N* | |LOGISTIC REGRESSION | P=0.390N P=0.391N P=0.388 P=0.367N | P=0.021N* P=0.102N P=0.057N P=0.020N* | |COCHRAN-ARMITAGE | P=0.449N | P=0.030N* | |FISHER EXACT | P=0.408N P=0.330 P=0.408N | P=0.308N P=0.104N P=0.044N* | |=================================================================================================================================| | | |Prostate | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | |ADJUSTED (b) | 9.5% 0.0% 0.0% 0.0% | | |TERMINAL (d) | 2/21 (10%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.163N P=0.314N P=0.314N P=0.348N | | |INCIDENTAL TUMOR | P=0.163N P=0.314N P=0.314N P=0.348N | | |LOGISTIC REGRESSION | P=0.163N P=0.314N P=0.314N P=0.348N | | |COCHRAN-ARMITAGE | P=0.118N | | |FISHER EXACT | P=0.247N P=0.247N P=0.247N | | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 8.3% 0.0% 6.7% 0.0% | 0.0% 0.0% 0.0% 2.6% | |TERMINAL (d) | 1/21 (5%) 0/15 (0%) 1/15 (7%) 0/13 (0%) | 0/30 (0%) 0/38 (0%) 0/32 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 685 --- 729 (T) --- | --- --- --- 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.254N P=0.290N P=0.591N P=0.311N | P=0.217 (e) (e) P=0.547 | |INCIDENTAL TUMOR | P=0.188N P=0.219N P=0.477N P=0.179N | P=0.217 (e) (e) P=0.547 | |LOGISTIC REGRESSION | P=0.205N P=0.251N P=0.513N P=0.244N | P=0.217 (e) (e) P=0.547 | |COCHRAN-ARMITAGE | P=0.192N | P=0.197 | |FISHER EXACT | P=0.247N P=0.500N P=0.247N | (e) (e) P=0.500 | |=================================================================================================================================| | | |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) | 5/50 (10%) 3/50 (6%) 3/50 (6%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 22.0% 15.2% 15.4% 2.1% | 3.3% 0.0% 0.0% 2.6% | |TERMINAL (d) | 4/21 (19%) 1/15 (7%) 2/15 (13%) 0/13 (0%) | 1/30 (3%) 0/38 (0%) 0/32 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 685 693 622 528 | 735 (T) --- --- 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.141N P=0.512N P=0.484N P=0.190N | P=0.623 P=0.453N P=0.487N P=0.708N | |INCIDENTAL TUMOR | P=0.094N P=0.368N P=0.442N P=0.159N | P=0.623 P=0.453N P=0.487N P=0.708N | |LOGISTIC REGRESSION | P=0.073N P=0.416N P=0.353N P=0.095N | P=0.623 P=0.453N P=0.487N P=0.708N | |COCHRAN-ARMITAGE | P=0.080N | P=0.591 | |FISHER EXACT | P=0.357N P=0.357N P=0.102N | P=0.500N P=0.500N P=0.753N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 10.8% 4.8% 6.7% 8.0% | 2.5% 5.3% 0.0% 2.6% | |TERMINAL (d) | 1/21 (5%) 0/15 (0%) 1/15 (7%) 0/13 (0%) | 0/30 (0%) 2/38 (5%) 0/32 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 534 561 729 (T) 673 | 648 735 (T) --- 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.448N P=0.526N P=0.385N P=0.568N | P=0.460N P=0.571 P=0.495N P=0.732N | |INCIDENTAL TUMOR | P=0.356N P=0.445N P=0.326N P=0.332N | P=0.521N P=0.529 P=0.500N P=0.672 | |LOGISTIC REGRESSION | P=0.407N P=0.518N P=0.292N P=0.488N | P=0.493N P=0.517 P=0.527N P=0.761N | |COCHRAN-ARMITAGE | P=0.404N | P=0.495N | |FISHER EXACT | P=0.500N P=0.309N P=0.500N | P=0.500 P=0.500N P=0.753N | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 17.5% 10.9% 15.4% 2.1% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/21 (14%) 1/15 (7%) 2/15 (13%) 0/13 (0%) | 0/30 (0%) 0/38 (0%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 685 693 622 528 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.245N P=0.468N P=0.614N P=0.276N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.207N P=0.363N P=0.573N P=0.236N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.153N P=0.391N P=0.493N P=0.168N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.164N | (e) | |FISHER EXACT | P=0.339N P=0.500N P=0.181N | (e) (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Skin | | Schwannoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 7.6% 0.0% 0.0% 11.9% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/21 (5%) 0/15 (0%) 0/15 (0%) 1/13 (8%) | 0/30 (0%) 0/38 (0%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 608 --- --- 570 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.220 P=0.266N P=0.251N P=0.457 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.171 P=0.232N P=0.288N P=0.413 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.234 P=0.235N P=0.231N P=0.493 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.241 | (e) | |FISHER EXACT | P=0.247N P=0.247N P=0.500 | (e) (e) (e) | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) 3/50 (6%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 17.5% 15.2% 15.4% 2.1% | 3.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/21 (14%) 1/15 (7%) 2/15 (13%) 0/13 (0%) | 1/30 (3%) 0/38 (0%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 685 693 622 528 | 735 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.212N P=0.640N P=0.614N P=0.276N | P=0.290N P=0.453N P=0.487N P=0.453N | |INCIDENTAL TUMOR | P=0.148N P=0.492N P=0.573N P=0.236N | P=0.290N P=0.453N P=0.487N P=0.453N | |LOGISTIC REGRESSION | P=0.125N P=0.556N P=0.493N P=0.168N | P=0.290N P=0.453N P=0.487N P=0.453N | |COCHRAN-ARMITAGE | P=0.136N | P=0.309N | |FISHER EXACT | P=0.500N P=0.500N P=0.181N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 17.5% 10.9% 15.4% 2.1% | 3.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/21 (14%) 1/15 (7%) 2/15 (13%) 0/13 (0%) | 1/30 (3%) 0/38 (0%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 685 693 622 528 | 735 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.245N P=0.468N P=0.614N P=0.276N | P=0.290N P=0.453N P=0.487N P=0.453N | |INCIDENTAL TUMOR | P=0.207N P=0.363N P=0.573N P=0.236N | P=0.290N P=0.453N P=0.487N P=0.453N | |LOGISTIC REGRESSION | P=0.153N P=0.391N P=0.493N P=0.168N | P=0.290N P=0.453N P=0.487N P=0.453N | |COCHRAN-ARMITAGE | P=0.164N | P=0.309N | |FISHER EXACT | P=0.339N P=0.500N P=0.181N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 46/50 (92%) 46/50 (92%) 49/50 (98%) 49/50 (98%) | | |ADJUSTED (b) | 100.0% 97.8% 100.0% 100.0% | | |TERMINAL (d) | 21/21 (100%) 14/15 (93%) 15/15 (100%) 13/13 (100%)| | |FIRST INCIDENCE (DAYS) | 486 458 372 485 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.112 P=0.233 P=0.180 P=0.103 | | |INCIDENTAL TUMOR | P=0.270 P=0.403N P=0.621 P=0.448 | | |LOGISTIC REGRESSION | P=0.223 P=0.365N P=0.225 P=0.680 | | |COCHRAN-ARMITAGE | P=0.076 | | |FISHER EXACT | P=0.643N P=0.181 P=0.181 | | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 2/50 (4%) 3/49 (6%) 4/49 (8%) | 7/50 (14%) 5/50 (10%) 7/50 (14%) 7/48 (15%) | |ADJUSTED (b) | 35.3% 8.2% 13.7% 12.3% | 21.2% 12.6% 20.5% 18.4% | |TERMINAL (d) | 6/21 (29%) 0/15 (0%) 1/15 (7%) 0/13 (0%) | 5/30 (17%) 4/38 (11%) 5/32 (16%) 7/38 (18%) | |FIRST INCIDENCE (DAYS) | 571 531 623 570 | 659 679 717 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.216N P=0.061N P=0.111N P=0.214N | P=0.524N P=0.241N P=0.557N P=0.440N | |INCIDENTAL TUMOR | P=0.145N P=0.033N* P=0.076N P=0.116N | P=0.416 P=0.297N P=0.578N P=0.610N | |LOGISTIC REGRESSION | P=0.137N P=0.026N* P=0.055N P=0.108N | P=0.493 P=0.293N P=0.549N P=0.561N | |COCHRAN-ARMITAGE | P=0.152N | P=0.435 | |FISHER EXACT | P=0.026N* P=0.065N P=0.125N | P=0.380N P=0.613N P=0.581 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 2/49 (4%) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 2/48 (4%) | |ADJUSTED (b) | 0.0% 0.0% 6.7% 11.3% | 3.3% 7.4% 0.0% 5.3% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 1/15 (7%) 0/13 (0%) | 1/30 (3%) 2/38 (5%) 0/32 (0%) 2/38 (5%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) 700 | 735 (T) 674 --- 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.044 * (e) P=0.433 P=0.168 | P=0.606N P=0.390 P=0.487N P=0.583 | |INCIDENTAL TUMOR | P=0.103 (e) P=0.433 P=0.455 | P=0.552 P=0.350 P=0.487N P=0.583 | |LOGISTIC REGRESSION | P=0.057 (e) P=0.433 P=0.219 | P=0.568 P=0.346 P=0.487N P=0.583 | |COCHRAN-ARMITAGE | P=0.067 | P=0.547 | |FISHER EXACT | (e) P=0.495 P=0.242 | P=0.309 P=0.500N P=0.485 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 2/50 (4%) 4/49 (8%) 6/49 (12%) | 8/50 (16%) 8/50 (16%) 7/50 (14%) 9/48 (19%) | |ADJUSTED (b) | 35.3% 8.2% 19.9% 22.2% | 24.3% 19.6% 20.5% 23.7% | |TERMINAL (d) | 6/21 (29%) 0/15 (0%) 2/15 (13%) 0/13 (0%) | 6/30 (20%) 6/38 (16%) 5/32 (16%) 9/38 (24%) | |FIRST INCIDENCE (DAYS) | 571 531 623 570 | 659 674 717 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.532N P=0.061N P=0.200N P=0.459N | P=0.520N P=0.419N P=0.442N P=0.514N | |INCIDENTAL TUMOR | P=0.369N P=0.033N* P=0.152N P=0.212N | P=0.394 P=0.504N P=0.460N P=0.548 | |LOGISTIC REGRESSION | P=0.386N P=0.026N* P=0.106N P=0.271N | P=0.471 P=0.503N P=0.429N P=0.574 | |COCHRAN-ARMITAGE | P=0.417N | P=0.410 | |FISHER EXACT | P=0.026N* P=0.125N P=0.303N | P=0.607N P=0.500N P=0.463 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/49 (4%) 3/49 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | |ADJUSTED (b) | 0.0% 3.6% 13.3% 16.1% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 2/15 (13%) 1/13 (8%) | 0/30 (0%) 0/38 (0%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | --- 646 729 (T) 685 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.039 * P=0.493 P=0.166 P=0.076 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.080 P=0.597 P=0.166 P=0.193 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.057 P=0.500 P=0.166 P=0.110 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.059 | (e) | |FISHER EXACT | P=0.500 P=0.242 P=0.117 | (e) (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/49 (4%) 3/49 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | |ADJUSTED (b) | 2.4% 3.6% 13.3% 16.1% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 2/15 (13%) 1/13 (8%) | 0/30 (0%) 0/38 (0%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 529 646 729 (T) 685 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.121 P=0.752N P=0.430 P=0.241 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.183 P=0.743N P=0.369 P=0.372 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.168 P=0.735 P=0.500 P=0.305 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.158 | (e) | |FISHER EXACT | P=0.753N P=0.492 P=0.301 | (e) (e) (e) | |=================================================================================================================================| | | |Tongue | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.1% 2.6% 0.0% 0.0% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | 0/30 (0%) 1/38 (3%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 370 735 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.093N P=0.453N P=0.230N P=0.222N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.120N P=0.661N P=0.336N P=0.362N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.094N P=0.657N P=0.343N P=0.216N | |COCHRAN-ARMITAGE | (e) | P=0.101N | |FISHER EXACT | (e) (e) (e) | P=0.500N P=0.247N P=0.247N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 26 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 4/50 (8%) 8/50 (16%) 6/50 (12%) 5/50 (10%) | |ADJUSTED (b) | | 12.6% 19.6% 17.8% 12.7% | |TERMINAL (d) | | 3/30 (10%) 6/38 (16%) 5/32 (16%) 4/38 (11%) | |FIRST INCIDENCE (DAYS) | | 700 435 697 697 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.431N P=0.299 P=0.412 P=0.632 | |INCIDENTAL TUMOR | | P=0.543N P=0.188 P=0.402 P=0.463 | |LOGISTIC REGRESSION | | P=0.533N P=0.197 P=0.424 P=0.558 | |COCHRAN-ARMITAGE | | P=0.539N | |FISHER EXACT | | P=0.178 P=0.370 P=0.500 | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 5/50 (10%) 8/50 (16%) 6/50 (12%) 5/50 (10%) | |ADJUSTED (b) | | 14.7% 19.6% 17.8% 12.7% | |TERMINAL (d) | | 3/30 (10%) 6/38 (16%) 5/32 (16%) 4/38 (11%) | |FIRST INCIDENCE (DAYS) | | 606 435 697 697 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.338N P=0.422 P=0.547 P=0.504N | |INCIDENTAL TUMOR | | P=0.457N P=0.267 P=0.544 P=0.544 | |LOGISTIC REGRESSION | | P=0.434N P=0.277 P=0.547 P=0.606N | |COCHRAN-ARMITAGE | | P=0.437N | |FISHER EXACT | | P=0.277 P=0.500 P=0.630N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 27 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.7% 0.0% 0.0% 10.0% | 0.0% 2.6% 0.0% 0.0% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 0/15 (0%) 1/13 (8%) | 0/30 (0%) 1/38 (3%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 577 --- --- 612 | --- 735 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.235 P=0.480N P=0.461N P=0.485 | P=0.535N P=0.547 (e) (e) | |INCIDENTAL TUMOR | P=0.190 P=0.425N P=0.519N P=0.445 | P=0.535N P=0.547 (e) (e) | |LOGISTIC REGRESSION | P=0.233 P=0.540N P=0.530N P=0.488 | P=0.535N P=0.547 (e) (e) | |COCHRAN-ARMITAGE | P=0.243 | P=0.559N | |FISHER EXACT | P=0.500N P=0.500N P=0.500 | P=0.500 (e) (e) | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.7% 0.0% 4.8% 10.0% | 0.0% 2.6% 0.0% 0.0% | |TERMINAL (d) | 0/21 (0%) 0/15 (0%) 0/15 (0%) 1/13 (8%) | 0/30 (0%) 1/38 (3%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 577 --- 701 612 | --- 735 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.223 P=0.480N P=0.759 P=0.485 | P=0.535N P=0.547 (e) (e) | |INCIDENTAL TUMOR | P=0.245 P=0.425N P=0.677N P=0.445 | P=0.535N P=0.547 (e) (e) | |LOGISTIC REGRESSION | P=0.244 P=0.540N P=0.760 P=0.488 | P=0.535N P=0.547 (e) (e) | |COCHRAN-ARMITAGE | P=0.244 | P=0.559N | |FISHER EXACT | P=0.500N P=0.753N P=0.500 | P=0.500 (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 28 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 31/50 (62%) 27/50 (54%) 24/50 (48%) 29/50 (58%) | 21/50 (42%) 21/50 (42%) 17/50 (34%) 14/50 (28%) | |ADJUSTED (b) | 76.0% 67.6% 65.0% 87.4% | 54.3% 44.4% 39.8% 31.4% | |TERMINAL (d) | 12/21 (57%) 5/15 (33%) 5/15 (33%) 10/13 (77%) | 13/30 (43%) 12/38 (32%) 7/32 (22%) 8/38 (21%) | |FIRST INCIDENCE (DAYS) | 330 458 383 524 | 515 549 601 434 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.448 P=0.503N P=0.284N P=0.412 | P=0.040N* P=0.285N P=0.212N P=0.046N* | |INCIDENTAL TUMOR | P=0.513N P=0.209N P=0.080N P=0.531 | P=0.200N P=0.578 P=0.223N P=0.235N | |LOGISTIC REGRESSION | P=0.457N P=0.291N P=0.116N P=0.421N | P=0.107N P=0.571N P=0.224N P=0.101N | |COCHRAN-ARMITAGE | P=0.416N | P=0.058N | |FISHER EXACT | P=0.272N P=0.114N P=0.419N | P=0.580N P=0.268N P=0.104N | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 8.4% 7.3% 0.0% 5.7% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/21 (5%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | 0/30 (0%) 0/38 (0%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 704 646 --- 636 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.564N P=0.623 P=0.308N P=0.651 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.382N P=0.595N P=0.173N P=0.572N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.541N P=0.694 P=0.247N P=0.682N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.553N | (e) | |FISHER EXACT | P=0.691N P=0.247N P=0.691N | (e) (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 29 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 47/50 (94%) 50/50 (100%) 49/50 (98%) 50/50 (100%)| 43/50 (86%) 49/50 (98%) 42/50 (84%) 41/50 (82%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 100.0% 100.0% 95.4% 95.3% | |TERMINAL (d) | 21/21 (100%) 15/15 (100%) 15/15 (100%) 13/13 (100%)| 30/30 (100%) 38/38 (100%) 30/32 (94%) 36/38 (95%) | |FIRST INCIDENCE (DAYS) | 407 458 372 485 | 370 435 391 506 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.148 P=0.136 P=0.219 P=0.107 | P=0.014N* P=0.289N P=0.281N P=0.016N* | |INCIDENTAL TUMOR | P=0.472 P=0.425 P=0.698N P=0.500 | P=0.129N P=0.220 P=0.352N P=0.391N | |LOGISTIC REGRESSION | P=0.354 P=0.456 P=0.480 P=0.602 | P=0.126N P=0.147 P=0.301N P=0.335N | |COCHRAN-ARMITAGE | P=0.089 | P=0.111N | |FISHER EXACT | P=0.121 P=0.309 P=0.121 | P=0.030 * P=0.500N P=0.393N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 35/50 (70%) 36/50 (72%) 31/50 (62%) 33/50 (66%) | 30/50 (60%) 25/50 (50%) 21/50 (42%) 23/50 (46%) | |ADJUSTED (b) | 80.2% 84.2% 81.6% 89.6% | 69.0% 52.9% 47.0% 47.5% | |TERMINAL (d) | 13/21 (62%) 9/15 (60%) 9/15 (60%) 10/13 (77%) | 17/30 (57%) 16/38 (42%) 9/32 (28%) 13/38 (34%) | |FIRST INCIDENCE (DAYS) | 330 458 383 524 | 370 549 568 271 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.467 P=0.297 P=0.491N P=0.399 | P=0.071N P=0.066N P=0.058N P=0.055N | |INCIDENTAL TUMOR | P=0.291N P=0.554N P=0.199N P=0.529N | P=0.151N P=0.272N P=0.045N* P=0.146N | |LOGISTIC REGRESSION | P=0.297N P=0.486 P=0.253N P=0.420N | P=0.096N P=0.239N P=0.061N P=0.127N | |COCHRAN-ARMITAGE | P=0.294N | P=0.103N | |FISHER EXACT | P=0.500 P=0.263N P=0.415N | P=0.211N P=0.055N P=0.115N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 PAGE 30 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENOLPHTHALEIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 12000 25000 50000 | 0 PPM 12000 25000 50000 | | | PPM PPM PPM | PPM PPM PPM | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 49/50 (98%) 50/50 (100%) 50/50 (100%) 50/50 (100%)| 49/50 (98%) 50/50 (100%) 50/50 (100%) 49/50 (98%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 100.0% 100.0% 100.0% 98.0% | |TERMINAL (d) | 21/21 (100%) 15/15 (100%) 15/15 (100%) 13/13 (100%)| 30/30 (100%) 38/38 (100%) 32/32 (100%) 37/38 (97%) | |FIRST INCIDENCE (DAYS) | 330 458 372 485 | 370 435 391 271 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.201 P=0.206 P=0.268 P=0.167 | P=0.131N P=0.073N P=0.401N P=0.086N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.627N P=0.814 P=0.682 P=0.734 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.627N P=0.834 P=0.716 P=0.758 | |COCHRAN-ARMITAGE | P=0.309 | P=0.591N | |FISHER EXACT | P=0.500 P=0.500 P=0.500 | P=0.500 P=0.500 P=0.753N | |=================================================================================================================================| (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).