TDMS Study 05100-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus TRICRESYL PHOSPHATE DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 TIME: 14:27:13 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-45050 ROUTE: DOSED FEED NTP C#: 10277D PATHOLOGIST: M. RYAN CAS: 1330-78-5 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus TRICRESYL PHOSPHATE DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 TIME: 14:27:13 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-45050 ROUTE: DOSED FEED NTP C#: 10277D PATHOLOGIST: M. RYAN CAS: 1330-78-5 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: Battelle Columbus TRICRESYL PHOSPHATE DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 TIME: 14:27:13 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-45050 ROUTE: DOSED FEED NTP C#: 10277D PATHOLOGIST: M. RYAN CAS: 1330-78-5 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF TRICRESYL PHOSPHATE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Skin Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma Testes Adenoma Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/79 (1%) 2/79 (3%) 2/80 (3%) 3/79 (4%) 0/30 (0%) | |ADJUSTED (b) | 3.2% 6.1% 5.3% 11.1% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/31 (3%) 1/29 (3%) 1/35 (3%) 3/27 (11%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) 690 701 729 (T) --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.272 P=0.478 P=0.534 P=0.256 (e) | |INCIDENTAL TUMOR | P=0.275 P=0.461 P=0.440 P=0.256 (e) | |LOGISTIC REGRESSION | P=0.287 P=0.477 P=0.514 P=0.256 (e) | |COCHRAN-ARMITAGE | P=0.605N | |FISHER EXACT | P=0.500 P=0.505 P=0.310 P=0.725N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 5/79 (6%) 7/80 (9%) 9/80 (11%) 5/80 (6%) 0/28 (0%) | |ADJUSTED (b) | 16.1% 20.6% 24.3% 16.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 5/31 (16%) 5/30 (17%) 7/35 (20%) 4/28 (14%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) 586 722 656 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.584 P=0.357 P=0.263 P=0.568 (e) | |INCIDENTAL TUMOR | P=0.605 P=0.379 P=0.187 P=0.566 (e) | |LOGISTIC REGRESSION | P=0.601N P=0.357 P=0.247 P=0.580 (e) | |COCHRAN-ARMITAGE | P=0.140N | |FISHER EXACT | P=0.392 P=0.208 P=0.619N P=0.212N | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 7/79 (9%) 8/80 (10%) 9/80 (11%) 5/80 (6%) 0/28 (0%) | |ADJUSTED (b) | 22.6% 22.7% 24.3% 16.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 7/31 (23%) 5/30 (17%) 7/35 (20%) 4/28 (14%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) 586 722 656 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.413N P=0.472 P=0.493 P=0.450N (e) | |INCIDENTAL TUMOR | P=0.394N P=0.486 P=0.400 P=0.451N (e) | |LOGISTIC REGRESSION | P=0.362N P=0.476 P=0.481 P=0.441N (e) | |COCHRAN-ARMITAGE | P=0.062N | |FISHER EXACT | P=0.510 P=0.407 P=0.374N P=0.111N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 4/79 (5%) 3/79 (4%) 3/77 (4%) 3/79 (4%) 0/30 (0%) | |ADJUSTED (b) | 11.6% 9.1% 8.6% 8.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/9 (11%) 0/10 (0%) | |TERMINAL (d) | 3/31 (10%) 2/29 (7%) 3/35 (9%) 1/28 (4%) 0/0 | |FIRST INCIDENCE (DAYS) | 558 614 729 (T) 455 (I) --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.455N P=0.529N P=0.448N P=0.550N (e) | |INCIDENTAL TUMOR | P=0.398N P=0.440N P=0.426N P=0.481N (e) | |LOGISTIC REGRESSION | P=0.431N P=0.521N P=0.499N P=0.503N P=0.845N | |COCHRAN-ARMITAGE | P=0.197N | |FISHER EXACT | P=0.500N P=0.514N P=0.500N P=0.270N | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 4/79 (5%) 4/79 (5%) 3/77 (4%) 3/79 (4%) 0/30 (0%) | |ADJUSTED (b) | 11.6% 12.4% 8.6% 8.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/9 (11%) 0/10 (0%) | |TERMINAL (d) | 3/31 (10%) 3/29 (10%) 3/35 (9%) 1/28 (4%) 0/0 | |FIRST INCIDENCE (DAYS) | 558 614 729 (T) 455 (I) --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.408N P=0.612 P=0.448N P=0.550N (e) | |INCIDENTAL TUMOR | P=0.354N P=0.597N P=0.426N P=0.481N (e) | |LOGISTIC REGRESSION | P=0.386N P=0.621 P=0.499N P=0.503N P=0.845N | |COCHRAN-ARMITAGE | P=0.164N | |FISHER EXACT | P=0.640N P=0.514N P=0.500N P=0.270N | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 3/80 (4%) 0/80 (0%) 3/79 (4%) 1/80 (1%) 1/30 (3%) | |ADJUSTED (b) | 7.5% 0.0% 8.3% 3.6% 10.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 1/32 (3%) 0/30 (0%) 2/35 (6%) 1/28 (4%) 0/0 | |FIRST INCIDENCE (DAYS) | 455 (I) --- 722 729 (T) 455 (I) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.509 P=0.133N P=0.626N P=0.349N P=0.766 | |INCIDENTAL TUMOR | P=0.512 P=0.140N P=0.565 P=0.340N P=0.766 | |LOGISTIC REGRESSION | P=0.442 P=0.125N P=0.657 P=0.312N P=0.572 | |COCHRAN-ARMITAGE | P=0.607N | |FISHER EXACT | P=0.123N P=0.653 P=0.310N P=0.701N | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 3/80 (4%) 1/80 (1%) 3/79 (4%) 1/80 (1%) 1/30 (3%) | |ADJUSTED (b) | 7.5% 3.3% 8.3% 3.6% 10.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 1/32 (3%) 1/30 (3%) 2/35 (6%) 1/28 (4%) 0/0 | |FIRST INCIDENCE (DAYS) | 455 (I) 729 (T) 722 729 (T) 455 (I) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.560 P=0.328N P=0.626N P=0.349N P=0.766 | |INCIDENTAL TUMOR | P=0.561 P=0.337N P=0.565 P=0.340N P=0.766 | |LOGISTIC REGRESSION | P=0.500 P=0.315N P=0.657 P=0.312N P=0.572 | |COCHRAN-ARMITAGE | P=0.525N | |FISHER EXACT | P=0.310N P=0.653 P=0.310N P=0.701N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/80 (1%) 0/80 (0%) 0/80 (0%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 3.1% 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/32 (3%) 0/30 (0%) 0/35 (0%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.584N P=0.513N P=0.482N P=0.527N (e) | |INCIDENTAL TUMOR | P=0.584N P=0.513N P=0.482N P=0.527N (e) | |LOGISTIC REGRESSION | P=0.584N P=0.513N P=0.482N P=0.527N (e) | |COCHRAN-ARMITAGE | P=0.449N | |FISHER EXACT | P=0.500N P=0.500N P=0.500N P=0.727N | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/80 (0%) 0/80 (0%) 0/80 (0%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/32 (0%) 0/30 (0%) 0/35 (0%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) (e) | |COCHRAN-ARMITAGE | (e) | |FISHER EXACT | (e) (e) (e) (e) | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/80 (0%) 0/80 (0%) 0/80 (0%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/32 (0%) 0/30 (0%) 0/35 (0%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) (e) | |COCHRAN-ARMITAGE | (e) | |FISHER EXACT | (e) (e) (e) (e) | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/80 (0%) 3/80 (4%) 2/80 (3%) 2/80 (3%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 7.5% 5.7% 5.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/32 (0%) 1/30 (3%) 2/35 (6%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- 498 729 (T) 614 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.409 P=0.119 P=0.258 P=0.232 (e) | |INCIDENTAL TUMOR | P=0.473 P=0.152 P=0.258 P=0.323 (e) | |LOGISTIC REGRESSION | P=0.532 P=0.119 P=0.258 P=0.234 (e) | |COCHRAN-ARMITAGE | P=0.567N | |FISHER EXACT | P=0.123 P=0.248 P=0.248 (e) | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/80 (0%) 3/80 (4%) 2/80 (3%) 2/80 (3%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 7.5% 5.7% 5.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/32 (0%) 1/30 (3%) 2/35 (6%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- 498 729 (T) 614 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.409 P=0.119 P=0.258 P=0.232 (e) | |INCIDENTAL TUMOR | P=0.473 P=0.152 P=0.258 P=0.323 (e) | |LOGISTIC REGRESSION | P=0.532 P=0.119 P=0.258 P=0.234 (e) | |COCHRAN-ARMITAGE | P=0.567N | |FISHER EXACT | P=0.123 P=0.248 P=0.248 (e) | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/80 (0%) 3/80 (4%) 2/80 (3%) 2/80 (3%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 7.5% 5.7% 5.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/32 (0%) 1/30 (3%) 2/35 (6%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- 498 729 (T) 614 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.409 P=0.119 P=0.258 P=0.232 (e) | |INCIDENTAL TUMOR | P=0.473 P=0.152 P=0.258 P=0.323 (e) | |LOGISTIC REGRESSION | P=0.532 P=0.119 P=0.258 P=0.234 (e) | |COCHRAN-ARMITAGE | P=0.567N | |FISHER EXACT | P=0.123 P=0.248 P=0.248 (e) | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 9/80 (11%) 12/80 (15%) 16/80 (20%) 5/80 (6%) 0/30 (0%) | |ADJUSTED (b) | 24.1% 38.1% 36.9% 14.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 1/10 (10%) 0/10 (0%) 2/10 (20%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 6/32 (19%) 11/30 (37%) 10/35 (29%) 3/28 (11%) 0/0 | |FIRST INCIDENCE (DAYS) | 455 (I) 614 454 455 (I) --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.131N P=0.256 P=0.123 P=0.260N P=0.500N | |INCIDENTAL TUMOR | P=0.126N P=0.270 P=0.089 P=0.276N P=0.500N | |LOGISTIC REGRESSION | P=0.112N P=0.267 P=0.085 P=0.207N P=0.591N | |COCHRAN-ARMITAGE | P=0.014N* | |FISHER EXACT | P=0.320 P=0.095 P=0.201N P=0.050N* | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma or Basosquamous Tumor Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 2/80 (3%) 0/80 (0%) 0/80 (0%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 6.3% 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/32 (6%) 0/30 (0%) 0/35 (0%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.246N P=0.252N P=0.219N P=0.268N (e) | |INCIDENTAL TUMOR | P=0.246N P=0.252N P=0.219N P=0.268N (e) | |LOGISTIC REGRESSION | P=0.246N P=0.252N P=0.219N P=0.268N (e) | |COCHRAN-ARMITAGE | P=0.209N | |FISHER EXACT | P=0.248N P=0.248N P=0.248N P=0.527N | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 2/80 (3%) 0/80 (0%) 0/80 (0%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 6.3% 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/32 (6%) 0/30 (0%) 0/35 (0%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.246N P=0.252N P=0.219N P=0.268N (e) | |INCIDENTAL TUMOR | P=0.246N P=0.252N P=0.219N P=0.268N (e) | |LOGISTIC REGRESSION | P=0.246N P=0.252N P=0.219N P=0.268N (e) | |COCHRAN-ARMITAGE | P=0.209N | |FISHER EXACT | P=0.248N P=0.248N P=0.248N P=0.527N | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, | | malignant or NOS), or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 2/80 (3%) 0/80 (0%) 0/80 (0%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 6.3% 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/32 (6%) 0/30 (0%) 0/35 (0%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.246N P=0.252N P=0.219N P=0.268N (e) | |INCIDENTAL TUMOR | P=0.246N P=0.252N P=0.219N P=0.268N (e) | |LOGISTIC REGRESSION | P=0.246N P=0.252N P=0.219N P=0.268N (e) | |COCHRAN-ARMITAGE | P=0.209N | |FISHER EXACT | P=0.248N P=0.248N P=0.248N P=0.527N | |=================================================================================================================================| | | |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) | 4/80 (5%) 1/80 (1%) 0/80 (0%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 11.8% 1.7% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 3/32 (9%) 0/30 (0%) 0/35 (0%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | 701 455 (I) --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.046N* P=0.202N P=0.055N P=0.083N (e) | |INCIDENTAL TUMOR | P=0.049N* P=0.207N P=0.077N P=0.081N (e) | |LOGISTIC REGRESSION | P=0.044N* P=0.189N P=0.059N P=0.076N (e) | |COCHRAN-ARMITAGE | P=0.046N* | |FISHER EXACT | P=0.184N P=0.060N P=0.060N P=0.274N | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 3/80 (4%) 1/80 (1%) 1/80 (1%) 1/80 (1%) 0/30 (0%) | |ADJUSTED (b) | 8.8% 3.0% 2.4% 3.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/32 (6%) 0/30 (0%) 0/35 (0%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | 701 701 624 711 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.365N P=0.339N P=0.292N P=0.356N (e) | |INCIDENTAL TUMOR | P=0.329N P=0.354N P=0.336N P=0.347N (e) | |LOGISTIC REGRESSION | P=0.323N P=0.326N P=0.306N P=0.336N (e) | |COCHRAN-ARMITAGE | P=0.194N | |FISHER EXACT | P=0.310N P=0.310N P=0.310N P=0.381N | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 1/80 (1%) 0/80 (0%) 0/80 (0%) 1/80 (1%) 0/30 (0%) | |ADJUSTED (b) | 3.1% 0.0% 0.0% 3.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/32 (3%) 0/30 (0%) 0/35 (0%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- 711 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.755 P=0.513N P=0.482N P=0.731 (e) | |INCIDENTAL TUMOR | P=0.740 P=0.513N P=0.482N P=0.735 (e) | |LOGISTIC REGRESSION | P=0.757 P=0.513N P=0.482N P=0.742 (e) | |COCHRAN-ARMITAGE | P=0.674N | |FISHER EXACT | P=0.500N P=0.500N P=0.752N P=0.727N | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 2/80 (3%) 0/80 (0%) 1/80 (1%) 1/80 (1%) 0/30 (0%) | |ADJUSTED (b) | 5.7% 0.0% 2.4% 3.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/32 (3%) 0/30 (0%) 0/35 (0%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | 701 --- 624 711 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.656N P=0.260N P=0.489N P=0.546N (e) | |INCIDENTAL TUMOR | P=0.595N P=0.269N P=0.552N P=0.538N (e) | |LOGISTIC REGRESSION | P=0.593N P=0.251N P=0.502N P=0.526N (e) | |COCHRAN-ARMITAGE | P=0.399N | |FISHER EXACT | P=0.248N P=0.500N P=0.500N P=0.527N | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 2/80 (3%) 0/80 (0%) 0/80 (0%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 5.7% 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/32 (3%) 0/30 (0%) 0/35 (0%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | 701 --- --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.248N P=0.260N P=0.224N P=0.271N (e) | |INCIDENTAL TUMOR | P=0.260N P=0.269N P=0.312N P=0.265N (e) | |LOGISTIC REGRESSION | P=0.241N P=0.251N P=0.236N P=0.254N (e) | |COCHRAN-ARMITAGE | P=0.209N | |FISHER EXACT | P=0.248N P=0.248N P=0.248N P=0.527N | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 3/80 (4%) 1/80 (1%) 0/80 (0%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 8.8% 1.7% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/32 (6%) 0/30 (0%) 0/35 (0%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | 701 455 (I) --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.089N P=0.329N P=0.110N P=0.148N (e) | |INCIDENTAL TUMOR | P=0.092N P=0.337N P=0.154N P=0.145N (e) | |LOGISTIC REGRESSION | P=0.088N P=0.314N P=0.117N P=0.137N (e) | |COCHRAN-ARMITAGE | P=0.085N | |FISHER EXACT | P=0.310N P=0.123N P=0.123N P=0.381N | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 2/80 (3%) 1/80 (1%) 0/80 (0%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 5.7% 1.7% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/32 (3%) 0/30 (0%) 0/35 (0%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | 701 455 (I) --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.165N P=0.521N P=0.224N P=0.271N (e) | |INCIDENTAL TUMOR | P=0.171N P=0.530N P=0.312N P=0.265N (e) | |LOGISTIC REGRESSION | P=0.174N P=0.506N P=0.236N P=0.254N (e) | |COCHRAN-ARMITAGE | P=0.160N | |FISHER EXACT | P=0.500N P=0.248N P=0.248N P=0.527N | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 58/80 (73%) 55/80 (69%) 55/80 (69%) 58/80 (73%) 10/30 (33%) | |ADJUSTED (b) | 100.0% 94.8% 100.0% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 10/10 (100%) 10/10 (100%) 9/10 (90%) 9/10 (90%) 10/10 (100%) | |TERMINAL (d) | 32/32 (100%) 27/30 (90%) 35/35 (100%) 28/28 (100%) 0/0 | |FIRST INCIDENCE (DAYS) | 455 (I) 455 (I) 455 (I) 455 (I) 455 (I) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.217 P=0.561N P=0.168N P=0.240 (e) | |INCIDENTAL TUMOR | P=0.443 P=0.362N P=0.437N P=0.705 (e) | |LOGISTIC REGRESSION | P=0.188 P=0.326N P=0.352N P=0.640N P=0.326 | |COCHRAN-ARMITAGE | P=0.001N** | |FISHER EXACT | P=0.364N P=0.364N P=0.570N P<0.001N** | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 12/80 (15%) 9/80 (11%) 6/80 (8%) 8/79 (10%) 0/30 (0%) | |ADJUSTED (b) | 32.8% 23.0% 17.1% 23.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 8/32 (25%) 4/30 (13%) 6/35 (17%) 5/28 (18%) 0/0 | |FIRST INCIDENCE (DAYS) | 647 586 729 (T) 589 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.276N P=0.374N P=0.073N P=0.329N (e) | |INCIDENTAL TUMOR | P=0.195N P=0.293N P=0.135N P=0.252N (e) | |LOGISTIC REGRESSION | P=0.176N P=0.269N P=0.088N P=0.271N P=0.957N | |COCHRAN-ARMITAGE | P=0.025N* | |FISHER EXACT | P=0.320N P=0.105N P=0.246N P=0.017N* | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 12/80 (15%) 10/80 (13%) 6/80 (8%) 8/79 (10%) 0/30 (0%) | |ADJUSTED (b) | 32.8% 26.0% 17.1% 23.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 8/32 (25%) 5/30 (17%) 6/35 (17%) 5/28 (18%) 0/0 | |FIRST INCIDENCE (DAYS) | 647 586 729 (T) 589 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.250N P=0.467N P=0.073N P=0.329N (e) | |INCIDENTAL TUMOR | P=0.174N P=0.388N P=0.135N P=0.252N (e) | |LOGISTIC REGRESSION | P=0.157N P=0.366N P=0.088N P=0.271N P=0.957N | |COCHRAN-ARMITAGE | P=0.021N* | |FISHER EXACT | P=0.409N P=0.105N P=0.246N P=0.017N* | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/80 (0%) 0/80 (0%) 0/80 (0%) 0/79 (0%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/32 (0%) 0/30 (0%) 0/35 (0%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) (e) | |COCHRAN-ARMITAGE | (e) | |FISHER EXACT | (e) (e) (e) (e) | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | | |ADJUSTED (b) | | |INTERIM SACRIFICE 1 (c)| | |INTERIM SACRIFICE 2 (c)| | |INTERIM SACRIFICE 3 (c)| | |TERMINAL (d) | | |FIRST INCIDENCE (DAYS) | | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | | |INCIDENTAL TUMOR | | |LOGISTIC REGRESSION | | |COCHRAN-ARMITAGE | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 1/80 (1%) 1/80 (1%) 1/80 (1%) 1/80 (1%) 0/30 (0%) | |ADJUSTED (b) | 2.0% 3.3% 2.1% 3.1% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/32 (0%) 1/30 (3%) 0/35 (0%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | 478 729 (T) 488 702 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.746 P=0.749 P=0.756 P=0.750 (e) | |INCIDENTAL TUMOR | P=0.710 P=0.753 P=0.712N P=0.705 (e) | |LOGISTIC REGRESSION | P=0.574N P=0.760 P=0.761N P=0.761 P=0.737N | |COCHRAN-ARMITAGE | P=0.487N | |FISHER EXACT | P=0.752N P=0.752N P=0.752N P=0.727N | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/80 (0%) 0/80 (0%) 0/80 (0%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/32 (0%) 0/30 (0%) 0/35 (0%) 0/28 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) (e) | |COCHRAN-ARMITAGE | (e) | |FISHER EXACT | (e) (e) (e) (e) | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 20/80 (25%) 18/80 (23%) 16/80 (20%) 20/80 (25%) 2/30 (7%) | |ADJUSTED (b) | 44.3% 39.5% 37.7% 44.9% 14.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 8/32 (25%) 4/30 (13%) 9/35 (26%) 5/28 (18%) 0/0 | |FIRST INCIDENCE (DAYS) | 486 455 (I) 553 578 273 (I) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.197 P=0.514N P=0.250N P=0.441 P=0.251 | |INCIDENTAL TUMOR | P=0.352 P=0.405N P=0.447N P=0.382N P=0.251 | |LOGISTIC REGRESSION | P=0.503 P=0.285N P=0.415N P=0.239N P=0.682N | |COCHRAN-ARMITAGE | P=0.069N | |FISHER EXACT | P=0.426N P=0.285N P=0.572N P=0.025N* | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 59/80 (74%) 58/80 (73%) 57/80 (71%) 59/80 (74%) 10/30 (33%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 10/10 (100%) 10/10 (100%) 9/10 (90%) 9/10 (90%) 10/10 (100%) | |TERMINAL (d) | 32/32 (100%) 30/30 (100%) 35/35 (100%) 28/28 (100%) 0/0 | |FIRST INCIDENCE (DAYS) | 455 (I) 455 (I) 454 455 (I) 455 (I) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.253 P=0.431 P=0.234N P=0.247 (e) | |INCIDENTAL TUMOR | P=0.522 P=0.785 P=0.570N P=0.716N (e) | |LOGISTIC REGRESSION | P=0.316 P=0.717N P=0.515N P=0.739N P=0.520 | |COCHRAN-ARMITAGE | P<0.001N** | |FISHER EXACT | P=0.500N P=0.430N P=0.571N P<0.001N** | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 29/80 (36%) 24/80 (30%) 19/80 (24%) 24/80 (30%) 2/30 (7%) | |ADJUSTED (b) | 59.6% 51.0% 42.7% 51.1% 14.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |INTERIM SACRIFICE 3 (c)| 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 13/32 (41%) 8/30 (27%) 10/35 (29%) 6/28 (21%) 0/0 | |FIRST INCIDENCE (DAYS) | 455 (I) 455 (I) 488 542 273 (I) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.541 P=0.360N P=0.057N P=0.404N P=0.512 | |INCIDENTAL TUMOR | P=0.309N P=0.208N P=0.068N P=0.081N P=0.512 | |LOGISTIC REGRESSION | P=0.189N P=0.152N P=0.081N P=0.040N* P=0.393N | |COCHRAN-ARMITAGE | P=0.006N** | |FISHER EXACT | P=0.251N P=0.060N P=0.251N P=0.001N** | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 60/80 (75%) 59/80 (74%) 58/80 (73%) 59/80 (74%) 11/30 (37%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |INTERIM SACRIFICE 3 (c)| 10/10 (100%) 10/10 (100%) 9/10 (90%) 9/10 (90%) 10/10 (100%) | |TERMINAL (d) | 32/32 (100%) 30/30 (100%) 35/35 (100%) 28/28 (100%) 0/0 | |FIRST INCIDENCE (DAYS) | 455 (I) 455 (I) 454 455 (I) 273 (I) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.203 P=0.432 P=0.242N P=0.303 P=0.521 | |INCIDENTAL TUMOR | P=0.273 (e) P=0.500N P=0.500N P=0.521 | |LOGISTIC REGRESSION | P=0.280 (e) P=0.522N P=0.500N P=0.521 | |COCHRAN-ARMITAGE | P<0.001N** | |FISHER EXACT | P=0.500N P=0.429N P=0.500N P<0.001N** | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/80 (1%) 1/81 (1%) 0/80 (0%) 1/80 (1%) 0/29 (0%) | |ADJUSTED (b) | 2.9% 2.6% 0.0% 3.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |TERMINAL (d) | 1/34 (3%) 1/38 (3%) 0/30 (0%) 1/26 (4%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- 729 (T) --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.763 P=0.737N P=0.525N P=0.701 (e) | |INCIDENTAL TUMOR | P=0.763 P=0.737N P=0.525N P=0.701 (e) | |LOGISTIC REGRESSION | P=0.763 P=0.737N P=0.525N P=0.701 (e) | |COCHRAN-ARMITAGE | P=0.521N | |FISHER EXACT | P=0.748N P=0.500N P=0.752N P=0.734N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/80 (1%) 2/81 (2%) 3/80 (4%) 0/80 (0%) 0/29 (0%) | |ADJUSTED (b) | 2.9% 4.7% 10.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |TERMINAL (d) | 1/34 (3%) 1/38 (3%) 3/30 (10%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) 620 729 (T) --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.541N P=0.544 P=0.261 P=0.553N (e) | |INCIDENTAL TUMOR | P=0.539N P=0.432 P=0.261 P=0.554N (e) | |LOGISTIC REGRESSION | P=0.455N P=0.526 P=0.261 P=0.554N (e) | |COCHRAN-ARMITAGE | P=0.253N | |FISHER EXACT | P=0.505 P=0.310 P=0.500N P=0.734N | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/80 (1%) 2/81 (2%) 3/80 (4%) 1/80 (1%) 0/29 (0%) | |ADJUSTED (b) | 2.9% 4.7% 10.0% 2.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |TERMINAL (d) | 1/34 (3%) 1/38 (3%) 3/30 (10%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) 620 729 (T) 625 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.646 P=0.544 P=0.261 P=0.734 (e) | |INCIDENTAL TUMOR | P=0.648 P=0.432 P=0.261 P=0.713 (e) | |LOGISTIC REGRESSION | P=0.652N P=0.526 P=0.261 P=0.756 (e) | |COCHRAN-ARMITAGE | P=0.375N | |FISHER EXACT | P=0.505 P=0.310 P=0.752N P=0.734N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/80 (1%) 4/81 (5%) 4/79 (5%) 3/79 (4%) 0/30 (0%) | |ADJUSTED (b) | 2.9% 10.5% 12.8% 11.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/34 (3%) 4/38 (11%) 3/29 (10%) 3/26 (12%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 705 729 (T) --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.258 P=0.214 P=0.146 P=0.214 (e) | |INCIDENTAL TUMOR | P=0.303 P=0.214 P=0.191 P=0.214 (e) | |LOGISTIC REGRESSION | P=0.304 P=0.214 P=0.175 P=0.214 (e) | |COCHRAN-ARMITAGE | P=0.431N | |FISHER EXACT | P=0.187 P=0.180 P=0.305 P=0.727N | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/80 (3%) 5/81 (6%) 4/79 (5%) 3/79 (4%) 0/30 (0%) | |ADJUSTED (b) | 5.9% 13.2% 12.8% 11.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/34 (6%) 5/38 (13%) 3/29 (10%) 3/26 (12%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 705 729 (T) --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.428 P=0.262 P=0.280 P=0.378 (e) | |INCIDENTAL TUMOR | P=0.477 P=0.262 P=0.342 P=0.378 (e) | |LOGISTIC REGRESSION | P=0.482 P=0.262 P=0.328 P=0.378 (e) | |COCHRAN-ARMITAGE | P=0.277N | |FISHER EXACT | P=0.226 P=0.335 P=0.494 P=0.527N | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/80 (0%) 0/81 (0%) 1/80 (1%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 0.0% 3.3% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/34 (0%) 0/38 (0%) 1/30 (3%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.868 (e) P=0.475 (e) (e) | |INCIDENTAL TUMOR | P=0.868 (e) P=0.475 (e) (e) | |LOGISTIC REGRESSION | P=0.868 (e) P=0.475 (e) (e) | |COCHRAN-ARMITAGE | P=0.778N | |FISHER EXACT | (e) P=0.500 (e) (e) | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/80 (0%) 1/81 (1%) 1/80 (1%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 2.6% 3.3% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/34 (0%) 0/38 (0%) 1/30 (3%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- 712 729 (T) --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.816N P=0.516 P=0.475 (e) (e) | |INCIDENTAL TUMOR | P=0.715N P=0.567 P=0.475 (e) (e) | |LOGISTIC REGRESSION | P=0.787N P=0.520 P=0.475 (e) (e) | |COCHRAN-ARMITAGE | P=0.555N | |FISHER EXACT | P=0.503 P=0.500 (e) (e) | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/80 (1%) 0/81 (0%) 1/80 (1%) 2/80 (3%) 0/30 (0%) | |ADJUSTED (b) | 2.9% 0.0% 2.3% 7.7% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/34 (3%) 0/38 (0%) 0/30 (0%) 2/26 (8%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) --- 642 729 (T) --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.295 P=0.478N P=0.760 P=0.406 (e) | |INCIDENTAL TUMOR | P=0.303 P=0.478N P=0.729 P=0.406 (e) | |LOGISTIC REGRESSION | P=0.369 P=0.478N P=0.752N P=0.406 (e) | |COCHRAN-ARMITAGE | P=0.600 | |FISHER EXACT | P=0.497N P=0.752N P=0.500 P=0.727N | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 3/80 (4%) 1/81 (1%) 0/80 (0%) 1/80 (1%) 0/30 (0%) | |ADJUSTED (b) | 8.8% 1.2% 0.0% 3.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 3/34 (9%) 0/38 (0%) 0/30 (0%) 1/26 (4%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) 92 (I) --- 729 (T) --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.280N P=0.277N P=0.143N P=0.405N (e) | |INCIDENTAL TUMOR | P=0.280N P=0.278N P=0.143N P=0.405N (e) | |LOGISTIC REGRESSION | P=0.221N P=0.300N P=0.143N P=0.405N (e) | |COCHRAN-ARMITAGE | P=0.188N | |FISHER EXACT | P=0.305N P=0.123N P=0.310N P=0.381N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 3/80 (4%) 2/81 (2%) 0/80 (0%) 1/80 (1%) 0/30 (0%) | |ADJUSTED (b) | 8.8% 2.7% 0.0% 3.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 3/34 (9%) 0/38 (0%) 0/30 (0%) 1/26 (4%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) 92 (I) --- 729 (T) --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.188N P=0.470N P=0.143N P=0.405N (e) | |INCIDENTAL TUMOR | P=0.188N P=0.470N P=0.143N P=0.405N (e) | |LOGISTIC REGRESSION | P=0.154N P=0.495N P=0.143N P=0.405N (e) | |COCHRAN-ARMITAGE | P=0.148N | |FISHER EXACT | P=0.494N P=0.123N P=0.310N P=0.381N | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 15/80 (19%) 16/81 (20%) 21/80 (26%) 15/80 (19%) 0/30 (0%) | |ADJUSTED (b) | 36.0% 37.9% 52.1% 42.9% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 8/34 (24%) 12/38 (32%) 11/30 (37%) 8/26 (31%) 0/0 | |FIRST INCIDENCE (DAYS) | 557 653 592 564 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.238 P=0.522N P=0.141 P=0.391 (e) | |INCIDENTAL TUMOR | P=0.420N P=0.560 P=0.391 P=0.482N (e) | |LOGISTIC REGRESSION | P=0.522N P=0.535 P=0.276 P=0.479N P=0.398N | |COCHRAN-ARMITAGE | P=0.023N* | |FISHER EXACT | P=0.515 P=0.172 P=0.580N P=0.006N** | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 18/80 (23%) 17/81 (21%) 21/80 (26%) 16/80 (20%) 0/30 (0%) | |ADJUSTED (b) | 43.4% 38.7% 52.1% 46.1% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 11/34 (32%) 12/38 (32%) 11/30 (37%) 9/26 (35%) 0/0 | |FIRST INCIDENCE (DAYS) | 557 92 (I) 592 564 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.387 P=0.360N P=0.290 P=0.505 (e) | |INCIDENTAL TUMOR | P=0.266N P=0.429N P=0.537N P=0.357N (e) | |LOGISTIC REGRESSION | P=0.359N P=0.409N P=0.523 P=0.328N P=0.415N | |COCHRAN-ARMITAGE | P=0.010N* | |FISHER EXACT | P=0.483N P=0.356 P=0.423N P=0.002N** | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 18/80 (23%) 18/81 (22%) 21/80 (26%) 16/80 (20%) 0/30 (0%) | |ADJUSTED (b) | 43.4% 39.6% 52.1% 46.1% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 11/34 (32%) 12/38 (32%) 11/30 (37%) 9/26 (35%) 0/0 | |FIRST INCIDENCE (DAYS) | 557 92 (I) 592 564 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.459 P=0.434N P=0.290 P=0.505 (e) | |INCIDENTAL TUMOR | P=0.213N P=0.513N P=0.537N P=0.357N (e) | |LOGISTIC REGRESSION | P=0.294N P=0.501N P=0.523 P=0.328N P=0.415N | |COCHRAN-ARMITAGE | P=0.009N** | |FISHER EXACT | P=0.558N P=0.356 P=0.423N P=0.002N** | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 30/80 (38%) 26/81 (32%) 27/80 (34%) 24/80 (30%) 3/30 (10%) | |ADJUSTED (b) | 66.7% 56.2% 63.0% 58.7% 33.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 1/8 (13%) 2/10 (20%) 1/10 (10%) 3/9 (33%) | |TERMINAL (d) | 19/34 (56%) 18/38 (47%) 15/30 (50%) 11/26 (42%) 0/0 | |FIRST INCIDENCE (DAYS) | 553 456 (I) 456 (I) 353 456 (I) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.256 P=0.160N P=0.465N P=0.454N P=0.109 | |INCIDENTAL TUMOR | P=0.394N P=0.232N P=0.124N P=0.088N P=0.109 | |LOGISTIC REGRESSION | P=0.460N P=0.287N P=0.223N P=0.153N P=0.285 | |COCHRAN-ARMITAGE | P=0.006N** | |FISHER EXACT | P=0.290N P=0.371N P=0.202N P=0.003N** | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 26 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma or Basosquamous Tumor Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/80 (0%) 0/81 (0%) 0/80 (0%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/34 (0%) 0/38 (0%) 0/30 (0%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) (e) | |COCHRAN-ARMITAGE | (e) | |FISHER EXACT | (e) (e) (e) (e) | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/80 (0%) 0/81 (0%) 0/80 (0%) 1/80 (1%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 1.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 1/10 (10%) 0/9 (0%) | |TERMINAL (d) | 0/34 (0%) 0/38 (0%) 0/30 (0%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- 456 (I) --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.646 (e) (e) P=0.521 (e) | |INCIDENTAL TUMOR | P=0.646 (e) (e) P=0.521 (e) | |LOGISTIC REGRESSION | P=0.569 (e) (e) P=0.503 (e) | |COCHRAN-ARMITAGE | P=0.550 | |FISHER EXACT | (e) (e) P=0.500 (e) | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 27 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, | | malignant or NOS), or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/80 (0%) 0/81 (0%) 0/80 (0%) 1/80 (1%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 1.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 1/10 (10%) 0/9 (0%) | |TERMINAL (d) | 0/34 (0%) 0/38 (0%) 0/30 (0%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- 456 (I) --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.646 (e) (e) P=0.521 (e) | |INCIDENTAL TUMOR | P=0.646 (e) (e) P=0.521 (e) | |LOGISTIC REGRESSION | P=0.569 (e) (e) P=0.503 (e) | |COCHRAN-ARMITAGE | P=0.550 | |FISHER EXACT | (e) (e) P=0.500 (e) | |=================================================================================================================================| | | |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) | 1/80 (1%) 0/81 (0%) 0/80 (0%) 2/80 (3%) 0/30 (0%) | |ADJUSTED (b) | 2.9% 0.0% 0.0% 5.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 1/10 (10%) 0/9 (0%) | |TERMINAL (d) | 1/34 (3%) 0/38 (0%) 0/30 (0%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- 456 (I) --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.527 P=0.478N P=0.525N P=0.456 (e) | |INCIDENTAL TUMOR | P=0.604 P=0.478N P=0.525N P=0.594 (e) | |LOGISTIC REGRESSION | P=0.487 P=0.478N P=0.525N P=0.493 (e) | |COCHRAN-ARMITAGE | P=0.586 | |FISHER EXACT | P=0.497N P=0.500N P=0.500 P=0.727N | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 28 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/80 (0%) 0/81 (0%) 3/80 (4%) 1/80 (1%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 0.0% 6.3% 2.9% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/34 (0%) 0/38 (0%) 0/30 (0%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- --- 372 691 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.534 (e) P=0.126 P=0.489 (e) | |INCIDENTAL TUMOR | P=0.627 (e) P=0.089 P=0.705 (e) | |LOGISTIC REGRESSION | P=0.564 (e) P=0.121 P=0.493 (e) | |COCHRAN-ARMITAGE | P=0.600 | |FISHER EXACT | (e) P=0.123 P=0.500 (e) | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/80 (0%) 0/81 (0%) 2/80 (3%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 0.0% 3.3% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/34 (0%) 0/38 (0%) 0/30 (0%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- --- 372 --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.612N (e) P=0.253 (e) (e) | |INCIDENTAL TUMOR | P=0.623N (e) P=0.113 (e) (e) | |LOGISTIC REGRESSION | P=0.620N (e) P=0.232 (e) (e) | |COCHRAN-ARMITAGE | P=0.675N | |FISHER EXACT | (e) P=0.248 (e) (e) | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 29 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/80 (0%) 0/81 (0%) 3/80 (4%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 0.0% 6.3% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/34 (0%) 0/38 (0%) 0/30 (0%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- --- 372 --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.644N (e) P=0.126 (e) (e) | |INCIDENTAL TUMOR | P=0.588N (e) P=0.089 (e) (e) | |LOGISTIC REGRESSION | P=0.625N (e) P=0.121 (e) (e) | |COCHRAN-ARMITAGE | P=0.617N | |FISHER EXACT | (e) P=0.123 (e) (e) | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/80 (0%) 0/81 (0%) 0/80 (0%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/34 (0%) 0/38 (0%) 0/30 (0%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) (e) | |COCHRAN-ARMITAGE | (e) | |FISHER EXACT | (e) (e) (e) (e) | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 30 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 1/80 (1%) 0/81 (0%) 0/80 (0%) 1/80 (1%) 0/30 (0%) | |ADJUSTED (b) | 2.9% 0.0% 0.0% 3.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/34 (3%) 0/38 (0%) 0/30 (0%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- 722 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.723 P=0.478N P=0.525N P=0.705 (e) | |INCIDENTAL TUMOR | P=0.823 P=0.478N P=0.525N P=0.691N (e) | |LOGISTIC REGRESSION | P=0.745 P=0.478N P=0.525N P=0.736 (e) | |COCHRAN-ARMITAGE | P=0.675N | |FISHER EXACT | P=0.497N P=0.500N P=0.752N P=0.727N | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/80 (0%) 0/81 (0%) 0/80 (0%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/34 (0%) 0/38 (0%) 0/30 (0%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) (e) | |COCHRAN-ARMITAGE | (e) | |FISHER EXACT | (e) (e) (e) (e) | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 31 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | | |ADJUSTED (b) | | |INTERIM SACRIFICE 1 (c)| | |INTERIM SACRIFICE 2 (c)| | |INTERIM SACRIFICE 3 (c)| | |TERMINAL (d) | | |FIRST INCIDENCE (DAYS) | | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | | |INCIDENTAL TUMOR | | |LOGISTIC REGRESSION | | |COCHRAN-ARMITAGE | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 10/80 (13%) 8/81 (10%) 3/80 (4%) 11/80 (14%) 0/30 (0%) | |ADJUSTED (b) | 23.7% 19.9% 7.5% 34.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 1/9 (11%) 1/8 (13%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 5/34 (15%) 7/38 (18%) 1/30 (3%) 6/26 (23%) 0/0 | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 670 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.499 P=0.335N P=0.047N* P=0.345 P=0.500N | |INCIDENTAL TUMOR | P=0.481N P=0.434N P=0.052N P=0.515 P=0.284N | |LOGISTIC REGRESSION | P=0.547N P=0.354N P=0.035N* P=0.472 P=0.280N | |COCHRAN-ARMITAGE | P=0.141N | |FISHER EXACT | P=0.391N P=0.040N* P=0.500 P=0.035N* | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 32 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 10/80 (13%) 8/81 (10%) 3/80 (4%) 12/80 (15%) 0/30 (0%) | |ADJUSTED (b) | 23.7% 19.9% 7.5% 37.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 1/9 (11%) 1/8 (13%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 5/34 (15%) 7/38 (18%) 1/30 (3%) 7/26 (27%) 0/0 | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 670 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.391 P=0.335N P=0.047N* P=0.258 P=0.500N | |INCIDENTAL TUMOR | P=0.587 P=0.434N P=0.052N P=0.403 P=0.284N | |LOGISTIC REGRESSION | P=0.530 P=0.354N P=0.035N* P=0.377 P=0.280N | |COCHRAN-ARMITAGE | P=0.179N | |FISHER EXACT | P=0.391N P=0.040N* P=0.409 P=0.035N* | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/80 (0%) 1/81 (1%) 2/80 (3%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 2.6% 5.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/34 (0%) 1/38 (3%) 1/30 (3%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- 729 (T) 456 (I) --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.592N P=0.522 P=0.237 (e) (e) | |INCIDENTAL TUMOR | P=0.592N P=0.522 P=0.237 (e) (e) | |LOGISTIC REGRESSION | P=0.641N P=0.522 P=0.242 (e) (e) | |COCHRAN-ARMITAGE | P=0.516N | |FISHER EXACT | P=0.503 P=0.248 (e) (e) | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 33 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 7/80 (9%) 2/81 (2%) 8/80 (10%) 9/80 (11%) 1/30 (3%) | |ADJUSTED (b) | 18.4% 4.3% 23.8% 30.4% 11.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 1/9 (11%) 1/8 (13%) 0/10 (0%) 0/10 (0%) 1/9 (11%) | |TERMINAL (d) | 5/34 (15%) 1/38 (3%) 6/30 (20%) 7/26 (27%) 0/0 | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 619 550 456 (I) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.063 P=0.070N P=0.444 P=0.245 P=0.767 | |INCIDENTAL TUMOR | P=0.097 P=0.065N P=0.520 P=0.321 P=0.767 | |LOGISTIC REGRESSION | P=0.095 P=0.072N P=0.544 P=0.366 P=0.594 | |COCHRAN-ARMITAGE | P=0.557 | |FISHER EXACT | P=0.081N P=0.500 P=0.397 P=0.303N | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/80 (0%) 2/81 (2%) 0/80 (0%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 4.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/34 (0%) 0/38 (0%) 0/30 (0%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- 397 --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.549N P=0.260 (e) (e) (e) | |INCIDENTAL TUMOR | P=0.492N P=0.196 (e) (e) (e) | |LOGISTIC REGRESSION | P=0.446N P=0.241 (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.429N | |FISHER EXACT | P=0.252 (e) (e) (e) | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 34 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 0/80 (0%) 2/81 (2%) 0/80 (0%) 0/80 (0%) 0/30 (0%) | |ADJUSTED (b) | 0.0% 4.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/34 (0%) 1/38 (3%) 0/30 (0%) 0/26 (0%) 0/0 | |FIRST INCIDENCE (DAYS) | --- 222 --- --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.541N P=0.254 (e) (e) (e) | |INCIDENTAL TUMOR | P=0.551N P=0.368 (e) (e) (e) | |LOGISTIC REGRESSION | P=0.412N P=0.240 (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.429N | |FISHER EXACT | P=0.252 (e) (e) (e) | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 8/80 (10%) 8/81 (10%) 13/80 (16%) 15/80 (19%) 0/30 (0%) | |ADJUSTED (b) | 22.7% 18.9% 29.6% 39.2% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 7/34 (21%) 5/38 (13%) 3/30 (10%) 5/26 (19%) 0/0 | |FIRST INCIDENCE (DAYS) | 675 464 592 546 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.016 * P=0.512N P=0.174 P=0.041 * (e) | |INCIDENTAL TUMOR | P=0.144 P=0.518N P=0.320 P=0.151 (e) | |LOGISTIC REGRESSION | P=0.093 P=0.535N P=0.434 P=0.064 P=1.000N | |COCHRAN-ARMITAGE | P=0.376N | |FISHER EXACT | P=0.593N P=0.175 P=0.088 P=0.071N | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 35 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 47/80 (59%) 36/81 (44%) 42/80 (53%) 44/80 (55%) 4/30 (13%) | |ADJUSTED (b) | 94.0% 71.4% 85.5% 93.4% 44.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 2/9 (22%) 3/8 (38%) 4/10 (40%) 2/10 (20%) 4/9 (44%) | |TERMINAL (d) | 31/34 (91%) 24/38 (63%) 23/30 (77%) 23/26 (88%) 0/0 | |FIRST INCIDENCE (DAYS) | 456 (I) 92 (I) 456 (I) 353 456 (I) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.074 P=0.013N* P=0.394N P=0.291 P=0.314 | |INCIDENTAL TUMOR | P=0.501 P=0.012N* P=0.043N* P=0.346N P=0.465 | |LOGISTIC REGRESSION | P=0.419 P=0.007N** P=0.068N P=0.365N P=0.475 | |COCHRAN-ARMITAGE | P=0.001N** | |FISHER EXACT | P=0.048N* P=0.262N P=0.375N P<0.001N** | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 14/80 (18%) 16/81 (20%) 18/80 (23%) 20/80 (25%) 0/30 (0%) | |ADJUSTED (b) | 34.8% 32.4% 37.9% 49.7% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 0/9 (0%) 0/8 (0%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 10/34 (29%) 7/38 (18%) 4/30 (13%) 7/26 (27%) 0/0 | |FIRST INCIDENCE (DAYS) | 274 (I) 222 372 546 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.152 P=0.530 P=0.269 P=0.077 P=0.406N | |INCIDENTAL TUMOR | P=0.535 P=0.510 P=0.297 P=0.183 P=0.284N | |LOGISTIC REGRESSION | P=0.541N P=0.461 P=0.309 P=0.133 P=0.218N | |COCHRAN-ARMITAGE | P=0.102N | |FISHER EXACT | P=0.435 P=0.277 P=0.167 P=0.008N** | |=================================================================================================================================| DATE: 11/10/95 EXPERIMENT: 05100 TEST: 03 PAGE 36 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- TRICRESYL PHOSPHATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| |DOSE | 0 PPM 75 PPM 150 PPM 300 PPM 600 PPM | | | 23 STOP | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # # | |----------- | | |OVERALL (a) | 50/80 (63%) 44/81 (54%) 48/80 (60%) 48/80 (60%) 4/30 (13%) | |ADJUSTED (b) | 96.1% 79.5% 88.7% 96.0% 44.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 3 (c)| 2/9 (22%) 3/8 (38%) 5/10 (50%) 2/10 (20%) 4/9 (44%) | |TERMINAL (d) | 32/34 (94%) 27/38 (71%) 24/30 (80%) 24/26 (92%) 0/0 | |FIRST INCIDENCE (DAYS) | 274 (I) 92 (I) 372 353 456 (I) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.139 P=0.082N P=0.550 P=0.227 P=0.548 | |INCIDENTAL TUMOR | P=0.446N P=0.121N P=0.251N P=0.520N P=0.626N | |LOGISTIC REGRESSION | P=0.376N P=0.094N P=0.239N P=0.477N P=0.507N | |COCHRAN-ARMITAGE | P<0.001N** | |FISHER EXACT | P=0.186N P=0.436N P=0.436N P<0.001N** | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 92 273 455 Female interim sacrifices(days): 92 274 456 (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).