TDMS Study 05165-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 TIME: 20:39:02 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-65156 ROUTE: DOSED FEED NTP C#: 61610B PATHOLOGIST: R. PERSING CAS: 96-69-5 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 TIME: 20:39:02 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-65156 ROUTE: DOSED FEED NTP C#: 61610B PATHOLOGIST: R. PERSING CAS: 96-69-5 MICE(B6C3F1) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Epididymis Gallbladder Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 TIME: 20:39:02 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-65156 ROUTE: DOSED FEED NTP C#: 61610B PATHOLOGIST: R. PERSING CAS: 96-69-5 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Ovary Teratoma Benign All Organs Hemangiosarcoma or Hemangioma ==================================================================================================== DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 250 PPM 500 PPM 1000 PPM | 0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/60 (18%) 7/60 (12%) 8/60 (13%) 6/60 (10%) | 1/60 (2%) 0/59 (0%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 25.3% 16.7% 15.7% 13.0% | 2.5% 0.0% 0.0% 4.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 10/42 (24%) 7/42 (17%) 7/49 (14%) 5/45 (11%) | 1/40 (3%) 0/38 (0%) 0/36 (0%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | 508 729 (T) 456 (I) 724 | 729 (T) --- --- 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.109N P=0.219N P=0.203N P=0.116N | P=0.237 P=0.510N P=0.521N P=0.481 | |INCIDENTAL TUMOR | P=0.150N P=0.192N P=0.275N P=0.192N | P=0.237 P=0.510N P=0.521N P=0.481 | |LOGISTIC REGRESSION | P=0.130N P=0.236N P=0.284N P=0.131N | P=0.252 P=0.510N P=0.521N P=0.504 | |COCHRAN-ARMITAGE | P=0.152N | P=0.247 | |FISHER EXACT | P=0.222N P=0.309N P=0.148N | P=0.504N P=0.500N P=0.500 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/58 (0%) 2/59 (3%) 2/60 (3%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 5.3% 5.6% 5.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/42 (0%) 0/49 (0%) 0/45 (0%) | 0/38 (0%) 2/38 (5%) 2/36 (6%) 2/35 (6%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.214 P=0.238 P=0.226 P=0.220 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.214 P=0.238 P=0.226 P=0.220 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.214 P=0.238 P=0.226 P=0.220 | |COCHRAN-ARMITAGE | (e) | P=0.252 | |FISHER EXACT | (e) (e) (e) | P=0.252 P=0.256 P=0.256 | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 250 PPM 500 PPM 1000 PPM | 0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | 0/58 (0%) 3/59 (5%) 2/60 (3%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 0.0% 2.0% 0.0% | 0.0% 6.9% 5.6% 5.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/42 (0%) 1/49 (2%) 0/45 (0%) | 0/38 (0%) 2/38 (5%) 2/36 (6%) 2/35 (6%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) --- | --- 450 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.707 (e) P=0.531 (e) | P=0.297 P=0.125 P=0.226 P=0.220 | |INCIDENTAL TUMOR | P=0.707 (e) P=0.531 (e) | P=0.186 P=0.084 P=0.226 P=0.220 | |LOGISTIC REGRESSION | P=0.707 (e) P=0.531 (e) | P=0.325 P=0.118 P=0.226 P=0.220 | |COCHRAN-ARMITAGE | P=0.694 | P=0.337 | |FISHER EXACT | (e) P=0.500 (e) | P=0.125 P=0.256 P=0.256 | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 1/59 (2%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 2.4% 7.1% 4.1% 0.0% | 0.0% 2.6% 2.6% 2.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/42 (2%) 3/42 (7%) 2/49 (4%) 0/45 (0%) | 0/40 (0%) 0/38 (0%) 0/36 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) --- | --- 723 701 565 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.216N P=0.305 P=0.554 P=0.486N | P=0.360 P=0.490 P=0.481 P=0.504 | |INCIDENTAL TUMOR | P=0.216N P=0.305 P=0.554 P=0.486N | P=0.522 P=0.669 P=0.695 P=0.581 | |LOGISTIC REGRESSION | P=0.215N P=0.305 P=0.554 P=0.486N | P=0.384 P=0.500 P=0.498 P=0.522 | |COCHRAN-ARMITAGE | P=0.242N | P=0.386 | |FISHER EXACT | P=0.309 P=0.500 P=0.500N | P=0.496 P=0.500 P=0.500 | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 250 PPM 500 PPM 1000 PPM | 0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | 1/60 (2%) 2/59 (3%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 4.5% 0.0% 2.0% 0.0% | 2.5% 5.3% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/42 (2%) 0/42 (0%) 1/49 (2%) 0/45 (0%) | 1/40 (3%) 2/38 (5%) 0/36 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 683 --- 729 (T) --- | 729 (T) 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.175N P=0.247N P=0.457N P=0.230N | P=0.211N P=0.482 P=0.521N P=0.527N | |INCIDENTAL TUMOR | P=0.233N P=0.314N P=0.640N P=0.305N | P=0.211N P=0.482 P=0.521N P=0.527N | |LOGISTIC REGRESSION | P=0.181N P=0.242N P=0.484N P=0.234N | P=0.211N P=0.482 P=0.521N P=0.527N | |COCHRAN-ARMITAGE | P=0.188N | P=0.188N | |FISHER EXACT | P=0.248N P=0.500N P=0.248N | P=0.494 P=0.500N P=0.500N | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 3/60 (5%) 3/60 (5%) 0/60 (0%) | 1/60 (2%) 3/59 (5%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 6.8% 7.1% 6.1% 0.0% | 2.5% 7.7% 2.6% 2.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/42 (5%) 3/42 (7%) 3/49 (6%) 0/45 (0%) | 1/40 (3%) 2/38 (5%) 0/36 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 683 729 (T) 729 (T) --- | 729 (T) 723 701 565 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.077N P=0.656 P=0.596N P=0.114N | P=0.487N P=0.289 P=0.738 P=0.748 | |INCIDENTAL TUMOR | P=0.096N P=0.610 P=0.615 P=0.153N | P=0.370N P=0.364 P=0.673N P=0.732N | |LOGISTIC REGRESSION | P=0.081N P=0.651 P=0.633N P=0.116N | P=0.457N P=0.296 P=0.757 P=0.762N | |COCHRAN-ARMITAGE | P=0.093N | P=0.442N | |FISHER EXACT | P=0.660N P=0.660N P=0.122N | P=0.303 P=0.752N P=0.752N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 250 PPM 500 PPM 1000 PPM | 0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/60 (28%) 24/60 (40%) 26/60 (43%) 14/60 (23%) | 20/60 (33%) 18/59 (31%) 18/60 (30%) 11/60 (18%) | |ADJUSTED (b) | 39.5% 52.7% 48.6% 29.1% | 45.5% 45.7% 48.1% 29.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 2/10 (20%) 4/10 (40%) 2/10 (20%) | 3/9 (33%) 1/9 (11%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 16/42 (38%) 21/42 (50%) 22/49 (45%) 12/45 (27%) | 17/40 (43%) 17/38 (45%) 17/36 (47%) 10/35 (29%) | |FIRST INCIDENCE (DAYS) | 690 456 (I) 456 (I) 456 (I) | 457 (I) 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.123N P=0.113 P=0.165 P=0.262N | P=0.067N P=0.489N P=0.549N P=0.080N | |INCIDENTAL TUMOR | P=0.132N P=0.119 P=0.129 P=0.287N | P=0.067N P=0.489N P=0.549N P=0.080N | |LOGISTIC REGRESSION | P=0.181N P=0.094 P=0.075 P=0.310N | P=0.046N* P=0.407N P=0.430N P=0.054N | |COCHRAN-ARMITAGE | P=0.210N | P=0.036N* | |FISHER EXACT | P=0.124 P=0.064 P=0.339N | P=0.447N P=0.422N P=0.047N* | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/60 (18%) 11/60 (18%) 10/60 (17%) 4/60 (7%) | 4/60 (7%) 8/59 (14%) 7/60 (12%) 5/60 (8%) | |ADJUSTED (b) | 24.2% 22.7% 19.4% 8.6% | 9.8% 20.1% 18.2% 12.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 8/42 (19%) 5/42 (12%) 8/49 (16%) 3/45 (7%) | 3/40 (8%) 7/38 (18%) 5/36 (14%) 3/35 (9%) | |FIRST INCIDENCE (DAYS) | 620 489 456 (I) 638 | 724 521 661 551 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.026N* P=0.577 P=0.374N P=0.041N* | P=0.466 P=0.159 P=0.213 P=0.426 | |INCIDENTAL TUMOR | P=0.059N P=0.517N P=0.509 P=0.034N* | P=0.499 P=0.163 P=0.363 P=0.584 | |LOGISTIC REGRESSION | P=0.056N P=0.591 P=0.495 P=0.043N* | P=0.519 P=0.182 P=0.238 P=0.473 | |COCHRAN-ARMITAGE | P=0.033N* | P=0.553N | |FISHER EXACT | P=0.593N P=0.500N P=0.048N* | P=0.173 P=0.264 P=0.500 | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 250 PPM 500 PPM 1000 PPM | 0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 25/60 (42%) 32/60 (53%) 31/60 (52%) 18/60 (30%) | 23/60 (38%) 24/59 (41%) 25/60 (42%) 15/60 (25%) | |ADJUSTED (b) | 55.4% 63.6% 57.1% 36.9% | 51.5% 59.5% 63.7% 38.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 2/10 (20%) 4/10 (40%) 2/10 (20%) | 3/9 (33%) 1/9 (11%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 22/42 (52%) 24/42 (57%) 26/49 (53%) 15/45 (33%) | 19/40 (48%) 22/38 (58%) 22/36 (61%) 12/35 (34%) | |FIRST INCIDENCE (DAYS) | 620 456 (I) 456 (I) 456 (I) | 457 (I) 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.024N* P=0.139 P=0.416 P=0.081N | P=0.122N P=0.415 P=0.271 P=0.157N | |INCIDENTAL TUMOR | P=0.047N* P=0.159 P=0.196 P=0.076N | P=0.108N P=0.421 P=0.374 P=0.106N | |LOGISTIC REGRESSION | P=0.040N* P=0.105 P=0.212 P=0.104N | P=0.071N P=0.518 P=0.409 P=0.097N | |COCHRAN-ARMITAGE | P=0.052N | P=0.056N | |FISHER EXACT | P=0.136 P=0.180 P=0.127N | P=0.470 P=0.426 P=0.085N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 25/60 (42%) 32/60 (53%) 31/60 (52%) 18/60 (30%) | 23/60 (38%) 24/59 (41%) 25/60 (42%) 15/60 (25%) | |ADJUSTED (b) | 55.4% 63.6% 57.1% 36.9% | 51.5% 59.5% 63.7% 38.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 2/10 (20%) 4/10 (40%) 2/10 (20%) | 3/9 (33%) 1/9 (11%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 22/42 (52%) 24/42 (57%) 26/49 (53%) 15/45 (33%) | 19/40 (48%) 22/38 (58%) 22/36 (61%) 12/35 (34%) | |FIRST INCIDENCE (DAYS) | 620 456 (I) 456 (I) 456 (I) | 457 (I) 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.024N* P=0.139 P=0.416 P=0.081N | P=0.122N P=0.415 P=0.271 P=0.157N | |INCIDENTAL TUMOR | P=0.047N* P=0.159 P=0.196 P=0.076N | P=0.108N P=0.421 P=0.374 P=0.106N | |LOGISTIC REGRESSION | P=0.040N* P=0.105 P=0.212 P=0.104N | P=0.071N P=0.518 P=0.409 P=0.097N | |COCHRAN-ARMITAGE | P=0.052N | P=0.056N | |FISHER EXACT | P=0.136 P=0.180 P=0.127N | P=0.470 P=0.426 P=0.085N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 250 PPM 500 PPM 1000 PPM | 0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/60 (12%) 8/60 (13%) 9/60 (15%) 3/60 (5%) | 2/60 (3%) 3/59 (5%) 1/60 (2%) 3/60 (5%) | |ADJUSTED (b) | 15.1% 18.1% 17.7% 6.7% | 5.0% 7.6% 2.8% 7.8% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 1/10 (10%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/42 (10%) 7/42 (17%) 8/49 (16%) 3/45 (7%) | 2/40 (5%) 2/38 (5%) 1/36 (3%) 2/35 (6%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 729 (T) | 729 (T) 718 729 (T) 597 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.097N P=0.497 P=0.504 P=0.142N | P=0.422 P=0.479 P=0.537N P=0.452 | |INCIDENTAL TUMOR | P=0.123N P=0.427 P=0.339 P=0.196N | P=0.486 P=0.555 P=0.537N P=0.488 | |LOGISTIC REGRESSION | P=0.119N P=0.491 P=0.405 P=0.156N | P=0.449 P=0.492 P=0.537N P=0.482 | |COCHRAN-ARMITAGE | P=0.127N | P=0.480 | |FISHER EXACT | P=0.500 P=0.395 P=0.161N | P=0.492 P=0.500N P=0.500 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 2/60 (3%) 1/60 (2%) 0/60 (0%) | 0/60 (0%) 0/59 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 7.0% 4.5% 2.0% 0.0% | 0.0% 0.0% 0.0% 2.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/42 (5%) 0/42 (0%) 1/49 (2%) 0/45 (0%) | 0/40 (0%) 0/38 (0%) 0/36 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 712 661 729 (T) --- | --- --- --- 680 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.054N P=0.504N P=0.256N P=0.111N | P=0.187 (e) (e) P=0.481 | |INCIDENTAL TUMOR | P=0.113N P=0.692 P=0.390N P=0.153N | P=0.242 (e) (e) P=0.669 | |LOGISTIC REGRESSION | P=0.058N P=0.510N P=0.276N P=0.113N | P=0.196 (e) (e) P=0.496 | |COCHRAN-ARMITAGE | P=0.062N | P=0.199 | |FISHER EXACT | P=0.500N P=0.309N P=0.122N | (e) (e) P=0.500 | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 250 PPM 500 PPM 1000 PPM | 0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/60 (15%) 10/60 (17%) 10/60 (17%) 3/60 (5%) | 2/60 (3%) 3/59 (5%) 1/60 (2%) 4/60 (7%) | |ADJUSTED (b) | 19.5% 21.7% 19.7% 6.7% | 5.0% 7.6% 2.8% 10.2% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 1/10 (10%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 6/42 (14%) 7/42 (17%) 9/49 (18%) 3/45 (7%) | 2/40 (5%) 2/38 (5%) 1/36 (3%) 2/35 (6%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 729 (T) | 729 (T) 718 729 (T) 597 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.033N* P=0.497 P=0.571N P=0.054N | P=0.245 P=0.479 P=0.537N P=0.293 | |INCIDENTAL TUMOR | P=0.055N P=0.366 P=0.472 P=0.078N | P=0.321 P=0.555 P=0.537N P=0.389 | |LOGISTIC REGRESSION | P=0.042N* P=0.487 P=0.520 P=0.060N | P=0.268 P=0.492 P=0.537N P=0.320 | |COCHRAN-ARMITAGE | P=0.048N* | P=0.295 | |FISHER EXACT | P=0.500 P=0.500 P=0.063N | P=0.492 P=0.500N P=0.340 | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/59 (0%) 3/59 (5%) 3/59 (5%) 2/60 (3%) | |ADJUSTED (b) | | 0.0% 7.9% 8.6% 5.4% | |INTERIM SACRIFICE 1 (c)| | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 0/39 (0%) 3/38 (8%) 3/35 (9%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | | --- 729 (T) 729 (T) 692 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.270 P=0.116 P=0.102 P=0.215 | |INCIDENTAL TUMOR | | P=0.298 P=0.116 P=0.102 P=0.315 | |LOGISTIC REGRESSION | | P=0.278 P=0.116 P=0.102 P=0.231 | |COCHRAN-ARMITAGE | | P=0.320 | |FISHER EXACT | | P=0.122 P=0.122 P=0.252 | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 250 PPM 500 PPM 1000 PPM | 0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Luteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/59 (0%) 2/59 (3%) 0/59 (0%) 0/60 (0%) | |ADJUSTED (b) | | 0.0% 4.3% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 0/39 (0%) 1/38 (3%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | | --- 450 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.416N P=0.241 (e) (e) | |INCIDENTAL TUMOR | | P=0.674N P=0.164 (e) (e) | |LOGISTIC REGRESSION | | P=0.381N P=0.214 (e) (e) | |COCHRAN-ARMITAGE | | P=0.402N | |FISHER EXACT | | P=0.248 (e) (e) | |=================================================================================================================================| | | |Ovary | | Teratoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/59 (0%) 0/59 (0%) 0/59 (0%) 2/60 (3%) | |ADJUSTED (b) | | 0.0% 0.0% 0.0% 3.3% | |INTERIM SACRIFICE 1 (c)| | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 0/39 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | | --- --- --- 113 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.047 * (e) (e) P=0.238 | |INCIDENTAL TUMOR | | P=0.362 (e) (e) (e) | |LOGISTIC REGRESSION | | P=0.170 (e) (e) (e) | |COCHRAN-ARMITAGE | | P=0.048 * | |FISHER EXACT | | (e) (e) P=0.252 | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 250 PPM 500 PPM 1000 PPM | 0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/55 (0%) 0/56 (0%) 1/58 (2%) 0/57 (0%) | 6/57 (11%) 6/58 (10%) 9/59 (15%) 4/58 (7%) | |ADJUSTED (b) | 0.0% 0.0% 2.1% 0.0% | 14.4% 14.8% 22.9% 11.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/40 (0%) 0/40 (0%) 1/48 (2%) 0/44 (0%) | 5/40 (13%) 4/38 (11%) 7/36 (19%) 3/35 (9%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) --- | 612 697 568 692 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.711 (e) P=0.536 (e) | P=0.441N P=0.587 P=0.238 P=0.450N | |INCIDENTAL TUMOR | P=0.711 (e) P=0.536 (e) | P=0.347N P=0.593N P=0.266 P=0.381N | |LOGISTIC REGRESSION | P=0.711 (e) P=0.536 (e) | P=0.397N P=0.616N P=0.276 P=0.412N | |COCHRAN-ARMITAGE | P=0.699 | P=0.335N | |FISHER EXACT | (e) P=0.513 (e) | P=0.607N P=0.316 P=0.360N | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 2/60 (3%) 2/59 (3%) 3/60 (5%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 4.1% 5.1% 7.7% 2.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/42 (0%) 0/49 (0%) 0/45 (0%) | 1/40 (3%) 1/38 (3%) 2/36 (6%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 369 718 655 701 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.453N P=0.679 P=0.472 P=0.537N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.457N P=0.696N P=0.442 P=0.689N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.408N P=0.679 P=0.502 P=0.482N | |COCHRAN-ARMITAGE | (e) | P=0.402N | |FISHER EXACT | (e) (e) (e) | P=0.684 P=0.500 P=0.500N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 250 PPM 500 PPM 1000 PPM | 0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 2/60 (3%) 0/59 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 4.7% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/42 (0%) 0/49 (0%) 0/45 (0%) | 1/40 (3%) 0/38 (0%) 0/36 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 622 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.122N P=0.243N P=0.246N P=0.257N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.103N P=0.277N P=0.251N P=0.209N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.116N P=0.239N P=0.239N P=0.242N | |COCHRAN-ARMITAGE | (e) | P=0.115N | |FISHER EXACT | (e) (e) (e) | P=0.252N P=0.248N P=0.248N | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | 2/60 (3%) 1/59 (2%) 1/60 (2%) 0/59 (0%) | |ADJUSTED (b) | 2.4% 2.4% 0.0% 2.1% | 5.0% 2.6% 2.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/42 (2%) 1/42 (2%) 0/49 (0%) 0/45 (0%) | 2/40 (5%) 1/38 (3%) 1/36 (3%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- 701 | 729 (T) 729 (T) 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.593N P=0.762 P=0.469N P=0.743N | P=0.176N P=0.518N P=0.537N P=0.268N | |INCIDENTAL TUMOR | P=0.635 P=0.762 P=0.469N P=0.695 | P=0.176N P=0.518N P=0.537N P=0.268N | |LOGISTIC REGRESSION | P=0.604N P=0.762 P=0.469N P=0.756N | P=0.176N P=0.518N P=0.537N P=0.268N | |COCHRAN-ARMITAGE | P=0.616N | P=0.155N | |FISHER EXACT | P=0.752N P=0.500N P=0.752N | P=0.506N P=0.500N P=0.252N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 250 PPM 500 PPM 1000 PPM | 0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | 2/60 (3%) 0/59 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 2.3% 0.0% 2.0% 0.0% | 5.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/42 (0%) 1/49 (2%) 0/45 (0%) | 2/40 (5%) 0/38 (0%) 0/36 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 690 --- 729 (T) --- | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.387N P=0.505N P=0.731N P=0.487N | P=0.128N P=0.250N P=0.262N P=0.268N | |INCIDENTAL TUMOR | P=0.481N P=0.638N P=0.617 P=0.638N | P=0.128N P=0.250N P=0.262N P=0.268N | |LOGISTIC REGRESSION | P=0.398N P=0.502N P=0.754N P=0.498N | P=0.128N P=0.250N P=0.262N P=0.268N | |COCHRAN-ARMITAGE | P=0.405N | P=0.115N | |FISHER EXACT | P=0.500N P=0.752N P=0.500N | P=0.252N P=0.248N P=0.248N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | 0/60 (0%) 1/59 (2%) 2/59 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 2.0% 0.0% | 0.0% 2.6% 5.6% 2.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/42 (0%) 1/49 (2%) 0/45 (0%) | 0/40 (0%) 1/38 (3%) 2/36 (6%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) --- | --- 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.707 (e) P=0.531 (e) | P=0.329 P=0.490 P=0.215 P=0.473 | |INCIDENTAL TUMOR | P=0.707 (e) P=0.531 (e) | P=0.329 P=0.490 P=0.215 P=0.473 | |LOGISTIC REGRESSION | P=0.707 (e) P=0.531 (e) | P=0.329 P=0.490 P=0.215 P=0.473 | |COCHRAN-ARMITAGE | P=0.694 | P=0.368 | |FISHER EXACT | (e) P=0.500 (e) | P=0.496 P=0.244 P=0.500 | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 250 PPM 500 PPM 1000 PPM | 0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 2/60 (3%) 0/59 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | | 5.0% 0.0% 2.8% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 2/40 (5%) 0/38 (0%) 1/36 (3%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | | 729 (T) --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.211N P=0.250N P=0.537N P=0.268N | |INCIDENTAL TUMOR | | P=0.211N P=0.250N P=0.537N P=0.268N | |LOGISTIC REGRESSION | | P=0.211N P=0.250N P=0.537N P=0.268N | |COCHRAN-ARMITAGE | | P=0.188N | |FISHER EXACT | | P=0.252N P=0.500N P=0.248N | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 2/60 (3%) 0/59 (0%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | | 5.0% 0.0% 5.3% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 2/40 (5%) 0/38 (0%) 1/36 (3%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | | 729 (T) --- 701 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.280N P=0.250N P=0.656 P=0.268N | |INCIDENTAL TUMOR | | P=0.236N P=0.250N P=0.643N P=0.268N | |LOGISTIC REGRESSION | | P=0.267N P=0.250N P=0.680 P=0.268N | |COCHRAN-ARMITAGE | | P=0.247N | |FISHER EXACT | | P=0.252N P=0.691N P=0.248N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 250 PPM 500 PPM 1000 PPM | 0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | 2/60 (3%) 0/59 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 2.4% 2.2% 0.0% 0.0% | 4.7% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/42 (2%) 0/42 (0%) 0/49 (0%) 0/45 (0%) | 1/40 (3%) 0/38 (0%) 0/36 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 661 --- --- | 622 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.224N P=0.758 P=0.469N P=0.486N | P=0.122N P=0.243N P=0.246N P=0.257N | |INCIDENTAL TUMOR | P=0.305N P=0.686 P=0.469N P=0.486N | P=0.103N P=0.277N P=0.251N P=0.209N | |LOGISTIC REGRESSION | P=0.233N P=0.759 P=0.469N P=0.486N | P=0.116N P=0.239N P=0.239N P=0.242N | |COCHRAN-ARMITAGE | P=0.236N | P=0.115N | |FISHER EXACT | P=0.752N P=0.500N P=0.500N | P=0.252N P=0.248N P=0.248N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 2/60 (3%) | 2/60 (3%) 2/59 (3%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 2.4% 2.4% 0.0% 4.3% | 5.0% 5.3% 2.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/42 (2%) 1/42 (2%) 0/49 (0%) 1/45 (2%) | 2/40 (5%) 2/38 (5%) 1/36 (3%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- 701 | 729 (T) 729 (T) 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.392 P=0.762 P=0.469N P=0.526 | P=0.148N P=0.676 P=0.537N P=0.268N | |INCIDENTAL TUMOR | P=0.332 P=0.762 P=0.469N P=0.438 | P=0.148N P=0.676 P=0.537N P=0.268N | |LOGISTIC REGRESSION | P=0.382 P=0.762 P=0.469N P=0.512 | P=0.148N P=0.676 P=0.537N P=0.268N | |COCHRAN-ARMITAGE | P=0.367 | P=0.125N | |FISHER EXACT | P=0.752N P=0.500N P=0.500 | P=0.684 P=0.500N P=0.248N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 250 PPM 500 PPM 1000 PPM | 0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 2/60 (3%) 0/60 (0%) 2/60 (3%) | 4/60 (7%) 2/59 (3%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 4.8% 4.6% 0.0% 4.3% | 9.6% 5.3% 2.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/42 (5%) 1/42 (2%) 0/49 (0%) 1/45 (2%) | 3/40 (8%) 2/38 (5%) 1/36 (3%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 661 --- 701 | 622 729 (T) 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.524N P=0.691 P=0.205N P=0.666N | P=0.038N* P=0.356N P=0.205N P=0.079N | |INCIDENTAL TUMOR | P=0.588 P=0.634 P=0.205N P=0.653 | P=0.033N* P=0.380N P=0.208N P=0.064N | |LOGISTIC REGRESSION | P=0.542N P=0.686 P=0.205N P=0.682N | P=0.033N* P=0.334N P=0.184N P=0.068N | |COCHRAN-ARMITAGE | P=0.556N | P=0.030N* | |FISHER EXACT | P=0.691N P=0.248N P=0.691N | P=0.348N P=0.182N P=0.059N | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 0/59 (0%) 4/60 (7%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.3% 0.0% 9.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/42 (0%) 0/49 (0%) 0/45 (0%) | 0/40 (0%) 0/38 (0%) 1/36 (3%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 705 --- 457 (I) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.558N P=0.509N P=0.172 P=0.541N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.423N P=0.331N P=0.302 P=0.331N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.524N P=0.499N P=0.181 P=0.509N | |COCHRAN-ARMITAGE | (e) | P=0.528N | |FISHER EXACT | (e) (e) (e) | P=0.504N P=0.182 P=0.500N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 250 PPM 500 PPM 1000 PPM | 0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 2/60 (3%) 3/60 (5%) 6/60 (10%) | 13/60 (22%) 7/59 (12%) 11/60 (18%) 8/60 (13%) | |ADJUSTED (b) | 4.8% 4.8% 5.7% 12.7% | 31.7% 16.7% 26.6% 19.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/42 (5%) 2/42 (5%) 2/49 (4%) 4/45 (9%) | 12/40 (30%) 4/38 (11%) 7/36 (19%) 4/35 (11%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 456 (I) 670 | 712 599 497 582 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.070 P=0.695 P=0.556 P=0.162 | P=0.333N P=0.133N P=0.509N P=0.257N | |INCIDENTAL TUMOR | P=0.049 * P=0.695 P=0.556 P=0.099 | P=0.217N P=0.078N P=0.428N P=0.131N | |LOGISTIC REGRESSION | P=0.060 P=0.695 P=0.499 P=0.146 | P=0.184N P=0.102N P=0.424N P=0.196N | |COCHRAN-ARMITAGE | P=0.056 | P=0.226N | |FISHER EXACT | P=0.691N P=0.500 P=0.136 | P=0.118N P=0.410N P=0.168N | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 31/60 (52%) 32/60 (53%) 38/60 (63%) 20/60 (33%) | 30/60 (50%) 31/59 (53%) 25/60 (42%) 25/60 (42%) | |ADJUSTED (b) | 67.1% 67.5% 70.1% 41.2% | 66.1% 70.1% 61.8% 57.8% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 3/10 (30%) 5/10 (50%) 2/10 (20%) | 3/9 (33%) 1/9 (11%) 1/10 (10%) 2/10 (20%) | |TERMINAL (d) | 27/42 (64%) 27/42 (64%) 33/49 (67%) 17/45 (38%) | 25/40 (63%) 25/38 (66%) 21/36 (58%) 18/35 (51%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 456 (I) | 457 (I) 450 457 (I) 113 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.006N** P=0.494 P=0.405 P=0.015N* | P=0.305N P=0.402 P=0.363N P=0.405N | |INCIDENTAL TUMOR | P=0.012N* P=0.487 P=0.226 P=0.033N* | P=0.131N P=0.477 P=0.296N P=0.183N | |LOGISTIC REGRESSION | P=0.009N** P=0.447 P=0.157 P=0.023N* | P=0.141N P=0.528 P=0.224N P=0.218N | |COCHRAN-ARMITAGE | P=0.024N* | P=0.135N | |FISHER EXACT | P=0.500 P=0.134 P=0.032N* | P=0.463 P=0.232N P=0.232N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 250 PPM 500 PPM 1000 PPM | 0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 17/60 (28%) 15/60 (25%) 16/60 (27%) 11/60 (18%) | 23/60 (38%) 22/59 (37%) 24/60 (40%) 18/60 (30%) | |ADJUSTED (b) | 36.1% 30.5% 30.4% 22.4% | 50.8% 48.2% 50.7% 39.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 12/42 (29%) 8/42 (19%) 13/49 (27%) 7/45 (16%) | 18/40 (45%) 15/38 (39%) 13/36 (36%) 8/35 (23%) | |FIRST INCIDENCE (DAYS) | 620 489 456 (I) 638 | 369 450 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.095N P=0.438N P=0.337N P=0.116N | P=0.370N P=0.565N P=0.370 P=0.380N | |INCIDENTAL TUMOR | P=0.235N P=0.423N P=0.444 P=0.170N | P=0.192N P=0.490N P=0.519N P=0.109N | |LOGISTIC REGRESSION | P=0.201N P=0.442N P=0.475 P=0.218N | P=0.146N P=0.484N P=0.492 P=0.248N | |COCHRAN-ARMITAGE | P=0.127N | P=0.194N | |FISHER EXACT | P=0.418N P=0.500N P=0.140N | P=0.529N P=0.500 P=0.221N | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 39/60 (65%) 41/60 (68%) 45/60 (75%) 27/60 (45%) | 41/60 (68%) 38/59 (64%) 40/60 (67%) 41/60 (68%) | |ADJUSTED (b) | 79.5% 78.6% 80.2% 52.7% | 83.4% 80.6% 79.8% 78.5% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 3/10 (30%) 6/10 (60%) 2/10 (20%) | 3/9 (33%) 1/9 (11%) 2/10 (20%) 3/10 (30%) | |TERMINAL (d) | 32/42 (76%) 31/42 (74%) 38/49 (78%) 21/45 (47%) | 32/40 (80%) 29/38 (76%) 26/36 (72%) 24/35 (69%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 456 (I) | 369 450 457 (I) 113 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.003N** P=0.416 P=0.546 P=0.012N* | P=0.214 P=0.475N P=0.427 P=0.310 | |INCIDENTAL TUMOR | P=0.011N* P=0.429 P=0.134 P=0.023N* | P=0.505 P=0.362N P=0.412N P=0.332N | |LOGISTIC REGRESSION | P=0.005N** P=0.361 P=0.186 P=0.013N* | P=0.415 P=0.297N P=0.493N P=0.577 | |COCHRAN-ARMITAGE | P=0.009N** | P=0.482 | |FISHER EXACT | P=0.423 P=0.160 P=0.022N* | P=0.398N P=0.500N P=0.578N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 02 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 456 Female interim sacrifices(days): 457 (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).