TDMS Study 05165-01 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: 01 TIME: 19:59:27 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-65156 ROUTE: DOSED FEED NTP C#: 61610B PATHOLOGIST: J. TOFT 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: 01 TIME: 19:59:27 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-65156 ROUTE: DOSED FEED NTP C#: 61610B PATHOLOGIST: J. TOFT CAS: 96-69-5 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 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 TIME: 19:59:27 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-65156 ROUTE: DOSED FEED NTP C#: 61610B PATHOLOGIST: J. TOFT 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 RATS ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Skin Fibroma Testes Adenoma All Organs Benign Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Clitoral/Preputial Gland Carcinoma or Adenoma Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma Uterus Polyp Stromal Sarcoma Stromal or Polyp Stromal ==================================================================================================== DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/60 (25%) 15/60 (25%) 10/60 (17%) 10/59 (17%) | 1/60 (2%) 2/60 (3%) 3/59 (5%) 1/60 (2%) | |ADJUSTED (b) | 59.5% 45.5% 40.9% 37.4% | 2.9% 6.2% 9.4% 3.6% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 0/7 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 9/18 (50%) 11/28 (39%) 8/22 (36%) 4/18 (22%) | 1/34 (3%) 1/31 (3%) 3/32 (9%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 449 (I) 449 (I) 697 449 (I) | 729 (T) 712 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.210N P=0.156N P=0.067N P=0.180N | P=0.614N P=0.459 P=0.283 P=0.718 | |INCIDENTAL TUMOR | P=0.138N P=0.331N P=0.077N P=0.141N | P=0.611N P=0.469 P=0.283 P=0.718 | |LOGISTIC REGRESSION | P=0.149N P=0.377N P=0.075N P=0.174N | P=0.619N P=0.459 P=0.283 P=0.718 | |COCHRAN-ARMITAGE | P=0.136N | P=0.541N | |FISHER EXACT | P=0.583N P=0.184N P=0.197N | P=0.500 P=0.303 P=0.752N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/60 (25%) 15/60 (25%) 10/60 (17%) 11/59 (19%) | 1/60 (2%) 2/60 (3%) 3/59 (5%) 2/60 (3%) | |ADJUSTED (b) | 59.5% 45.5% 40.9% 41.9% | 2.9% 6.2% 9.4% 5.6% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 0/7 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 9/18 (50%) 11/28 (39%) 8/22 (36%) 5/18 (28%) | 1/34 (3%) 1/31 (3%) 3/32 (9%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 449 (I) 449 (I) 697 449 (I) | 729 (T) 712 729 (T) 541 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.302N P=0.156N P=0.067N P=0.245N | P=0.394 P=0.459 P=0.283 P=0.455 | |INCIDENTAL TUMOR | P=0.212N P=0.331N P=0.077N P=0.201N | P=0.426 P=0.469 P=0.283 P=0.488 | |LOGISTIC REGRESSION | P=0.226N P=0.377N P=0.075N P=0.243N | P=0.421 P=0.459 P=0.283 P=0.492 | |COCHRAN-ARMITAGE | P=0.202N | P=0.462 | |FISHER EXACT | P=0.583N P=0.184N P=0.269N | P=0.500 P=0.303 P=0.500 | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Bone | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/59 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 4.7% 0.0% | 2.9% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 0/28 (0%) 0/22 (0%) 0/18 (0%) | 1/34 (3%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 466 --- | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.713 (e) P=0.273 (e) | P=0.418N P=0.518N P=0.512N P=0.539N | |INCIDENTAL TUMOR | P=0.710N (e) P=0.292 (e) | P=0.418N P=0.518N P=0.512N P=0.539N | |LOGISTIC REGRESSION | P=0.708 (e) P=0.220 (e) | P=0.418N P=0.518N P=0.512N P=0.539N | |COCHRAN-ARMITAGE | P=0.713 | P=0.394N | |FISHER EXACT | (e) P=0.248 (e) | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Brain | | Astrocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 2/59 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 6.3% 0.0% 7.6% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 1/28 (4%) 0/22 (0%) 1/18 (6%) | 0/34 (0%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- 669 --- 533 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.218 P=0.332 (e) P=0.245 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.227 P=0.298 (e) P=0.220 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.238 P=0.279 (e) P=0.235 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.245 | (e) | |FISHER EXACT | P=0.248 (e) P=0.244 | (e) (e) (e) | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 0/60 (0%) 2/59 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 5.6% 6.3% 0.0% 7.6% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/18 (6%) 1/28 (4%) 0/22 (0%) 1/18 (6%) | 0/34 (0%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 669 --- 533 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.411 P=0.643 P=0.460N P=0.505 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.421 P=0.611 P=0.460N P=0.479 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.435 P=0.585 P=0.460N P=0.499 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.446 | (e) | |FISHER EXACT | P=0.500 P=0.500N P=0.494 | (e) (e) (e) | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 5/59 (8%) 3/59 (5%) 4/59 (7%) | 4/59 (7%) 1/58 (2%) 0/60 (0%) 1/59 (2%) | |ADJUSTED (b) | 5.6% 14.9% 10.3% 10.7% | 12.1% 3.3% 0.0% 2.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/18 (6%) 2/28 (7%) 1/22 (5%) 0/18 (0%) | 4/33 (12%) 1/30 (3%) 0/32 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 625 627 533 | 729 (T) 729 (T) --- 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.246 P=0.213 P=0.391 P=0.199 | P=0.196N P=0.207N P=0.066N P=0.245N | |INCIDENTAL TUMOR | P=0.330 P=0.104 P=0.324 P=0.168 | P=0.197N P=0.207N P=0.066N P=0.244N | |LOGISTIC REGRESSION | P=0.282 P=0.146 P=0.347 P=0.175 | P=0.189N P=0.207N P=0.066N P=0.228N | |COCHRAN-ARMITAGE | P=0.291 | P=0.158N | |FISHER EXACT | P=0.100 P=0.303 P=0.177 | P=0.187N P=0.057N P=0.182N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 2/59 (3%) 0/59 (0%) 0/59 (0%) | 1/59 (2%) 1/58 (2%) 0/60 (0%) 2/59 (3%) | |ADJUSTED (b) | 9.2% 7.1% 0.0% 0.0% | 2.3% 2.4% 0.0% 4.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/18 (6%) 2/28 (7%) 0/22 (0%) 0/18 (0%) | 0/33 (0%) 0/30 (0%) 0/32 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 663 729 (T) --- --- | 673 652 --- 597 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.119N P=0.536N P=0.193N P=0.236N | P=0.303 P=0.739 P=0.519N P=0.448 | |INCIDENTAL TUMOR | P=0.110N P=0.571N P=0.193N P=0.213N | P=0.496 P=0.746 P=0.557N P=0.660N | |LOGISTIC REGRESSION | P=0.115N P=0.604N P=0.211N P=0.238N | P=0.350 P=0.757 P=0.501N P=0.513 | |COCHRAN-ARMITAGE | P=0.114N | P=0.345 | |FISHER EXACT | P=0.684 P=0.252N P=0.252N | P=0.748 P=0.496N P=0.500 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 7/59 (12%) 3/59 (5%) 4/59 (7%) | 5/59 (8%) 2/58 (3%) 0/60 (0%) 3/59 (5%) | |ADJUSTED (b) | 14.5% 21.5% 10.3% 10.7% | 14.1% 5.6% 0.0% 7.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/18 (11%) 4/28 (14%) 1/22 (5%) 0/18 (0%) | 4/33 (12%) 1/30 (3%) 0/32 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 663 625 627 533 | 673 652 --- 597 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.567 P=0.361 P=0.554N P=0.520 | P=0.475N P=0.259N P=0.038N* P=0.460N | |INCIDENTAL TUMOR | P=0.505N P=0.220 P=0.612N P=0.499 | P=0.348N P=0.257N P=0.041N* P=0.217N | |LOGISTIC REGRESSION | P=0.551N P=0.249 P=0.609N P=0.495 | P=0.419N P=0.248N P=0.037N* P=0.387N | |COCHRAN-ARMITAGE | P=0.534N | P=0.395N | |FISHER EXACT | P=0.154 P=0.652 P=0.491 | P=0.226N P=0.027N* P=0.358N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 0/60 (0%) 0/59 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/59 (0%) | |ADJUSTED (b) | 6.9% 1.7% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 0/28 (0%) 0/22 (0%) 0/18 (0%) | 0/34 (0%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 619 449 (I) --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.145N P=0.448N P=0.193N P=0.246N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.135N P=0.623N P=0.250N P=0.229N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.142N P=0.520N P=0.227N P=0.239N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.140N | (e) | |FISHER EXACT | P=0.500N P=0.248N P=0.252N | (e) (e) (e) | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 2/60 (3%) 1/60 (2%) 0/59 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/59 (0%) | |ADJUSTED (b) | 6.9% 4.9% 4.5% 0.0% | 2.9% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 0/28 (0%) 1/22 (5%) 0/18 (0%) | 1/34 (3%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 619 449 (I) 729 (T) --- | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.153N P=0.615N P=0.427N P=0.246N | P=0.418N P=0.518N P=0.512N P=0.539N | |INCIDENTAL TUMOR | P=0.129N P=0.610 P=0.491N P=0.229N | P=0.418N P=0.518N P=0.512N P=0.539N | |LOGISTIC REGRESSION | P=0.141N P=0.690 P=0.466N P=0.239N | P=0.418N P=0.518N P=0.512N P=0.539N | |COCHRAN-ARMITAGE | P=0.141N | P=0.397N | |FISHER EXACT | P=0.691N P=0.500N P=0.252N | P=0.500N P=0.500N P=0.504N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 3/60 (5%) 4/59 (7%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 5.6% 7.1% 13.6% 17.0% | 0.0% 0.0% 0.0% 3.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/18 (6%) 2/28 (7%) 3/22 (14%) 2/18 (11%) | 0/34 (0%) 0/31 (0%) 0/32 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 625 | --- --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.079 P=0.653 P=0.377 P=0.182 | P=0.188 (e) (e) P=0.461 | |INCIDENTAL TUMOR | P=0.095 P=0.653 P=0.377 P=0.186 | P=0.188 (e) (e) P=0.461 | |LOGISTIC REGRESSION | P=0.090 P=0.653 P=0.377 P=0.176 | P=0.188 (e) (e) P=0.461 | |COCHRAN-ARMITAGE | P=0.126 | P=0.211 | |FISHER EXACT | P=0.500 P=0.309 P=0.177 | (e) (e) P=0.500 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 3/60 (5%) 5/59 (8%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 5.6% 10.7% 13.6% 21.0% | 0.0% 0.0% 0.0% 3.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/18 (6%) 3/28 (11%) 3/22 (14%) 2/18 (11%) | 0/34 (0%) 0/31 (0%) 0/32 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 625 | --- --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.047 * P=0.472 P=0.377 P=0.107 | P=0.188 (e) (e) P=0.461 | |INCIDENTAL TUMOR | P=0.063 P=0.472 P=0.377 P=0.118 | P=0.188 (e) (e) P=0.461 | |LOGISTIC REGRESSION | P=0.055 P=0.472 P=0.377 P=0.100 | P=0.188 (e) (e) P=0.461 | |COCHRAN-ARMITAGE | P=0.085 | P=0.211 | |FISHER EXACT | P=0.309 P=0.309 P=0.100 | (e) (e) P=0.500 | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 3/60 (5%) 5/59 (8%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 5.6% 10.7% 13.6% 21.0% | 0.0% 0.0% 0.0% 3.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/18 (6%) 3/28 (11%) 3/22 (14%) 2/18 (11%) | 0/34 (0%) 0/31 (0%) 0/32 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 625 | --- --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.047 * P=0.472 P=0.377 P=0.107 | P=0.188 (e) (e) P=0.461 | |INCIDENTAL TUMOR | P=0.063 P=0.472 P=0.377 P=0.118 | P=0.188 (e) (e) P=0.461 | |LOGISTIC REGRESSION | P=0.055 P=0.472 P=0.377 P=0.100 | P=0.188 (e) (e) P=0.461 | |COCHRAN-ARMITAGE | P=0.085 | P=0.211 | |FISHER EXACT | P=0.309 P=0.309 P=0.100 | (e) (e) P=0.500 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 2/60 (3%) 0/60 (0%) 0/59 (0%) | 1/60 (2%) 0/59 (0%) 1/59 (2%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 7.1% 0.0% 0.0% | 2.9% 0.0% 3.2% 3.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 2/28 (7%) 0/22 (0%) 0/18 (0%) | 1/34 (3%) 0/31 (0%) 1/31 (3%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | 729 (T) --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.457N P=0.339 (e) (e) | P=0.517 P=0.518N P=0.741 P=0.718 | |INCIDENTAL TUMOR | P=0.457N P=0.339 (e) (e) | P=0.517 P=0.518N P=0.741 P=0.718 | |LOGISTIC REGRESSION | P=0.457N P=0.339 (e) (e) | P=0.517 P=0.518N P=0.741 P=0.718 | |COCHRAN-ARMITAGE | P=0.426N | P=0.563 | |FISHER EXACT | P=0.252 (e) (e) | P=0.504N P=0.748 P=0.752N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 3/60 (5%) 0/60 (0%) 0/59 (0%) | 1/60 (2%) 0/59 (0%) 1/59 (2%) 1/60 (2%) | |ADJUSTED (b) | 5.6% 10.7% 0.0% 0.0% | 2.9% 0.0% 3.2% 3.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/18 (6%) 3/28 (11%) 0/22 (0%) 0/18 (0%) | 1/34 (3%) 0/31 (0%) 1/31 (3%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- --- | 729 (T) --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.188N P=0.472 P=0.460N P=0.500N | P=0.517 P=0.518N P=0.741 P=0.718 | |INCIDENTAL TUMOR | P=0.188N P=0.472 P=0.460N P=0.500N | P=0.517 P=0.518N P=0.741 P=0.718 | |LOGISTIC REGRESSION | P=0.188N P=0.472 P=0.460N P=0.500N | P=0.517 P=0.518N P=0.741 P=0.718 | |COCHRAN-ARMITAGE | P=0.173N | P=0.563 | |FISHER EXACT | P=0.316 P=0.496N P=0.500N | P=0.504N P=0.748 P=0.752N | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/59 (0%) | 2/60 (3%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.6% 3.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 0/28 (0%) 0/22 (0%) 0/18 (0%) | 1/34 (3%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 725 712 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.167N P=0.547N P=0.263N P=0.293N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.163N P=0.531N P=0.278N P=0.282N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.158N P=0.538N P=0.259N P=0.289N | |COCHRAN-ARMITAGE | (e) | P=0.139N | |FISHER EXACT | (e) (e) (e) | P=0.500N P=0.248N P=0.248N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/59 (0%) | 3/60 (5%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 8.4% 3.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 0/28 (0%) 0/22 (0%) 0/18 (0%) | 2/34 (6%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 725 712 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.088N P=0.353N P=0.139N P=0.165N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.086N P=0.338N P=0.148N P=0.159N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.083N P=0.348N P=0.138N P=0.164N | |COCHRAN-ARMITAGE | (e) | P=0.069N | |FISHER EXACT | (e) (e) (e) | P=0.309N P=0.122N P=0.122N | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 4/60 (7%) 0/60 (0%) 2/59 (3%) | 29/60 (48%) 25/60 (42%) 11/60 (18%) 16/60 (27%) | |ADJUSTED (b) | 11.0% 14.3% 0.0% 7.7% | 72.2% 59.5% 28.6% 44.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/18 (6%) 4/28 (14%) 0/22 (0%) 1/18 (6%) | 23/34 (68%) 15/31 (48%) 6/32 (19%) 9/28 (32%) | |FIRST INCIDENCE (DAYS) | 625 729 (T) --- 555 | 673 372 626 572 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.372N P=0.615N P=0.097N P=0.501N | P=0.042N* P=0.465N P=0.001N** P=0.076N | |INCIDENTAL TUMOR | P=0.348N P=0.496 P=0.160N P=0.542N | P=0.009N** P=0.294N P<0.001N** P=0.014N* | |LOGISTIC REGRESSION | P=0.343N P=0.605 P=0.110N P=0.502N | P=0.013N* P=0.367N P<0.001N** P=0.028N* | |COCHRAN-ARMITAGE | P=0.332N | P=0.007N** | |FISHER EXACT | P=0.500 P=0.122N P=0.508N | P=0.291N P<0.001N** P=0.012N* | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 4/60 (7%) 0/60 (0%) 2/59 (3%) | 31/60 (52%) 25/60 (42%) 11/60 (18%) 16/60 (27%) | |ADJUSTED (b) | 11.0% 14.3% 0.0% 7.7% | 75.4% 59.5% 28.6% 44.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/18 (6%) 4/28 (14%) 0/22 (0%) 1/18 (6%) | 24/34 (71%) 15/31 (48%) 6/32 (19%) 9/28 (32%) | |FIRST INCIDENCE (DAYS) | 625 729 (T) --- 555 | 673 372 626 572 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.372N P=0.615N P=0.097N P=0.501N | P=0.024N* P=0.338N P<0.001N** P=0.041N* | |INCIDENTAL TUMOR | P=0.348N P=0.496 P=0.160N P=0.542N | P=0.004N** P=0.176N P<0.001N** P=0.005N** | |LOGISTIC REGRESSION | P=0.343N P=0.605 P=0.110N P=0.502N | P=0.006N** P=0.232N P<0.001N** P=0.011N* | |COCHRAN-ARMITAGE | P=0.332N | P=0.003N** | |FISHER EXACT | P=0.500 P=0.122N P=0.508N | P=0.180N P<0.001N** P=0.004N** | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 4/60 (7%) 0/60 (0%) 2/59 (3%) | 32/60 (53%) 25/60 (42%) 11/60 (18%) 16/60 (27%) | |ADJUSTED (b) | 11.0% 14.3% 0.0% 7.7% | 77.8% 59.5% 28.6% 44.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/18 (6%) 4/28 (14%) 0/22 (0%) 1/18 (6%) | 25/34 (74%) 15/31 (48%) 6/32 (19%) 9/28 (32%) | |FIRST INCIDENCE (DAYS) | 625 729 (T) --- 555 | 673 372 626 572 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.372N P=0.615N P=0.097N P=0.501N | P=0.018N* P=0.279N P<0.001N** P=0.028N* | |INCIDENTAL TUMOR | P=0.348N P=0.496 P=0.160N P=0.542N | P=0.002N** P=0.130N P<0.001N** P=0.003N** | |LOGISTIC REGRESSION | P=0.343N P=0.605 P=0.110N P=0.502N | P=0.004N** P=0.176N P<0.001N** P=0.006N** | |COCHRAN-ARMITAGE | P=0.332N | P=0.002N** | |FISHER EXACT | P=0.500 P=0.122N P=0.508N | P=0.136N P<0.001N** P=0.002N** | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Nose | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/59 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 6.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 0/28 (0%) 0/22 (0%) 0/18 (0%) | 0/34 (0%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 627 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.708 (e) P=0.297 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.672N (e) P=0.222 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.713 (e) P=0.251 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.713 | (e) | |FISHER EXACT | (e) P=0.248 (e) | (e) (e) (e) | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 1/60 (2%) 0/59 (0%) | 2/60 (3%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 4.3% 8.7% 4.2% 0.0% | 5.9% 0.0% 6.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 2/28 (7%) 0/22 (0%) 0/18 (0%) | 2/34 (6%) 0/31 (0%) 2/32 (6%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 688 449 (I) 723 --- | 729 (T) --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.222N P=0.419 P=0.705N P=0.500N | P=0.288N P=0.259N P=0.674 P=0.282N | |INCIDENTAL TUMOR | P=0.190N P=0.395 P=0.693N P=0.452N | P=0.288N P=0.259N P=0.674 P=0.282N | |LOGISTIC REGRESSION | P=0.203N P=0.320 P=0.725N P=0.501N | P=0.288N P=0.259N P=0.674 P=0.282N | |COCHRAN-ARMITAGE | P=0.202N | P=0.250N | |FISHER EXACT | P=0.309 P=0.752N P=0.504N | P=0.248N P=0.691N P=0.248N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 1/60 (2%) 0/59 (0%) | 3/60 (5%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 4.3% 8.7% 4.2% 0.0% | 7.9% 0.0% 6.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 2/28 (7%) 0/22 (0%) 0/18 (0%) | 2/34 (6%) 0/31 (0%) 2/32 (6%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 688 449 (I) 723 --- | 623 --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.222N P=0.419 P=0.705N P=0.500N | P=0.168N P=0.138N P=0.530N P=0.159N | |INCIDENTAL TUMOR | P=0.190N P=0.395 P=0.693N P=0.452N | P=0.118N P=0.047N* P=0.387N P=0.046N* | |LOGISTIC REGRESSION | P=0.203N P=0.320 P=0.725N P=0.501N | P=0.156N P=0.128N P=0.527N P=0.134N | |COCHRAN-ARMITAGE | P=0.202N | P=0.138N | |FISHER EXACT | P=0.309 P=0.752N P=0.504N | P=0.122N P=0.500N P=0.122N | |=================================================================================================================================| | | |Parathyroid Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/57 (4%) 0/55 (0%) 0/57 (0%) 1/56 (2%) | 0/58 (0%) 0/58 (0%) 0/56 (0%) 0/60 (0%) | |ADJUSTED (b) | 11.1% 0.0% 0.0% 5.9% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/18 (11%) 0/26 (0%) 0/22 (0%) 1/17 (6%) | 0/34 (0%) 0/30 (0%) 0/31 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- 729 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.619N P=0.161N P=0.194N P=0.520N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.619N P=0.161N P=0.194N P=0.520N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.619N P=0.161N P=0.194N P=0.520N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.563N | (e) | |FISHER EXACT | P=0.257N P=0.248N P=0.507N | (e) (e) (e) | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Pharynx | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/59 (0%) | 1/60 (2%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 5.2% 0.0% 0.0% | 2.9% 0.0% 6.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 1/28 (4%) 0/22 (0%) 0/18 (0%) | 1/34 (3%) 0/31 (0%) 2/32 (6%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- 449 (I) --- --- | 729 (T) --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.442N P=0.288 (e) (e) | P=0.482N P=0.518N P=0.479 P=0.539N | |INCIDENTAL TUMOR | P=0.442N P=0.288 (e) (e) | P=0.482N P=0.518N P=0.479 P=0.539N | |LOGISTIC REGRESSION | P=0.429N P=0.226 (e) (e) | P=0.482N P=0.518N P=0.479 P=0.539N | |COCHRAN-ARMITAGE | P=0.428N | P=0.438N | |FISHER EXACT | P=0.248 (e) (e) | P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/60 (25%) 12/59 (20%) 13/60 (22%) 10/59 (17%) | 30/59 (51%) 16/60 (27%) 17/60 (28%) 18/59 (31%) | |ADJUSTED (b) | 44.9% 33.2% 44.3% 33.7% | 70.0% 40.3% 41.4% 49.2% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/10 (20%) 1/7 (14%) 0/10 (0%) | 3/10 (30%) 1/10 (10%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 3/18 (17%) 7/28 (25%) 8/22 (36%) 3/18 (17%) | 21/33 (64%) 9/31 (29%) 9/32 (28%) 11/28 (39%) | |FIRST INCIDENCE (DAYS) | 449 (I) 449 (I) 416 555 | 450 (I) 450 (I) 481 450 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.288N P=0.110N P=0.268N P=0.201N | P=0.187N P=0.019N* P=0.027N* P=0.089N | |INCIDENTAL TUMOR | P=0.172N P=0.392N P=0.359N P=0.151N | P=0.092N P=0.011N* P=0.016N* P=0.025N* | |LOGISTIC REGRESSION | P=0.202N P=0.283N P=0.359N P=0.169N | P=0.095N P=0.007N** P=0.012N* P=0.029N* | |COCHRAN-ARMITAGE | P=0.195N | P=0.070N | |FISHER EXACT | P=0.349N P=0.415N P=0.197N | P=0.006N** P=0.010N** P=0.019N* | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/60 (25%) 12/59 (20%) 13/60 (22%) 10/59 (17%) | 30/59 (51%) 16/60 (27%) 17/60 (28%) 19/59 (32%) | |ADJUSTED (b) | 44.9% 33.2% 44.3% 33.7% | 70.0% 40.3% 41.4% 51.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/10 (20%) 1/7 (14%) 0/10 (0%) | 3/10 (30%) 1/10 (10%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 3/18 (17%) 7/28 (25%) 8/22 (36%) 3/18 (17%) | 21/33 (64%) 9/31 (29%) 9/32 (28%) 11/28 (39%) | |FIRST INCIDENCE (DAYS) | 449 (I) 449 (I) 416 555 | 450 (I) 450 (I) 481 450 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.288N P=0.110N P=0.268N P=0.201N | P=0.254N P=0.019N* P=0.027N* P=0.130N | |INCIDENTAL TUMOR | P=0.172N P=0.392N P=0.359N P=0.151N | P=0.139N P=0.011N* P=0.016N* P=0.042N* | |LOGISTIC REGRESSION | P=0.202N P=0.283N P=0.359N P=0.169N | P=0.141N P=0.007N** P=0.012N* P=0.046N* | |COCHRAN-ARMITAGE | P=0.195N | P=0.105N | |FISHER EXACT | P=0.349N P=0.415N P=0.197N | P=0.006N** P=0.010N** P=0.031N* | |=================================================================================================================================| | | |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) | 4/60 (7%) 2/60 (3%) 1/60 (2%) 3/59 (5%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 13.9% 7.1% 3.3% 8.8% | 2.2% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/18 (6%) 2/28 (7%) 0/22 (0%) 0/18 (0%) | 0/34 (0%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 533 729 (T) 695 539 | 651 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.579N P=0.218N P=0.131N P=0.500N | P=0.419N P=0.518N P=0.528N P=0.538N | |INCIDENTAL TUMOR | P=0.525N P=0.326N P=0.151N P=0.515N | P=0.420N P=0.517N P=0.557N P=0.536N | |LOGISTIC REGRESSION | P=0.549N P=0.294N P=0.167N P=0.507N | P=0.394N P=0.499N P=0.499N P=0.499N | |COCHRAN-ARMITAGE | P=0.543N | P=0.394N | |FISHER EXACT | P=0.340N P=0.182N P=0.509N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/60 (8%) 1/60 (2%) 4/60 (7%) 2/59 (3%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 20.9% 3.6% 13.1% 8.5% | 2.9% 3.2% 0.0% 3.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 3/18 (17%) 1/28 (4%) 0/22 (0%) 1/18 (6%) | 1/34 (3%) 1/31 (3%) 0/32 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 533 729 (T) 688 649 | 729 (T) 729 (T) --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.339N P=0.046N* P=0.368N P=0.211N | P=0.642 P=0.741 P=0.512N P=0.718 | |INCIDENTAL TUMOR | P=0.274N P=0.080N P=0.393N P=0.224N | P=0.642 P=0.741 P=0.512N P=0.718 | |LOGISTIC REGRESSION | P=0.310N P=0.077N P=0.433N P=0.217N | P=0.642 P=0.741 P=0.512N P=0.718 | |COCHRAN-ARMITAGE | P=0.297N | P=0.679 | |FISHER EXACT | P=0.103N P=0.500N P=0.226N | P=0.752N P=0.500N P=0.752N | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/60 (8%) 2/60 (3%) 4/60 (7%) 2/59 (3%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 20.9% 5.9% 13.1% 8.5% | 2.9% 3.2% 0.0% 3.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 3/18 (17%) 1/28 (4%) 0/22 (0%) 1/18 (6%) | 1/34 (3%) 1/31 (3%) 0/32 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 533 625 688 649 | 729 (T) 729 (T) --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.292N P=0.116N P=0.368N P=0.211N | P=0.642 P=0.741 P=0.512N P=0.718 | |INCIDENTAL TUMOR | P=0.229N P=0.245N P=0.393N P=0.224N | P=0.642 P=0.741 P=0.512N P=0.718 | |LOGISTIC REGRESSION | P=0.262N P=0.178N P=0.433N P=0.217N | P=0.642 P=0.741 P=0.512N P=0.718 | |COCHRAN-ARMITAGE | P=0.254N | P=0.679 | |FISHER EXACT | P=0.219N P=0.500N P=0.226N | P=0.752N P=0.500N P=0.752N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/59 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 5.9% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 1/28 (4%) 0/22 (0%) 0/18 (0%) | 0/34 (0%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- 625 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.450N P=0.310 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.429N P=0.148 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.433N P=0.261 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.428N | (e) | |FISHER EXACT | P=0.248 (e) (e) | (e) (e) (e) | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 2/59 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 4.2% 3.6% 3.3% 6.1% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 1/28 (4%) 0/22 (0%) 0/18 (0%) | 0/34 (0%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 678 729 (T) 695 539 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.326 P=0.677N P=0.683N P=0.505 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.379 P=0.702N P=0.693N P=0.535 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.345 P=0.717N P=0.737N P=0.496 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.352 | (e) | |FISHER EXACT | P=0.752N P=0.752N P=0.494 | (e) (e) (e) | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 0/60 (0%) 1/59 (2%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 7.7% 3.6% 0.0% 2.9% | 2.2% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/18 (6%) 1/28 (4%) 0/22 (0%) 0/18 (0%) | 0/34 (0%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 533 729 (T) --- 621 | 651 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.473N P=0.399N P=0.213N P=0.498N | P=0.419N P=0.518N P=0.528N P=0.538N | |INCIDENTAL TUMOR | P=0.469N P=0.419N P=0.202N P=0.539N | P=0.420N P=0.517N P=0.557N P=0.536N | |LOGISTIC REGRESSION | P=0.454N P=0.473N P=0.235N P=0.504N | P=0.394N P=0.499N P=0.499N P=0.499N | |COCHRAN-ARMITAGE | P=0.452N | P=0.394N | |FISHER EXACT | P=0.500N P=0.248N P=0.506N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 2/60 (3%) 1/60 (2%) 3/59 (5%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 11.5% 7.1% 3.3% 8.8% | 2.2% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/18 (6%) 2/28 (7%) 0/22 (0%) 0/18 (0%) | 0/34 (0%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 533 729 (T) 695 539 | 651 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.497 P=0.357N P=0.231N P=0.654N | P=0.419N P=0.518N P=0.528N P=0.538N | |INCIDENTAL TUMOR | P=0.540 P=0.390N P=0.225N P=0.660 | P=0.420N P=0.517N P=0.557N P=0.536N | |LOGISTIC REGRESSION | P=0.523 P=0.445N P=0.284N P=0.657 | P=0.394N P=0.499N P=0.499N P=0.499N | |COCHRAN-ARMITAGE | P=0.528 | P=0.394N | |FISHER EXACT | P=0.500N P=0.309N P=0.652 | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 2/60 (3%) 1/60 (2%) 3/59 (5%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 11.5% 7.1% 3.3% 8.8% | 2.2% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/18 (6%) 2/28 (7%) 0/22 (0%) 0/18 (0%) | 0/34 (0%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 533 729 (T) 695 539 | 651 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.497 P=0.357N P=0.231N P=0.654N | P=0.419N P=0.518N P=0.528N P=0.538N | |INCIDENTAL TUMOR | P=0.540 P=0.390N P=0.225N P=0.660 | P=0.420N P=0.517N P=0.557N P=0.536N | |LOGISTIC REGRESSION | P=0.523 P=0.445N P=0.284N P=0.657 | P=0.394N P=0.499N P=0.499N P=0.499N | |COCHRAN-ARMITAGE | P=0.528 | P=0.394N | |FISHER EXACT | P=0.500N P=0.309N P=0.652 | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 52/60 (87%) 52/59 (88%) 53/60 (88%) 50/59 (85%) | | |ADJUSTED (b) | 100.0% 98.0% 100.0% 100.0% | | |INTERIM SACRIFICE 1 (c)| 6/10 (60%) 8/10 (80%) 6/7 (86%) 6/10 (60%) | | |TERMINAL (d) | 18/18 (100%) 26/27 (96%) 22/22 (100%) 18/18 (100%)| | |FIRST INCIDENCE (DAYS) | 418 416 449 (I) 441 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.364 P=0.038N* P=0.278N P=0.436N | | |INCIDENTAL TUMOR | P=0.275N P=0.621N P=0.546N P=0.360N | | |LOGISTIC REGRESSION | P=0.326N P=0.612 P=0.605 P=0.406N | | |COCHRAN-ARMITAGE | P=0.388N | | |FISHER EXACT | P=0.514 P=0.500 P=0.485N | | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/60 (8%) 3/60 (5%) 8/60 (13%) 3/59 (5%) | 3/59 (5%) 2/59 (3%) 8/60 (13%) 8/60 (13%) | |ADJUSTED (b) | 21.7% 9.5% 26.7% 12.7% | 8.0% 6.7% 22.8% 24.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/18 (11%) 1/28 (4%) 3/22 (14%) 2/18 (11%) | 2/34 (6%) 2/30 (7%) 6/32 (19%) 5/28 (18%) | |FIRST INCIDENCE (DAYS) | 632 676 466 449 (I) | 663 729 (T) 598 591 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.463N P=0.187N P=0.421 P=0.360N | P=0.019 * P=0.554N P=0.084 P=0.061 | |INCIDENTAL TUMOR | P=0.355N P=0.314N P=0.415 P=0.336N | P=0.031 * P=0.545N P=0.113 P=0.093 | |LOGISTIC REGRESSION | P=0.403N P=0.249N P=0.352 P=0.357N | P=0.025 * P=0.540N P=0.089 P=0.075 | |COCHRAN-ARMITAGE | P=0.386N | P=0.041 * | |FISHER EXACT | P=0.359N P=0.279 P=0.368N | P=0.500N P=0.107 P=0.107 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/59 (2%) | 0/59 (0%) 2/59 (3%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 3.0% | 0.0% 6.7% 0.0% 6.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 0/28 (0%) 0/22 (0%) 0/18 (0%) | 0/34 (0%) 2/30 (7%) 0/32 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | --- --- --- 633 | --- 729 (T) --- 620 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.199 (e) (e) P=0.519 | P=0.210 P=0.211 (e) P=0.202 | |INCIDENTAL TUMOR | P=0.250 (e) (e) P=0.469 | P=0.284 P=0.211 (e) P=0.393 | |LOGISTIC REGRESSION | P=0.208 (e) (e) P=0.498 | P=0.232 P=0.211 (e) P=0.233 | |COCHRAN-ARMITAGE | P=0.208 | P=0.255 | |FISHER EXACT | (e) (e) P=0.496 | P=0.248 (e) P=0.252 | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/60 (8%) 3/60 (5%) 8/60 (13%) 4/59 (7%) | 3/59 (5%) 4/59 (7%) 8/60 (13%) 9/60 (15%) | |ADJUSTED (b) | 21.7% 9.5% 26.7% 15.3% | 8.0% 13.3% 22.8% 26.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/18 (11%) 1/28 (4%) 3/22 (14%) 2/18 (11%) | 2/34 (6%) 4/30 (13%) 6/32 (19%) 5/28 (18%) | |FIRST INCIDENCE (DAYS) | 632 676 466 449 (I) | 663 729 (T) 598 591 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.535 P=0.187N P=0.421 P=0.495N | P=0.017 * P=0.434 P=0.084 P=0.036 * | |INCIDENTAL TUMOR | P=0.504N P=0.314N P=0.415 P=0.488N | P=0.034 * P=0.442 P=0.113 P=0.085 | |LOGISTIC REGRESSION | P=0.559N P=0.249N P=0.352 P=0.502N | P=0.024 * P=0.445 P=0.089 P=0.048 * | |COCHRAN-ARMITAGE | P=0.537N | P=0.040 * | |FISHER EXACT | P=0.359N P=0.279 P=0.511N | P=0.500 P=0.107 P=0.067 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 3/60 (5%) 1/60 (2%) 0/59 (0%) | 0/59 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 8.7% 3.6% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 2/28 (7%) 0/22 (0%) 0/18 (0%) | 0/34 (0%) 0/30 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- 449 (I) 698 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.372N P=0.177 P=0.557 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.348N P=0.177 P=0.562 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.349N P=0.123 P=0.530 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.348N | (e) | |FISHER EXACT | P=0.122 P=0.500 (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 2/60 (3%) 1/59 (2%) | 0/59 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 5.6% 8.7% 7.8% 5.6% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/18 (6%) 2/28 (7%) 0/22 (0%) 1/18 (6%) | 0/34 (0%) 0/30 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 449 (I) 698 729 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.520N P=0.429 P=0.572 P=0.763 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.471N P=0.429 P=0.595 P=0.763 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.480N P=0.328 P=0.575 P=0.763 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.466N | (e) | |FISHER EXACT | P=0.309 P=0.500 P=0.748 | (e) (e) (e) | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 2/60 (3%) 5/60 (8%) 10/60 (17%) 9/60 (15%) | |ADJUSTED (b) | | 5.9% 14.9% 25.6% 24.5% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | | 2/34 (6%) 4/31 (13%) 6/32 (19%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | | 729 (T) 626 450 (I) 591 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.017 * P=0.183 P=0.014 * P=0.015 * | |INCIDENTAL TUMOR | | P=0.034 * P=0.262 P=0.017 * P=0.018 * | |LOGISTIC REGRESSION | | P=0.025 * P=0.185 P=0.015 * P=0.019 * | |COCHRAN-ARMITAGE | | P=0.033 * | |FISHER EXACT | | P=0.219 P=0.015 * P=0.027 * | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 2/60 (3%) 6/60 (10%) 10/60 (17%) 10/60 (17%) | |ADJUSTED (b) | | 5.9% 16.7% 25.6% 27.4% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | | 2/34 (6%) 4/31 (13%) 6/32 (19%) 3/28 (11%) | |FIRST INCIDENCE (DAYS) | | 729 (T) 590 450 (I) 591 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.011 * P=0.114 P=0.014 * P=0.008 ** | |INCIDENTAL TUMOR | | P=0.027 * P=0.231 P=0.017 * P=0.009 ** | |LOGISTIC REGRESSION | | P=0.017 * P=0.120 P=0.015 * P=0.010 ** | |COCHRAN-ARMITAGE | | P=0.023 * | |FISHER EXACT | | P=0.136 P=0.015 * P=0.015 * | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 30/60 (50%) 36/60 (60%) 34/60 (57%) 33/59 (56%) | 18/60 (30%) 18/60 (30%) 22/60 (37%) 20/60 (33%) | |ADJUSTED (b) | 78.6% 79.5% 81.5% 73.9% | 41.8% 43.5% 51.6% 48.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 11/18 (61%) 19/28 (68%) 15/22 (68%) 7/18 (39%) | 10/34 (29%) 8/31 (26%) 12/32 (38%) 8/28 (29%) | |FIRST INCIDENCE (DAYS) | 467 352 477 423 | 453 604 481 452 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.261 P=0.319N P=0.445N P=0.407 | P=0.192 P=0.448 P=0.226 P=0.222 | |INCIDENTAL TUMOR | P=0.468 P=0.094 P=0.372 P=0.349 | P=0.363 P=0.551 P=0.210 P=0.412 | |LOGISTIC REGRESSION | P=0.515 P=0.165 P=0.222 P=0.362 | P=0.407 P=0.529N P=0.288 P=0.475 | |COCHRAN-ARMITAGE | P=0.412 | P=0.370 | |FISHER EXACT | P=0.179 P=0.292 P=0.321 | P=0.579N P=0.281 P=0.422 | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 0/60 (0%) 1/59 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 10.5% 3.6% 0.0% 1.8% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/18 (6%) 1/28 (4%) 0/22 (0%) 0/18 (0%) | 0/34 (0%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 726 729 (T) --- 449 (I) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.486N P=0.355N P=0.202N P=0.506N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.454N P=0.389N P=0.186N P=0.472N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.455N P=0.371N P=0.192N P=0.504N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.452N | (e) | |FISHER EXACT | P=0.500N P=0.248N P=0.506N | (e) (e) (e) | |=================================================================================================================================| | | |All Organs | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/59 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 4.7% 0.0% | 2.9% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 0/28 (0%) 0/22 (0%) 0/18 (0%) | 1/34 (3%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 466 --- | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.713 (e) P=0.273 (e) | P=0.418N P=0.518N P=0.512N P=0.539N | |INCIDENTAL TUMOR | P=0.710N (e) P=0.292 (e) | P=0.418N P=0.518N P=0.512N P=0.539N | |LOGISTIC REGRESSION | P=0.708 (e) P=0.220 (e) | P=0.418N P=0.518N P=0.512N P=0.539N | |COCHRAN-ARMITAGE | P=0.713 | P=0.394N | |FISHER EXACT | (e) P=0.248 (e) | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/59 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 4.7% 0.0% | 2.9% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/18 (0%) 0/28 (0%) 0/22 (0%) 0/18 (0%) | 1/34 (3%) 0/31 (0%) 0/32 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 466 --- | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.713 (e) P=0.273 (e) | P=0.418N P=0.518N P=0.512N P=0.539N | |INCIDENTAL TUMOR | P=0.710N (e) P=0.292 (e) | P=0.418N P=0.518N P=0.512N P=0.539N | |LOGISTIC REGRESSION | P=0.708 (e) P=0.220 (e) | P=0.418N P=0.518N P=0.512N P=0.539N | |COCHRAN-ARMITAGE | P=0.713 | P=0.394N | |FISHER EXACT | (e) P=0.248 (e) | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 56/60 (93%) 56/60 (93%) 57/60 (95%) 53/59 (90%) | 45/60 (75%) 37/60 (62%) 37/60 (62%) 39/60 (65%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 93.6% 79.7% 80.1% 88.5% | |INTERIM SACRIFICE 1 (c)| 7/10 (70%) 9/10 (90%) 7/7 (100%) 7/10 (70%) | 3/10 (30%) 2/10 (20%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 18/18 (100%) 28/28 (100%) 22/22 (100%) 18/18 (100%)| 31/34 (91%) 22/31 (71%) 23/32 (72%) 23/28 (82%) | |FIRST INCIDENCE (DAYS) | 418 416 416 441 | 450 (I) 372 450 (I) 450 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.396 P=0.024N* P=0.288N P=0.392N | P=0.362 P=0.283N P=0.232N P=0.464 | |INCIDENTAL TUMOR | P=0.110N P=0.641N P=0.623N P=0.221N | P=0.374N P=0.092N P=0.117N P=0.287N | |LOGISTIC REGRESSION | P=0.139N P=0.628N P=0.338 P=0.236N | P=0.404N P=0.099N P=0.104N P=0.270N | |COCHRAN-ARMITAGE | P=0.262N | P=0.268N | |FISHER EXACT | P=0.641N P=0.500 P=0.361N | P=0.085N P=0.085N P=0.160N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1000 PPM 2500 PPM | 0 PPM 500 PPM 1000 PPM 2500 PPM | | | 65 PATH 65 PATH 65 PATH 65 PATH | 65 PATH 65 PATH 65 PATH 65 PATH | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 37/60 (62%) 41/60 (68%) 41/60 (68%) 37/59 (63%) | 22/60 (37%) 23/60 (38%) 24/60 (40%) 25/60 (42%) | |ADJUSTED (b) | 87.2% 85.2% 84.8% 80.1% | 49.0% 51.5% 54.0% 56.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 13/18 (72%) 21/28 (75%) 15/22 (68%) 9/18 (50%) | 12/34 (35%) 10/31 (32%) 12/32 (38%) 10/28 (36%) | |FIRST INCIDENCE (DAYS) | 418 352 403 423 | 453 428 481 452 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.377 P=0.168N P=0.404N P=0.537N | P=0.155 P=0.370 P=0.341 P=0.164 | |INCIDENTAL TUMOR | P=0.381N P=0.205 P=0.476 P=0.559N | P=0.396 P=0.546 P=0.362 P=0.498 | |LOGISTIC REGRESSION | P=0.379N P=0.427 P=0.254 P=0.565N | P=0.432 P=0.571N P=0.480 P=0.508 | |COCHRAN-ARMITAGE | P=0.484N | P=0.323 | |FISHER EXACT | P=0.283 P=0.283 P=0.529 | P=0.500 P=0.426 P=0.354 | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 56/60 (93%) 58/60 (97%) 59/60 (98%) 56/59 (95%) | 50/60 (83%) 47/60 (78%) 44/60 (73%) 48/60 (80%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 96.1% 90.3% 88.0% 96.0% | |INTERIM SACRIFICE 1 (c)| 7/10 (70%) 9/10 (90%) 7/7 (100%) 7/10 (70%) | 3/10 (30%) 2/10 (20%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 18/18 (100%) 28/28 (100%) 22/22 (100%) 18/18 (100%)| 32/34 (94%) 26/31 (84%) 26/32 (81%) 26/28 (93%) | |FIRST INCIDENCE (DAYS) | 418 352 403 423 | 450 (I) 372 450 (I) 450 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.270 P=0.048N* P=0.383N P=0.538N | P=0.191 P=0.497 P=0.371N P=0.203 | |INCIDENTAL TUMOR | P=0.562N P=0.347 P=0.385 P=0.683 | P=0.360N P=0.240N P=0.098N P=0.329N | |LOGISTIC REGRESSION | P=0.516N P=0.370 P=0.167 P=0.669N | P=0.375N P=0.385N P=0.164N P=0.348N | |COCHRAN-ARMITAGE | P=0.543 | P=0.450N | |FISHER EXACT | P=0.340 P=0.182 P=0.509 | P=0.322N P=0.134N P=0.407N | |=================================================================================================================================| DATE: 11/09/95 EXPERIMENT: 05165 TEST: 01 PAGE 26 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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): 449 Female interim sacrifices(days): 450 (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).