TDMS Study 05181-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest TETRAHYDROFURAN DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 TIME: 12:48:55 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-95259 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 60560C PATHOLOGIST: R. MILLER CAS: 0109-99-9 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest TETRAHYDROFURAN DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 TIME: 12:48:55 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-95259 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 60560C PATHOLOGIST: R. MILLER CAS: 0109-99-9 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 Larynx 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 Northwest TETRAHYDROFURAN DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 TIME: 12:48:55 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-95259 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 60560C PATHOLOGIST: R. MILLER CAS: 0109-99-9 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF TETRAHYDROFURAN ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Skin Sarcoma Thyroid Gland: C-Cell Carcinoma All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/48 (6%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) | |ADJUSTED (b) | 9.4% 3.2% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/32 (9%) 1/31 (3%) 0/28 (0%) 0/12 (0%) | 0/29 (0%) 0/33 (0%) 0/26 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) 733 (T) --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.194N P=0.316N P=0.145N P=0.336N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.194N P=0.316N P=0.145N P=0.336N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.194N P=0.316N P=0.145N P=0.336N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.094N | (e) | |FISHER EXACT | P=0.293N P=0.117N P=0.114N | (e) (e) (e) | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | 0/49 (0%) 1/49 (2%) 0/50 (0%) 2/45 (4%) | |ADJUSTED (b) | 3.1% 0.0% 3.4% 0.0% | 0.0% 3.0% 0.0% 5.6% | |TERMINAL (d) | 1/32 (3%) 0/31 (0%) 0/28 (0%) 0/12 (0%) | 0/29 (0%) 1/33 (3%) 0/26 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 721 --- | --- 733 (T) --- 599 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.661N P=0.506N P=0.731 P=0.695N | P=0.155 P=0.526 (e) P=0.253 | |INCIDENTAL TUMOR | P=0.573N P=0.506N P=0.669 P=0.695N | P=0.202 P=0.526 (e) P=0.345 | |LOGISTIC REGRESSION | P=0.644N P=0.506N P=0.725 P=0.695N | P=0.141 P=0.526 (e) P=0.223 | |COCHRAN-ARMITAGE | P=0.454N | P=0.130 | |FISHER EXACT | P=0.490N P=0.747N P=0.490N | P=0.500 (e) P=0.226 | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | 0/49 (0%) 1/49 (2%) 1/50 (2%) 2/45 (4%) | |ADJUSTED (b) | 3.1% 0.0% 3.4% 0.0% | 0.0% 3.0% 3.8% 5.6% | |TERMINAL (d) | 1/32 (3%) 0/31 (0%) 0/28 (0%) 0/12 (0%) | 0/29 (0%) 1/33 (3%) 1/26 (4%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 721 --- | --- 733 (T) 733 (T) 599 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.661N P=0.506N P=0.731 P=0.695N | P=0.200 P=0.526 P=0.478 P=0.253 | |INCIDENTAL TUMOR | P=0.573N P=0.506N P=0.669 P=0.695N | P=0.246 P=0.526 P=0.478 P=0.345 | |LOGISTIC REGRESSION | P=0.644N P=0.506N P=0.725 P=0.695N | P=0.188 P=0.526 P=0.478 P=0.223 | |COCHRAN-ARMITAGE | P=0.454N | P=0.169 | |FISHER EXACT | P=0.490N P=0.747N P=0.490N | P=0.500 P=0.505 P=0.226 | |=================================================================================================================================| | | |Bone | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.4% 3.0% 0.0% 5.5% | |TERMINAL (d) | 0/32 (0%) 0/31 (0%) 0/28 (0%) 0/12 (0%) | 1/29 (3%) 1/33 (3%) 0/26 (0%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 733 (T) 733 (T) --- 598 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.350 P=0.733N P=0.522N P=0.532 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.408 P=0.733N P=0.522N P=0.620 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.347 P=0.733N P=0.522N P=0.527 | |COCHRAN-ARMITAGE | (e) | P=0.332 | |FISHER EXACT | (e) (e) (e) | P=0.753N P=0.500N P=0.500 | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) 1/50 (2%) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | |ADJUSTED (b) | 2.5% 9.7% 10.3% 5.6% | 6.1% 3.0% 7.7% 3.1% | |TERMINAL (d) | 0/32 (0%) 3/31 (10%) 2/28 (7%) 0/12 (0%) | 1/29 (3%) 1/33 (3%) 2/26 (8%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 658 733 (T) 721 658 | 604 733 (T) 733 (T) 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.485 P=0.289 P=0.255 P=0.574 | P=0.459N P=0.458N P=0.669 P=0.471N | |INCIDENTAL TUMOR | P=0.585 P=0.273 P=0.171 P=0.702 | P=0.410N P=0.431N P=0.683N P=0.380N | |LOGISTIC REGRESSION | P=0.533 P=0.284 P=0.262 P=0.664 | P=0.460N P=0.473N P=0.672N P=0.473N | |COCHRAN-ARMITAGE | P=0.418N | P=0.476N | |FISHER EXACT | P=0.309 P=0.309 P=0.753N | P=0.500N P=0.691N P=0.500N | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 8.3% 0.0% 0.0% 8.3% | 0.0% 3.0% 0.0% 0.0% | |TERMINAL (d) | 2/32 (6%) 0/31 (0%) 0/28 (0%) 1/12 (8%) | 0/29 (0%) 1/33 (3%) 0/26 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 582 --- --- 733 (T) | --- 733 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.694 P=0.135N P=0.148N P=0.669N | P=0.575N P=0.526 (e) (e) | |INCIDENTAL TUMOR | P=0.708 P=0.127N P=0.088N P=0.690N | P=0.575N P=0.526 (e) (e) | |LOGISTIC REGRESSION | P=0.646N P=0.121N P=0.121N P=0.579N | P=0.575N P=0.526 (e) (e) | |COCHRAN-ARMITAGE | P=0.442N | P=0.585N | |FISHER EXACT | P=0.121N P=0.121N P=0.309N | P=0.500 (e) (e) | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) 3/50 (6%) 2/50 (4%) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) | |ADJUSTED (b) | 10.6% 9.7% 10.3% 13.4% | 6.1% 6.1% 7.7% 3.1% | |TERMINAL (d) | 2/32 (6%) 3/31 (10%) 2/28 (7%) 1/12 (8%) | 1/29 (3%) 2/33 (6%) 2/26 (8%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 582 733 (T) 721 658 | 604 733 (T) 733 (T) 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.479 P=0.531N P=0.578N P=0.585 | P=0.364N P=0.649N P=0.669 P=0.471N | |INCIDENTAL TUMOR | P=0.568 P=0.534N P=0.585N P=0.651 | P=0.323N P=0.628N P=0.683N P=0.380N | |LOGISTIC REGRESSION | P=0.559 P=0.521N P=0.540N P=0.653N | P=0.365N P=0.664N P=0.672N P=0.473N | |COCHRAN-ARMITAGE | P=0.304N | P=0.381N | |FISHER EXACT | P=0.500N P=0.500N P=0.339N | P=0.691N P=0.691N P=0.500N | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/48 (0%) | |ADJUSTED (b) | 3.1% 3.0% 7.1% 0.0% | 0.0% 3.0% 0.0% 0.0% | |TERMINAL (d) | 1/32 (3%) 0/31 (0%) 2/28 (7%) 0/12 (0%) | 0/29 (0%) 1/33 (3%) 0/26 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) 706 733 (T) --- | --- 733 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.587N P=0.753 P=0.453 P=0.695N | P=0.575N P=0.526 (e) (e) | |INCIDENTAL TUMOR | P=0.534N P=0.725 P=0.453 P=0.695N | P=0.575N P=0.526 (e) (e) | |LOGISTIC REGRESSION | P=0.566N P=0.749 P=0.453 P=0.695N | P=0.575N P=0.526 (e) (e) | |COCHRAN-ARMITAGE | P=0.332N | P=0.593N | |FISHER EXACT | P=0.753N P=0.500 P=0.500N | P=0.500 (e) (e) | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 24/50 (48%) 19/50 (38%) 16/50 (32%) 14/50 (28%) | 12/50 (24%) 17/50 (34%) 18/50 (36%) 31/48 (65%) | |ADJUSTED (b) | 60.5% 53.4% 48.7% 59.0% | 35.9% 47.1% 52.5% 76.8% | |TERMINAL (d) | 17/32 (53%) 15/31 (48%) 12/28 (43%) 4/12 (33%) | 8/29 (28%) 14/33 (42%) 11/26 (42%) 23/32 (72%) | |FIRST INCIDENCE (DAYS) | 362 324 440 245 | 648 640 469 399 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.097 P=0.273N P=0.199N P=0.181 | P<0.001 ** P=0.313 P=0.119 P=0.001 ** | |INCIDENTAL TUMOR | P=0.389N P=0.224N P=0.203N P=0.395N | P<0.001 ** P=0.196 P=0.197 P<0.001 ** | |LOGISTIC REGRESSION | P=0.506N P=0.211N P=0.142N P=0.414N | P<0.001 ** P=0.249 P=0.188 P<0.001 ** | |COCHRAN-ARMITAGE | P=0.041N* | P<0.001 ** | |FISHER EXACT | P=0.210N P=0.076N P=0.032N* | P=0.189 P=0.138 P<0.001 ** | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 13/50 (26%) 14/50 (28%) 9/50 (18%) | 6/50 (12%) 10/50 (20%) 10/50 (20%) 16/48 (33%) | |ADJUSTED (b) | 33.3% 28.9% 31.4% 50.0% | 16.5% 26.3% 30.0% 40.8% | |TERMINAL (d) | 6/32 (19%) 3/31 (10%) 2/28 (7%) 4/12 (33%) | 2/29 (7%) 6/33 (18%) 5/26 (19%) 10/32 (31%) | |FIRST INCIDENCE (DAYS) | 481 441 376 359 | 478 552 544 562 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.161 P=0.557N P=0.455 P=0.190 | P=0.027 * P=0.297 P=0.210 P=0.035 * | |INCIDENTAL TUMOR | P=0.555N P=0.425N P=0.352N P=0.518 | P=0.028 * P=0.242 P=0.319 P=0.042 * | |LOGISTIC REGRESSION | P=0.459 P=0.412N P=0.270N P=0.363 | P=0.012 * P=0.234 P=0.229 P=0.014 * | |COCHRAN-ARMITAGE | P=0.136N | P=0.009 ** | |FISHER EXACT | P=0.500N P=0.588N P=0.171N | P=0.207 P=0.207 P=0.011 * | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 35/50 (70%) 31/50 (62%) 30/50 (60%) 18/50 (36%) | 17/50 (34%) 24/50 (48%) 26/50 (52%) 41/48 (85%) | |ADJUSTED (b) | 77.2% 67.9% 66.9% 73.4% | 46.3% 61.3% 69.1% 93.0% | |TERMINAL (d) | 22/32 (69%) 17/31 (55%) 14/28 (50%) 6/12 (50%) | 10/29 (34%) 18/33 (55%) 15/26 (58%) 29/32 (91%) | |FIRST INCIDENCE (DAYS) | 362 324 376 245 | 478 552 469 399 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.181 P=0.407N P=0.501N P=0.237 | P<0.001 ** P=0.253 P=0.056 P<0.001 ** | |INCIDENTAL TUMOR | P=0.098N P=0.213N P=0.185N P=0.171N | P<0.001 ** P=0.149 P=0.118 P<0.001 ** | |LOGISTIC REGRESSION | P=0.105N P=0.210N P=0.121N P=0.175N | P<0.001 ** P=0.188 P=0.086 P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001N** | P<0.001 ** | |FISHER EXACT | P=0.263N P=0.201N P<0.001N** | P=0.111 P=0.053 P<0.001 ** | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 35/50 (70%) 31/50 (62%) 30/50 (60%) 18/50 (36%) | 17/50 (34%) 24/50 (48%) 26/50 (52%) 41/48 (85%) | |ADJUSTED (b) | 77.2% 67.9% 66.9% 73.4% | 46.3% 61.3% 69.1% 93.0% | |TERMINAL (d) | 22/32 (69%) 17/31 (55%) 14/28 (50%) 6/12 (50%) | 10/29 (34%) 18/33 (55%) 15/26 (58%) 29/32 (91%) | |FIRST INCIDENCE (DAYS) | 362 324 376 245 | 478 552 469 399 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.181 P=0.407N P=0.501N P=0.237 | P<0.001 ** P=0.253 P=0.056 P<0.001 ** | |INCIDENTAL TUMOR | P=0.098N P=0.213N P=0.185N P=0.171N | P<0.001 ** P=0.149 P=0.118 P<0.001 ** | |LOGISTIC REGRESSION | P=0.105N P=0.210N P=0.121N P=0.175N | P<0.001 ** P=0.188 P=0.086 P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001N** | P<0.001 ** | |FISHER EXACT | P=0.263N P=0.201N P<0.001N** | P=0.111 P=0.053 P<0.001 ** | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocholangiocarcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/48 (0%) | |ADJUSTED (b) | 8.7% 0.0% 2.4% 0.0% | 5.6% 2.4% 0.0% 0.0% | |TERMINAL (d) | 2/32 (6%) 0/31 (0%) 0/28 (0%) 0/12 (0%) | 0/29 (0%) 0/33 (0%) 0/26 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 675 --- 574 --- | 630 601 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.303N P=0.132N P=0.362N P=0.329N | P=0.174N P=0.467N P=0.231N P=0.243N | |INCIDENTAL TUMOR | P=0.260N P=0.144N P=0.313N P=0.276N | P=0.114N P=0.468N P=0.140N P=0.215N | |LOGISTIC REGRESSION | P=0.219N P=0.130N P=0.305N P=0.291N | P=0.182N P=0.511N P=0.236N P=0.246N | |COCHRAN-ARMITAGE | P=0.156N | P=0.174N | |FISHER EXACT | P=0.121N P=0.309N P=0.121N | P=0.500N P=0.247N P=0.258N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 7/50 (14%) 8/50 (16%) 4/50 (8%) | 1/50 (2%) 2/50 (4%) 4/50 (8%) 3/49 (6%) | |ADJUSTED (b) | 51.0% 19.0% 26.6% 30.8% | 3.4% 6.1% 14.2% 8.4% | |TERMINAL (d) | 15/32 (47%) 3/31 (10%) 7/28 (25%) 3/12 (25%) | 1/29 (3%) 2/33 (6%) 3/26 (12%) 2/32 (6%) | |FIRST INCIDENCE (DAYS) | 582 554 512 721 | 733 (T) 733 (T) 690 574 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.230N P=0.017N* P=0.043N* P=0.183N | P=0.332 P=0.545 P=0.158 P=0.344 | |INCIDENTAL TUMOR | P=0.148N P=0.017N* P=0.038N* P=0.129N | P=0.342 P=0.545 P=0.182 P=0.410 | |LOGISTIC REGRESSION | P=0.137N P=0.014N* P=0.043N* P=0.110N | P=0.321 P=0.545 P=0.186 P=0.330 | |COCHRAN-ARMITAGE | P=0.004N** | P=0.294 | |FISHER EXACT | P=0.010N** P=0.020N* P<0.001N** | P=0.500 P=0.181 P=0.301 | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 9/50 (18%) 7/50 (14%) 3/50 (6%) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 2/49 (4%) | |ADJUSTED (b) | 17.5% 25.4% 21.4% 19.6% | 3.4% 3.0% 6.3% 5.6% | |TERMINAL (d) | 5/32 (16%) 6/31 (19%) 4/28 (14%) 1/12 (8%) | 1/29 (3%) 1/33 (3%) 1/26 (4%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 557 532 554 658 | 733 (T) 733 (T) 610 604 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.538 P=0.261 P=0.408 P=0.509 | P=0.400 P=0.733N P=0.484 P=0.529 | |INCIDENTAL TUMOR | P=0.519N P=0.283 P=0.532 P=0.574 | P=0.499 P=0.733N P=0.528 P=0.620 | |LOGISTIC REGRESSION | P=0.455N P=0.263 P=0.455 P=0.619 | P=0.396 P=0.733N P=0.523 P=0.524 | |COCHRAN-ARMITAGE | P=0.097N | P=0.375 | |FISHER EXACT | P=0.288 P=0.500 P=0.243N | P=0.753N P=0.500 P=0.492 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 21/50 (42%) 16/50 (32%) 15/50 (30%) 7/50 (14%) | 2/50 (4%) 3/50 (6%) 5/50 (10%) 5/49 (10%) | |ADJUSTED (b) | 57.7% 41.1% 45.5% 46.0% | 6.9% 9.1% 16.4% 13.7% | |TERMINAL (d) | 17/32 (53%) 9/31 (29%) 11/28 (39%) 4/12 (33%) | 2/29 (7%) 3/33 (9%) 3/26 (12%) 3/32 (9%) | |FIRST INCIDENCE (DAYS) | 557 532 512 658 | 733 (T) 733 (T) 610 574 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.437N P=0.270N P=0.288N P=0.444N | P=0.220 P=0.559 P=0.196 P=0.259 | |INCIDENTAL TUMOR | P=0.250N P=0.258N P=0.199N P=0.318N | P=0.279 P=0.559 P=0.241 P=0.354 | |LOGISTIC REGRESSION | P=0.213N P=0.248N P=0.248N P=0.280N | P=0.212 P=0.559 P=0.241 P=0.245 | |COCHRAN-ARMITAGE | P=0.002N** | P=0.183 | |FISHER EXACT | P=0.204N P=0.149N P=0.002N** | P=0.500 P=0.218 P=0.210 | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/49 (0%) 0/50 (0%) 2/50 (4%) 1/46 (2%) | |ADJUSTED (b) | | 0.0% 0.0% 7.7% 3.3% | |TERMINAL (d) | | 0/29 (0%) 0/33 (0%) 2/26 (8%) 1/30 (3%) | |FIRST INCIDENCE (DAYS) | | --- --- 733 (T) 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.351 (e) P=0.214 P=0.507 | |INCIDENTAL TUMOR | | P=0.351 (e) P=0.214 P=0.507 | |LOGISTIC REGRESSION | | P=0.351 (e) P=0.214 P=0.507 | |COCHRAN-ARMITAGE | | P=0.332 | |FISHER EXACT | | (e) P=0.253 P=0.484 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/45 (2%) 0/47 (0%) 1/45 (2%) 0/47 (0%) | 10/47 (21%) 8/48 (17%) 14/48 (29%) 8/48 (17%) | |ADJUSTED (b) | 3.2% 0.0% 2.3% 0.0% | 32.7% 23.4% 47.3% 23.4% | |TERMINAL (d) | 1/31 (3%) 0/30 (0%) 0/27 (0%) 0/12 (0%) | 7/27 (26%) 6/31 (19%) 11/26 (42%) 6/32 (19%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 560 --- | 651 582 599 631 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.648N P=0.507N P=0.740 P=0.689N | P=0.306N P=0.292N P=0.222 P=0.287N | |INCIDENTAL TUMOR | P=0.635N P=0.507N P=0.667N P=0.689N | P=0.308N P=0.331N P=0.338 P=0.342N | |LOGISTIC REGRESSION | P=0.485N P=0.507N P=0.735N P=0.689N | P=0.298N P=0.285N P=0.330 P=0.267N | |COCHRAN-ARMITAGE | P=0.454N | P=0.386N | |FISHER EXACT | P=0.489N P=0.753N P=0.489N | P=0.378N P=0.259 P=0.378N | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |Skin | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | |ADJUSTED (b) | 0.0% 3.2% 0.0% 0.0% | 0.0% 0.0% 2.4% 8.9% | |TERMINAL (d) | 0/32 (0%) 1/31 (3%) 0/28 (0%) 0/12 (0%) | 0/29 (0%) 0/33 (0%) 0/26 (0%) 2/32 (6%) | |FIRST INCIDENCE (DAYS) | --- 733 (T) --- --- | --- --- 574 631 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.749N P=0.494 (e) (e) | P=0.025 * (e) P=0.515 P=0.136 | |INCIDENTAL TUMOR | P=0.749N P=0.494 (e) (e) | P=0.054 (e) P=0.594 P=0.186 | |LOGISTIC REGRESSION | P=0.749N P=0.494 (e) (e) | P=0.022 * (e) P=0.476 P=0.135 | |COCHRAN-ARMITAGE | P=0.585N | P=0.021 * | |FISHER EXACT | P=0.500 (e) (e) | (e) P=0.500 P=0.121 | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.4% 6.1% 0.0% 0.0% | |TERMINAL (d) | 0/32 (0%) 0/31 (0%) 0/28 (0%) 0/12 (0%) | 1/29 (3%) 2/33 (6%) 0/26 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 733 (T) 733 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.209N P=0.545 P=0.522N P=0.480N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.209N P=0.545 P=0.522N P=0.480N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.209N P=0.545 P=0.522N P=0.480N | |COCHRAN-ARMITAGE | (e) | P=0.214N | |FISHER EXACT | (e) (e) (e) | P=0.500 P=0.500N P=0.500N | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/47 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 6.3% | |TERMINAL (d) | 0/32 (0%) 0/31 (0%) 0/28 (0%) 0/12 (0%) | 0/29 (0%) 0/33 (0%) 0/26 (0%) 2/32 (6%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- --- 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.049 * (e) (e) P=0.260 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.049 * (e) (e) P=0.260 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.049 * (e) (e) P=0.260 | |COCHRAN-ARMITAGE | (e) | P=0.037 * | |FISHER EXACT | (e) (e) (e) | (e) (e) P=0.232 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | 1/50 (2%) 0/50 (0%) 0/49 (0%) 2/47 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.4% 0.0% 0.0% 6.3% | |TERMINAL (d) | 0/32 (0%) 0/31 (0%) 0/28 (0%) 0/12 (0%) | 1/29 (3%) 0/33 (0%) 0/26 (0%) 2/32 (6%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 733 (T) --- --- 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.206 P=0.474N P=0.522N P=0.535 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.206 P=0.474N P=0.522N P=0.535 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.206 P=0.474N P=0.522N P=0.535 | |COCHRAN-ARMITAGE | (e) | P=0.177 | |FISHER EXACT | (e) (e) (e) | P=0.500N P=0.505N P=0.477 | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 0/50 (0%) 1/49 (2%) 1/49 (2%) | 2/50 (4%) 1/50 (2%) 3/49 (6%) 1/47 (2%) | |ADJUSTED (b) | 12.5% 0.0% 3.6% 7.1% | 6.9% 3.0% 9.1% 3.1% | |TERMINAL (d) | 4/32 (13%) 0/31 (0%) 1/28 (4%) 0/12 (0%) | 2/29 (7%) 1/33 (3%) 1/26 (4%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 733 (T) 715 | 733 (T) 733 (T) 599 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.613N P=0.066N P=0.220N P=0.548N | P=0.451N P=0.455N P=0.481 P=0.465N | |INCIDENTAL TUMOR | P=0.567N P=0.066N P=0.220N P=0.492N | P=0.443N P=0.455N P=0.558 P=0.465N | |LOGISTIC REGRESSION | P=0.590N P=0.066N P=0.220N P=0.517N | P=0.460N P=0.455N P=0.530 P=0.465N | |COCHRAN-ARMITAGE | P=0.299N | P=0.494N | |FISHER EXACT | P=0.056N P=0.181N P=0.181N | P=0.500N P=0.490 P=0.523N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 0/50 (0%) 1/49 (2%) 1/49 (2%) | 3/50 (6%) 1/50 (2%) 3/49 (6%) 1/47 (2%) | |ADJUSTED (b) | 12.5% 0.0% 3.6% 7.1% | 10.3% 3.0% 9.1% 3.1% | |TERMINAL (d) | 4/32 (13%) 0/31 (0%) 1/28 (4%) 0/12 (0%) | 3/29 (10%) 1/33 (3%) 1/26 (4%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 733 (T) 715 | 733 (T) 733 (T) 599 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.613N P=0.066N P=0.220N P=0.548N | P=0.325N P=0.259N P=0.637 P=0.269N | |INCIDENTAL TUMOR | P=0.567N P=0.066N P=0.220N P=0.492N | P=0.317N P=0.259N P=0.622N P=0.269N | |LOGISTIC REGRESSION | P=0.590N P=0.066N P=0.220N P=0.517N | P=0.331N P=0.259N P=0.633N P=0.269N | |COCHRAN-ARMITAGE | P=0.299N | P=0.365N | |FISHER EXACT | P=0.056N P=0.181N P=0.181N | P=0.309N P=0.651 P=0.332N | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 1/50 (2%) 4/50 (8%) 2/50 (4%) 1/50 (2%) | |ADJUSTED (b) | | 2.9% 10.6% 6.7% 2.3% | |TERMINAL (d) | | 0/29 (0%) 2/33 (6%) 1/26 (4%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | | 651 526 680 577 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.328N P=0.221 P=0.501 P=0.747N | |INCIDENTAL TUMOR | | P=0.371N P=0.135 P=0.606 P=0.759N | |LOGISTIC REGRESSION | | P=0.336N P=0.186 P=0.522 P=0.753 | |COCHRAN-ARMITAGE | | P=0.340N | |FISHER EXACT | | P=0.181 P=0.500 P=0.753N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 0/50 (0%) | |ADJUSTED (b) | 3.1% 6.2% 7.1% 8.3% | 2.6% 8.5% 7.7% 0.0% | |TERMINAL (d) | 1/32 (3%) 1/31 (3%) 2/28 (7%) 1/12 (8%) | 0/29 (0%) 2/33 (6%) 2/26 (8%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) 706 733 (T) 733 (T) | 599 640 733 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.448 P=0.489 P=0.453 P=0.529 | P=0.183N P=0.347 P=0.481 P=0.490N | |INCIDENTAL TUMOR | P=0.490 P=0.459 P=0.453 P=0.529 | P=0.127N P=0.390 P=0.528 P=0.326N | |LOGISTIC REGRESSION | P=0.473 P=0.477 P=0.453 P=0.529 | P=0.175N P=0.324 P=0.522 P=0.525N | |COCHRAN-ARMITAGE | P=0.524N | P=0.187N | |FISHER EXACT | P=0.500 P=0.500 P=0.753N | P=0.309 P=0.500 P=0.500N | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | 2/50 (4%) 3/50 (6%) 3/50 (6%) 0/50 (0%) | |ADJUSTED (b) | 5.9% 6.2% 10.7% 8.3% | 4.9% 8.5% 11.5% 0.0% | |TERMINAL (d) | 1/32 (3%) 1/31 (3%) 3/28 (11%) 1/12 (8%) | 0/29 (0%) 2/33 (6%) 3/26 (12%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 699 706 733 (T) 733 (T) | 495 640 733 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.529 P=0.679 P=0.434 P=0.673 | P=0.124N P=0.549 P=0.483 P=0.220N | |INCIDENTAL TUMOR | P=0.596 P=0.637 P=0.391 P=0.724 | P=0.095N P=0.564 P=0.512 P=0.191N | |LOGISTIC REGRESSION | P=0.559 P=0.673 P=0.422 P=0.698 | P=0.121N P=0.497 P=0.513 P=0.283N | |COCHRAN-ARMITAGE | P=0.378N | P=0.128N | |FISHER EXACT | P=0.691N P=0.500 P=0.500N | P=0.500 P=0.500 P=0.247N | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 3/50 (6%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |ADJUSTED (b) | 3.1% 0.0% 3.6% 0.0% | 7.6% 0.0% 6.2% 0.0% | |TERMINAL (d) | 1/32 (3%) 0/31 (0%) 1/28 (4%) 0/12 (0%) | 0/29 (0%) 0/33 (0%) 1/26 (4%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 733 (T) --- | 442 --- 594 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.668N P=0.506N P=0.732 P=0.695N | P=0.170N P=0.109N P=0.487N P=0.113N | |INCIDENTAL TUMOR | P=0.668N P=0.506N P=0.732 P=0.695N | P=0.134N P=0.139N P=0.381N P=0.131N | |LOGISTIC REGRESSION | P=0.668N P=0.506N P=0.732 P=0.695N | P=0.194N P=0.140N P=0.528N P=0.145N | |COCHRAN-ARMITAGE | P=0.459N | P=0.173N | |FISHER EXACT | P=0.500N P=0.753N P=0.500N | P=0.121N P=0.500N P=0.121N | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | 7/50 (14%) 2/50 (4%) 4/50 (8%) 5/50 (10%) | |ADJUSTED (b) | 6.3% 3.2% 7.1% 0.0% | 21.4% 5.5% 12.7% 13.3% | |TERMINAL (d) | 2/32 (6%) 1/31 (3%) 2/28 (7%) 0/12 (0%) | 5/29 (17%) 1/33 (3%) 2/26 (8%) 2/32 (6%) | |FIRST INCIDENCE (DAYS) | 733 (T) 733 (T) 733 (T) --- | 502 635 631 599 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.445N P=0.511N P=0.647 P=0.471N | P=0.573N P=0.059N P=0.288N P=0.324N | |INCIDENTAL TUMOR | P=0.445N P=0.511N P=0.647 P=0.471N | P=0.426N P=0.054N P=0.229N P=0.192N | |LOGISTIC REGRESSION | P=0.445N P=0.511N P=0.647 P=0.471N | P=0.576N P=0.066N P=0.227N P=0.343N | |COCHRAN-ARMITAGE | P=0.209N | P=0.570 | |FISHER EXACT | P=0.500N P=0.691N P=0.247N | P=0.080N P=0.262N P=0.380N | |=================================================================================================================================| | | |All Organs | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.4% 3.0% 0.0% 5.5% | |TERMINAL (d) | 0/32 (0%) 0/31 (0%) 0/28 (0%) 0/12 (0%) | 1/29 (3%) 1/33 (3%) 0/26 (0%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 733 (T) 733 (T) --- 598 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.350 P=0.733N P=0.522N P=0.532 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.408 P=0.733N P=0.522N P=0.620 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.347 P=0.733N P=0.522N P=0.527 | |COCHRAN-ARMITAGE | (e) | P=0.332 | |FISHER EXACT | (e) (e) (e) | P=0.753N P=0.500N P=0.500 | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.4% 3.0% 0.0% 5.5% | |TERMINAL (d) | 0/32 (0%) 0/31 (0%) 0/28 (0%) 0/12 (0%) | 1/29 (3%) 1/33 (3%) 0/26 (0%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 733 (T) 733 (T) --- 598 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.350 P=0.733N P=0.522N P=0.532 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.408 P=0.733N P=0.522N P=0.620 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.347 P=0.733N P=0.522N P=0.527 | |COCHRAN-ARMITAGE | (e) | P=0.332 | |FISHER EXACT | (e) (e) (e) | P=0.753N P=0.500N P=0.500 | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 36/50 (72%) 27/50 (54%) 26/50 (52%) 17/50 (34%) | 21/50 (42%) 29/50 (58%) 31/50 (62%) 37/50 (74%) | |ADJUSTED (b) | 85.4% 70.5% 75.7% 71.6% | 56.6% 72.4% 85.6% 85.7% | |TERMINAL (d) | 26/32 (81%) 20/31 (65%) 20/28 (71%) 6/12 (50%) | 13/29 (45%) 22/33 (67%) 21/26 (81%) 26/32 (81%) | |FIRST INCIDENCE (DAYS) | 362 324 440 245 | 495 526 469 399 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.187 P=0.109N P=0.176N P=0.336 | P=0.014 * P=0.235 P=0.031 * P=0.016 * | |INCIDENTAL TUMOR | P=0.161N P=0.066N P=0.157N P=0.136N | P=0.005 ** P=0.072 P=0.062 P=0.004 ** | |LOGISTIC REGRESSION | P=0.327N P=0.056N P=0.103N P=0.167N | P=0.005 ** P=0.159 P=0.064 P=0.004 ** | |COCHRAN-ARMITAGE | P<0.001N** | P=0.002 ** | |FISHER EXACT | P=0.048N* P=0.032N* P<0.001N** | P=0.081 P=0.036 * P=0.001 ** | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 200 PPM 600 PPM 1800 PPM | CONTROL 200 PPM 600 PPM 1800 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 24/50 (48%) 25/50 (50%) 26/50 (52%) 12/50 (24%) | 21/50 (42%) 18/50 (36%) 21/50 (42%) 28/50 (56%) | |ADJUSTED (b) | 56.0% 55.7% 57.5% 65.2% | 51.6% 44.4% 54.8% 64.6% | |TERMINAL (d) | 14/32 (44%) 12/31 (39%) 10/28 (36%) 6/12 (50%) | 10/29 (34%) 11/33 (33%) 10/26 (38%) 17/32 (53%) | |FIRST INCIDENCE (DAYS) | 481 441 376 359 | 442 552 544 562 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.290 P=0.424 P=0.261 P=0.306 | P=0.091 P=0.227N P=0.537 P=0.258 | |INCIDENTAL TUMOR | P=0.348N P=0.516 P=0.490N P=0.552N | P=0.171 P=0.235N P=0.318N P=0.388 | |LOGISTIC REGRESSION | P=0.430N P=0.504 P=0.547N P=0.570 | P=0.098 P=0.211N P=0.344N P=0.280 | |COCHRAN-ARMITAGE | P=0.002N** | P=0.036 * | |FISHER EXACT | P=0.500 P=0.421 P=0.011N* | P=0.341N P=0.580N P=0.115 | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 47/50 (94%) 39/50 (78%) 44/50 (88%) 21/50 (42%) | 34/50 (68%) 38/50 (76%) 41/50 (82%) 44/50 (88%) | |ADJUSTED (b) | 95.9% 82.7% 93.4% 86.7% | 79.0% 86.3% 95.3% 93.5% | |TERMINAL (d) | 30/32 (94%) 23/31 (74%) 25/28 (89%) 9/12 (75%) | 20/29 (69%) 27/33 (82%) 24/26 (92%) 29/32 (91%) | |FIRST INCIDENCE (DAYS) | 362 324 376 245 | 442 526 469 399 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.224 P=0.216N P=0.388 P=0.386 | P=0.131 P=0.546N P=0.115 P=0.188 | |INCIDENTAL TUMOR | P=0.013N* P=0.023N* P=0.300N P=0.010N* | P=0.124 P=0.415 P=0.272 P=0.151 | |LOGISTIC REGRESSION | P=0.017N* P=0.020N* P=0.225N P=0.011N* | P=0.049 * P=0.490 P=0.204 P=0.059 | |COCHRAN-ARMITAGE | P<0.001N** | P=0.016 * | |FISHER EXACT | P=0.020N* P=0.243N P<0.001N** | P=0.252 P=0.083 P=0.014 * | |=================================================================================================================================| DATE: 02/21/96 EXPERIMENT: 05181 TEST: 04 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TETRAHYDROFURAN 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. (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).