TDMS Study 05075-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus DIPHENYLHYDANTOIN DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 TIME: 16:07:42 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-82151 ROUTE: DOSED FEED NTP C#: 55765 PATHOLOGIST: S. GRUMBEIN S. EUSTIS CAS: 57-41-0 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus DIPHENYLHYDANTOIN DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 TIME: 16:07:42 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-82151 ROUTE: DOSED FEED NTP C#: 55765 PATHOLOGIST: S. GRUMBEIN S. EUSTIS CAS: 57-41-0 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 Gland Bone Marrow Brain Clitoral Gland Epididymis Gallbladder Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus DIPHENYLHYDANTOIN DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 TIME: 16:07:42 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-82151 ROUTE: DOSED FEED NTP C#: 55765 PATHOLOGIST: S. GRUMBEIN S. EUSTIS CAS: 57-41-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF DIPHENYLHYDANTOIN ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hemangiosarcoma Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma All Organs Hemangiosarcoma Hemangiosarcoma or Hemangioma Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma: Benign, Complex, Malignant, NOS Harderian Gland Carcinoma or Adenoma Liver Hemangiosarcoma Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Spleen Hemangiosarcoma Stomach, Forestomach Squamous Cell Papilloma All Organs Hemangiosarcoma Hemangiosarcoma or Hemangioma Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/64 (2%) 0/11 (0%) 0/37 (0%) 1/94 (1%) | 4/64 (6%) 1/14 (7%) 1/36 (3%) 2/98 (2%) | |ADJUSTED (b) | 1.1% 0.0% 0.0% 1.4% | 7.9% 0.0% 0.0% 2.6% | |TERMINAL (d) | 0/40 (0%) 0/1 (0%) 0/2 (0%) 1/74 (1%) | 2/36 (6%) 0/0 0/0 2/76 (3%) | |FIRST INCIDENCE (DAYS) | 609 --- --- 734 (T) | 607 682 675 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.694N P=0.660N P=0.428N P=0.700N | P=0.095N P=0.727 P=0.332N P=0.139N | |INCIDENTAL TUMOR | P=0.687 P=0.617N P=0.412N P=0.767N | P=0.101N P=0.696 P=0.354N P=0.155N | |LOGISTIC REGRESSION | P=0.676N P=0.703N P=0.524N P=0.671N | P=0.080N P=0.601 P=0.461N P=0.142N | |COCHRAN-ARMITAGE | P=0.676N | P=0.127N | |FISHER EXACT | P=0.853N P=0.634N P=0.648N | P=0.639 P=0.405N P=0.168N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/64 (2%) 0/11 (0%) 0/37 (0%) 1/94 (1%) | 6/64 (9%) 1/14 (7%) 1/36 (3%) 3/98 (3%) | |ADJUSTED (b) | 1.1% 0.0% 0.0% 1.4% | 11.7% 0.0% 0.0% 3.9% | |TERMINAL (d) | 0/40 (0%) 0/1 (0%) 0/2 (0%) 1/74 (1%) | 3/36 (8%) 0/0 0/0 3/76 (4%) | |FIRST INCIDENCE (DAYS) | 609 --- --- 734 (T) | 607 682 675 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.694N P=0.660N P=0.428N P=0.700N | P=0.049N* P=0.577N P=0.155N P=0.065N | |INCIDENTAL TUMOR | P=0.687 P=0.617N P=0.412N P=0.767N | P=0.051N P=0.707N P=0.161N P=0.074N | |LOGISTIC REGRESSION | P=0.676N P=0.703N P=0.524N P=0.671N | P=0.041N* P=0.698 P=0.271N P=0.063N | |COCHRAN-ARMITAGE | P=0.676N | P=0.085N | |FISHER EXACT | P=0.853N P=0.634N P=0.648N | P=0.632N P=0.207N P=0.088N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |Bone Marrow | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/64 (3%) 0/11 (0%) 0/40 (0%) 0/100 (0%) | 3/64 (5%) 0/15 (0%) 0/36 (0%) 0/99 (0%) | |ADJUSTED (b) | 3.6% 0.0% 0.0% 0.0% | 3.7% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/40 (3%) 0/1 (0%) 0/3 (0%) 0/78 (0%) | 0/36 (0%) 0/1 (0%) 0/0 0/76 (0%) | |FIRST INCIDENCE (DAYS) | 650 --- --- --- | 607 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.123N P=0.619N P=0.387N P=0.170N | P=0.093N P=0.275N P=0.053N P=0.107N | |INCIDENTAL TUMOR | P=0.130N P=0.740N P=0.389N P=0.205N | P=0.097N P=0.320N P=0.058N P=0.121N | |LOGISTIC REGRESSION | P=0.122N P=0.711N P=0.406N P=0.149N | P=0.060N P=0.444N P=0.230N P=0.077N | |COCHRAN-ARMITAGE | P=0.124N | P=0.055N | |FISHER EXACT | P=0.726N P=0.376N P=0.151N | P=0.527N P=0.258N P=0.059N | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 7/100 (7%) 1/50 (2%) 7/148 (5%) 6/100 (6%) | 4/100 (4%) 2/50 (4%) 6/150 (4%) 1/100 (1%) | |ADJUSTED (b) | 9.2% 2.6% 6.4% 7.7% | 5.6% 5.7% 4.9% 1.3% | |TERMINAL (d) | 7/76 (9%) 1/39 (3%) 7/109 (6%) 6/78 (8%) | 3/70 (4%) 2/35 (6%) 4/113 (4%) 1/77 (1%) | |FIRST INCIDENCE (DAYS) | 734 (T) 734 (T) 734 (T) 734 (T) | 726 736 (T) 625 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.529 P=0.175N P=0.337N P=0.481N | P=0.108N P=0.669 P=0.581N P=0.155N | |INCIDENTAL TUMOR | P=0.529 P=0.175N P=0.337N P=0.481N | P=0.122N P=0.626 P=0.628N P=0.161N | |LOGISTIC REGRESSION | P=0.529 P=0.175N P=0.337N P=0.481N | P=0.114N P=0.670 P=0.610N P=0.146N | |COCHRAN-ARMITAGE | P=0.510 | P=0.131N | |FISHER EXACT | P=0.188N P=0.312N P=0.500N | P=0.683N P=0.621N P=0.184N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 1/50 (2%) 1/148 (1%) 1/100 (1%) | 4/100 (4%) 0/50 (0%) 4/150 (3%) 0/100 (0%) | |ADJUSTED (b) | 1.3% 2.6% 0.8% 1.3% | 5.3% 0.0% 3.4% 0.0% | |TERMINAL (d) | 1/76 (1%) 1/39 (3%) 0/109 (0%) 0/78 (0%) | 3/70 (4%) 0/35 (0%) 3/113 (3%) 0/77 (0%) | |FIRST INCIDENCE (DAYS) | 734 (T) 734 (T) 645 723 | 491 --- 662 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.606N P=0.605 P=0.677N P=0.753N | P=0.075N P=0.188N P=0.376N P=0.056N | |INCIDENTAL TUMOR | P=0.653N P=0.605 P=0.673N P=0.719 | P=0.094N P=0.171N P=0.432N P=0.085N | |LOGISTIC REGRESSION | P=0.623N P=0.605 P=0.665N P=0.762 | P=0.091N P=0.186N P=0.421N P=0.074N | |COCHRAN-ARMITAGE | P=0.613N | P=0.088N | |FISHER EXACT | P=0.557 P=0.645N P=0.751N | P=0.194N P=0.405N P=0.061N | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 8/100 (8%) 2/50 (4%) 8/148 (5%) 7/100 (7%) | 8/100 (8%) 2/50 (4%) 10/150 (7%) 1/100 (1%) | |ADJUSTED (b) | 10.5% 5.1% 7.2% 8.9% | 10.8% 5.7% 8.3% 1.3% | |TERMINAL (d) | 8/76 (11%) 2/39 (5%) 7/109 (6%) 6/78 (8%) | 6/70 (9%) 2/35 (6%) 7/113 (6%) 1/77 (1%) | |FIRST INCIDENCE (DAYS) | 734 (T) 734 (T) 645 723 | 491 736 (T) 625 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.554 P=0.268N P=0.312N P=0.478N | P=0.019N* P=0.284N P=0.379N P=0.015N* | |INCIDENTAL TUMOR | P=0.537 P=0.268N P=0.310N P=0.502N | P=0.026N* P=0.299N P=0.453N P=0.022N* | |LOGISTIC REGRESSION | P=0.548 P=0.268N P=0.305N P=0.473N | P=0.023N* P=0.284N P=0.432N P=0.018N* | |COCHRAN-ARMITAGE | P=0.535 | P=0.026N* | |FISHER EXACT | P=0.291N P=0.287N P=0.500N | P=0.291N P=0.435N P=0.017N* | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |Heart | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/64 (2%) 0/12 (0%) 2/40 (5%) 0/99 (0%) | 0/66 (0%) 0/15 (0%) 0/38 (0%) 0/100 (0%) | |ADJUSTED (b) | 2.5% 0.0% 1.6% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/40 (3%) 0/1 (0%) 0/2 (0%) 0/78 (0%) | 0/36 (0%) 0/0 0/1 (0%) 0/77 (0%) | |FIRST INCIDENCE (DAYS) | 734 (T) --- 633 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.276N P=0.999N P=0.354 P=0.367N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.323N P=0.999N P=0.369 P=0.367N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.224N P=0.999N P=0.281 P=0.367N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.225N | (e) | |FISHER EXACT | P=0.842N P=0.328 P=0.393N | (e) (e) (e) | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/100 (8%) 0/50 (0%) 7/148 (5%) 4/99 (4%) | 3/97 (3%) 2/50 (4%) 0/149 (0%) 0/100 (0%) | |ADJUSTED (b) | 10.0% 0.0% 5.8% 5.0% | 4.2% 5.2% 0.0% 0.0% | |TERMINAL (d) | 6/76 (8%) 0/39 (0%) 3/109 (3%) 3/78 (4%) | 2/69 (3%) 1/35 (3%) 0/113 (0%) 0/77 (0%) | |FIRST INCIDENCE (DAYS) | 642 --- 633 710 | 682 633 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.323N P=0.048N* P=0.237N P=0.179N | P=0.040N* P=0.568 P=0.051N P=0.103N | |INCIDENTAL TUMOR | P=0.411N P=0.053N P=0.211N P=0.234N | P=0.045N* P=0.576 P=0.051N P=0.111N | |LOGISTIC REGRESSION | P=0.352N P=0.048N* P=0.211N P=0.207N | P=0.045N* P=0.574 P=0.054N P=0.108N | |COCHRAN-ARMITAGE | P=0.338N | P=0.046N* | |FISHER EXACT | P=0.035N* P=0.214N P=0.191N | P=0.555 P=0.060N P=0.117N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |Liver | | Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/100 (0%) 1/50 (2%) 2/148 (1%) 0/99 (0%) | 0/97 (0%) 0/50 (0%) 0/149 (0%) 1/100 (1%) | |ADJUSTED (b) | 0.0% 2.6% 1.8% 0.0% | 0.0% 0.0% 0.0% 1.3% | |TERMINAL (d) | 0/76 (0%) 1/39 (3%) 1/109 (1%) 0/78 (0%) | 0/69 (0%) 0/35 (0%) 0/113 (0%) 1/77 (1%) | |FIRST INCIDENCE (DAYS) | --- 734 (T) 697 --- | --- --- --- 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.453N P=0.367 P=0.325 (e) | P=0.243 (e) (e) P=0.522 | |INCIDENTAL TUMOR | P=0.480N P=0.367 P=0.327 (e) | P=0.243 (e) (e) P=0.522 | |LOGISTIC REGRESSION | P=0.468N P=0.367 P=0.325 (e) | P=0.243 (e) (e) P=0.522 | |COCHRAN-ARMITAGE | P=0.464N | P=0.232 | |FISHER EXACT | P=0.333 P=0.355 (e) | (e) (e) P=0.508 | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 42/100 (42%) 16/50 (32%) 62/148 (42%) 53/99 (54%) | 16/97 (16%) 11/50 (22%) 50/149 (34%) 48/100 (48%)| |ADJUSTED (b) | 49.6% 38.0% 51.1% 63.0% | 21.4% 30.2% 41.9% 52.5% | |TERMINAL (d) | 34/76 (45%) 13/39 (33%) 51/109 (47%) 47/78 (60%) | 12/69 (17%) 10/35 (29%) 44/113 (39%) 34/77 (44%) | |FIRST INCIDENCE (DAYS) | 540 584 535 612 | 607 587 660 503 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.030 * P=0.151N P=0.482 P=0.109 | P<0.001 ** P=0.257 P=0.006 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.006 ** P=0.180N P=0.513 P=0.035 * | P<0.001 ** P=0.241 P=0.005 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.008 ** P=0.173N P=0.517 P=0.040 * | P<0.001 ** P=0.255 P=0.005 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.015 * | P<0.001 ** | |FISHER EXACT | P=0.157N P=0.545N P=0.068 | P=0.274 P=0.002 ** P<0.001 ** | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 27/100 (27%) 13/50 (26%) 50/148 (34%) 27/99 (27%) | 1/97 (1%) 4/50 (8%) 8/149 (5%) 21/100 (21%)| |ADJUSTED (b) | 30.7% 28.4% 38.7% 31.9% | 1.0% 9.6% 6.8% 25.4% | |TERMINAL (d) | 17/76 (22%) 7/39 (18%) 32/109 (29%) 21/78 (27%) | 0/69 (0%) 1/35 (3%) 6/113 (5%) 17/77 (22%) | |FIRST INCIDENCE (DAYS) | 463 495 481 564 | 486 587 675 570 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.467N P=0.517N P=0.151 P=0.537N | P<0.001 ** P=0.040 * P=0.092 P<0.001 ** | |INCIDENTAL TUMOR | P=0.308 P=0.551N P=0.155 P=0.336 | P<0.001 ** P=0.125 P=0.068 P<0.001 ** | |LOGISTIC REGRESSION | P=0.260 P=0.467N P=0.139 P=0.504 | P<0.001 ** P=0.036 * P=0.074 P<0.001 ** | |COCHRAN-ARMITAGE | P=0.513N | P<0.001 ** | |FISHER EXACT | P=0.530N P=0.160 P=0.546 | P=0.046 * P=0.072 P<0.001 ** | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 27/100 (27%) 13/50 (26%) 51/148 (34%) 27/99 (27%) | 1/97 (1%) 4/50 (8%) 8/149 (5%) 22/100 (22%)| |ADJUSTED (b) | 30.7% 28.4% 39.5% 31.9% | 1.0% 9.6% 6.8% 26.6% | |TERMINAL (d) | 17/76 (22%) 7/39 (18%) 33/109 (30%) 21/78 (27%) | 0/69 (0%) 1/35 (3%) 6/113 (5%) 18/77 (23%) | |FIRST INCIDENCE (DAYS) | 463 495 481 564 | 486 587 675 570 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.461N P=0.517N P=0.129 P=0.537N | P<0.001 ** P=0.040 * P=0.092 P<0.001 ** | |INCIDENTAL TUMOR | P=0.314 P=0.551N P=0.130 P=0.336 | P<0.001 ** P=0.125 P=0.068 P<0.001 ** | |LOGISTIC REGRESSION | P=0.267 P=0.467N P=0.149 P=0.504 | P<0.001 ** P=0.036 * P=0.074 P<0.001 ** | |COCHRAN-ARMITAGE | P=0.507N | P<0.001 ** | |FISHER EXACT | P=0.530N P=0.135 P=0.546 | P=0.046 * P=0.072 P<0.001 ** | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 62/100 (62%) 25/50 (50%) 95/148 (64%) 67/99 (68%) | 17/97 (18%) 13/50 (26%) 56/149 (38%) 64/100 (64%)| |ADJUSTED (b) | 65.8% 53.0% 71.1% 76.1% | 22.2% 33.5% 46.1% 67.9% | |TERMINAL (d) | 44/76 (58%) 17/39 (44%) 71/109 (65%) 57/78 (73%) | 12/69 (17%) 10/35 (29%) 48/113 (42%) 47/77 (61%) | |FIRST INCIDENCE (DAYS) | 463 495 481 564 | 486 587 660 503 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.203 P=0.145N P=0.338 P=0.362 | P<0.001 ** P=0.150 P=0.002 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.016 * P=0.132N P=0.373 P=0.065 | P<0.001 ** P=0.183 P=0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.011 * P=0.096N P=0.344 P=0.127 | P<0.001 ** P=0.155 P=0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.100 | P<0.001 ** | |FISHER EXACT | P=0.110N P=0.413 P=0.245 | P=0.161 P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 62/100 (62%) 25/50 (50%) 95/148 (64%) 67/99 (68%) | 17/97 (18%) 13/50 (26%) 56/149 (38%) 64/100 (64%)| |ADJUSTED (b) | 65.8% 53.0% 71.1% 76.1% | 22.2% 33.5% 46.1% 67.9% | |TERMINAL (d) | 44/76 (58%) 17/39 (44%) 71/109 (65%) 57/78 (73%) | 12/69 (17%) 10/35 (29%) 48/113 (42%) 47/77 (61%) | |FIRST INCIDENCE (DAYS) | 463 495 481 564 | 486 587 660 503 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.203 P=0.145N P=0.338 P=0.362 | P<0.001 ** P=0.150 P=0.002 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.016 * P=0.132N P=0.373 P=0.065 | P<0.001 ** P=0.183 P=0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.011 * P=0.096N P=0.344 P=0.127 | P<0.001 ** P=0.155 P=0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.100 | P<0.001 ** | |FISHER EXACT | P=0.110N P=0.413 P=0.245 | P=0.161 P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/69 (20%) 5/19 (26%) 10/63 (16%) 11/99 (11%) | 7/70 (10%) 1/20 (5%) 4/41 (10%) 3/100 (3%) | |ADJUSTED (b) | 23.4% 40.4% 29.8% 14.1% | 17.5% 2.7% 75.2% 3.9% | |TERMINAL (d) | 8/45 (18%) 3/8 (38%) 7/25 (28%) 11/78 (14%) | 7/40 (18%) 0/5 (0%) 3/4 (75%) 3/77 (4%) | |FIRST INCIDENCE (DAYS) | 491 574 649 734 (T) | 736 (T) 690 636 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.019N* P=0.455 P=0.467N P=0.062N | P=0.007N** P=0.665N P=0.018 * P=0.016N* | |INCIDENTAL TUMOR | P=0.029N* P=0.383 P=0.464N P=0.113N | P=0.008N** P=0.705 P=0.015 * P=0.016N* | |LOGISTIC REGRESSION | P=0.025N* P=0.352 P=0.475N P=0.081N | P=0.008N** P=0.692N P=0.225 P=0.016N* | |COCHRAN-ARMITAGE | P=0.042N* | P=0.052N | |FISHER EXACT | P=0.389 P=0.334N P=0.078N | P=0.431N P=0.621N P=0.058N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/69 (13%) 4/19 (21%) 15/63 (24%) 6/99 (6%) | 1/70 (1%) 1/20 (5%) 3/41 (7%) 0/100 (0%) | |ADJUSTED (b) | 17.4% 39.1% 60.0% 7.7% | 2.5% 20.0% 26.1% 0.0% | |TERMINAL (d) | 7/45 (16%) 3/8 (38%) 15/25 (60%) 6/78 (8%) | 1/40 (3%) 1/5 (20%) 1/4 (25%) 0/77 (0%) | |FIRST INCIDENCE (DAYS) | 633 713 734 (T) 734 (T) | 736 (T) 736 (T) 565 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.002N** P=0.216 P=0.003 ** P=0.065N | P=0.101N P=0.264 P=0.086 P=0.369N | |INCIDENTAL TUMOR | P=0.003N** P=0.201 P=0.003 ** P=0.083N | P=0.120N P=0.264 P=0.056 P=0.369N | |LOGISTIC REGRESSION | P=0.003N** P=0.158 P=0.007 ** P=0.088N | P=0.129N P=0.264 P=0.129 P=0.369N | |COCHRAN-ARMITAGE | P=0.019N* | P=0.141N | |FISHER EXACT | P=0.294 P=0.084 P=0.100N | P=0.397 P=0.142 P=0.412N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/69 (32%) 8/19 (42%) 23/63 (37%) 17/99 (17%) | 8/70 (11%) 2/20 (10%) 7/41 (17%) 3/100 (3%) | |ADJUSTED (b) | 37.2% 76.2% 80.5% 21.8% | 20.0% 22.2% 100.0% 3.9% | |TERMINAL (d) | 14/45 (31%) 6/8 (75%) 20/25 (80%) 17/78 (22%) | 8/40 (20%) 1/5 (20%) 4/4 (100%) 3/77 (4%) | |FIRST INCIDENCE (DAYS) | 491 574 649 734 (T) | 736 (T) 690 565 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001N** P=0.267 P=0.068 P=0.012N* | P=0.001N** P=0.433 P=0.002 ** P=0.006N** | |INCIDENTAL TUMOR | P<0.001N** P=0.217 P=0.067 P=0.028N* | P=0.002N** P=0.369 P<0.001 ** P=0.006N** | |LOGISTIC REGRESSION | P<0.001N** P=0.166 P=0.094 P=0.021N* | P=0.003N** P=0.416 P=0.092 P=0.006N** | |COCHRAN-ARMITAGE | P=0.003N** | P=0.016N* | |FISHER EXACT | P=0.285 P=0.353 P=0.021N* | P=0.610N P=0.287 P=0.031N* | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 0/148 (0%) 0/100 (0%) | 2/100 (2%) 2/50 (4%) 2/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.2% 5.7% 1.7% 0.0% | |TERMINAL (d) | 0/76 (0%) 0/39 (0%) 0/109 (0%) 0/78 (0%) | 0/70 (0%) 2/35 (6%) 1/113 (1%) 0/77 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 528 736 (T) 690 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.098N P=0.426 P=0.512N P=0.226N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.137N P=0.515 P=0.631N P=0.369N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.124N P=0.423 P=0.587N P=0.331N | |COCHRAN-ARMITAGE | (e) | P=0.110N | |FISHER EXACT | (e) (e) (e) | P=0.407 P=0.525N P=0.249N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 1/77 (1%) 1/36 (3%) 5/83 (6%) 3/99 (3%) | |ADJUSTED (b) | | 2.1% 4.3% 9.3% 3.9% | |TERMINAL (d) | | 1/48 (2%) 1/23 (4%) 4/47 (9%) 3/76 (4%) | |FIRST INCIDENCE (DAYS) | | 736 (T) 736 (T) 735 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.598 P=0.589 P=0.120 P=0.480 | |INCIDENTAL TUMOR | | P=0.599 P=0.589 P=0.121 P=0.480 | |LOGISTIC REGRESSION | | P=0.577N P=0.589 P=0.111 P=0.480 | |COCHRAN-ARMITAGE | | P=0.495 | |FISHER EXACT | | P=0.538 P=0.123 P=0.410 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/56 (0%) 0/4 (0%) 0/31 (0%) 0/76 (0%) | 14/63 (22%) 3/17 (18%) 13/46 (28%) 6/85 (7%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 31.6% 100.0% 84.9% 9.1% | |TERMINAL (d) | 0/35 (0%) 0/1 (0%) 0/2 (0%) 0/64 (0%) | 11/38 (29%) 3/3 (100%) 11/13 (85%) 6/66 (9%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 530 736 (T) 689 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P<0.001N** P=0.338 P=0.023 * P=0.002N** | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P<0.001N** P=0.259 P=0.015 * P=0.003N** | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P<0.001N** P=0.419 P=0.070 P=0.003N** | |COCHRAN-ARMITAGE | (e) | P=0.004N** | |FISHER EXACT | (e) (e) (e) | P=0.486N P=0.308 P=0.008N** | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/56 (0%) 1/4 (25%) 0/31 (0%) 0/76 (0%) | 15/63 (24%) 3/17 (18%) 13/46 (28%) 6/85 (7%) | |ADJUSTED (b) | 0.0% 2.4% 0.0% 0.0% | 32.4% 100.0% 84.9% 9.1% | |TERMINAL (d) | 0/35 (0%) 0/1 (0%) 0/2 (0%) 0/64 (0%) | 11/38 (29%) 3/3 (100%) 11/13 (85%) 6/66 (9%) | |FIRST INCIDENCE (DAYS) | --- 669 --- --- | 530 736 (T) 689 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.545N P=0.362 (e) (e) | P<0.001N** P=0.449 P=0.053 P=0.001N** | |INCIDENTAL TUMOR | P=0.725N P=0.056 (e) (e) | P<0.001N** P=0.329 P=0.036 * P=0.002N** | |LOGISTIC REGRESSION | P=0.424N P=0.061 (e) (e) | P<0.001N** P=0.513 P=0.149 P=0.002N** | |COCHRAN-ARMITAGE | P=0.425N | P=0.002N** | |FISHER EXACT | P=0.067 (e) (e) | P=0.430N P=0.379 P=0.004N** | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/100 (2%) 0/50 (0%) 0/148 (0%) 0/100 (0%) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 2.6% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/76 (1%) 0/39 (0%) 0/109 (0%) 0/78 (0%) | 0/70 (0%) 0/35 (0%) 0/113 (0%) 0/77 (0%) | |FIRST INCIDENCE (DAYS) | 696 --- --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.202N P=0.394N P=0.163N P=0.232N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.217N P=0.475N P=0.160N P=0.281N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.209N P=0.404N P=0.160N P=0.248N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.204N | (e) | |FISHER EXACT | P=0.443N P=0.162N P=0.249N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/100 (2%) 0/50 (0%) 3/148 (2%) 0/100 (0%) | 2/100 (2%) 1/50 (2%) 2/150 (1%) 1/100 (1%) | |ADJUSTED (b) | 2.5% 0.0% 2.7% 0.0% | 2.4% 2.9% 1.5% 1.0% | |TERMINAL (d) | 1/76 (1%) 0/39 (0%) 2/109 (2%) 0/78 (0%) | 0/70 (0%) 1/35 (3%) 0/113 (0%) 0/77 (0%) | |FIRST INCIDENCE (DAYS) | 673 --- 678 --- | 544 736 (T) 625 423 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.232N P=0.401N P=0.659 P=0.236N | P=0.373N P=0.730 P=0.509N P=0.474N | |INCIDENTAL TUMOR | P=0.256N P=0.475N P=0.666 P=0.281N | P=0.535N P=0.704 P=0.628N P=0.746 | |LOGISTIC REGRESSION | P=0.244N P=0.399N P=0.668 P=0.244N | P=0.514N P=0.729 P=0.591N P=0.701N | |COCHRAN-ARMITAGE | P=0.236N | P=0.403N | |FISHER EXACT | P=0.443N P=0.678 P=0.249N | P=0.742N P=0.525N P=0.500N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 0/148 (0%) 1/100 (1%) | 3/100 (3%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 1.2% | 3.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/76 (0%) 0/39 (0%) 0/109 (0%) 0/78 (0%) | 0/70 (0%) 0/35 (0%) 0/113 (0%) 0/77 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 710 | 579 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.240 (e) (e) P=0.510 | P=0.095N P=0.275N P=0.056N P=0.111N | |INCIDENTAL TUMOR | P=0.182 (e) (e) P=0.419 | P=0.118N P=0.212N P=0.080N P=0.133N | |LOGISTIC REGRESSION | P=0.225 (e) (e) P=0.493 | P=0.125N P=0.279N P=0.079N P=0.166N | |COCHRAN-ARMITAGE | P=0.230 | P=0.102N | |FISHER EXACT | (e) (e) P=0.500 | P=0.293N P=0.063N P=0.123N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/100 (4%) 0/50 (0%) 3/148 (2%) 1/100 (1%) | 3/100 (3%) 1/50 (2%) 2/150 (1%) 1/100 (1%) | |ADJUSTED (b) | 5.0% 0.0% 2.7% 1.3% | 3.5% 2.9% 1.5% 1.0% | |TERMINAL (d) | 2/76 (3%) 0/39 (0%) 2/109 (2%) 1/78 (1%) | 0/70 (0%) 1/35 (3%) 0/113 (0%) 0/77 (0%) | |FIRST INCIDENCE (DAYS) | 673 --- 678 734 (T) | 544 736 (T) 625 423 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.228N P=0.184N P=0.313N P=0.176N | P=0.245N P=0.575N P=0.294N P=0.286N | |INCIDENTAL TUMOR | P=0.259N P=0.251N P=0.303N P=0.227N | P=0.387N P=0.547N P=0.423N P=0.513N | |LOGISTIC REGRESSION | P=0.246N P=0.186N P=0.303N P=0.195N | P=0.370N P=0.581N P=0.379N P=0.494N | |COCHRAN-ARMITAGE | P=0.234N | P=0.268N | |FISHER EXACT | P=0.194N P=0.294N P=0.184N | P=0.593N P=0.316N P=0.311N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/100 (2%) 0/50 (0%) 3/148 (2%) 1/100 (1%) | 3/100 (3%) 1/50 (2%) 2/150 (1%) 1/100 (1%) | |ADJUSTED (b) | 2.5% 0.0% 2.7% 1.3% | 3.5% 2.9% 1.5% 1.0% | |TERMINAL (d) | 1/76 (1%) 0/39 (0%) 2/109 (2%) 1/78 (1%) | 0/70 (0%) 1/35 (3%) 0/113 (0%) 0/77 (0%) | |FIRST INCIDENCE (DAYS) | 673 --- 678 734 (T) | 544 736 (T) 625 423 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.493N P=0.401N P=0.659 P=0.493N | P=0.245N P=0.575N P=0.294N P=0.286N | |INCIDENTAL TUMOR | P=0.531N P=0.475N P=0.666 P=0.540N | P=0.387N P=0.547N P=0.423N P=0.513N | |LOGISTIC REGRESSION | P=0.518N P=0.399N P=0.668 P=0.514N | P=0.370N P=0.581N P=0.379N P=0.494N | |COCHRAN-ARMITAGE | P=0.503N | P=0.268N | |FISHER EXACT | P=0.443N P=0.678 P=0.500N | P=0.593N P=0.316N P=0.311N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/70 (9%) 0/18 (0%) 3/62 (5%) 2/96 (2%) | 7/71 (10%) 0/27 (0%) 0/73 (0%) 0/98 (0%) | |ADJUSTED (b) | 9.5% 0.0% 5.3% 2.6% | 11.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/47 (6%) 0/9 (0%) 1/27 (4%) 2/77 (3%) | 3/43 (7%) 0/13 (0%) 0/37 (0%) 0/77 (0%) | |FIRST INCIDENCE (DAYS) | 633 --- 633 734 (T) | 579 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.089N P=0.179N P=0.266N P=0.065N | P=0.004N** P=0.101N P=0.005N** P=0.003N** | |INCIDENTAL TUMOR | P=0.119N P=0.202N P=0.246N P=0.102N | P=0.005N** P=0.090N P=0.006N** P=0.005N** | |LOGISTIC REGRESSION | P=0.081N P=0.209N P=0.314N P=0.061N | P=0.004N** P=0.105N P=0.009N** P=0.003N** | |COCHRAN-ARMITAGE | P=0.081N | P=0.004N** | |FISHER EXACT | P=0.242N P=0.310N P=0.060N | P=0.096N P=0.006N** P=0.002N** | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/100 (2%) 0/50 (0%) 2/148 (1%) 0/100 (0%) | 5/100 (5%) 3/50 (6%) 3/150 (2%) 0/100 (0%) | |ADJUSTED (b) | 2.6% 0.0% 1.8% 0.0% | 7.1% 8.0% 2.7% 0.0% | |TERMINAL (d) | 2/76 (3%) 0/39 (0%) 2/109 (2%) 0/78 (0%) | 5/70 (7%) 2/35 (6%) 3/113 (3%) 0/77 (0%) | |FIRST INCIDENCE (DAYS) | 734 (T) --- 734 (T) --- | 736 (T) 628 736 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.229N P=0.395N P=0.558N P=0.233N | P=0.013N* P=0.550 P=0.143N P=0.027N* | |INCIDENTAL TUMOR | P=0.229N P=0.395N P=0.558N P=0.233N | P=0.014N* P=0.592 P=0.143N P=0.027N* | |LOGISTIC REGRESSION | P=0.229N P=0.395N P=0.558N P=0.233N | P=0.013N* P=0.545 P=0.143N P=0.027N* | |COCHRAN-ARMITAGE | P=0.232N | P=0.017N* | |FISHER EXACT | P=0.443N P=0.531N P=0.249N | P=0.535 P=0.170N P=0.030N* | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/64 (0%) 0/12 (0%) 0/39 (0%) 2/100 (2%) | | |ADJUSTED (b) | 0.0% 0.0% 0.0% 2.6% | | |TERMINAL (d) | 0/40 (0%) 0/1 (0%) 0/2 (0%) 2/78 (3%) | | |FIRST INCIDENCE (DAYS) | --- --- --- 734 (T) | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.292 (e) (e) P=0.395 | | |INCIDENTAL TUMOR | P=0.292 (e) (e) P=0.395 | | |LOGISTIC REGRESSION | P=0.292 (e) (e) P=0.395 | | |COCHRAN-ARMITAGE | P=0.171 | | |FISHER EXACT | (e) (e) P=0.370 | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/63 (2%) 1/11 (9%) 1/39 (3%) 0/99 (0%) | 4/63 (6%) 0/15 (0%) 0/37 (0%) 8/99 (8%) | |ADJUSTED (b) | 1.1% 2.2% 0.8% 0.0% | 11.1% 0.0% 0.0% 10.4% | |TERMINAL (d) | 0/40 (0%) 0/1 (0%) 0/2 (0%) 0/78 (0%) | 4/36 (11%) 0/0 0/1 (0%) 7/76 (9%) | |FIRST INCIDENCE (DAYS) | 646 584 639 --- | 736 (T) --- --- 730 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.277N P=0.587 P=0.678N P=0.505N | P=0.543 (e) P=0.897N P=0.624 | |INCIDENTAL TUMOR | P=0.357N P=0.545 P=0.659N P=0.564N | P=0.546 (e) P=0.897N P=0.622 | |LOGISTIC REGRESSION | P=0.129N P=0.528 P=0.717 P=0.397N | P=0.586N (e) P=0.897N P=0.582N | |COCHRAN-ARMITAGE | P=0.141N | P=0.189 | |FISHER EXACT | P=0.277 P=0.621 P=0.389N | P=0.418N P=0.152N P=0.467 | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 2/100 (2%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | |ADJUSTED (b) | | 2.9% 0.0% 1.6% 0.0% | |TERMINAL (d) | | 2/70 (3%) 0/35 (0%) 1/113 (1%) 0/77 (0%) | |FIRST INCIDENCE (DAYS) | | 736 (T) --- 465 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.217N P=0.401N P=0.519N P=0.218N | |INCIDENTAL TUMOR | | P=0.275N P=0.401N P=0.601N P=0.218N | |LOGISTIC REGRESSION | | P=0.258N P=0.401N P=0.570N P=0.218N | |COCHRAN-ARMITAGE | | P=0.232N | |FISHER EXACT | | P=0.443N P=0.525N P=0.249N | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 3/100 (3%) 0/50 (0%) 3/150 (2%) 1/100 (1%) | |ADJUSTED (b) | | 4.3% 0.0% 2.4% 1.3% | |TERMINAL (d) | | 3/70 (4%) 0/35 (0%) 2/113 (2%) 1/77 (1%) | |FIRST INCIDENCE (DAYS) | | 736 (T) --- 465 736 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.322N P=0.268N P=0.436N P=0.274N | |INCIDENTAL TUMOR | | P=0.378N P=0.268N P=0.504N P=0.274N | |LOGISTIC REGRESSION | | P=0.360N P=0.268N P=0.479N P=0.274N | |COCHRAN-ARMITAGE | | P=0.351N | |FISHER EXACT | | P=0.293N P=0.456N P=0.311N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 12/100 (12%) 1/50 (2%) 9/148 (6%) 4/100 (4%) | 10/100 (10%) 2/50 (4%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 14.8% 2.6% 7.6% 5.0% | 12.9% 5.2% 0.0% 0.0% | |TERMINAL (d) | 9/76 (12%) 1/39 (3%) 5/109 (5%) 3/78 (4%) | 6/70 (9%) 1/35 (3%) 0/113 (0%) 0/77 (0%) | |FIRST INCIDENCE (DAYS) | 633 734 (T) 633 710 | 579 633 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.077N P=0.042N* P=0.095N P=0.033N* | P<0.001N** P=0.179N P<0.001N** P=0.001N** | |INCIDENTAL TUMOR | P=0.109N P=0.042N* P=0.078N P=0.053N | P<0.001N** P=0.148N P<0.001N** P=0.002N** | |LOGISTIC REGRESSION | P=0.088N P=0.042N* P=0.080N P=0.041N* | P<0.001N** P=0.169N P<0.001N** P=0.002N** | |COCHRAN-ARMITAGE | P=0.078N | P<0.001N** | |FISHER EXACT | P=0.033N* P=0.080N P=0.033N* | P=0.170N P<0.001N** P<0.001N** | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 12/100 (12%) 1/50 (2%) 9/148 (6%) 4/100 (4%) | 10/100 (10%) 2/50 (4%) 1/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 14.8% 2.6% 7.6% 5.0% | 12.9% 5.2% 0.7% 0.0% | |TERMINAL (d) | 9/76 (12%) 1/39 (3%) 5/109 (5%) 3/78 (4%) | 6/70 (9%) 1/35 (3%) 0/113 (0%) 0/77 (0%) | |FIRST INCIDENCE (DAYS) | 633 734 (T) 633 710 | 579 633 525 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.077N P=0.042N* P=0.095N P=0.033N* | P<0.001N** P=0.179N P<0.001N** P=0.001N** | |INCIDENTAL TUMOR | P=0.109N P=0.042N* P=0.078N P=0.053N | P=0.001N** P=0.148N P=0.001N** P=0.002N** | |LOGISTIC REGRESSION | P=0.088N P=0.042N* P=0.080N P=0.041N* | P=0.001N** P=0.169N P<0.001N** P=0.002N** | |COCHRAN-ARMITAGE | P=0.078N | P<0.001N** | |FISHER EXACT | P=0.033N* P=0.080N P=0.033N* | P=0.170N P<0.001N** P<0.001N** | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 23/100 (23%) 6/50 (12%) 25/148 (17%) 14/100 (14%)| 34/100 (34%) 11/50 (22%) 42/150 (28%) 28/100 (28%)| |ADJUSTED (b) | 26.1% 14.9% 20.6% 16.6% | 39.5% 27.8% 32.8% 32.1% | |TERMINAL (d) | 13/76 (17%) 5/39 (13%) 16/109 (15%) 9/78 (12%) | 20/70 (29%) 7/35 (20%) 29/113 (26%) 19/77 (25%) | |FIRST INCIDENCE (DAYS) | 576 669 412 408 | 128 544 185 568 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.138N P=0.095N P=0.193N P=0.079N | P=0.238N P=0.121N P=0.124N P=0.135N | |INCIDENTAL TUMOR | P=0.260N P=0.133N P=0.150N P=0.194N | P=0.377N P=0.115N P=0.197N P=0.227N | |LOGISTIC REGRESSION | P=0.147N P=0.202N P=0.139N P=0.079N | P=0.407N P=0.093N P=0.226N P=0.267N | |COCHRAN-ARMITAGE | P=0.138N | P=0.371N | |FISHER EXACT | P=0.080N P=0.151N P=0.072N | P=0.092N P=0.192N P=0.222N | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 23/100 (23%) 6/50 (12%) 25/148 (17%) 14/100 (14%)| 34/100 (34%) 11/50 (22%) 42/150 (28%) 28/100 (28%)| |ADJUSTED (b) | 26.1% 14.9% 20.6% 16.6% | 39.5% 27.8% 32.8% 32.1% | |TERMINAL (d) | 13/76 (17%) 5/39 (13%) 16/109 (15%) 9/78 (12%) | 20/70 (29%) 7/35 (20%) 29/113 (26%) 19/77 (25%) | |FIRST INCIDENCE (DAYS) | 576 669 412 408 | 128 544 185 568 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.138N P=0.095N P=0.193N P=0.079N | P=0.238N P=0.121N P=0.124N P=0.135N | |INCIDENTAL TUMOR | P=0.260N P=0.133N P=0.150N P=0.194N | P=0.377N P=0.115N P=0.197N P=0.227N | |LOGISTIC REGRESSION | P=0.147N P=0.202N P=0.139N P=0.079N | P=0.407N P=0.093N P=0.226N P=0.267N | |COCHRAN-ARMITAGE | P=0.138N | P=0.371N | |FISHER EXACT | P=0.080N P=0.151N P=0.072N | P=0.092N P=0.192N P=0.222N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 57/100 (57%) 20/50 (40%) 72/148 (49%) 62/100 (62%)| 45/100 (45%) 18/50 (36%) 75/150 (50%) 61/100 (61%)| |ADJUSTED (b) | 62.3% 46.3% 58.1% 73.8% | 56.6% 45.8% 59.3% 66.9% | |TERMINAL (d) | 42/76 (55%) 16/39 (41%) 58/109 (53%) 56/78 (72%) | 36/70 (51%) 14/35 (40%) 62/113 (55%) 47/77 (61%) | |FIRST INCIDENCE (DAYS) | 491 574 535 612 | 530 587 525 503 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.100 P=0.050N P=0.201N P=0.354 | P=0.029 * P=0.203N P=0.469 P=0.101 | |INCIDENTAL TUMOR | P=0.018 * P=0.048N* P=0.150N P=0.111 | P=0.010 ** P=0.239N P=0.383 P=0.037 * | |LOGISTIC REGRESSION | P=0.023 * P=0.039N* P=0.142N P=0.145 | P=0.011 * P=0.198N P=0.412 P=0.043 * | |COCHRAN-ARMITAGE | P=0.061 | P=0.003 ** | |FISHER EXACT | P=0.037N* P=0.123N P=0.282 | P=0.190N P=0.259 P=0.017 * | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 60/100 (60%) 24/50 (48%) 95/148 (64%) 43/100 (43%)| 56/100 (56%) 22/50 (44%) 65/150 (43%) 48/100 (48%)| |ADJUSTED (b) | 61.7% 50.8% 66.4% 47.7% | 58.0% 48.5% 47.7% 51.8% | |TERMINAL (d) | 39/76 (51%) 16/39 (41%) 61/109 (56%) 31/78 (40%) | 30/70 (43%) 12/35 (34%) 43/113 (38%) 33/77 (43%) | |FIRST INCIDENCE (DAYS) | 463 495 412 408 | 128 461 185 423 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.025N* P=0.156N P=0.267 P=0.024N* | P=0.173N P=0.184N P=0.024N* P=0.090N | |INCIDENTAL TUMOR | P=0.105N P=0.149N P=0.273 P=0.100N | P=0.414N P=0.124N P=0.049N* P=0.246N | |LOGISTIC REGRESSION | P=0.151N P=0.086N P=0.222 P=0.119N | P=0.470N P=0.082N P=0.061N P=0.309N | |COCHRAN-ARMITAGE | P=0.010N* | P=0.316N | |FISHER EXACT | P=0.111N P=0.296 P=0.012N* | P=0.112N P=0.033N* P=0.161N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 02 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- DIPHENYLHYDANTOIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O PPM 30 PPM 100 PPM 300 PPM | 0 PPM 60 PPM 200 PPM 600 PPM | | | 10-0 1-1 0-3 0-10 | 10-0 1-1 0-3 0-10 | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 86/100 (86%) 33/50 (66%) 126/148 (85%) 81/100 (81%)| 76/100 (76%) 28/50 (56%) 111/150 (74%) 88/100 (88%)| |ADJUSTED (b) | 86.8% 68.6% 86.9% 89.0% | 78.2% 62.0% 78.1% 88.0% | |TERMINAL (d) | 63/76 (83%) 24/39 (62%) 90/109 (83%) 68/78 (87%) | 49/70 (70%) 18/35 (51%) 82/113 (73%) 65/77 (84%) | |FIRST INCIDENCE (DAYS) | 463 495 412 408 | 128 461 185 423 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.443N P=0.030N* P=0.459 P=0.232N | P=0.094 P=0.052N P=0.197N P=0.349 | |INCIDENTAL TUMOR | P=0.064 P=0.005N** P=0.572 P=0.341 | P<0.001 ** P=0.013N* P=0.456N P=0.012 * | |LOGISTIC REGRESSION | P=0.049 * P=0.003N** P=0.513 P=0.571N | P<0.001 ** P=0.010N** P=0.449N P=0.010 * | |COCHRAN-ARMITAGE | P=0.530N | P<0.001 ** | |FISHER EXACT | P=0.005N** P=0.501N P=0.223N | P=0.011N* P=0.419N P=0.021 * | |=================================================================================================================================| (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).