TDMS Study 05134-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest 1,3 BUTADIENE (BUTADIENE) DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 TIME: 14:24:25 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES5510500 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 50602C PATHOLOGIST: R. MILLER CAS: 106-99-0 ------------------------------------------------------------------------------------------------------------------------------------ LOW DOSE GROUPS REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 CONTROL INCLUDE 002 CONTROL INCLUDE 003 6.25 PPM INCLUDE 004 6.25 PPM INCLUDE 005 20 PPM INCLUDE 006 20 PPM NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest 1,3 BUTADIENE (BUTADIENE) DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 TIME: 14:24:25 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES5510500 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 50602C PATHOLOGIST: R. MILLER CAS: 106-99-0 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 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 1,3 BUTADIENE (BUTADIENE) DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 TIME: 14:24:25 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES5510500 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 50602C PATHOLOGIST: R. MILLER CAS: 106-99-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF 1,3 BUTADIENE (BUTADIENE) ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Harderian Gland Carcinoma or Adenoma Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Carcinoma All Organs Histiocytic Sarcoma Malignant Lymphoma And Histiocytic Sarcoma Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Stomach, Forestomach Squamous Cell Carcinoma or Papilloma Squamous Squamous Cell Papilloma Uterus Polyp Stromal All Organs Histiocytic Sarcoma Malignant Lymphoma And Histiocytic Sarcoma Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/70 (3%) 4/69 (6%) 0/70 (0%) | 1/70 (1%) 0/69 (0%) 0/68 (0%) | |ADJUSTED (b) | 5.1% 10.3% 0.0% | 2.7% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/35 (3%) 4/39 (10%) 0/24 (0%) | 1/37 (3%) 0/33 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 596 734 (T) --- | 734 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.238N P=0.387 P=0.296N | P=0.479N P=0.523N P=0.586N | |INCIDENTAL TUMOR | P=0.183N P=0.380 P=0.187N | P=0.479N P=0.523N P=0.586N | |LOGISTIC REGRESSION | P=0.195N P=0.363 P=0.256N | P=0.479N P=0.523N P=0.586N | |COCHRAN-ARMITAGE | P=0.153N | P=0.415N | |FISHER EXACT | P=0.333 P=0.248N | P=0.504N P=0.507N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 1/68 (1%) 0/67 (0%) | 0/70 (0%) 0/68 (0%) 2/67 (3%) | |ADJUSTED (b) | 0.0% 2.6% 0.0% | 0.0% 0.0% 6.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/35 (0%) 1/39 (3%) 0/24 (0%) | 0/37 (0%) 0/33 (0%) 1/24 (4%) | |FIRST INCIDENCE (DAYS) | --- 734 (T) --- | --- --- 645 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.773N P=0.522 (e) | P=0.062 (e) P=0.178 | |INCIDENTAL TUMOR | P=0.773N P=0.522 (e) | P=0.102 (e) P=0.251 | |LOGISTIC REGRESSION | P=0.773N P=0.522 (e) | P=0.069 (e) P=0.193 | |COCHRAN-ARMITAGE | P=0.706N | P=0.088 | |FISHER EXACT | P=0.493 (e) | (e) P=0.237 | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 6/70 (9%) 7/70 (10%) 10/70 (14%) | 10/70 (14%) 11/70 (16%) 7/70 (10%) | |ADJUSTED (b) | 14.8% 17.3% 28.3% | 23.5% 30.4% 22.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 2/10 (20%) | 2/10 (20%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 2/35 (6%) 6/39 (15%) 4/24 (17%) | 7/37 (19%) 9/33 (27%) 4/24 (17%) | |FIRST INCIDENCE (DAYS) | 543 652 456 (I) | 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.055 P=0.575 P=0.107 | P=0.531N P=0.409 P=0.565N | |INCIDENTAL TUMOR | P=0.211 P=0.492 P=0.297 | P=0.437N P=0.439 P=0.497N | |LOGISTIC REGRESSION | P=0.121 P=0.548 P=0.178 | P=0.342N P=0.473 P=0.386N | |COCHRAN-ARMITAGE | P=0.173 | P=0.238N | |FISHER EXACT | P=0.500 P=0.213 | P=0.500 P=0.303N | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 6/70 (9%) 7/70 (10%) 11/70 (16%) | 10/70 (14%) 11/70 (16%) 8/70 (11%) | |ADJUSTED (b) | 14.8% 17.3% 31.9% | 23.5% 30.4% 23.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 2/10 (20%) | 2/10 (20%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 2/35 (6%) 6/39 (15%) 5/24 (21%) | 7/37 (19%) 9/33 (27%) 4/24 (17%) | |FIRST INCIDENCE (DAYS) | 543 652 456 (I) | 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.028 * P=0.575 P=0.065 | P=0.492 P=0.409 P=0.534 | |INCIDENTAL TUMOR | P=0.131 P=0.492 P=0.203 | P=0.524N P=0.439 P=0.556N | |LOGISTIC REGRESSION | P=0.070 P=0.548 P=0.118 | P=0.446N P=0.473 P=0.484N | |COCHRAN-ARMITAGE | P=0.112 | P=0.332N | |FISHER EXACT | P=0.500 P=0.150 | P=0.500 P=0.401N | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |Intestine Small | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 1/70 (1%) 1/70 (1%) | 0/70 (0%) 3/70 (4%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 2.6% 3.8% | 0.0% 9.1% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/35 (0%) 1/39 (3%) 0/24 (0%) | 0/37 (0%) 3/33 (9%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | --- 734 (T) 689 | --- 734 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.339 P=0.522 P=0.430 | P=0.608N P=0.101 (e) | |INCIDENTAL TUMOR | P=0.470 P=0.522 P=0.617 | P=0.608N P=0.101 (e) | |LOGISTIC REGRESSION | P=0.384 P=0.522 P=0.473 | P=0.608N P=0.101 (e) | |COCHRAN-ARMITAGE | P=0.437 | P=0.483N | |FISHER EXACT | P=0.500 P=0.500 | P=0.122 (e) | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 2/70 (3%) 0/70 (0%) | 1/69 (1%) 0/69 (0%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 5.0% 0.0% | 2.7% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/35 (0%) 1/39 (3%) 0/24 (0%) | 1/37 (3%) 0/33 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | --- 723 --- | 734 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.665N P=0.267 (e) | P=0.479N P=0.523N P=0.586N | |INCIDENTAL TUMOR | P=0.530N P=0.252 (e) | P=0.479N P=0.523N P=0.586N | |LOGISTIC REGRESSION | P=0.645N P=0.260 (e) | P=0.479N P=0.523N P=0.586N | |COCHRAN-ARMITAGE | P=0.563N | P=0.409N | |FISHER EXACT | P=0.248 (e) | P=0.500N P=0.496N | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 19/70 (27%) 13/70 (19%) 24/70 (34%) | 12/69 (17%) 11/69 (16%) 9/70 (13%) | |ADJUSTED (b) | 37.9% 31.3% 56.0% | 30.9% 29.2% 30.1% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 0/10 (0%) 4/10 (40%) | 1/10 (10%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 9/35 (26%) 11/39 (28%) 8/24 (33%) | 11/37 (30%) 8/33 (24%) 6/24 (25%) | |FIRST INCIDENCE (DAYS) | 281 (I) 484 281 (I) | 457 (I) 457 (I) 365 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.019 * P=0.111N P=0.081 | P=0.491 P=0.586 P=0.522 | |INCIDENTAL TUMOR | P=0.107 P=0.177N P=0.251 | P=0.417N P=0.557N P=0.515N | |LOGISTIC REGRESSION | P=0.096 P=0.149N P=0.226 | P=0.428N P=0.523N P=0.468N | |COCHRAN-ARMITAGE | P=0.115 | P=0.274N | |FISHER EXACT | P=0.157N P=0.232 | P=0.500N P=0.306N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/70 (16%) 17/70 (24%) 16/70 (23%) | 4/69 (6%) 6/69 (9%) 8/70 (11%) | |ADJUSTED (b) | 26.0% 37.7% 44.8% | 10.3% 14.5% 25.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 5/35 (14%) 12/39 (31%) 7/24 (29%) | 3/37 (8%) 2/33 (6%) 3/24 (13%) | |FIRST INCIDENCE (DAYS) | 540 456 (I) 517 | 677 467 600 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.057 P=0.228 P=0.071 | P=0.056 P=0.330 P=0.064 | |INCIDENTAL TUMOR | P=0.358 P=0.128 P=0.335 | P=0.239 P=0.413 P=0.226 | |LOGISTIC REGRESSION | P=0.438 P=0.106 P=0.412 | P=0.298 P=0.400 P=0.104 | |COCHRAN-ARMITAGE | P=0.243 | P=0.172 | |FISHER EXACT | P=0.145 P=0.196 | P=0.372 P=0.190 | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 27/70 (39%) 24/70 (34%) 35/70 (50%) | 16/69 (23%) 15/69 (22%) 15/70 (21%) | |ADJUSTED (b) | 52.4% 53.8% 72.5% | 40.3% 35.6% 45.3% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 1/10 (10%) 4/10 (40%) | 1/10 (10%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 13/35 (37%) 19/39 (49%) 12/24 (50%) | 14/37 (38%) 8/33 (24%) 8/24 (33%) | |FIRST INCIDENCE (DAYS) | 281 (I) 456 (I) 281 (I) | 457 (I) 457 (I) 365 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.005 ** P=0.246N P=0.027 * | P=0.212 P=0.553 P=0.226 | |INCIDENTAL TUMOR | P=0.083 P=0.377N P=0.186 | P=0.506N P=0.514N P=0.557 | |LOGISTIC REGRESSION | P=0.038 * P=0.324N P=0.095 | P=0.448 P=0.523N P=0.454 | |COCHRAN-ARMITAGE | P=0.064 | P=0.465N | |FISHER EXACT | P=0.363N P=0.117 | P=0.500N P=0.482N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 27/70 (39%) 24/70 (34%) 35/70 (50%) | 16/69 (23%) 15/69 (22%) 15/70 (21%) | |ADJUSTED (b) | 52.4% 53.8% 72.5% | 40.3% 35.6% 45.3% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 1/10 (10%) 4/10 (40%) | 1/10 (10%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 13/35 (37%) 19/39 (49%) 12/24 (50%) | 14/37 (38%) 8/33 (24%) 8/24 (33%) | |FIRST INCIDENCE (DAYS) | 281 (I) 456 (I) 281 (I) | 457 (I) 457 (I) 365 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.005 ** P=0.246N P=0.027 * | P=0.212 P=0.553 P=0.226 | |INCIDENTAL TUMOR | P=0.083 P=0.377N P=0.186 | P=0.506N P=0.514N P=0.557 | |LOGISTIC REGRESSION | P=0.038 * P=0.324N P=0.095 | P=0.448 P=0.523N P=0.454 | |COCHRAN-ARMITAGE | P=0.064 | P=0.465N | |FISHER EXACT | P=0.363N P=0.117 | P=0.500N P=0.482N | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/70 (26%) 21/70 (30%) 11/70 (16%) | 4/70 (6%) 11/70 (16%) 12/70 (17%) | |ADJUSTED (b) | 46.9% 48.1% 29.3% | 10.5% 30.9% 40.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 15/35 (43%) 17/39 (44%) 3/24 (13%) | 3/37 (8%) 9/33 (27%) 8/24 (33%) | |FIRST INCIDENCE (DAYS) | 572 281 (I) 281 (I) | 714 524 492 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.312N P=0.502 P=0.346N | P=0.004 ** P=0.031 * P=0.003 ** | |INCIDENTAL TUMOR | P=0.081N P=0.478 P=0.108N | P=0.020 * P=0.045 * P=0.015 * | |LOGISTIC REGRESSION | P=0.111N P=0.446 P=0.159N | P=0.012 * P=0.038 * P=0.009 ** | |COCHRAN-ARMITAGE | P=0.062N | P=0.053 | |FISHER EXACT | P=0.353 P=0.105N | P=0.049 * P=0.030 * | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/70 (9%) 6/70 (9%) 11/70 (16%) | 0/70 (0%) 5/70 (7%) 11/70 (16%) | |ADJUSTED (b) | 15.5% 15.4% 38.3% | 0.0% 13.3% 42.9% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 5/35 (14%) 6/39 (15%) 7/24 (29%) | 0/37 (0%) 3/33 (9%) 10/24 (42%) | |FIRST INCIDENCE (DAYS) | 281 (I) 734 (T) 568 | --- 519 507 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.012 * P=0.550N P=0.038 * | P<0.001 ** P=0.029 * P<0.001 ** | |INCIDENTAL TUMOR | P=0.035 * P=0.550N P=0.088 | P<0.001 ** P=0.045 * P<0.001 ** | |LOGISTIC REGRESSION | P=0.039 * P=0.577N P=0.086 | P<0.001 ** P=0.032 * P<0.001 ** | |COCHRAN-ARMITAGE | P=0.096 | P<0.001 ** | |FISHER EXACT | P=0.618N P=0.150 | P=0.029 * P<0.001 ** | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/70 (31%) 24/70 (34%) 20/70 (29%) | 4/70 (6%) 15/70 (21%) 19/70 (27%) | |ADJUSTED (b) | 55.5% 55.2% 54.3% | 10.5% 39.5% 63.7% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 18/35 (51%) 20/39 (51%) 9/24 (38%) | 3/37 (8%) 11/33 (33%) 14/24 (58%) | |FIRST INCIDENCE (DAYS) | 281 (I) 281 (I) 281 (I) | 714 519 492 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.218 P=0.551N P=0.282 | P<0.001 ** P=0.004 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.508N P=0.575N P=0.512N | P<0.001 ** P=0.006 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.548N P=0.534 P=0.579N | P<0.001 ** P=0.004 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.357N | P=0.002 ** | |FISHER EXACT | P=0.429 P=0.427N | P=0.006 ** P<0.001 ** | |=================================================================================================================================| | | |Mammary Gland | | Adenoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/70 (0%) 0/70 (0%) | 0/70 (0%) 1/70 (1%) 2/70 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 0.0% 2.9% 7.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/35 (0%) 0/39 (0%) 0/24 (0%) | 0/37 (0%) 0/33 (0%) 1/24 (4%) | |FIRST INCIDENCE (DAYS) | --- --- --- | --- 732 686 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.100 P=0.489 P=0.152 | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.261 P=0.557 P=0.266 | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.123 P=0.491 P=0.184 | |COCHRAN-ARMITAGE | (e) | P=0.180 | |FISHER EXACT | (e) (e) | P=0.500 P=0.248 | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/70 (0%) 0/70 (0%) | 0/70 (0%) 2/70 (3%) 2/70 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 0.0% 5.8% 5.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/35 (0%) 0/39 (0%) 0/24 (0%) | 0/37 (0%) 1/33 (3%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- | --- 732 645 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.173 P=0.221 P=0.192 | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.405 P=0.258 P=0.418 | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.210 P=0.227 P=0.218 | |COCHRAN-ARMITAGE | (e) | P=0.260 | |FISHER EXACT | (e) (e) | P=0.248 P=0.248 | |=================================================================================================================================| | | |Ovary | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/69 (3%) 4/69 (6%) 1/68 (1%) | |ADJUSTED (b) | | 5.6% 12.1% 4.2% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 2/36 (6%) 4/33 (12%) 1/24 (4%) | |FIRST INCIDENCE (DAYS) | | 734 (T) 734 (T) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.504N P=0.296 P=0.640N | |INCIDENTAL TUMOR | | P=0.504N P=0.296 P=0.640N | |LOGISTIC REGRESSION | | P=0.504N P=0.296 P=0.640N | |COCHRAN-ARMITAGE | | P=0.339N | |FISHER EXACT | | P=0.340 P=0.506N | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/70 (1%) 0/67 (0%) 0/67 (0%) | 7/70 (10%) 12/69 (17%) 5/68 (7%) | |ADJUSTED (b) | 2.9% 0.0% 0.0% | 17.4% 33.7% 17.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/35 (3%) 0/38 (0%) 0/24 (0%) | 5/37 (14%) 10/33 (30%) 3/24 (13%) | |FIRST INCIDENCE (DAYS) | 734 (T) --- --- | 625 653 645 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.473N P=0.484N P=0.575N | P=0.534N P=0.107 P=0.600 | |INCIDENTAL TUMOR | P=0.473N P=0.484N P=0.575N | P=0.348N P=0.124 P=0.481N | |LOGISTIC REGRESSION | P=0.473N P=0.484N P=0.575N | P=0.429N P=0.132 P=0.552N | |COCHRAN-ARMITAGE | P=0.417N | P=0.251N | |FISHER EXACT | P=0.511N P=0.511N | P=0.154 P=0.403N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 1/70 (1%) 1/70 (1%) | 1/70 (1%) 2/70 (3%) 2/70 (3%) | |ADJUSTED (b) | 0.0% 2.6% 2.5% | 2.7% 5.2% 8.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/35 (0%) 1/39 (3%) 0/24 (0%) | 1/37 (3%) 1/33 (3%) 2/24 (8%) | |FIRST INCIDENCE (DAYS) | --- 734 (T) 585 | 734 (T) 572 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.374 P=0.522 P=0.486 | P=0.323 P=0.471 P=0.350 | |INCIDENTAL TUMOR | P=0.502 P=0.522 P=0.662 | P=0.337 P=0.448 P=0.350 | |LOGISTIC REGRESSION | P=0.416 P=0.522 P=0.500 | P=0.383 P=0.492 P=0.350 | |COCHRAN-ARMITAGE | P=0.437 | P=0.460 | |FISHER EXACT | P=0.500 P=0.500 | P=0.500 P=0.500 | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 0/70 (0%) 1/70 (1%) | 1/70 (1%) 2/70 (3%) 3/70 (4%) | |ADJUSTED (b) | 2.3% 0.0% 3.3% | 2.4% 5.3% 8.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/35 (0%) 0/39 (0%) 0/24 (0%) | 0/37 (0%) 1/33 (3%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 572 --- 680 | 677 642 569 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.612 P=0.483N P=0.729 | P=0.182 P=0.476 P=0.238 | |INCIDENTAL TUMOR | P=0.618N P=0.500N P=0.598N | P=0.382 P=0.494 P=0.523 | |LOGISTIC REGRESSION | P=0.639 P=0.503N P=0.755 | P=0.544 P=0.491 P=0.282 | |COCHRAN-ARMITAGE | P=0.645 | P=0.258 | |FISHER EXACT | P=0.500N P=0.752N | P=0.500 P=0.310 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 0/70 (0%) 1/70 (1%) | 1/70 (1%) 2/70 (3%) 3/70 (4%) | |ADJUSTED (b) | 2.3% 0.0% 3.3% | 2.4% 5.3% 8.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/35 (0%) 0/39 (0%) 0/24 (0%) | 0/37 (0%) 1/33 (3%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 572 --- 680 | 677 642 569 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.612 P=0.483N P=0.729 | P=0.182 P=0.476 P=0.238 | |INCIDENTAL TUMOR | P=0.618N P=0.500N P=0.598N | P=0.382 P=0.494 P=0.523 | |LOGISTIC REGRESSION | P=0.639 P=0.503N P=0.755 | P=0.544 P=0.491 P=0.282 | |COCHRAN-ARMITAGE | P=0.645 | P=0.258 | |FISHER EXACT | P=0.500N P=0.752N | P=0.500 P=0.310 | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 0/70 (0%) 1/70 (1%) | 1/70 (1%) 2/70 (3%) 2/70 (3%) | |ADJUSTED (b) | 2.3% 0.0% 3.3% | 2.4% 5.3% 5.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/35 (0%) 0/39 (0%) 0/24 (0%) | 0/37 (0%) 1/33 (3%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 572 --- 680 | 677 642 650 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.612 P=0.483N P=0.729 | P=0.359 P=0.476 P=0.415 | |INCIDENTAL TUMOR | P=0.618N P=0.500N P=0.598N | P=0.608 P=0.494 P=0.722N | |LOGISTIC REGRESSION | P=0.639 P=0.503N P=0.755 | P=0.414 P=0.491 P=0.464 | |COCHRAN-ARMITAGE | P=0.645 | P=0.460 | |FISHER EXACT | P=0.500N P=0.752N | P=0.500 P=0.500 | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 1/70 (1%) 1/70 (1%) | 2/69 (3%) 1/69 (1%) 0/68 (0%) | |ADJUSTED (b) | 0.0% 2.1% 4.2% | 5.4% 3.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/35 (0%) 0/39 (0%) 1/24 (4%) | 2/37 (5%) 1/33 (3%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | --- 587 734 (T) | 734 (T) 734 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.367 P=0.522 P=0.425 | P=0.259N P=0.540N P=0.338N | |INCIDENTAL TUMOR | P=0.502 P=0.500 P=0.425 | P=0.259N P=0.540N P=0.338N | |LOGISTIC REGRESSION | P=0.416 P=0.498 P=0.425 | P=0.259N P=0.540N P=0.338N | |COCHRAN-ARMITAGE | P=0.437 | P=0.183N | |FISHER EXACT | P=0.500 P=0.500 | P=0.500N P=0.252N | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 0/70 (0%) 0/70 (0%) | 0/70 (0%) 0/70 (0%) 3/70 (4%) | |ADJUSTED (b) | 2.5% 0.0% 0.0% | 0.0% 0.0% 12.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/35 (0%) 0/39 (0%) 0/24 (0%) | 0/37 (0%) 0/33 (0%) 3/24 (13%) | |FIRST INCIDENCE (DAYS) | 652 --- --- | --- --- 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.449N P=0.481N P=0.545N | P=0.011 * (e) P=0.056 | |INCIDENTAL TUMOR | P=0.313N P=0.500N P=0.383N | P=0.011 * (e) P=0.056 | |LOGISTIC REGRESSION | P=0.421N P=0.495N P=0.514N | P=0.011 * (e) P=0.056 | |COCHRAN-ARMITAGE | P=0.411N | P=0.031 * | |FISHER EXACT | P=0.500N P=0.500N | (e) P=0.122 | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 0/70 (0%) 0/70 (0%) | 0/70 (0%) 0/70 (0%) 2/70 (3%) | |ADJUSTED (b) | 2.5% 0.0% 0.0% | 0.0% 0.0% 8.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/35 (0%) 0/39 (0%) 0/24 (0%) | 0/37 (0%) 0/33 (0%) 2/24 (8%) | |FIRST INCIDENCE (DAYS) | 652 --- --- | --- --- 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.449N P=0.481N P=0.545N | P=0.048 * (e) P=0.149 | |INCIDENTAL TUMOR | P=0.313N P=0.500N P=0.383N | P=0.048 * (e) P=0.149 | |LOGISTIC REGRESSION | P=0.421N P=0.495N P=0.514N | P=0.048 * (e) P=0.149 | |COCHRAN-ARMITAGE | P=0.411N | P=0.092 | |FISHER EXACT | P=0.500N P=0.500N | (e) P=0.248 | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/70 (3%) 4/70 (6%) 0/70 (0%) | 1/70 (1%) 1/69 (1%) 1/69 (1%) | |ADJUSTED (b) | 5.7% 9.8% 0.0% | 2.4% 2.5% 3.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/35 (6%) 3/39 (8%) 0/24 (0%) | 0/37 (0%) 0/33 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 734 (T) 653 --- | 677 673 657 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.242N P=0.388 P=0.324N | P=0.604 P=0.747 P=0.689 | |INCIDENTAL TUMOR | P=0.197N P=0.380 P=0.324N | P=0.490N P=0.702N P=0.602N | |LOGISTIC REGRESSION | P=0.206N P=0.379 P=0.324N | P=0.652 P=0.757 P=0.734 | |COCHRAN-ARMITAGE | P=0.153N | P=0.681 | |FISHER EXACT | P=0.340 P=0.248N | P=0.748 P=0.748 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/70 (3%) 4/70 (6%) 0/70 (0%) | 1/70 (1%) 2/69 (3%) 1/69 (1%) | |ADJUSTED (b) | 5.7% 9.8% 0.0% | 2.4% 5.5% 3.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/35 (6%) 3/39 (8%) 0/24 (0%) | 0/37 (0%) 1/33 (3%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 734 (T) 653 --- | 677 673 657 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.242N P=0.388 P=0.324N | P=0.616 P=0.473 P=0.689 | |INCIDENTAL TUMOR | P=0.197N P=0.380 P=0.324N | P=0.466N P=0.554 P=0.602N | |LOGISTIC REGRESSION | P=0.206N P=0.379 P=0.324N | P=0.368N P=0.495 P=0.734 | |COCHRAN-ARMITAGE | P=0.153N | P=0.608N | |FISHER EXACT | P=0.340 P=0.248N | P=0.495 P=0.748 | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 4/70 (6%) 2/70 (3%) 0/70 (0%) | |ADJUSTED (b) | | 7.6% 5.8% 0.0% | |INTERIM SACRIFICE 1 (c)| | 2/10 (20%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 1/37 (3%) 1/33 (3%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | | 282 (I) 732 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.076N P=0.363N P=0.084N | |INCIDENTAL TUMOR | | P=0.050N* P=0.352N P=0.078N | |LOGISTIC REGRESSION | | P=0.047N* P=0.331N P=0.049N* | |COCHRAN-ARMITAGE | | P=0.050N | |FISHER EXACT | | P=0.340N P=0.060N | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 1/70 (1%) 0/70 (0%) | 2/70 (3%) 2/70 (3%) 1/70 (1%) | |ADJUSTED (b) | 2.9% 2.6% 0.0% | 5.1% 5.0% 4.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/35 (3%) 1/39 (3%) 0/24 (0%) | 1/37 (3%) 0/33 (0%) 1/24 (4%) | |FIRST INCIDENCE (DAYS) | 734 (T) 734 (T) --- | 708 572 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.439N P=0.738N P=0.575N | P=0.547N P=0.667 P=0.657N | |INCIDENTAL TUMOR | P=0.439N P=0.738N P=0.575N | P=0.349N P=0.675N P=0.514N | |LOGISTIC REGRESSION | P=0.439N P=0.738N P=0.575N | P=0.472N P=0.685 P=0.618N | |COCHRAN-ARMITAGE | P=0.355N | P=0.406N | |FISHER EXACT | P=0.752N P=0.500N | P=0.690N P=0.500N | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 4/70 (6%) 3/70 (4%) | 3/70 (4%) 2/70 (3%) 2/70 (3%) | |ADJUSTED (b) | 2.9% 9.4% 9.8% | 8.1% 5.2% 8.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/35 (3%) 2/39 (5%) 1/24 (4%) | 3/37 (8%) 1/33 (3%) 2/24 (8%) | |FIRST INCIDENCE (DAYS) | 734 (T) 587 585 | 734 (T) 572 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.222 P=0.219 P=0.219 | P=0.624 P=0.543N P=0.671 | |INCIDENTAL TUMOR | P=0.461 P=0.203 P=0.357 | P=0.626N P=0.562N P=0.671 | |LOGISTIC REGRESSION | P=0.296 P=0.200 P=0.262 | P=0.572N P=0.514N P=0.671 | |COCHRAN-ARMITAGE | P=0.363 | P=0.466N | |FISHER EXACT | P=0.183 P=0.310 | P=0.500N P=0.500N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/70 (3%) 5/70 (7%) 3/70 (4%) | 5/70 (7%) 3/70 (4%) 3/70 (4%) | |ADJUSTED (b) | 5.7% 11.9% 9.8% | 13.0% 7.9% 12.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/35 (6%) 3/39 (8%) 1/24 (4%) | 4/37 (11%) 1/33 (3%) 3/24 (13%) | |FIRST INCIDENCE (DAYS) | 734 (T) 587 585 | 708 572 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.367 P=0.267 P=0.372 | P=0.571N P=0.409N P=0.611N | |INCIDENTAL TUMOR | P=0.600 P=0.252 P=0.521 | P=0.429N P=0.373N P=0.519N | |LOGISTIC REGRESSION | P=0.460 P=0.249 P=0.434 | P=0.489N P=0.375N P=0.591N | |COCHRAN-ARMITAGE | P=0.548 | P=0.347N | |FISHER EXACT | P=0.221 P=0.500 | P=0.359N P=0.359N | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/70 (0%) 4/70 (6%) | 3/70 (4%) 2/70 (3%) 7/70 (10%) | |ADJUSTED (b) | 0.0% 0.0% 10.6% | 6.9% 4.5% 20.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/35 (0%) 0/39 (0%) 0/24 (0%) | 0/37 (0%) 0/33 (0%) 1/24 (4%) | |FIRST INCIDENCE (DAYS) | --- --- 531 | 485 467 492 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.006 ** (e) P=0.051 | P=0.032 * P=0.518N P=0.077 | |INCIDENTAL TUMOR | P=0.051 (e) P=0.148 | P=0.256 P=0.290N P=0.425 | |LOGISTIC REGRESSION | P=0.010 ** (e) P=0.061 | P=0.213 P=0.501N P=0.345 | |COCHRAN-ARMITAGE | P=0.011 * | P=0.074 | |FISHER EXACT | (e) P=0.060 | P=0.500N P=0.163 | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 4/70 (6%) 2/70 (3%) 8/70 (11%) | 10/70 (14%) 14/70 (20%) 18/70 (26%) | |ADJUSTED (b) | 9.8% 5.1% 21.2% | 21.9% 37.0% 52.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/35 (3%) 2/39 (5%) 2/24 (8%) | 3/37 (8%) 10/33 (30%) 9/24 (38%) | |FIRST INCIDENCE (DAYS) | 511 734 (T) 456 | 457 (I) 467 492 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.034 * P=0.302N P=0.118 | P=0.005 ** P=0.195 P=0.010 ** | |INCIDENTAL TUMOR | P=0.146 P=0.388N P=0.288 | P=0.086 P=0.302 P=0.128 | |LOGISTIC REGRESSION | P=0.167 P=0.317N P=0.327 | P=0.022 * P=0.223 P=0.030 * | |COCHRAN-ARMITAGE | P=0.077 | P=0.066 | |FISHER EXACT | P=0.340N P=0.183 | P=0.251 P=0.069 | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 4/70 (6%) 2/70 (3%) 4/70 (6%) | 7/70 (10%) 12/70 (17%) 11/70 (16%) | |ADJUSTED (b) | 9.8% 5.1% 11.8% | 16.0% 34.0% 38.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/35 (3%) 2/39 (5%) 2/24 (8%) | 3/37 (8%) 10/33 (30%) 8/24 (33%) | |FIRST INCIDENCE (DAYS) | 511 734 (T) 456 | 457 (I) 695 533 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.391 P=0.302N P=0.528 | P=0.052 P=0.115 P=0.057 | |INCIDENTAL TUMOR | P=0.563 P=0.388N P=0.613N | P=0.178 P=0.140 P=0.187 | |LOGISTIC REGRESSION | P=0.494 P=0.317N P=0.621 | P=0.122 P=0.136 P=0.127 | |COCHRAN-ARMITAGE | P=0.529 | P=0.273 | |FISHER EXACT | P=0.340N P=0.641N | P=0.162 P=0.225 | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 42/70 (60%) 36/70 (51%) 41/70 (59%) | 33/70 (47%) 38/70 (54%) 25/70 (36%) | |ADJUSTED (b) | 81.5% 81.5% 79.5% | 69.1% 88.0% 68.9% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 1/10 (10%) 2/10 (20%) | 2/10 (20%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 0/10 (0%) 5/10 (50%) | 3/10 (30%) 2/10 (20%) 1/10 (10%) | |TERMINAL (d) | 26/35 (74%) 31/39 (79%) 14/24 (58%) | 23/37 (62%) 28/33 (85%) 14/24 (58%) | |FIRST INCIDENCE (DAYS) | 281 (I) 281 (I) 281 (I) | 282 (I) 457 (I) 365 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.037 * P=0.067N P=0.136 | P=0.468 P=0.105 P=0.453 | |INCIDENTAL TUMOR | P=0.408 P=0.115N P=0.475N | P=0.140N P=0.156 P=0.230N | |LOGISTIC REGRESSION | P=0.357 P=0.087N P=0.543 | P=0.147N P=0.172 P=0.232N | |COCHRAN-ARMITAGE | P=0.521 | P=0.056N | |FISHER EXACT | P=0.198N P=0.500N | P=0.250 P=0.115N | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6.25 PPM 20 PPM | CONTROL 6.25 PPM 20 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 20/70 (29%) 27/70 (39%) 34/70 (49%) | 16/70 (23%) 32/70 (46%) 40/70 (57%) | |ADJUSTED (b) | 43.3% 58.1% 78.4% | 35.0% 70.7% 85.1% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 10/35 (29%) 20/39 (51%) 15/24 (63%) | 8/37 (22%) 20/33 (61%) 17/24 (71%) | |FIRST INCIDENCE (DAYS) | 281 (I) 456 (I) 456 | 457 (I) 467 492 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.263 P=0.001 ** | P<0.001 ** P=0.003 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.015 * P=0.122 P=0.019 * | P<0.001 ** P=0.002 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.010 * P=0.174 P=0.012 * | P<0.001 ** P=0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.012 * | P<0.001 ** | |FISHER EXACT | P=0.141 P=0.012 * | P=0.004 ** P<0.001 ** | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 51/70 (73%) 42/70 (60%) 52/70 (74%) | 40/70 (57%) 49/70 (70%) 44/70 (63%) | |ADJUSTED (b) | 90.8% 87.3% 92.7% | 77.9% 98.0% 89.7% | |INTERIM SACRIFICE 1 (c)| 5/10 (50%) 1/10 (10%) 2/10 (20%) | 2/10 (20%) 0/10 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 1/10 (10%) 5/10 (50%) | 3/10 (30%) 2/10 (20%) 1/10 (10%) | |TERMINAL (d) | 30/35 (86%) 33/39 (85%) 20/24 (83%) | 26/37 (70%) 32/33 (97%) 19/24 (79%) | |FIRST INCIDENCE (DAYS) | 281 (I) 281 (I) 281 (I) | 282 (I) 457 (I) 365 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.007 ** P=0.023N* P=0.052 | P=0.006 ** P=0.031 * P=0.009 ** | |INCIDENTAL TUMOR | P=0.261 P=0.032N* P=0.556 | P=0.313 P=0.025 * P=0.325 | |LOGISTIC REGRESSION | P=0.156 P=0.026N* P=0.380 | P=0.101 P=0.022 * P=0.085 | |COCHRAN-ARMITAGE | P=0.316 | P=0.394 | |FISHER EXACT | P=0.076N P=0.500 | P=0.080 P=0.302 | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 281 456 Female interim sacrifices(days): 282 457 (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's exact tests compare directly the overall incidence rates. For all tests, a negative trend is indicated by "N". (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01). NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest 1,3 BUTADIENE (BUTADIENE) DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 TIME: 14:25:01 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES5510500 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 50602C PATHOLOGIST: R. MILLER CAS: 106-99-0 ------------------------------------------------------------------------------------------------------------------------------------ HIGH DOSE GROUPS REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 CONTROL INCLUDE 002 CONTROL INCLUDE 007 62.5 PPM INCLUDE 008 62.5 PPM INCLUDE 009 200 PPM INCLUDE 010 200 PPM INCLUDE 011 625 PPM INCLUDE 012 625 PPM NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest 1,3 BUTADIENE (BUTADIENE) DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 TIME: 14:25:01 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES5510500 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 50602C PATHOLOGIST: R. MILLER CAS: 106-99-0 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 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 1,3 BUTADIENE (BUTADIENE) DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 TIME: 14:25:01 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES5510500 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 50602C PATHOLOGIST: R. MILLER CAS: 106-99-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF 1,3 BUTADIENE (BUTADIENE) ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Clitoral/Preputial Gland Carcinoma Harderian Gland Adenoma Carcinoma or Adenoma Heart Hemangiosarcoma Intestine Small Carcinoma Carcinoma or Adenoma Kidney: Renal Tubule Carcinoma or Adenoma Liver Hepatocellular Adenoma Hepatocellular Carcinoma 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 Stomach, Forestomach Squamous Cell Carcinoma Squamous Cell Carcinoma or Papilloma Squamous Squamous Cell Papilloma All Organs Hemangiosarcoma Hemangiosarcoma or Hemangioma Histiocytic Sarcoma Malignant Lymphoma And Histiocytic Sarcoma Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest 1,3 BUTADIENE (BUTADIENE) DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 TIME: 14:25:01 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES5510500 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 50602C PATHOLOGIST: R. MILLER CAS: 106-99-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF 1,3 BUTADIENE (BUTADIENE) ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Cortex Adenoma Adrenal Medulla Pheochromocytoma Benign Harderian Gland Adenoma Carcinoma Carcinoma or Adenoma Heart Hemangiosarcoma Islets, Pancreatic Adenoma Kidney: Renal Tubule Adenoma Carcinoma or Adenoma Liver Hepatocellular Adenoma Hepatocellular Carcinoma 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 Mammary Gland Adenoacanthoma Carcinoma Mixed Tumor Malignant Ovary Granulosa Cell Tumor Benign Granulosa Cell Tumor Malignant Granulosa Cell Tumor, Benign, Malignant, NOS Mixed Tumor Benign Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Skin: Subcutaneous Tissue Hemangiosarcoma Neurofibrosarcoma, Fibrosarcoma, Sarcoma, Neurofibroma, or Fibroma Neurofibrosarcoma, Fibrosarcoma, or Sarcoma Sarcoma Spleen Hemangiosarcoma Stomach, Forestomach Squamous Cell Carcinoma Squamous Cell Carcinoma or Papilloma Squamous Squamous Cell Papilloma Thyroid Gland: Follicular Cell Adenoma Uterus Carcinoma Polyp Stromal Sarcoma Stromal or Polyp Stromal Zymbal's Gland Carcinoma or Adenoma All Organs Hemangiosarcoma Hemangiosarcoma or Hemangioma Histiocytic Sarcoma Malignant Lymphoma And Histiocytic Sarcoma NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest 1,3 BUTADIENE (BUTADIENE) DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 TIME: 14:25:01 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES5510500 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 50602C PATHOLOGIST: R. MILLER CAS: 106-99-0 Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/70 (3%) 1/67 (1%) 0/68 (0%) 0/90 (0%) | 1/70 (1%) 0/69 (0%) 3/70 (4%) 0/88 (0%) | |ADJUSTED (b) | 5.1% 3.4% 0.0% 0.0% | 2.7% 0.0% 18.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 1/35 (3%) 0/22 (0%) 0/4 (0%) 0/0 | 1/37 (3%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 596 680 --- --- | 733 (T) --- 370 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.885N P=0.601N P=0.535N (e) | P=0.300 P=0.740N P=0.024 * (e) | |INCIDENTAL TUMOR | P=0.484N P=0.449N P=0.171N (e) | P=0.563N P=0.740N P=0.515 (e) | |LOGISTIC REGRESSION | P=0.551N P=0.553N P=0.371N P=0.881N | P=0.608N P=0.740N P=0.237 (e) | |COCHRAN-ARMITAGE | P=0.141N | P=0.365N | |FISHER EXACT | P=0.517N P=0.255N P=0.190N | P=0.504N P=0.310 P=0.443N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/64 (0%) 0/64 (0%) 1/86 (1%) | 0/70 (0%) 0/65 (0%) 2/70 (3%) 0/86 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 7.7% | 0.0% 0.0% 15.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 0/35 (0%) 0/21 (0%) 0/4 (0%) 0/0 | 0/37 (0%) 0/10 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- 376 | --- --- 543 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.035 * (e) (e) P=0.200 | P=0.168 (e) P=0.030 * (e) | |INCIDENTAL TUMOR | P=0.183 (e) (e) P=0.500 | P=0.781N (e) P=0.561 (e) | |LOGISTIC REGRESSION | P=0.369 (e) (e) P=0.673 | P=0.738 (e) P=0.153 (e) | |COCHRAN-ARMITAGE | P=0.262 | P=0.630N | |FISHER EXACT | (e) (e) P=0.551 | (e) P=0.248 (e) | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/27 (0%) 0/29 (0%) 5/26 (19%) 0/19 (0%) | 0/20 (0%) 0/20 (0%) 0/20 (0%) 0/10 (0%) | |ADJUSTED (b) | 0.0% 0.0% 100.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 0/5 (0%) 0/3 (0%) 1/1 (100%) 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- --- 596 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** (e) P<0.001 ** (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.023 * (e) P=0.028 * (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.050 (e) P=0.003 ** (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.619 | (e) | |FISHER EXACT | (e) P=0.023 * (e) | (e) (e) (e) | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/70 (9%) 23/70 (33%) 33/70 (47%) 9/90 (10%) | 10/70 (14%) 16/70 (23%) 23/70 (33%) 10/90 (11%) | |ADJUSTED (b) | 14.8% 66.0% 95.6% 61.5% | 23.5% 61.7% 89.8% 40.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/8 (13%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 4/10 (40%) 3/10 (30%) 3/7 (43%) | 2/10 (20%) 1/10 (10%) 3/10 (30%) 0/2 (0%) | |TERMINAL (d) | 2/35 (6%) 12/22 (55%) 3/4 (75%) 0/0 | 7/37 (19%) 4/11 (36%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 543 456 (I) 382 289 | 457 (I) 457 (I) 370 282 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.003 ** P<0.001 ** P<0.001 ** P=0.071 | P=0.423 P=0.089 P=0.023 * P=0.491 | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P=0.014 * | P=0.043 * P=0.032 * P=0.020 * P=0.235 | |COCHRAN-ARMITAGE | P=0.022N* | P=0.069N | |FISHER EXACT | P<0.001 ** P<0.001 ** P=0.490 | P=0.139 P=0.008 ** P=0.357N | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 3/70 (4%) 2/70 (3%) 0/90 (0%) | 0/70 (0%) 0/70 (0%) 1/70 (1%) 0/90 (0%) | |ADJUSTED (b) | 0.0% 11.7% 6.3% 0.0% | 0.0% 0.0% 50.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 0/35 (0%) 1/22 (5%) 0/4 (0%) 0/0 | 0/37 (0%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- 680 495 --- | --- --- 695 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.227 P=0.067 P=0.166 (e) | P=0.800 (e) P=0.016 * (e) | |INCIDENTAL TUMOR | P=0.787 P=0.166 P=0.509 (e) | P=0.907 (e) P=0.362 (e) | |LOGISTIC REGRESSION | P=0.728 P=0.082 P=0.238 (e) | P=0.811 (e) P=0.090 (e) | |COCHRAN-ARMITAGE | P=0.217N | P=0.739N | |FISHER EXACT | P=0.122 P=0.248 (e) | (e) P=0.500 (e) | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/70 (9%) 24/70 (34%) 34/70 (49%) 9/90 (10%) | 10/70 (14%) 16/70 (23%) 23/70 (33%) 10/90 (11%) | |ADJUSTED (b) | 14.8% 67.4% 95.8% 61.5% | 23.5% 61.7% 89.8% 40.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/8 (13%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 4/10 (40%) 3/10 (30%) 3/7 (43%) | 2/10 (20%) 1/10 (10%) 3/10 (30%) 0/2 (0%) | |TERMINAL (d) | 2/35 (6%) 12/22 (55%) 3/4 (75%) 0/0 | 7/37 (19%) 4/11 (36%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 543 456 (I) 382 289 | 457 (I) 457 (I) 370 282 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.004 ** P<0.001 ** P<0.001 ** P=0.071 | P=0.423 P=0.089 P=0.023 * P=0.491 | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P=0.014 * | P=0.043 * P=0.032 * P=0.020 * P=0.235 | |COCHRAN-ARMITAGE | P=0.017N* | P=0.069N | |FISHER EXACT | P<0.001 ** P<0.001 ** P=0.490 | P=0.139 P=0.008 ** P=0.357N | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Heart | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 5/68 (7%) 21/68 (31%) 7/90 (8%) | 0/70 (0%) 1/69 (1%) 22/70 (31%) 25/90 (28%) | |ADJUSTED (b) | 0.0% 19.4% 93.4% 55.9% | 0.0% 4.0% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 3/7 (43%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/2 (100%) | |TERMINAL (d) | 0/35 (0%) 3/22 (14%) 3/4 (75%) 0/0 | 0/37 (0%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- 649 456 (I) 289 | --- 649 343 307 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** | P<0.001 ** P=0.392 P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.028 * P<0.001 ** P=0.018 * | P<0.001 ** P=0.682 P=0.006 ** P=0.005 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.017 * P<0.001 ** P=0.003 ** | P<0.001 ** P=0.453 P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.383 | P<0.001 ** | |FISHER EXACT | P=0.027 * P<0.001 ** P=0.016 * | P=0.496 P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |Intestine Small | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 1/70 (1%) 2/70 (3%) 0/90 (0%) | 0/70 (0%) 1/70 (1%) 0/70 (0%) 0/90 (0%) | |ADJUSTED (b) | 0.0% 4.5% 28.3% 0.0% | 0.0% 4.3% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 0/35 (0%) 1/22 (5%) 1/4 (25%) 0/0 | 0/37 (0%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- 733 (T) 596 --- | --- 653 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.147 P=0.407 P=0.032 * (e) | P=1.000 P=0.375 (e) (e) | |INCIDENTAL TUMOR | P=0.391 P=0.407 P=0.121 (e) | P=1.000N P=0.682 (e) (e) | |LOGISTIC REGRESSION | P=0.398 P=0.407 P=0.091 (e) | P=0.975N P=0.451 (e) (e) | |COCHRAN-ARMITAGE | P=0.436N | P=0.541N | |FISHER EXACT | P=0.500 P=0.248 (e) | P=0.500 (e) (e) | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 1/70 (1%) 2/70 (3%) 0/90 (0%) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 0/90 (0%) | |ADJUSTED (b) | 0.0% 4.5% 28.3% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 0/35 (0%) 1/22 (5%) 1/4 (25%) 0/0 | 0/37 (0%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- 733 (T) 596 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.147 P=0.407 P=0.032 * (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.391 P=0.407 P=0.121 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.398 P=0.407 P=0.091 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.436N | (e) | |FISHER EXACT | P=0.500 P=0.248 (e) | (e) (e) (e) | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/68 (0%) 0/66 (0%) 0/87 (0%) | 0/69 (0%) 1/67 (1%) 2/69 (3%) 0/88 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 2.8% 100.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 0/35 (0%) 0/22 (0%) 0/4 (0%) 0/0 | 0/37 (0%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 570 502 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.093 P=0.451 P=0.007 ** (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.768N P=0.701 P=0.334 (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.738 P=0.497 P=0.078 (e) | |COCHRAN-ARMITAGE | (e) | P=0.435N | |FISHER EXACT | (e) (e) (e) | P=0.493 P=0.248 (e) | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 2/68 (3%) 1/69 (1%) 1/90 (1%) | 0/69 (0%) 0/70 (0%) 2/70 (3%) 0/90 (0%) | |ADJUSTED (b) | 0.0% 9.1% 3.7% 14.3% | 0.0% 0.0% 34.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/7 (14%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 0/35 (0%) 2/22 (9%) 0/4 (0%) 0/0 | 0/37 (0%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- 733 (T) 573 456 (I) | --- --- 418 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.051 P=0.143 P=0.407 P=0.429 | P=0.379 (e) P=0.037 * (e) | |INCIDENTAL TUMOR | P=0.093 P=0.143 P=0.831 P=0.429 | P=0.793 (e) P=0.334 (e) | |LOGISTIC REGRESSION | P=0.152 P=0.141 P=0.480 P=0.487 | P=0.774 (e) P=0.182 (e) | |COCHRAN-ARMITAGE | P=0.624N | P=0.623N | |FISHER EXACT | P=0.241 P=0.496 P=0.563 | (e) P=0.252 (e) | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 3/68 (4%) 1/69 (1%) 1/90 (1%) | 0/69 (0%) 0/70 (0%) 2/70 (3%) 0/90 (0%) | |ADJUSTED (b) | 0.0% 13.6% 3.7% 14.3% | 0.0% 0.0% 34.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/7 (14%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 0/35 (0%) 3/22 (14%) 0/4 (0%) 0/0 | 0/37 (0%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- 733 (T) 573 456 (I) | --- --- 418 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.044 * P=0.053 P=0.407 P=0.429 | P=0.379 (e) P=0.037 * (e) | |INCIDENTAL TUMOR | P=0.080 P=0.053 P=0.831 P=0.429 | P=0.793 (e) P=0.334 (e) | |LOGISTIC REGRESSION | P=0.126 P=0.053 P=0.480 P=0.487 | P=0.774 (e) P=0.182 (e) | |COCHRAN-ARMITAGE | P=0.482N | P=0.623N | |FISHER EXACT | P=0.117 P=0.496 P=0.563 | (e) P=0.252 (e) | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 19/70 (27%) 19/68 (28%) 29/68 (43%) 9/89 (10%) | 12/69 (17%) 15/70 (21%) 15/70 (21%) 2/90 (2%) | |ADJUSTED (b) | 37.9% 59.2% 92.8% 65.9% | 30.9% 66.4% 89.6% 66.7% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 0/10 (0%) 1/10 (10%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 3/10 (30%) 4/10 (40%) 3/7 (43%) | 1/10 (10%) 1/10 (10%) 3/10 (30%) 1/2 (50%) | |TERMINAL (d) | 9/35 (26%) 11/22 (50%) 3/4 (75%) 0/0 | 11/37 (30%) 5/11 (45%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 281 (I) 434 281 (I) 281 (I) | 457 (I) 457 (I) 370 450 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.209 P<0.001 ** P=0.037 * | P<0.001 ** P<0.001 ** P<0.001 ** P=0.020 * | |INCIDENTAL TUMOR | P=0.126 P=0.396 P=0.101 P=0.569 | P=0.191 P=0.043 * P=0.007 ** P=0.335 | |LOGISTIC REGRESSION | P=0.332 P=0.503 P=0.022 * P=0.343N | P=0.150 P=0.047 * P=0.004 ** P=0.469 | |COCHRAN-ARMITAGE | P<0.001N** | P<0.001N** | |FISHER EXACT | P=0.534 P=0.041 * P=0.005N** | P=0.350 P=0.350 P<0.001N** | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/70 (16%) 17/68 (25%) 27/68 (40%) 4/89 (4%) | 4/69 (6%) 9/70 (13%) 9/70 (13%) 1/90 (1%) | |ADJUSTED (b) | 26.0% 58.1% 100.0% 49.2% | 10.3% 39.9% 83.0% 10.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 3/7 (43%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/2 (0%) | |TERMINAL (d) | 5/35 (14%) 11/22 (50%) 4/4 (100%) 0/0 | 3/37 (8%) 2/11 (18%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 540 434 351 422 | 677 546 353 418 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.020 * P<0.001 ** P=0.007 ** | P<0.001 ** P=0.003 ** P<0.001 ** P=0.157 | |INCIDENTAL TUMOR | P=0.024 * P=0.102 P=0.010 ** P=0.128 | P=0.549 P=0.163 P=0.028 * P=0.948 | |LOGISTIC REGRESSION | P<0.001 ** P=0.110 P<0.001 ** P=0.013 * | P=0.080 P=0.030 * P=0.002 ** P=0.664 | |COCHRAN-ARMITAGE | P<0.001N** | P=0.016N* | |FISHER EXACT | P=0.126 P=0.001 ** P=0.016N* | P=0.127 P=0.127 P=0.112N | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 27/70 (39%) 28/68 (41%) 38/68 (56%) 11/89 (12%) | 16/69 (23%) 20/70 (29%) 19/70 (27%) 3/90 (3%) | |ADJUSTED (b) | 52.4% 80.3% 100.0% 83.0% | 40.3% 75.3% 92.1% 70.0% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 0/10 (0%) 1/10 (10%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 3/10 (30%) 4/10 (40%) 5/7 (71%) | 1/10 (10%) 1/10 (10%) 3/10 (30%) 1/2 (50%) | |TERMINAL (d) | 13/35 (37%) 16/22 (73%) 4/4 (100%) 0/0 | 14/37 (38%) 6/11 (55%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 281 (I) 434 281 (I) 281 (I) | 457 (I) 457 (I) 353 418 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.092 P<0.001 ** P=0.007 ** | P<0.001 ** P<0.001 ** P<0.001 ** P=0.001 ** | |INCIDENTAL TUMOR | P=0.064 P=0.332 P=0.104 P=0.419 | P=0.407 P=0.045 * P=0.005 ** P=0.306 | |LOGISTIC REGRESSION | P=0.106 P=0.361 P=0.029 * P=0.514N | P=0.114 P=0.026 * P=0.001 ** P=0.293 | |COCHRAN-ARMITAGE | P<0.001N** | P<0.001N** | |FISHER EXACT | P=0.445 P=0.031 * P<0.001N** | P=0.298 P=0.367 P<0.001N** | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 27/70 (39%) 28/68 (41%) 38/68 (56%) 11/89 (12%) | 16/69 (23%) 20/70 (29%) 19/70 (27%) 3/90 (3%) | |ADJUSTED (b) | 52.4% 80.3% 100.0% 83.0% | 40.3% 75.3% 92.1% 70.0% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 0/10 (0%) 1/10 (10%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 3/10 (30%) 4/10 (40%) 5/7 (71%) | 1/10 (10%) 1/10 (10%) 3/10 (30%) 1/2 (50%) | |TERMINAL (d) | 13/35 (37%) 16/22 (73%) 4/4 (100%) 0/0 | 14/37 (38%) 6/11 (55%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 281 (I) 434 281 (I) 281 (I) | 457 (I) 457 (I) 353 418 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.092 P<0.001 ** P=0.007 ** | P<0.001 ** P<0.001 ** P<0.001 ** P=0.001 ** | |INCIDENTAL TUMOR | P=0.064 P=0.332 P=0.104 P=0.419 | P=0.407 P=0.045 * P=0.005 ** P=0.306 | |LOGISTIC REGRESSION | P=0.106 P=0.361 P=0.029 * P=0.514N | P=0.114 P=0.026 * P=0.001 ** P=0.293 | |COCHRAN-ARMITAGE | P<0.001N** | P<0.001N** | |FISHER EXACT | P=0.445 P=0.031 * P<0.001N** | P=0.298 P=0.367 P<0.001N** | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/70 (26%) 26/69 (38%) 26/70 (37%) 10/90 (11%) | 4/70 (6%) 20/70 (29%) 18/70 (26%) 19/88 (22%) | |ADJUSTED (b) | 46.9% 74.6% 100.0% 78.1% | 10.5% 66.7% 100.0% 87.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 2/10 (20%) 2/10 (20%) | 0/10 (0%) 0/10 (0%) 2/10 (20%) 1/8 (13%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/10 (10%) 3/10 (30%) 5/7 (71%) | 0/10 (0%) 3/10 (30%) 2/10 (20%) 1/2 (50%) | |TERMINAL (d) | 15/35 (43%) 14/22 (64%) 4/4 (100%) 0/0 | 3/37 (8%) 4/11 (36%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 572 434 281 (I) 251 | 714 443 282 (I) 275 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.002 ** P=0.020 * P=0.004 ** P<0.001 ** | P=0.006 ** P<0.001 ** P=0.011 * P=0.037 * | |LOGISTIC REGRESSION | P=0.007 ** P=0.017 * P=0.004 ** P=0.002 ** | P<0.001 ** P<0.001 ** P<0.001 ** P=0.001 ** | |COCHRAN-ARMITAGE | P<0.001N** | P=0.200 | |FISHER EXACT | P=0.091 P=0.101 P=0.014N* | P<0.001 ** P<0.001 ** P=0.004 ** | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/70 (9%) 13/69 (19%) 24/70 (34%) 6/90 (7%) | 0/70 (0%) 9/70 (13%) 20/70 (29%) 8/88 (9%) | |ADJUSTED (b) | 15.5% 44.0% 94.8% 43.9% | 0.0% 40.8% 100.0% 58.6% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/10 (10%) 2/10 (20%) 2/7 (29%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/2 (0%) | |TERMINAL (d) | 5/35 (14%) 8/22 (36%) 3/4 (75%) 0/0 | 0/37 (0%) 3/11 (27%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 281 (I) 456 (I) 456 (I) 251 | --- 532 373 307 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.010 ** P<0.001 ** P=0.007 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.019 * P<0.001 ** P=0.087 | P=0.065 P=0.004 ** P<0.001 ** P=0.488 | |LOGISTIC REGRESSION | P<0.001 ** P=0.036 * P<0.001 ** P=0.147 | P<0.001 ** P<0.001 ** P<0.001 ** P=0.014 * | |COCHRAN-ARMITAGE | P=0.053N | P=0.434 | |FISHER EXACT | P=0.064 P<0.001 ** P=0.436N | P=0.001 ** P<0.001 ** P=0.008 ** | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/70 (31%) 33/69 (48%) 41/70 (59%) 11/90 (12%) | 4/70 (6%) 27/70 (39%) 30/70 (43%) 24/88 (27%) | |ADJUSTED (b) | 55.5% 88.2% 100.0% 78.7% | 10.5% 79.7% 100.0% 91.1% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 2/10 (20%) 3/10 (30%) | 0/10 (0%) 0/10 (0%) 2/10 (20%) 1/8 (13%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 2/10 (20%) 4/10 (40%) 5/7 (71%) | 0/10 (0%) 3/10 (30%) 3/10 (30%) 1/2 (50%) | |TERMINAL (d) | 18/35 (51%) 18/22 (82%) 4/4 (100%) 0/0 | 3/37 (8%) 6/11 (55%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 281 (I) 434 281 (I) 251 | 714 443 282 (I) 275 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.003 ** P<0.001 ** P=0.002 ** | P=0.001 ** P<0.001 ** P<0.001 ** P=0.019 * | |LOGISTIC REGRESSION | P=0.002 ** P=0.003 ** P<0.001 ** P=0.014 * | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001N** | P=0.218 | |FISHER EXACT | P=0.035 * P=0.001 ** P=0.003N** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |Mammary Gland | | Adenoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 0/90 (0%) | 0/70 (0%) 6/70 (9%) 4/70 (6%) 0/90 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 32.5% 11.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 0/35 (0%) 0/22 (0%) 0/4 (0%) 0/0 | 0/37 (0%) 2/11 (18%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 579 268 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.124 P<0.001 ** P=0.024 * (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.144N P=0.018 * P=0.787 (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.409N P=0.003 ** P=0.132 (e) | |COCHRAN-ARMITAGE | (e) | P=0.084N | |FISHER EXACT | (e) (e) (e) | P=0.014 * P=0.060 (e) | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 0/90 (0%) | 0/70 (0%) 6/70 (9%) 13/70 (19%) 13/90 (14%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 15.9% 41.0% 83.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 2/10 (20%) 1/2 (50%) | |TERMINAL (d) | 0/35 (0%) 0/22 (0%) 0/4 (0%) 0/0 | 0/37 (0%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 392 370 280 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.136 P=0.104 P=0.083 P=0.129 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.002 ** P=0.019 * P<0.001 ** P=0.002 ** | |COCHRAN-ARMITAGE | (e) | P=0.016 * | |FISHER EXACT | (e) (e) (e) | P=0.014 * P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |Mammary Gland | | Mixed Tumor Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 0/90 (0%) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 4/90 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 23.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 0/35 (0%) 0/22 (0%) 0/4 (0%) 0/0 | 0/37 (0%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- --- 335 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P<0.001 ** (e) (e) P=0.002 ** | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.094 (e) (e) P=0.834 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.020 * (e) (e) P=0.159 | |COCHRAN-ARMITAGE | (e) | P=0.006 ** | |FISHER EXACT | (e) (e) (e) | (e) (e) P=0.097 | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Mesentery | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 2/70 (3%) 0/70 (0%) 0/90 (0%) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 0/90 (0%) | |ADJUSTED (b) | 0.0% 8.2% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 0/35 (0%) 1/22 (5%) 0/4 (0%) 0/0 | 0/37 (0%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- 707 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.985 P=0.158 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.987N P=0.255 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.986 P=0.178 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.329N | (e) | |FISHER EXACT | P=0.248 (e) (e) | (e) (e) (e) | |=================================================================================================================================| | | |Ovary | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/69 (3%) 3/70 (4%) 1/70 (1%) 1/89 (1%) | |ADJUSTED (b) | | 5.6% 15.5% 7.7% 1.3% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | | 2/36 (6%) 1/11 (9%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | | 733 (T) 457 (I) 543 257 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.144 P=0.159 P=0.242 P=0.522 | |INCIDENTAL TUMOR | | P=0.624N P=0.277 P=0.967 (e) | |LOGISTIC REGRESSION | | P=0.662 P=0.375 P=0.619 P=0.825 | |COCHRAN-ARMITAGE | | P=0.221N | |FISHER EXACT | | P=0.507 P=0.495N P=0.405N | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 1/69 (1%) 7/70 (10%) 10/70 (14%) 7/89 (8%) | |ADJUSTED (b) | | 2.8% 29.8% 100.0% 62.1% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 1/10 (10%) 3/10 (30%) 1/2 (50%) | |TERMINAL (d) | | 1/36 (3%) 1/11 (9%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | | 733 (T) 457 (I) 282 (I) 311 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | | P=0.018 * P=0.053 P=0.005 ** P=0.166 | |LOGISTIC REGRESSION | | P=0.037 * P=0.013 * P=0.003 ** P=0.055 | |COCHRAN-ARMITAGE | | P=0.374 | |FISHER EXACT | | P=0.033 * P=0.005 ** P=0.068 | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/69 (0%) 3/70 (4%) 3/70 (4%) 0/89 (0%) | |ADJUSTED (b) | | 0.0% 19.3% 55.3% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/2 (0%) | |TERMINAL (d) | | 0/36 (0%) 1/11 (9%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | | --- 645 457 (I) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.040 * P=0.018 * P=0.005 ** (e) | |INCIDENTAL TUMOR | | P=0.229 P=0.133 P=0.111 (e) | |LOGISTIC REGRESSION | | P=0.479 P=0.042 * P=0.038 * (e) | |COCHRAN-ARMITAGE | | P=0.215N | |FISHER EXACT | | P=0.125 P=0.125 (e) | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor, Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 1/69 (1%) 10/70 (14%) 13/70 (19%) 7/89 (8%) | |ADJUSTED (b) | | 2.8% 43.9% 100.0% 62.1% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 1/10 (10%) 4/10 (40%) 1/2 (50%) | |TERMINAL (d) | | 1/36 (3%) 2/11 (18%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | | 733 (T) 457 (I) 282 (I) 311 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | | P=0.006 ** P=0.008 ** P<0.001 ** P=0.166 | |LOGISTIC REGRESSION | | P=0.018 * P<0.001 ** P<0.001 ** P=0.055 | |COCHRAN-ARMITAGE | | P=0.534N | |FISHER EXACT | | P=0.005 ** P<0.001 ** P=0.068 | |=================================================================================================================================| | | |Ovary | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 1/69 (1%) 2/70 (3%) 0/70 (0%) 0/89 (0%) | |ADJUSTED (b) | | 2.8% 6.6% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | | 1/36 (3%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | | 733 (T) 594 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.988 P=0.282 (e) (e) | |INCIDENTAL TUMOR | | P=0.865N P=0.557 (e) (e) | |LOGISTIC REGRESSION | | P=0.732N P=0.417 (e) (e) | |COCHRAN-ARMITAGE | | P=0.177N | |FISHER EXACT | | P=0.505 P=0.496N P=0.437N | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Mixed Tumor Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/69 (0%) 2/70 (3%) 6/70 (9%) 1/89 (1%) | |ADJUSTED (b) | | 0.0% 13.6% 100.0% 2.5% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/2 (0%) | |TERMINAL (d) | | 0/36 (0%) 1/11 (9%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | | --- 664 457 (I) 328 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P<0.001 ** P=0.067 P<0.001 ** P=0.419 | |INCIDENTAL TUMOR | | P=0.441 P=0.186 P=0.067 (e) | |LOGISTIC REGRESSION | | P=0.321 P=0.128 P=0.005 ** P=0.785 | |COCHRAN-ARMITAGE | | P=0.462N | |FISHER EXACT | | P=0.252 P=0.015 * P=0.563 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/70 (1%) 0/68 (0%) 0/66 (0%) 0/79 (0%) | 7/70 (10%) 4/67 (6%) 0/68 (0%) 0/81 (0%) | |ADJUSTED (b) | 2.9% 0.0% 0.0% 0.0% | 17.4% 24.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 1/35 (3%) 0/22 (0%) 0/4 (0%) 0/0 | 5/37 (14%) 2/11 (18%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 733 (T) --- --- --- | 625 594 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=1.000N P=0.593N P=0.905N (e) | P=0.948 P=0.378 P=0.861N (e) | |INCIDENTAL TUMOR | P=1.000N P=0.593N P=0.905N (e) | P=0.613N P=0.544N P=0.254N (e) | |LOGISTIC REGRESSION | P=1.000N P=0.593N P=0.905N (e) | P=0.501N P=0.624N P=0.343N P=0.845N | |COCHRAN-ARMITAGE | P=0.463N | P=0.004N** | |FISHER EXACT | P=0.507N P=0.515N P=0.470N | P=0.292N P=0.007N** P=0.004N** | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/70 (1%) 1/68 (1%) 0/66 (0%) 0/79 (0%) | 7/70 (10%) 4/67 (6%) 0/68 (0%) 0/81 (0%) | |ADJUSTED (b) | 2.9% 2.2% 0.0% 0.0% | 17.4% 24.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 1/35 (3%) 0/22 (0%) 0/4 (0%) 0/0 | 5/37 (14%) 2/11 (18%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 733 (T) 464 --- --- | 625 594 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.944N P=0.699 P=0.905N (e) | P=0.948 P=0.378 P=0.861N (e) | |INCIDENTAL TUMOR | P=0.563N P=0.759 P=0.905N (e) | P=0.613N P=0.544N P=0.254N (e) | |LOGISTIC REGRESSION | P=0.503N P=0.753 P=0.905N (e) | P=0.501N P=0.624N P=0.343N P=0.845N | |COCHRAN-ARMITAGE | P=0.289N | P=0.004N** | |FISHER EXACT | P=0.745 P=0.515N P=0.470N | P=0.292N P=0.007N** P=0.004N** | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/70 (0%) 3/70 (4%) 0/90 (0%) | 1/70 (1%) 2/70 (3%) 2/70 (3%) 2/90 (2%) | |ADJUSTED (b) | 0.0% 0.0% 11.7% 0.0% | 2.7% 13.2% 21.4% 5.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 0/35 (0%) 0/22 (0%) 0/4 (0%) 0/0 | 1/37 (3%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- --- 530 --- | 733 (T) 665 569 328 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.101 (e) P=0.051 (e) | P<0.001 ** P=0.173 P=0.014 * P=0.130 | |INCIDENTAL TUMOR | P=0.697 (e) P=0.419 (e) | P=0.387 P=0.583 P=0.371 (e) | |LOGISTIC REGRESSION | P=0.640 (e) P=0.094 (e) | P=0.120 P=0.292 P=0.166 P=0.523 | |COCHRAN-ARMITAGE | P=0.560N | P=0.605 | |FISHER EXACT | (e) P=0.122 (e) | P=0.500 P=0.500 P=0.594 | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 0/70 (0%) 0/70 (0%) 0/90 (0%) | 1/70 (1%) 5/70 (7%) 3/70 (4%) 4/90 (4%) | |ADJUSTED (b) | 2.3% 0.0% 0.0% 0.0% | 2.4% 20.3% 43.0% 58.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/2 (50%) | |TERMINAL (d) | 0/35 (0%) 0/22 (0%) 0/4 (0%) 0/0 | 0/37 (0%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 572 --- --- --- | 677 597 524 316 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.964N P=0.529N P=0.597N (e) | P<0.001 ** P=0.017 * P=0.002 ** P=0.001 ** | |INCIDENTAL TUMOR | P=0.794N P=0.419N P=0.169N (e) | P=0.027 * P=0.399 P=0.380 P=0.177 | |LOGISTIC REGRESSION | P=0.631N P=0.499N P=0.518N P=0.821N | P=0.004 ** P=0.424 P=0.074 P=0.163 | |COCHRAN-ARMITAGE | P=0.444N | P=0.515 | |FISHER EXACT | P=0.500N P=0.500N P=0.438N | P=0.104 P=0.310 P=0.272 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 0/70 (0%) 0/70 (0%) 0/90 (0%) | 1/70 (1%) 5/70 (7%) 3/70 (4%) 4/90 (4%) | |ADJUSTED (b) | 2.3% 0.0% 0.0% 0.0% | 2.4% 20.3% 43.0% 58.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/2 (50%) | |TERMINAL (d) | 0/35 (0%) 0/22 (0%) 0/4 (0%) 0/0 | 0/37 (0%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 572 --- --- --- | 677 597 524 316 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.964N P=0.529N P=0.597N (e) | P<0.001 ** P=0.017 * P=0.002 ** P=0.001 ** | |INCIDENTAL TUMOR | P=0.794N P=0.419N P=0.169N (e) | P=0.027 * P=0.399 P=0.380 P=0.177 | |LOGISTIC REGRESSION | P=0.631N P=0.499N P=0.518N P=0.821N | P=0.004 ** P=0.424 P=0.074 P=0.163 | |COCHRAN-ARMITAGE | P=0.444N | P=0.515 | |FISHER EXACT | P=0.500N P=0.500N P=0.438N | P=0.104 P=0.310 P=0.272 | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 0/70 (0%) 0/70 (0%) 0/90 (0%) | 1/70 (1%) 5/70 (7%) 3/70 (4%) 3/90 (3%) | |ADJUSTED (b) | 2.3% 0.0% 0.0% 0.0% | 2.4% 20.3% 43.0% 16.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 0/35 (0%) 0/22 (0%) 0/4 (0%) 0/0 | 0/37 (0%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 572 --- --- --- | 677 597 524 316 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.964N P=0.529N P=0.597N (e) | P<0.001 ** P=0.017 * P=0.002 ** P=0.011 * | |INCIDENTAL TUMOR | P=0.794N P=0.419N P=0.169N (e) | P=0.176 P=0.399 P=0.380 P=0.834 | |LOGISTIC REGRESSION | P=0.631N P=0.499N P=0.518N P=0.821N | P=0.026 * P=0.424 P=0.074 P=0.353 | |COCHRAN-ARMITAGE | P=0.444N | P=0.507N | |FISHER EXACT | P=0.500N P=0.500N P=0.438N | P=0.104 P=0.310 P=0.410 | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/68 (0%) 1/66 (2%) 0/87 (0%) | 2/69 (3%) 0/68 (0%) 0/70 (0%) 1/88 (1%) | |ADJUSTED (b) | 0.0% 0.0% 3.0% 0.0% | 5.4% 0.0% 0.0% 10.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 0/35 (0%) 0/22 (0%) 0/4 (0%) 0/0 | 2/37 (5%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- --- 568 --- | 733 (T) --- --- 418 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.866 (e) P=0.443 (e) | P=0.038 * P=0.528N (e) P=0.157 | |INCIDENTAL TUMOR | P=0.980 (e) P=0.823 (e) | P=0.397 P=0.528N (e) P=0.948 | |LOGISTIC REGRESSION | P=0.877 (e) P=0.476 (e) | P=0.300 P=0.528N (e) P=0.596 | |COCHRAN-ARMITAGE | P=0.741N | P=0.583N | |FISHER EXACT | (e) P=0.485 (e) | P=0.252N P=0.245N P=0.409N | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/70 (0%) 2/70 (3%) 4/90 (4%) | 0/70 (0%) 1/70 (1%) 1/70 (1%) 7/90 (8%) | |ADJUSTED (b) | 0.0% 0.0% 7.7% 36.6% | 0.0% 8.3% 3.8% 75.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/7 (29%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/2 (50%) | |TERMINAL (d) | 0/35 (0%) 0/22 (0%) 0/4 (0%) 0/0 | 0/37 (0%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- --- 456 (I) 302 | --- 723 472 275 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** (e) P=0.148 P=0.007 ** | P<0.001 ** P=0.277 P=0.374 P<0.001 ** | |INCIDENTAL TUMOR | P=0.006 ** (e) P=0.401 P=0.087 | P=0.001 ** P=0.682 P=0.967 P=0.141 | |LOGISTIC REGRESSION | P=0.015 * (e) P=0.238 P=0.041 * | P<0.001 ** P=0.329 P=0.561 P=0.015 * | |COCHRAN-ARMITAGE | P=0.027 * | P=0.002 ** | |FISHER EXACT | (e) P=0.248 P=0.097 | P=0.500 P=0.500 P=0.016 * | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 1/70 (1%) 9/70 (13%) 8/90 (9%) | 0/70 (0%) 3/70 (4%) 6/70 (9%) 23/90 (26%) | |ADJUSTED (b) | 2.5% 4.5% 55.4% 58.7% | 0.0% 18.2% 100.0% 92.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 3/7 (43%) | 0/10 (0%) 1/10 (10%) 2/10 (20%) 1/2 (50%) | |TERMINAL (d) | 0/35 (0%) 1/22 (5%) 1/4 (25%) 0/0 | 0/37 (0%) 1/11 (9%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 652 733 (T) 456 (I) 281 (I) | --- 457 (I) 457 (I) 246 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.679 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.026 * P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.745N P=0.050 * P=0.005 ** | P<0.001 ** P=0.092 P=0.072 P=0.041 * | |LOGISTIC REGRESSION | P<0.001 ** P=0.723 P=0.002 ** P=0.010 * | P<0.001 ** P=0.086 P=0.012 * P<0.001 ** | |COCHRAN-ARMITAGE | P=0.037 * | P<0.001 ** | |FISHER EXACT | P=0.752N P=0.009 ** P=0.041 * | P=0.122 P=0.014 * P<0.001 ** | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 1/70 (1%) 7/70 (10%) 4/90 (4%) | 0/70 (0%) 2/70 (3%) 5/70 (7%) 16/90 (18%) | |ADJUSTED (b) | 2.5% 4.5% 51.7% 30.3% | 0.0% 10.8% 100.0% 67.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/7 (14%) | 0/10 (0%) 1/10 (10%) 2/10 (20%) 0/2 (0%) | |TERMINAL (d) | 0/35 (0%) 1/22 (5%) 1/4 (25%) 0/0 | 0/37 (0%) 1/11 (9%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 652 733 (T) 530 281 (I) | --- 457 (I) 457 (I) 246 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.679 P<0.001 ** P=0.005 ** | P<0.001 ** P=0.119 P=0.002 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.745N P=0.100 P=0.060 | P<0.001 ** P=0.119 P=0.076 P=0.399 | |LOGISTIC REGRESSION | P<0.001 ** P=0.723 P=0.005 ** P=0.093 | P<0.001 ** P=0.224 P=0.021 * P=0.002 ** | |COCHRAN-ARMITAGE | P=0.284 | P<0.001 ** | |FISHER EXACT | P=0.752N P=0.031 * P=0.272 | P=0.248 P=0.029 * P<0.001 ** | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/70 (3%) 4/68 (6%) 2/67 (3%) 0/87 (0%) | 1/70 (1%) 2/69 (3%) 2/69 (3%) 1/88 (1%) | |ADJUSTED (b) | 5.7% 17.4% 12.5% 0.0% | 2.4% 11.5% 100.0% 3.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 2/35 (6%) 3/22 (14%) 0/4 (0%) 0/0 | 0/37 (0%) 1/11 (9%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 733 (T) 716 623 --- | 677 569 569 353 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.250 P=0.155 P=0.163 (e) | P=0.004 ** P=0.249 P=0.005 ** P=0.368 | |INCIDENTAL TUMOR | P=0.774 P=0.216 P=0.728 (e) | P=0.470 P=0.567 P=0.404 (e) | |LOGISTIC REGRESSION | P=0.575 P=0.182 P=0.394 (e) | P=0.287 P=0.401 P=0.110 P=0.801 | |COCHRAN-ARMITAGE | P=0.060N | P=0.424N | |FISHER EXACT | P=0.327 P=0.674 P=0.197N | P=0.495 P=0.495 P=0.691N | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/70 (0%) 2/70 (3%) 1/70 (1%) 0/90 (0%) | |ADJUSTED (b) | | 0.0% 18.2% 50.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | | 0/37 (0%) 2/11 (18%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | | --- 733 (T) 695 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.144 P=0.038 * P=0.016 * (e) | |INCIDENTAL TUMOR | | P=0.386 P=0.038 * P=0.362 (e) | |LOGISTIC REGRESSION | | P=0.307 P=0.038 * P=0.090 (e) | |COCHRAN-ARMITAGE | | P=0.318N | |FISHER EXACT | | P=0.248 P=0.500 (e) | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 4/70 (6%) 3/70 (4%) 1/70 (1%) 4/90 (4%) | |ADJUSTED (b) | | 7.6% 6.5% 50.0% 100.0% | |INTERIM SACRIFICE 1 (c)| | 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 2/10 (20%) 0/10 (0%) 2/2 (100%) | |TERMINAL (d) | | 1/37 (3%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | | 282 (I) 457 (I) 695 319 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.004 ** P=0.640N P=0.685N P=0.050 * | |INCIDENTAL TUMOR | | P=0.121 P=0.466N P=0.310N P=0.346 | |LOGISTIC REGRESSION | | P=0.605 P=0.419N P=0.146N P=0.502N | |COCHRAN-ARMITAGE | | P=0.553N | |FISHER EXACT | | P=0.500N P=0.183N P=0.494N | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 4/70 (6%) 4/70 (6%) 1/70 (1%) 4/90 (4%) | |ADJUSTED (b) | | 7.6% 10.0% 50.0% 100.0% | |INTERIM SACRIFICE 1 (c)| | 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 2/10 (20%) 0/10 (0%) 2/2 (100%) | |TERMINAL (d) | | 1/37 (3%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | | 282 (I) 457 (I) 695 319 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.004 ** P=0.478 P=0.685N P=0.050 * | |INCIDENTAL TUMOR | | P=0.138 P=0.564N P=0.310N P=0.346 | |LOGISTIC REGRESSION | | P=0.618 P=0.573N P=0.146N P=0.502N | |COCHRAN-ARMITAGE | | P=0.469N | |FISHER EXACT | | P=0.641N P=0.183N P=0.494N | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 0/70 (0%) 0/70 (0%) 0/90 (0%) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 2/90 (2%) | |ADJUSTED (b) | 2.9% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 37.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 1/35 (3%) 0/22 (0%) 0/4 (0%) 0/0 | 0/37 (0%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 733 (T) --- --- --- | --- --- --- 387 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=1.000N P=0.593N P=0.905N (e) | P<0.001 ** (e) (e) P=0.004 ** | |INCIDENTAL TUMOR | P=1.000N P=0.593N P=0.905N (e) | P=0.110 (e) (e) P=0.834 | |LOGISTIC REGRESSION | P=1.000N P=0.593N P=0.905N (e) | P=0.073 (e) (e) P=0.287 | |COCHRAN-ARMITAGE | P=0.444N | P=0.067 | |FISHER EXACT | P=0.500N P=0.500N P=0.438N | (e) (e) P=0.315 | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 4/70 (6%) 0/70 (0%) 0/90 (0%) | 2/70 (3%) 4/70 (6%) 1/70 (1%) 0/90 (0%) | |ADJUSTED (b) | 2.9% 17.0% 0.0% 0.0% | 5.1% 16.3% 2.1% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 1/35 (3%) 3/22 (14%) 0/4 (0%) 0/0 | 1/37 (3%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 733 (T) 707 --- --- | 708 594 411 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.892 P=0.075 P=0.905N (e) | P=0.554 P=0.078 P=0.455 (e) | |INCIDENTAL TUMOR | P=0.937 P=0.111 P=0.905N (e) | P=0.411N P=0.592 P=0.666N (e) | |LOGISTIC REGRESSION | P=0.922 P=0.091 P=0.905N (e) | P=0.487N P=0.195 P=0.780N (e) | |COCHRAN-ARMITAGE | P=0.084N | P=0.054N | |FISHER EXACT | P=0.183 P=0.500N P=0.438N | P=0.340 P=0.500N P=0.190N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 7/70 (10%) 25/70 (36%) 7/90 (8%) | 3/70 (4%) 5/70 (7%) 24/70 (34%) 29/90 (32%) | |ADJUSTED (b) | 2.9% 26.6% 94.4% 55.9% | 8.1% 31.8% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 3/7 (43%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/2 (100%) | |TERMINAL (d) | 1/35 (3%) 4/22 (18%) 3/4 (75%) 0/0 | 3/37 (8%) 2/11 (18%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 733 (T) 649 456 (I) 289 | 733 (T) 649 343 307 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.021 * P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.023 * P<0.001 ** P=0.018 * | P<0.001 ** P=0.149 P=0.002 ** P=0.004 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.012 * P<0.001 ** P=0.003 ** | P<0.001 ** P=0.075 P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.520N | P<0.001 ** | |FISHER EXACT | P=0.031 * P<0.001 ** P=0.067 | P=0.359 P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/70 (3%) 11/70 (16%) 25/70 (36%) 7/90 (8%) | 5/70 (7%) 9/70 (13%) 25/70 (36%) 29/90 (32%) | |ADJUSTED (b) | 5.7% 41.3% 94.4% 55.9% | 13.0% 42.9% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 3/7 (43%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/2 (100%) | |TERMINAL (d) | 2/35 (6%) 7/22 (32%) 3/4 (75%) 0/0 | 4/37 (11%) 2/11 (18%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 733 (T) 649 456 (I) 289 | 708 594 343 307 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.003 ** P<0.001 ** P=0.018 * | P<0.001 ** P=0.165 P=0.005 ** P=0.004 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.001 ** P<0.001 ** P=0.004 ** | P<0.001 ** P=0.027 * P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.281N | P<0.001 ** | |FISHER EXACT | P=0.008 ** P<0.001 ** P=0.161 | P=0.199 P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 5/70 (7%) 7/70 (10%) 4/90 (4%) | 3/70 (4%) 4/70 (6%) 7/70 (10%) 4/90 (4%) | |ADJUSTED (b) | 0.0% 14.0% 31.4% 8.0% | 6.9% 17.7% 27.4% 9.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/2 (0%) | |TERMINAL (d) | 0/35 (0%) 1/22 (5%) 0/4 (0%) 0/0 | 0/37 (0%) 0/11 (0%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- 398 288 120 | 485 524 344 300 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.021 * P<0.001 ** P=0.044 * | P<0.001 ** P=0.195 P=0.002 ** P=0.027 * | |INCIDENTAL TUMOR | P=0.463N P=0.046 * P=0.184 (e) | P=0.052N P=0.168N P=0.320N P=0.166N | |LOGISTIC REGRESSION | P=0.488 P=0.032 * P=0.009 ** P=0.801 | P=0.432 P=0.425 P=0.146 P=0.634 | |COCHRAN-ARMITAGE | P=0.492 | P=0.457N | |FISHER EXACT | P=0.029 * P=0.007 ** P=0.097 | P=0.500 P=0.163 P=0.637 | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/70 (6%) 11/70 (16%) 9/70 (13%) 58/90 (64%) | 10/70 (14%) 11/70 (16%) 17/70 (24%) 37/90 (41%) | |ADJUSTED (b) | 9.8% 29.0% 33.3% 84.7% | 21.9% 47.0% 55.9% 65.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/8 (13%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/7 (29%) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/2 (0%) | |TERMINAL (d) | 1/35 (3%) 2/22 (9%) 0/4 (0%) 0/0 | 3/37 (8%) 3/11 (27%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 511 200 171 120 | 457 (I) 407 205 189 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.022 * P=0.005 ** P<0.001 ** | P<0.001 ** P=0.041 * P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.001 ** P=0.167 P=0.478N P=0.022 * | P=0.317N P=0.266N P=0.236N P=0.624N | |LOGISTIC REGRESSION | P<0.001 ** P=0.044 * P=0.155 P<0.001 ** | P<0.001 ** P=0.319 P=0.072 P=0.057 | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P=0.049 * P=0.122 P<0.001 ** | P=0.500 P=0.099 P<0.001 ** | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/70 (6%) 6/70 (9%) 2/70 (3%) 54/90 (60%) | 7/70 (10%) 7/70 (10%) 10/70 (14%) 33/90 (37%) | |ADJUSTED (b) | 9.8% 17.2% 2.9% 83.4% | 16.0% 35.6% 39.2% 61.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/8 (13%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/7 (29%) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/2 (0%) | |TERMINAL (d) | 1/35 (3%) 1/22 (5%) 0/4 (0%) 0/0 | 3/37 (8%) 3/11 (27%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 511 200 171 161 | 457 (I) 407 205 189 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.238 P=0.628 P<0.001 ** | P<0.001 ** P=0.110 P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.594N P=0.049N* P=0.022 * | P=0.325 P=0.596N P=0.472N P=0.442 | |LOGISTIC REGRESSION | P<0.001 ** P=0.352 P=0.266N P<0.001 ** | P<0.001 ** P=0.445 P=0.264 P=0.060 | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P=0.372 P=0.340N P<0.001 ** | P=0.610N P=0.303 P<0.001 ** | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 26 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 42/70 (60%) 45/70 (64%) 52/70 (74%) 21/90 (23%) | 33/70 (47%) 44/70 (63%) 47/70 (67%) 41/90 (46%) | |ADJUSTED (b) | 81.5% 100.0% 100.0% 94.4% | 69.1% 97.6% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 0/10 (0%) 3/10 (30%) 3/10 (30%) | 2/10 (20%) 0/10 (0%) 2/10 (20%) 2/8 (25%) | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 6/10 (60%) 6/10 (60%) 6/7 (86%) | 3/10 (30%) 6/10 (60%) 9/10 (90%) 2/2 (100%) | |TERMINAL (d) | 26/35 (74%) 22/22 (100%) 4/4 (100%) 0/0 | 23/37 (62%) 10/11 (91%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 281 (I) 434 281 (I) 251 | 282 (I) 443 282 (I) 246 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.004 ** P=0.117 P=0.016 * P=0.050 | P=0.001 ** P=0.003 ** P<0.001 ** P=0.050 * | |LOGISTIC REGRESSION | P=0.018 * P=0.128 P=0.001 ** P=0.138 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001N** | P=0.083N | |FISHER EXACT | P=0.364 P=0.052 P<0.001N** | P=0.044 * P=0.013 * P=0.484N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 20/70 (29%) 43/70 (61%) 50/70 (71%) 66/90 (73%) | 16/70 (23%) 42/70 (60%) 56/70 (80%) 74/90 (82%) | |ADJUSTED (b) | 43.3% 91.1% 100.0% 97.5% | 35.0% 92.8% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 2/10 (20%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/8 (13%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/10 (10%) 4/10 (40%) 6/7 (86%) | 1/10 (10%) 0/10 (0%) 7/10 (70%) 2/2 (100%) | |TERMINAL (d) | 10/35 (29%) 18/22 (82%) 4/4 (100%) 0/0 | 8/37 (22%) 8/11 (73%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 281 (I) 200 171 120 | 457 (I) 392 205 189 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** P=0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P=0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 27 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 62.5 PPM 200 PPM 625 PPM | CONTROL 62.5 PPM 200 PPM 625 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 51/70 (73%) 54/70 (77%) 58/70 (83%) 74/90 (82%) | 40/70 (57%) 54/70 (77%) 61/70 (87%) 77/90 (86%) | |ADJUSTED (b) | 90.8% 100.0% 100.0% 100.0% | 77.9% 100.0% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 5/10 (50%) 0/10 (0%) 3/10 (30%) 5/10 (50%) | 2/10 (20%) 0/10 (0%) 2/10 (20%) 3/8 (38%) | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 6/10 (60%) 6/10 (60%) 7/7 (100%) | 3/10 (30%) 6/10 (60%) 10/10 (100%) 2/2 (100%) | |TERMINAL (d) | 30/35 (86%) 22/22 (100%) 4/4 (100%) 0/0 | 26/37 (70%) 11/11 (100%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 281 (I) 200 171 120 | 282 (I) 392 205 189 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.001 ** P=0.281 P=0.172 P=0.020 * | P<0.001 ** P=0.006 ** P<0.001 ** P=0.025 * | |LOGISTIC REGRESSION | P<0.001 ** P=0.114 P=0.006 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.127 | P<0.001 ** | |FISHER EXACT | P=0.348 P=0.111 P=0.110 | P=0.009 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 281 456 Female interim sacrifices(days): 282 457 (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's exact tests compare directly the overall incidence rates. For all tests, a negative trend is indicated by "N". (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01). NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest 1,3 BUTADIENE (BUTADIENE) DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 TIME: 14:36:36 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES5510500 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 50602C PATHOLOGIST: R. MILLER CAS: 106-99-0 ------------------------------------------------------------------------------------------------------------------------------------ STOP EXPOSURES REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 CONTROL INCLUDE 013 200 PPM SE40 INCLUDE 014 312 PPM SE52 INCLUDE 015 625 PPM SE13 INCLUDE 016 625 PPM SE 26 NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest 1,3 BUTADIENE (BUTADIENE) DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 TIME: 14:36:36 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES5510500 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 50602C PATHOLOGIST: R. MILLER CAS: 106-99-0 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 Epididymis Gallbladder Heart Islets, Pancreatic Kidney Larynx Liver Lung Nose 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 1,3 BUTADIENE (BUTADIENE) DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 TIME: 14:36:36 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES5510500 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 50602C PATHOLOGIST: R. MILLER CAS: 106-99-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF 1,3 BUTADIENE (BUTADIENE) ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign All Organs Hemangioma Hemangiosarcoma Hemangiosarcoma or Hemangioma Histiocytic Sarcoma Malignant Lymphoma And Histiocytic Sarcoma Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant Tumors Malignant and Benign Tumors Brain Glioma Malignant Neuroblastoma Malignant Clitoral/Preputial Gland Carcinoma Carcinoma or Adenoma Harderian Gland Adenoma Carcinoma Carcinoma or Adenoma Heart Hemangiosarcoma Kidney: Renal Tubule 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 Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Mesentery Hemangioma Stomach, Forestomach Squamous Cell Carcinoma Squamous Cell Carcinoma or Papilloma Squamous Squamous Cell Papilloma Thyroid Gland: Follicular Cell Adenoma Zymbal's Gland Carcinoma Carcinoma or Adenoma ==================================================================================================== DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |Adrenal Cortex | | Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/70 (3%) 1/45 (2%) 0/49 (0%) 1/100 (1%) | |ADJUSTED (b) | 5.1% 5.0% 0.0% 4.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 1/35 (3%) 0/9 (0%) 0/1 (0%) 0/5 (0%) | |FIRST INCIDENCE (DAYS) | 596 651 --- 566 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.533 P=0.701 P=0.716N P=0.654 | |INCIDENTAL TUMOR | P=0.322N P=0.435N P=0.274N P=0.327N | |LOGISTIC REGRESSION | P=0.508N P=0.678N P=0.487N P=0.639N | |COCHRAN-ARMITAGE | P=0.255N | |FISHER EXACT | P=0.662N P=0.344N P=0.368N | |==============================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/70 (0%) 0/45 (0%) 1/48 (2%) 2/97 (2%) | |ADJUSTED (b) | 0.0% 0.0% 3.3% 23.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 0/35 (0%) 0/9 (0%) 0/1 (0%) 1/5 (20%) | |FIRST INCIDENCE (DAYS) | --- --- 449 567 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.017 * (e) P=0.365 P=0.039 * | |INCIDENTAL TUMOR | P=0.061 (e) P=0.781 P=0.138 | |LOGISTIC REGRESSION | P=0.078 (e) P=0.466 P=0.116 | |COCHRAN-ARMITAGE | P=0.164 | |FISHER EXACT | (e) P=0.407 P=0.336 | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |Bone Marrow | | Mast Cell Tumor NOS | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/70 (1%) 3/50 (6%) 1/49 (2%) 1/97 (1%) | |ADJUSTED (b) | 2.4% 15.6% 20.0% 2.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 0/35 (0%) 0/9 (0%) 0/1 (0%) 0/5 (0%) | |FIRST INCIDENCE (DAYS) | 609 555 649 429 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.356 P=0.117 P=0.348 P=0.646 | |INCIDENTAL TUMOR | P=0.287N P=0.669 P=0.679N P=0.439N | |LOGISTIC REGRESSION | P=0.570N P=0.179 P=0.593 P=0.738N | |COCHRAN-ARMITAGE | P=0.344N | |FISHER EXACT | P=0.195 P=0.656 P=0.664N | |==============================================================================| | | |Brain | | Glioma Malignant | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/70 (0%) 0/50 (0%) 0/50 (0%) 3/100 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 14.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 0/35 (0%) 0/9 (0%) 0/1 (0%) 0/5 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 544 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.005 ** (e) (e) P=0.037 * | |INCIDENTAL TUMOR | P=0.029 * (e) (e) P=0.334 | |LOGISTIC REGRESSION | P=0.011 * (e) (e) P=0.078 | |COCHRAN-ARMITAGE | P=0.044 * | |FISHER EXACT | (e) (e) P=0.201 | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |Brain | | Neuroblastoma Malignant | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/70 (0%) 0/50 (0%) 0/50 (0%) 2/100 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 6.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 0/35 (0%) 0/9 (0%) 0/1 (0%) 0/5 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 342 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.039 * (e) (e) P=0.165 | |INCIDENTAL TUMOR | P=0.280 (e) (e) P=0.805 | |LOGISTIC REGRESSION | P=0.118 (e) (e) P=0.341 | |COCHRAN-ARMITAGE | P=0.107 | |FISHER EXACT | (e) (e) P=0.345 | |==============================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/27 (0%) 1/8 (13%) 4/4 (100%) 7/16 (44%) | |ADJUSTED (b) | 0.0% 10.0% 100.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 1/1 (100%) 0/0 | |FIRST INCIDENCE (DAYS) | --- 699 639 520 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P=0.247 P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.183 P=0.718 P=0.028 * P=0.545 | |LOGISTIC REGRESSION | P<0.001 ** P=0.421 P=0.001 ** P=0.002 ** | |COCHRAN-ARMITAGE | P<0.001 ** | |FISHER EXACT | P=0.229 P<0.001 ** P<0.001 ** | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/27 (0%) 1/8 (13%) 4/4 (100%) 8/16 (50%) | |ADJUSTED (b) | 0.0% 10.0% 100.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 0/5 (0%) 0/2 (0%) 1/1 (100%) 0/0 | |FIRST INCIDENCE (DAYS) | --- 699 639 520 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P=0.247 P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.128 P=0.718 P=0.028 * P=0.455 | |LOGISTIC REGRESSION | P<0.001 ** P=0.421 P=0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | |FISHER EXACT | P=0.229 P<0.001 ** P<0.001 ** | |==============================================================================| | | |Harderian Gland | | Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 6/70 (9%) 26/50 (52%) 28/50 (56%) 33/100 (33%) | |ADJUSTED (b) | 14.8% 87.9% 100.0% 95.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 2/35 (6%) 6/9 (67%) 1/1 (100%) 4/5 (80%) | |FIRST INCIDENCE (DAYS) | 543 440 344 306 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P=0.002 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.020 * | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |Harderian Gland | | Carcinoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 0/70 (0%) 2/50 (4%) 2/50 (4%) 4/100 (4%) | |ADJUSTED (b) | 0.0% 5.6% 51.5% 38.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 0/35 (0%) 0/9 (0%) 0/1 (0%) 1/5 (20%) | |FIRST INCIDENCE (DAYS) | --- 510 441 567 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.002 ** P=0.182 P=0.021 * P<0.001 ** | |INCIDENTAL TUMOR | P=0.049 * P=0.437 P=0.347 P=0.049 * | |LOGISTIC REGRESSION | P=0.022 * P=0.168 P=0.127 P=0.007 ** | |COCHRAN-ARMITAGE | P=0.141 | |FISHER EXACT | P=0.172 P=0.172 P=0.117 | |==============================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 6/70 (9%) 27/50 (54%) 30/50 (60%) 36/100 (36%) | |ADJUSTED (b) | 14.8% 88.3% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 2/35 (6%) 6/9 (67%) 1/1 (100%) 5/5 (100%) | |FIRST INCIDENCE (DAYS) | 543 440 344 306 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.008 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |Heart | | Hemangiosarcoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/70 (0%) 15/50 (30%) 33/50 (66%) 20/100 (20%) | |ADJUSTED (b) | 0.0% 76.2% 100.0% 73.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 0/35 (0%) 5/9 (56%) 1/1 (100%) 2/5 (40%) | |FIRST INCIDENCE (DAYS) | --- 330 328 306 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.082 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.028 * | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | |==============================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/70 (0%) 4/48 (8%) 3/49 (6%) 2/100 (2%) | |ADJUSTED (b) | 0.0% 17.4% 27.8% 16.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 0/35 (0%) 0/9 (0%) 0/1 (0%) 0/5 (0%) | |FIRST INCIDENCE (DAYS) | --- 516 539 440 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.089 P=0.016 * P=0.007 ** P=0.073 | |INCIDENTAL TUMOR | P=0.550N P=0.234 P=0.275 P=0.410 | |LOGISTIC REGRESSION | P=0.314 P=0.026 * P=0.044 * P=0.203 | |COCHRAN-ARMITAGE | P=0.562 | |FISHER EXACT | P=0.025 * P=0.067 P=0.345 | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |Liver | | Hemangiosarcoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/70 (0%) 0/49 (0%) 1/50 (2%) 3/99 (3%) | |ADJUSTED (b) | 0.0% 0.0% 16.7% 12.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 0/35 (0%) 0/9 (0%) 0/1 (0%) 0/5 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 639 543 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.005 ** (e) P=0.136 P=0.040 * | |INCIDENTAL TUMOR | P=0.108 (e) P=0.718 P=0.453 | |LOGISTIC REGRESSION | P=0.018 * (e) P=0.313 P=0.084 | |COCHRAN-ARMITAGE | P=0.073 | |FISHER EXACT | (e) P=0.417 P=0.198 | |==============================================================================| | | |Liver | | Hepatocellular Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 19/70 (27%) 27/49 (55%) 19/50 (38%) 30/99 (30%) | |ADJUSTED (b) | 37.9% 91.1% 100.0% 93.2% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 0/0 0/0 0/0 | |TERMINAL (d) | 9/35 (26%) 7/9 (78%) 1/1 (100%) 4/5 (80%) | |FIRST INCIDENCE (DAYS) | 281 (I) 399 326 313 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.010 ** P=0.002 ** P=0.104 P=0.011 * | |LOGISTIC REGRESSION | P=0.073 P=0.002 ** P=0.127 P=0.129 | |COCHRAN-ARMITAGE | P=0.361N | |FISHER EXACT | P=0.002 ** P=0.144 P=0.394 | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 11/70 (16%) 14/49 (29%) 10/50 (20%) 18/99 (18%) | |ADJUSTED (b) | 26.0% 50.3% 74.6% 91.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 5/35 (14%) 1/9 (11%) 0/1 (0%) 4/5 (80%) | |FIRST INCIDENCE (DAYS) | 540 407 382 483 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.221 P=0.419N P=0.308N P=0.179 | |LOGISTIC REGRESSION | P=0.074 P=0.590 P=0.117 P=0.105 | |COCHRAN-ARMITAGE | P=0.516N | |FISHER EXACT | P=0.072 P=0.355 P=0.419 | |==============================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 11/70 (16%) 14/49 (29%) 11/50 (22%) 18/99 (18%) | |ADJUSTED (b) | 26.0% 50.3% 77.1% 91.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 5/35 (14%) 1/9 (11%) 0/1 (0%) 4/5 (80%) | |FIRST INCIDENCE (DAYS) | 540 407 382 483 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.240 P=0.419N P=0.370N P=0.179 | |LOGISTIC REGRESSION | P=0.077 P=0.590 P=0.389 P=0.105 | |COCHRAN-ARMITAGE | P=0.513N | |FISHER EXACT | P=0.072 P=0.260 P=0.419 | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 27/70 (39%) 33/49 (67%) 24/50 (48%) 37/99 (37%) | |ADJUSTED (b) | 52.4% 93.4% 100.0% 95.9% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 0/0 0/0 0/0 | |TERMINAL (d) | 13/35 (37%) 7/9 (78%) 1/1 (100%) 4/5 (80%) | |FIRST INCIDENCE (DAYS) | 281 (I) 399 326 313 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.049 * P=0.022 * P=0.431 P=0.081 | |LOGISTIC REGRESSION | P=0.077 P=0.002 ** P=0.122 P=0.104 | |COCHRAN-ARMITAGE | P=0.161N | |FISHER EXACT | P=0.002 ** P=0.200 P=0.500N | |==============================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 27/70 (39%) 33/49 (67%) 25/50 (50%) 37/99 (37%) | |ADJUSTED (b) | 52.4% 93.4% 100.0% 95.9% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 0/0 0/0 0/0 | |TERMINAL (d) | 13/35 (37%) 7/9 (78%) 1/1 (100%) 4/5 (80%) | |FIRST INCIDENCE (DAYS) | 281 (I) 399 326 313 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.054 P=0.022 * P=0.373 P=0.081 | |LOGISTIC REGRESSION | P=0.074 P=0.002 ** P=0.078 P=0.104 | |COCHRAN-ARMITAGE | P=0.160N | |FISHER EXACT | P=0.002 ** P=0.145 P=0.500N | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 18/70 (26%) 24/50 (48%) 26/50 (52%) 29/100 (29%) | |ADJUSTED (b) | 46.9% 94.3% 100.0% 89.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 15/35 (43%) 8/9 (89%) 1/1 (100%) 3/5 (60%) | |FIRST INCIDENCE (DAYS) | 572 399 344 327 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.056 P=0.006 ** P=0.007 ** P=0.036 * | |LOGISTIC REGRESSION | P=0.008 ** P=0.002 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.409N | |FISHER EXACT | P=0.010 * P=0.003 ** P=0.385 | |==============================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 6/70 (9%) 22/50 (44%) 16/50 (32%) 29/100 (29%) | |ADJUSTED (b) | 15.5% 89.5% 100.0% 90.8% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 5/35 (14%) 7/9 (78%) 1/1 (100%) 3/5 (60%) | |FIRST INCIDENCE (DAYS) | 281 (I) 481 392 241 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P=0.002 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.027 * | |FISHER EXACT | P<0.001 ** P=0.001 ** P<0.001 ** | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 22/70 (31%) 36/50 (72%) 32/50 (64%) 45/100 (45%) | |ADJUSTED (b) | 55.5% 100.0% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 18/35 (51%) 9/9 (100%) 1/1 (100%) 5/5 (100%) | |FIRST INCIDENCE (DAYS) | 281 (I) 399 344 241 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.297 | |FISHER EXACT | P<0.001 ** P<0.001 ** P=0.052 | |==============================================================================| | | |Mesentery | | Hemangioma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 0/70 (0%) 3/50 (6%) 0/50 (0%) 2/100 (2%) | |ADJUSTED (b) | 0.0% 26.1% 0.0% 40.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 0/35 (0%) 2/9 (22%) 0/1 (0%) 2/5 (40%) | |FIRST INCIDENCE (DAYS) | --- 651 --- 729 (T) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.005 ** P=0.008 ** (e) P=0.003 ** | |INCIDENTAL TUMOR | P=0.011 * P=0.028 * (e) P=0.003 ** | |LOGISTIC REGRESSION | P=0.023 * P=0.023 * (e) P=0.003 ** | |COCHRAN-ARMITAGE | P=0.456 | |FISHER EXACT | P=0.070 (e) P=0.345 | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 0/70 (0%) 0/50 (0%) 5/50 (10%) 10/100 (10%) | |ADJUSTED (b) | 0.0% 0.0% 33.1% 56.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 0/35 (0%) 0/9 (0%) 0/1 (0%) 2/5 (40%) | |FIRST INCIDENCE (DAYS) | --- --- 422 288 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.004 ** (e) P=0.213 P=0.009 ** | |LOGISTIC REGRESSION | P<0.001 ** (e) P=0.007 ** P=0.004 ** | |COCHRAN-ARMITAGE | P=0.002 ** | |FISHER EXACT | (e) P=0.011 * P=0.004 ** | |==============================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 1/70 (1%) 3/50 (6%) 9/50 (18%) 17/100 (17%) | |ADJUSTED (b) | 2.5% 21.4% 100.0% 63.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 0/35 (0%) 1/9 (11%) 1/1 (100%) 2/5 (40%) | |FIRST INCIDENCE (DAYS) | 652 584 401 288 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P=0.065 P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.003 ** P=0.431 P=0.058 P=0.023 * | |LOGISTIC REGRESSION | P<0.001 ** P=0.148 P<0.001 ** P=0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | |FISHER EXACT | P=0.195 P=0.002 ** P<0.001 ** | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 1/70 (1%) 3/50 (6%) 4/50 (8%) 8/100 (8%) | |ADJUSTED (b) | 2.5% 21.4% 100.0% 32.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 0/35 (0%) 1/9 (11%) 1/1 (100%) 1/5 (20%) | |FIRST INCIDENCE (DAYS) | 652 584 401 327 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P=0.065 P=0.003 ** P=0.002 ** | |INCIDENTAL TUMOR | P=0.057 P=0.431 P=0.223 P=0.254 | |LOGISTIC REGRESSION | P=0.030 * P=0.148 P=0.070 P=0.057 | |COCHRAN-ARMITAGE | P=0.066 | |FISHER EXACT | P=0.195 P=0.096 P=0.057 | |==============================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/70 (3%) 2/48 (4%) 1/49 (2%) 2/99 (2%) | |ADJUSTED (b) | 5.7% 15.3% 25.0% 40.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 2/35 (6%) 1/9 (11%) 0/1 (0%) 2/5 (40%) | |FIRST INCIDENCE (DAYS) | 729 (T) 650 664 729 (T) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.033 * P=0.257 P=0.171 P=0.058 | |INCIDENTAL TUMOR | P=0.083 P=0.413 P=0.500 P=0.058 | |LOGISTIC REGRESSION | P=0.115 P=0.383 P=0.446 P=0.058 | |COCHRAN-ARMITAGE | P=0.402N | |FISHER EXACT | P=0.538 P=0.632N P=0.550N | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |Zymbal's Gland | | Carcinoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 0/70 (0%) 1/50 (2%) 0/50 (0%) 4/100 (4%) | |ADJUSTED (b) | 0.0% 4.8% 0.0% 12.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 0/35 (0%) 0/9 (0%) 0/1 (0%) 0/5 (0%) | |FIRST INCIDENCE (DAYS) | --- 650 --- 429 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.004 ** P=0.372 (e) P=0.026 * | |INCIDENTAL TUMOR | P=0.048 * P=0.674 (e) P=0.347 | |LOGISTIC REGRESSION | P=0.019 * P=0.412 (e) P=0.069 | |COCHRAN-ARMITAGE | P=0.051 | |FISHER EXACT | P=0.417 (e) P=0.117 | |==============================================================================| | | |Zymbal's Gland | | Carcinoma or Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 1/70 (1%) 1/50 (2%) 0/50 (0%) 4/100 (4%) | |ADJUSTED (b) | 2.9% 4.8% 0.0% 12.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 1/35 (3%) 0/9 (0%) 0/1 (0%) 0/5 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 650 --- 429 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.011 * P=0.531 P=0.998N P=0.042 * | |INCIDENTAL TUMOR | P=0.092 P=0.750 P=0.998N P=0.414 | |LOGISTIC REGRESSION | P=0.059 P=0.625 P=0.998N P=0.153 | |COCHRAN-ARMITAGE | P=0.169 | |FISHER EXACT | P=0.662 P=0.583N P=0.314 | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |All Organs | | Hemangioma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 1/70 (1%) 4/50 (8%) 0/50 (0%) 4/100 (4%) | |ADJUSTED (b) | 2.9% 28.8% 0.0% 51.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 1/35 (3%) 2/9 (22%) 0/1 (0%) 2/5 (40%) | |FIRST INCIDENCE (DAYS) | 729 (T) 595 --- 595 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P=0.012 * P=0.998N P<0.001 ** | |INCIDENTAL TUMOR | P=0.016 * P=0.060 P=0.998N P=0.020 * | |LOGISTIC REGRESSION | P=0.013 * P=0.045 * P=0.998N P=0.010 ** | |COCHRAN-ARMITAGE | P=0.391 | |FISHER EXACT | P=0.096 P=0.583N P=0.314 | |==============================================================================| | | |All Organs | | Hemangiosarcoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 1/70 (1%) 17/50 (34%) 34/50 (68%) 26/100 (26%) | |ADJUSTED (b) | 2.9% 78.2% 100.0% 83.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 1/35 (3%) 5/9 (56%) 1/1 (100%) 2/5 (40%) | |FIRST INCIDENCE (DAYS) | 729 (T) 330 328 306 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.012 * P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.007 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 2/70 (3%) 20/50 (40%) 34/50 (68%) 28/100 (28%) | |ADJUSTED (b) | 5.7% 85.1% 100.0% 89.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 2/35 (6%) 6/9 (67%) 1/1 (100%) 3/5 (60%) | |FIRST INCIDENCE (DAYS) | 729 (T) 330 328 306 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.006 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.009 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | |==============================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 0/70 (0%) 5/50 (10%) 7/50 (14%) 4/100 (4%) | |ADJUSTED (b) | 0.0% 21.3% 43.0% 32.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 0/35 (0%) 0/9 (0%) 0/1 (0%) 1/5 (20%) | |FIRST INCIDENCE (DAYS) | --- 576 314 364 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.013 * P=0.006 ** P<0.001 ** P=0.005 ** | |INCIDENTAL TUMOR | P=0.406N P=0.171 P=0.160 P=0.080 | |LOGISTIC REGRESSION | P=0.211 P=0.011 * P=0.005 ** P=0.040 * | |COCHRAN-ARMITAGE | P=0.377 | |FISHER EXACT | P=0.011 * P=0.002 ** P=0.117 | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 4/70 (6%) 13/50 (26%) 15/50 (30%) 59/100 (59%) | |ADJUSTED (b) | 9.8% 46.8% 100.0% 80.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 1/35 (3%) 1/9 (11%) 1/1 (100%) 2/5 (40%) | |FIRST INCIDENCE (DAYS) | 511 208 217 159 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.003 ** P=0.297 P=0.153 P=0.038 * | |LOGISTIC REGRESSION | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | |FISHER EXACT | P=0.002 ** P<0.001 ** P<0.001 ** | |==============================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 4/70 (6%) 8/50 (16%) 8/50 (16%) 55/100 (55%) | |ADJUSTED (b) | 9.8% 32.4% 100.0% 69.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 1/35 (3%) 1/9 (11%) 1/1 (100%) 1/5 (20%) | |FIRST INCIDENCE (DAYS) | 511 208 217 159 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.640N P=0.521 P=0.192 | |LOGISTIC REGRESSION | P<0.001 ** P=0.064 P=0.013 * P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | |FISHER EXACT | P=0.062 P=0.062 P<0.001 ** | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |All Organs | | Benign Tumors | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 42/70 (60%) 41/50 (82%) 41/50 (82%) 56/100 (56%) | |ADJUSTED (b) | 81.5% 100.0% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 0/0 0/0 0/0 | |TERMINAL (d) | 26/35 (74%) 9/9 (100%) 1/1 (100%) 5/5 (100%) | |FIRST INCIDENCE (DAYS) | 281 (I) 399 326 306 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.006 ** P=0.020 * P=0.017 * P=0.005 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.004 ** P<0.001 ** P=0.001 ** | |COCHRAN-ARMITAGE | P=0.093N | |FISHER EXACT | P=0.008 ** P=0.008 ** P=0.359N | |==============================================================================| | | |All Organs | | Malignant Tumors | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 20/70 (29%) 43/50 (86%) 50/50 (100%) 98/100 (98%) | |ADJUSTED (b) | 43.3% 95.3% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/0 0/0 0/0 | |TERMINAL (d) | 10/35 (29%) 7/9 (78%) 1/1 (100%) 5/5 (100%) | |FIRST INCIDENCE (DAYS) | 281 (I) 208 217 159 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | |==============================================================================| DATE: 09/21/94 EXPERIMENT: 05134 TEST: 02 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- 1,3 BUTADIENE (BUTADIENE) TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | CONTROL 200 PPM 312 PPM 625 PPM | | | SE40 SE52 SE 26 | |==============================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 51/70 (73%) 49/50 (98%) 50/50 (100%) 98/100 (98%) | |ADJUSTED (b) | 90.8% 100.0% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 5/10 (50%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 0/0 0/0 0/0 | |TERMINAL (d) | 30/35 (86%) 9/9 (100%) 1/1 (100%) 5/5 (100%) | |FIRST INCIDENCE (DAYS) | 281 (I) 208 217 159 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.035 * P=0.105 P=0.198 P=0.137 | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | |==============================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 281 456 Female interim sacrifices(days): (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).